{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 333 sorted by section_id", "rows": [["21:21:5.0.1.1.14.2.1.1", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.101 Scope.", "FDA", "", "", "", "(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in \u00a7 330.1.\n\n(b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted."], ["21:21:5.0.1.1.14.2.1.2", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.103 Definitions.", "FDA", "", "", "[52 FR 47322, Dec. 11, 1987, as amended at 64 FR 403, Jan. 5, 1999]", "As used in this subpart:\n\nFirst aid antibiotic.  An antibiotic-containing drug product applied topically to the skin to help prevent infection in minor cuts, scrapes, and burns."], ["21:21:5.0.1.1.14.2.1.3", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.110 First aid antibiotic active ingredients.", "FDA", "", "", "[52 FR 47322, Dec. 11, 1987, as amended at 53 FR 18838, May 25, 1988; 64 FR 403, Jan. 5, 1999]", "The product consists of any of the following active ingredients within the specified concentration established for each ingredient and in the specified dosage form:\n\n(a) Bacitracin ointment containing, in each gram, 500 units of bacitracin in a suitable ointment base.\n\n(b) Bacitracin zinc ointment containing, in each gram, 500 units of bacitracin zinc in a suitable ointment base.\n\n(c) Chlortetracycline hydrochloride ointment containing, in each gram, 30 milligrams of chlortetracycline hydrochloride in a suitable ointment base.\n\n(d) Neomycin sulfate ointment containing, in each gram, 3.5 milligrams of neomycin in a suitable water soluble or oleaginous ointment base.\n\n(e) Neomycin sulfate cream containing, in each gram, 3.5 milligrams of neomycin in a suitable cream base.\n\n(f) Tetracycline hydrochloride ointment containing, in each gram, 30 milligrams of tetracycline hydrochloride in a suitable ointment base."], ["21:21:5.0.1.1.14.2.1.4", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.120 Permitted combinations of active ingredients.", "FDA", "", "", "[52 FR 47322, Dec. 11, 1987; 52 FR 48792, Dec. 24, 1987, as amended at 53 FR 18838, May 25, 1988; 55 FR 9722, Mar. 15, 1990; 55 FR 40381, Oct. 3, 1990; 55 FR 50172, Dec. 5, 1990; 64 FR 403, Jan. 5, 1999]", "The following combinations are permitted provided each active ingredient is present within the established concentration and in the specified dosage form, and the product is labeled in accordance with \u00a7 333.160.\n\n(a)  Combinations of antibiotic active ingredients.  (1) Bacitracin-neomycin sulfate ointment containing, in each gram, 500 units of bacitracin and 3.5 milligrams of neomycin in a suitable ointment base.\n\n(2) Bacitracin-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 500 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B;\n\n(3) Bacitracin-polymyxin B sulfate topical aerosol containing, in each gram, 500 units of bacitracin and 5,000 units of polymyxin B in a suitable vehicle, packaged in a pressurized container with suitable inert gases.\n\n(4) Bacitracin zinc-neomycin sulfate ointment containing, in each gram, 500 units of bacitracin and 3.5 milligrams of neomycin in a suitable ointment base.\n\n(5) Bacitracin zinc-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 400 units of bacitracin, 3 milligrams of neomycin, and 8,000 units of polymyxin B; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; or\n\n(iii) 500 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; or\n\n(iv) 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B;\n\n(6) Bacitracin zinc-polymyxin B sulfate ointment containing, in each gram, 500 units of bacitracin and 10,000 units of polymyxin B in a suitable ointment base.\n\n(7) Bacitracin zinc-polymyxin B sulfate topical aerosol containing, in each gram, 120 units of bacitracin and 2,350 units of polymyxin B in a suitable vehicle, packaged in a pressurized container with suitable inert gases.\n\n(8) Bacitracin zinc-polymyxin B sulfate topical powder containing, in each gram, 500 units of bacitracin and 10,000 units of polymyxin B in a suitable base.\n\n(9) Neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, 3.5 milligrams of neomycin and 5,000 units of polymyxin B in a suitable water miscible base.\n\n(10) Neomycin sulfate-polymyxin B sulfate cream containing, in each gram, 3.5 milligrams of neomycin and 10,000 units of polymyxin B in a suitable vehicle.\n\n(11) Oxytetracycline hydrochloride-polymyxin B sulfate ointment containing, in each gram, 30 milligrams of oxytetracycline and 10,000 units of polymyxin B in a suitable ointment base.\n\n(12) Oxytetracycline hydrochloride-polymyxin B sulfate topical powder containing, in each gram, 30 milligrams of oxytetracycline and 10,000 units of polymyxin B with a suitable filler.\n\n(b)  Combinations of first aid antibiotic active ingredients and local anesthetic active ingredients.  (1) Bacitracin ointment containing, in each gram, 500 units of bacitracin and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable ointment base.\n\n(2) Bacitracin-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 500 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient.\n\n(3) Bacitracin-polymyxin B sulfate topical aerosol containing, in each gram, 500 units of bacitracin and 5,000 units of polymyxin B and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable vehicle, packaged in a pressurized container with suitable inert gases.\n\n(4) Bacitracin zinc-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following:\n\n(i) 400 units of bacitracin, 3 milligrams of neomycin, 8,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(ii) 400 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(iii) 500 units of bacitracin, 3.5 milligrams of neomycin, 5,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient; or\n\n(iv) 500 units of bacitracin, 3.5 milligrams of neomycin, 10,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient;\n\n(5) Bacitracin zinc-polymyxin B sulfate ointment containing, in each gram, 500 units of bacitracin, 10,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable ointment base.\n\n(6) Neomycin sulfate-polymyxin B sulfate cream containing, in each gram, 3.5 milligrams of neomycin, 10,000 units of polymyxin B, and any single generally recognized as safe and effective amine or \u201ccaine\u201d-type local anesthetic active ingredient in a suitable vehicle."], ["21:21:5.0.1.1.14.2.1.5", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.150 Labeling of first aid antibiotic drug products.", "FDA", "", "", "[52 FR 47332, Dec. 11, 1987, as amended at 61 FR 58472, Nov. 15, 1996]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product as a \u201cfirst aid antibiotic.\u201d\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the following: \u201cFirst aid to help\u201d [select one of the following: \u201cprevent,\u201d (\u201cdecrease\u201d (\u201cthe risk of\u201d or \u201cthe chance of\u201d)), (\u201creduce\u201d (\u201cthe risk of\u201d or \u201cthe chance of\u201d)), \u201cguard against,\u201d or \u201cprotect against\u201d] [select one of the following: \u201cinfection,\u201d \u201cbacterial contamination,\u201d or \u201cskin infection\u201d] \u201cin minor cuts, scrapes, and burns.\u201d Other truthful and nonmisleading statements describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in \u00a7 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings\u201d:\n\n(1) \u201cFor external use only. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.\u201d\n\n(2)  For products containing chlortetracycline hydrochloride or tetracycline hydrochloride. \u201cStop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by doctor.\u201d\n\n(3)  For any product containing bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, and/or polymyxin B sulfate.  \u201cStop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use if you are allergic to any of the ingredients. Do not use longer than 1 week unless directed by a doctor.\u201d\n\n(d)  Directions.  The labeling of the product contains the following statements under the heading \u201cDirections\u201d: (1)  For ointment and cream products.  \u201cClean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.\u201d\n\n(2)  For powder products.  \u201cClean the affected area. Apply a light dusting of the powder on the area 1 to 3 times daily. May be covered with a sterile bandage.\u201d\n\n(3)  For aerosol products.  \u201cClean the affected area. Spray a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.\u201d\n\n(e) The word \u201cdoctor\u201d may be substituted for the word \u201cphysician\u201d in any of the labeling statements in this subpart."], ["21:21:5.0.1.1.14.2.1.6", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014First Aid Antibiotic Drug Products", "", "\u00a7 333.160 Labeling of permitted combinations of active ingredients.", "FDA", "", "", "", "Statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable.\n\n(a)  Statement of identity.  For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs.\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the indication(s) for each ingredient in the combination, as established in the \u201cIndications\u201d sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in \u00a7 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.\n\n(1)  For permitted combinations identified in \u00a7 333.120(a).  The indications in \u00a7 333.150 should be used.\n\n(2)  For permitted combinations identified in \u00a7 333.120(b).  In addition to the required indication identified in \u00a7 333.150, the labeling of the product may state, under the heading \u201cIndications,\u201d the following additional indication: \u201cFirst aid for the temporary relief of\u201d (select one of the following: \u201cpain,\u201d \u201cdiscomfort,\u201d \u201cpain or discomfort\u201d or \u201cpain and itching\u201d) \u201cin minor cuts, scrapes, and burns.\u201d\n\n(c)  Warnings.  The labeling of the product states, under the heading \u201cWarnings,\u201d the warning(s) for each ingredient in the combination, as established in the warnings sections of the applicable OTC drug monographs.\n\n(d)  Directions.  The labeling of the product states, under the heading \u201cDirections,\u201d directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs. When the time intervals or age limitations for administrations of the individual ingredients differ, the directions for the combination product may not exceed any maximum dosage limits established for the individual ingredients in the applicable OTC drug monograph."], ["21:21:5.0.1.1.14.3.1.1", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.201 Scope.", "FDA", "", "", "", "(a) An over-the-counter antifungal drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in \u00a7 330.1 of this chapter.\n\n(b) Reference in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted."], ["21:21:5.0.1.1.14.3.1.2", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.203 Definitions.", "FDA", "", "", "", "As used in this subpart:\n\n(a)  Antifungal.  A drug which inhibits the growth and reproduction of fungal cells and decreases the number of fungi present.\n\n(b)  Athlete's foot.  An infection of the feet caused by certain dermatophytic fungi.\n\n(c)  Dermatophyte.  A fungus that invades and lives upon the skin or in the hair or nails.\n\n(d)  Fungus.  Any of a large division of plants, including dermatophytes, yeasts, and molds, characterized by a simple cell structure and the absence of chlorophyll.\n\n(e)  Jock itch.  A chronic and recurrent infection caused by certain dermatophytic fungi; affects the upper, inner thighs and sometimes extends to the groin and the pubic area; the condition most frequently occurs in men, but may also occur in women.\n\n(f)  Ringworm.  A skin infection caused by certain dermatophytic fungi."], ["21:21:5.0.1.1.14.3.1.3", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.210 Antifungal active ingredients.", "FDA", "", "", "[58 FR 49898, Sept. 23, 1993, as amended at 67 FR 5943, Feb. 8, 2002]", "The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient:\n\n(a) Clioquinol 3 percent.\n\n(b) Haloprogin 1 percent.\n\n(c) Miconazole nitrate 2 percent.\n\n(d) Povidone-iodine 10 percent.\n\n(e) Tolnaftate 1 percent.\n\n(f) Undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent.\n\n(g) Clotrimazole 1 percent."], ["21:21:5.0.1.1.14.3.1.4", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.250 Labeling of antifungal drug products.", "FDA", "", "", "[58 FR 49898, Sept. 23, 1993, as amended at 65 FR 52305, Aug. 29, 2000]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product as an \u201cantifungal.\u201d\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the phrase listed in paragraph (b)(1)(i) of this section and may contain the additional phrase listed in paragraph (b)(1)(ii) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, may also be used, as provided in \u00a7 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.\n\n(1)  For products containing any ingredient identified in \u00a7 333.210 labeled for the treatment of athlete's foot, jock itch, and ringworm.  (i) (Select one of the following: \u201cTreats,\u201d \u201cFor the treatment of,\u201d \u201cFor effective treatment of,\u201d \u201cCures,\u201d \u201cFor the cure of,\u201d \u201cClears up,\u201d or \u201cProven clinically effective in the treatment of\u201d) \u201cmost\u201d (select one condition from any one or more of the following groups of conditions:\n\n(A) \u201cAthlete's foot,\u201d athlete's foot (dermatophytosis),\u201d \u201cathlete's foot (tinea pedis),\u201d or \u201ctinea pedis (athlete's foot)\u201d;\n\n(B) \u201cJock itch,\u201d \u201cjock itch (tinea cruris),\u201d or \u201ctinea cruris (jock itch)\u201d; or\n\n(C) \u201cRingworm,\u201d \u201cringworm (tinea corporis),\u201d or \u201ctinea corporis (ringworm).\u201d)\n\n(ii) In addition to the information identified in paragraph (b)(1)(i) of this section, the labeling of the product may contain the following statement: (Select one of the following: \u201cRelieves,\u201d \u201cFor relief of,\u201d \u201cFor effective relief of,\u201d or \u201cSoothes,\u201d) (select one or more of the following: \u201cItching,\u201d \u201cscaling,\u201d \u201ccracking,\u201d \u201cburning,\u201d \u201credness,\u201d \u201csoreness,\u201d \u201cirritation,\u201d \u201cdiscomfort,\u201d \u201cchafing associated with jock itch,\u201d \u201citchy, scaly skin between the toes,\u201d or \u201citching, burning feet\u201d).\n\n(2)  For products containing the ingredient identified in \u00a7 333.210(e) labeled for the prevention of athlete's foot.  (i) (Select one of the following: \u201cClinically proven to prevent,\u201d \u201cPrevents,\u201d \u201cProven effective in the prevention of,\u201d \u201cHelps prevent,\u201d \u201cFor the prevention of,\u201d \u201cFor the prophylaxis (prevention) of,\u201d \u201cGuards against,\u201d or \u201cPrevents the recurrence of\u201d) \u201cmost\u201d (select one of the following: \u201cAthlete's foot,\u201d \u201cathlete's foot (dermatophytosis),\u201d \u201cathlete's foot (tinea pedis),\u201d or \u201ctinea pedis (athlete's foot)\u201d) \u201cwith daily use.\u201d\n\n(ii) In addition to the information identified in paragraph (b)(2)(i) of this section, the labeling of the product may contain the following statement: \u201cClears up most athlete's foot infection and with daily use helps keep it from coming back.\u201d\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings\u201d:\n\n(1)  For products containing any ingredient identified in \u00a7 330.210.  (i) \u201cDo not use on children under 2 years of age unless directed by a doctor.\u201d\n\n(ii) \u201cFor external use only.\u201d\n\n(iii) \u201cAvoid contact with the eyes.\u201d\n\n(2)  For products labeled according to paragraph (b)(1) of this section for the treatment of athlete's foot and ringworm.  \u201cIf irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.\u201d\n\n(3)  For products labeled according to paragraph (b)(1) of this section for the treatment of jock itch.  \u201cIf irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.\u201d\n\n(4)  For products labeled according to paragraph (b)(2) of this section for the prevention of athlete's foot.  \u201cIf irritation occurs, discontinue use and consult a doctor.\u201d\n\n(5)  For products containing the ingredient identified in \u00a7 333.210(a) labeled according to paragraph (b)(1) of this section.  The following statements must appear in boldface type as the first warnings under the \u201cWarnings\u201d heading. (i) \u201cDo not use on children under 2 years of age.\u201d (This warning is to be used in place of the warning in paragraph (c)(1)(i) of this section.)\n\n(ii) \u201cDo not use for diaper rash.\u201d\n\n(d)  Directions.  The labeling of the product contains the following statements under the heading \u201cDirections\u201d:\n\n(1)  For products labeled according to paragraph (b)(1) of this section for the treatment of athlete's foot, jock itch, and ringworm.  [Select one of the following: \u201cClean\u201d or \u201cWash\u201d] \u201cthe affected area and dry thoroughly. Apply\u201d (the word \u201cspray\u201d may be used to replace the word \u201capply\u201d for aerosol products) \u201ca thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.\u201d\n\n(2)  For products labeled according to paragraph (b)(2) of this section for the prevention of athlete's foot.  \u201cTo prevent athlete's foot,\u201d (select one of the following: \u201cclean\u201d or \u201cwash\u201d) \u201cthe feet and dry thoroughly. Apply\u201d (the word \u201cspray\u201d may be used to replace the word \u201capply\u201d for aerosol products) \u201ca thin layer of the product to the feet once or twice daily (morning and/or night). Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.\u201d\n\n(e) The word \u201cphysician\u201d may be substituted for the word \u201cdoctor\u201d in any of the labeling statements in this section."], ["21:21:5.0.1.1.14.3.1.5", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Topical Antifungal Drug Products", "", "\u00a7 333.280 Professional labeling.", "FDA", "", "", "", "The labeling provided to health professionals (but not to the general public) may contain the following additional indication:\n\n(a)  For products containing haloprogin or miconazole nitrate identified in \u00a7 333.210 (a) and (c).  \u201cFor the treatment of superficial skin infections caused by yeast ( Candida albicans ).\u201d\n\n(b) [Reserved]"], ["21:21:5.0.1.1.14.4.1.1", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.301 Scope.", "FDA", "", "", "", "(a) An over-the-counter acne drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in \u00a7 330.1 of this chapter.\n\n(b) References in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted."], ["21:21:5.0.1.1.14.4.1.2", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.303 Definitions.", "FDA", "", "", "", "As used in this subpart:\n\n(a)  Acne.  A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes.\n\n(b)  Acne blemish.  A flaw in the skin resulting from acne.\n\n(c)  Acne drug product.  A drug product used to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads.\n\n(d)  Acne pimple.  A small, prominent, inflamed elevation of the skin resulting from acne.\n\n(e)  Blackhead.  A condition of the skin that occurs in acne and is characterized by a black tip.\n\n(f)  Whitehead.  A condition of the skin that occurs in acne and is characterized by a small, firm, whitish elevation of the skin."], ["21:21:5.0.1.1.14.4.1.3", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.310 Acne active ingredients.", "FDA", "", "", "[75 FR 9776, Mar. 4, 2010]", "The active ingredient of the product consists of any of the following:\n\n(a) Benzoyl peroxide, 2.5 to 10 percent.\n\n(b) Resorcinol, 2 percent, when combined with sulfur in accordance with \u00a7 333.320(a).\n\n(c) Resorcinol monoacetate, 3 percent, when combined with sulfur in accordance with \u00a7 333.320(b).\n\n(d) Salicylic acid, 0.5 to 2 percent.\n\n(e) Sulfur, 3 to 10 percent.\n\n(f) Sulfur, 3 to 8 percent, when combined with resorcinol or resorcinol monoacetate in accordance with \u00a7 333.320."], ["21:21:5.0.1.1.14.4.1.4", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.320 Permitted combinations of active ingredients.", "FDA", "", "", "[75 FR 9776, Mar. 4, 2010]", "(a) Resorcinol identified in \u00a7 333.310(b) may be combined with sulfur identified in \u00a7 333.310(f).\n\n(b) Resorcinol monoacetate identified in \u00a7 333.310(c) may be combined with sulfur identified in \u00a7 333.310(f)."], ["21:21:5.0.1.1.14.4.1.5", 21, "Food and Drugs", "I", "D", "333", "PART 333\u2014TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "D", "Subpart D\u2014Topical Acne Drug Products", "", "\u00a7 333.350 Labeling of acne drug products.", "FDA", "", "", "[56 FR 41019, Aug. 16, 1991, as amended at 75 FR 9776, Mar. 4, 2010]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product as an \u201cacne medication,\u201d \u201cacne treatment,\u201d \u201cacne medication\u201d (insert dosage form, e.g., \u201ccream,\u201d \u201cgel,\u201d \u201clotion,\u201d or \u201cointment\u201d), or \u201cacne treatment\u201d (insert dosage form, e.g., \u201ccream,\u201d \u201cgel,\u201d \u201clotion,\u201d or \u201cointment\u201d).\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\u201d the phrase listed in paragraph (b)(1) of this section and may contain any of the additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in \u00a7 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.\n\n(1) \u201cFor the\u201d (select one of the following: \u201cmanagement\u201d or \u201ctreatment\u201d) \u201cof acne.\u201d\n\n(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any one or more of the following statements:\n\n(i) (Select one of the following: \u201cClears,\u201d \u201cClears up,\u201d \u201cClears up most,\u201d \u201cDries,\u201d \u201cDries up,\u201d \u201cDries and clears,\u201d \u201cHelps clear,\u201d \u201cHelps clear up,\u201d \u201cReduces the number of,\u201d or \u201cReduces the severity of\u201d) (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d) which may be followed by \u201cand allows skin to heal.\u201d\n\n(ii) \u201cPenetrates pores to\u201d (select one of the following: \u201celiminate most,\u201d \u201ccontrol,\u201d \u201cclear most,\u201d or \u201creduce the number of\u201d) (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d).\n\n(iii) \u201cHelps keep skin clear of new\u201d (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d).\n\n(iv) \u201cHelps prevent new\u201d (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d) which may be followed by \u201cfrom forming.\u201d\n\n(v) \u201cHelps prevent the development of new\u201d (select one or more of the following: \u201cacne blemishes,\u201d \u201cacne pimples,\u201d \u201cblackheads,\u201d or \u201cwhiteheads\u201d).\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings\u201d:\n\n(1)  For products containing any ingredients identified in \u00a7 330.310.\n\n(i) The labeling states \u201cFor external use only.\u201d\n\n(ii) The labeling states \u201cWhen using this product [bullet] skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.\u201d\n\n(2)  For products containing sulfur identified in \u00a7 333.310(e) and (f).\n\n(i) The labeling states \u201cDo not use on [bullet] broken skin [bullet] large areas of the skin.\u201d\n\n(ii) The labeling states \u201cWhen using this product [bullet] apply only to areas with acne.\u201d\n\n(3)  For products containing any combination identified in \u00a7 333.320.  (i) The labeling states \u201cWhen using this product [bullet] rinse right away with water if it gets in eyes.\u201d\n\n(ii) The labeling states \u201cStop use and ask a doctor [bullet] if skin irritation occurs or gets worse.\u201d\n\n(4)  For products containing benzoyl peroxide identified in \u00a7 333.310(a).\n\n(i) The labeling states \u201cDo not use if you [bullet] have very sensitive skin [bullet] are sensitive to benzoyl peroxide.\u201d\n\n(ii) The labeling states \u201cWhen using this product [bullet] avoid unnecessary sun exposure and use a sunscreen [bullet] avoid contact with the eyes, lips, and mouth [bullet] avoid contact with hair and dyed fabrics, which may be bleached by this product [bullet] skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.\u201d\n\n(iii) The labeling states \u201cStop use and ask a doctor if [bullet] irritation becomes severe.\u201d\n\n(d)  Directions.  The labeling of the product contains the following information under the heading \u201cDirections\u201d:\n\n(1)  For products applied containing any ingredient identified in \u00a7 333.310.  The labeling states \u201c[bullet] clean the skin thoroughly before applying this product [bullet] cover the entire affected area with a thin layer one to three times daily [bullet] because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor [bullet] if bothersome dryness or peeling occurs, reduce application to once a day or every other day.\u201d\n\n(2)  For products applied and left on the skin containing benzoyl peroxide identified in \u00a7 333.310(a).\n\n(i) The labeling states the directions in paragraph (d)(1) of this section.\n\n(ii) The labeling states \u201c[bullet] if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.\u201d\n\n(3)  For products applied and removed from the skin containing any ingredient identified in \u00a7 333.310.  Products, such as soaps and masks, may be applied and removed and should include appropriate directions. All products containing benzoyl peroxide should include the directions in paragraph (d)(2)(ii) of this section.\n\n(4)  Optional directions.  In addition to the required directions in paragraphs (d)(1) and (d)(2) of this section, the product may contain the following optional labeling: \u201c Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated (select one of the following: \u2018elsewhere on this label,\u2019 \u2018above,\u2019 or \u2018below\u2019).\u201d"], ["33:33:3.0.1.1.27.1.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "A", "Subpart A\u2014Purpose and Policy", "", "\u00a7 333.1 Purpose and policy.", "USACE", "", "", "", "(a) The purpose of these procedures is to integrate the National Environmental Policy Act (NEPA) into the U.S. Army Corps of Engineers' (Corps) decision-making processes for evaluating applications from other, non-Corps entities for authorization by the Corps. Specifically, the procedures: describe the process by which a District or Division Engineer determines what actions are subject to NEPA's procedural requirements and the applicable level of NEPA review; ensure that relevant environmental information is identified and considered early in the process in order to ensure informed decision making; enable District Engineers to conduct coordinated, consistent, predictable and timely environmental reviews; reduce unnecessary burdens and delays; and implement NEPA's mandates regarding lead and cooperating agency roles, page and time limits, and sponsor preparation of environmental documents.\n\n(b) This part sets forth the Corps procedures and practices for implementing NEPA when considering Department of the Army permit applications under 33 U.S.C. 1344 (Clean Water Act, section 404); 33 U.S.C. 401 (Rivers and Harbors Act of 1899, section 9); 33 U.S.C. 403 (Rivers and Harbors Act of 1899, section 10); and 33 U.S.C. 1413 (Marine Protection, Research, and Sanctuaries Act of 1972, section 103) and requests for permission under 33 U.S.C. 408 (Rivers and Harbors Act of 1899, section 14). The Regulatory Program of the Corps implements 33 U.S.C. 1344, 33 U.S.C. 401, and 33 U.S.C. 1413 and references to the Regulatory Program in this part refer to the processing of permit applications under those authorities. As used in this part, \u201cpermit\u201d means an authorization under any of the authorities in this paragraph, and \u201capplication\u201d means any request for authorization under any of the above identified authorities. This part further explains the Corps' interpretation of certain key terms in NEPA. It does not, nor does it intend to, govern the rights and obligations of any party outside the government. It does, however, establish the procedures under which Corps District Engineers will typically fulfill requirements under NEPA for decisions under the authorities in this paragraph. The responsibilities of the District Engineer, as described in this part, may be elevated to a higher authority consistent with existing delegations and authorities and in such cases the role of the District Engineer described in the part will be assumed by the entity with decision making authority.\n\n(c) Consultation with the Council on Environmental Quality (\u201cCEQ\u201d). In addition to the process for establishing or revising categorical exclusions set forth in \u00a7 333.14(b) and (d), the Corps will consult with CEQ while developing or revising their proposed NEPA implementing procedures, in accord with NEPA section 102(2)(B), 42 U.S.C. 4332(B)."], ["33:33:3.0.1.1.27.1.1.2", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "A", "Subpart A\u2014Purpose and Policy", "", "\u00a7 333.2 Applicability.", "USACE", "", "", "", "(a)  Applicability.  This Part applies to all Corps elements processing applications for Department of the Army Permits or requests for permission under the authorities listed in 33 CFR 333.1(b).\n\n(b)  Authority.  NEPA imposes certain procedural requirements on the exercise of the Corps' existing legal authority in relevant circumstances. Nothing contained in these procedures is intended or should be construed to limit the Corps' other authorities or legal responsibilities."], ["33:33:3.0.1.1.27.2.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.11 Determining when NEPA applies.", "USACE", "", "", "", "District Engineers will determine that NEPA does not apply to a proposed agency permitting action when:\n\n(a) The activities or decision do not result in final agency action under the Administrative Procedure Act, 5 U.S.C. 704, or any other relevant statute that includes a finality requirement;\n\n(b) The proposed activity or decision is exempted from NEPA by law;\n\n(c) Compliance with NEPA would clearly and fundamentally conflict with the requirements of another provision of law;\n\n(d) In circumstances where Congress by statute has prescribed decisional criteria with sufficient completeness and precision such that the Corps retains no residual discretion to alter its action based on the consideration of environmental factors, then that function of the Corps is nondiscretionary within the meaning of NEPA section 106(a)(4) and/or section 111(10)(B)(vii) (42 U.S.C. 4336(a)(4) and 4336e(10)(B)(vii), respectively), and NEPA does not apply to the action in question;\n\n(e) The proposed action is an action for which another statute's requirements serve the function of agency compliance with the Act; or\n\n(f) The proposed action is not a \u201cmajor Federal action,\u201d which is defined at 42 U.S.C. 4336e(10). Additionally, the terms \u201cmajor\u201d and \u201cFederal action\u201d each have independent force. NEPA applies only when both of these two criteria are met. Such a determination is specific to the facts and circumstances of each individual situation and is reserved to the judgment of the District Engineer in each instance. In addition to the illustrative general categories in NEPA section 111(10), 42 U.S.C. 4336e(10), the Corps has determined that the following non-exhaustive list of Corps activities related to the Regulatory Program and 33 U.S.C. 408 are presumptively not subject to NEPA as not meeting the definition of a major Federal action:\n\n(1) Preliminary Jurisdictional Determinations;\n\n(2) Approved Jurisdictional Determinations;\n\n(3) Determination of whether an activity requires a Corps permit or permission;\n\n(4) Aquatic resource delineation concurrence or non-concurrence determinations; or\n\n(5) Determination that the modification of unimproved real estate of a project would not affect the function and usefulness of the project.\n\n(g) NEPA does not apply to \u201cnon-Federal actions.\u201d Therefore, under the terms of the statute, NEPA does not apply to actions with no or minimal Federal funding, or with no or minimal Federal involvement where a Federal agency cannot control the outcome of the project. NEPA \u00a7 111(10)(B)(i), 42 U.S.C. 4336e(10)(B)(i). A but-for causal relationship is insufficient to make the Corps responsible for a particular action under NEPA.\n\n(h) The issuance or update of the Corps' NEPA procedures is not subject to NEPA review.\n\n(i) In determining whether NEPA applies to a proposed action, the Corps will consider only the project at hand."], ["33:33:3.0.1.1.27.2.1.2", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.12 Determine the appropriate level of NEPA review.", "USACE", "", "", "", "(a) If the District Engineer determines under \u00a7 333.11 that NEPA applies to a proposed activity or decision, the District Engineer will then determine the appropriate level of NEPA review in the following sequence and manner. At all steps in the following process, the Corps will consider the proposed activity and  its  effects.\n\n(1) If the Corps has established, or adopted pursuant to NEPA section 109, 42 U.S.C. 4336c, a categorical exclusion that covers the proposed activity, the District Engineer will analyze whether to apply the categorical exclusion to the proposed activity and apply the categorical exclusion, if appropriate, pursuant to \u00a7 333.14(e).\n\n(2) If another agency has already established a categorical exclusion that covers the proposed activity, the District Engineer will consider whether to recommend that the Headquarters, U.S. Army Corps of Engineers adopt that exclusion pursuant to \u00a7 333.14(c) so that it can be applied to the proposed activity at issue, and so that Headquarters may consider applying to future activities of that type.\n\n(3) If the proposed activity warrants the establishment of a new categorical exclusion, or the revision of an existing categorical exclusion, pursuant to \u00a7 333.14(b), the Chief of Engineers will consider whether to so establish or revise, and then apply the categorical exclusion to the proposed action pursuant to \u00a7 333.14(e).\n\n(4) If the District Engineer cannot apply a categorical exclusion to the proposed activity consistent with paragraphs (a)(1)-(3), the District Engineer will determine the appropriate level of review,  i.e.,  whether the proposed activity warrants preparation of an environmental assessment or an environmental impact statement. Most activities requiring a Corps permit that are not otherwise covered by a categorical exclusion normally require only an environmental assessment. In determining the level of review, the District Engineer will consider the proposed action's reasonably foreseeable effects consistent with paragraph (b), and then will:\n\n(i) develop an environmental assessment, as described in \u00a7 333.15, if the proposed activity is not likely to have reasonably foreseeable significant effects or the significance of the effects is unknown; or\n\n(ii) develop an environmental impact statement, as described in \u00a7 333.21, if the proposed activity is likely to have reasonably foreseeable significant effects.\n\n(b) When considering whether the reasonably foreseeable effects of the proposed activity are significant, the District Engineer will analyze the potentially affected environment and degree of the effects of the activity within their jurisdiction or control. The District Engineer may use any reliable data source, but will not undertake new research of any type unless it is essential to evaluating alternatives and the cost and time of obtaining it are not unreasonable. District Engineers should not determine that a proposed activity is significant based solely on public interest or opposition.\n\n(1) In considering the potentially affected environment, the District Engineer may consider, as appropriate to the specific activity, the affected area (national, regional, or local) and its resources. The District Engineer may, as appropriate, consider the regulated activity's effect on factors such as conservation, economics, aesthetics, general environmental concerns, wetlands, historic properties, fish and wildlife values, flood hazards, floodplain values, land use, navigation, shore erosion and accretion, recreation, water supply and conservation, water quality, energy needs, safety, food and fiber production, mineral needs, considerations of property ownership and, in general, the needs and welfare of the people.\n\n(2) In considering the degree of the effects, the District Engineer may consider the following, as appropriate to the specific action:\n\n(i) Both short- and long-term effects.\n\n(ii) Both beneficial and adverse effects.\n\n(iii) Effects on public health and safety.\n\n(iv) Economic effects."], ["33:33:3.0.1.1.27.2.1.3", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.13 NEPA and agency decision-making.", "USACE", "", "", "", "(a)  Process.  The District Engineer will consider input received in response to the public notice, where public notice is required by the legal authority governing the proposed activity for which authorization is sought, advising interested parties of the proposed activity for which authorization is sought when determining the environmental effects that should be considered in the NEPA analysis. District Engineers will promote efficiency through the adoption or incorporation of existing applicable EAs and EISs and other relevant environmental analysis to the extent practicable. Information developed through the NEPA process will inform the District Engineer's decision on the permit application or request for permission.\n\n(b)  Limitations on actions during the NEPA process.  Except as provided in paragraph (c) of this section, until the Corps issues a record of decision or a finding of no significant impact, or makes a categorical exclusion determination, as applicable, the permit applicant should take no action concerning their application that would:\n\n(1) have an adverse environmental effect within an area under the jurisdiction of the Corps; or\n\n(2) limit the choice of reasonable alternatives.\n\n(c) If the Corps is considering an application from a non-Federal entity and becomes aware that the applicant is about to take an action within the Corps' jurisdiction that would meet either of the criteria in \u00a7 333.13(b), the Corps will promptly notify the applicant that the Corps will take appropriate action to ensure that the objectives and procedures of NEPA are achieved.\n\n(d)  Coordination with the Applicant.\n\n(1) The District Engineer will:\n\n(i) Coordinate at the earliest reasonable time in the application review process to inform the applicant what information the District Engineer might need to comply with NEPA and, if the lead agency, establish a schedule for completing steps in the NEPA review process, consistent with NEPA's statutory deadlines and any internal agency NEPA schedule requirements; and\n\n(ii) Begin the NEPA process by determining whether NEPA applies, as described in \u00a7 333.11, and if it does, determine the appropriate level of NEPA review, as described in \u00a7 333.12, as soon as practicable after receiving the complete application\n\n(2) The District Engineer may require the applicant to furnish appropriate information that the District Engineer considers necessary for the preparation of an EA or EIS. An applicant or a contractor hired by the applicant may prepare an environmental assessment or environmental impact statement under the District Engineer's supervision. The Corps procedures for applicant-prepared environmental assessments and environmental impact statement are included in \u00a7 333.51 of this part."], ["33:33:3.0.1.1.27.2.1.4", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.14 Categorical exclusions.", "USACE", "", "", "", "(a)  Generally.  This section describes the process the Corps uses for establishing and revising categorical exclusions, for adopting other agencies' categorical exclusions, and for applying categorical exclusions to a proposed agency action. The Corps categorical exclusions, including Corps categorical exclusions specifically applicable to evaluating applications from other entities for authorization by the Corps established consistent with its NEPA procedures, any legislative categorical exclusions, and categorical exclusions adopted from other agencies, are listed in paragraph (g) in this section.\n\n(b)  Establishing and revising categorical exclusions.  To establish or revise a categorical exclusion, the Chief of Engineers will determine that the category of actions normally does not significantly affect the quality of the human environment. In making this determination, the Headquarters, U.S. Army Corps of Engineers will:\n\n(1) Develop a written record containing information to substantiate its determination;\n\n(2) Consult with CEQ on its proposed categorical exclusion, including the written record, for a period not to exceed 30 days prior to providing public notice as described in paragraph (b)(3) of this section;\n\n(3) Provide public notice in the  Federal Register  of the Corps' establishment or revisions of the categorical exclusion and where the record is available; and\n\n(4) Document the establishment or revision of the categorical exclusion in the Corps' implementing procedures at \u00a7 333.14(g).\n\n(c)  Adopting categorical exclusions from other Federal agencies.  (1) Consistent with NEPA section 109, 42 U.S.C. 4336c, the Corps may adopt a categorical exclusion listed in another agency's NEPA procedures. When adopting a categorical exclusion, the Headquarters, U.S. Army Corps of Engineers, in coordination with any recommending Districts, will:\n\n(i) Identify the categorical exclusion listed in another agency's NEPA procedures that covers its category of proposed or related actions;\n\n(ii) Consult with the agency that established the categorical exclusion to ensure that the proposed adoption of the categorical exclusion is appropriate;\n\n(iii) Provide public notification of the categorical exclusion that the Corps is adopting, including a brief description of the proposed action or category of proposed actions to which the Corps intends to apply the adopted categorical exclusion; and\n\n(iv) Document the adoption of the categorical exclusion in the Corps' implementing procedures at \u00a7 333.14(g).\n\n(2) The Corps may rely on another agency's determination that a categorical exclusion applies to a specific proposed activity if the specific activity covered by the original categorical exclusion determination and the Corps' proposed regulatory activity are substantially the same. For the Corps, actions occurring at essentially the same time and place are considered substantially the same when a proposed action would result in a categorical exclusion determination by one agency and an environmental assessment and a finding of no significant impact by another agency. For example, this would be the case when another agency's action may be a funding decision for a proposed project covered by a categorical exclusion established by the funding agency, and the Corps' proposed regulatory action is to consider a permit for construction activities with less than significant adverse environmental effects for that same project. When relying on another agency's determination that a categorical exclusion applies to a specific proposed Corps regulatory activity, the District Engineer will document the reliance on the agency's categorical exclusion determination in the administrative record for the proposal under Corps review.\n\n(d)  Removal of categorical exclusions.  The Assistant Secretary of the Army for Civil Works must approve the removal of a categorical exclusion from \u00a7 333.14(g) and, in coordination with the Corps, will:\n\n(1) Develop a written justification for the removal;\n\n(2) Consult with CEQ on its proposed removal of the categorical exclusion, including a description of the rationale for the removal, for a period not to exceed 30 days prior to providing public notice as described in paragraph (d)(3) of this section;\n\n(3) Provide public notice of the Corps' removal of the categorical exclusion and a summary of the justification in the  Federal Register ; and\n\n(4) Document the removal of the categorical exclusion in the Corps' implementing procedures at \u00a7 333.14(g).\n\n(e)  Applying categorical exclusions.  (1) If the District Engineer determines that a categorical exclusion covers a proposed agency action, they should evaluate the presence of extraordinary circumstances where normally excluded actions could have reasonably foreseeable significant environmental effects. If an extraordinary circumstance is not present, the District Engineer will determine that the categorical exclusion applies to the proposed agency action and conclude review.\n\n(2) If an extraordinary circumstance is present, the District Engineer will determine that the categorical exclusion applies to the proposed agency action and conclude review if the permit applicant modifies the proposed agency action to avoid those effects or if the District Engineer determines that, notwithstanding the extraordinary circumstance, the proposed action is not likely to result in reasonably foreseeable significant effects. If the District Engineer determines that they cannot apply the categorical exclusion to the proposed action, the District Engineer will prepare an environmental assessment or environmental impact statement, as appropriate.\n\n(3) In cases where a single action's constituent parts are covered by multiple categorical exclusions, the District Engineer may conclude the entire action is categorically excluded when there are no extraordinary circumstances present that are likely to result in reasonably foreseeable significant effects, or there are extraordinary circumstances present, but the District Engineer determines that applying a categorical exclusion is appropriate consistent with paragraph (e)(2) of this section.\n\n(4) Documentation of categorical exclusion determinations. The District Engineer will document its evaluation of the applicability of a categorical exclusion in the statement of findings supporting the permit or permission decision.\n\n(5) The documentation of evaluation of the applicability of a categorical exclusion does not have a prescribed format but should briefly address consideration of any potential extraordinary circumstances and any mitigation measures that reduce the level of impact. The level of analysis should reflect the sensitivity of the resources being impacted and the scale of the activity.\n\n(f)  Reliance on categorical exclusion determinations of other agencies.  The District Engineer may also rely on another agency's determination that a categorical exclusion applies to a particular proposed activity if the agency action covered by that determination and the proposed activity are substantially the same. The District Engineer will document its reliance on another agency's categorical exclusion determination in the statement of findings supporting the permit or permission decision.\n\n(g)  List of categorical exclusions.  The following activities normally do not significantly affect the quality of the human environment t and are therefore categorically excluded from NEPA documentation:\n\n(1) For permit applications for Clean Water Act, Section 404, River and Harbors Act of 1899, Section 10, and Marine Protection, Research, and Sanctuaries Act of 1972, section 103:\n\n(i) Fixed or floating small private piers, small docks, boat hoists and boathouses.\n\n(ii) Minor utility distribution and collection lines including irrigation;\n\n(iii) Minor maintenance dredging using existing disposal sites;\n\n(iv) Boat launching ramps;\n\n(v) All applications which qualify as letters of permission (as described at 33 CFR 325.5(b)(2)).\n\n(2) In addition to those listed for other permit applications in this section, the District Engineer can rely on the categorical exclusions at 33 CFR 230.9 for requests for permission under 33 U.S.C. 408."], ["33:33:3.0.1.1.27.2.1.5", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.15 Environmental assessments.", "USACE", "", "", "", "(a)  Generally.  If an activity is subject to NEPA, as determined following the procedures in \u00a7 333.11, and unless the District Engineer finds that the proposed activity is excluded from having to prepare an environmental assessment or environmental impact statement pursuant to a categorical exclusion as determined following the procedures in \u00a7 333.14, or by another provision of law, the District Engineer will prepare an environmental assessment with respect to the proposed activity that does not have a reasonably foreseeable significant effect on the quality of the human environment, or if the significance of such effect is unknown. District Engineers must follow Congress' direction that environmental assessments are to be \u201cconcise.\u201d NEPA section 106(b)(2); 42 U.S.C. 4336(b)(2). The environmental assessment should normally be combined with any other required documents including Clean Water Act, section 404(b)(1) guidelines documentation, any applicable public interest review, any statement of findings, a finding of no significant impact or a determination that an environmental impact statement is required. Environmental assessment as used throughout this part normally refers to this combined document. When the environmental assessment is a separate document, it must be completed prior to completion of the statement of finding. The District Engineer may delegate the signing of the NEPA document. Should the environmental assessment demonstrate that an environmental impact statement is necessary, the District Engineer shall follow the procedures outlined in subpart C of this part. In those cases where an environmental impact statement is required, an environmental assessment is not required. However, the District Engineer must document their reasons for requiring an environmental impact statement.\n\n(b)  Elements.  For the purpose of providing evidence and analysis for determining whether to prepare an environmental impact statement or a finding of no significant impact, environmental assessments will:\n\n(1) Briefly discuss the:\n\n(i) Purpose and need for the proposed activity based on the Corps' statutory authority. The purpose and need for the proposed activity will also be informed by the applicant's goals (See 33 CFR 333.22 for considerations in developing purpose and need);\n\n(ii) Alternatives to the extent required by NEPA section 102(2)(H), 42 U.S.C. 4332(2)(H).\n\n(A) If the EA confirms that the impact of the applicant's proposal is not significant and there are no unresolved conflicts concerning alternative uses of available resources, and, for activities evaluated under section 404 of the Clean Water Act, the proposed activity is a \u201cwater dependent\u201d activity as defined in 40 CFR 230.10(a)(3), the EA need not include a discussion on alternatives.\n\n(B) In all other cases where the district engineer determines that there are unresolved conflicts concerning alternative uses of available resources, the EA shall include a discussion of the reasonable alternatives which are to be considered. The decision options available to the Corps, which embrace all of the applicant's alternatives, are issue the permit, issue with modifications, or deny the permit. Modifications are limited to those project modifications within the scope of established permit conditioning policy (see 33 CFR 325.4) or within the scope of authority under Section 408. The decision option to deny the permit results in the \u201cno action\u201d alternative ( i.e.  no activity requiring a Corps permit).\n\n(iii) The reasonably foreseeable effects of the proposed activity and the alternatives considered.\n\n(iv) The combined document shall conclude with a finding of no significant impact or a determination that an environmental impact statement is required.\n\n(c)  Agency actions normally requiring an environmental assessment.  Most permits or permissions under the authorities identified in \u00a7 333.1(b) normally require environmental assessments, but likely do not require an environmental impact statement.\n\n(d)  Page limits.  (1) The text of an environmental assessment is strictly prohibited from exceeding 75 pages, not including citations or appendices.\n\n(2) Appendices are to be used for voluminous materials, such as scientific tables, collections of data, statistical calculations, and the like, which substantiate the analysis provided in the environmental assessment. Appendices are not to be used to provide additional substantive analysis, because that would circumvent the Congressionally mandated page limits.\n\n(3) Environmental assessments will be formatted for an 8.5\u201dx11\u201d page with one-inch margins using a word processor with 12-point proportionally spaced font, single spaced. Footnotes may be in 10-point font. Such size restrictions do not apply to explanatory maps, diagrams, graphs, tables, and other means of graphically displaying quantitative or geospatial information, although pages containing such material do count towards the page limit. When an item of graphical material is larger than 8.5\u201dx11\u201d, each such item will count as one page.\n\n(4) Certification related to page limits. The breadth and depth of analysis in an environmental assessment will be tailored to ensure that the environmental analysis does not exceed this page limit. As part of the finalization of the environmental assessment, the District Engineer will certify (and the certification will be incorporated into the environmental assessment) that the District Engineer has considered the factors mandated by NEPA; that the environmental assessment represents the Corps' good-faith effort to prioritize documentation of the most important considerations required by the statute within the congressionally mandated page limits; that this prioritization reflects the District Engineer's expert judgment; and that any considerations addressed briefly or left unaddressed were, in the District Engineer's judgment, comparatively not of a substantive nature that meaningfully informed the consideration of environmental effects and the resulting decision on how to proceed.\n\n(e)  Deadlines.  (1) NEPA is governed by a rule of reason. Congress supplied the measure of that reason in the 2003 revision of NEPA by setting the deadlines in NEPA 107(g), 42 U.S.C. 4336a(g). These deadlines indicate Congress's determination that an agency has presumptively spent a reasonable amount of time on analysis and the document should issue, absent very unusual circumstances. In such circumstances, an extension will be given only for such time as is  necessary  to complete the analysis. Thus, unless otherwise specified in statute, the District Engineer will complete the environmental assessment not later than the date that is one year after the date on which they determine the preparation of an environmental assessment for the proposed activity is required. The District Engineer will typically make this decision at the start of the comment period for the public notice of the permit application, request for permission, or proposed general permit.\n\n(2) The end date is either:\n\n(i)When the District Engineer reaches a permit decision and initially proffers the permit to the applicant or provides permission to the requestor under 33 U.S.C. 408;\n\n(ii) When the District Engineer denies the permit or denies permission under 33 U.S.C. 408 with or without prejudice; or\n\n(iii) When the District Engineer publishes a general permit or categorical permission; or\n\n(iv) When the District Engineer reaches a decision on the mitigation instrument and provides the bank or in-lieu fee program sponsor with an instrument signed by the Corps.\n\n(3) The District Engineer may publish notification of the environmental assessment (unless the deadline is extended pursuant to the provision below), within a reasonable time after the deadline elapses or the completion of the document, whichever comes first.\n\n(4) Deadline extensions. If the District Engineer determines they are not able to meet the deadline prescribed by NEPA section 107(g)(1)(B), 42 U.S.C. 4336a(g)(1)(B), they must consult with the applicant pursuant to NEPA section 107(g)(2), 42 U.S.C. 4336a(g)(2). After such consultation, if needed, and for cause stated, the District Engineer may establish a new deadline. Cause for establishing a new deadline is only established if the environmental assessment is so incomplete, at the time at which the District Engineer determines it is not able to meet the statutory deadline, that issuance pursuant to \u00a7 333.15(e)(3) above would, in the Corps' view, result in an inadequate analysis. Such new deadline must provide only so much additional time as is necessary to complete such environmental assessment. The District Engineer will document in the administrative record for the proposed action the new deadline the reason why the environmental assessment was not able to be completed under the statutory deadline and whether the applicant consented to the new deadline.\n\n(5) Certification related to deadline. When the environmental assessment is complete, the District Engineer will certify (and the certification will be incorporated into the environmental assessment) that the resulting environmental assessment represents the Corps' good-faith effort to fulfill NEPA's requirements within the Congressional timeline; that such effort is substantially complete; that, in the District Engineer's expert opinion, they have thoroughly considered the factors mandated by NEPA; and that, in the District Engineer's judgment, the analysis contained therein is adequate to inform and reasonably explain the District Engineer's final decision regarding the proposed Federal activity."], ["33:33:3.0.1.1.27.2.1.6", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.16 Findings of no significant impact.", "USACE", "", "", "", "(a) The District Engineer will prepare a finding of no significant impact if the District Engineer determines, based on the environmental assessment, not to prepare an environmental impact statement because the proposed activity will not have significant effects. The finding of no significant impact will:\n\n(1) Be included in the environmental assessment;\n\n(2) Document the reasons why the District Engineer has determined that the selected alternative will not have a significant effect on the quality of the human environment;\n\n(3) If the District Engineer finds no significant effects based on mitigation, the mitigated finding of no significant impact will state any mitigation requirements enforceable by the agency or voluntary mitigation commitments that will be undertaken by the applicant to avoid significant effects;\n\n(4) Identify any other documents related to the finding of no significant impact; and\n\n(5) State that the District Engineer will not prepare an environmental impact statement, concluding the NEPA process for that permit application, request for permission, or mitigation instrument.\n\n(b) The District Engineer may publish notification of the environmental assessment and finding of no significant impact on a public website."], ["33:33:3.0.1.1.27.2.1.7", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.17 Lead and cooperating agencies.", "USACE", "", "", "", "(a)  Corps as lead agency.  In many instances, a proposed activity or decision is undertaken in the context which entails activities or decisions undertaken by other Federal agencies ( e.g.,  where multiple Federal authorizations are required with respect to a project sponsor's overall purpose and goal). These activities and decisions may be \u201crelated actions,\u201d in that they are each the responsibility of a particular agency and they may be all related in a matter relevant to NEPA,  e.g.,  by their relationship with one overarching project. In such instances, Congress has provided that the multiple agencies involved shall determine which of them will be the lead agency pursuant to the criteria identified in NEPA section 107(a)(1)(A), 42 U.S.C. 4336a(a)(1)(A), or any other applicable statute. When serving as the lead agency, the Corps is responsible for managing the NEPA process, including those portions of a non-Federal applicant's proposed project which come under the jurisdiction of other Federal agencies. When serving as the lead agency, the Corps will also determine and document the scope of analysis. When a joint lead relationship is established pursuant to NEPA section 107(a)(1)(B), 42 U.S.C. 4336a(a)(1)(B), the Corps and the other joint lead agency or agencies are collectively responsible for completing the NEPA process. The Corps may reimburse, under agreement, staff support from other Federal agencies beyond the immediate jurisdiction of those agencies.\n\n(b)  Corps as cooperating agency.  As a cooperating agency the Corps will be responsible to the lead agency for providing environmental information which is directly related to the regulatory matter involved and which is required for the preparation of the NEPA documentation. This in no way shall be construed as lessening the District Engineer's ability to request the applicant to furnish appropriate information as discussed in \u00a7 333.51 of this part. The District Engineer will identify to the lead agency the information and analysis that is required to be included in the resulting NEPA documentation so that it can be relied on by the Corps for purposes of exercising its permitting authority. When the Corps is a cooperating agency because of a regulatory responsibility, the district engineer should make available staff support at the lead agency's request to enhance the latter's interdisciplinary capability provided the request pertains to the Corps regulatory action covered by the NEPA document, to the extent this is practicable. Beyond this, Corps staff support will generally be made available to the lead agency to the extent practicable within its own responsibility and available resources. Any assistance to a lead agency beyond this will normally be by written agreement with the lead agency providing for the Corps expenses on a cost reimbursable basis. If the District Engineer believes a public hearing should be held and another agency is lead agency, the District Engineer should request such a hearing and provide their reasoning for the request. The District Engineer should suggest a joint hearing and offer to take an active part in the hearing and ensure coverage of the Corps concerns. When the applicant's proposed activities qualify for an existing general permit or categorical permission, the Corps' obligations under NEPA were satisfied when the Corps issued the general permit or categorical permission. On this basis, Corps contributions as a cooperating agency on an environmental impact statement or environmental assessment should be limited to assisting the lead agency with accurate information pertaining to the proposed impacts under Corps authorities."], ["33:33:3.0.1.1.27.2.1.8", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "B", "Subpart B\u2014NEPA and General Concepts", "", "\u00a7 333.18 Notices of intent and scoping.", "USACE", "", "", "", "(a)  Notice of intent.  As soon as practicable after determining that a proposed activity for which Corps authorization is sought is sufficiently developed to allow for meaningful public comment and requires an environmental impact statement, the District Engineer will publish a notice of intent to prepare an environmental impact statement.\n\n(1) The notice of intent for an environmental impact statement will include a request for public comment on alternatives or effects and on relevant information, studies, or analyses with respect to the proposed agency action.\n\n(2) In addition to a request for comment required for notices of intent for environmental impact statements, notice of intent for any environmental document may include:\n\n(i) The purpose and need for the proposed action;\n\n(ii) A preliminary description of the proposed action and alternatives the environmental impact statement will consider;\n\n(iii) A brief summary of expected effects;\n\n(iv) Anticipated permits and other authorizations ( i.e.,  anticipated related actions);\n\n(v) A schedule for the decision-making process;\n\n(vi) A description of the public scoping process, including any scoping meeting(s);\n\n(vii) Contact information for the project manager handling the permit application, who can answer questions about the proposed action and the environmental impact statement; and\n\n(viii) Identification of any cooperating and participating agencies ( i.e.,  agencies responsible for related actions), and any information that such agencies require in the notice to facilitate their decisions or authorizations\n\n(b)  Scoping.  In addition to the notice of intent process described above, the District Engineer may also use other early and open processes to determine the scope of issues for analysis in an environmental document, including substantive issues that meaningfully inform the consideration of environmental effects and the resulting decision on how to proceed, eliminating from further study non-substantive issues, and determining whether connected actions should be addressed in the same environmental document. Scoping may begin as soon as practicable after the proposal for action is sufficiently developed for consideration. Scoping may include appropriate pre-application procedures, public meetings, or work conducted prior to publication of the notice of intent.\n\n(c)  Scope of analysis.  It is the exclusive responsibility of the District Engineer to determine the appropriate scope of analysis for the applicant's proposed activity based on the Corps' legal authority over the activity and whether the Corps has sufficient control and responsibility over any aspect of the applicant's proposed activity beyond the Corps' limited statutory authorities. When determining the scope of an environmental assessment or an environmental impact statement, the District Engineer must consider the following:\n\n(1) In some situations, a permit applicant may propose to conduct a specific activity requiring a Department of the Army (DA) permit ( e.g.,  construction of a pier in a navigable water of the United States), which is merely one component of a larger project ( e.g.,  construction of an oil refinery on an upland area). The district engineer should establish the scope of the Corps' NEPA review to address the impacts of the specific activity requiring a DA permit or 33 U.S.C. 408 permission and those portions of the entire project over which the district engineer has sufficient control, responsibility, and legal authority to warrant Federal review.\n\n(2) The District Engineer is considered to have control, responsibility, and legal authority for portions of the project beyond the limits of Corps jurisdiction where the Federal involvement is sufficient to turn an essentially private action into a Federal action, consistent with Congress's exclusions from the definition of \u201cmajor Federal action\u201d at NEPA Section 111(10) and the Supreme Court's holding in  Seven County  that NEPA does not require an agency to analyze effects from actions beyond the action the agency itself is taking or authorizing.. These are cases where the environmental consequences of the larger project are essentially products of the Corps permit or 33 U.S.C. 408 permission action. Typical factors to be considered in determining whether sufficient control, responsibility, and legal authority exist to turn an essentially private action occurring outside of Corps jurisdiction into a Federal action include:\n\n(i) Whether or not the regulated activity comprises merely a link in a corridor type project ( e.g.,  a transportation or utility transmission project).\n\n(ii) Whether there are aspects of the upland facility in the immediate vicinity of the regulated activity which affect the location and configuration of the regulated activity.\n\n(iii) The extent to which the entire project will be within Corps jurisdiction.\n\n(iv) The extent of cumulative Federal control, responsibility, and legal authority.\n\n(A) Federal control, responsibility, and legal authority will include the portions of the project beyond the limits of Corps jurisdiction where the cumulative Federal involvement of the Corps and other Federal agencies is sufficient to grant legal control over such additional portions of the project. These are cases where the environmental consequences of the additional portions of the projects are essentially products of Federal financing, assistance, direction, regulation, or approval (not including funding assistance solely in the form of general revenue sharing funds, with no Federal agency control over the subsequent use of such funds, and not including judicial or administrative civil or criminal enforcement actions).\n\n(B) In determining whether sufficient cumulative Federal involvement exists to expand the scope of Federal action the district engineer should consider whether other Federal agencies are required to take Federal action under their statutory authorities, and/or other environmental review laws and executive orders.\n\n(C) The District Engineer should also refer to \u00a7 333.17 of this part for guidance on determining whether the Corps should be the lead or a cooperating agency in these situations.\n\n(3) Examples:\n\n(i) If a non-Federal oil refinery, electric generating plant, or industrial facility is proposed to be built on an upland site and the only DA permit or 33 U.S.C. 408 permission requirement relates to a connecting pipeline, supply loading terminal, or fill road, that pipeline, terminal or fill road permit, in and of itself, normally would not constitute sufficient overall Federal involvement with the project to justify expanding the scope of a Corps NEPA document to cover upland portions of the facility beyond the structures in the immediate vicinity of the regulated activity that would affect the location and configuration of the regulated activity.\n\nSimilarly, if an applicant seeks a DA permit to fill waters or wetlands or 33 U.S.C. 408 permission to alter a covered project on which other construction or work is proposed, the control, responsibility, and legal authority of the Corps, as well as its overall Federal involvement, would extend to the portions of the project to be located on the permitted fill or within the boundary of the project covered by 33 U.S.C. 408. However, the NEPA review would be extended to the entire project, including portions outside waters of the United States or the project area covered by 33 U.S.C. 408, only if sufficient Federal control, responsibility, and legal authority over the entire project is determined to exist; that is, if the regulated activities, and those activities involving regulation, funding, etc., by other Federal agencies, comprise a substantial portion of the overall project. In any case, once the scope of analysis has been defined, the NEPA analysis for that action should include the effects or impacts from the proposed action or alternatives on all Federal interests within the purview of the NEPA statute. The District Engineer should, whenever practicable, incorporate by reference and rely upon the reviews of other Federal, State, Tribal, and local agencies.\n\n(ii) For those regulated activities that comprise merely a link in a transportation or utility transmission project, the scope of analysis should address the Federal action,  i.e.,  the specific activity requiring a DA permit or 33 U.S.C. 408 permission and any other portion of the project that is within the control, responsibility, and legal authority of the Corps of Engineers (or other Federal agencies).\n\nFor example, a 50-mile electrical transmission cable crossing a 1 \n 1/4  mile-wide river that is a navigable water of the United States requires a DA permit. Neither the origin nor the destination of the cable, nor its route to and from the navigable water, except as the route applies to the location and configuration of the crossing, are within the control, responsibility, or legal authority of the Corps. Those matters would not be included in the Corps' scope of analysis which, in this case, would address the impacts of the specific cable crossing.\n\nAs another example, the same 50-mile electrical transmission cable crossing a Corps civil works project requires a 33 U.S.C. 408 permission. As with the previous example, neither the origin nor the destination of the cable, nor its route to and from the civil works project, except as the route applies to the location and configuration of the crossing within the civil works project, are within the control, responsibility, or legal authority of the Corps. Those matters would not be included in the Corps' scope of analysis which, in this case, would address the impacts of the specific cable crossing on the Corps civil works project.\n\nConversely, for those activities that require a DA permit or 33 U.S.C. 408 permission for a major portion of a transportation or utility transmission project, such that the Corps permit or 33 U.S.C. 408 permission bears upon the origin and destination as well as the route of the project outside the Corps regulatory boundaries (including those covered by 33 U.S.C. 408), the scope of analysis should include those portions of the project outside the boundaries of the Corps jurisdiction. To use the same example, if 30 miles of the 50-mile transmission line would cross jurisdictional wetlands, other \u201cwaters of the United States,\u201d or Corps civil works boundaries covered by 33 U.S.C. 408, the scope of analysis should reflect impacts of the whole 50-mile transmission line.\n\n(iii) For those activities that require a DA permit for a major portion of a shoreside facility, the scope of analysis should extend to upland portions of the facility. For example, a shipping terminal normally requires dredging, wharves, bulkheads, berthing areas, and disposal of dredged material in order to function. Permits for such activities are normally considered sufficient Federal control, responsibility, and legal authority to warrant extending the scope of analysis to include the upland portions of the facility.\n\n(4) In all cases, the scope of analysis used for analyzing both impacts and alternatives should be the same scope of analysis used for analyzing the benefits of a proposal.\n\n(5) In preparing the environmental assessment or environmental impact statement, the District Engineer will focus its analysis on whether the environmental effects of the regulated activity are significant.\n\n(i) Similarly, the District Engineer will document in the environmental assessment or environmental impact statement where and how it drew a reasonable and manageable line relating to its consideration of any environmental effects from the regulated activity that extend outside the geographical territory of the project or might materialize later in time.\n\n(ii) To the extent it assists in reasoned decision-making, the District Engineer may, but is not required to by NEPA, analyze environmental effects from other projects separate in time, or separate in place, or that fall outside of the Corps' regulatory authority, or that would have to be initiated by a third party. If the District Engineer determines that such analysis would assist it in reasoned decisionmaking, it will document this determination in the environmental assessment and explain where it drew a reasonable and manageable line relating to the consideration of such effects from such separate projects."], ["33:33:3.0.1.1.27.3.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.20 Significance determination.", "USACE", "", "", "", "(a)  General.  Prior to initiating an environmental impact statement, the District Engineer must determine the proposed activity is likely to have reasonably foreseeable significant effects on the quality of the human environment, after consideration of any mitigation the Corps may require. As described in \u00a7 333.12(a)(5)(i) and \u00a7 333.15 of this part, this determination can be made following the completion of an environmental assessment in cases where that environmental assessment cannot conclude in a finding of no significant impact; in other situations, it can be made without first preparing an environmental assessment in instances where initial consideration as to the appropriate level of review as described indicates that the proposed activity is likely to have reasonably foreseeable significant effects. In cases where it is obvious that the proposed activity is likely to result in reasonably foreseeable significant effects and an environmental assessment terminating in a finding of no significant impact is therefore not prepared, the District Engineer must make a determination that an environmental impact statement is required due to the likely significant effects of the activity. This determination will be made in accordance with \u00a7 333.12(b) and documented. Whether an impact rises to the level of significant is a matter of the District Engineer's expert judgment.\n\n(b)  Timing.  The determination to prepare an environmental impact statement should be made as soon as the Corps has sufficient information to consider on whether the project would result in significant effects on the human environment, after consideration of any mitigation the Corps would require. In many cases this is soon after the receipt of a complete DA permit application or request for permission, although in some cases a determination may not be made until after an environmental assessment has been prepared. After a determination has been made to prepare an environmental impact statement as the lead agency, the Corps will notify the applicant in writing as soon as practicable."], ["33:33:3.0.1.1.27.3.1.10", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.29 Review of other agencies' environmental impact statements.", "USACE", "", "", "", "District Engineers should provide comments directly to the requesting agency specifically related to the Corps jurisdiction by law or special expertise. If the District Engineer determines that another agency's environmental impact statement which involves a Corps permit or permission action is inadequate with respect to the Corps permit or permission action, the district engineer should attempt to resolve the differences concerning the Corps permit or permission action prior to the filing of the environmental impact statement by the other agency."], ["33:33:3.0.1.1.27.3.1.2", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.21 Preparation of environmental impact statements.", "USACE", "", "", "", "(a) During the process of preparing an environmental impact statement, the District Engineer:\n\n(1) Will contact all appropriate Federal agencies to determine their respective role(s),  i.e.,  that of lead agency or cooperating agency consistent with \u00a7 333.17 of this part.\n\n(2) Will obtain the comments of:\n\n(i) Any Federal agency that has specific statutory jurisdiction or special expertise identified in statute with respect to any environmental impact involved or is authorized to develop and enforce environmental standards. The District Engineer shall only consider comments directly tied to the commenting Federal agency's specific statutory jurisdiction or special expertise identified in statute and relevant to impacts or issues within the scope of analysis as determined by the District Engineer. The District Engineer shall only include those comments in the permit or 33 U.S.C. 408 permission administrative file and record.\n\n(ii) Appropriate State, Tribal, and local agencies that are authorized to develop and enforce environmental standards.\n\n(3) May request the comments of:\n\n(i) State, Tribal, or local governments that may be affected by the proposed action;\n\n(ii) Any Federal agency that has requested it receive statements on actions of the kind proposed to the extent the comments are directly tied to that agency's statutory jurisdiction or special expertise as identified in statute;\n\n(iii) The applicant, and\n\n(iv) The public, including by affirmatively soliciting comments in a manner designed to inform those persons or organizations who may be interested in or affected by the proposed action.\n\n(b) This process of obtaining and requesting comments pursuant to paragraph (a) of this section may be undertaken at any time that is reasonable in the process of preparing the environmental impact statement. The District Engineer will ensure the process of obtaining and request comments pursuant to paragraph (a) of this part, and the District Engineers' analysis of and response to those comments, does not cause the Corps to violate the congressionally mandated deadline for completion of an environmental impact statement.\n\n(c) The District Engineer will address any substantive and significant comments received consistent with paragraph (a) of this section in the environmental impact statement. Such responses to comments will be documented and may include:\n\n(1) Modifying alternatives, including the proposed activity.\n\n(2) Developing and evaluating alternatives not previously given serious consideration.\n\n(3) Supplementing, improving, or modifying analyses, to include consideration of science or literature not previously considered.\n\n(4) Making factual corrections.\n\n(5) No action needed. The agency may provide a brief rationale for taking no action, such as:\n\n(i) The comment is outside the scope of what is being proposed;\n\n(ii) There is no cause-effect relationship between the actions the agency is proposing and the issue raised and/or recommendation made;\n\n(iii) The commenter misinterpreted the information provided; or\n\n(iv) The recommendation made does not comply with applicable laws or regulations and/or are not feasible to implement (technically or economically), etc.\n\n(d) In those instances in which the District Engineer solicits comments from the public, the request for comments will provide clear instructions on how comments should be submitted, including electronic submission, and the dates during which comments will be accepted. The solicitation of comments should include requests for comments on specific questions or issues or for information that would be helpful in informing the District Engineer's decision.\n\n(e) If the District Engineer determines that an environmental impact statement is not required after a notice of intent has been published, the District Engineer shall terminate the environmental impact statement preparation and withdraw the notice of intent. The District Engineer shall notify in writing the appropriate Division Engineer; Headquarters U.S. Army Corps of Engineers; any appropriate federal agencies; and the public of the determination."], ["33:33:3.0.1.1.27.3.1.3", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.22 Purpose and need.", "USACE", "", "", "", "(a) The statement will include the purpose and need for the proposed agency action based on the Corps' statutory authority and independent judgment. The purpose and need for the proposed agency action must be informed by the goals of the applicant. The applicant may provide a statement of the purpose and need from their perspective, but the District Engineer will exercise independent judgment in defining the purpose and need for the project.\n\n(b) If the scope of analysis for the NEPA document (see \u00a7 333.18(b) of this part) covers only the proposed specific activity requiring a Department of the Army permit or 33 U.S.C. 408 permission, then the underlying purpose and need for that specific activity should be stated. (For example, \u201cThe purpose and need for the pipe is to obtain cooling water from the river for the electric generating plant.\u201d)\n\n(c) If the scope of analysis covers a more extensive project, only part of which may require a DA permit or 33 U.S.C. 408 permission, then the underlying purpose and need for the entire project should be stated. (For example, \u201cThe purpose and need for the electric generating plant is to provide increased supplies of electricity to the (named) geographic area.\u201d)"], ["33:33:3.0.1.1.27.3.1.4", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.23 Analysis within the environmental impact statement.", "USACE", "", "", "", "(a) The Corps is neither an opponent nor proponent of the applicant's proposal; therefore, the applicant's final proposal will be identified as the \u201capplicant's preferred alternative\u201d in the final EIS. Decision options available to the District Engineer, which embrace all of the applicant's alternatives, are issue the permit, issue with modifications or conditions, or deny the permit.\n\n(b) The environmental impact statement will include a detailed statement on:\n\n(1) Reasonably foreseeable environmental effects of the applicant's preferred alternative;\n\n(2) Any reasonably foreseeable adverse environmental effects which cannot be avoided should the applicant's preferred alternative be implemented;\n\n(3) A reasonable range of alternatives to the applicant's preferred alternative, including an analysis of any negative environmental impacts of not implementing the applicant's preferred alternative in the case of a no action alternative.\n\n(i) Only reasonable alternatives need be considered in detail. Reasonable alternatives must be those that are, in the District Engineer's expert judgment, technically, legally, and economically feasible and such feasibility must focus on the accomplishment of the underlying purpose and need.\n\n(ii) The alternatives analysis should be thorough enough to use the 404(b)(1) guidelines (40 CFR part 230) where applicable.\n\n(iii) Those alternatives that are unavailable to the applicant, whether or not they require Federal action (permits), should normally be included in the analysis of the no-Federal-action (denial) alternative.\n\n(iv) The EIS should discuss geographic alternatives,  e.g.,  changes in location and other site-specific variables, and functional alternatives,  e.g.,  project substitutes and design modifications.\n\n(v) The \u201cno-action\u201d alternative is one which results in no construction requiring a Corps permit or permission. It may be brought by either the applicant electing to modify their proposal to eliminate work under the jurisdiction of the Corps or by the denial of the permit or permission. District engineers, when evaluating this alternative, should discuss, when appropriate, the consequences of other likely uses of a project site, should the permit be denied.\n\n(4) The relationship between local short-term uses of man's environment and the maintenance and enhancement of long-term productivity; and\n\n(5) Any irreversible and irretrievable commitments of Federal resources which would be involved in the proposed agency action should it be implemented; and\n\n(6) Any means identified to mitigate adverse environmental effects of the proposed action. (To note, NEPA itself does not require or authorize the Corps to impose any mitigation measures); and\n\n(7) Such alternatives should be evaluated only to the extent necessary to allow a complete and objective evaluation and a fully informed decision regarding the permit application or request for permission.\n\n(b) Environmental impact statements will discuss effects in proportion to their significance. With respect to issues that are not of a substantive nature and do not meaningfully inform the consideration of environmental effects and the resulting decision on how to proceed, there will be no more than the briefest possible discussion to explain why those issues are not substantive and therefore not worthy of any further analysis. Environmental impact statements will be analytic, concise, and no longer than necessary to comply with NEPA in light of the congressionally mandated page limits and deadlines.\n\n(c) The District Engineer will not include a cost-benefit analysis for projects requiring a Corps permit or permission, but may indicate any cost considerations relevant to the permit decision or 33 U.S.C. 408 permission decision."], ["33:33:3.0.1.1.27.3.1.5", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.24 Page limits.", "USACE", "", "", "", "(a)  Page limits.  Except as provided in paragraph (b) of this section, the text of an environmental impact statement will not exceed 150 pages, not including citations or appendices.\n\n(b) An environmental impact statement for a proposed agency action of extraordinary complexity is strictly prohibited from not exceeding 300 pages, not including any citations or appendices. The District Engineer will determine at the earliest possible stage of preparation of an environmental impact statement whether the conditions for exceeding the page limit in paragraph (a) of this section are present. Factors that may indicate extraordinary complexity include: a geographically expansive project that affects multiple resource types; numerous alternatives that must be considered; involves a long time period for implementation; impacts multiple sensitive resources; involve authorization decisions by multiple agencies.\n\n(c) Appendices are to be used for voluminous materials, such as scientific tables, collections of data, statistical calculations, and the like, which substantiate the analysis provided in the environmental assessment. Appendices are not to be used to provide additional substantive analysis, because that would circumvent the Congressionally mandated page limits.\n\n(d)  Format.  Environmental impact statements will be formatted for 8.5\u201dx11\u201d paper with one-inch margins using a word processor with 12-point proportionally spaced font, single spaced. Footnotes may be in 10-point font. Such size restrictions do not apply to explanatory maps, diagrams, graphs, tables, and other means of graphically displaying quantitative or geospatial information. When an item of graphical material is larger than 8.5\u201dx11\u201d, each such item will count as one page.\n\n(e)  Certification related to page limits.  The breadth and depth of analysis in an environmental impact statement will be tailored to ensure that the environmental impact statement does not exceed these page limits. In this regard, as part of the finalization of the environmental impact statement, a responsible official will certify that the Corps has considered the factors mandated by NEPA; that the environmental impact statement represents the Corps' good-faith effort to prioritize documentation of the most important considerations required by the statute within the congressionally mandated page limits; that this prioritization reflects the District Engineer's expert judgment; and that any considerations addressed briefly or left unaddressed were, in the District Engineer's judgment, comparatively unimportant or frivolous."], ["33:33:3.0.1.1.27.3.1.6", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.25 Deadlines.", "USACE", "", "", "", "(a) NEPA is governed by a \u201crule of reason.\u201d Congress supplied the measure of that reason in the 2023 revision of NEPA by settling the deadlines in NEPA 107(g), 42 U.S.C. 4336a(g). These deadlines indicate Congress's determination that an agency, working with Congress's allocation of resources has presumptively spent a reasonable amount of time on analysis and the document should issue, absent very unusual circumstances. In such circumstances, an extension will be given only for such time as is  necessary  to complete the analysis. Thus, unless otherwise specified in statute, the District Engineer will complete the environmental impact statement not later than the date that is two years after the date on which the District Engineer determines that the activity requires the issuance of an environmental impact statement.\n\n(b) The end date is either:\n\n(1) When the District Engineer reaches a decision and initially proffers the permit to the applicant or provides the requestor 33 U.S.C. 408 permission; or\n\n(2) When the District Engineer denies the permit or denies permission under 33 U.S.C. 408 with or without prejudice.\n\n(c) The District Engineer will publish the environmental impact statement.\n\n(d) If the District Engineer determines they are not able to meet the deadline prescribed by NEPA section 107(g)(1)(A), 42 U.S.C. 4336a(g)(1)(A), they must consult with the applicant pursuant to NEPA section 107(g)(2), 42 U.S.C. 4336a(g)(2). After such consultation, if needed, and for cause stated, the District Engineer may establish a new deadline and must notify the Division Engineer and Headquarters, U.S. Army Corps of Engineers of the deadline extension. Cause for establishing a new deadline is only established if the environmental impact statement is so incomplete, at the time at which the District Engineer determines they are not able to meet the statutory deadline, that issuance pursuant to paragraph (c) of this section above would, in the District Engineer's view, result in an inadequate analysis. Such new deadline must provide only so much additional time as is necessary to complete such environmental impact statement. The District Engineer will document in the administrative record for the proposed action the new deadline, the reason why the environmental impact statement was not able to be completed under the statutory deadline, when the District Engineer consulted with the applicant on the new deadline, and whether the applicant consented to the new deadline.\n\n(e) When the environmental impact statement is published, the District Engineer will certify (and the certification will be incorporated into the environmental impact statement) that the resulting environmental impact statement represents the Corps' good-faith effort to fulfill NEPA's requirements within the Congressional timeline; that such effort is substantially complete; and that, in the District Engineer's expert opinion, they have thoroughly considered the factors mandated by NEPA; and that, in the District Engineer's judgment, the analysis contained therein is adequate to inform and reasonably explain the District Engineer's decision regarding the proposed Federal activity. ."], ["33:33:3.0.1.1.27.3.1.7", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.26 Publication of the environmental impact statement.", "USACE", "", "", "", "The District Engineer will publish the entire environmental impact statement on a publicly available website. During the process of preparing the environmental impact statement, the District Engineer may publish a draft statement or other materials that in their judgment may assist in fulfilling their NEPA responsibilities."], ["33:33:3.0.1.1.27.3.1.8", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.27 Public hearing.", "USACE", "", "", "", "If a public hearing is to be held pursuant to 33 CFR part 327, or any other authority, for a permit application requiring an environmental impact statement, the actions analyzed by the environmental impact statement should be considered at the public hearing. The District Engineer can, but need not, make a draft of the environmental impact statement available to the public and, in instances where the District Engineer does so, should do so at least 15 days in advance of the hearing. If a hearing request is received from another agency having jurisdiction over an element of the applicant's activity, the district engineer should coordinate a joint hearing with that agency whenever appropriate."], ["33:33:3.0.1.1.27.3.1.9", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "C", "Subpart C\u2014Environmental Impact Statements", "", "\u00a7 333.28 Comments received on an environmental impact statement.", "USACE", "", "", "", "For permit applications or requests for permissions to be decided at the district level, the District Engineer should consider incoming comments and provide responses in the environmental impact statement when substantive issues are raised. For permit applications or requests for permissions to be decided at a higher authority, the District Engineer shall forward any comment letters together with appropriate responses to the higher authority."], ["33:33:3.0.1.1.27.4.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.31 Tiered and programmatic environmental documents.", "USACE", "", "", "", "(a) Activities that require Corps authorization under 33 U.S.C. 1344, 33 U.S.C. 401, 33 U.S.C. 403, and 33 U.S.C. 1413 are reviewed (and when applicable, permitted) on a site-specific basis based upon an application containing a complete description of the proposed activity, and all activities which the applicant plans to undertake which are reasonably related to the same project and for which a Corps permit will be required. See 33 CFR 325.1(d)(1)-(2). However, only for reviews of activities under 33 U.S.C. 408, the District Engineer may prepare tiered environmental documents when conducting multi-phased reviews of proposed alterations or in other appropriate circumstances. Multi-phased reviews under 33 U.S.C. 408 evaluate proposed alterations in multiple successive iterations of progressively greater detail. Each successive review must be accompanied by a NEPA document that considers the potential impacts of the alteration at the level of detail of the given phase of review to help inform the development of the proposed alteration. The analysis in each environmental document will reflect the level of planning in each tier. For example, the first tier may consider the differing impacts of selecting different sites for the alteration, the second tier may consider different project configurations, and the final tier may consider the impacts from different construction methods. Each successive analysis should build off the previous analysis, formally incorporating the prior environmental documents.\n\n(b) After completing a programmatic environmental assessment or environmental impact statement for a review under 33 U.S.C. 408, the District Engineer may rely on that document for 5 years if there are not substantial new circumstances or information about the significance of adverse effects that bear on the analysis. After 5 years, as long as the District Engineer reevaluates the analysis in the programmatic environmental document and any underlying assumption to ensure reliance on the analysis remains valid and briefly documents its reevaluation and explains why the analysis remains valid considering any new and substantial information or circumstances, the District Engineer may continue to rely on the document."], ["33:33:3.0.1.1.27.4.1.2", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.32 Reliance on existing environmental documents.", "USACE", "", "", "", "(a)  Generally.  The District Engineer may rely on an environmental impact statement, environmental assessment, or portion thereof, provided that the statement, assessment, or portion thereof meets the standards for an adequate statement or assessment under these procedures. When relying on an environmental impact statement, environmental assessment, or portion thereof, the District Engineer will cite, briefly describe the content and relevance to the environmental document, and may make modifications that are necessary to render the relied-upon document, or portion thereof, fit for fulfilling NEPA's analytic requirements for the action. If the District Engineer finds that the other agency's environmental impact statement or environmental assessment is inadequate with respect to the Corps permit or permission action, the District Engineer should incorporate the other agency's NEPA document or a portion thereof and prepare an appropriate and adequate NEPA document to address the Corps involvement with the proposed action.\n\n(b)  Substantial similarity.  (1) If the actions covered by the original environmental impact statement or environmental assessment and the proposed action are substantially the same, the District Engineer will document their reliance on the statement or assessment.\n\n(2) If the actions are not substantially the same, the District Engineer may modify the statement or assessment as necessary to render the statement fit for fulfilling NEPA's analytic requirements for the action at hand, and document the reliance on the statement or assessment, as modified, or may incorporate relevant portions in the District Engineer's own NEPA document. Where appropriate, the District Engineer may solicit comment to the extent that solicitation of comment will assist the District Engineer in expeditiously adapting the relied-upon statement or assessment so that it is fit for the District Engineer's purposes."], ["33:33:3.0.1.1.27.4.1.3", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.33 Incorporation.", "USACE", "", "", "", "The District Engineer may incorporate material, such as planning studies, analyses, or other relevant information, into environmental documents by reference when the effect will be to cut down on bulk without impeding the Corps review of the action. When incorporating material by reference, the District Engineer will cite, briefly describe the content and relevance to the environmental document, and make the materials reasonably available for review by potentially interested parties. The District Engineer will not use incorporation as a means to evade the statutory page limits."], ["33:33:3.0.1.1.27.4.1.4", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.34 Supplements to environmental documents.", "USACE", "", "", "", "The District Engineer will prepare supplements to environmental documents only if a major Federal action remains to occur, and:\n\n(a) The applicant makes substantial changes to the proposed action that are relevant to environmental concerns; or\n\n(b) The District Engineer decides, in their discretion, that there are substantial significant new circumstances or information about the significance of the adverse effects that bear on the proposed action or its effects."], ["33:33:3.0.1.1.27.4.1.5", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.35 Integrity and completeness of information.", "USACE", "", "", "", "(a) The District Engineer will not undertake new scientific and technical research to inform their analyses unless that is essential to a reasoned choice among alternatives and the overall costs and time frame of such undertaking are not unreasonable. Rather, the District Engineer will make use of reliable existing data and resources.\n\n(b) When the District Engineer is evaluating an action's reasonably foreseeable effects on the human environment, and there is incomplete or unavailable information that cannot be obtained at a reasonable cost or the means to obtain it are unknown, the District Engineer will make clear in the relevant environmental document that such information is lacking."], ["33:33:3.0.1.1.27.4.1.6", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.36 Integrating NEPA with other environmental requirements.", "USACE", "", "", "", "(a) To the fullest extent possible, the District Engineer will prepare environmental documents concurrently with and integrated with analyses and related surveys and studies required by other Federal statutes. In appropriate instances, the District Engineer may participate in preparing single environmental assessment, finding of no significant impact, environmental impact statement, and Record of Decision documents.\n\n(b) The District Engineer will combine an environmental document prepared in compliance with NEPA with any other agency document to reduce duplication and paperwork. Thus, the District Engineer may combine an environmental document with related plans, rules, or amendments as a single consolidated document.\n\n(c) If comments on a notice of intent or other aspects of a scoping process identify consultations, permits, or licenses necessary under other environmental laws, the environmental document may contain a section briefly listing the applicable requirements and how the applicant has or will meet them ( e.g.,  permits applied for or received, consultations initiated or concluded)."], ["33:33:3.0.1.1.27.4.1.7", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.37 Elimination of duplication with State, Tribal, and local procedures.", "USACE", "", "", "", "(a) The District Engineer will, where appropriate, cooperate with State, Tribal, and local agencies that are responsible for preparing environmental documents.\n\n(b) To the fullest extent practicable unless specifically prohibited by law, the District Engineer will cooperate with State, Tribal, and local agencies to reduce duplication between NEPA and State, Tribal, and local requirements, including through use of studies, analysis, and decisions developed by State, Tribal, or local agencies. Such cooperation may include:\n\n(1) Joint planning processes;\n\n(2) Joint environmental research and studies;\n\n(3) Joint public hearings (except where otherwise provided by statute); or\n\n(4) Joint environmental documents."], ["33:33:3.0.1.1.27.4.1.8", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.38 Unique identification numbers.", "USACE", "", "", "", "For all environmental documents, the District Engineer will provide a unique identification number for tracking purposes, which the District Engineer will reference on all associated environmental review documents prepared for the proposed agency action and in any database or tracking system for such documents. The District Engineer will coordinate with the CEQ and other Federal agencies to ensure uniformity of such identification numbers across Federal agencies."], ["33:33:3.0.1.1.27.4.1.9", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "D", "Subpart D\u2014Efficient Environmental Reviews", "", "\u00a7 333.39 Emergency procedures.", "USACE", "", "", "", "In responding to emergency situations to prevent or reduce imminent risk of life, health, property, or severe economic losses, district commanders may proceed without the specific documentation and procedural requirements of other sections of this regulation. District Engineers shall consider the probable environmental consequences in determining appropriate emergency actions and when requesting approval to proceed on emergency actions, will describe proposed NEPA documentation or reasons for exclusion from documentation. NEPA documentation should be accomplished prior to initiation of emergency work if time constraints render this practicable. Such documentation may also be accomplished after the completion of emergency work, if appropriate. When possible, emergency actions considered major in scope with potentially significant environmental impacts shall be referred through the Division Engineers to Headquarters, U.S. Army Corps of Engineers for consultation with CEQ about NEPA alternative arrangements."], ["33:33:3.0.1.1.27.5.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "E", "Subpart E\u2014Agency Decision Making", "", "\u00a7 333.41 Decision documents.", "USACE", "", "", "", "At the time of its decision on its proposed action, the Corps may prepare and timely publish a concise public decision document notifying the public that the District Engineer has certified that the Corps has considered all relevant information raised in the NEPA process and that the NEPA process has closed. To avoid duplication, a finding of no significant impact may reference the environmental assessment and a record of decision may reference the environmental impact statement. The decision document prepared for NEPA compliance informs the final agency action of making the decision on the permit application or the request for permission under 33 U.S.C. 408(a) but is not the final agency action."], ["33:33:3.0.1.1.27.5.1.2", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "E", "Subpart E\u2014Agency Decision Making", "", "\u00a7 333.42 Filing requirements.", "USACE", "", "", "", "The District Engineer will file environmental impact statements together with comments and any responses with the Environmental Protection Agency (EPA), Office of Federal Activities for publication in the  Federal Register ."], ["33:33:3.0.1.1.27.6.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "F", "Subpart F\u2014Procedures for Applicant-Prepared NEPA Documents", "", "\u00a7 333.51 Procedures for applicant-prepared environmental documents.", "USACE", "", "", "", "The District Engineer may require the applicant to furnish appropriate information that the district engineer considers necessary for the preparation of an EA or EIS. The District Engineer may prepare an EA or an EIS, or may obtain information needed to prepare an EA or an EIS, either with Corps staff or by third-party contract. In accordance with NEPA section 107(f), 42 U.S.C. 4336a(f), the Corps has established procedures allowing applicants, or contractors hired by applicants, to prepare environmental assessments and environmental impact statements documents under the District Engineer supervision.\n\n(a) The District Engineer will independently evaluate the environmental document and will take responsibility for its contents. The District Engineer is responsible for ensuring that the information provided by the applicant-hired contractor is consistent with Corps' need to take a hard, objective look at the public interest and environmental factors consistent with its statutory requirements.\n\n(b) The District Engineer will assist applicants and applicant-hired contractors by providing guidance and outlining the types of information required for the preparation of the environmental document. Third party contracting is the primary method for preparing all or part of environmental impact statements covered by this part. The District Engineer may also provide appropriate guidance and assist in environmental document preparation, to the extent that the District Engineer's resources and policy priorities allow. The District Engineer will work with the applicant to define the purpose and need, and, when appropriate, to develop a reasonable range of alternatives to meet that purpose and need.\n\n(c) The District Engineer will work develop and modify, as appropriate, a schedule for preparation of the environmental document. Major changes to the schedule or related matters will be documented through written correspondence.\n\n(d) The District Engineer may request from an applicant environmental information for use by the Corps in preparing or evaluating an environmental document. This may include a decision file consisting of any factual, scientific, or technical information used, developed, or considered by the applicant or applicant-hired contractor in the course of preparing the environmental document, including any correspondence with the Corps or with third parties.\n\n(e) The applicant may accept or reject the District Engineer's guidance. The District Engineer, however, may after specifying the information in contention, require the applicant to resubmit any previously submitted data which the District Engineer considers inadequate or inaccurate. The District Engineer must document in the record the Corps' independent evaluation of the information and its accuracy."], ["33:33:3.0.1.1.27.7.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "G", "Subpart G\u2014Definitions", "", "\u00a7 333.61 Definitions.", "USACE", "", "", "", "As used in these implementing procedures, terms have the meanings provided in NEPA section 111, 42 U.S.C. 4336e. In addition:\n\n(a)  NEPA  means the National Environmental Policy Act, as amended (42 U.S.C. 4321,  et seq. ).\n\n(b)  Authorization  means a permit or permission.\n\n(c)  Connected action  means a separate Federal action within the Corps' authority that is closely related to the proposed agency action and should be addressed in a single environmental document because the proposed agency action:\n\n(1) Automatically triggers the separate Federal action, which independently would require the preparation of additional environmental documents;\n\n(2) Cannot proceed unless the separate Federal action is taken previously or simultaneously; or\n\n(3) Is an interdependent part of a larger Federal action that includes a separate Federal action, which mutually depend on the larger Federal action for their justification.\n\n(d)  Effects or impacts  means changes to the human environment from the proposed action or alternatives that are reasonably foreseeable and have a reasonably close causal relationship to the proposed action or alternatives.\n\n(1) Effects include ecological (such as the effects on natural resources and on the components, structures, and functioning of affected ecosystems), aesthetic, historic, cultural, economic (such as the effects on employment), social, or health effects. Effects appropriate for analysis under NEPA may be either beneficial or adverse, or both, with respect to these values.\n\n(2) A \u201cbut for\u201d causal relationship is insufficient to make an agency responsible for a particular effect under NEPA. Effects should generally not be considered if they are remote in time, geographically remote, or the product of a lengthy causal chain. Effects do not include those effects that the agency has no ability to prevent due to the limits of its regulatory authority, or that would occur regardless of the proposed action, or that would need to be initiated by a third party.\n\n(e)  Human environment  means comprehensively the natural and physical environment and the relationship of Americans with that environment. (See also the definition of \u201ceffects or impacts\u201d in paragraph (c) of this section.)\n\n(f)  Jurisdiction  means the specific legal authority to approve an activity, such as 33 U.S.C. 1344 (Clean Water Act, section 404); 33 U.S.C. 401 (Rivers and Harbors Act of 1899, section 9); 33 U.S.C. 403 (Rivers and Harbors Act of 1899, section 10); and 33 U.S.C. 1413 (Marine Protection, Research, and Sanctuaries Act of 1972, section 103) or 33 U.S.C. 408 (Rivers and Harbors Act of 1899, section 14).\n\n(g)  Mitigation  for the purposes of NEPA means measures that avoid, minimize, or compensate for effects caused by a proposed action or alternatives as described in an environmental document or record of decision and that have a nexus to those effects. While NEPA requires consideration of mitigation, it does not mandate the form or adoption of any mitigation. Mitigation includes:\n\n(1) Avoiding the impact altogether by not taking a certain action or parts of an action.\n\n(2) Minimizing effects by limiting the degree or magnitude of the action and its implementation.\n\n(3) Rectifying the impact by repairing, rehabilitating, or restoring the affected environment.\n\n(4) Reducing or eliminating the impact over time by preservation and maintenance operations during the life of the action.\n\n(5) Compensating for the impact by replacing or providing substitute resources or environments.\n\n(h)  NEPA process  means all measures necessary for compliance with the requirements of NEPA section 102(2), 42 U.S.C. 4332(2).\n\n(i)  Notice of intent  means a public notice that an agency will prepare and consider an environmental document.\n\n(j)  Participating agency  means a Federal, State, Tribal, or local agency participating in an environmental review or authorization of an action.\n\n(k)  Permit,  as used in this part, is the authorization described in 33 CFR 325.5 or the document granting Corps permission under 33 U.S.C. 408(a). A permit decision is the final agency action.\n\n(l)  Publish  and  publication  mean methods found by the agency to efficiently and effectively make environmental documents and information available for review by interested persons, including electronic publication.\n\n(m)  Reasonable alternatives  means a reasonable range of alternatives that are technically, legally, and economically feasible, meet the purpose and need for the proposed action, and, where applicable, meet the goals of the applicant.\n\n(n)  Reasonably foreseeable  means sufficiently likely to occur such that a person of ordinary prudence would take it into account in reaching a decision.\n\n(o)  Related action  means an action undertaken by an agency,  e.g.,  a permitting action, some other type of authorization action, an analysis required by statute, or the like, that bears a relationship to other actions undertaken by other agencies relevant to NEPA,  e.g.,  that a set of related actions are all related to one overarching project.\n\n(p)  Scope  consists of the range of actions, alternatives, and effects subject to the Corps legal authority or subject to the Corps control and responsibility that should be considered in an environmental document. This part addresses the considerations for use by District Engineers when determining scope for NEPA compliance in \u00a7 333.18 of this part.\n\n(q)  Tiering  when used for the purposes of multi-phased reviews of activities under 33 U.S.C. 408, refers to the coverage of general matters in broader environmental impact statements or environmental assessments (such as a general plan to address a need that identifies different conceptual options) with subsequent narrower or more detailed statements or environmental analyses (such as an analysis of how one of those conceptual options could be implemented at a specific site) incorporating by reference the general discussions and concentrating solely on the issues specific to the statement subsequently prepared."], ["33:33:3.0.1.1.27.8.1.1", 33, "Navigation and Navigable Waters", "II", "", "333", "PART 333\u2014PROCESSING OF DEPARTMENT OF THE ARMY PERMITS AND 33 U.S.C. 408 PERMISSIONS, NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES", "H", "Subpart H\u2014Severability", "", "\u00a7 333.71 Severability.", "USACE", "", "", "", "The sections of this part are separate and severable from one another. If any section or portion therein is stayed or determined to be invalid, or the applicability of any section to any person or entity is held invalid, it is the Corps' intention that the validity of the remainder of those parts will not be affected. The remaining sections or portions, and all applications thereof, shall continue to be in effect."], ["44:44:1.0.1.6.81.1.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "A", "Subpart A\u2014Purpose", "", "\u00a7 333.1 Purpose of this part.", "FEMA", "", "", "", "The Federal Emergency Management Agency (FEMA) refers to this part as the Emergency Management Priorities and Allocations System (EMPAS). The EMPAS implements those priorities and allocations authorities under the Defense Production Act that are the subject of a delegation from the President to the Secretary of DHS and re-delegated to the FEMA Administrator, or to the FEMA Administrator directly, as described in \u00a7 333.10 of this part. This includes the use of authority to support critical infrastructure restoration and protection, stockpiling, and emergency preparedness activities pursuant to Title VI of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5195  et seq. ), and related statutes, with respect to health and medical resources needed to respond to the spread of COVID-19 within the United States."], ["44:44:1.0.1.6.81.10.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Adjustments, Exceptions, and Appeals", "", "\u00a7 333.70 Adjustments or exceptions.", "FEMA", "", "", "", "(a) A person may submit a request to FEMA for an adjustment or exception on the ground that:\n\n(1) A provision of this part or an official action results in an undue or exceptional hardship on that person not suffered generally by others in similar situations and circumstances; or\n\n(2) The consequence of following a provision of this part or an official action is contrary to the intent of the Defense Production Act, other applicable statutes, or this part.\n\n(b) Each request for adjustment or exception must be in writing and contain a complete statement of all the facts and circumstances related to the provision of this part or official action from which adjustment is sought and a full and precise statement of the reasons why relief should be provided.\n\n(c) The submission of a request for adjustment or exception shall not relieve any person from the obligation of complying with the provisions of this part or official action in question while the request is being considered unless such interim relief is granted in writing by FEMA.\n\n(d) A decision of FEMA under this section may be appealed to the Administrator. (For information on the appeal procedure, see \u00a7 333.71.)"], ["44:44:1.0.1.6.81.10.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Adjustments, Exceptions, and Appeals", "", "\u00a7 333.71 Appeals.", "FEMA", "", "", "", "(a) Any person who has had a request for adjustment or exception denied by FEMA under \u00a7 333.70 may appeal to the Administrator, who shall review and reconsider the denial. Such appeals should be submitted to the Office of Policy and Programs at  FEMA-DPA@fema.dhs.gov,  Ref: EMPAS Appeals.\n\n(b)(1) Appeals of denied requests for exceptions from or adjustments to compliance with the provisions of this part or an official action must be received by FEMA no later than 45 days after receipt of a written notice of denial from FEMA. After this 45-day period, an appeal may be accepted at the discretion of the Administrator.\n\n(2) For requests for adjustment or exception involving rated orders placed for the purpose of emergency preparedness in response to a hazard that has occurred or is imminent, an appeal must be received by FEMA no later than 15 days after receipt of a written notice of denial.\n\n(c) Each appeal must be in writing and contain a complete statement of all the facts and circumstances related to the action appealed from and a full and precise statement of the reasons the decision should be modified or reversed.\n\n(d) In addition to the written materials submitted in support of an appeal, an appellant may request, in writing, an opportunity for an informal hearing. This request may be granted or denied at the discretion of the Administrator.\n\n(e) When a hearing is granted, the Administrator may designate an employee of FEMA to conduct the hearing and to prepare a report. The hearing officer shall determine all procedural questions and impose such time or other limitations deemed reasonable. In the event that the hearing officer decides that a printed transcript is necessary, all expenses shall be borne by the appellant.\n\n(f) When determining an appeal, the Administrator may consider all information submitted during the appeal as well as any recommendations, reports, or other relevant information and documents available to FEMA, or consult with any other persons or groups.\n\n(g) The submission of an appeal under this section shall not relieve any person from the obligation of complying with the provisions of this part or official action in question while the appeal is being considered, unless such relief is granted in writing by the Administrator.\n\n(h) The decision of the Administrator shall be made within a reasonable time after receipt of the appeal and shall be the final administrative action. It shall be issued to the appellant in writing with a statement of the reasons for the decision."], ["44:44:1.0.1.6.81.11.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "K", "Subpart K\u2014Miscellaneous Provisions", "", "\u00a7 333.80 Protection against claims.", "FEMA", "", "", "", "A person shall not be held liable for damages or penalties for any act or failure to act resulting directly or indirectly from compliance with any provision of this part, or an official action, notwithstanding that such provision or action shall subsequently be declared invalid by judicial or other competent authority."], ["44:44:1.0.1.6.81.11.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "K", "Subpart K\u2014Miscellaneous Provisions", "", "\u00a7 333.81 Records and reports.", "FEMA", "", "", "", "(a) Persons are required to make and preserve for at least three years, accurate and complete records of any transaction covered by this part or an official action.\n\n(b) Records must be maintained in sufficient detail to permit the determination, upon examination, of whether each transaction complies with the provisions of this part or any official action. However, this part does not specify any particular method or system to be used.\n\n(c) Records required to be maintained by this part must be made available for examination on demand by duly authorized representatives of FEMA as provided in \u00a7 333.61.\n\n(d) In addition, persons must develop, maintain, and submit any other records and reports to FEMA that may be required for the administration of the Defense Production Act and other applicable statutes, and this part.\n\n(e) Under section 705(d) of the Act and the ultimate delegation of that authority to the FEMA Administrator, information obtained under section 705 of the Act which the Administrator deems confidential, or with reference to which a request for confidential treatment is made by the person furnishing such information, shall not be published or disclosed unless the Administrator determines that the withholding of this information is contrary to the interest of the national defense. Information required to be submitted to FEMA in connection with the enforcement or administration of the Act, this part, or an official action, is deemed to be confidential under section 705(d) of the Act and shall not be published or disclosed except as required by applicable Federal law."], ["44:44:1.0.1.6.81.11.10.3", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "K", "Subpart K\u2014Miscellaneous Provisions", "", "\u00a7 333.82 Applicability of this part and official actions.", "FEMA", "", "", "", "(a) This part and all official actions, unless specifically stated otherwise, apply to transactions in any state, territory, or possession of the United States and the District of Columbia.\n\n(b) This part and all official actions apply not only to deliveries to other persons but also include deliveries to affiliates and subsidiaries of a person and deliveries from one branch, division, or section of a single entity to another branch, division, or section under common ownership or control.\n\n(c) This part shall not be construed to affect any administrative actions taken by FEMA, or any outstanding contracts or orders placed pursuant to any of the regulations, orders, schedules, or delegations of authority issued by FEMA prior to May 13, 2020. Such actions, contracts, or orders shall continue in full force and effect under this part unless modified or terminated by proper authority."], ["44:44:1.0.1.6.81.11.10.4", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "K", "Subpart K\u2014Miscellaneous Provisions", "", "\u00a7 333.83 Communications.", "FEMA", "", "", "", "General communications concerning this part, including how to obtain copies of this part and explanatory information, requests for guidance or clarification, may be addressed to FEMA's Office of Policy and Program Analysis at  FEMA-DPA@fema.dhs.gov."], ["44:44:1.0.1.6.81.11.10.5", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "K", "Subpart K\u2014Miscellaneous Provisions", "", "\u00a7 333.84 Severability.", "FEMA", "", "", "", "FEMA intends the various provisions of this part to be severable from each other to the extent practicable, such that if a court of competent jurisdiction were to vacate or enjoin any one provision, the other provisions are intended to remain in effect unless they are dependent upon the vacated or enjoined provision."], ["44:44:1.0.1.6.81.2.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "B", "Subpart B\u2014Overview", "", "\u00a7 333.2 Program eligibility.", "FEMA", "", "", "", "(a) Certain programs to promote the national defense are eligible for priorities and allocations support. These include programs for military and energy production or construction, military or critical infrastructure assistance to any foreign nation, deployment and sustainment of military forces, homeland security, stockpiling, space, and any directly related activity. Other eligible programs include emergency preparedness activities conducted pursuant to Title VI of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5195  et seq. ) and critical infrastructure protection and restoration. For a current and complete list reflecting the latest changes to approved programs, please visit FEMA's website at  www.FEMA.gov.\n\n(b) FEMA may delegate authority to place priority ratings on contracts or orders necessary to promote the national defense to appropriate officials in certain Federal Government agencies that issue such contracts or orders, to the extent consistent with the delegation of Presidential authority under which FEMA is operating. Such delegations may include authority to authorize recipients of rated orders to place ratings on contracts or orders to contractors, subcontractors, and suppliers."], ["44:44:1.0.1.6.81.2.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "B", "Subpart B\u2014Overview", "", "\u00a7 333.3 Priority ratings and rated orders.", "FEMA", "", "", "", "(a) Rated orders are identified by a priority rating and a program identification symbol. Rated orders take precedence over all unrated orders as necessary to meet required delivery dates. Among rated orders, DX rated orders take precedence over DO rated orders.\n\n(b) Persons receiving rated orders must give them preferential treatment as required by this part.\n\n(c) All rated orders must be scheduled to the extent possible to ensure delivery by the required delivery date.\n\n(d) Persons who receive rated orders must in turn place rated orders with their suppliers for the items they need to fill the orders. This provision ensures that suppliers will give priority treatment to rated orders from contractor to subcontractor to suppliers throughout the procurement chain.\n\n(e) Persons may place a priority rating on orders only when they are in receipt of a rated order, have been explicitly authorized to do so by FEMA or a Delegate Agency, or are otherwise permitted to do so by this part."], ["44:44:1.0.1.6.81.2.10.3", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "B", "Subpart B\u2014Overview", "", "\u00a7\u00a7 333.4-333.7 [Reserved]", "FEMA", "", "", "", ""], ["44:44:1.0.1.6.81.3.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "C", "Subpart C\u2014Definitions", "", "\u00a7 333.8 Definitions.", "FEMA", "", "", "", "The definitions in this section apply throughout this part:\n\nAct or DPA  means the Defense Production Act of 1950, as amended (50 U.S.C. 4501,  et seq. ).\n\nAdministrator  means the Administrator of the Federal Emergency Management Agency.\n\nAllocation  means the control of the distribution of materials, services or facilities for a purpose deemed necessary or appropriate to promote the national defense.\n\nAllocation order  means an official action to control the distribution of materials, services, or facilities for a purpose deemed necessary or appropriate to promote the national defense.\n\nAllotment  means an official action that specifies the maximum quantity of a material, service, or facility authorized for a specific use to promote the national defense.\n\nApproved program  means a program determined as necessary or appropriate for priorities and allocations support to promote the national defense by the Secretary of Defense, the Secretary of Energy, or the Secretary of Homeland Security, under the authority of the Defense Production Act and Executive Order 13603.\n\nConstruction  means the erection, addition, extension, or alteration of any building, structure, or project, using materials or products which are to be an integral and permanent part of the building, structure, or project. Construction does not include maintenance and repair.\n\nCritical infrastructure  means any systems and assets, whether physical or cyber-based, so vital to the United States that the degradation or destruction of such systems and assets would have a debilitating impact on national security, including, but not limited to, national economic security and national public health or safety.\n\nDelegate Agency  means a Federal Government agency authorized by delegation from FEMA to place priority ratings on contracts or orders needed to support approved programs.\n\nDirective  means an official action which requires a person to take or refrain from taking certain actions in accordance with its provisions.\n\nEmergency preparedness  means all those activities and measures designed or undertaken to prepare for or minimize the effects of a hazard upon the civilian population, to deal with the immediate emergency conditions which would be created by the hazard, and to effectuate emergency repairs to, or the emergency restoration of, vital utilities and facilities destroyed or damaged by the hazard. \u201cEmergency preparedness\u201d includes the following:\n\n(1) Measures to be undertaken in preparation for anticipated hazards (including the establishment of appropriate organizations, operational plans, and supporting agreements, the recruitment and training of personnel, the conduct of research, the procurement and stockpiling of necessary materials and supplies, the provision of suitable warning systems, the construction or preparation of shelters, shelter areas, and control centers, and, when appropriate, the nonmilitary evacuation of the civilian population).\n\n(2) Measures to be undertaken during a hazard (including the enforcement of passive defense regulations prescribed by duly established military or civil authorities, the evacuation of personnel to shelter areas, the control of traffic and panic, and the control and use of lighting and civil communications).\n\n(3) Measures to be undertaken following a hazard (including activities for firefighting, rescue, emergency medical, health and sanitation services, monitoring for specific dangers of special weapons, unexploded bomb reconnaissance, essential debris clearance, emergency welfare measures, and immediately essential emergency repair or restoration of damaged vital facilities).\n\nFacilities  includes all types of buildings, structures, or other improvements to real property (but excluding farms, churches or other places of worship, and private dwelling houses), and services related to the use of any such building, structure, or other improvement.\n\nHazard  means an emergency or disaster resulting from:\n\n(1) A natural disaster, or\n\n(2) An accidental or man-caused event.\n\nHealth and medical resources  means drugs, biological products, medical devices, materials, facilities, health supplies, services, and equipment required to diagnose, mitigate, prevent the impairment of, improve, treat, cure, or restore the physical or mental health conditions of the population.\n\nHomeland security  includes efforts:\n\n(1) To prevent terrorist attacks within the United States;\n\n(2) To reduce the vulnerability of the United States to terrorism;\n\n(3) To minimize damage from a terrorist attack in the United States; and\n\n(4) To recover from a terrorist attack in the United States.\n\nIndustrial resources  means all materials, services, and facilities, including construction materials, but not including: food resources, food resource facilities, and the domestic distribution of farm equipment and commercial fertilizer; all forms of health resources; all forms of civil transportation; and water resources. This term also includes the term \u201citem\u201d as defined and used in this part.\n\nItem  means any raw, in process, or manufactured material, article, commodity, supply, equipment, component, accessory, part, assembly, or product of any kind, technical information, process, or service.\n\nMaintenance and repair and/or operating supplies (MRO).\n\n(1)  Maintenance  is the upkeep necessary to continue any plant, facility, or equipment in working condition.\n\n(2)  Repair  is the restoration of any plant, facility, or equipment to working condition when it has been rendered unsafe or unfit for service by wear and tear, damage, or failure of parts.\n\n(3)  Operating supplies  are any items carried as operating supplies according to a person's established accounting practice. Operating supplies may include hand tools and expendable tools, jigs, dies, fixtures used on production equipment, lubricants, cleaners, chemicals, and other expendable items.\n\n(4) MRO does not include items produced or obtained for sale to other persons or for installation upon or attachment to the property of another person, or items required for the production of such items; items needed for the replacement of any plant, facility, or equipment; or items for the improvement of any plant, facility, or equipment by replacing items which are still in working condition with items of a new or different kind, quality, or design.\n\nMaterials  includes:\n\n(1) Any raw materials (including minerals, metals, and advanced processed materials), commodities, articles, components (including critical components), products, and items of supply; and\n\n(2) Any technical information or services ancillary to the use of any such materials, commodities, articles, components, products, or items.\n\nNational defense  means programs for military and energy production, or construction, military or critical infrastructure assistance to any foreign nation, homeland security, stockpiling, space, and any directly related activity. Such term includes emergency preparedness activities conducted pursuant to Title VI of The Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5195  et seq. ) and critical infrastructure protection and restoration.\n\nOfficial action  means an action taken by FEMA under the authority of the Defense Production Act, the Robert T. Stafford Disaster Relief and Emergency Assistance Act and related statutes, or this part. Such actions include the issuance of rating authorizations, directives, letters and memoranda of understanding, demands for information, inspection authorizations, administrative subpoenas, and allocation orders.\n\nPerson  includes any individual, corporation, partnership, association, or any other organized group of persons, or legal successor or representative thereof; or any State or local government or agency thereof; and for purposes of administration of this part, includes the Federal Government and any authorized foreign government or international organization or agency thereof, delegated authority as provided in this part.\n\nPriorities authority  means the authority of FEMA, pursuant to Section 101 of the Defense Production Act, to require acceptance and priority performance of contracts and orders for health and medical resource items and other resources as further delegated by the President to the Secretary of Homeland Security or Administrator for use in approved programs.\n\nPriority rating  means an identifying code assigned by a Delegate Agency, FEMA, or authorized person placed on all rated orders and consisting of the rating symbol and the program identification symbol.\n\nProduction equipment  means any item of capital equipment used in producing materials or furnishing services that has a unit acquisition cost of $2,500 or more, an anticipated service life in excess of one year, and the potential for maintaining its integrity as a capital item.\n\nProgram identification symbols  means abbreviations used to indicate which approved program is supported by a rated order.\n\nRated order  means a prime contract, a subcontract, or a purchase order in support of an approved program issued in accordance with the provisions of this part.\n\nServices  includes any effort that is needed for or incidental to:\n\n(1) The development, production, processing, distribution, delivery, or use of an industrial resource or a critical technology item;\n\n(2) The construction of facilities;\n\n(3) The movement of individuals and property by all modes of civil transportation; or\n\n(4) Other national defense programs and activities.\n\nSet-aside  means an official action that requires a person to reserve materials, services, or facilities capacity in anticipation of the receipt of rated orders.\n\nWritten  and  in writing  mean documented via printing, typewriting, handwriting, or similar means, whether in tangible or electronic form.\n\nWritten electronic  means written and in electronic form, except that when electronic form is impracticable under the circumstances, FEMA may construe this term to allow for a tangible format."], ["44:44:1.0.1.6.81.4.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.10 Authority.", "FEMA", "", "", "", "(a) The priorities and allocations authorities of the President under Title I of the Act that have been delegated to the Secretary of Homeland Security have been redelegated to the Administrator. These rules are issued pursuant to Title I of the Act, and implementing authorities, including such authorities as are contained in subchapter III of chapter 55 of title 50, United States Code (50 U.S.C. 4554, 4555, 4556, and 4560), which have been delegated to FEMA.\n\n(b)  Delegations by FEMA.  FEMA may authorize Delegate Agencies to assign priority ratings to orders under these regulations as authorized.\n\n(c)  Jurisdictional limitations.  Unless delegated by the President to DHS or FEMA, the provisions of this part are not applicable to the following resource categories, as defined in Executive Order 13603, a successor executive order, or implementing regulations issued thereunder:\n\n(1) Food resources, food resource facilities, and the domestic distribution of farm equipment and commercial fertilizer (Resource department with jurisdiction\u2014Department of Agriculture);\n\n(2) Energy supplies (Resources agency with jurisdiction\u2014Department of Energy);\n\n(3) All forms of civil transportation (Resource department with jurisdiction\u2014Department of Transportation);\n\n(4) Health resources (Resource department with jurisdiction\u2014Department of Health and Human Services), except that pursuant to Executive Order 13911, the provisions of this part are applicable to health and medical resources needed to respond to the spread of COVID-19;\n\n(5) Water resources (Resource department with jurisdiction\u2014Department of Defense); and\n\n(6) All other materials, services, and facilities, including construction materials (\u201cindustrial resources\u201d) (Resource department with jurisdiction\u2014Department of Commerce)."], ["44:44:1.0.1.6.81.4.10.10", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.19 Special provisions applicable to rated orders for third parties.", "FEMA", "", "", "", "(a) The provisions of this part apply to rated orders placed by FEMA or a Delegate Agency to facilitate sales to third parties, regardless of the nature of their relationship to the Federal Government, unless otherwise specified.\n\n(b) Where FEMA or a Delegate Agency has placed a rated order to facilitate a sale to a third party, the third party is responsible for satisfying the applicable terms of sale and payment. The Federal Government shall not be liable for any failure to meet the terms of sale or payment.\n\n(c) If a third party is unable to satisfy the applicable terms of sale or payment, FEMA or the Delegate Agency may amend or cancel the rated order pursuant to \u00a7 333.16 of this part. If FEMA or the Delegate Agency amend the rated order to provide that delivery shall be made to FEMA, the Delegate Agency, or another third party instead of the original third party, and the amendment shall not constitute a new rated order."], ["44:44:1.0.1.6.81.4.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.11 Priority ratings.", "FEMA", "", "", "", "(a)  Levels of priority.  (1) There are two levels of priority established by Federal Priorities and Allocations System regulations, identified by the rating symbols \u201cDO\u201d and \u201cDX.\u201d\n\n(2) All DO rated orders have equal priority with each other and take preference over unrated orders. All DX rated orders have equal priority with each other and take preference over DO rated orders and unrated orders. (For resolution of conflicts among rated orders of equal priority, see \u00a7 333.14(c)).\n\n(3) In addition, a Directive issued by FEMA regarding priority treatment for a given item takes preference over any DX rated order, DO rated order, or unrated order, as stipulated in the Directive. (For a full discussion of Directives, see \u00a7 333.52).\n\n(b)  Program identification symbols.  Program identification symbols indicate which approved program is being supported by a rated order. Program identification symbols, in themselves, do not connote any priority.\n\n(c)  Priority ratings.  A priority rating consists of the rating symbol\u2014DO or DX\u2014and the program identification symbol."], ["44:44:1.0.1.6.81.4.10.3", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.12 Elements of a rated order.", "FEMA", "", "", "", "(a)  Elements required for all rated orders.  (1) The appropriate priority rating and program identification symbol;\n\n(2) A required delivery date or dates. The words \u201cimmediately\u201d or \u201cas soon as possible\u201d do not constitute a delivery date. When a \u201crequirements contract,\u201d \u201cbasic ordering agreement,\u201d \u201cprime vendor contract,\u201d or similar procurement document bearing a priority rating contains no specific delivery date or dates, but provides for the furnishing of items from time-to-time or within a stated period against specific purchase orders, such as \u201ccalls,\u201d \u201crequisitions,\u201d and \u201cdelivery orders,\u201d the purchase orders under such contracts or agreements must specify a required delivery date or dates and are to be considered as rated as of the date of their receipt by the supplier and not as of the date of the original procurement document.\n\n(3) The written signature on a manually placed order, or the digital signature or name on an electronically placed order, of an individual authorized to sign rated orders for the person placing the order. The signature, manual or digital, certifies that the rated order is authorized under this part and that the requirements of this part are being followed; and\n\n(4) A statement that reads in substance: \u201cThis is a rated order certified for national defense use and you are required to follow all the provisions of the Emergency Management Priorities and Allocations System regulations (44 CFR part 333).\u201d\n\n(b)  Additional element required for certain emergency preparedness rated orders.  If a rated order is placed for the purpose of emergency preparedness requirements and expedited action is necessary or appropriate to meet these requirements, the following statement must be included in the order: \u201cThis rated order is placed for the purpose of emergency preparedness. It must be accepted or rejected pursuant to the mandatory acceptance and mandatory rejection requirements found in 44 CFR 333.13 within [Insert a time limit no less than the minimum applicable time limit specified in \u00a7 333.13(d)(2)].\u201d\n\n(c)  Additional elements required for rated orders issued by FEMA or a Delegate Agency to facilitate sales to third parties.  If a rated order is placed by FEMA or the Delegate Agency to facilitate a sale to a third party who desires to order the materials, the following statement must also be included in the order: \u201cThis rated order is placed for the purpose of facilitating a sale to [Insert third party] to promote the national defense. It must be accepted or rejected pursuant to the mandatory acceptance and mandatory rejection requirements found in 44 CFR 333.13 within [Insert the applicable time limit consistent with \u00a7 333.13(d)], and it is subject to the additional requirements of 44 CFR 333.19. [Third party] is responsible for satisfying the applicable terms of sale and payment. The Federal Government is not be liable for any failure to meet the terms of sale or payment. For purposes of these and any other notification requirements set forth in FEMA's Emergency Management Priorities and Allocations System regulations (44 CFR part 333), both [Insert FEMA or Delegate Agency] and [Insert third party] are the `customer.'\u201d"], ["44:44:1.0.1.6.81.4.10.4", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.13 Acceptance and rejection of rated orders.", "FEMA", "", "", "", "(a)  Mandatory acceptance.  (1) Except as otherwise specified in this section, a person must accept every rated order received and must fill such orders regardless of any other rated or unrated orders that have been accepted.\n\n(2) A person must not discriminate against rated orders in any manner such as by charging higher prices or by imposing different terms and conditions than for comparable unrated orders.\n\n(b)  Mandatory rejection.  Unless otherwise directed by FEMA:\n\n(1) A person must not accept a rated order for delivery on a specific date if unable to fill the order by that date. However, the person must inform the customer of the earliest date on which delivery can be made and offer to accept the order on the basis of that date. Scheduling conflicts with previously accepted lower rated or unrated orders are not sufficient reason for rejection under this section.\n\n(2) A person must not accept a DO rated order for delivery on a date which would interfere with delivery of any previously accepted DO or DX rated orders. However, the person must offer to accept the order based on the earliest delivery date otherwise possible.\n\n(3) A person must not accept a DX rated order for delivery on a date which would interfere with delivery of any previously accepted DX rated orders, but must offer to accept the order based on the earliest delivery date otherwise possible.\n\n(4) If a person is unable to fill all the rated orders of equal priority status received on the same day, the person must accept, based upon the earliest delivery dates, only those orders which can be filled, and reject the other orders. For example, a person must accept order A requiring delivery on December 15 before accepting order B requiring delivery on December 31. However, the person must offer to accept the rejected orders based on the earliest delivery dates otherwise possible.\n\n(c)  Optional rejection.  Unless otherwise directed by FEMA, rated orders may be rejected in any of the following cases as long as a supplier does not discriminate among customers:\n\n(1) If the person placing the order is unwilling or unable to meet regularly established terms of sale or payment;\n\n(2) If the order is for an item not supplied or for a service not performed;\n\n(3) If the order is for an item produced, acquired, or provided only for the supplier's own use for which no orders have been filled for two years prior to the date of receipt of the rated order. If, however, a supplier has sold some of these items, the supplier is obligated to accept rated orders up to that quantity or portion of production, whichever is greater, sold within the past two years;\n\n(4) If the person placing the rated order, other than the Federal Government, makes the item or performs the service being ordered;\n\n(5) If acceptance of a rated order or performance against a rated order would violate any other regulation, official action, or order of FEMA issued under the authority of the Defense Production Act or another relevant statute.\n\n(d)  Customer notification requirements.  (1) Except as provided in paragraph (d)(2) of this section, a person must accept or reject a rated order in written electronic format within 15 working days after receipt of a DO rated order and within 10 working days after receipt of a DX rated order. If the order is rejected, the person must give reasons in written electronic format for the rejection.\n\n(2) If a rated order is placed for the purpose of emergency preparedness requirements and expedited action is necessary or appropriate to meet these requirements and the order includes the statement set forth in \u00a7 333.12(b), a person must accept or reject the rated order and transmit the acceptance or rejection in written electronic format within the time specified in the rated order. The minimum times for acceptance or rejection that such orders may specify are 6 hours after receipt of the order if the order is issued by an authorized person in response to a hazard that has occurred, or 12 hours after receipt if the order is issued by an authorized person to prepare for an imminent hazard.\n\n(3) If a person has accepted a rated order and subsequently finds that shipment or performance will be delayed, the person must notify the customer immediately, give the reasons for the delay, and advise of a new shipment or performance date. If notification is given verbally, written electronic confirmation must be provided within 24 hours of the verbal notice."], ["44:44:1.0.1.6.81.4.10.5", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.14 Preferential scheduling.", "FEMA", "", "", "", "(a) A person must schedule operations, including the acquisition of all needed production items, in a timely manner to satisfy the delivery requirements of each rated order. Modifying production or delivery schedules is necessary only when required delivery dates for rated orders cannot otherwise be met.\n\n(b) DO rated orders must be given production preference over unrated orders, if necessary, to meet required delivery dates, even if this requires the diversion of items being processed or ready for delivery against unrated orders. Similarly, DX rated orders must be given preference over DO rated orders and unrated orders.\n\n(1)  Examples:  If a person receives a DO rated order with a delivery date of June 3 and if meeting that date would mean delaying production or delivery of an item for an unrated order, the unrated order must be delayed. If a DX rated order is received calling for delivery on July 15 and a person has a DO rated order requiring delivery on June 2 and operations can be scheduled to meet both deliveries, there is no need to alter production schedules to give any additional preference to the DX rated order. However, if business operations cannot be altered to meet both the June 3 and July 15 delivery dates, then the DX rated order must be given priority over the DO rated order.\n\n(2) [Reserved]\n\n(c)  Conflicting rated orders.  (1) If a person finds that delivery or performance against any accepted rated orders conflicts with the delivery or performance against other accepted rated orders of equal priority status, the person must give preference to the conflicting orders in the sequence in which they are to be delivered or performed (not to the receipt dates). If the conflicting rated orders are scheduled to be delivered or performed on the same day, the person must give preference to those orders which have the earliest receipt dates.\n\n(2) If a person is unable to resolve rated order delivery or performance conflicts under this section, the person should promptly seek special priorities assistance as provided in subpart E of this part. If the person's customer objects to the rescheduling of delivery or performance of a rated order, the customer should promptly seek special priorities assistance as provided in subpart E of this part. For any rated order against which delivery or performance will be delayed, the person must notify the customer as provided in \u00a7 333.13(d)(3).\n\n(d) If a person is unable to purchase needed production items in time to fill a rated order by its required delivery date, the person must fill the rated order by using inventoried production items. A person who uses inventoried items to fill a rated order may replace those items with the use of a rated order as provided in \u00a7 333.17(b)."], ["44:44:1.0.1.6.81.4.10.6", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.15 Extension of priority ratings.", "FEMA", "", "", "", "(a) A person must use rated orders with suppliers to obtain items needed to fill a rated order. The person must use the priority rating indicated on the customer's rated order, except as otherwise provided in this part or as directed by FEMA.\n\n(b) The priority rating must be included on each successive order placed to obtain items needed to fill a customer's rated order. Therefore, the inclusion of the rating will continue from contractor to subcontractor to supplier throughout the entire supply chain.\n\n(c) A person must use rated orders with suppliers to obtain items needed to fill an emergency preparedness rated order. That person must require acceptance or rejection, and transmission of that acceptance or rejection by the supplier within the time limit stated in the rated order that is being filled."], ["44:44:1.0.1.6.81.4.10.7", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.16 Changes or cancellations of priority ratings and rated orders.", "FEMA", "", "", "", "(a) The priority rating on a rated order may be changed or cancelled by:\n\n(1) An official action of FEMA; or\n\n(2) Written electronic notification from the person who placed the rated order (including a Delegate Agency).\n\n(b) If an unrated order is amended so as to make it a rated order, or a DO rating is changed to a DX rating, the supplier must give the appropriate preferential treatment to the order as of the date the change is received by the supplier.\n\n(c) An amendment to a rated order that significantly alters a supplier's original production or delivery schedule shall constitute a new rated order as of the date of its receipt. The supplier must accept or reject the amended order according to the provisions of \u00a7 333.13.\n\n(d) The following amendments do not constitute a new rated order: A change in shipping destination; A reduction in the total amount of the order; an increase in the total amount of the order which has negligible impact upon deliveries; a minor variation in size or design (prior to the start of production); or a change which is agreed upon between the supplier and the customer.\n\n(e) A person must cancel any rated orders that the person (or a predecessor in interest) has placed with suppliers or cancel the priority ratings on those orders if the person no longer needs the items in those orders to fill a rated order.\n\n(f) A person adding a rating to an unrated order, or changing or cancelling a priority rating must promptly provide written electronic notification to all suppliers to whom the order was sent of the addition, change, or cancellation."], ["44:44:1.0.1.6.81.4.10.8", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.17 Use of rated orders.", "FEMA", "", "", "", "(a) A person must use rated orders to obtain:\n\n(1) Items which will be physically incorporated into other items to fill rated orders, including that portion of such items normally consumed, or converted into scrap or by-products, in the course of processing;\n\n(2) Containers or other packaging materials required to make delivery of the finished items against rated orders;\n\n(3) Services, other than contracts of employment, needed to fill rated orders; and\n\n(4) MRO needed to produce the finished items to fill rated orders.\n\n(b) A person may use a rated order to replace inventoried items (including finished items) if such items were used to fill rated orders, as follows:\n\n(1) The order must be placed within 90 days of the date of use of the inventory.\n\n(2) A DO rating symbol and the program identification symbol indicated on the customer's rated order must be used on the order. A DX rating symbol may not be used even if the inventory was used to fill a DX rated order.\n\n(3) If the priority ratings on rated orders from one customer or several customers contain different program identification symbols, the rated orders may be combined.\n\n(c) A person may combine DX and DO rated orders from one customer or several customers if the items covered by each level of priority are identified separately and clearly.\n\n(d)  Combining rated and unrated orders.  (1) A person may combine rated and unrated order quantities on one purchase order provided that:\n\n(i) The rated quantities are separately and clearly identified; and\n\n(ii) The elements of a rated order, as required by \u00a7 333.12, are included on the order with the statement required in \u00a7 333.12(d) modified to read in substance: \u201cThis purchase order contains rated order quantities certified for national defense use, and you are required to follow all the provisions of the Emergency Management Priorities and Allocations System regulations (44 CFR part 333) as it pertains to the rated quantities.\u201d\n\n(2) A supplier must accept or reject the rated portion of the purchase order as provided in \u00a7 333.13 and give preferential treatment only to the rated quantities as required by this part. This part may not be used to give preferential treatment to the unrated portion of the order.\n\n(3) Any supplier who believes that rated and unrated orders are being combined in a manner contrary to the intent of this part or in a fashion that causes undue or exceptional hardship may submit a request for adjustment or exception under \u00a7 333.70.\n\n(e) A person may place a rated order for the minimum commercially procurable quantity even if the quantity needed to fill a rated order is less than that minimum. However, a person must combine rated orders as provided in paragraph (c) of this section, if possible, to obtain minimum procurable quantities.\n\n(f) A person is not required to place a priority rating on an order for less than one half of the Simplified Acquisition Threshold (as established in the Federal Acquisition Regulation (FAR)) (see 48 CFR 2.101) or in other authorized acquisition regulatory or management systems, provided that delivery can be obtained in a timely fashion without the use of the priority rating."], ["44:44:1.0.1.6.81.4.10.9", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Priorities and Placement of Rated Orders", "", "\u00a7 333.18 Limitations on placing rated orders.", "FEMA", "", "", "", "(a)  General limitations on placing rated orders.  A person may not place a DO or DX rated order pursuant to this part unless the person is in receipt of a rated order, has been explicitly authorized to do so by FEMA or a Delegate Agency or is otherwise permitted to do so by this part.\n\n(b)  Specific limitations on placing rated orders.  Rated orders may not be used to obtain:\n\n(1) Delivery on a date earlier than needed;\n\n(2) A greater quantity of the item than needed, except to obtain a minimum procurable quantity. Separate rated orders may not be placed solely for the purpose of obtaining minimum procurable quantities on each order if the minimum procurable quantity would be sufficient to cover more than one rated order;\n\n(3) Items in advance of the receipt of a rated order, except as specifically authorized by FEMA (see \u00a7 333.21(c) for information on obtaining authorization for a priority rating in advance of a rated order); or\n\n(4) Any of the following items unless specific priority rating authority has been obtained from FEMA, a Delegate Agency, or the Department of Commerce:\n\n(i) Items for plant improvement, expansion, or construction, unless they will be physically incorporated into a construction project covered by a rated order; or\n\n(ii) Production or construction equipment or items to be used for the manufacture of production equipment (for information on requesting priority rating authority, see \u00a7 333.21).\n\n(5) Any items related to the development of chemical or biological warfare capabilities or the production of chemical or biological weapons, unless such development or production has been authorized by the President or the Secretary of Defense."], ["44:44:1.0.1.6.81.5.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "E", "Subpart E\u2014Special Priorities Assistance", "", "\u00a7 333.20 General provisions.", "FEMA", "", "", "[85 FR 28510, May 13, 2020, as amended at 86 FR 1292, Jan. 8, 2021]", "(a) EMPAS is designed to be largely self-executing. However, if production or delivery problems arise, a person should immediately contact FEMA (or the Delegate Agency, as appropriate) for special priorities assistance pursuant to \u00a7\u00a7 333.20 through 333.24 and as directed by \u00a7 333.83. If FEMA (or the Delegate Agency, as appropriate) is unable to resolve the problem or to authorize the use of a priority rating and believes additional assistance is warranted, FEMA (or the Delegate Agency, as appropriate) may forward the request to another resource agency, as appropriate, for action. Special priorities assistance is a service provided to alleviate problems.\n\n(b) Special priorities assistance can be provided for any reason consistent with this part, such as assisting in obtaining timely deliveries of items needed to satisfy rated orders or authorizing the use of priority ratings on orders to obtain items not otherwise ratable under this part. Special priorities assistance may also be used to request rating authority for items that are not normally eligible for priority treatment.\n\n(c) A request for special priorities assistance or priority rating authority may be submitted on FEMA Form 009-0-142 (OMB control number 1660-0149) to FEMA. Form 009-0-142 may be obtained from the Delegate Agency or from FEMA."], ["44:44:1.0.1.6.81.5.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "E", "Subpart E\u2014Special Priorities Assistance", "", "\u00a7 333.21 Requests for priority rating authority.", "FEMA", "", "", "", "(a) If a rated order is likely to be delayed because a person is unable to obtain items not normally rated under this part, the person may request the authority to use a priority rating in ordering the needed items.\n\n(b)  Rating authority for production or construction equipment.  (1) A request for priority rating authority for production or construction equipment, if needed, must be submitted to the U.S. Department of Commerce on Form BIS-999.\n\n(2) When the use of a priority rating is authorized for the procurement of production or construction equipment, a rated order may be used either to purchase or to lease such equipment. However, in the latter case, the equipment may be leased only from a person engaged in the business of leasing such equipment or from a person willing to lease rather than sell.\n\n(c)  Rating authority in advance of a rated prime contract.  (1) In certain cases, and upon specific request, FEMA, in order to promote the national defense, may authorize a person to place a priority rating on an order to a supplier in advance of the issuance of a rated prime contract. In these instances, the person requesting advance rating authority must obtain sponsorship of the request from FEMA or the appropriate Delegate Agency. The person shall also assume any business risk associated with the placing of rated orders if these orders have to be cancelled in the event the rated prime contract is not issued.\n\n(2) The person must state the following in the request: \u201cIt is understood that the authorization of a priority rating in advance of our receiving a rated prime contract from FEMA (or a Delegate Agency) and our use of that priority rating with our suppliers in no way commits the Delegate Agency, FEMA, or any other Federal Government agency to enter into a contract or order or to expend funds. Further, we understand that the Federal Government shall not be liable for any cancellation charges, termination costs, or other damages that may accrue if a rated prime contract is not eventually placed and, as a result, we must subsequently cancel orders placed with the use of the priority rating authorized as a result of this request.\u201d\n\n(3) In reviewing requests for rating authority in advance of a rated prime contract, FEMA will consider, among other things, the following criteria:\n\n(i) The probability that the prime contract will be awarded;\n\n(ii) The impact of the resulting rated orders on suppliers and on other authorized programs;\n\n(iii) Whether the contractor is the sole source;\n\n(iv) Whether the item being produced has a long lead time; and\n\n(v) The time period for which the rating is being requested.\n\n(4) FEMA may require periodic reports on the use of the rating authority granted under paragraph (c) of this section.\n\n(5) If a rated prime contract is not issued, the person must promptly notify all suppliers who have received rated orders pursuant to the advance rating authority that the priority rating on those orders is cancelled."], ["44:44:1.0.1.6.81.5.10.3", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "E", "Subpart E\u2014Special Priorities Assistance", "", "\u00a7 333.22 Examples of assistance.", "FEMA", "", "", "", "(a) While special priorities assistance may be provided for any reason in support of this part, it is usually provided in situations where:\n\n(1) A person is experiencing difficulty in obtaining delivery against a rated order by the required delivery date; or\n\n(2) A person cannot locate a supplier for an item needed to fill a rated order.\n\n(b) Other examples of special priorities assistance include:\n\n(1) Ensuring that rated orders receive preferential treatment by suppliers;\n\n(2) Resolving production or delivery conflicts between various rated orders;\n\n(3) Assisting in placing rated orders with suppliers;\n\n(4) Verifying the urgency of rated orders; and\n\n(5) Determining the validity of rated orders."], ["44:44:1.0.1.6.81.5.10.4", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "E", "Subpart E\u2014Special Priorities Assistance", "", "\u00a7 333.23 Criteria for assistance.", "FEMA", "", "", "", "Requests for special priorities assistance should be timely,  i.e.,  the request must be submitted promptly and in enough time for FEMA or the Delegate Agency to effect a meaningful resolution to the problem, and must establish that:\n\n(a) There is an urgent need for the item; and\n\n(b) The applicant has made a reasonable effort to resolve the problem."], ["44:44:1.0.1.6.81.5.10.5", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "E", "Subpart E\u2014Special Priorities Assistance", "", "\u00a7 333.24 Instances where assistance will not be provided.", "FEMA", "", "", "", "Special priorities assistance is provided at the discretion of FEMA or the Delegate Agency when it is determined that such assistance is warranted to meet the objectives of this part. Examples where assistance may not be provided include situations when a person is attempting to:\n\n(a) Secure a price advantage;\n\n(b) Obtain delivery prior to the time required to fill a rated order;\n\n(c) Gain competitive advantage;\n\n(d) Disrupt an industry apportionment program in a manner designed to provide a person with an unwarranted share of scarce items; or\n\n(e) Overcome a supplier's regularly established terms of sale or conditions of doing business."], ["44:44:1.0.1.6.81.6.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 333.30 Policy.", "FEMA", "", "", "", "(a) Allocation orders will:\n\n(1) Be used only when there is insufficient supply of a material, service, or facility to satisfy national defense requirements through the use of the priorities authority or when the use of the priorities authority would cause a severe and prolonged disruption in the supply of materials, services, or facilities available to support normal U.S. economic activities; and\n\n(2) Not be used to ration materials or services at the retail level.\n\n(b) Allocation orders, when used, will be distributed equitably among the suppliers of the materials, services, or facilities being allocated and not require any person to relinquish a disproportionate share of the civilian market.\n\n(c) When a hazard has occurred or is imminent, an allocation order may be used without regard to paragraphs (a) and (b) of this section whenever it is deemed by the Administrator to be necessary or appropriate to promote the national defense."], ["44:44:1.0.1.6.81.6.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 333.31 General procedures.", "FEMA", "", "", "", "Before FEMA uses its allocations authority to address a supply problem within its resource jurisdiction, it will develop a plan that includes:\n\n(a) A copy of the written determination that the program or programs that would be supported by the allocation action are necessary or appropriate to promote the national defense;\n\n(b) A detailed description of the situation to include any unusual events or circumstances that have created the requirement for an allocation action;\n\n(c) A statement of the specific objective(s) of the allocation action;\n\n(d) A list of the materials, services, or facilities to be allocated;\n\n(e) A list or description of the sources of the materials, services, or facilities that will be subject to the allocation action;\n\n(f) A detailed description of the provisions that will be included in the allocation orders, including the type(s) of allocation orders, the percentages or quantity of capacity or output to be allocated for each purpose, and the duration of the allocation action ( e.g.,  anticipated start and end dates);\n\n(g) An evaluation of the impact of the proposed allocation action on the civilian market; and\n\n(h) Proposed actions, if any, to mitigate disruptions to civilian market operations."], ["44:44:1.0.1.6.81.6.10.3", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 333.32 Controlling the general distribution of a material in the civilian market.", "FEMA", "", "", "", "No allocation action by FEMA may be used to control the general distribution of a material in the civilian market unless the President, the Administrator, or another official with lawful authority under section 101(b) of the Act has made a written finding that:\n\n(a) Such material is a scarce and critical material essential to the national defense, and\n\n(b) The requirements of the national defense for such material cannot otherwise be met without creating a significant dislocation of the normal distribution of such material in the civilian market to such a degree as to create appreciable hardship."], ["44:44:1.0.1.6.81.6.10.4", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 333.33 Types of allocation orders.", "FEMA", "", "", "", "There are three types of allocation orders available for communicating allocation actions.\n\n(a)  Set-aside.  A set-aside is an official action that requires a person to reserve materials, services, or facilities capacity in anticipation of the receipt of rated orders.\n\n(b)  Directive.  A directive is an official action that requires a person to take or refrain from taking certain actions in accordance with its provisions. For example, a directive can require a person to: Stop or reduce production of an item; prohibit the use of selected materials, services, or facilities; or divert the use of materials, services, or facilities from one purpose to another.\n\n(c)  Allotment.  An allotment is an official action that specifies the maximum quantity of a material, service, or facility authorized for a specific use to promote the national defense."], ["44:44:1.0.1.6.81.6.10.5", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 333.34 Elements of an allocation order.", "FEMA", "", "", "", "Allocation orders may be issued directly to the affected persons or by constructive notice through publication in the  Federal Register.  This section describes the elements that each order must include.\n\n(a)  Elements to be included in all allocation orders.  (1) A detailed description of the required allocation action(s), including its relationship to previously or subsequently received DX rated orders, DO rated orders, and unrated orders.\n\n(2) Specific start and end calendar dates for each required allocation action.\n\n(b)  Elements to be included in orders issued directly to affected persons.  (1) A statement that reads in substance: \u201cThis is an allocation order certified for national defense use. [Insert the name of the person receiving the order] is required to comply with this order, in accordance with the provisions of the Emergency Management Priorities and Allocations System regulations (44 CFR part 333), which is part of the Federal Priorities and Allocations System.\u201d\n\n(2) The written signature on a manually placed order, or the digital signature or name on an electronically placed order, of the FEMA Administrator.\n\n(c)  Elements to be included in an allocation order that gives constructive notice through publication in the   Federal Register . (1) A statement that reads in substance: \u201cThis is an allocation order certified for national defense use. [Insert the name(s) of the person(s) to whom the order applies or a description of the class of persons to whom the order applies] is (are) required to comply with this order, in accordance with the provisions of the Emergency Management Priorities and Allocations System regulations (44 CFR part 333), which is part of the Federal Priorities and Allocations System.\u201d\n\n(2) The order must be signed by the FEMA Administrator."], ["44:44:1.0.1.6.81.6.10.6", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 333.35 Mandatory acceptance of an allocation order.", "FEMA", "", "", "", "(a) Except as otherwise specified in this section, a person must accept and comply with every allocation order received.\n\n(b) A person must not discriminate against an allocation order in any manner such as by charging higher prices for materials, services, or facilities covered by the order or by imposing terms and conditions for contracts and orders involving allocated materials, services, or facilities that differ from the person's terms and conditions for contracts and orders for the materials, services, or facilities prior to receiving the allocation order.\n\n(c) If a person is unable to comply fully with the required action(s) specified in an allocation order, the person must notify FEMA immediately, explain the extent to which compliance is possible, and give the reasons why full compliance is not possible. If notification is given verbally, written, electronic confirmation must be provided within 24 hours. Such notification does not release the person from complying with the order to the fullest extent possible, until the person is notified by FEMA that the order has been changed or cancelled."], ["44:44:1.0.1.6.81.6.10.7", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 333.36 Changes or cancellations of allocation orders.", "FEMA", "", "", "", "An allocation order may be changed or cancelled by an official action from FEMA. Notice of such changes or cancellations may be provided directly to persons to whom the order being cancelled or modified applies or constructive notice may be provided by publication in the  Federal Register ."], ["44:44:1.0.1.6.81.8.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Official Actions", "", "\u00a7 333.50 General provisions.", "FEMA", "", "", "", "(a) FEMA may, from time-to-time, take specific official actions to implement or enforce the provisions of this part.\n\n(b) Some of these official actions (rating authorizations and letters and memoranda of understanding) are discussed in this subpart. Official actions that pertain to compliance (administrative subpoenas, demands for information, and inspection authorizations) are discussed in \u00a7 333.61(c). Directives are discussed in \u00a7 333.52."], ["44:44:1.0.1.6.81.8.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Official Actions", "", "\u00a7 333.51 Rating authorizations.", "FEMA", "", "", "", "(a) A rating authorization is an official action granting specific priority rating authority that:\n\n(1) Permits a person to place a priority rating on an order for an item not normally ratable under this part; or\n\n(2) Authorizes a person to modify a priority rating on a specific order or series of contracts or orders.\n\n(b) To request priority rating authority, see \u00a7 333.21."], ["44:44:1.0.1.6.81.8.10.3", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Official Actions", "", "\u00a7 333.52 Directives.", "FEMA", "", "", "", "(a) A directive is an official action which requires a person to take or refrain from taking certain actions in accordance with its provisions.\n\n(b) A person must comply with each directive issued. However, a person may not use or extend a directive to obtain any items from a supplier, unless expressly authorized to do so in the directive.\n\n(c) A priorities directive takes precedence over all DX-rated orders, DO-rated orders, and unrated orders previously or subsequently received, unless a contrary instruction appears in the directive.\n\n(d) An allocations directive takes precedence over all priorities directives, DX-rated orders, DO-rated orders, and unrated orders previously or subsequently received, unless a contrary instruction appears in the directive."], ["44:44:1.0.1.6.81.8.10.4", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Official Actions", "", "\u00a7 333.53 Letters and memoranda of understanding.", "FEMA", "", "", "", "(a) A letter or memorandum of understanding is an official action, which may be issued electronically, to resolve special priorities assistance cases to reflect an agreement reached by all parties (FEMA, the Department of Commerce (if applicable), a Delegate Agency (if applicable), the supplier, and the customer).\n\n(b) A letter or memorandum of understanding is not used to alter scheduling between rated orders, to authorize the use of priority ratings, to impose restrictions under this part, or to take other official actions. Rather, letters or memoranda of understanding are used to confirm production or shipping schedules which do not require modifications to other rated orders."], ["44:44:1.0.1.6.81.9.10.1", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Compliance", "", "\u00a7 333.60 General provisions.", "FEMA", "", "", "", "(a) Compliance actions may be taken for any reason necessary or appropriate to the enforcement or the administration of the Defense Production Act and related statutes, this part, or an official action. Compliance actions include audits, investigations, or other inquiries and FEMA may utilize other official actions, such as administrative subpoenas, demands for information, and inspection authorizations as part of the compliance actions under this part.\n\n(b) Any person who places or receives a rated order or an allocation order must comply with the provisions of this part.\n\n(c) Willful violation of any of the provisions of Title I or section 705 of the Defense Production Act and other applicable statutes, this part, or an official action of FEMA, is a criminal act, punishable as provided in the Defense Production Act and other applicable statutes, and as set forth in \u00a7 333.64 of this part."], ["44:44:1.0.1.6.81.9.10.2", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Compliance", "", "\u00a7 333.61 Audits and investigations.", "FEMA", "", "", "", "(a) Audits and investigations are official actions involving the examination of books, records, documents, other writings and information to ensure that the provisions of the Defense Production Act and other applicable statutes, this part, and official actions have been properly followed. An audit or investigation may also include interviews and a systems evaluation to detect problems or failures in the implementation of this part.\n\n(b) When undertaking an audit, investigation, or other inquiry, FEMA must:\n\n(1) Define the scope and purpose in the official action given to the person under investigation, and\n\n(2) Have ascertained that the information sought, or other adequate and authoritative data are not available from any Federal or other responsible agency.\n\n(c) In administering this part, FEMA may issue the following documents, which constitute official actions:\n\n(1)  Administrative subpoenas.  An administrative subpoena requires a person to appear as a witness before an official designated by FEMA to testify under oath on matters of which that person has knowledge relating to the enforcement or the administration of the Defense Production Act and other applicable statutes, this part, or official actions. An administrative subpoena may also require the production of books, papers, records, documents and physical objects or property.\n\n(2)  Demand for information.  A demand for information requires a person to furnish to a duly authorized representative of FEMA any information necessary or appropriate to the enforcement or the administration of the Defense Production Act and other applicable statutes, this part, or official actions.\n\n(3)  Inspection authorizations.  An inspection authorization requires a person to permit a duly authorized representative of FEMA to interview the person's employees or agents; to inspect books, records, documents, other writings and information, including electronically-stored information, in the person's possession or control at the place where that person usually keeps them or otherwise; and to inspect a person's property when such interviews and inspections are necessary or appropriate to the enforcement or the administration of the Defense Production Act and related statutes, this part, or official actions.\n\n(d) The production of books, records, documents, other writings and information will not be required at any place other than where they are usually kept if, prior to the return date specified in the administrative subpoena or demand for information, a duly authorized official of FEMA is furnished with copies of such material that are certified under oath to be true copies. As an alternative, a person may enter into a stipulation with a duly authorized official of FEMA as to the content of the material.\n\n(e) An administrative subpoena, demand for information, or inspection authorization must include the name, title, or official position of the person to be served, the evidence sought to be adduced, and its general relevance to the scope and purpose of the audit, investigation, or other inquiry. If employees or agents are to be interviewed; if books, records, documents, other writings, or information are to be produced; or if property is to be inspected; the administrative subpoena, demand for information, or inspection authorization will describe them with particularity.\n\n(f) Service of documents must be made in the following manner:\n\n(1) Service of a demand for information or inspection authorization must be made personally, or by certified mail\u2014return receipt requested at the person's last known address. Service of an administrative subpoena must be made personally. Personal service may also be made by leaving a copy of the document with someone at least 18 years of age at the person's last known dwelling or place of business. When a hazard has occurred or is imminent, service of a demand for information or inspection authorization may additionally be made by written electronic communication.\n\n(2) Service upon other than an individual may be made by serving a partner, corporate officer, or a managing or general agent authorized by appointment or by law to accept service of process. If an agent is served, a copy of the document must be mailed to the person named in the document.\n\n(3) Any individual 18 years of age or older may serve an administrative subpoena, demand for information, or inspection authorization. When personal service is made, the individual making the service shall prepare an affidavit as to the manner in which service was made and the identity of the person served, and return the affidavit, and in the case of subpoenas, the original document, to the issuing officer. In case of failure to make service, the reasons for the failure must be stated on the original document."], ["44:44:1.0.1.6.81.9.10.3", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Compliance", "", "\u00a7 333.62 Compulsory process.", "FEMA", "", "", "", "(a) If a person refuses to permit a duly authorized representative of FEMA to have access to any premises or source of information necessary to the administration or enforcement of the Defense Production Act and other applicable statutes, this part, or official actions, FEMA may seek compulsory process. Compulsory process means the institution of appropriate legal action, including  ex parte  application for an inspection warrant or its equivalent, in any forum of appropriate jurisdiction.\n\n(b) Compulsory process may be sought in advance of an audit, investigation, or other inquiry, if, in the judgment of the Administrator, in consultation with the FEMA Chief Counsel, there is reason to believe that a person will refuse to permit an audit, investigation, or other inquiry, or that other circumstances exist which make such process desirable or necessary."], ["44:44:1.0.1.6.81.9.10.4", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Compliance", "", "\u00a7 333.63 Notification of failure to comply.", "FEMA", "", "", "", "(a) At the conclusion of an audit, investigation, or other inquiry, or at any other time, FEMA may inform the person in writing where compliance with the requirements of the Defense Production Act and other applicable statutes, this part, or an official action were not met.\n\n(b) In cases where FEMA determines that a person, either willingly or inadvertently, has failed to comply with the provisions of the Defense Production Act and other applicable statutes, this part, or an official action, the person may be informed in writing of the particulars involved and the corrective action to be taken. Failure to take corrective action may then be construed as a willful violation of the Defense Production Act and other applicable statutes, this part, or an official action."], ["44:44:1.0.1.6.81.9.10.5", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Compliance", "", "\u00a7 333.64 Violations, penalties, and remedies.", "FEMA", "", "", "", "(a) Willful violation of the provisions of Title I or Sections 705 or 707 of the Defense Production Act, this part, or an official action, is a crime and upon conviction, a person may be punished by fine or imprisonment, or both. The maximum penalty provided by the Defense Production Act is a $10,000 fine, or one year in prison, or both.\n\n(b) The government may also seek an injunction from a court of appropriate jurisdiction to prohibit the continuance of any violation of, or to enforce compliance with, the Defense Production Act and other applicable statutes, this part, or an official action.\n\n(c) In order to secure the effective enforcement of the Defense Production Act and other applicable statutes, this part, and official actions, the following are prohibited (see section 705 of the Defense Production Act; see also, for example, sections 2 and 371 of Title 18 United States Code):\n\n(1) No person may solicit, influence, or permit another person to perform any act prohibited by, or to omit any act required by, the Defense Production Act and other applicable statutes, this part, or an official action.\n\n(2) No person may conspire or act in concert with any other person to perform any act prohibited by, or to omit any act required by, the Defense Production Act and other applicable statutes, this part, or an official action.\n\n(3) No person shall deliver any item if the person knows or has reason to believe that the item will be accepted, redelivered, held, or used in violation of the Defense Production Act and other applicable statutes, this part, or an official action. In such instances, the person must immediately notify FEMA that, in accordance with this section, delivery has not been made."], ["44:44:1.0.1.6.81.9.10.6", 44, "Emergency Management and Assistance", "I", "F", "333", "PART 333\u2014EMERGENCY MANAGEMENT PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Compliance", "", "\u00a7 333.65 Compliance conflicts.", "FEMA", "", "", "", "If compliance with any provision of the Defense Production Act and other applicable statutes, this part, or an official action would prevent a person from filling a rated order or from complying with another provision of the Defense Production Act, this part, or an official action, the person must immediately notify FEMA for resolution of the conflict."]], "truncated": false, "filtered_table_rows_count": 94, "expanded_columns": [], "expandable_columns": [], "columns": ["section_id", "title_number", "title_name", "chapter", "subchapter", "part_number", "part_name", "subpart", "subpart_name", "section_number", "section_heading", "agency", "authority", "source_citation", "amendment_citations", "full_text"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select section_id, title_number, title_name, chapter, subchapter, part_number, part_name, subpart, subpart_name, section_number, section_heading, agency, authority, source_citation, amendment_citations, full_text from cfr_sections where \"part_number\" = :p0 order by section_id limit 101", "params": {"p0": "333"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=333", "results": [{"value": 44, "label": 44, "count": 44, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&title_number=44", "selected": false}, {"value": 33, "label": 33, "count": 34, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&title_number=33", "selected": false}, {"value": 21, "label": 21, "count": 16, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&title_number=21", "selected": false}], "truncated": false}, "agency": {"name": "agency", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=333", "results": [{"value": "FEMA", "label": "FEMA", "count": 44, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&agency=FEMA", "selected": false}, {"value": "USACE", "label": "USACE", "count": 34, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&agency=USACE", "selected": false}, {"value": "FDA", "label": "FDA", "count": 16, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&agency=FDA", "selected": false}], "truncated": false}, "part_number": {"name": "part_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=333", "results": [{"value": "333", "label": "333", "count": 94, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "title_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&_facet=title_name"}, {"name": "chapter", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&_facet=chapter"}, {"name": "subchapter", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&_facet=subchapter"}, {"name": "part_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&_facet=part_name"}, {"name": "subpart", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&_facet=subpart"}, {"name": "subpart_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&_facet=subpart_name"}, {"name": "amendment_citations", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=333&_facet=amendment_citations"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 767.9823050275445, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}