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
21:21:6.0.1.1.6.1.1.1,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,A,Subpart A—General Provisions,,§ 510.3 Definitions and interpretations.,FDA,,,"[40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999; 72 FR 41017, July 26, 2007]","As used in this part:

(a) The term  act  means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040  et seq.,  as amended; 21 U.S.C. 321-392).

(b)  Department  means the Department of Health and Human Services.

(c)  Secretary  means the Secretary of Health and Human Services.

(d)  Commissioner  means the Commissioner of Food and Drugs.

(e)  Person  means individuals, partnerships, corporations, and associations.

(f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.

(g) The term  new animal drug  means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed:

(1) The composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a  new animal drug  if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or

(2) The composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

(h) The term  animal feed  means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.

(i) The newness of an animal drug, including a new animal drug intended for use in or on animal feed, may arise by reason of: (1) The newness for its intended drug use of any substance of which the drug is comprised, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component; (2) the newness for its intended drug use of a combination of two or more substances, none of which is itself a new animal drug; (3) the newness for its intended drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new animal drug; (4) the newness for its intended drug use in a different species of animal; (5) the newness of its intended drug use in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the animal body, even though such drug is not a new animal drug when used in another disease or to affect another structure or function of the body; or (6) the newness of a dosage, or method or duration of administration or application, or any other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug or animal feed containing such drug when used in another dosage, or another method or duration of administration or application, or different condition, is not a new animal drug.

(j)  Animals used only for laboratory research  and  laboratory research animals  mean individual animals or groups of animals intended for use and used solely for laboratory research purposes, regardless of species, and does not include animals intended to be used for any food purposes or animals intended to be kept as livestock.

(k)  Sponsor  means the person requesting designation for a minor-use or minor-species drug as defined in part 516 of this chapter, who must be the real party in interest of the development and the intended or actual production and sales of such drug (in this context, the sponsor may be an individual, partnership, organization, or association). Sponsor also means the person responsible for an investigation of a new animal drug. In this context, the sponsor may be an individual, partnership, corporation, or Government agency or may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new animal drugs. Sponsor also means the person submitting or receiving approval for a new animal drug application (in this context, the sponsor may be an individual, partnership, organization, or association). In all contexts, the sponsor is responsible for compliance with applicable provisions of the act and regulations."
21:21:6.0.1.1.6.1.1.2,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,A,Subpart A—General Provisions,,§ 510.4 Biologics; products subject to license control.,FDA,,,,"An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151  et seq.  ) and any regulations issued thereunder shall not be deemed to be subject to section 512 of the Federal Food, Drug, and Cosmetic Act."
21:21:6.0.1.1.6.1.1.3,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,A,Subpart A—General Provisions,,§ 510.7 Consignees of new animal drugs for use in the manufacture of animal feed.,FDA,,,"[40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999]","(a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time of its removal from the establishment of a manufacturer, packer, or distributor of such drug, such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or a notice from the Secretary, to the effect that with respect to the use of such drug in animal feed the consignee:

(1) Holds a license issued under § 515.20 of this chapter; or

(2) Will, if the consignee is not the user of the drug, ship such drug only to a holder of an approved application under § 515.10 of this chapter.

(b) The requirements of paragraph (a) of this section do not apply:

(1) Where such drugs are intended for export and/or

(2) When the use of such drug in the manufacture of a finished feed has been exempted from the requirements of section 512(m) of the act under the conditions specified by regulations published in part 558 of this chapter."
21:21:6.0.1.1.6.1.1.4,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,A,Subpart A—General Provisions,,§ 510.95 [Reserved],FDA,,,,
21:21:6.0.1.1.6.2.1.1,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,B,Subpart B—Specific Administrative Rulings and Decisions,,§ 510.105 Labeling of drugs for use in milk-producing animals.,FDA,,,"[40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998; 64 FR 51241, Sept. 22, 1999]","(a) Part 526 of this chapter provides for new animal drugs intended for intramammary use in animals and includes conditions of use intended to prevent the contamination of milk from the use of such drugs.

(b) Preparations containing antibiotics and other potent drugs labeled with directions for use in milk-producing animals will be misbranded under section 502(f)(2) of the act unless their labeling bears appropriate warnings and directions for use to avoid adulteration of milk under section 402(a)(2)(c)(ii) of the act.

(c) It is the position of the Food and Drug Administration that the labeling for such preparations should bear a clear warning that either:

(1) The article should not be administered to animals producing milk, since to do so would result in contamination of the milk; or

(2) The label should bear the following statement: “Warning: Milk that has been taken from animals during treatment and for __ hours after the latest treatment must not be used for food”, the blank being filled in with the figure that the manufacturer has determined by appropriate investigation is needed to insure that the milk will not carry violative residues resulting from use of the preparation. If the use of the preparation as recommended does not result in contamination of the milk, neither of the above warning statements is required."
21:21:6.0.1.1.6.2.1.2,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,B,Subpart B—Specific Administrative Rulings and Decisions,,§ 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.,FDA,,,"[63 FR 32980, June 17, 1998]","Whenever the labeling of an antibiotic drug included in the regulations in this chapter suggests or recommends its use in milk-producing animals, the label of such drugs shall bear either the statement “Warning: Not for use in animals producing milk, since this use will result in contamination of the milk” or the statement “Warning: Milk that has been taken from animals during treatment and for __hours after the latest treatment must not be used for food”, the blank being filled in with the figure that the Commissioner has authorized the manufacturer of the drug to use. The Commissioner shall determine what such figures shall be from information submitted by the manufacturer and which the Commissioner considers is adequate to prove that period of time after the latest treatment that the milk from treated animals will contain no violative residues from use of the preparation. If the Commissioner determines from the information submitted that the use of the antibiotic drug as recommended does not result in its appearance in the milk, the Commissioner may exempt the drug from bearing either of the above warning statements."
21:21:6.0.1.1.6.2.1.3,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,B,Subpart B—Specific Administrative Rulings and Decisions,,§ 510.110 Antibiotics used in food-producing animals.,FDA,,,"[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 64 FR 403, Jan. 5, 1999]","(a) The Food and Drug Administration in the interest of fulfilling its responsibilities with regard to protection of the public health has requested an evaluation of the public health aspects of the use of antibiotics in veterinary medical and nonmedical uses. There is particular concern with regard to the potential hazards associated with the extensive use of antibiotics administered to food-producing animals. Accordingly, an ad hoc committee on the Veterinary Medical and Nonmedical Uses of Antibiotics was established by the Food and Drug Administration to study and advise the Commissioner of Food and Drugs on the uses of antibiotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with respect to their safety and effectiveness.

(b) Based upon an evaluation of the conclusions of said Committee and other relevant material, § 510.112 was published in the  Federal Register  of August 23, 1966 (31 FR 11141), asking sponsors of drugs containing any antibiotic intended for use in food-producing animals to submit data to establish whether such antibiotic and its metabolites are present as residues in edible tissues, milk, and eggs from treated animals. The data on the residues of antibiotics in milk from intramammary infusion preparations were requested within 60 days and the data on all other products were requested within 180 days following the date of publication of § 510.112 in the  Federal Register.

(c) An evaluation of the data now available shows that use of many antibiotic preparations cause residues in edible products of treated animals for varying and, in some cases, for long periods of time following the last administration. Because of the accumulation of new information with regard to the development of resistance of bacteria to antibiotics, the ability of bacteria to transfer this resistance, and the development of sensitivity to antibiotics in humans, unauthorized and unsafe residues of antibiotics cannot be permitted in food obtained from treated animals.

(d) Based on evaluation of information available, including the conclusions of the aforementioned ad hoc Committee, the Commissioner concludes that antibiotic preparations intended for use in food-producing animals, other than topical and ophthalmic preparations, are not generally recognized among qualified experts as having been shown to be safe for their intended use(s) within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act.

(e) Therefore, all exemptions from the provisions of section 409 of the act for use of antibiotics in food-producing animals based on sanctions or approvals granted prior to enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929; 72 Stat. 1784) will be revoked and the uses which are concluded to be safe will be covered by food additive regulations. On those products for which there are inadequate residue data, actions will be initiated to withdraw approval of new-drug applications under the provisions of section 505 of the act. Antibiotic preparations, other than those for topical and ophthalmic application in food-producing animals, which are not covered by food additive regulations will be subject to regulatory action within 180 days after publication of the forthcoming revocation order.

(f) Because of the variation in the period of time that antibiotic residues may remain in edible products from treated animals, all injectable, intramammary infusion, intrauterine, and oral preparations, including medicated premixes intended for use in food-producing animals, are deemed to be new drugs as well as food additives."
21:21:6.0.1.1.6.2.1.4,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,B,Subpart B—Specific Administrative Rulings and Decisions,,§ 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data.,FDA,,,"[40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54 FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]","(a) An ad hoc committee, Committee on the Veterinary Medical and Nonmedical Uses of Antibiotics, was formed by the Food and Drug Administration to study, and advise the Commissioner on, the use of antibiotics in veterinary medicine and for various nonmedical purposes as such uses may affect the enforcement of the Federal Food, Drug, and Cosmetic Act with respect to the safety and effectiveness of such substances. A copy of the report may be obtained from the Food and Drug Administration, Office of Public Affairs, Room 15-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.

(b) On the basis of the report of the Committee and other information, sponsors of drugs containing any antibiotic intended for use in food-producing animals shall submit data for determining whether or not such antibiotics and their metabolites are present as residues in edible tissues, milk, and eggs from treated animals; however, in the case of a drug for which such data have already been submitted and for which a regulation has been promulgated under section 409 of the act, only such data as has been accumulated since the issuance of the regulation need be submitted.

(c) The required data shall be submitted within 180 days of the date of publication of this section in the  Federal Register ; except that in the case of data on intramammary infusion preparations the data shall be submitted within 60 days of such publication. Data demonstrating the absence in milk of residues of intramammary infusion preparations when used as directed in their labeling are needed within the 60-day period because of the importance of milk in the human diet.

(d) Regulatory proceedings including revocation of prior sanctions, or actions to suspend or amend new drug or antibiotic approvals granted prior to passage of the Food Additives Amendment of 1958 (72 Stat. 1784), may be initiated with regard to the continued marketing of any antibiotic preparation on which the required information is not submitted within the period of time prescribed by paragraph (c) of this section.

(e) Questions relating to the acceptability of proposed research protocols and assay methods for determining the amount of antibiotic residues in food should be directed to the Director, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855."
21:21:6.0.1.1.6.3.1.1,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.201 Scope.,FDA,,,,"This subpart applies to tolerances for residues of new animal drugs not approved or conditionally approved for use in the United States, but lawfully used in another country and present in imported, animal-derived food and food products."
21:21:6.0.1.1.6.3.1.10,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.213 Administrative stay of action.,FDA,,,,"(a) The Commissioner may at any time, on his or her own initiative or on the request of an interested person under part 10 of this chapter, stay or extend the effective date of a decision to establish, not establish, amend, or revoke an import tolerance.

(b) A request for stay must be submitted in accordance with § 10.20 of this chapter and in the form specified in § 10.35 of this chapter no later than 30 days after public notification of the decision involved. The Commissioner may, for good cause, permit a petition to be filed more than 30 days after public notification of the decision."
21:21:6.0.1.1.6.3.1.2,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.202 Definitions.,FDA,,,,"The following definitions of terms apply when used in this subpart:

CNADA  means an application for conditional approval of a new animal drug submitted under section 571 of the Federal Food, Drug, and Cosmetic Act, and includes all amendments and permissible supplements.

Import tolerance  means a tolerance for a residue of a new animal drug not approved or conditionally approved for use in the United States, but present in any imported edible portion of any animal.

NADA  means a new animal drug application submitted under section 512 of the Federal Food, Drug, and Cosmetic Act, including all amendments and permissible supplements, for approval of a new animal drug.

Request  means a request to establish or amend an import tolerance."
21:21:6.0.1.1.6.3.1.3,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.203 Initiation of a proceeding to establish or amend an import tolerance.,FDA,,,,"(a) Any interested person may request that the Commissioner establish or amend an import tolerance. Such a request must be in the form specified in § 510.205 of this chapter.

(b) The Commissioner may initiate a proceeding to establish or amend an import tolerance on his or her own initiative pursuant to § 10.25(b) of this chapter."
21:21:6.0.1.1.6.3.1.4,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.205 Content and administration of a request.,FDA,,,,"(a) Pertinent information previously submitted to and currently retained in the files of the Food and Drug Administration (FDA) may be incorporated in, and will be considered as part of, a request on the basis of specific reference to such information. If the requester refers to any nonpublic information other than its own, the requester shall obtain a written right of reference to that nonpublic information and submit the right of reference with the request. Any reference to published information offered in support of a request should be accompanied by reprints or copies of such references.

(b) Requests shall be submitted and addressed to the Document Control Unit (HFV-199), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Requests may be submitted in an electronic format as authorized by FDA. See FDA′s Electronic Submissions Gateway website:  https://www.fda.gov/industry/electronic-submissions-gateway.

(c) Any material submitted in a foreign language shall be accompanied by a complete and accurate English translation. Translations of literature printed in a language other than English shall be accompanied by copies of the original publication.

(d) The request must be dated and must be signed by the requester or by his or her authorized attorney, agent, or official and shall state the requester's correspondence address. If the requester or such authorized representative does not reside or have a place of business within the United States, the requester must also furnish the name and post office address of, and the request must be countersigned by, an authorized attorney, agent, or official residing or maintaining a place of business within the United States.

(e) The request must include the following information:

(1) The established name and all pertinent information concerning the new animal drug, including chemical identity and composition of the new animal drug, and its physical, chemical, and biological properties;

(2) The conditions of use for the new animal drug, including the route of administration and dosage, together with all labeling, directions, and recommendations regarding the uses in countries in which the new animal drug is lawfully used;

(3) The proposed import tolerance(s) for residues of the new animal drug;

(4) Human food safety information to support the proposed import tolerance(s) in either of the following forms:

(i) If a permanent maximum residue limit (MRL) has been established by the Codex Alimentarius Committee (Codex MRL), the requester shall provide the permanent Codex MRL and monographs and reports from the Joint Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) of the United Nations and/or monographs and reports from the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) that support the development of the permanent Codex MRL. FDA may request additional information as needed.

(ii) If no permanent Codex MRL has been established, or upon notification by FDA, the requester must provide full reports of investigations made with respect to the human food safety of the new animal drug. A request may be regarded as incomplete unless it includes full reports of adequate tests by all methods reasonably applicable to show whether or not any imported edible portion of any animal receiving the new animal drug will be safe for human consumption. The reports must include detailed data derived from appropriate animal and other biological experiments in which the methods used and the results obtained are clearly set forth, including data submitted to the appropriate regulatory authority in any country where the new animal drug is lawfully used. The request must also include a statement that all such reports have been submitted or contain an explanation of why such reports were not submitted. With respect to each nonclinical laboratory study contained in the request, the requestor must submit either a statement that the study was conducted in compliance with the good laboratory practice regulations set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance, and how this may have impacted the study;

(5) Other human food safety information as deemed necessary by the Commissioner;

(6) A description of practicable methods for determining the quantity, if any, of the new animal drug in or on food, and any substance formed in or on food because of its use;

(7) An environmental assessment under § 25.40 of this chapter; and

(8) Any information required under §§ 500.80 through 500.92 of this chapter (Subpart E, Regulation of Carcinogenic Compounds Used in Food-Producing Animals), where applicable.

(f) A request to amend an established import tolerance must contain information to support each proposed change. The request may omit statements made in the original request for which no change is proposed.

(g) The requester may withdraw the request at any time before the notification provided for in § 510.207(a) of this chapter has been made publicly available."
21:21:6.0.1.1.6.3.1.5,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.206 Review of information supporting actions to establish or amend an import tolerance.,FDA,,,,"In establishing or amending an import tolerance, the Commissioner shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Commissioner to establish tolerances for applications for new animal drugs filed under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. In establishing or amending an import tolerance, the Commissioner will give appropriate consideration to the anticipated residue concentrations and conditions of use of the new animal drug specified."
21:21:6.0.1.1.6.3.1.6,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.207 Disclosure of information submitted in a request.,FDA,,,,"(a) When a request is determined to be complete for FDA's consideration, the Commissioner will provide public notification of the request containing the name of the requester and a brief description of the request in general terms. A copy of the notification will be sent to the requester at the time the information is made available to the public.

(b) Any notification establishing, amending, or revoking an import tolerance will be made publicly available. A summary of the basis for the decision will be publicly released in accordance with the provisions of part 20 of this chapter. If FDA determines that the new animal drug referred to in the request is a new animal drug that induces cancer when ingested by people or animals, and the requester complies with the requirements of §§ 500.80 through 500.92 of this chapter (Subpart E, Regulation of Carcinogenic Compounds Used in Food-Producing Animals), the regulatory method for ascertaining the marker residue in the target tissue will be made publicly available. All information and safety data submitted with the request, or previously submitted information incorporated in, and considered as part of, a request on the basis of specific reference to such information, shall be available for public disclosure, also in accordance with the provisions of part 20 of this chapter. Trade secrets and confidential commercial or financial information are exempted from release under § 20.61 of this chapter."
21:21:6.0.1.1.6.3.1.7,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,"§ 510.209 Establishment, denial, or amendment of an import tolerance.",FDA,,,,"(a) If an import tolerance is established or amended, the Commissioner will provide public notification of the action, which will be effective from the date of public notification. A copy of the notification will be sent to any requestor at the time the information is made available to the public.

(b) If a request to establish or amend an import tolerance is denied, a notification of the denial will be made publicly available, and a copy of the denial letter, including the reasons for such action, will be sent to the requester.

(c) A tolerance established in an approved NADA or conditionally approved CNADA will supersede an existing import tolerance. In the event the conditionally approved CNADA is not renewed or is withdrawn, or such drug does not achieve approval under section 512 of the Federal Food, Drug, and Cosmetic Act within 5 years following the date of the conditional approval, the Agency will reinstate the import tolerance unless § 510.210(a)(1) or (a)(2) is applicable at that time."
21:21:6.0.1.1.6.3.1.8,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.210 Revocation of an import tolerance.,FDA,,,,"(a) The Commissioner, on his or her own initiative or on the petition of an interested person, under § 10.25 of this chapter, may revoke an import tolerance if:

(1) Scientific evidence shows an import tolerance to be unsafe; or

(2) Information demonstrates that the use of a new animal drug under actual use conditions results in food being imported into the United States with residues exceeding the import tolerance.

(b) The Commissioner will provide public notification under § 510.207(b) that will specify the basis for the decision and will be effective at the time the information is made available to the public.

(c) A petition for revocation must be submitted in the form specified in § 10.30 of this chapter."
21:21:6.0.1.1.6.3.1.9,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,C,Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food,,§ 510.212 Administrative reconsideration of action.,FDA,,,,"(a) The Commissioner may at any time, on his or her own initiative or on the petition of an interested person under part 10 of this chapter, reconsider part or all of a decision to establish, not establish, amend, or revoke an import tolerance.

(b) A petition for reconsideration must be submitted in accordance with § 10.20 of this chapter and in the form specified in § 10.33 of this chapter no later than 30 days after the date of public notification of the decision involved. The Commissioner may, for good cause, permit a petition to be filed more than 30 days after public notification of the decision. The petition for reconsideration must demonstrate that relevant information contained in the administrative record was not previously or not adequately considered by the Commissioner. No new information may be included in a petition for reconsideration.

(c) An interested person who wishes to rely on information not included in the administrative record shall submit either a petition to amend an import tolerance under § 510.205 or to revoke an import tolerance under § 510.210 and § 10.25 of this chapter."
21:21:6.0.1.1.6.4.1.1,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,D,Subpart D—Records and Reports,,§ 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.,FDA,,,"[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 72 FR 69121, Dec. 6, 2007]","Records and reports of clinical and other experience with the new animal drug will be maintained and reported, appropriately identified with the new animal drug application(s) or index listing(s) to which they relate, to the Center for Veterinary Medicine in duplicate in accordance with the following:

(a) Immediately upon receipt by the applicant, complete records or reports covering information of the following kinds:

(1) Information concerning any mixup in the new animal drug or its labeling with another article.

(2) Information concerning any bacteriological or any significant chemical, physical, or other change or deterioration in the drug, or any failure of one or more distributed batches of the drug to meet the specifications established for it in the new animal drug application or request for determination of eligibility for indexing.

(b) As soon as possible, and in any event within 15 working days of its receipt by the applicant, complete records or reports concerning any information of the following kinds:

(1) Information concerning any unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidence or severity thereof associated with clinical uses, studies, investigations, or tests, whether or not determined to be attributable to the new animal drug, except that this requirement shall not apply to the submission of information described in a written communication to the applicant from the Food and Drug Administration as types of information that may be submitted at other designated intervals.  Unexpected  as used in this paragraph refers to conditions or developments not previously submitted as part of the new animal drug application or in support of the index listing or not encountered during clinical trials of the drug, or conditions or developments occurring at a rate higher than shown by information previously submitted as part of the new animal drug application or in support of the index listing or at a rate higher than encountered during such clinical trials.

(2) Information concerning any unusual failure of the new animal drug to exhibit its expected pharmacological activity."
21:21:6.0.1.1.6.4.1.2,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,D,Subpart D—Records and Reports,,§ 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.,FDA,,,"[64 FR 63203, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007]","Each applicant shall maintain in a single accessible location:

(a) A copy of the approved medicated feed mill license (Form FDA 3448) on the premises of the manufacturing establishment; and

(b) Approved or index listed labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated."
21:21:6.0.1.1.6.5.1.1,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,E,Subpart E—Requirements for Specific New Animal Drugs,,"§ 510.410 Corticosteroids for oral, injectable, and ophthalmic use in animals; warnings and labeling requirements.",FDA,,,"[49 FR 48535, Dec. 13, 1984]","(a) The Food and Drug Administration has received reports of side effects associated with the oral, injectable, and ophthalmic use of corticosteroid animal drugs. The use of these drugs administered orally or by injection has resulted in premature parturition when administered during the last trimester of pregnancy. Premature parturition may be followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids used in dogs, rabbits, and rodents during pregnancy have produced cleft palate in offspring. Use in dogs has resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca. Drugs subject to this section are required to carry the veterinary prescription legend and are subject to the labeling requirements of § 201.105 of this chapter.

(b) In view of these potentially serious side effects, the Food and Drug Administration has concluded that the labeling on or within packaged corticosteroid-containing preparations intended for animal use shall bear conspicuously the following warning statement:

Warning:  Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
 
 Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca.

Warning:  Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs, phocomelia, and anasarca."
21:21:6.0.1.1.6.5.1.2,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,E,Subpart E—Requirements for Specific New Animal Drugs,,§ 510.440 Injectable iron preparations.,FDA,,,,"There has been an increasing interest in the use of injectable iron compounds for the prevention or treatment of iron-deficiency anemia in animals. Although some such preparations have been shown to be safe, such articles are regarded as new animal drugs within the meaning of the Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new animal drug application is required prior to the marketing of such preparations within the jurisdiction of the act. In addition to the need for demonstrating the safety of such articles, the labeling of such preparations should not only recommend appropriate dosages of iron but also declare the amount (in milligrams) of available iron (Fe) per milliliter of the subject product."
21:21:6.0.1.1.6.5.1.3,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,E,Subpart E—Requirements for Specific New Animal Drugs,,§ 510.455 Requirements for free-choice medicated feeds.,FDA,,,"[69 FR 30197, May 27, 2004, as amended at 72 FR 69121, Dec. 6, 2007]","(a)  What is free-choice medicated feed?  For the purpose of this part, free-choice medicated feed is medicated feed that is placed in feeding or grazing areas and is not intended to be consumed fully at a single feeding or to constitute the entire diet of the animal. Free-choice feeds include, but are not limited to, medicated blocks (agglomerated feed compressed or rendered into a solid mass and cohesive enough to hold its form), mineral mixes, and liquid feed tank supplements (“lick tank” supplements) containing one or more new animal drugs. The manufacture of medicated free-choice feeds is subject to the current good manufacturing practice regulations in part 225 of this chapter for medicated feeds.

(b)  What is required for new animal drugs intended for use in free-choice feed?  Any new animal drug intended for use in free-choice feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)) or listed in the index under section 572 of the act (21 U.S.C. 360ccc-1). Such approvals under section 512 of the act must be:

(1) An original new animal drug application (NADA),

(2) A supplemental NADA, or

(3) An abbreviated NADA.

(c)  What are the approval requirements under section 512 of the act for new animal drugs intended for use in free-choice feed?  An approval under section 512 of the act for a Type A medicated article intended for use in free-choice feed must contain the following information:

(1) Data, or reference to data in a master file (MF), showing that the target animal consumes the new animal drug in the Type C free-choice feed in an amount that is safe and effective (consumption/effectiveness data); and

(2) Data, or reference to data in an MF, showing the relevant ranges of conditions under which the drug will be chemically and physically stable in the Type C free-choice feed under field conditions.

(d)  How are consumption/effectiveness and/or stability data to be submitted?  The data must be submitted as follows:

(1) Directly in the NADA, by a sponsor; and/or

(2) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder.

(e)  What will be stated in the published approval for a new animal drug intended for use in free-choice feed?  The approval of a new animal drug intended for use in free-choice feed, as published in this subchapter, will include:

(1) The formula and/or specifications of the free-choice medicated feed, where the owner of this information requests such publication, or

(2) A statement that the approval has been granted for a proprietary formula and/or specifications.

(f)  When is a medicated feed mill license required for the manufacture of a free-choice medicated feed?  An approved medicated feed mill license is required for the manufacture of the following types of feeds:

(1) All free-choice medicated feeds that contain a Category II drug, and

(2) Free-choice medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications."
21:21:6.0.1.1.6.7.1.1,21,Food and Drugs,I,E,510,PART 510—NEW ANIMAL DRUGS,G,Subpart G—Sponsors of Approved Applications,,"§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.",FDA,,,"[40 FR 13807, Mar. 27, 1975]","(a) Section 512(i) of the act requires publication of names and addresses of sponsors of approved applications for new animal drugs.

(b) In this section each name and address is identified by a numerical drug labeler code. The labeler codes identify the sponsors of the new animal drug applications associated with the regulations published pursuant to section 512(i) of the act. The codes appear in the appropriate regulations and serve as a reference to the names and addresses listed in this section. The drug labeler code is established pursuant to section 510 of the act.

(c) The names, addresses, and drug labeler codes of sponsors of approved new animal drug applications are as follows:

(1) Alphabetical Listing of Sponsors

(2) Numerical Listing of Sponsors"
24:24:3.1.1.2.2.0.1.1,24,Housing and Urban Development,V,B,510,PART 510—SECTION 312 REHABILITATION LOAN PROGRAM,,,,§ 510.1 Multi-family property loans.,HUD,,,"[44 FR 21751, Apr. 11, 1979, as amended at 44 FR 47513, Aug. 13, 1979; 44 FR 55562, Sept. 27, 1979. Redesignated and amended at 61 FR 7061, Feb. 23, 1996]","(a) In cases in which a corporation is a borrower on a section 312 loan, the Assistant Secretary for CPD or his designee may require an officer of the corporation or a principal stockholder to personally guarantee the section 312 loan or to cosign the loan note as a borrower, where necessary to make the finding of acceptable risk required for assumption of the loan.

(b) All partners of any partnership which is a borrower on a section 312 loan shall be personally liable for repayment of the section 312 loan. Limited partners shall assume personal liability by co-signing the loan note as a borrower or by personally guaranteeing the loan.

(c) Any personal guarantee or endorsement shall not relieve the partnership or corporate borrower from securing the section 312 loan by a mortgage or deed of trust on the property to be rehabilitated."
29:29:3.1.1.1.10.1.88.1,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,A,Subpart A—General,,§ 510.1 Summary.,DOL-WHD,,,,"(a) The Fair Labor Standards Amendments of 1989 (Pub. L. 101-157) were enacted into law on November 17, 1989. Among other provisions, these amendments to the Fair Labor Standards Act (FLSA) increased the minimum wage in section 6(a)(1) of the Act to $3.80 an hour effective April 1, 1990, and to $4.25 an hour effective April 1, 1991. With respect to certain industries and governmental entities in the Commonwealth of Puerto Rico, the Amendments provided that these increases would be phased in over extended periods of time.

(b) Section 6(c) of the FLSA provides for four separate categories or tiers for implementing the minimum wage rate increases in Puerto Rico.

(1) For Tier 1, which includes employees of the United States, employees of hotels, motels, or restaurants, retail or service establishments that employ such employees primarily in connection with the preparation or offering of food or beverages for human consumption, and industries in which the average hourly wage is greater than $4.64, there shall be no phase-in. The wage rates and effective dates shall be those specified in section 6(a)(1) of FLSA, i.e., $3.80 per hour beginning April 1, 1990 and $4.25 per hour beginning April 1, 1991.

(2) For Tier 2, which includes industries in which the average hourly wage is not less than $4.00 but not more than $4.64, the increases in the minimum wage rates shall be phased-in in five annual increments (rounded to the nearest 5 cents) beginning April 1, 1990, and ending April 1, 1994.

(3) For Tier 3, which includes industries in which the average hourly wage is less than $4.00, the increases in the minimum wage shall be phased-in in six annual increments (rounded to the nearest 5 cents) beginning April 1, 1990, and ending April 1, 1995.

(4) For Tier 4, which includes certain employees of the Commonwealth of Puerto Rico, municipalities, and other governmental entities of the Commonwealth in which the average hourly wage is less than $4.00, the increases shall be phased-in in seven annual increments (rounded to the nearest 5 cents) beginning April 1, 1990 and ending April 1, 1996.

(c) The Amendments also eliminated reference to Puerto Rico in those sections of FLSA relating to the establishment and conduct of special industry committees which recommend minimum wage rates in certain territories. These sections now apply only to American Samoa. (Industry committee regulations pertaining to American Samoa are found in 29 CFR parts 511 and 697)."
29:29:3.1.1.1.10.1.88.2,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,A,Subpart A—General,,§ 510.2 Purpose and scope of regulations.,DOL-WHD,,,,"(a) The purpose of these regulations is to implement the 1989 Amendments to the FLSA with respect to minimum wage increases in Puerto Rico. These regulations establish the applicable wage rates and effective dates in the four statutory tiers and categorize industries and governmental entities in Puerto Rico in those tiers according to average hourly wage rates. In addition, these regulations explain the methodology used to determine appropriate tiers, including the use of standard industrial classification (SIC) codes to categorize industries.

(b) Subpart A of this part summarizes the provisions of the Amendments as applicable to Puerto Rico and defines the terms used herein. Subpart B of this part states the specific minimum wage rates for each tier and the effective dates of those rates. Subpart C of this part explains how industry and governmental categories were determined, the general methodology used to conduct the surveys which provided the data used to determine average hourly wage rates, and special issues in the classification of governmental entities. Appendix A of this part contains a listing of manufacturing industries by Standard Industrial Classification (SIC) code and indicates the tier to which each industry is subject. Appendix B of this part contains a listing of nonmanufacturing industries by SIC code and indicates the tier to which each industry is subject. Appendix C of this part contains a listing of government corporations and indicates the tier to which each such corporation is subject. Appendix D of this part contains a listing of municipalities and indicates the tier to which each municipality is subject.

(c) Nothing contained in this part should be construed as precluding the Puerto Rico Minimum Wage Board, which has been granted authority to promulgate minimum wage rates above the Federal statutory minimum, from providing for increases in any industry which would exceed the rates provided for in these regulations or in section 6(a)(1) of the Act."
29:29:3.1.1.1.10.1.88.3,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,A,Subpart A—General,,§ 510.3 Definitions.,DOL-WHD,,,,"(a)  Act  or  FLSA  means the Fair Labor Standards Act of 1938, as amended (29 U.S.C. 201,  et seq. ).

(b)  Amendments  or  1989 Amendments  means the Fair Labor Standards Amendments of 1989 (Pub. L. 101-157).

(c)  Secretary  means the Secretary of Labor, or a duly authorized representative of the Secretary.

(d)  Administrator  means the Administrator of the Wage and Hour Division of the Employment Standards Administration, U.S. Department of Labor, or a duly authorized representative of the Administrator.

(e)  Department  means the U.S. Department of Labor.

(f)  Tier  means one of the four categories established for an extended phase-in of the statutory increases in the minimum wage under section 6(c) of the Act as amended.

(g)  Standard Industrial Classification (SIC)  refers to the classifications established in the  Standard Industrial Classification Manual, 1987,  published by the Office of Management and Budget, Executive Office of the President."
29:29:3.1.1.1.10.2.88.1,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,B,Subpart B—Schedule of Minimum Wage Rates Applicable in Puerto Rico,,§ 510.10 Table of wage rates and effective dates.,DOL-WHD,,,,"(a) The following table provides effective dates of minimum wage increases for the four statutory tiers. Appendices A and B to these regulations contain listings of manufacturing and non-manufacturing industries in Puerto Rico by SIC code, and indicate which tier is applicable. Appendices C and D contain listings of government corporations and municipalities and indicate which tier is applicable.

Effective Dates

(b) Tier 1 applies to employees of the United States, employees of hotels, motels, or restaurants, retail or service establishments that employ such employees primarily in connection with the preparation or offering of food or beverages for human consumption, and industries in which the average hourly wage is greater than $4.64.

(c) Tier 2 applies to industries in which the average hourly wage is not less than $4.00 but not more than $4.64.

(d) Tier 3 applies to industries in which the average hourly wage is less than $4.00.

(e) Tier 4 applies to certain employees of the Commonwealth of Puerto Rico, municipalities, and other governmental entities of the Commonwealth in which the average hourly wage is less than $4.00."
29:29:3.1.1.1.10.3.88.1,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,C,Subpart C—Classification of Industries,,§ 510.20 Wage surveys in Puerto Rico.,DOL-WHD,,,"[55 FR 12120, Mar. 30, 1990, as amended at 55 FR 53247, Dec. 27, 1990]","(a) The legislative history to the 1989 Amendments (Conference Report 101-47 on H.R. 2, May 8, 1989) stated that for any industry to qualify for an extended minimum wage phase-in, the government of Puerto Rico would be required to furnish official survey data substantiating that an industry's average hourly wage is below either the $4.65 or $4.00 threshold level. Such data were to be compiled and submitted for review to the Department.

(b)  Manufacturing industries.  For purposes of implementing section 6(c) of the Act, as amended, Puerto Rico has submitted its Census of Manufacturing Industries. The Bureau of Labor Statistics of Puerto Rico regularly gathers data from manufacturing establishments regarding employment, hours and earnings. The data include hourly earnings for production and related workers and are generally specific to the four-digit SIC code level.

(c)  Non-manufacturing industries.  The Bureau of Labor Statistics of Puerto Rico designed and executed a survey to supplement data regularly gathered for the U.S. Bureau of Labor Statistics ( i.e. , that included in the payroll establishment survey published in  Employment and Earnings ). The supplemental survey was carried out to determine average hourly earnings for production workers or non-supervisory employees in the private non-agricultural, non-manufacturing sector. Employment and payroll information was collected for the payroll period which included April 12, 1989. The data provided to the Department were generally specific to the four-digit SIC code level.

(d)  Agriculture.  At the request of the Department, the Bureau of Labor Statistics of Puerto Rico conducted a survey of wages paid to agricultural workers which included employment and earnings from at least a specified number of sugarcane farms, coffee farms, ornamental farms, vegetable farms, and other farms, following standard statistical random sampling techniques. The survey included information on earnings, employment, and hourly wage rates paid to workers for the workweek including March 11 through March 17, 1990. In addition, applicable collective bargaining agreements were reviewed for sugarcane farms.

(e)  Commonwealth government.  In the case of the Commonwealth Government of Puerto Rico, a census of hourly earnings was undertaken of all government departments, commissions and other agencies. A separate survey was conducted of government corporations. Managers, officials and employees in positions which require a college degree were excluded from the surveys.

(f)  Municipalities.  In the case of the municipalities of Puerto Rico, a census of hourly earnings was conducted. Managers, officials and employees in positions which require a college degree were excluded from the survey."
29:29:3.1.1.1.10.3.88.2,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,C,Subpart C—Classification of Industries,,§ 510.21 SIC codes.,DOL-WHD,,,"[55 FR 12120, Mar. 30, 1990; 55 FR 12778, Apr. 5, 1990, as amended at 69 FR 18803, Apr. 9, 2004]","(a) The Conference Report specifically cites Puerto Rico's annual Census of Manufacturing Industries as a source of average hourly wage data by industry. Industries in that census are organized by Standard Industrial Classification (SIC), the statistical classification system used for a variety of governmental and statistical purposes. With respect to non-manufacturing industries, or other industries not included in the Census of Manufacturing, the Conference Report stated that data “should be at a level of specificity comparable to the four digit Standard Industry Code (SIC) code level.”

(b) The Standard Industrial Classification (SIC) codes listed in appendix A and B herein are designated in accordance with the Standard Industrial Classification (SIC) Manual, 1987, published by the Executive Office of the President, Office of Management and Budget. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161. Copies may be inspected at all federal depository libraries in the Commonwealth of Puerto Rico; at the district office of the Wage and Hour Division, U.S. Department of Labor, New San Juan Office Building, 159 Chardon St., room 102, Hato Rey, PR 00918; at the Commonwealth of Puerto Rico Department of Labor and Human Resources, Prudencio Rivera Building, Munoz Rivera Avenue 505, Mato Rey, PR 00918; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.  Establishments are classified according to their primary activity. The classification structure classifies industries by:

(1) Two-digit major group,

(2) Three digit industry group, or

(3) Four-digit industry code, according to the level of industrial detail which may be required.

Each operating establishment is assigned an industry code on the basis of its primary activity, which is determined by its principal product or group of products produced or distributed, or services rendered."
29:29:3.1.1.1.10.3.88.3,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,C,Subpart C—Classification of Industries,,§ 510.22 Industries eligible for minimum wage phase-in.,DOL-WHD,,,"[55 FR 12120, Mar. 30, 1990; 55 FR 12778, Apr. 5, 1990]","(a) Appendix A contains a listing of all industries included in the Census of Manufacturing. Appendix B contains a listing of non-manufacturing industries. These listing are organized by SIC numbers, presented by:

(1) Major group (two-digit classification),

(2) Industry group (three-digit classification), and (3) industry (four-digit classification). In each instance the phase-in tier which applies to that industry or group is indicated.

(b) Employers are required to utilize the most detailed classification which applies to their industry. Where an employer's four-digit SIC code is listed, the tier applicable to that code determines the minimum wage phase-in schedule for that employer. (See § 510.10, above).

(c) Where an industry is not listed by four-digit SIC code, employers shall utilize the three-digit which applies to their industry. If a three-digit code is not listed, employers shall use the applicable two-digit code."
29:29:3.1.1.1.10.3.88.4,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,C,Subpart C—Classification of Industries,,§ 510.23 Agricultural activities eligible for minimum wage phase-in.,DOL-WHD,,,"[55 FR 53247, Dec. 27, 1990]","Agriculture activities eligible for an extended phase-in of the minimum wage in Major groups 01, 02, and 07 have been incorporated into Appendix B—Nonmanufacturing Industries Eligible for Minimum Wage Phase-In. Applicable wage rates are effective retroactive to April 1, 1990. Employers in the sugarcane farming industry (SIC Number 0133) who are subject to Tier 3 wage rates but who have paid wage rates based on Tier 2 wage rates may not take any action to recoup such payments where those actions would have the effect of reducing the wage rate being paid at the time of such recoupment to below that required under Tier 3."
29:29:3.1.1.1.10.3.88.5,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,C,Subpart C—Classification of Industries,,§ 510.24 Governmental entities eligible for minimum wage phase-in.,DOL-WHD,,,"[55 FR 12120, Mar. 30, 1990; 55 FR 12778, Apr. 5, 1990]","(a) The Commonwealth government of Puerto Rico has been determined to be eligible for treatment under Tier 2, on the basis of wage data supplied to the Department.

(b) Appendix C of this part contains a listing of Commonwealth government corporations, indicating the phase-in tier which applies. Entities which do not appear on the list are those for which no wage data were supplied. These entities are therefore categorized under Tier 1, and are ineligible for an extended phase-in.

(c) Appendix D of the part contains a listing of municipalities, indicating the phase-in tier which applies. Municipalities categorized under Tier 1 are those which failed to supply wage data.

(d) Employees of municipalities who have reason to believe that the municipality by which they are employed has been incorrectly categorized, e.g., categorized under Tier 3 instead of Tier 2, may no later than June 1, 1990, file with the Administrator a petition for review. The petition shall be accompanied by any information the employee may have to support a determination that the municipality is incorrectly categorized. In the event the Administrator determines that a tier other than that listed in appendix D of this part applies, the affected municipality shall be liable for retroactive payment of any back wages found to be due.

(e) Certain employees of municipalities or government corporations in which the average wage is less than $4.00 per hour are eligible to be paid under Tier 4, rather than Tier 3. Tier 4 applies only to those employees employed by municipalities or government corporations who are principally engaged in one or more of the “traditional” functions listed in § 510.24 (a) or (b). All other employees of such entities must be paid in accordance with Tier 3."
29:29:3.1.1.1.10.3.88.6,29,Labor,V,A,510,PART 510—IMPLEMENTATION OF THE MINIMUM WAGE PROVISIONS OF THE 1989 AMENDMENTS TO THE FAIR LABOR STANDARDS ACT IN PUERTO RICO,C,Subpart C—Classification of Industries,,§ 510.25 Traditional functions of government.,DOL-WHD,,,,"(a) Section 6(c)(4) of the Act, as amended, limits the six-year phase-in of the statutory minimum wage (“Tier 4”) to those employees with an average wage of less than $4.00 per hour who were brought under minimum wage coverage “pursuant to an amendment made by the Fair Labor Standards Amendments of 1985.” The Department has interpreted this language as referring to section 2(c) of the 1985 FLSA Amendments, which provided for deferred liability for minimum wage violations (until April 15, 1986) “with respect to any employee who would not have been covered under the Secretary's special enforcement policy” published in 29 CFR 775.2 and 775.4. The latter subsection listed those functions of State or local government which were determined by the Supreme Court's ruling in  National League of Cities  v.  Usery,  426 U.S. 833 (1976) (subsequently overruled by  Garcia  v.  San Antonio Metropolitan Transit Authority,  469 U.S. 528 (1985)) to be integral operations of the governments in areas of traditional governmental functions. The listed “traditional” functions included the following:

(1) Schools.

(2) Hospitals.

(3) Fire prevention.

(4) Police protection.

(5) Sanitation.

(6) Public health.

(7) Parks and recreation.

(8) Libraries.

(9) Museums.

(b) The Supreme Court in  National League of Cities  clearly did not limit “traditional” functions of government to those set out in paragraph (a) of this section. The Court included within this concept all those governmental services which the States and their political subdivisions have traditionally afforded their citizens, which the States have regarded as integral parts of their governmental activities, and which State and local governments are created to provide. The Department interprets the Court's analysis of “traditional” functions as turning in large part upon whether the States or local governments had, prior to initial enactment of federal regulatory legislation applicable to a particular field of service or activity (such as FLSA), generally established themselves as providers of the services. The Department therefore views the following government functions as falling within the “traditional” category:

(1) Finance (including Auditor, Budget and Comptroller).

(2) Elections.

(3) Personnel.

(4) Public works.

(5) Office of the Mayor.

(6) Legal Affairs.

(7) Planning.

(8) Waterworks.

(9) Social services.

(10) Street and highway construction and maintenance.

(11) Automobile licensing.

(12) Sewage treatment.

(c) Employees whose primary function falls within one or more of the activities listed in paragraph (a) or (b) of this section, are therefore considered to be engaged in “traditional” functions of government. This would include employees who provide support functions for such activities, such as clerical, secretarial, supply and janitorial.

(d) No employees of a municipality or government corporation may be paid in accordance with the Tier 4 phase-in schedule unless the employee:

(1) Is engaged in one of the specific activities listed in paragraphs (a) and (b) of this section, and

(2) Is employed by a municipality or government corporation in which the average wage is less than $4.00 per hour."
49:49:6.1.2.3.4.0.1.1,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.1 Scope and purpose.,NHTSA,,,,"This rule governs the use of the information gathering powers of the National Highway Traffic Safety Administration contained in section 112 of the National Traffic and Motor Vehicle Safety Act of 1966, as amended 15 U.S.C. 1401, and sections 104, 204, 414, and 505 of the Motor Vehicle Information and Cost Savings Act, as amended 15 U.S.C. 1914, 1944, 1990d, and 2005."
49:49:6.1.2.3.4.0.1.10,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.10 Supplementation of responses to process.,NHTSA,,,,"(a) A person, sole proprietorship, partnership, corporation, or other entity which has provided NHTSA with information under this part, which information was complete and accurate at the time the information was given to NHTSA, is not required to supplement that information in the light of after acquired information, except:

(1) The person or entity to whom the process is addressed shall supplement the response with respect to any question directly addressed to the identity and location of persons having knowledge of information obtainable under this part.

(2) The person or entity to whom the process is addressed shall seasonably amend a prior response if that person or entity obtains information upon the basis of which the person or entity knows that the response was incorrect when made or the person or entity knows that the response, though correct when made, is no longer true and the circumstances are such that a failure to amend the response is in substance a knowing concealment.

(b) The requirement to supplement information set forth in paragraph (a) of this section terminates when:

(1) The compulsory process stated that it was issued in connection with a contemplated rulemaking action, and a final rule is issued on that subject or a notice is issued announcing that the rulemaking action has been suspended or terminated.

(2) The compulsory process stated that it was issued in connection with an enforcement investigation, and the investigation is closed.

(3) The compulsory process does not state that it is issued in connection with a specific rulemaking action or enforcement investigation, and 18 months have passed since the date of the original response.

(c) This section in no way limits NHTSA's authority to obtain supplemental information by specific demands through the means specified in § 510.3."
49:49:6.1.2.3.4.0.1.11,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.11 Fees.,NHTSA,,,,"Any person compelled to appear in person in response to a subpoena issued under this part at an information gathering hearing or an administrative deposition is paid the same attendance and mileage fees as are paid witnesses in the courts of the United States, in accordance with title 28, U.S.C., section 1821."
49:49:6.1.2.3.4.0.1.12,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.12 Remedies for failure to comply with compulsory process.,NHTSA,,,,"Any failure to comply with compulsory process authorized by law and issued under this part is a violation of this part. In the event of such failure to comply, NHTSA may take appropriate action pursuant to the authority conferred by the National Traffic and Motor Vehicle Safety Act or the Motor Vehicle Information and Cost Savings Act, as appropriate, including institution of judicial proceedings to enforce the order and to collect civil penalties."
49:49:6.1.2.3.4.0.1.2,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.2 Definitions.,NHTSA,,,"[45 FR 29042, May 1, 1980; 45 FR 32001, May 15, 1980]","(a)  NHTSA  means the National Highway Traffic Safety Administration.

(b)  Administrator  means the Administrator of the National Highway Traffic Safety Administration.

(c)  Chief Counsel  means the Chief Counsel of the National Highway Traffic Safety Administration.

(d)  Deputy Administrator  means the Deputy Administrator of the National Highway Traffic Safety Administration.

(e)  Person  includes agents, officers, and employees of sole proprietorships, partnerships, corporations, and other entities."
49:49:6.1.2.3.4.0.1.3,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,"§ 510.3 Compulsory process, the service thereof, claims for confidential treatment, and terms of compliance.",NHTSA,,,,"(a) NHTSA may use any of the following means to conduct investigations, inspections, or inquiries to obtain information to carry out its functions under the National Traffic and Motor Vehicle Safety Act of 1966, as amended, 15 U.S.C. 1381  et seq.,  and the Motor Vehicle Information and Cost Savings Act, as amended, 15 U.S.C. 1901  et seq. :

(1) Subpoenas;

(2) Information gathering hearings;

(3) Administrative depositions;

(4) General or special orders; and

(5) Written requests for the production of documents and things.

(b) A person, sole proprietorship, partnership, corporation, or other entity served with compulsory process under this part shall be provided with the following information at the time of the service:

(1) The name of the person, sole proprietorship, partnership, corporation, or other entity to which the process is addressed;

(2) The statutory provision under which the compulsory process is issued;

(3) The date, time, and place of return;

(4) A brief statement of the subject matter of the investigation, inspection, or inquiry; and

(5) In the case of a subpoena  duces tecum  or a written request for the production of documents and things, a reasonably specific description of the documents or things to be produced.

(c) Service of the compulsory processes specified in paragraph (a) of this section is effected:

(1) By personal service upon the person, agent-in-charge, or agent designated to receive process under 15 U.S.C. 1399(e) of the sole proprietorship, partnership, corporation or other entity being investigated, inspected, or inquired of; or

(2) By mail (registered or certified) or delivery to the last known residence or business address of such person or agent.

(d) The date of service of any compulsory process specified in paragraph (a) of this section is the date on which the process is mailed by the agency, or delivered in person, as the case may be. Whenever a period is prescribed for compliance with compulsory process, and the process is served upon the party by mail, 3 days are added to the period.

(e)(1) Any person, sole proprietorship, partnership, corporation, or other entity submitting information or producing documents or things in response to any compulsory process issued under this part may request confidential treatment for all or part of that information or for those documents or things.

(2)(i) Except as provided in paragraph (e)(2)(ii) of this section, requests for confidentiality shall be in writing, and addressed to the Chief Counsel.

(ii) Requests for confidentiality made during an information gathering hearing or an administrative deposition may be made orally to the presiding officer. Any oral request for confidentiality shall be supplemented by a written request, and this written request must be addressed to the Chief Counsel and received by NHTSA within five days of the date of the oral request.

(iii) A written request for confidentiality under paragraph (e) of this section shall specify the information, documents, or things which are to be kept confidential, specify the grounds upon which the claim is based, provide such information as may be necessary to permit the NHTSA to determine whether the claim is valid, and specify the period of time for which confidential treatment is requested.

(f) The Chief Counsel, or his or her delegate, is authorized to negotiate and approve the terms of satisfactory compliance with any compulsory process issued under this part."
49:49:6.1.2.3.4.0.1.4,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,"§ 510.4 Subpoenas, generally.",NHTSA,,,"[53 FR 26261, July 12, 1988]","NHTSA may issue to any person, sole proprietorship, partnership, corporation, or other entity a subpoena requiring the production of documents or things (subpoena duces tecum) and testimony of witnesses (subpoena ad testificandum), or both, relating to any matter under investigation or the subject of any inquiry. Subpoenas are issued by the Chief Counsel. When a person, sole proprietorship, partnership, corporation, or other entity is served with a subpoena ad testificandum under this part, the subpoena will describe with reasonable particularity the matters on which the testimony is required. In response to a subpoena ad testificandum, the sole proprietorship, partnership, corporation, or other entity so named shall designate one or more officers, directors, or managing agents, or other persons who consent to testify on its behalf, and set forth, for each person designated, the matters on which he or she will testify. The persons so designated shall testify as to matters known or reasonably available to the entity."
49:49:6.1.2.3.4.0.1.5,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.5 Information gathering hearings.,NHTSA,,,,"(a) NHTSA may issue a subpoena to compel any person, sole proprietorship, partnership, corporation, or other entity to provide information at an information gathering hearing. The subpoenas are used for the purpose of obtaining testimony from a witness under oath and obtaining relevant documents and things. The Administrator, or a NHTSA employee designated by the Administrator, presides at the hearing. Information gathering hearings are open to the public unless the presiding officer rules otherwise, and the hearings are stenographically reported.

(b) In addition to the presiding officer, one or more other persons may comprise the panel. Each member of the panel may question any witness at the hearing. No person who is not a member of the panel may ask questions of a witness. However, any person may submit to the panel, in writing, proposed questions to be asked of a witness. A member of the panel may pose these questions to the witness if that member deems the questions useful and appropriate. Proposed questions may be submitted to the panel at any time before or during the course of the hearing.

(c) The stenographic record of each witness's testimony will be available to the public, unless the testimony was not given publicly and the witness requests confidential treatment for some or all of his or her testimony. When an oral request for confidential treatment is made during the course of a witness's testimony, the presiding officer may order the hearing closed to the public at that point and continue the questioning of the witness, or may note the request for confidentiality and direct the witness not to answer the question at that time, but require the witness to answer the question in writing within some specified period, or take such other action as the presiding officer deems appropriate. If a request for confidential treatment is made, the release of the record is governed by the applicable laws or regulations relating to the handling of allegedly confidential information. To the extent that some or all of a witness's testimony is not publicly available, that witness may procure a copy of his or her testimony as recorded upon payment of lawfully prescribed costs.

(d)(1) Any person who is required by subpoena or designated by an entity that is required by subpoena to provide information at an information gathering hearing conducted under this section may be accompanied, represented, and advised by counsel. Any member of the bar of a Federal court or the courts of any State or Territory of the United States, the Commonwealth of Puerto Rico, or the District of Columbia, and any representative, official, or employee of the sole proprietorship, partnership, corporation or other entity under subpoena may act as counsel.

(2) A witness appearing in response to subpoena may confer in confidence with his or her counsel or representative concerning any questions asked of the witness. If such witness, counsel, or representative objects to a question, he or she shall state the objection and basis therefor on the record.

(e) The presiding officer at an information gathering hearing takes all necessary action to regulate the course of the hearing, to avoid delay, and to assure that reasonable standards of orderly and ethical conduct are maintained. In any case in which counsel for or a representative of a witness has refused to comply with the presiding officer's directions, or to adhere to reasonable standards of orderly and ethical conduct in the course of a hearing, the presiding officer states on the record the reasons given, if any, for the refusal and, if the presiding officer is someone other than the Administrator, immediately reports the refusal to the Administrator. The Administrator thereupon takes such action as the circumstances warrant.

(f) Where appropriate, the procedures established in this subsection may be utilized in informal hearings conducted by NHTSA pursuant to its authority under sections 152 and 156 of the Safety Act (15 U.S.C. 1412, 1416) to receive data, views and arguments concerning alleged safety-related defects. The rights accorded to witnesses in this subsection may also be accorded to witnesses who appear voluntarily at such hearings."
49:49:6.1.2.3.4.0.1.6,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.6 Administrative depositions.,NHTSA,,,,"(a) NHTSA may issue a subpoena to compel any person, sole proprietorship, partnership, corporation, or other entity to provide information as a witness at an administrative deposition. These depositions are for the purpose of obtaining information from the witness under oath and receiving documents and things relevant to an agency investigation. These depositions shall be taken before an officer authorized to administer oaths by the laws of the United States or of the place where the deposition is taken. Unless otherwise ordered by the Administrator, administrative depositions are closed to the public.

(b) Any person who is required by subpoena or designated by an entity that is required by subpoena to produce documents or things or to give testimony as a witness at an administrative deposition conducted under this section may be accompanied, represented, and advised by counsel. Any member of the bar or a Federal court or the courts of any State or Territory of the United States, the Commonwealth of Puerto Rico, or the District of Columbia and any representative, official, or employee of the person, sole proprietorship, partnership, corporation, or other entity under subpoena may act as counsel.

(c) During an administrative deposition:

(1) The presiding officer before whom the deposition is to be taken puts the witness on oath and personally, or by someone acting under his or her direction and in his or her presence, records the testimony of the witness. The testimony is stenographically reported.

(2) After NHTSA has examined the witness at the deposition, that witness' counsel or representative may examine the witness. NHTSA may then reexamine the witness and the witness' counsel or representative may reexamine the witness and so forth, as appropriate.

(3) A witness appearing in response to a subpoena may confer in confidence with his or her counsel or representative concerning any questions asked of the witness. If such witness, counsel, or representative objects to a question, he or she shall state the objection and the basis therefor on the record.

(4) Objections to the qualifications of the officer taking the deposition, or to the manner of taking it, or to the evidence presented, and any other objection to the proceedings shall be noted by the officer on the record, and shall be treated as continuing. Evidence objected to shall be taken subject to the objections. Errors and irregularities occurring at a deposition in the manner of the taking of the deposition, in the form of questions or answers, or in the oath or affirmation, and errors of any kind which might be obviated, removed, or cured if promptly presented shall be deemed to be waived unless reasonable objection is made thereto at the taking of the deposition.

(5) If the witness refuses to answer any question or answers evasively, or if the witness or his or her counsel engages in conduct likely to delay or obstruct the administrative deposition, such refusal, evasive answer or conduct shall be a failure to comply with the subpoena issued to the witness.

(6) Upon completion of the examination of a witness, the witness may clarify on the record any of his or her answers.

(d) The transcript of the testimony of a witness who testified in response to a subpoena at an administrative deposition is submitted to the witness for signature, unless the witness waives the right to sign the transcript. If a witness desires to make any changes in the form or substance contained in the transcript, the witness shall submit, together with the transcript, a separate document setting forth the changes and stating the reasons for such changes. If the deposition is not signed by the witness within 30 days of its submission to the witness, or such other period as the NHTSA may designate, the officer before whom the deposition was taken or a NHTSA employee signs the transcript and states on the record the fact of the waiver of the right to sign or the fact of the witness' unavailability or inability or refusal to sign together with the reasons, if any, given therefor.

(e) The transcript of the testimony of a witness will be inspected by NHTSA to determine if there are any errors in the transcription of the questions posed to the witness and the testimony in response to those questions. If NHTSA discovers any errors, it notes that fact and forwards the notation of errors together with the transcript to the witness, requesting the witness to stipulate that the transcript is in error and that the corrections made by NHTSA are accurate. If the witness will not make this stipulation, NHTSA may make a motion to the presiding officer to include its notation of error and its corrections in the record along with the version of the testimony signed by the witness.

(f)(1) Upon payment of lawfully prescribed costs, any person who is required by subpoena or designated by a sole proprietorship, partnership, corporation, or other entity that is required by subpoena to appear as a witness at an administrative deposition may procure a copy of the deposition as recorded, except that in a nonpublic investigatory proceeding, the witness may, for good cause, be limited to an inspection of the record of the deposition.

(2) A copy of the record of the deposition may be furnished to the witness without charge or at a reduced charge if the Associate Administrator for Administration determines that waiver of the fee is in the public interest because furnishing the copy can be considered as primarily benefitting the general public. Any witness who seeks a waiver of the copying charge may apply in writing to the Associate Administrator for Administration, and shall state the reasons justifying waiver of the fee in the application.

(g) The testimony obtained in an adminstrative deposition may be used or considered by the NHTSA in any of its activities, and may be used or offered into evidence in any administrative proceeding in accordance with the provisions of 5 U.S.C. 554, or in any judicial proceeding."
49:49:6.1.2.3.4.0.1.7,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.7 General or special orders.,NHTSA,,,,"The NHTSA may require by the issuance of general or special orders any person, sole proprietorship, partnership, corporation, or other entity to file with the NHTSA, in such form as NHTSA may prescribe, periodic or special reports or answers in writing to specific questions. The responses to general or special orders will provide NHTSA with such information as it may require, including, but not limited to, information relating to the organization of that person, sole proprietorship, partnership, corporation, or other entity, its business, conduct, practices, management, and relation to any other person or entity. General or special orders which are required to be answered under oath are issued by the Chief Counsel. Any general or special order issued under this section contains the information specified in § 510.3(b). Reports and answers filed in response to general or special orders must be made under oath, or otherwise, as NHTSA may prescribe."
49:49:6.1.2.3.4.0.1.8,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,§ 510.8 Written requests for the production of documents and things.,NHTSA,,,,"The NHTSA may, by the issuance of a written request for the production of documents and things, require any person, sole proprietorship, partnership, corporation, or other entity to produce documents or things. A written request for the production of documents and things may be issued alone, or as a part of a general or special order issued under § 510.7. Written requests for the production of documents and things are issued by the Chief Counsel. Any written request for the production of documents and things issued under this section shall contain the information specified in § 510.3(b)."
49:49:6.1.2.3.4.0.1.9,49,Transportation,V,,510,PART 510—INFORMATION GATHERING POWERS,,,,"§ 510.9 Motions to modify, limit, or quash process.",NHTSA,,,,"(a)(1) Any person, sole proprietorship, partnership, corporation, or other entity served with a subpoena issued under § 510.4 may file with the Deputy Administrator a motion to modify, limit, or quash that subpoena. If there is no Deputy Administrator, or the Deputy Administrator is not available, such motions shall be filed with and decided by the Associate Administrator for Administration. A motion to modify, limit, or quash must be filed not later than 15 days after the service of the process or five days before the return date specified in the process, whichever is earlier, except that, if the process is served within five days of its return date, such motion may be filed at any time before the return date. Any motion must set forth the grounds and theories of why and how the party believes the process should be modified, limited, or quashed and must contain all facts and arguments which support those grounds and theories.

(2) The Deputy Administrator may, upon receiving a motion filed pursuant to paragraph (a)(1) of this section:

(i) Deny the motion;

(ii) Modify the return date of the subpoena;

(iii) Modify, limit or quash the subpoena;

(iv) Condition granting the motion upon certain requirements; or

(v) Take any other action he or she believes to be appropriate in the circumstances.

(3) The Office of the Deputy Administrator serves the decision on the motion on the moving party or the counsel or representative of the moving party. This service may be made by personal service, by registered or certified mail, or by reading a copy of the decision to the moving party or the counsel or representative of the moving party.

(4) A denial of any motion properly filed under this section shall be in writing, and shall contain a brief statement of the facts involved and the conclusions drawn from those facts by the Deputy Administrator.

(b) The Deputy Administrator's decision on the motion to modify, limit, or quash, filed under paragraph (a) of this section is not subject to reconsideration by NHTSA."
50:50:11.0.4.12.3.0.1.1,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.1 Purpose.,MMC,,,,"The regulations prescribed in this part set forth the administrative guidelines and management controls for advisory committees reporting to the Marine Mammal Commission. These regulations are authorized by section 8(a) of the Federal Advisory Committee Act, 5 U.S.C. appendix I. Guidelines and controls are prescribed for calling of meetings, notice of meetings, public participation, closing of meetings, keeping of minutes, and compensation of committee members, their staff and consultants."
50:50:11.0.4.12.3.0.1.2,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.2 Scope.,MMC,,,,These regulations shall apply to the operation of advisory committees reporting to the agency.
50:50:11.0.4.12.3.0.1.3,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.3 Definitions.,MMC,,,,"For the purposes of this part,

(a) The term  Act  means the Federal Advisory Committee Act, 5 U.S.C. appendix I;

(b) The term  Chairperson  means each person selected to chair an advisory committee established by the Commission;

(c) The term  Commission  means the Marine Mammal Commission, established by 16 U.S.C. 1401(a);

(d) The term  committee  means any advisory committee reporting to the Commission; and

(e) The term  Designee  means the agency official designated by the Chairman of the Commission (1) to perform those functions specified by sections 10(e) and (f) of the Act, and (2) to perform such other responsibilities as are required by the Act and applicable regulations to be performed by the “agency head.”"
50:50:11.0.4.12.3.0.1.4,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.4 Calling of meetings.,MMC,,,"[41 FR 3306, Jan. 22, 1976; 41 FR 4020, Jan. 28, 1976]","(a) No committee shall hold any meeting except with the advance approval of the Designee. Requests for approval may be made, and approval to hold meetings may be given orally or in writing, but if approval is given orally, the fact that approval has been given shall be stated in the public notice published pursuant to § 510.5 of these regulations.

(b) An agenda shall be submitted to, and must be approved by, the Designee in advance of each committee meeting, and that meeting shall be conducted in accordance with the approved agenda. The agenda shall list all matters to be considered at the meeting, and shall indicate when any part of the meeting will be closed to the public on the authority of exemptions contained in the Freedom of Information Act, 5 U.S.C. 552(b)."
50:50:11.0.4.12.3.0.1.5,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.5 Notice of meetings.,MMC,,,,"(a) Notice of each committee meeting shall be timely published in the  Federal Register.  Publication shall be considered timely if made at least 15 days before the date of the meeting, except that shorter notice may be provided in emergency situations.

(b) The notice shall state the time, place, schedule and purposes of the committee meeting, and shall include, whenever it is available, a summary of the agenda. The notice shall indicate the approximate times at which any portion of the meeting will be closed to the public and shall include an explanation for the closing of any portion of the meeting pursuant to § 510.7."
50:50:11.0.4.12.3.0.1.6,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.6 Public participation.,MMC,,,,"(a) All committee meetings, or portions of meetings, that are open to the public shall be held at a reasonable time and at a place that is reasonably accessible to the public. A meeting room shall be selected which, within the bounds of the resources and facilities available, affords space to accommodate all members of the public who reasonably could be expected to attend.

(b) Any member of the public shall be permitted to file a written statement with the committee, either by personally delivering a copy to the Chairperson, or by submitting the statement by mail to the Marine Mammal Commission Offices at the address indicated in the notice of meeting. Such statements should be received at least one week in advance of the scheduled meeting at which they are expected to be considered by the committee.

(c) Opportunities will ordinarily be afforded to interested persons to speak to agenda items during that portion of the open meeting during which that item is to be considered by the committee, subject to such reasonable time limits as the committee may establish, and consideration of the extent to which the committee has received the benefit of comments by interested persons, the complexity and the importance of the subject, the time constraints under which the meeting is to be conducted, the number of persons who wish to speak during the meeting, and the extent to which the statement provides the committee with information which has not previously been available and is relevant to its decision or other action on that subject. Interested persons may be required to serve reasonable notice of their intentions to speak so that the committee may assess whether procedures and scheduling for the meeting can be adjusted to accommodate large numbers of participants."
50:50:11.0.4.12.3.0.1.7,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.7 Closed meetings.,MMC,,,,"(a) Whenever the committee seeks to have all or a portion of a meeting closed to the public on the basis of an exemption provided in 5 U.S.C. 552(b), the Chairperson shall notify the Designee at least 30 days before the scheduled date of the meeting. The notification shall be in writing and shall specify all the reasons for closing any part of the meeting.

(b) If, after consultation with the General Counsel of the Commission, the Designee finds the request to be warranted and in accordance with the policy of the Act, the request shall be granted. The determination of the Designee to grant any such request shall be in writing and shall state the specific reasons for closing all or a part of the meeting. Copies of the determination shall be made available to the public upon request."
50:50:11.0.4.12.3.0.1.8,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.8 Minutes.,MMC,,,,"Detailed minutes shall be kept of each portion of each committee meeting. The minutes shall include: the time and place of the meeting; a list of the committee members and staff in attendance; a complete summary of matters discussed and conclusions reached; copies of all reports received, issued, or approved by the committee; a description of the extent to which the meeting was open to the public; and a description of public participation, including a list of members of the public who presented oral or written statements and an estimate of the number of members of the public who attended the open sessions. The Chairperson shall certify to the accuracy of the minutes."
50:50:11.0.4.12.3.0.1.9,50,Wildlife and Fisheries,V,,510,PART 510—IMPLEMENTATION OF THE FEDERAL ADVISORY COMMITTEE ACT,,,,§ 510.9 Uniform pay guidelines.,MMC,,,,"(a) Compensation of members and staff of, and consultants to the Committee of Scientific Advisors on Marine Mammals is fixed in accordance with 16 U.S.C. 1401(e), 1403(b), and 1406.

(b) Compensation for members and staff of, and consultants to all advisory committees reporting to the Commission except the Committee of Scientific Advisors on Marine Mammals shall be fixed in accordance with guidelines established by the Director of the Office of Management and Budget pursuant to section 7(d) of the Act, 5 U.S.C. appendix I."
7:7:6.1.2.1.7.0.1.1,7,Agriculture,V,,510,PART 510—PUBLIC INFORMATION,,,,§ 510.1 General statement.,ARS,,,,"This part is issued in accordance with the regulations of the Secretary of Agriculture in part 1, subpart A of this title and appendix A thereto, implementing the Freedom of Information Act (FOIA) (5 U.S.C. 552). The Secretary's regulations, as implemented by the regulations in this part, govern the availability of records of the Agricultural Research Service (ARS) to the public."
7:7:6.1.2.1.7.0.1.2,7,Agriculture,V,,510,PART 510—PUBLIC INFORMATION,,,,"§ 510.2 Public inspection, copying, and indexing.",ARS,,,,"5 U.S.C. 552(a)(2) requires that certain materials be made available for public inspection and copying and that a current index of these materials be published quarterly or otherwise be made available. Members of the public may request access to such materials maintained by ARS at the following office: Information Staff, ARS, REE, USDA, Room 1-2248, Mail Stop 5128, 5601 Sunnyside Avenue, Beltsville, MD 20705-5128; Telephone (301) 504-1640 or (301) 504-1655; TTY-VOICE (301) 504-1743. Office hours are 8 a.m. to 4:30 p.m. Information maintained in our electronic reading room can be accessed at  http://www.ars.usda.gov/is/foia/#Electronic."
7:7:6.1.2.1.7.0.1.3,7,Agriculture,V,,510,PART 510—PUBLIC INFORMATION,,,,§ 510.3 Requests for records.,ARS,,,,"Requests for records of ARS under 5 U.S.C. 552(a)(3) shall be made in accordance with Subsection 1.5 of this title and submitted to the FOIA Coordinator, Information Staff, ARS, REE, USDA, Mail Stop 5128, 5601 Sunnyside Avenue, Beltsville, MD 20705-5128; Telephone (301) 504-1640 or (301) 504-1655; TTY-VOICE (301) 504-1743; Facsimile (301) 504-1648; e-mail  vherberger@ars.usda.gov  or  shutchison@ars.usda.gov.  The FOIA Coordinator is delegated authority to make determinations regarding such requests in accordance with Subsection 1.3(c) of this title."
7:7:6.1.2.1.7.0.1.4,7,Agriculture,V,,510,PART 510—PUBLIC INFORMATION,,,,§ 510.4 Multitrack processing.,ARS,,,,"(a) When ARS has a significant number of requests, the nature of which precludes a determination within 20 working days, the requests may be processed in a multitrack processing system, based on the date of receipt, the amount of work and time involved in processing the request, and whether the request qualifies for expedited processing.

(b) ARS may establish as many processing tracks as appropriate; processing within each track shall be based on a first-in, first-out concept, and rank-ordered by the date of receipt of the request.

(c) A requester whose request does not qualify for the fastest track may be given an opportunity to limit the scope of the request in order to qualify for the fastest track. This multitrack processing system does not lessen agency responsibility to exercise due diligence in processing requests in the most expeditious manner possible.

(d) ARS shall process requests in each track on a “first-in, first-out” basis, unless there are unusual circumstances as set forth in § 1.16 of this title, or the requester is entitled to expedited processing as set forth in § 1.9 of this title."
7:7:6.1.2.1.7.0.1.5,7,Agriculture,V,,510,PART 510—PUBLIC INFORMATION,,,,§ 510.5 Denials.,ARS,,,,"If the FOIA Coordinator determines that a requested record is exempt from mandatory disclosure and that discretionary release would be improper, the FOIA Coordinator shall give written notice of denial in accordance with § 1.7(a) of this title."
7:7:6.1.2.1.7.0.1.6,7,Agriculture,V,,510,PART 510—PUBLIC INFORMATION,,,,§ 510.6 Appeals.,ARS,,,,"Any person whose request is denied shall have the right to appeal such denial. Appeals shall be made in accordance with § 1.14 of this title and should be addressed as follows: Administrator, ARS, U.S. Department of Agriculture, Washington, DC 20250."