cfr_sections
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175 rows where part_number = 660 sorted by section_id
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| 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 |
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| 21:21:7.0.1.1.8.1.1.1 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | A | Subpart A—Antibody to Hepatitis B Surface Antigen | § 660.1 Antibody to Hepatitis B Surface Antigen. | FDA | [40 FR 29711, July 15, 1975] | (a) Proper name and definition. The proper name of this product shall be Antibody to Hepatitis B Surface Antigen. The product is defined as a preparation of serum containing antibody to hepatitis B surface antigen. (b) Source. The source of this product shall be plasma or blood, obtained aseptically from animals immunized with hepatitis B surface antigen, which have met the applicable requirements of § 600.11 of this chapter, or from human donor whose blood is positive for hepatitis B surface antigen. | |||
| 21:21:7.0.1.1.8.1.1.2 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | A | Subpart A—Antibody to Hepatitis B Surface Antigen | § 660.2 General requirements. | FDA | [38 FR 32098, Nov. 20, 1973, as amended at 40 FR 29711, July 15, 1975; 46 FR 36134, July 14, 1981; 49 FR 1684, Jan. 13, 1984; 81 FR 38924, June 15, 2016] | (a) Processing. The processing method shall be one that has been shown to consistently yield a specific and potent final product free of properties which would adversely affect the test results when the product is tested by the methods recommended by the manufacturer in the package enclosure. (b) Ancillary reagents and materials. All ancillary reagents and materials supplied in the package with the product shall meet generally accepted standards of purity and quality and shall be effectively segregated and otherwise manufactured in a manner (such as heating at 60 °C. for 10 hours) that will reduce the risk of contaminating the product and other biological products. Ancillary reagents and materials accompanying the product which are used in the performance of the test as described by the manufacturer's recommended test procedures shall have been shown not to adversely affect the product within the prescribed dating period. (c) Labeling. (1) In addition to the items required by other applicable labeling provisions of this subchapter, the following shall also be included: (i) Indication of the source of the product immediately following the proper name on both the final container and package label, e.g., human, guinea pig. (ii) Name of the test method(s) recommended for the product on the package label and on the final container label when capable of bearing a full label (see § 610.60(a) of this chapter). (iii) A warning on the package label and on the final container label if capable of bearing a full label (see § 610.60(a) of this chapter) indicating that the product and antigen if supplied, shall be handled as if capable of transmitting hepatitis. (iv) If the product is dried, the final container label shall indicate “Reconstitution date: ___” and a statement indicating the period within which the product may be used after reconstitution. (v) The package shall include a package enclosure providing: (A) Adequate instructions for use; (B) A description of all recommended test methods; and (C) Warn… | |||
| 21:21:7.0.1.1.8.1.1.3 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | A | Subpart A—Antibody to Hepatitis B Surface Antigen | § 660.3 Reference panel. | FDA | [40 FR 29711, July 15, 1975, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] | A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Food and Drug Administration, Center for Biologics Evaluation and Research, Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002 and shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen. | |||
| 21:21:7.0.1.1.8.1.1.4 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | A | Subpart A—Antibody to Hepatitis B Surface Antigen | § 660.4 Potency test. | FDA | [40 FR 29711, July 15, 1975] | To be satisfactory for release, each filling of Antibody to Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Surface Antigen Panel and shall be sufficiently potent to detect the antigen in the appropriate sera of the reference panel by all test methods recommended by the manufacturer in the package insert. | |||
| 21:21:7.0.1.1.8.1.1.5 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | A | Subpart A—Antibody to Hepatitis B Surface Antigen | § 660.5 Specificity. | FDA | [40 FR 29712, July 15, 1975, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990] | Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as determined by specificity tests found acceptable by the Director, Center for Biologics Evaluation and Research. | |||
| 21:21:7.0.1.1.8.1.1.6 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | A | Subpart A—Antibody to Hepatitis B Surface Antigen | § 660.6 Samples; protocols; official release. | FDA | [48 FR 20407, May 6, 1983, as amended at 49 FR 23834, June 8, 1984; 51 FR 15611, Apr. 25, 1986; 55 FR 11013, 11014, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] | (a) Samples. (1) For the purposes of this section, a sample of product not iodinated with 125 I means a sample from each filling of each lot packaged as for distribution, including all ancillary reagents and materials; and a sample of product iodinated with 125 I means a sample from each lot of diagnostic test kits in a finished package, including all ancillary reagents and materials. (2) Unless the Director, Center for Biologics Evaluation and Research, determines that the reliability and consistency of the finished product can be assured with a smaller quantity of sample or no sample and specifically reduces or eliminates the required quantity of sample, each manufacturer shall submit the following samples to the Director, Center for Biologics Evaluation and Research (see mailing addresses in § 600.2(c) of this chapter), within 5 working days after the manufacturer has satisfactorily completed all tests on the samples: (i) One sample until written notification of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample at periodic intervals of 90 days, beginning after written notification of official release is no longer required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from the first lot or filling, as applicable, released by manufacturer, under the requirements of § 610.1 of this chapter, after the end of the previous 90-day interval. The sample shall be identified as “surveillance sample” and shall include the date of manufacture. (iii) Samples may at any time be required to be submitted to the Director, Center for Biologics Evaluation and Research, if the Director finds that continued evaluation is necessary to ensure the potency, quality, and reliability of the product. (b) Protocols. For each sample submitted as required in paragraph (a)(1) of this section, the manufacturer shall send a protocol that consists of a summary of the history of manufacture of the product, including all results of each test fo… | |||
| 21:21:7.0.1.1.8.3.1.1 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | C | Subpart C—Blood Grouping Reagent | § 660.20 Blood Grouping Reagent. | FDA | [53 FR 12764, Apr. 19, 1988, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38925, June 15, 2016] | (a) Proper name and definition. The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4). (b) Source. The source of this product shall be blood, plasma, serum, or protein-rich fluids, such as those derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts. | |||
| 21:21:7.0.1.1.8.3.1.2 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | C | Subpart C—Blood Grouping Reagent | § 660.21 Processing. | FDA | [53 FR 12764, Apr. 19, 1988, as amended at 64 FR 56454, Oct. 20, 1999; 65 FR 77499, Dec. 12, 2000; 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005] | (a) Processing method. (1) The processing method shall be one that has been shown to yield consistently a specific, potent final product, free of properties that would affect adversely the intended use of the product throughout its dating period. Stability testing shall be performed on an adequate number of representative samples of each group of products manufactured in the same fashion. (2) Only that material that has been fully processed, thoroughly mixed in a single vessel, and filtered shall constitute a lot. (3) A lot may be subdivided into sublots. If lots are to be subdivided, the manufacturer shall include this information in the biologics license application. The manufacturer shall describe the test specifications to verify that each sublot is identical to other sublots of the lot. (4) Each lot of Blood Grouping Reagent shall be identified by a lot number. Each sublot shall be identified by that lot number to which a distinctive prefix or suffix shall be added. Final container and package labels shall bear the lot number and all distinctive prefixes and suffixes that have been applied to identify the sublot from which filling was accomplished. (b) Color coding of reagents. Blood Grouping Reagents may be colored provided the added colorant does not adversely affect the safety, purity, or potency of the product and the colorant is approved by the Director, Center for Biologics Evaluation and Research. (c) Final containers and dropper assemblies. Final containers and dropper pipettes shall be colorless and sufficiently transparent to permit observation of the contents to detect particulate matter or increased turbidity during use. (d) Volume of final product. Each manufacturer shall identify the possible final container volumes in the biologics license application. (e) Date of manufacture. The date of manufacture shall be the date the manufacturer begins the last entire group of potency tests. | |||
| 21:21:7.0.1.1.8.3.1.3 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | C | Subpart C—Blood Grouping Reagent | § 660.22 Potency requirements with reference preparations. | FDA | [53 FR 12764, Apr. 19, 1988, as amended at 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] | (a) Potency requirements. Products for which reference Blood Grouping Reagents are available shall have a potency titer value at least equal to that of the reference preparation. (b) Reference preparations. Reference Blood Grouping Reagents shall be obtained from the Food and Drug Administration, Center for Biologics Evaluation and Research, Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002, and shall be used as described in the accompanying package insert for determining the potency of Blood Grouping Reagents. | |||
| 21:21:7.0.1.1.8.3.1.4 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | C | Subpart C—Blood Grouping Reagent | § 660.25 Potency tests without reference preparations. | FDA | [53 FR 12764, Apr. 19, 1988, as amended at 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005] | Products for which Reference Blood Grouping Reagents are not available shall be tested for potency by a method approved by the Director, Center for Biologics Evaluation and Research. (a) Potency requirements. Blood Grouping Reagents recommended for the test tube methods, including the indirect antiglobulin tests, shall have the following potency titer values, unless other values are approved by the Director, Center for Biologics Evaluation and Research. (1) For Anti-K, Anti-k , Anti-Jk a , Anti-Fy a , Anti-C w , at least 1 + reaction with a 1:8 dilution of the reagent. (2) For Anti-S, Anti-s , Anti-P 1 , Anti-M, Anti-I, Anti-e (saline), Anti-c (saline), and Anti-A 1 , at least 1 + reaction with a 1:4 dilution of the reagent. (3) For Anti-U, Anti-Kp a , Anti-Kp b , Anti-Js a , Anti-Js b , Anti-Fy b , Anti-N, Anti-Le a , Anti-Le b , Anti-Lu a , Anti-Lu b , Anti-Di a , Anti-M g , Anti-Jk b , Anti-Co b , Anti-Wr a , and Anti-Xg a , at least 2 + reaction with undiluted reagent. (b) Products recommended for slide tests or microplate techniques. Blood Grouping Reagent recommended for slide test methods or microplate techniques shall produce clearly positive macroscopic results when both undiluted reagent and reagent diluted with an equal volume of diluent are tested by all methods recommended in the manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the corresponding antigen. The dilution shall be made with an equal volume of compatible serum or approved diluent. (c) Products recomended for use in an automated system. The manufacturer of Blood Grouping Reagent that is recommended for use in an automated system shall demonstrate that its product when used both undiluted and diluted with an equal volume of diluent satisfactorily performs when tested with cells representing heterozygous or diminished expression of the corresponding antigen. | |||
| 21:21:7.0.1.1.8.3.1.5 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | C | Subpart C—Blood Grouping Reagent | § 660.26 Specificity tests and avidity tests. | FDA | [53 FR 12764, Apr. 19, 1988, as amended at 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005] | Specificity and avidity tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research. | |||
| 21:21:7.0.1.1.8.3.1.6 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | C | Subpart C—Blood Grouping Reagent | § 660.28 Labeling. | FDA | [81 FR 38925, June 15, 2016] | (a) In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following requirements shall be met: (1) Final container label —(i) Color coding. The final container label of all Blood Grouping Reagents shall be completely white, except that all or a portion of the final container label of the following Blood Grouping Reagents may be color coded with the specified color which shall be a visual match to a specific color sample designated by the Director, Center for Biologics Evaluation and Research. Printing on all final container labels shall be in solid black. A logo or company name may be placed on the final container label; however, the logo or company name shall be located along the bottom or end of the label, outside the main panel. (ii) Required information. The proper name “Blood Grouping Reagent” need not appear on the final container label provided the final container is distributed in a package and the package label bears the proper name. The final container label shall bear the following information: (A) Name of the antibody or antibodies present as set forth in paragraph (a)(4) of this section. (B) Name, address (including ZIP code), and license number of the manufacturer. (C) Lot number, including sublot designations. (D) Expiration date. (E) Source of product if other than human plasma or serum. (F) Test method(s) recommended. (G) Recommended storage temperature in degrees Celsius. (H) Volume of product if a liquid, or equivalent volume for a dried product if it is to be reconstituted. (I) If a dried product, to remind users to record the reconstitution date on the label, the statement “RECONSTITUTION DATE ___. EXPIRES 1 YEAR AFTER RECONSTITUTION DATE.” (iii) Lettering size. The type size for the specificity of the antibody designation on the labels of a final container with a capacity of less than 5 milliliters shall be not less than 12 point. The type si… | |||
| 21:21:7.0.1.1.8.4.1.1 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | D | Subpart D—Reagent Red Blood Cells | § 660.30 Reagent Red Blood Cells. | FDA | [52 FR 37450, Oct. 7, 1987, as amended at 64 FR 56454, Oct. 20, 1999] | (a) Proper name and definition. The proper name of the product shall be Reagent Red Blood Cells, which shall consist of a preparation of human red blood cells used to detect or identify human blood-group antibodies. (b) Source. Reagent Red Blood Cells shall be prepared from human peripheral blood meeting the criteria of §§ 660.31 and 660.32 of this chapter, or from umbilical cord cells which shall be collected and prepared according to the manufacturer's biologics license application. | |||
| 21:21:7.0.1.1.8.4.1.2 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | D | Subpart D—Reagent Red Blood Cells | § 660.31 Eligibility of donor. | FDA | [80 FR 29906, May 22, 2015] | Donors of peripheral blood for Reagent Red Blood Cells must meet all the criteria for donor eligibility under §§ 630.10 and 630.15 of this chapter. | |||
| 21:21:7.0.1.1.8.4.1.3 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | D | Subpart D—Reagent Red Blood Cells | § 660.32 Collection of source material. | FDA | Blood for Reagent Red Blood Cells from donors of peripheral blood shall be collected as prescribed under § 640.4 of this chapter, except that paragraphs (c), (d), (g), and (h) of § 640.4 shall not apply. | ||||
| 21:21:7.0.1.1.8.4.1.4 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | D | Subpart D—Reagent Red Blood Cells | § 660.33 Testing of source material. | FDA | [52 FR 37450, Oct. 7, 1987, as amended at 55 FR 11013, Mar. 26, 1990; 64 FR 56454, Oct. 20, 1999] | Except as provided in this section, a sample of each blood incorporated into the Reagent Red Blood Cell product shall be individually tested, with no fewer than two donor sources of each antibody specificity employed, to confirm the identification of all blood group antigens specified in the labeling as present or absent. The manufacturer shall perform at least one of the required tests for each factor. The Reagent Red Blood Cell product may be tested with a single donor source of antibody specificity if only one source of antibody is available, and the Director, Center for Biologics Evaluation and Research, has approved the use of a single donor source of antiserum. Each of these tests shall be conducted and interpreted independently, and any discrepancy between the results of these two tests shall be resolved by testing with at least one additional antiserum before concluding that the antigen is present or absent. Where fewer than three donor sources of an antibody specificity are available, test discrepancies shall be resolved in accordance with the manufacturer's biologics license application. Group O Reagent Red Blood Cells used in the detection or identification of unexpected antibodies shall include at least the following common antigens in each lot of the product: D, C, E, c , e, K, k , Fy a , Fy b , Jk a , Jk b , Le a , Le b , P 1 , M, N, S, and s . | |||
| 21:21:7.0.1.1.8.4.1.5 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | D | Subpart D—Reagent Red Blood Cells | § 660.34 Processing. | FDA | [52 FR 37450, Oct. 7, 1987, as amended at 55 FR 11013, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002] | (a) Processing method. The processing method shall be one that has been shown to yield consistently a product that is capable of detecting, throughout the dating period, alloantibodies corresponding to all required blood group antigens specified in the labeling as present. (b) Products prepared from pooled red blood cells. If the product is recommended for the detection of unexpected antibodies, the pool shall be prepared by combining equal amounts of cells from no more than two donors. Umbilical cord cells are exempt from this requirement. Pooled cells shall not be recommended for pretransfusion tests, done in lieu of a major crossmatch, to detect unexpected antibodies in patients' samples. (c) Absence of antibodies. Each lot of final product shall be free of demonstrable antibodies, including anti-A and anti-B, unless the package insert and container lable include instructions to wash the cells before use. The final product shall also be direct antiglobulin test negative when tested with polyspecific anti-human globulin. (d) Final container. The final containers used for each lot of product shall be clean and shall permit observation of the contents for hemolysis or a change in color. The final container label, container cap, and dropper bulb of a Reagent Red Blood Cell product may be color-coded with a visual match to a specific color approved by the Director, Center for Biologics Evaluation and Research. (e) Date of manufacture. The date of manufacture of the product shall be the date that the blood is withdrawn from the donor or obtained from umbilical cords. The period during which the reagent red blood cell source material is kept by the manufacturer in storage in a frozen state at −65 °C or colder is excluded from the dating period. If the product consists of red blood cells from two or more donors, the date of manufacture of the final product shall be the date of withdrawal of blood from the donor of the oldest constituent blood. When a product consists of more than one container, e.g., cel… | |||
| 21:21:7.0.1.1.8.4.1.6 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | D | Subpart D—Reagent Red Blood Cells | § 660.35 Labeling. | FDA | [81 FR 38926, June 15, 2016] | (a) In addition to the items required by § 809.10 of this chapter and other applicable labeling provisions of this chapter, the following information shall be included in the labeling: (1)(i) A logo or company name may be placed on the final container label, however, the logo or company name shall be located along the bottom or end of the label, outside of the main panel. (ii) If washing the cells is required by the manufacturer, the container label shall include appropriate instructions; if the cells should not be washed before use, e.g., if washing will adversely affect the product, the package insert shall explain. (2) The container label of Group O cells shall state: “FOR USE IN DETECTION OF UNEXPECTED ANTIBODIES” or “FOR USE IN IDENTIFICATION OF UNEXPECTED ANTIBODIES” or “NOT FOR USE IN DETECTION OR IDENTIFICATION OF UNEXPECTED ANTIBODIES”. (3) Except as provided in this section, the container and package labels shall state the percentage of red blood cells in the suspension either as a discrete figure with a variance of more than [±] 1 percentage unit or as a range the extremes of which differ by no more than 2 percentage units. If the stated red blood cell concentration is less than 2 percent, the variance shall be no more than [±] 0.5 percentage unit. (4) The words “pooled cells” shall appear on the container and package labels of products prepared from pooled cells. The package label or package insert shall state that pooled cells are not recommended for pre-transfusion tests, done in lieu of a major crossmatch, to detect unexpected antibodies in patients' samples. (5) The package insert of a pooled product intended for detection of unexpected antibodies shall identify the number of donors contributing to the pool. Products designed exclusively for ABO Serum Grouping and umbilical cord cells need not identify the number of donors in the pool. (6) When the product is a multicontainer product, e.g., a cell panel, the container label and package label shall be assigned the same identifying lot n… | |||
| 21:21:7.0.1.1.8.4.1.7 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | D | Subpart D—Reagent Red Blood Cells | § 660.36 Samples and protocols. | FDA | [52 FR 37450, Oct. 7, 1987, as amended at 55 FR 11013, 11015, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] | (a) The following shall be submitted to the Center for Biologics Evaluation and Research Sample Custodian (see mailing addresses in § 600.2(c) of this chapter), within 30 days after each routine establishment inspection by FDA. (1) From a lot of final product, samples from a cell panel intended for identification of unexpected antibodies. The sample shall be packaged as for distribution and shall have at least 14 days remaining in the dating period when shipped to the Center for Biologics Evaluation and Research. (2) A protocol which shall include the following: (i) Complete test records of at least two donors of the samples submitted, including original and confirmation phenotyping records. (ii) Bleeding records or receipt records which indicate collection date, volume, and HBsAg test results. (iii) Manufacturing records which document all steps involved in the preparation of the product. (iv) Test results which verify that the final product meets specifications. (v) Identity test results. (b) A copy of the antigenic constitution matrix specifying the antigens present or absent shall be submitted to the Director, Center for Biologics Evaluation and Research (see mailing addresses in § 600.2(c) of this chapter), at the time of initial distribution of each lot of Reagent Red Blood Cells for detection or identification of unexpected antibodies. Products designed exclusively to identify Anti-A, Anti-A 1 , and Anti-B, as well as products composed entirely of umbilical cord cells, are excluded from this requirement. (c) Except for umbilical cord samples, whenever a new donor is used, a sample of red blood cells from each new donor used in a cell panel intended for the identification of unexpected antibodies shall be submitted by the manufacturer to the Director, Center for Biologics Evaluation and Research (see mailing addresses in § 600.2(c) of this chapter). The sample should contain a minimum volume of 0.5 milliliter of red blood cells. | |||
| 21:21:7.0.1.1.8.5.1.1 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | E | Subpart E—Hepatitis B Surface Antigen | § 660.40 Hepatitis B Surface Antigen. | FDA | (a) Proper name and definition. The proper name of this product shall be Hepatitis B Surface Antigen (HBsAg), which shall consist of a serum or tissue preparation containing one or more subtypes of the Hepatitis B Surface Antigen. (b) Source. The source of the product shall be blood, plasma, serum, or tissue, obtained aseptically from nonhuman primates that have met the applicable requirements of § 600.11 of this chapter, or from human donors whose blood is positive for the Hepatitis B Surface Antigen. | ||||
| 21:21:7.0.1.1.8.5.1.2 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | E | Subpart E—Hepatitis B Surface Antigen | § 660.41 Processing. | FDA | [44 FR 36382, June 22, 1979, as amended at 49 FR 1685, Jan. 13, 1984] | (a) Method. The processing method shall be one that has been shown to yield consistently a specific and potent final product, free of properties which would adversely affect the test results when the product is tested by the methods recommended by the manufacturer in the package insert. The product and all ancillary reagents and materials supplied in the package with the product shall be manufactured in a manner that will reduce the risk of transmitting type B viral hepatitis. (b) Ancillary reagents and materials. All ancillary reagents and materials supplied in the package with the product shall meet generally accepted standards of purity and quality and shall be effectively segregated and otherwise manufactured in a manner that will reduce the risk of contaminating the product and other biological products. Ancillary reagents and materials accompanying the product, which are used in the performance of the test as described by the manufacturer's recommended test procedures, shall have been shown not to affect adversely the product within the prescribed dating period. (c) Final container. A final container shall be sufficiently transparent to permit visual inspection of the contents for presence of particulate matter and increased turbidity. The effectiveness of the contents of a final container shall be maintained throughout its dating period. (d) Date of manufacture. The date of manufacture of Hepatitis B Surface Antigen that has been iodinated with radioactive iodine ( 125 I) shall be the day of labeling the antibody with the radionuclide. | |||
| 21:21:7.0.1.1.8.5.1.3 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | E | Subpart E—Hepatitis B Surface Antigen | § 660.43 Potency test. | FDA | To be satisfactory for release, each filling of Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Antiserum Panel and shall be sufficiently potent to be able to detect the antibody in the appropriate sera of the reference panel by all test methods recommended by the manufacturer in the package insert. | ||||
| 21:21:7.0.1.1.8.5.1.4 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | E | Subpart E—Hepatitis B Surface Antigen | § 660.44 Specificity. | FDA | [44 FR 36382, June 22, 1979, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990] | Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by specificity tests found acceptable to the Director, Center for Biologics Evaluation and Research. | |||
| 21:21:7.0.1.1.8.5.1.5 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | E | Subpart E—Hepatitis B Surface Antigen | § 660.45 Labeling. | FDA | [81 FR 38928, June 15, 2016] | (a) In addition to the requirements of §§ 610.60, 610.61, and 809.10 of this chapter, the labeling shall bear the following: (1) The “d and y” antigen subtype and the source of the product to follow immediately the proper name on both the final container label and the package label. If the product is intended to identify antibodies to the “r and w” antigen subtype, the antigen subtype designation shall include the “r and w” antigen subtype. (2) The name of the test method(s) recommended for use of the product on the package label and on the final container label, when capable of bearing a full label (see § 610.60(a) of this chapter). (3) A warning on the package label and on the final container label stating that the product is capable of transmitting hepatitis and should be handled accordingly. (4) The package shall include a package insert providing: (i) Detailed instructions for use, (ii) An adequate description of all recommended test methods, and (iii) Warnings as to possible hazards, including hepatitis transmitted in handling the product and any ancillary reagents and materials accompanying the product. (b) The applicant may provide the labeling information referenced in paragraph (a) of this section in the form of: (1) A symbol accompanied by explanatory text adjacent to the symbol; (2) A symbol not accompanied by adjacent explanatory text that: (i) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act; (ii) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and (iii) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is … | |||
| 21:21:7.0.1.1.8.5.1.6 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | E | Subpart E—Hepatitis B Surface Antigen | § 660.46 Samples; protocols; official release. | FDA | [48 FR 20407, May 6, 1983, as amended at 49 FR 23834, June 8, 1984; 51 FR 15611, Apr. 25, 1986; 55 FR 11013, 11014, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] | (a) Samples. (1) For the purposes of this section, a sample of product not iodinated with 125 I means a sample from each filling of each lot packaged as for distribution, including all ancillary reagents and materials; and a sample of product iodinated with 125 I or unlyophilized HBsAg-coated red blood cells means a sample from each lot of diagnostic test kits in a finished package, including all ancillary reagents and materials. (2) Unless the Director, Center for Biologics Evaluation and Research, determines that the reliability and consistency of the finished product can be assured with a smaller quantity of sample or no sample and specifically reduces or eliminates the required quantity of sample, each manufacturer shall submit the following samples to the Director, Center for Biologics Evaluation and Research (see mailing addresses in § 600.2(c) of this chapter), within 5 working days after the manufacturer has satisfactorily completed all tests on the samples: (i) One sample until written notification of official release is no longer required under paragraph (c)(2) of this section. (ii) One sample of product at periodic intervals of 90 days, beginning after written notification of official release is no longer required under paragraph (c)(2) of this section. The sample submitted at the 90-day interval shall be from the first lot or filling, as applicable, released by the manufacturer, under the requirements of § 610.1 of this chapter, after the end of the previous 90-day interval. The sample shall be identified as “surveillance sample” and shall include the date of manufacture. (iii) Samples may at any time be required to be submitted to the Director, Center for Biologics Evaluation and Research, if the Director finds that continued evaluation is necessary to ensure the potency, quality, and reliability of the product. (b) Protocols. For each sample submitted as required in paragraph (a)(1) of this section, the manufacturer shall send a protocol that consists of a summary of the history of manu… | |||
| 21:21:7.0.1.1.8.6.1.1 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | F | Subpart F—Anti-Human Globulin | § 660.50 Anti-Human Globulin. | FDA | [50 FR 5579, Feb. 11, 1985, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38928, June 15, 2016] | (a) Proper name and definition. The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in § 660.55(a)(4). (b) Source. The source of this product shall be either serum from animals immunized with one or more human serum globulins or protein-rich fluids derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts. | |||
| 21:21:7.0.1.1.8.6.1.2 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | F | Subpart F—Anti-Human Globulin | § 660.51 Processing. | FDA | [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 65 FR 77499, Dec. 12, 2000; 67 FR 9587, Mar. 4, 2002] | (a) Processing method. (1) The processing method shall be one that has been shown to yield consistently a specific, potent final product, free of properties that would adversely affect the product for its intended use throughout its dating period. (2) Anti-IgG, -C3d (polyspecific) reagents and anti-IgG products may be colored green. (3) Only that material which has been fully processed, thoroughly mixed in a single vessel, and filtered shall constitute a lot. Each lot shall be identified by a lot number. (4) A lot may be subdivided into sublots which shall be identified by the lot number to which has been added a distinctive prefix or suffix. If lots are to be subdivided, the manufacturer shall include this information in the license application . The manufacturer shall describe the test specifications to verify that each sublot is identical to other sublots of the lot. (b) Final containers and dropper assemblies. (1) Final containers and dropper assemblies shall be clean. (2) Final containers and dropper pipettes shall be colorless and sufficiently transparent to permit observation of the contents for presence of particulate matter or increased turbidity. (c) Date of manufacture. The date of manufacture shall be the date the manufacturer begins the last entire group of potency tests. | |||
| 21:21:7.0.1.1.8.6.1.3 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | F | Subpart F—Anti-Human Globulin | § 660.52 Reference preparations. | FDA | [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11015, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] | Reference Anti-Human Globulin preparations shall be obtained from the Food and Drug Administration, Center for Biologics Evaluation and Research, Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002, and shall be used as described in the accompanying package insert for determining the potency of Anti-Human Globulin. | |||
| 21:21:7.0.1.1.8.6.1.4 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | F | Subpart F—Anti-Human Globulin | § 660.53 Controls for serological procedures. | FDA | [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005] | Red blood cells sensitized with complement shall be tested with appropriate positive and negative control antisera. All tests shall be performed in accordance with serological testing procedures approved by the Director, Center for Biologics Evaluation and Research. | |||
| 21:21:7.0.1.1.8.6.1.5 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | F | Subpart F—Anti-Human Globulin | § 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. | FDA | [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005] | The following tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research: (a) Potency tests for determining anti-IgG and anti-complement activity. (b) Specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. | |||
| 21:21:7.0.1.1.8.6.1.6 | 21 | Food and Drugs | I | F | 660 | PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | F | Subpart F—Anti-Human Globulin | § 660.55 Labeling. | FDA | [81 FR 38928, June 15, 2016] | (a) In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following requirements shall be met: (1) Final container label —(i) Color coding. The main panel of the final container label of all Anti-IgG, -C3d (polyspecific) reagents shall be white or colorless and printing shall be solid dark contrasting lettering. The main panel of the final container label of all other Anti-Human Globulin reagents shall be black with solid white lettering. A logo or company name may be placed on the final container label; however, the logo or company name shall be located along the bottom or end of the label, outside of the main panel. (ii) Required information. The proper name “Anti-Human Globulin” need not appear on the final container label provided the final container is distributed in a package and the package label bears the proper name. The final container label shall bear the following information: (A) Name of the antibody or antibodies present as set forth in paragraph (a)(4) of this section. Anti-Human Globulin may contain one or more antibodies to either immunoglobulins or complement components but the name of each significant antibody must appear on the final container label ( e.g., anti-C3b, -C3d, -C4d). The final container labels of polyspecific Anti-Human Globulin are not required to identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human Globulin shall be accurately described in the package insert. (B) Name, address, and license number of the manufacturer. (C) Lot number, including any sublot designations. (D) Expiration date. (E) Source of the product. (F) Recommended storage temperature in degrees Celsius. (G) Volume of product. (H) Appropriate cautionary statement if the Anti-Human Globulin is not polyspecific. For example, “DOES NOT CONTAIN ANTIBODIES TO IMMUNOGLOBULINS” or “DOES NOT CONTAIN ANTIBODIES TO COMPLEMENT COM… | |||
| 34:34:3.1.3.1.25.1.17.1 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | A | Subpart A—General | § 660.1 What is the International Research and Studies Program? | ED | [47 FR 14124, Apr. 1, 1982, as amended at 58 FR 32577, June 10, 1993; 64 FR 7740, Feb. 16, 1999; 74 FR 35074, July 17, 2009] | The Secretary may, directly or through grants or contracts, conduct research and studies which contribute to the purposes of the International Education Program authorized by part A of title VI of the Higher Education Act of 1965, as amended (HEA). The research and studies may include, but are not limited to— (a) Studies and surveys to determine needs for increased or improved instruction in modern foreign languages, area studies, or other international fields, including the demand for foreign language, area, and other international specialists in government, education, and the private sector; (b) Research on more effective methods of providing instruction and achieving competency in foreign languages, area studies, or other international fields; (c) Research on applying performance tests and standards across all areas of foreign language instruction and classroom use; (d) Developing and publishing specialized materials for use in foreign language, area studies, and other international fields or for training foreign language, area, and other international specialists; (e) Studies and surveys to assess the use of graduates of programs supported under title VI of the HEA by governmental, educational, and private-sector organizations and other studies assessing the outcomes and effectiveness of supported programs; (f) Comparative studies of the effectiveness of strategies to provide international capabilities at institutions of higher education; (g) Evaluations of the extent to which programs assisted under title VI of the HEA that address national needs would not otherwise be offered; (h) Studies and surveys of the use of technologies in foreign language, area studies, and international studies programs; (i) Studies and evaluations of effective practices in the dissemination of international information, materials, research, teaching strategies, and testing techniques throughout the educational community, including elementary and secondary schools; (j) Evaluations of the extent to which programs assisted … | ||||
| 34:34:3.1.3.1.25.1.17.2 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | A | Subpart A—General | § 660.2 Who is eligible to apply for grants under this program? | ED | Public and private agencies, organizations, and institutions, and individuals are eligible to apply for grants under this part. | |||||
| 34:34:3.1.3.1.25.1.17.3 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | A | Subpart A—General | § 660.3 What regulations apply? | ED | [58 FR 32577, June 10, 1993] | The following regulations apply to this program: (a) The regulations in 34 CFR part 655. (b) The regulations in this part 660. | ||||
| 34:34:3.1.3.1.25.1.17.4 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | A | Subpart A—General | § 660.4 What definitions apply to the International Research and Studies Program? | ED | The definitions in 34 CFR 655.4 apply to this program. | |||||
| 34:34:3.1.3.1.25.2.17.1 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | B | Subpart B—What Kinds of Projects Does the Secretary Assist Under This Program? | § 660.10 What activities does the Secretary assist? | ED | [47 FR 14124, Apr. 1, 1982, as amended at 52 FR 28424, July 29, 1987; 58 FR 32577, June 10, 1993; 64 FR 7740, Feb. 16, 1999; 74 FR 35074, July 17, 2009] | An applicant may apply for funds to carry out any of the following types of activities: (a) Studies and surveys to determine the need for increased or improved instruction in— (1) Modern foreign languages; and (2) Area studies and other international fields needed to provide full understanding of the places in which those languages are commonly used. (b) Research and studies— (1) On more effective methods of instruction and achieving competency in modern foreign languages, area studies, or other international fields; (2) To evaluate competency in those foreign languages, area studies, or other international fields; or (3) On the application of performance tests and standards across all areas of foreign language instruction and classroom use. (c) The development and publication of specialized materials— (1) For use by students and teachers of modern foreign languages, area studies, and other international fields; and (2) For use in— (i) Providing such instruction and evaluation; or (ii) Training individuals to provide such instruction and evaluation. (d) Research, surveys, studies, or the development of instructional materials that serve to enhance international understanding. (e) Other research or material development projects that further the purposes of the International Education Program authorized by part A of title VI of the HEA. (f) Studies and surveys to assess the use of graduates of programs supported under title VI of the HEA by governmental, educational, and private-sector organizations, and other studies assessing the outcomes and effectiveness of supported programs. (g) Comparative studies of the effectiveness of strategies to provide international capabilities at institutions of higher education. (h) Evaluations of the extent to which programs assisted under title VI of the HEA that address national needs would not otherwise be offered. (i) Studies and surveys of the uses of technology in foreign language, area studies, and international studies programs. (j) Studies and evaluatio… | ||||
| 34:34:3.1.3.1.25.4.17.1 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | D | Subpart D—How Does the Secretary Make a Grant? | § 660.30 How does the Secretary evaluate an application? | ED | [70 FR 13375, Mar. 21, 2005] | (a) The Secretary evaluates an application for a research project, a study, or a survey on the basis of the criteria in §§ 660.31 and 660.32. The Secretary informs applicants of the maximum possible score for each criterion in the application package or in a notice published in the Federal Register . (b) The Secretary evaluates an application for the development of specialized instructional materials on the basis of the criteria in §§ 660.31 and 660.33. The Secretary informs applicants of the maximum possible score for each criterion in the application package or in a notice published in the Federal Register . | ||||
| 34:34:3.1.3.1.25.4.17.2 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | D | Subpart D—How Does the Secretary Make a Grant? | § 660.31 What selection criteria does the Secretary use for all applications for a grant? | ED | [47 FR 14124, Apr. 1, 1982, as amended at 58 FR 32577, June 10, 1993; 70 FR 13376, Mar. 21, 2005] | The Secretary evaluates an application for a project under this program on the basis of the criteria in this section. The Secretary informs applicants of the maximum possible score for each criterion in the application package or in a notice published in the Federal Register . (a) Plan of operation. (See 34 CFR 655.31(a)) (b) Quality of key personnel. (See 34 CFR 655.31(b)) (c) Budget and cost effectiveness. (See 34 CFR 655.31(c)) (d) Evaluation plan. (See 34 CFR 655.31(d)) (e) Adequacy of resources. (See 34 CFR 655.31(e)) | ||||
| 34:34:3.1.3.1.25.4.17.3 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | D | Subpart D—How Does the Secretary Make a Grant? | § 660.32 What additional selection criteria does the Secretary use for an application for a research project, a survey, or a study? | ED | [47 FR 14124, Apr. 1, 1982, as amended at 58 FR 32577, June 10, 1993; 70 FR 13376, Mar. 21, 2005] | In addition to the criteria referred to in § 660.31, the Secretary evaluates an application for a research project, study, or survey on the basis of the criteria in this section. (a) Need for the project. The Secretary reviews each application for information that shows— (1) A need for the proposed project in the field of study on which the project focuses; and (2) That the proposed project will provide information about the present and future needs of the United States for study in foreign language and other international fields. (b) Usefulness of expected results. The Secretary reviews each application for information that shows the extent to which the results of the proposed project are likely to be used by other research projects or programs with similar objectives. (c) Development of new knowledge. The Secretary reviews each application for information that shows that the extent to which the proposed project is likely to develop new knowledge that will contribute to the purposes of the International Education Program authorized by part A of title VI of the HEA. (d) Formulation of problems and knowledge of related research. The Secretary reviews each application for information that shows that problems, questions, or hypotheses to be dealt with by the applicant— (1) Are well formulated; and (2) Reflect adequate knowledge of related research. (e) Specificity of statement of procedures. The Secretary reviews each application for the specificity and completeness of the statement of procedures to be followed, including a discussion of such components as sampling techniques, controls, data to be gathered, and statistical and other analyses to be undertaken. (f) Adequacy of methodology and scope of project. The Secretary reviews each application for information that shows— (1) The adequacy of the proposed teaching, testing, and research methodology; and (2) The size, scope, and duration of the proposed project. | ||||
| 34:34:3.1.3.1.25.4.17.4 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | D | Subpart D—How Does the Secretary Make a Grant? | § 660.33 What additional selection criteria does the Secretary use for an application to develop specialized instructional materials? | ED | [47 FR 14124, Apr. 1, 1982, as amended at 58 FR 32577, June 10, 1993; 70 FR 13376, Mar. 21, 2005] | In addition to the criteria referred to in § 660.31, the Secretary evaluates an application to develop specialized instructional materials on the basis of the criteria in this section. (a) Need for the project. The Secretary reviews each application for information that shows that— (1) The proposed materials are needed in the educational field of study on which the project focuses; and (2) The language or languages, the area, region, or country, or the issues or studies for which the materials are to be developed, are of sufficient priority and significance to the national interest to warrant financial support by the Federal Government. (b) Potential for the use of materials in other programs. The Secretary reviews each application for information that shows the extent to which the proposed materials may be used elsewhere in the United States. (c) Account of related materials. The Secretary reviews each application for information that shows that— (1) All existing related or similar materials have been accounted for and the critical commentary on their adequacy is appropriate and accurate; and (2) The proposed materials will not duplicate any existing adequate materials. (d) Likelihood of achieving results. The Secretary reviews each application for information that shows that the outlined methods and procedures for preparing the materials are practicable and can be expected to produce the anticipated results. (e) Expected contribution to other programs. The Secretary reviews each application for information that shows the extent to which the proposed work may contribute significantly to strengthening, expanding, or improving programs of foreign language studies, area studies, or international studies in the United States. (f) Description of final form of materials. The Secretary reviews each application for information that shows a high degree of specificity in the description of the contents and final form of the proposed materials. (g) Provisions for pretesting and revision. The Secret… | ||||
| 34:34:3.1.3.1.25.4.17.5 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | D | Subpart D—How Does the Secretary Make a Grant? | § 660.34 What priorities may the Secretary establish? | ED | [47 FR 14124, Apr. 1, 1982, as amended at 58 FR 32577, June 10, 1993] | (a) The Secretary may each year select for funding from among the following priorities: (1) Categories of eligible projects described in § 660.10. (2) Specific languages or regions for study or materials development; for example, the Near or Middle East, South Asia, Southeast Asia, Eastern Europe, Inner Asia, the Far East, Africa or Latin America, or the languages of those regions. (3) Topics of research and studies; for example, language acquisition processes, methodology of foreign language instruction, foreign language performance testing, or assessments of resources and needs. (4) Levels of education; for example, elementary, secondary, postsecondary or university-level education, or teacher education. (b) The Secretary announces any priorities in the application notice published in the Federal Register. | ||||
| 34:34:3.1.3.1.25.5.17.1 | 34 | Education | VI | 660 | PART 660—THE INTERNATIONAL RESEARCH AND STUDIES PROGRAM | E | Subpart E—What Conditions Must Be Met by a Grantee? | § 660.40 What are the limitations on allowable costs? | ED | Funds awarded under this part may not be used for the training of students and teachers. | |||||
| 50:50:13.0.1.1.1.1.1.1 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | A | Subpart A—General | § 660.1 Purpose and scope. | FWS | [61 FR 34572, July 2, 1996, as amended at 67 FR 6201, Feb. 11, 2002; 69 FR 53362, Sept. 1, 2004; 71 FR 17989, Apr. 10, 2006; 81 FR 19057, Apr. 4, 2016] | (a) The regulations in this part govern fishing activity by vessels of the United States that fish or support fishing inside the outer boundary of the EEZ off the states of Washington, Oregon, and California. (b) General regulations governing fishing by all vessels of the United States and by fishing vessels other than vessels of the United States are contained in part 600 of this chapter. (c) Regulations governing the harvest, possession, landing, purchase, and sale of shark fins are found at part 600, subpart N, of this chapter. | ||||
| 50:50:13.0.1.1.1.1.1.2 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | A | Subpart A—General | § 660.2 Relation to other laws. | FWS | [72 FR 29235, May 24, 2007, as amended at 80 FR 62501, Oct. 16, 2015; 81 FR 51138, Aug. 3, 2016] | (a) NMFS recognizes that any state law pertaining to vessels registered under the laws of that state while operating in the fisheries regulated under this part, and that is consistent with this part and the FMPs implemented by this part, shall continue in effect with respect to fishing activities regulated under this part. (b) Fishing activities addressed by this Part may also be subject to regulation under 15 CFR part 922, subpart G, if conducted in the Channel Islands National Marine Sanctuary. (c) Fishing activities on the high seas are governed by regulations of the High Seas Fishing Compliance Act set forth in 50 CFR part 300, subparts A and R. | ||||
| 50:50:13.0.1.1.1.1.1.3 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | A | Subpart A—General | § 660.3 Reporting and recordkeeping. | FWS | [71 FR 17989, Apr. 10, 2006] | Any person who is required to do so by applicable state law or regulation must make and/or file all reports of management unit species landings containing all data and in the exact manner required by applicable state law or regulation. | ||||
| 50:50:13.0.1.1.1.1.1.4 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | A | Subpart A—General | § 660.4 Usual and accustomed fishing areas for Pacific Coast treaty Indian tribes. | FWS | [81 FR 36807, June 8, 2016, as amended at 83 FR 53828, Oct. 25, 2018; 89 FR 59678, July 23, 2024] | (a) The Pacific Coast treaty Indian tribes' usual and accustomed (U&A) fishing areas within the EEZ are set out below in paragraphs (a)(1) through (a)(4) of this section. Boundaries of a tribe's fishing area may be revised as ordered by a Federal court. (1) Makah. The area north of 48°02.25′ N. lat. (Norwegian Memorial) and east of 125°44′ W. long. (2) Quileute. The area commencing at Cape Alava, located at 48°10′00″ N lat., 124°43′56.9″ W long.; then proceeding west approximately forty nautical miles at that latitude to a northwestern point located at 48°10′00″ N lat., 125°44′00″ W long.; then proceeding in a southeasterly direction mirroring the coastline at a distance no farther than forty nautical miles from the mainland Pacific coast shoreline at any line of latitude, to a southwestern point at 47°31′42″ N lat., 125°20′26″ W long.; then proceeding east along that line of latitude to the Pacific coast shoreline at 47°31′42″ N lat., 124°21′9.0″ W long. (3) Hoh. A polygon commencing at the Pacific coast shoreline near the mouth of the Quillayute River, located at latitude 47°54′30″ north, longitude 124°38′31″ west; then proceeding west approximately forty nautical miles at that latitude to a northwestern point located at latitude 47°54′30″ north, longitude 125°38′18″ west; then proceeding in a southeasterly direction mirroring the coastline at a distance no farther than forty nautical miles from the mainland Pacific coast shoreline, to a point located at latitude 47°31′42″ north, longitude 125°20′26″ west, then proceeding east along that line of latitude approximately ten nautical miles to a point located at latitude 47°31′42″ north, longitude 125°5′48″ west, then proceeding in a southeasterly direction mirroring the coastline at a distance no farther than thirty nautical miles from the mainland Pacific coast shoreline to a point located at latitude 47°21′00″ north, longitude 125°2′52″ west; then proceeding east along that line of latitude to the Pacific coast shoreline near the mouth of the Quinault R… | ||||
| 50:50:13.0.1.1.1.10.1.1 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | J | Subpart J—West Coast Groundfish Electronic Monitoring Program | § 660.600 Applicability. | FWS | (a) General. This subpart contains requirements for vessels using EM in lieu of observers, as authorized under § 660.140(h)(1)(i) (Shorebased IFQ Program) and § 660.150(j)(1)(i) (MS Co-op Program), and requirements for EM service providers. Vessel owners, operators, and managers are jointly and severally liable for a vessel's compliance with EM requirements under this subpart. This subpart also contains requirements for a first receiver receiving catch from a trip monitored by EM ( see § 660.604(u)). The table below provides references to the sections that contain vessel owner, operator, first receiver, and service provider responsibilities. (b) EM program purpose. The purpose of the EM program is to provide NMFS with the best scientific information available to determine individual accountability for catch (including discards) of IFQ species and compliance with requirements of the Shorebased IFQ Program (§ 660.140) and MS Co-op Program (§ 660.150). NMFS will develop EM Program Guidelines, which will document best practices and other information that NMFS will use to evaluate proposed service and vessel monitoring plans submitted by EM service providers and vessel owners under this subpart, and to evaluate the performance of EM service providers and vessels, in meeting the requirements of this subpart to achieve the purpose of the EM program. NMFS will develop the EM Program Guidelines in consultation with the Council and publish notice of their availability in the Federal Register. NMFS will maintain the EM Program Guidelines on its website and make them available to vessel owners and operators and EM service providers to assist in developing service plans and vessel monitoring plans that comply with the requirements of this subpart and meet the purpose of the EM program. | |||||
| 50:50:13.0.1.1.1.10.1.2 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | J | Subpart J—West Coast Groundfish Electronic Monitoring Program | § 660.601 Definitions. | FWS | [84 FR 31160, June 28, 2019, as amended at 87 FR 59713, Oct. 3, 2022] | These definitions are specific to this subpart. General groundfish definitions are found at § 660.11, subpart C, and trawl fishery definitions are found at § 660.111, subpart D. Active sampling unit means the portion of the groundfish fleet in which an observer coverage plan is being applied. Discard control point means the location on the vessel designated by a vessel operator where allowable discarding may occur. Discard event means a single occurrence of discarding of fish or other species. Electronic Monitoring or EM consists of the use of an electronic monitoring system (EMS) to passively monitor fishing operations through observing or tracking. Electronic Monitoring Authorization means the official document provided by NMFS that allows a vessel with a limited entry trawl permit to use electronic monitoring under the provisions of this subpart. Electronic Monitoring System or EMS means a data collection tool that uses a software operating system connected to an assortment of electronic components, including video recorders, to create a collection of data on vessel activities. Electronic Monitoring System Certification Form means the official document provided by NMFS, signed by a representative of a NMFS-permitted electronic monitoring service provider that attest that an EM system and associated equipment meets the performance standards defined at § 660.604(j) of this subpart, as required by § 660.604(e)(3)(i). EM data means the information output of the Electronic Monitoring System ( e.g., imagery, sensor data, and other associated data files). EM data processing means the review, interpretation, and analysis of EM data and associated meta data. EM dataset means a collection of EM data from a single EM trip or group of EM trips. EM Program means the Electronic Monitoring Program of the West Coast Region, National Marine Fisheries Service. EM Service Plan means the document required under § 660.603 that describes in detail how the EM service provider will provide EM services. E… | ||||
| 50:50:13.0.1.1.1.10.1.3 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | J | Subpart J—West Coast Groundfish Electronic Monitoring Program | § 660.602 Prohibitions. | FWS | In addition to the general prohibitions specified in § 600.725 of this chapter, it is unlawful for any person to: (a) Electronic monitoring program. (1) Make a false or inaccurate/incorrect statement on an application for issuance, renewal, or changes to an EM Authorization or NMFS-accepted VMP. (2) Fish for or land fish from a trip without electronic monitoring or observer coverage when a vessel is required to carry electronic monitoring or an observer under §§ 660.140(h) or 660.150(j). (3) Fish for or land fish from a trip taken under electronic monitoring without a valid EM Authorization and NMFS-accepted vessel monitoring plan onboard, and a valid gear and monitoring declaration with NMFS OLE as required by § 660.604(c)(1) and § 660.604(m). (4) Fail to comply with the terms of a NMFS-accepted VMP. (5) Fail to notify the NMFS West Coast Groundfish Observer Program at least 48-hours prior to departing port of the vessel operator's intent to take a trip under EM, as required by § 660.604(n). (6) Fail to conduct a pre-departure test of the EM system prior to departing port as required by § 660.604(l)(2). (7) Fish on an EM trip without a fully functional EM system, unless authorized by a NMFS-accepted VMP as required by § 660.604(l)(3). (8) Fail to make the EM system, associated equipment, logbooks, EM data, and other records available for inspection immediately upon request by NMFS, its agent, or authorized officers, as required by §§ 660.604(o) and 660.604(t). (9) Discard species other than those allowed to be discarded as specified at § 660.604(p). (10) Fail to handle fish and other marine organisms in a manner that enables the EM system to record it as required by § 660.604(r). (11) Fail to submit complete and accurate logbook(s) and EM data for each EM trip as specified at § 660.604(s), (12) Tamper with, disconnect, damage, destroy, alter, or in any way distort, render useless, inoperative, ineffective, or inaccurate any component of the EM system or associated equipment. (13) Assault, resist, … | |||||
| 50:50:13.0.1.1.1.10.1.4 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | J | Subpart J—West Coast Groundfish Electronic Monitoring Program | § 660.603 Electronic monitoring provider permits and responsibilities. | FWS | [84 FR 31160, June 28, 2019, as amended at 85 FR 74614, Nov. 23, 2020; 86 FR 55527, Oct. 6, 2021; 87 FR 59713, Oct. 3, 2022; 88 FR 81359, Nov. 22, 2023] | (a) General. This section contains requirements for EM service providers providing EM services, pursuant to contracts with vessel owners whose vessels operate in the Shorebased IFQ Program (§ 660.140) or the MS Co-op Program (§ 660.150) and use EM under this subpart. A person must obtain a permit and endorsement as provided under § 660.603(b) in order to be an EM service provider. An EM service provider must: (1) Operate under a NMFS-accepted EM Service Plan (see paragraph (b)(1)(vii) of this section). (2) Provide and manage EM systems, field services, and technical assistance as required under § 660.603(k); (3) Provide technical and litigation information to NMFS or its agent ( see § 660.603(l)). (4) Provide technical support to contracted fishing vessels 24-hours per day, seven days per week, and year-round as provided under § 660.603(k)(4); (5) Provide EM data processing, reporting, and record retention services to contracted vessels using EM ( see § 660.603(m)). (6) Comply with data integrity and security requirements, including requirements pertaining to hard drives and data files containing EM data, ( see § 660.603(n)). (b) Provider permits. To be an EM service provider, a person must obtain an EM service provider permit and endorsement by submitting an application to the NMFS West Coast Region Fisheries Permit Office. NMFS will issue a public notice at least 90 calendar days prior to when it will begin accepting applications for EM service provider permits for the first year of the Program. A person may meet some requirements of this section through a partnership or subcontract with another entity, in which case the application for an EM service provider permit must include information about the partnership. Once NMFS begins accepting applications, if a new EM service provider, or an existing EM service provider seeking to deploy a new EMS or software version, submits an application by June 1, NMFS will issue a new permit by January 1 of the following calendar year. Applications submitted aft… | ||||
| 50:50:13.0.1.1.1.10.1.5 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | J | Subpart J—West Coast Groundfish Electronic Monitoring Program | § 660.604 Vessel and first receiver responsibilities. | FWS | [84 FR 31160, June 28, 2019; 84 FR 36035, July 26, 2019, as amended at 84 FR 67680, Dec. 11, 2019; 85 FR 74614, Nov. 23, 2020; 86 FR 55527, Oct. 6, 2021; 87 FR 59714, Oct. 3, 2022; 87 FR 77007, Dec. 16, 2022; 88 FR 81358, Nov. 22, 2023; 89 FR 101544, Dec. 16, 2024] | (a) General. This section lays out the requirements for catcher vessels to obtain an exemption to use EM in place of 100-percent observer coverage required by the Shorebased IFQ Program (§ 660.140(h)(1)(i)) and MS Co-op Program (§ 660.150(j)(1)(i)(B)). Requirements are also described for first receivers receiving landings from EM trips. (b) Vessel owner responsibilities. To use EM under this section, vessel owners must: (1) Obtain an EM Authorization from the NMFS West Coast Region Fisheries Permit Office ( see § 660.604(e)); (2) Install an EM system using a NMFS-permitted EM service provider that meets performance standards under § 660.604(j); (3) Have a signed EM system certification form ( see § 660.604(e)(3)(i)); (4) Have a NMFS-accepted vessel monitoring plan ( see § 660.604(e)(3)(iii)); (5) Ensure that the vessel operator attends a mandatory EM orientation session provided by the NMFS West Coast Region EM Program (NMFS may waive this requirement on a case-by-case basis, such as when the vessel operator has prior EM experience); (6) Maintain logbooks and other records for three years and provide them to NMFS or authorized officers for inspection ( see § 660.604(t)). (7) Obtain EM data processing, reporting, and recordkeeping services from a NMFS-permitted EM service provider ( see § 660.604(k)). (c) Vessel operator responsibilities. To use EM under this section, vessel operators must: (1) Maintain a valid EM Authorization and NMFS-accepted vessel monitoring plan onboard the vessel at all times that the vessel is fishing on an EM trip or when fish harvested during an EM trip are onboard the vessel; (2) Ensure that the EM system is installed, operated, and maintained consistent with performance standards ( see § 660.604(l)); (3) Comply with a NMFS-accepted vessel monitoring plan ( see § 660.604(e)(3)(iii); (4) Make declaration reports to OLE prior to leaving port ( see § 660.604(m)); (5) Provide advance notice to the NMFS WCGOP at least 48 hours prior to departing port ( see § 660.… | ||||
| 50:50:13.0.1.1.1.11.1.1 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.701 Purpose and scope. | FWS | This subpart implements the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (FMP). These regulations govern commercial and recreational fishing for HMS in the U.S. EEZ off the coasts of Washington, Oregon, and California and in adjacent high seas waters. | |||||
| 50:50:13.0.1.1.1.11.1.10 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.710 Closure of directed fishery. | FWS | (a) When a quota has been taken, the Regional Administrator will announce in the Federal Register the date of closure of the fishery for the species of concern. (b) When a harvest guideline has been taken, the Regional Administrator will initiate review of the species of concern according to section 8.4.8 of the FMP and publish in the Federal Register any necessary and appropriate regulations following Council recommendations. | |||||
| 50:50:13.0.1.1.1.11.1.11 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.711 General catch restrictions. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 80 FR 46520, Aug. 5, 2015] | (a) Incidental landings. HMS caught by gear not authorized by this subpart may be landed in incidental amounts as follows: (1) Drift gillnet vessels with stretched mesh less than 14 inches may land up to 10 HMS per trip, except that no swordfish may be landed. (2) Bottom longline vessels may land up to 20 percent by weight of management unit sharks in landings of all species, or 3 individual sharks of the species in the management unit, whichever is greater. (3) Trawl and pot gear vessels may land up to 1 percent by weight of management unit sharks in a landing of all species or 2 individual sharks of the species in the management unit, whichever is greater. (b) Marlin prohibition. The sale of striped marlin by a vessel with a permit under this subpart is prohibited. (c) Sea turtle handling and resuscitation. All sea turtles taken incidentally in fishing operations by any HMS vessel other than vessels subject to § 660.712 must be handled in accordance with 50 CFR 223.206(d)(1). | ||||
| 50:50:13.0.1.1.1.11.1.12 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.712 Longline fishery. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 77 FR 15975, Mar. 19, 2012] | (a) Gear and fishing restrictions. (1) Owners and operators of vessels registered for use of longline gear may not use longline gear to fish for or target HMS within the U.S. EEZ. (2) Owners and operators of vessels registered for use of longline gear may not make shallow sets with longline gear to fish for or target swordfish ( Xiphias gladius ) west of 150° W. long. and north of the equator (0° N. lat.). (3) A person aboard a vessel registered for use of longline gear fishing for HMS west of 150° W. long. and north of the equator (0° N. lat.) may not possess or deploy any float line that is shorter than or equal to 20 m (65.6 ft or 10.9 fm). As used in this paragraph, float line means a line used to suspend the main longline beneath a float. (4) From April 1 through May 31, owners and operators of vessels registered for use of longline gear may not use longline gear in waters bounded on the south by 0° lat., on the north by 15° N. lat., on the east by 145° W. long., and on the west by 180° long. (5) From April 1 through May 31, owners and operators of vessels registered for use of longline gear may not receive from another vessel HMS that were harvested by longline gear in waters bounded on the south by 0° lat., on the north by 15° N. lat., on the east by 145° W. long., and on the west by 180° long. (6) From April 1 through May 31, owners and operators of vessels registered for use of longline gear may not land or transship HMS that were harvested by longline gear in waters bounded on the south by 0° lat., on the north by 15° N. lat., on the east by 145° W. long., and on the west by 180° long. (7) No light stick may be possessed on board a vessel registered for use of longline gear during fishing trips that include any fishing west of 150° W. long. and north of the equator (0° N. lat.). A light stick as used in this paragraph is any type of light emitting device, including any flourescent glow bead, chemical, or electrically powered light that is affixed underwater to the longline gear. (8) When a conv… | ||||
| 50:50:13.0.1.1.1.11.1.13 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.713 Drift gillnet fishery. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 72 FR 31757, June 8, 2007; 78 FR 54551, Sept. 4, 2013; 80 FR 10395, Feb. 26, 2015; 85 FR 7250, Feb. 7, 2020] | (a) Take Reduction Plan gear restrictions. Gear restrictions resulting from the Pacific Offshore Cetacean Take Reduction Plan established under the authority of the Marine Mammal Protection Act of 1972 can be found at 50 CFR 229.31. (b) Other gear restrictions. (1) The maximum length of a drift gillnet on board a vessel shall not exceed 6,000 ft (1828 m). (2) Up to 1,500 ft (457 m) of drift gillnet in separate panels of 600 ft (182.88 m) may be on board the vessel in a storage area. (c) Protected Resource Area closures. (1) Pacific leatherback conservation area. No person may fish with, set, or haul back drift gillnet gear in U.S. waters of the Pacific Ocean from August 15 through November 15 in the area bounded by straight lines connecting the following coordinates in the order listed: (i) Pt. Sur at 36°18.5′ N. lat., to (ii) 34°27′ N. lat. 123°35′ W. long., to (iii) 34°27′ N. lat. 129° W. long., to (iv) 45° N. lat. 129° W. long., thence to (v) the point where 45° N. lat. intersects the Oregon coast. (2) Pacific loggerhead conservation area. No person may fish with, set, or haul back drift gillnet gear in U.S. waters of the Pacific Ocean east of the 120° W. meridian from June 1 through August 31 during a forecasted, or occurring, El Nino event off the coast of southern California. (i) Notification of an El Nino event. The Assistant Administrator will publish in the Federal Register a notification that an El Nino event is occurring, or is forecast to occur, off the coast of southern California and the requirement of a closure under this paragraph (c)(2). Furthermore, the Assistant Administrator will announce the requirement of such a closure by other methods as are necessary and appropriate to provide actual notice to the participants in the California/Oregon drift gillnet fishery. (ii) Determination of El Nino conditions. The Assistant Administrator will rely on information developed by NOAA offices which monitor El Nino events, such as NOAA's Climate Prediction Center and the West Coast… | ||||
| 50:50:13.0.1.1.1.11.1.14 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.714 Purse seine fishery. [Reserved] | FWS | ||||||
| 50:50:13.0.1.1.1.11.1.15 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.715 Deep-set buoy gear fishery. | FWS | [88 FR 29552, May 8, 2023] | (a) Gear configurations. Deep-set buoy gear (DSBG) configurations must conform to the following specifications: (1) Standard buoy gear (SBG). An individual piece of SBG must consist of a vertical monofilament mainline suspended from a buoy-array with a terminal weight. No more than three gangions with hooks may be attached to the mainline. No gangions with hooks may be attached at a depth shallower than 90 meters. (2) Linked buoy gear (LBG). An individual piece (section) of LBG must consist of a monofilament mainline that extends vertically from a buoy-array (either directly or from a minimum 50-foot (15.24-meter) extender) to a weight; then horizontally to a second weight; then vertically to a minimum 50-foot (15.24-meter) extender attached to a second buoy-array. No more than three gangions with hooks may be connected to each horizontal section of the mainline. No gangions with hooks may be attached at a depth shallower than 90 meters. Individual pieces may be linked together by the mainline. The links between each piece of LBG must be serviceable. (b) Additional gear configuration specifications. Use of SBG and LBG must conform with the following requirements: (1) Surface buoy flotation and strike detection array requirements. The surface buoy flotation and strike detection array must include a minimum of three buoys (a minimum 45-pound (20.41 kilogram) buoyancy non-compressible hard ball, a minimum 6-pound (2.72 kilogram) buoyancy buoy, and a strike detection buoy), with no more than 6 feet (1.83 meters) of line between adjacent buoys, all connected in-line by a minimum of 3/8 inch (9.53 millimeter) diameter line. (i) Buoys must be free of tether attachments ( e.g., non-streamlined gear with loops and/or dangling components). (ii) SBG and terminal LBG buoy-arrays must include a locator flag, a radar reflector, and the buoy must be marked with a number clearly identifying the owner or operator of the vessel. The number may be either: (A) If required by applicable state law, the vessel's nu… | ||||
| 50:50:13.0.1.1.1.11.1.16 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.716 [Reserved] | FWS | ||||||
| 50:50:13.0.1.1.1.11.1.17 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.717 Framework for revising regulations. | FWS | (a) General. NMFS will establish and adjust specifications and management measures in accordance with procedures and standards in the FMP. (b) Annual actions. Annual specifications are developed and implemented according to § 660.709. (c) Routine management measures. Consistent with section 3.4 of the FMP, management measures designated as routine may be adjusted during the year after recommendation from the Council, approval by NMFS, and publication in the Federal Register. (d) Changes to the regulations. Regulations under this subpart may be promulgated, removed, or revised. Any such action will be made according to the framework measures in section 8.3.4 of the FMP and will be published in the Federal Register. | |||||
| 50:50:13.0.1.1.1.11.1.18 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.718 Exempted fishing. | FWS | (a) In the interest of developing an efficient and productive fishery for HMS, the Regional Administrator may issue exempted fishing permits (EFP) for the harvest of HMS that otherwise would be prohibited. (b) No exempted fishing for HMS may be conducted unless authorized by an EFP issued for the participating vessel in accordance with the criteria and procedures specified in 50 CFR 600.745. | |||||
| 50:50:13.0.1.1.1.11.1.19 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.719 Scientific observers. | FWS | (a) All fishing vessels with permits issued under this subpart and operating in HMS fisheries, including catcher/processors, at-sea processors, and vessels that embark from a port in Washington, Oregon, or California and land catch in another area, may be required to accommodate an NMFS certified observer on board to collect scientific data. (b) All vessels with observers on board must comply with the safety regulations at 50 CFR 600.746. (c) NMFS shall advise the permit holder or the designated agent of any observer requirement in response to any pre-trip notification in this subpart. (d) When NMFS notifies the permit holder or designated agent of the obligation to carry an observer in response to a notification under this subpart or as a condition of an EFP issued under 50 CFR 660.718, the vessel may not engage in the fishery without taking the observer. (e) A permit holder must accommodate a NMFS observer assigned under this section. The Regional Administrator's office, and not the observer, will address any concerns raised over accommodations. (f) The permit holder, vessel operator, and crew must cooperate with the observer in the performance of the observer's duties, including: (1) Allowing for the embarking and debarking of the observer. (2) Allowing the observer access to all areas of the vessel necessary to conduct observer duties. (3) Allowing the observer access to communications equipment and navigation equipment as necessary to perform observer duties. (4) Allowing the observer access to VMS units to verify operation, obtain data, and use the communication capabilities of the units for official purposes. (5) Providing accurate vessel locations by latitude and longitude or loran coordinates, upon request by the observer. (6) Providing sea turtle, marine mammal, or sea bird specimens as requested. (7) Notifying the observer in a timely fashion when commercial fishing operations are to begin and end. (g) The permit holder, operator, and crew must comply with other terms and conditions to ens… | |||||
| 50:50:13.0.1.1.1.11.1.2 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.702 Definitions. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 76 FR 56328, Sept. 13, 2011; 80 FR 10394, Feb. 26, 2015; 80 FR 46520, Aug. 5, 2015; 83 FR 11150, Mar. 14, 2018; 85 FR 7250, Feb. 7, 2020; 88 FR 29548, May 8, 2023] | Basket-style longline gear means a type of longline gear that is divided into units called baskets, each consisting of a segment of main line to which 10 or more branch lines with hooks are spliced. The mainline and all branch lines are made of multiple braided strands of cotton, nylon, or other synthetic fibers impregnated with tar or other heavy coatings that cause the lines to sink rapidly in seawater. Change in ownership means the addition of a new shareholder or partner to the membership of the corporation, partnership, or other entity. A change in ownership is not considered to have occurred if a member dies or becomes legally incapacitated and a trustee is appointed to act on their behalf, nor if the ownership of shares among existing members changes, nor if a member leaves the corporation or partnership or other entity and is not replaced. A change in ownership is not considered to have occurred if only the name of the entity changes. Closure, when referring to closure of a fishery, means that taking and retaining, possessing, or landing the particular species or species group is prohibited. Commercial fishing means: (1) Fishing by a person who possesses a commercial fishing license or is required by law to possess such license issued by one of the states or the Federal Government as a prerequisite to taking, retaining, possessing, landing and/or selling of fish; or (2) Fishing that results in or can be reasonably expected to result in sale, barter, trade, or other disposition of fish for other than personal consumption. Commercial fishing gear includes the following types of gear and equipment used in the highly migratory species fisheries: (1) Deep-set buoy gear. Line fishing gear which consists of vertical mainlines suspended from a buoy array, with gangions with hooks attached to either a vertical line or a horizontal line connected to the terminal ends of two vertical lines. All configurations must be set at or below a minimum depth and actively tended; (2) Drift gillnet. A panel o… | ||||
| 50:50:13.0.1.1.1.11.1.20 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.720 Interim protection for sea turtles. | FWS | (a) Until the effective date of §§ 660.707 and 660.712 (d) and (e), it is unlawful for any person who is not operating under a Hawaii longline limited access permit under § 660.21(b) to do any of the following: (1) Direct fishing effort toward the harvest of swordfish ( Xiphias gladius ) using longline gear deployed on the high seas of the Pacific Ocean west of 150° W. long. and north of the equator (0° lat.). (2) Possess a light stick on board a longline vessel on the high seas of the Pacific Ocean west of 150° W. long. north of the equator. A light stick as used in this paragraph is any type of light emitting device, including any fluorescent glow bead, chemical, or electrically powered light that is affixed underwater to the longline gear. (3) An operator of a longline vessel subject to this section may land or possess no more than 10 swordfish from a fishing trip where any part of the trip included fishing west of 150° W. long. and north of the equator (0° N. lat.). (4) Fail to employ basket-style longline gear such that the mainline is deployed slack when fishing on the high seas of the Pacific Ocean west of 150° W. long. north of the equator. (5) When a conventional monofilament longline is deployed by a vessel subject to this section, no fewer than 15 branch lines may be set between any two floats. Vessel operators using basket-style longline gear must set a minimum of 10 branch lines between any 2 floats when fishing in waters west of 150° W. long. north of the equator. (6) Longline gear deployed by a vessel subject to this section must be deployed such that the deepest point of the main longline between any two floats, i.e., the deepest point in each sag of the main line, is at a depth greater than 100 m (328.1 ft or 54.6 fm) below the sea surface. (b) [Reserved] | |||||
| 50:50:13.0.1.1.1.11.1.21 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.721 Recreational fishing bag limits and filleting requirements. | FWS | [72 FR 58259, Oct. 15, 2007, as amended at 80 FR 44891, July 28, 2015] | This section applies to recreational fishing for albacore tuna in the U.S. EEZ off the coast of California, Oregon, and Washington and for bluefin tuna in the U.S. EEZ off the coast of California. In addition to individual fishermen, the operator of a U.S. sportsfishing vessel that fishes for albacore or bluefin tuna is responsible for ensuring that the bag and possession limits of this section are not exceeded. The bag limits of this section apply on the basis of each 24-hour period at sea, regardless of the number of trips per day. The provisions of this section do not authorize any person to take and retain more than one daily bag limit of fish during 1 calendar day. Federal recreational HMS regulations are not intended to supersede any more restrictive state recreational HMS regulations relating to federally-managed HMS. (a) Albacore Tuna Daily Bag Limit. Except pursuant to a multi-day possession permit referenced in paragraph (c) of this section, a recreational fisherman may take and retain, or possess onboard no more than: (1) Ten albacore tuna if any part of the fishing trip occurs in the U.S. EEZ south of a line running due west true from 34°27′ N. latitude (at Point Conception, Santa Barbara County) to the U.S.-Mexico border. (2) Twenty-five albacore tuna if any part of the fishing trip occurs in the U.S. EEZ north of a line running due west true from 34°27′ N. latitude (at Point Conception, Santa Barbara County) to the California-Oregon border. (b) Bluefin Tuna Daily Bag Limit. A recreational fisherman may take and retain, or possess on board no more than two bluefin tuna during any part of a fishing trip that occurs in the U.S. EEZ off California south of a line running due west true from the California—Oregon border [42°00′ N. latitude]. (c) Possession Limits. If the State of California requires a multi-day possession permit for albacore or bluefin tuna harvested by a recreational fishing vessel and landed in California, aggregating daily trip limits for multi-day trips would be deemed cons… | ||||
| 50:50:13.0.1.1.1.11.1.3 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.703 Management area. | FWS | The fishery management area for the regulation of fishing for HMS has the following designations and boundaries: (a) Southern boundary—the United States-Mexico International Boundary, which is a line connecting the following coordinates: 32°35′22″ N. lat. 117°27′49″ W. long. 32°37′37″ N. lat. 117°49′31″ W. long. 31°07′58″ N. lat. 118°36′18″ W. long. 30°32′31″ N. lat. 121°51′58″ W. long. (b) Northern boundary—the United States-Canada Provisional International Boundary, which is a line connecting the following coordinates: 48°29′37.19″ N. lat. 124°43′33.19″ W. long. 48°30′11″ N. lat. 124°47′13″ W. long. 48°30′22″ N. lat. 124°50′21″ W. long. 48°30′14″ N. lat. 124°54′52″ W. long. 48°29′57″ N. lat. 124°59′14″ W. long. 48°29′44″ N. lat. 125°00′06″ W. long. 48°28′09″ N. lat. 125°05′47″ W. long. 48°27′10″ N. lat. 125°08′25″ W. long. 48°26′47″ N. lat 125°09′12″ W. long. 48°20′16″ N. lat. 125°22′48″ W. long. 48°18′22″ N. lat. 125°29′58″ W. long. 48°11′05″ N. lat. 125°53′48″ W. long. 47°49′15″ N. lat. 126°40′57″ W. long. 47°36′47″ N. lat. 127°11′58″ W. long. 47°22′00″ N. lat. 127°41′23″ W. long. 46°42′05″ N. lat. 128°51′56″ W. long. 46°31′47″ N. lat. 129°07′39″ W. long. (c) Adjacent waters on the high seas in which persons subject to this subpart may fish. | |||||
| 50:50:13.0.1.1.1.11.1.4 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.704 Vessel identification. | FWS | [76 FR 73520, Nov. 29, 2011] | (a) Applicability. This section only applies to commercial fishing vessels that fish for HMS off, or land HMS in the States of California, Oregon, and Washington. This section does not apply to recreational charter vessels that fish for HMS off or land HMS in the States of California, Oregon, and Washington. Each fishing vessel must be marked for identification purposes, as follows: (1) A vessel used to fish on the high seas within the Convention Area as defined in § 300.211 of this title must be marked in accordance with the requirements at §§ 300.14 and 300.217 of this title. (2) A vessel not used to fish on the high seas within the Convention Area as defined in § 300.211 of this title must be marked in accordance with either: (i) Sections 300.14 and 300.217 of this title, or (ii) The vessel's official number must be affixed to the port and starboard sides of the deckhouse or hull, and on an appropriate weather deck so as to be visible from enforcement vessels and aircraft. The official number must be affixed to each vessel subject to this section in block Arabic numerals at least 10 inches (25.40 cm) in height for vessels more than 25 ft (7.62 m) but equal to or less than 65 ft (19.81 m) in length; and 18 inches (45.72 cm) in height for vessels longer than 65 ft (19.81 m) in length. Markings must be legible and of a color that contrasts with the background. (b) [Reserved] | ||||
| 50:50:13.0.1.1.1.11.1.5 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.705 Prohibitions. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 72 FR 58259, Oct. 15, 2007; 77 FR 15975, Mar. 19, 2012; 80 FR 10395, Feb. 26, 2015; 80 FR 46520, Aug. 5, 2015; 85 FR 7250, Feb. 7, 2020; 88 FR 29548, May 8, 2023] | In addition to the general prohibitions specified in § 600.725 of this chapter, it is unlawful for any person to do any of the following: (a) Fish for HMS in the U.S. EEZ off the Pacific coast without a permit issued under § 660.707 for the use of authorized fishing gear. (b) Fish with gear in any closed area specified in this subpart that prohibits the use of such gear. (c) Land HMS at Pacific coast ports without a permit issued under § 600.707 for the use of authorized fishing gear. (d) Sell HMS without an applicable commercial state fishery license. (e) When fishing for HMS, fail to return a prohibited species to the sea immediately with a minimum of injury, except under the following circumstances: (1) Any prohibited species may be retained for examination by an authorized observer or to return tagged fish as specified by the tagging agency. (2) Salmon may be retained if harvested in accordance with subpart H of this part, and other applicable law. (3) Great white sharks, basking sharks, and megamouth sharks may be retained if incidentally caught and subsequently sold or donated to a recognized scientific or educational organization for research or display purposes. (4) Pacific halibut may be retained if harvested in accordance with part 300, subpart E of this Title, and other applicable law. (f) Falsify or fail to affix and maintain vessel markings as required by § 660.704. (g) Fish for HMS in violation of any terms or conditions attached to an exempted fishing permit issued under § 600.745 of this chapter. (h) When a directed fishery has been closed for a specific species, take and retain, possess, or land that species after the closure date. (i) Refuse to submit fishing gear or fish subject to such person's control to inspection by an authorized officer, or to interfere with or prevent, by any means, such an inspection. (j) Falsify or fail to make and/or file any and all reports of fishing, landing, or any other activity involving HMS, containing all data, and in the exact manner, required by… | ||||
| 50:50:13.0.1.1.1.11.1.6 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.706 Pacific Coast Treaty Indian rights. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 81 FR 36808, June 8, 2016] | (a) Pacific Coast treaty Indian tribes have treaty rights to harvest HMS in their usual and accustomed (U&A) fishing areas in the EEZ. (b) Pacific Coast treaty Indian tribes means the Hoh, Makah, and Quileute Indian Tribes and the Quinault Indian Nation. (c) The Pacific Coast treaty Indian tribes' U&A fishing areas within the EEZ are set forth in § 660.4 of this chapter. (d) Procedures. The rights referred to in paragraph (a) of this section will be implemented by the Secretary of Commerce, after consideration of the tribal request, the recommendation of the Council, and the comments of the public. The rights will be implemented either through an allocation of fish that will be managed by the tribes, or through regulations that will apply specifically to the tribal fisheries. An allocation or a regulation specific to the tribes shall be initiated by a written request from a Pacific Coast treaty Indian tribe to the NMFS West Coast Regional Administrator, at least 120 days prior to the time the allocation is desired to be effective, and will be subject to public review through the Council process. The Secretary of Commerce recognizes the sovereign status and co-manager role of Indian tribes over shared Federal and tribal fishery resources. Accordingly, the Secretary of Commerce will develop tribal allocations and regulations in consultation with the affected tribe(s) and, insofar as possible, with tribal consensus. (e) Identification. A valid treaty Indian identification card issued pursuant to 25 CFR part 249, subpart A, is prima facie evidence that the holder is a member of the Pacific Coast treaty Indian tribe named on the card. (f) Fishing (on a tribal allocation or under a Federal regulation applicable to tribal fisheries) by a member of a Pacific Coast treaty Indian tribe within that tribe's U&A fishing area is not subject to provisions of the HMS regulations applicable to non-treaty fisheries. (g) Any member of a Pacific Coast treaty Indian tribe must comply with any applicable Federal and tribal l… | ||||
| 50:50:13.0.1.1.1.11.1.7 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.707 Permits. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 72 FR 10937, Mar. 12, 2007; 74 FR 37178, July 28, 2009; 83 FR 11150, Mar. 14, 2018; 88 FR 29549, May 8, 2023] | (a) General. This section applies to vessels that fish for HMS off or land HMS in the States of California, Oregon, and Washington. (1) A commercial fishing vessel of the United States must be registered for use under a general HMS permit that authorizes the use of specific gear, and a recreational charter vessel must be registered for use under a HMS permit if that vessel is used: (i) To fish for HMS in the U.S. EEZ off the States of California, Oregon, and Washington; or (ii) To land or transship HMS shoreward of the outer boundary of the U.S. EEZ off the States of California, Oregon, and Washington. (2) The permit must be on board the vessel and available for inspection by an authorized officer, except that if the permit was issued while the vessel was at sea, this requirement applies only to any subsequent trip. (3) A permit is valid only for the vessel for which it is registered. A permit not registered for use with a particular vessel may not be used. (4) Only a person eligible to own a documented vessel under the terms of 46 U.S.C. 12102(a) may be issued or may hold (by ownership or otherwise) a general HMS permit. (b) Application. (1) Following publication of the final rule implementing the FMP, NMFS will issue general HMS permits to the owners of those vessels on a list of vessels obtained from owners previously applying for a permit under the authority of the High Seas Fishing Compliance Act, the Tuna Conventions Act of 1950, the Marine Mammal Protection Act, and the Fishery Management Plan for Pelagic Fisheries of the Western Pacific Region, or whose vessels are listed on the vessel register of the Inter-American Tropical Tuna Commission. (2) All permits issued by NMFS in accordance with paragraph (b)(1) of this section will authorize the use of specific fishing gear by the identified commercial fishing vessels. (3) An owner of a vessel subject to these requirements who has not received a permit under this section from NMFS and who wants to engage in the fisheries must apply to the SFD for… | ||||
| 50:50:13.0.1.1.1.11.1.8 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.708 Reporting and recordkeeping. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 80 FR 62501, Oct. 16, 2015] | (a) Logbooks. The operator of any commercial fishing vessel and any recreational charter vessel fishing for HMS in the management area must maintain on board the vessel an accurate and complete record of catch, effort, and other data on report forms provided by the Regional Administrator or a state agency. All information specified on the forms must be recorded on the forms within 24 hours after the completion of each fishing day. The original logbook form for each day of the fishing trip must be submitted to either the Regional Administrator or the appropriate state management agency within 30 days of each landing or transhipment of HMS. Each form must be signed and dated by the fishing vessel operator. (1) Logbooks that meet the logbook reporting requirement may be found at http://swr.nmfs.noaa.gov/logbooks.htm and include: (i) The logbook required under 50 CFR 300.21 implementing the Tuna Conventions Act of 1950; (ii) The logbook required under § 660.14 implementing the Fishery Management Plan for Pelagic Fisheries of the Western Pacific Region; (iii) Any logbook required by the fishery management agency of the States of California, Oregon, or Washington. (2) Any holder of a permit who does not submit logbooks under any of the above authorities must submit a written request to the SFD for the appropriate logbook. The applicant must provide his or her name and address, the name of the vessel, and the type of fishing gear used. (3) The Regional Administrator may, after consultation with the Council, act to modify the information to be provided on the fishing record forms. (b) Any person who is required to do so by the applicable state law must make and/or file, retain, or make available any and all reports of HMS containing all data, and in the exact manner, required by the applicable state law. | ||||
| 50:50:13.0.1.1.1.11.1.9 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | K | Subpart K—Highly Migratory Fisheries | § 660.709 Annual specifications. | FWS | [69 FR 18453, Apr. 7, 2004, as amended at 76 FR 56328, Sept. 13, 2011; 83 FR 19982, May 7, 2018] | (a) Procedure. (1) Each year, the HMSMT will deliver a stock assessment and fishery evaluation report to the Council for all HMS with any necessary recommendations for harvest guidelines, quotas or other management measures to protect HMS, including updated maximum sustainable yield (MSY) and optimum yield (OY) estimates based on the best available science. The Council's Scientific and Statistical Committee may review the estimates and make a recommendation on their suitability for management. As described in the fishery management plan, the Council will periodically review these recommendations and decide whether to adopt updated numerical estimates of MSY and OY, which are then submitted as recommendations for NMFS to review as part of the management measures review process. (2) Based on recommendations of the Council, the Regional Administrator will approve or disapprove any harvest guideline, quota, or other management measure including updated MSY and OY estimates after reviewing such recommendations to determine compliance with the FMP, the Magnuson Act, and other applicable law. The Regional Administrator will implement through rulemaking any approved harvest guideline, quota, or other management measure adopted under this section. (b) Fishing seasons for all species will begin on April 1 of each year at 0001 hours local time and terminate on March 31 of each year at 2400 hours local time. (c) Harvest guidelines, quotas, and other management measures announced for a particular year will be in effect the following year unless changed through the public review process described in paragraph (a) of this section. (d) Irrespective of the normal review process, the Council may propose management action to protect HMS at any time. The Council may adopt a management cycle different from the one described in the fishery management plan provided that such change is made by a majority vote of the Council and a 6-month notice of the change is given. | ||||
| 50:50:13.0.1.1.1.2.1.1 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | B | Subpart B—All West Coast EEZ Fisheries | § 660.5 Shared Ecosystem Component Species. | FWS | [81 FR 19057, Apr. 4, 2016, as amended at 89 FR 101522, Dec. 16, 2024] | (a) General. The FMPs implemented in this part 660 each contain ecosystem component species specific to each FMP, as well as a group of ecosystem component species shared between all of the FMPs. Ecosystem component species shared between all of the Pacific Fishery Management Council's FMPs, and known collectively as “Shared EC Species,” are: (1) Round herring ( Etrumeus teres ) and thread herring ( Ophisthonema libertate and O. medirastre ). (2) Mesopelagic fishes of the families Myctophidae, Bathylagidae, Paralepididae, and Gonostomatidae . (3) Pacific sand lance ( Ammodytes personatus ) (4) Pacific saury ( Cololabis saira ). (5) Silversides (family Atherinopsidae ). (6) Smelts of the family Osmeridae . (7) Pelagic squids (families: Cranchiidae, Gonatidae, Histioteuthidae, Octopoteuthidae, Ommastrephidae except Humboldt squid [ Dosidicus gigas, ] Onychoteuthidae, and Thysanoteuthidae ). (b) Directed commercial fishing for Shared EC Species. For the purposes of this section, “directed commercial fishing” means that a fishing vessel lands Shared EC Species without landing any species other than Shared EC Species, or lands Shared EC Species with other species and in amounts more than: (1) 10 mt combined weight of all Shared EC Species from any fishing trip; or (2) 30 mt combined weight of all Shared EC Species in any calendar year. | ||||
| 50:50:13.0.1.1.1.2.1.2 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | B | Subpart B—All West Coast EEZ Fisheries | § 660.6 Prohibitions. | FWS | In addition to the general prohibitions specified in § 600.725 of this chapter, and the other prohibitions specified in this part, it is unlawful for any person to: (a) Directed commercial fishing. Engage in directed commercial fishing for Shared EC Species from a vessel engaged in commercial fishing within the EEZ off Washington, Oregon, or California. This prohibition does not apply to: (1) Fishing authorized by the Hoh, Makah, or Quileute Indian Tribes, or by the Quinault Indian Nation, or (2) Fishing trips conducted entirely within state marine waters. (b) At-sea processing. At-sea processing of Shared EC Species is prohibited within the EEZ, except while processing groundfish in accordance with subpart D of this part. | |||||
| 50:50:13.0.1.1.1.3.1.1 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.10 Purpose and scope. | FWS | (a) Subparts C through G of this part implement the Pacific Coast Groundfish Fishery Management Plan (PCGFMP) developed by the Pacific Fishery Management Council. Subparts C through G govern fishing vessels of the U.S. in the EEZ off the coasts of Washington, Oregon, and California. All weights are in round weight or round-weight equivalents, unless specified otherwise. (b) Any person fishing subject to subparts C through G of this part is bound by the international boundaries described in this section, notwithstanding any dispute or negotiation between the U.S. and any neighboring country regarding their respective jurisdictions, until such time as new boundaries are established or recognized by the U.S. | |||||
| 50:50:13.0.1.1.1.3.1.10 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.19 Appeals process for catch monitors, observers, and provider permits. | FWS | [80 FR 22285, Apr. 21, 2015, as amended at 84 FR 31159, June 28, 2019] | (a) Allowed appeals. This section describes the procedure for appealing IADs described at §§ 660.17(g), 660.18(d) and (f), 660.140(h), 660.150(j), 660.160(g), 660.603(b)(3) for catch monitor decertification, observer decertification, provider permit expirations due to inactivity, and EM service provider permit denials. Any person whose interest is directly and adversely affected by an IAD may file a written appeal. For purposes of this section, such person will be referred to as the “applicant.” (b) Appeals process. In cases where the applicant disagrees with the IAD, the applicant may appeal that decision. Final decisions on appeals of IADs will be made in writing by the Regional Administrator or designee acting on behalf of the Secretary of Commerce and will state the reasons therefore. (1) Submission of appeals. (i) The appeal must be in writing and comply with this paragraph. (ii) Appeals must be mailed or faxed to: National Marine Fisheries Service, West Coast Region, Sustainable Fisheries Division, ATTN: Appeals, 7600 Sand Point Way NE., Seattle, WA 98115; Fax: 206-526-6426; or delivered to National Marine Fisheries Service at the same address. (2) Timing of appeals. The appeal must be filed within 30 calendar days after the IAD is issued. The IAD becomes the final decision of the Regional Administrator or designee acting on behalf of the Secretary of Commerce if no appeal is filed within 30 calendar days. The time period to submit an appeal begins with the date on the IAD. If the last day of the time period is a Saturday, Sunday, or Federal holiday, the time period will extend to the close of business on the next business day. (3) Address of record. The address used by the applicant in initial correspondence to NMFS concerning the application will be the address used by NMFS for the appeal. Notifications and correspondence associated with all actions affecting the applicant will be mailed to the address of record unless the applicant provides NMFS, in writing, an address change. NMFS bears n… | ||||
| 50:50:13.0.1.1.1.3.1.11 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.20 Vessel and gear identification. | FWS | (a) Vessel identification —(1) Display. The operator of a vessel that is over 25 ft (7.6 m) in length and is engaged in commercial fishing for groundfish must display the vessel's official number on the port and starboard sides of the deckhouse or hull, and on a weather deck so as to be visible from above. The number must contrast with the background and be in block Arabic numerals at least 18 inches (45.7 cm) high for vessels over 65 ft (19.8 m) long and at least 10 inches (25.4 cm) high for vessels between 25 and 65 ft (7.6 and 19.8 m) in length. The length of a vessel for purposes of this section is the length set forth in USCG records or in state records, if no USCG record exists. (2) Maintenance of numbers. The operator of a vessel engaged in commercial fishing for groundfish must keep the identifying markings required by paragraph (a)(1) of this section clearly legible and in good repair, and must ensure that no part of the vessel, its rigging, or its fishing gear obstructs the view of the official number from an enforcement vessel or aircraft. (3) Commercial passenger vessels. This section does not apply to vessels carrying fishing parties on a per-capita basis or by charter. (b) Gear identification. Gear identification requirements specific to fisheries using fixed gear (limited entry and open access) are described at § 660.219, subpart E and § 660.319, subpart F. | |||||
| 50:50:13.0.1.1.1.3.1.12 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.21 Seabird Avoidance Program. | FWS | [80 FR 71980, Nov. 18, 2015, as amended at 84 FR 67678, Dec. 11, 2019] | This section contains the requirements of the Seabird Avoidance Program. (a) Purpose. The purpose of the Seabird Avoidance Program is to minimize interactions between fishing gear and seabird species, including short-tailed albatross ( Phoebastria albatrus ). (b) Applicability. The requirements specified in paragraph (c) of this section apply to the following fishing vessels when operating within the EEZ north of 36° N latitude: (1) Vessels greater than or equal to 26 ft (7.9 m) LOA engaged in commercial fishing for groundfish with bottom longline gear, including snap gear, as defined under “Fishing gear” in § 660.11, including those operating under the gear switching provisions of the Limited Entry Trawl Fishery, Shorebased IFQ Program as specified in § 660.140(k), or those operating under the limited entry fixed gear fishery in subpart E or under the open access fishery in subpart F of this part, except as provided in paragraphs (b)(2) of this section. (2) Exemptions. The requirements specified in paragraph (c) of this section do not apply to Pacific Coast treaty Indian fisheries, as described at § 660.50, or to anglers engaged in recreational fishing for groundfish, as described in Subpart G of this Part. (c) Seabird Avoidance Requirements —(1) General requirements. The operator of a vessel described in paragraph (b)(1) of this section must comply with the following requirements, unless operating under the provisions of paragraph (c)(3) of this section: (i) Gear onboard. Have onboard the vessel seabird avoidance gear meeting the material standards specified in paragraph (c)(1)(iv) of this section and in accordance to the vessel size and gear type specific requirements as specified in paragraph (c)(2) of this section. (ii) Gear inspection. Upon request by an authorized officer or observer, make the seabird avoidance gear available for inspection. (iii) Gear use. Use seabird avoidance gear as specified in paragraph (c)(2) of this section that meets the material standards specified in parag… | ||||
| 50:50:13.0.1.1.1.3.1.13 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.24 Limited entry and open access fisheries. | FWS | (a) General. All commercial fishing for groundfish must be conducted in accordance with the regulations governing limited entry and open access fisheries, except such fishing by treaty Indian tribes as may be separately provided for. (b) [Reserved] | |||||
| 50:50:13.0.1.1.1.3.1.14 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.25 Permits. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 78381, Dec. 15, 2010; 76 FR 53835, Aug. 30, 2011; 76 FR 74734, Dec. 1, 2011; 77 FR 55155, Sept. 7, 2012; 78 FR 68767, Nov. 15, 2013; 78 FR 75278, Dec. 11, 2013; 81 FR 84426, Nov. 23, 2016; 83 FR 62276, Dec. 3, 2018; 85 FR 37029, June 19, 2020; 85 FR 68003, Oct. 27, 2020; 86 FR 26442, May 14, 2021; 86 FR 58813, Oct. 25, 2021; 86 FR 59875, Oct. 29, 2021; 86 FR 70422, Dec. 10, 2021; 87 FR 77014, Dec. 16, 2022; 87 FR 77005, Dec. 16, 2022; 88 FR 81358, Nov. 22, 2023; 89 FR 101522, 101524, Dec. 16, 2024] | (a) General. Each of the permits or licenses in this section has different conditions or privileges as part of the permit or license. The permits or licenses in this section confer a conditional privilege of participating in the Pacific coast groundfish fishery, in accordance with Federal regulations in 50 CFR part 660, subparts C through G. (b) Limited entry permit —(1) Eligibility and registration —(i) General. In order for a vessel to be used to fish in the limited entry fishery, the vessel owner must hold a limited entry permit and, through SFD, must register that vessel for use with a limited entry permit. When participating in the limited entry fishery, a vessel is authorized to fish with the gear type endorsed on the limited entry permit registered for use with that vessel, except that the MS permit does not have a gear endorsement. There are three types of gear endorsements: Trawl, longline, and pot (or trap). All limited entry permits, except the MS permit, have size endorsements; a vessel registered for use with a limited entry permit must comply with the vessel size requirements of this subpart. A sablefish endorsement is also required for a vessel to be used to fish in the primary season for the limited entry fixed gear sablefish fishery, north of 36° N. lat. Certain limited entry permits will also have endorsements required for participation in a specific fishery, such as the MS/CV endorsement and the C/P endorsement. (ii) Eligibility. Only a person eligible to own a documented vessel under the terms of 46 U.S.C. 12113 (a) may be issued or may hold a limited entry permit. (iii) Registration. Limited entry permits will normally be registered for use with a particular vessel at the time the permit is issued, renewed, or replaced. If the permit will be used with a vessel other than the one registered on the permit, the permit owner must register that permit for use with the new vessel through the SFD. The reissued permit must be placed on board the new vessel in order for the vessel to be u… | ||||
| 50:50:13.0.1.1.1.3.1.15 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.30 Compensation with fish for collecting resource information—EFPs. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 76 FR 27529, May 11, 2011] | In addition to the reasons stated in § 600.745(b)(1) of this chapter, an EFP may be issued under this subpart C for the purpose of compensating the owner or operator of a vessel for collecting resource information according to a protocol approved by NMFS. NMFS may issue an EFP allowing a vessel to retain fish as compensation in excess of trip limits or to be exempt from other specified management measures for the Pacific coast groundfish fishery. (a) Compensation EFP for vessels under contract with NMFS to conduct a resource survey. NMFS may issue an EFP to the owner or operator of a vessel that conducted a resource survey according to a contract with NMFS. A vessel's total compensation from all sources (in terms of dollars or amount of fish, including fish from survey samples or compensation fish) will be determined through normal Federal procurement procedures. The compensation EFP will specify the maximum amount or value of fish the vessel may take and retain after the resource survey is completed. (1) Competitive offers. NMFS may initiate a competitive solicitation (request for proposals or RFP) to select vessels to conduct resource surveys that use fish as full or partial compensation, following normal Federal procurement procedures. (2) Consultation and approval. At a Council meeting, NMFS will consult with the Council and receive public comment on upcoming resource surveys to be conducted if groundfish could be used as whole or partial compensation. Generally, compensation fish would be similar to surveyed species, but there may be reasons to provide payment with healthier, more abundant, less restricted stocks, or more easily targeted species. For example, NMFS may decline to pay a vessel with species that are, or are expected to be, overfished, or that are subject to overfishing, or that are unavoidably caught with species that are overfished or subject to overfishing. NMFS may also consider levels of discards, bycatch, and other factors. If the Council does not approve providing whole or partia… | ||||
| 50:50:13.0.1.1.1.3.1.16 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.40 Rebuilding plans. | FWS | [82 FR 9638, Feb. 7, 2017, as amended at 83 FR 63991, Dec. 12, 2018; 85 FR 79892, Dec. 11, 2020; 89 FR 101525, Dec. 16, 2024] | For each overfished groundfish stock with an approved rebuilding plan, this section contains the standards to be used to establish annual or biennial ACLs, specifically the target date for rebuilding the stock to its MSY level and the harvest control rule to be used to rebuild the stock. The harvest control rule may be expressed as a “Spawning Potential Ratio” or “SPR” harvest rate. (a) Yelloweye rockfish. Yelloweye rockfish was declared overfished in 2002. The target year for rebuilding the yelloweye rockfish stock to B MSY is 2029. The harvest control rule to be used to rebuild the yelloweye rockfish stock is an annual SPR harvest rate of 65.0 percent. (b) Quillback rockfish off California. Quillback rockfish off California was declared overfished in 2023. The target year for rebuilding the California quillback rockfish stock to B MSY is 2060. The harvest control rule to be used to rebuild the quillback rockfish stock off California is the ABC Rule (P* 0.45). | ||||
| 50:50:13.0.1.1.1.3.1.17 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.50 Pacific Coast treaty Indian fisheries. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 75421, Dec. 3, 2010; 75 FR 82300, Dec. 30, 2010; 76 FR 27529, May 11, 2011; 76 FR 28903, May 19, 2011; 77 FR 28507, May 15, 2012; 78 FR 588, Jan. 3, 2013; 78 FR 26532, May 7, 2013; 79 FR 27204, May 13, 2014; 80 FR 12572, Mar. 10, 2015; 80 FR 27593, May 14, 2015; 81 FR 30208, May 16, 2016; 81 FR 36807, June 8, 2016; 82 FR 9639, Feb. 7, 2017; 82 FR 21321, May 8, 2017; 83 FR 22405, May 15, 2018; 83 FR 63991, Dec. 12, 2018; 84 FR 20584, May 10, 2019; 85 FR 36812, June 18, 2020; 85 FR 79893, Dec. 11, 2020; 86 FR 10867, Feb. 23, 2021; 86 FR 32809, June 23, 2021; 87 FR 33441, June 2, 2022; 87 FR 77015, Dec. 16, 2022; 88 FR 34787, May 31, 2023; 88 FR 89315, Dec. 27, 2023; 89 FR 52403, June 24, 2024; 89 FR 101525, Dec. 16, 2024; 90 FR 27266, June 26, 2025; 91 FR 2717, Jan. 22, 2026] | (a) Pacific Coast treaty Indian tribes have treaty rights. Pacific Coast treaty Indian tribes have treaty rights to harvest groundfish in their usual and accustomed fishing areas in U.S. waters. In 1994, the United States formally recognized that the four Washington coastal treaty Indian tribes (Makah, Quileute, Hoh, and Quinault) have treaty rights to fish for groundfish in the Pacific Ocean, and concluded that, in general terms, the quantification of those rights is 50 percent of the harvestable surplus of groundfish that pass through the tribes U&A fishing areas. (b) Pacific Coast treaty Indian tribes. For the purposes of this part, Pacific Coast treaty Indian tribes means the Hoh Indian Tribe, Makah Indian Tribe, Quileute Indian Tribe and the Quinault Indian Nation. (c) Usual and accustomed fishing areas or U&A fishing areas. The Pacific Coast treaty Indian tribes' U&A fishing areas within the EEZ are set out in § 660.4. (d) Procedures. The rights referred to in paragraph (a) of this section will be implemented by the Secretary, after consideration of the tribal request, the recommendation of the Council, and the comments of the public. The rights will be implemented either through an allocation or set-aside of fish that will be managed by the tribes, or through regulations in this section that will apply specifically to the tribal fisheries. (1) Tribal allocations, set-asides, and regulations. An allocation, set-aside or a regulation specific to the tribes shall be initiated by a written request from a Pacific Coast treaty Indian tribe to the Regional Administrator, prior to the first Council meeting in which biennial harvest specifications and management measures are discussed for an upcoming biennial management period. The Secretary generally will announce the annual tribal allocations at the same time as the announcement of the harvest specifications. (2) Co-management. The Secretary recognizes the sovereign status and co-manager role of Indian tribes over shared Federal and tribal fisher… | ||||
| 50:50:13.0.1.1.1.3.1.18 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.55 Allocations. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 78382, Dec. 15, 2010; 75 FR 82300, Dec. 30, 2010; 76 FR 27529, May 11, 2011; 76 FR 53835, Aug. 30, 2011; 76 FR 74737, Dec. 1, 2011; 77 FR 28507, May 15, 2012; 78 FR 588, Jan. 3, 2013; 80 FR 77270, Dec. 14, 2015; 81 FR 84428, Nov. 23, 2016; 82 FR 9639, Feb. 7, 2017; 83 FR 759, Jan. 8, 2018; 83 FR 63991, Dec. 12, 2018; 84 FR 68805, Dec. 17, 2019; 87 FR 77015, Dec. 16, 2022; 88 FR 81358, Nov. 22, 2023; 89 FR 101522, 101526, Dec. 16, 2024; 90 FR 15414, Apr. 11, 2025] | (a) General. The opportunity to harvest Pacific Coast groundfish is allocated among participants in the fishery when the ACLs for a given year are established in the biennial harvest specifications. For any stock that has been declared overfished, any formal allocation may be temporarily revised for the duration of the rebuilding period. For certain species, primarily trawl-dominant species, separate allocations for the trawl and non-trawl fishery (which for this purpose includes limited entry fixed gear, directed open access, and recreational fisheries) will be established biennially or annually using the standards and procedures described in Chapter 6 of the PCGFMP. Chapter 6 of the PCGFMP provides the allocation structure and percentages for species allocated between the trawl and non-trawl fisheries. Also, for those species not subject to the trawl and non-trawl allocations specified under Amendment 21 and in paragraph (c)(1) of this section, separate allocations for the limited entry and open access fisheries may be established using the procedures described in Chapters 6 and 11 of the PCGFMP and this subpart. Allocation of sablefish north of 36° N lat. is described in paragraph (h) of this section and in the PCGFMP. Allocation of Pacific whiting is described in paragraph (i) of this section and in the PCGFMP. Allocation of black rockfish is described in paragraph (l) of this section. Allocation of Pacific halibut bycatch is described in paragraph (m) of this section. Allocations not specified in the PCGFMP are established in regulation through the biennial harvest specifications and are listed in Tables 1 a through d and Tables 2 a through d of this subpart. (b) Fishery harvest guidelines and reductions made prior to fishery allocations. Prior to the setting of fishery allocations, the TAC, ACL, or ACT when specified, is reduced by the Pacific Coast treaty Indian Tribal harvest (allocations, set-asides, and estimated harvest under regulations at § 660.50); projected scientific research catch of all gro… | ||||
| 50:50:13.0.1.1.1.3.1.19 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.60 Specifications and management measures. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 78382, Dec. 15, 2010; 75 FR 82301, Dec. 30, 2010; 76 FR 27530, May 11, 2011; 76 FR 53835, Aug. 30, 2011; 76 FR 74738, Dec. 1, 2011; 77 FR 28507, May 15, 2012; 78 FR 588, Jan. 3, 2013; 80 FR 12572, Mar. 10, 2015; 80 FR 22285, Apr. 21, 2015; 80 FR 77271, Dec. 14, 2015; 81 FR 84429, Nov. 23, 2016; 82 FR 9639, Feb. 7, 2017; 82 FR 48658, Oct. 19, 2017; 83 FR 760, Jan. 8, 2018; 83 FR 62276, Dec. 3, 2018; 83 FR 63991, Dec. 12, 2018; 84 FR 63973, Nov. 19, 2019; 84 FR 68806, Dec. 17, 2019; 86 FR 10867, Feb. 23, 2021; 88 FR 52048, Aug. 7, 2023; 88 FR 81358, Nov. 22, 2023; 88 FR 83842, Dec. 1, 2023; 89 FR 101522, 101526, Dec. 16, 2024] | (a) General. NMFS will establish and adjust specifications and management measures biennially or annually and during the fishing year. Management of the Pacific Coast groundfish fishery will be conducted consistent with the standards and procedures in the PCGFMP and other applicable law. The PCGFMP is available from the Regional Administrator or the Council. Regulations under this subpart may be promulgated, removed, or revised during the fishing year. Any such action will be made according to the framework standards and procedures in the PCGFMP and other applicable law, and will be published in the Federal Register. (b) Biennial actions. The Pacific Coast Groundfish fishery is managed on a biennial, calendar year basis. Harvest specifications and management measures will be announced biennially, with the harvest specifications for each species or species group set for two sequential calendar years. In general, management measures are designed to achieve, but not exceed, the specifications, particularly optimum yields (harvest guidelines and quotas), fishery harvest guidelines, commercial harvest guidelines and quotas, limited entry and open access allocations, or other approved fishery allocations, and to protect overfished and depleted stocks. Management measures will be designed to take into account the co-occurrence ratios of target species with overfished species, and will select measures that will minimize bycatch to the extent practicable. (1) Except for Pacific whiting, every biennium, NMFS will implement OFLs, ABCs, and ACLs, if applicable, for each species or species group based on the harvest controls used in the previous biennium (referred to as default harvest control rules) applied to the best available scientific information. The default harvest control rules for each species or species group are listed in the biennial SAFE document. NMFS may implement OFLs, ABCs, and ACLs, if applicable, that vary from the default harvest control rules based on a Council recommendation. (2) [Reserved] (c)… | ||||
| 50:50:13.0.1.1.1.3.1.2 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.11 General definitions. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 78373, Dec. 15, 2010; 76 FR 27529, May 11, 2011; 76 FR 53834, Aug. 30, 2011; 76 FR 74733, Dec. 1, 2011; 78 FR 587, Jan. 3, 2013; 78 FR 68767, Nov. 15, 2013; 78 FR 75278, Dec. 11, 2013; 80 FR 12571, Mar. 10, 2015; 80 FR 22279, Apr. 21, 2015; 80 FR 71980, Nov. 18, 2015; 80 FR 77270, Dec. 14, 2015; 81 FR 36807, June 8, 2016; 81 FR 84425, Nov. 23, 2016; 82 FR 9638, Feb. 7, 2017; 82 FR 60569, Dec. 21, 2017; 83 FR 62275, Dec. 3, 2018; 83 FR 63990, Dec. 12, 2018; 84 FR 49961, Sept. 24, 2019; 84 FR 63972, Nov. 19, 2019; 85 FR 35600, June 11, 2020; 85 FR 79892, Dec. 11, 2020; 86 FR 10867, Feb. 23, 2021; 87 FR 59728, Oct. 3, 2022; 87 FR 77014, Dec. 16, 2022; 88 FR 83840, Dec. 1, 2023; 89 FR 101522, Dec. 16, 2024; 90 FR 15414, Apr. 11, 2025] | These definitions are specific to the fisheries covered in subparts C through G of this part. Acceptable Biological Catch (ABC) means a harvest specification that is set below the overfishing limit to account for scientific uncertainty in the estimate of OFL, and other scientific uncertainty. Active sampling unit means the portion of the groundfish fleet in which an observer coverage plan is being applied. Address of Record means the business address a person has provided to NMFS for NMFS use in providing notice of agency actions and other business with that person. Allocation. ( See § 600.10 of this chapter) Annual Catch Limit (ACL) is a harvest specification set equal to or below the ABC threshold in consideration of conservation objectives, socioeconomic concerns, management uncertainty and other factors. The ACL is a harvest limit that includes all sources of fishing-related mortality including landings, discard mortality, research catches, and catches in exempted fishing permit activities. Sector-specific annual catch limits can be specified, especially in cases where a sector has a formal, long-term allocation of the harvestable surplus of a stock or stock complex. Annual Catch Target (ACT) is a management target set below the annual catch limit and may be used as an accountability measure in cases where there is great uncertainty in inseason catch monitoring to ensure against exceeding an annual catch limit. Since the annual catch target is a target and not a limit it can be used in lieu of harvest guidelines or strategically to accomplish other management objectives. Sector-specific annual catch targets can also be specified to accomplish management objectives. Artificial lure means any manufactured or man-made non-scented/non-flavored (regardless if scent or flavor is added in the manufacturing process or added afterwards) device complete with hooks, intended to attract fish. Artificial lures include, but are not limited to: spoons, spinners, artificial flies, and plugs. Artificial lures a… | ||||
| 50:50:13.0.1.1.1.3.1.20 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.65 Groundfish harvest specifications. | FWS | [89 FR 101527, Dec. 16, 2024] | Harvest specifications include OFLs, ABCs, and the designation of OYs and ACLs. Management measures necessary to keep catch within the ACL include ACTs, HGs, or quotas for species that need individual management, the allocation of fishery HGs between the trawl and non-trawl segments of the fishery, and the allocation of commercial HGs between the open access and limited entry segments of the fishery. These specifications account for fish caught in state ocean waters (0-3 nm (0-5.6 km) offshore), though that fishing activity is governed by the States of Washington, Oregon, and California respectively. Catch of a stock in State waters is taken off the top of the harvest specifications for the stock in the EEZ (3-200 nm (5.6-370.4 km) offshore). Harvest specifications are provided in tables 1a through 2d of this subpart. | ||||
| 50:50:13.0.1.1.1.3.1.21 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.70 Groundfish conservation areas. | FWS | [71 FR 78663, Dec. 29, 2006, as amended at 72 FR 53167, Sept. 18, 2007; 74 FR 9893, Mar. 6, 2009. Redesignated at 75 FR 60995, Oct. 1, 2010; 76 FR 53835, Aug. 30, 2011; 82 FR 9640, Feb. 7, 2017; 84 FR 63973, Nov. 19, 2019; 88 FR 83842, Dec. 1, 2023; 89 FR 101527, Dec. 16, 2024; 90 FR 57719, Dec. 12, 2025] | (a) General. Groundfish conservation area (GCA) is defined in § 660.11. This section defines GCAs whose shapes are not exclusively defined by boundary lines approximating depth contours found in §§ 660.71 through 660.74 or commonly used geographic coordinates at § 660.11. Fishing activity that is prohibited or permitted within a particular GCA is detailed at subparts C through G of part 660. (b) North Coast Recreational Yelloweye Rockfish Conservation Area. The North Coast Recreational Yelloweye Rockfish Conservation Area (YRCA) is a C-shaped area off the northern Washington coast intended to protect yelloweye rockfish. The North Coast Recreational YRCA is defined by straight lines connecting the following specific latitude and longitude coordinates in the order listed: (1) 48°18.00′ N. lat.; 125°18.00′ W. long.; (2) 48°18.00′ N. lat.; 124°59.00′ W. long.; (3) 48°11.00′ N. lat.; 124°59.00′ W. long.; (4) 48°11.00′ N. lat.; 125°11.00′ W. long.; (5) 48°04.00′ N. lat.; 125°11.00′ W. long.; (6) 48°04.00′ N. lat.; 124°59.00′ W. long.; (7) 48°00.00′ N. lat.; 124°59.00′ W. long.; (8) 48°00.00′ N. lat.; 125°18.00′ W. long.; and connecting back to 48°18.00′ N. lat.; 125°18.00′ W. long. (c) North Coast Commercial Yelloweye Rockfish Conservation Area. The North Coast Commercial Yelloweye Rockfish Conservation Area (YRCA) is an area off the northern Washington coast, overlapping the northern part of North Coast Recreational YRCA, intended to protect yelloweye rockfish. The North Coast Commercial YRCA is defined by straight lines connecting the following specific latitude and longitude coordinates in the order listed: (1) 48°11.77′ N. lat., 125°13.03′ W. long.; (2) 48°16.43′ N. lat., 125°07.55′ W. long.; (3) 48°14.72′ N. lat., 125°01.84′ W. long.; (4) 48°13.36′ N. lat., 125°03.20′ W. long.; (5) 48°12.74′ N. lat., 125°05.83′ W. long.; (6) 48°11.55′ N. lat., 125°04.99′ W. long.; (7) 48°09.96′ N. lat., 125°06.63′ W. long.; (8) 48°09.68′ N. lat., 125°08.75′ W. long.; and connecting back to 48°11.77′ N. la… | ||||
| 50:50:13.0.1.1.1.3.1.22 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.71 Latitude/longitude coordinates defining the 10-fm (18-m) through 40-fm (73-m) depth contours. | FWS | [69 FR 77042, Dec. 23, 2004, as amended at 70 FR 16149, Mar. 30, 2005; 71 FR 8498, Feb. 17, 2006; 71 FR 78665, Dec. 29, 2006; 72 FR 13045, Mar. 20, 2007; 74 FR 9893, Mar. 6, 2009. Redesignated at 75 FR 60995, Oct. 1, 2010; 76 FR 27530, May 11, 2011; 77 FR 55155, Sept. 7, 2012; 82 FR 9640, Feb. 7, 2017; 83 FR 63991, Dec. 12, 2018; 84 FR 63974, Nov. 19, 2019; 85 FR 79893, Dec. 11, 2020; 87 FR 77015, Dec. 16, 2022; 88 FR 12867, Mar. 1, 2023] | Boundaries for some GCAs are defined by straight lines connecting a series of latitude/longitude coordinates. This section provides coordinates for the 10-fm (18-m) through 40-fm (73-m) depth contours. (a) The 10-fm (18-m) depth contour between the U.S. border with Canada and 46°16′ N. lat. is defined by straight lines connecting all of the following points in the order stated: (1) 48°23.80′ N. lat., 124°44.18′ W. long.; (2) 48°23.60′ N. lat., 124°44.80′ W. long.; (3) 48°23.45′ N. lat., 124°44.80′ W. long.; (4) 48°23.30′ N. lat., 124°44.20′ W. long.; (5) 48°22.20′ N. lat., 124°44.30′ W. long.; (6) 48°20.25′ N. lat., 124°42.20′ W. long.; (7) 48°12.80′ N. lat., 124°43.10′ W. long.; (8) 48°11.10′ N. lat., 124°46.50′ W. long.; (9) 48°10.00′ N. lat., 124°46.50′ W. long.; (10) 48°08.50′ N. lat., 124°44.20′ W. long.; (11) 47°59.40′ N. lat., 124°42.50′ W. long.; (12) 47°52.60′ N. lat., 124°38.80′ W. long.; (13) 47°51.50′ N. lat., 124°34.60′ W. long.; (14) 47°39.80′ N. lat., 124°28.10′ W. long.; (15) 47°31.70′ N. lat., 124°26.30′ W. long.; (16) 47°25.20′ N. lat., 124°24.80′ W. long.; (17) 47°09.80′ N. lat., 124°15.20′ W. long.; (18) 46°54.40′ N. lat., 124°14.80′ W. long.; (19) 46°48.30′ N. lat., 124°10.25′ W. long.; (20) 46°38.17′ N. lat., 124°10.30′ W. long.; (21) 46°27.20′ N. lat., 124°06.50′ W. long.; and (22) 46°16.00′ N. lat., 124°10.00′ W. long. (b) The 20-fm (37-m) depth contour between the U.S. border with Canada and 42° N. lat. is defined by straight lines connecting all of the following points in the order stated: (1) 48°23.90′ N. lat., 124°44.20′ W. long.; (2) 48°23.60′ N. lat., 124°44.90′ W. long.; (3) 48°18.60′ N. lat., 124°43.60′ W. long.; (4) 48°18.60′ N. lat., 124°48.20′ W. long.; (5) 48°10.00′ N. lat., 124°48.80′ W. long.; (6) 48°02.40′ N. lat., 124°49.30′ W. long.; (7) 47°37.60′ N. lat., 124°34.30′ W. long.; (8) 47°31.70′ N. lat., 124°32.40′ W. long.; (9) 47°17.90′ N. lat., 124°25.00′ W. long.; (10) 46°58.80′ N. lat., 124°18.30′ W. long.; (11) 46°47.40′ N. lat., 124°12.… | ||||
| 50:50:13.0.1.1.1.3.1.23 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.72 Latitude/longitude coordinates defining the 50 fm (91 m) through 75 fm (137 m) depth contours. | FWS | [69 FR 77051, Dec. 23, 2004, as amended at 71 FR 8500, Feb. 17, 2006; 71 FR 78672, Dec. 29, 2006; 74 FR 9898, Mar. 6, 2009. Redesignated at 75 FR 60995, Oct. 1, 2010; 76 FR 27530, May 11, 2011; 76 FR 54714, Sept. 2, 2011; 78 FR 589, Jan. 3, 2013; 80 FR 12573, Mar. 10, 2015; 82 FR 9640, Feb. 7, 2017; 83 FR 63992, Dec. 12, 2018; 84 FR 63974, Nov. 19, 2019; 87 FR 77016, Dec. 16, 2022; 88 FR 83845, Dec. 1, 2023; 89 FR 101527, Dec. 16, 2024] | Boundaries for some GCAs are defined by straight lines connecting a series of latitude/longitude coordinates. This section provides coordinates for the 50 fm (91 m) through 75 fm (137 m) depth contours. (a) The 50-fm (91-m) depth contour between the U.S. border with Canada and the U.S. border with Mexico is defined by straight lines connecting all of the following points in the order stated: (1) 48°22.15′ N. lat., 124°43.15′ W. long.; (2) 48°22.15′ N. lat., 124°49.10′ W. long.; (3) 48°20.03′ N. lat., 124°51.18′ W. long.; (4) 48°16.61′ N. lat., 124°53.72′ W. long.; (5) 48°14.68′ N. lat., 124°54.50′ W. long.; (6) 48°12.02′ N. lat., 124°55.29′ W. long.; (7) 48°10.00′ N. lat., 124°55.68′ W. long.; (8) 48°03.14′ N. lat., 124°57.02′ W. long.; (9) 47°56.05′ N. lat., 124°55.60′ W. long.; (10) 47°52.58′ N. lat., 124°54.00′ W. long.; (11) 47°50.18′ N. lat., 124°52.36′ W. long.; (12) 47°45.34′ N. lat., 124°51.07′ W. long.; (13) 47°40.96′ N. lat., 124°48.84′ W. long.; (14) 47°34.59′ N. lat., 124°46.24′ W. long.; (15) 47°27.86′ N. lat., 124°42.12′ W. long.; (16) 47°22.34′ N. lat., 124°39.43′ W. long.; (17) 47°17.66′ N. lat., 124°38.75′ W. long.; (18) 47°06.25′ N. lat., 124°39.74′ W. long.; (19) 47°00.43′ N. lat., 124°38.01′ W. long.; (20) 46°52.00′ N. lat., 124°32.44′ W. long.; (21) 46°38.17′ N. lat., 124°26.66′ W. long.; (22) 46°35.41′ N. lat., 124°25.51′ W. long.; (23) 46°25.43′ N. lat., 124°23.46′ W. long.; (24) 46°16.00′ N. lat., 124°17.32′ W. long.; (25) 45°50.88′ N. lat., 124°09.68′ W. long.; (26) 45°46.00′ N. lat., 124°09.39′ W. long.; (27) 45°20.25′ N. lat., 124°07.34′ W. long.; (28) 45°12.99′ N. lat., 124°06.71′ W. long.; (29) 45°03.83′ N. lat., 124°09.17′ W. long.; (30) 44°52.48′ N. lat., 124°11.22′ W. long.; (31) 44°42.41′ N. lat., 124°19.70′ W. long.; (32) 44°38.80′ N. lat., 124°26.58′ W. long.; (33) 44°23.39′ N. lat., 124°31.70′ W. long.; (34) 44°20.30′ N. lat., 124°38.72′ W. long.; (35) 44°13.52′ N. lat., 124°40.45′ W. long.; (36) 44°18.80′ N. lat., 124°35.48′ W. long.; (37)… | ||||
| 50:50:13.0.1.1.1.3.1.24 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.73 Latitude/longitude coordinates defining the 100 fm (183 m) through 150 fm (274 m) depth contours. | FWS | [69 FR 77059, Dec. 23, 2004; 70 FR 13119, Mar. 18, 2005, as amended at 70 FR 16149, Mar. 30, 2005; 71 FR 8500, Feb. 17, 2006; 71 FR 78678, Dec. 29, 2006; 74 FR 9905, Mar. 6, 2009. Redesignated at 75 FR 60995, Oct. 1, 2010; 76 FR 27531, May 11, 2011; 76 FR 54714, Sept. 2, 2011; 78 FR 589, Jan. 3, 2013; 80 FR 12573, Mar. 10, 2015; 82 FR 9640, Feb. 7, 2017; 83 FR 63992, Dec. 12, 2018; 83 FR 66639, Dec. 27, 2018; 84 FR 63974, Nov. 19, 2019; 85 FR 79893, Dec. 11, 2020; 86 FR 14381, Mar. 16, 2021; 87 FR 77017, Dec. 16, 2022; 88 FR 83846, Dec. 1, 2023] | Boundaries for some GCAs are defined by straight lines connecting a series of latitude/longitude coordinates. This section provides coordinates for the 100 fm (183 m) through 150 fm (274 m) depth contours. (a) The 100-fm (183-m) depth contour used between the U.S. border with Canada and the U.S. border with Mexico is defined by straight lines connecting all of the following points in the order stated: (1) 48°15.00′ N. lat., 125°41.00′ W. long.; (2) 48°14.00′ N. lat., 125°36.00′ W. long.; (3) 48°10.00′ N. lat., 125°40.00′ W. long.; (4) 48°09.50′ N. lat., 125°40.50′ W. long.; (5) 48°08.00′ N. lat., 125°38.00′ W. long.; (6) 48°05.00′ N. lat., 125°37.25′ W. long.; (7) 48°02.60′ N. lat., 125°34.70′ W. long.; (8) 47°59.00′ N. lat., 125°34.00′ W. long.; (9) 47°57.26′ N. lat., 125°29.82′ W. long.; (10) 47°59.87′ N. lat., 125°25.81′ W. long.; (11) 48°01.80′ N. lat., 125°24.53′ W. long.; (12) 48°02.08′ N. lat., 125°22.98′ W. long.; (13) 48°02.97′ N. lat., 125°22.89′ W. long.; (14) 48°04.47′ N. lat., 125°21.75′ W. long.; (15) 48°06.11′ N. lat., 125°19.33′ W. long.; (16) 48°07.95′ N. lat., 125°18.55′ W. long.; (17) 48°09.00′ N. lat., 125°18.00′ W. long.; (18) 48°10.00′ N. lat., 125°17.81′ W. long.; (19) 48°11.31′ N. lat., 125°17.55′ W. long.; (20) 48°14.60′ N. lat., 125°13.46′ W. long.; (21) 48°16.67′ N. lat., 125°14.34′ W. long.; (22) 48°18.73′ N. lat., 125°14.41′ W. long.; (23) 48°19.67′ N. lat., 125°13.70′ W. long.; (24) 48°19.70′ N. lat., 125°11.13′ W. long.; (25) 48°22.95′ N. lat., 125°10.79′ W. long.; (26) 48°21.61′ N. lat., 125°02.54′ W. long.; (27) 48°23.00′ N. lat., 124°49.34′ W. long.; (28) 48°17.00′ N. lat., 124°56.50′ W. long.; (29) 48°06.00′ N. lat., 125°00.00′ W. long.; (30) 48°04.62′ N. lat., 125°01.73′ W. long.; (31) 48°04.84′ N. lat., 125°04.03′ W. long.; (32) 48°06.41′ N. lat., 125°06.51′ W. long.; (33) 48°06.00′ N. lat., 125°08.00′ W. long.; (34) 48°07.08′ N. lat., 125°09.34′ W. long.; (35) 48°07.28′ N. lat., 125°11.14′ W. long.; (36) 48°03.45′ N. lat., 125°16.66′ W. lo… | ||||
| 50:50:13.0.1.1.1.3.1.25 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.74 Latitude/longitude coordinates defining the 180 fm (329 m) through 250 fm (457 m) depth contours. | FWS | [69 FR 77069, Dec. 23, 2004; 70 FR 13119, Mar. 18, 2005, as amended at 70 FR 16149, Mar. 30, 2005; 71 FR 78687, Dec. 29, 2006; 72 FR 13045, Mar. 20, 2007; 72 FR 53167, Sept. 18, 2007; 74 FR 9911, Mar. 6, 2009. Redesignated at 75 FR 60995, Oct. 1, 2010; 76 FR 27531, May 11, 2011; 76 FR 54714, Sept. 2, 2011; 78 FR 589, Jan. 3, 2013; 80 FR 12573, Mar. 10, 2015; 84 FR 63974, Nov. 19, 2019; 87 FR 77020, Dec. 16, 2022; 88 FR 12867, Mar. 1, 2023] | Boundaries for some GCAs are defined by straight lines connecting a series of latitude/longitude coordinates. This section provides coordinates for the 180 fm (329 m) through 250 fm (457 m) depth contours. (a) The 180-fm (329-m) depth contour used between the U.S. border with Canada and the U.S. border with Mexico is defined by straight lines connecting all of the following points in the order stated: (1) 48°14.82′ N. lat., 125°41.61′ W. long.; (2) 48°12.86′ N. lat., 125°37.95′ W. long.; (3) 48°11.28′ N. lat., 125°39.67′ W. long.; (4) 48°10.13′ N. lat., 125°42.62′ W. long.; (5) 48°10.00′ N. lat., 125°42.55′ W. long.; (6) 48°08.86′ N. lat., 125°41.92′ W. long.; (7) 48°08.15′ N. lat., 125°44.95′ W. long.; (8) 48°07.18′ N. lat., 125°45.67′ W. long.; (9) 48°05.79′ N. lat., 125°44.64′ W. long.; (10) 48°06.04′ N. lat., 125°41.84′ W. long.; (11) 48°04.26′ N. lat., 125°40.09′ W. long.; (12) 48°04.18′ N. lat., 125°36.94′ W. long.; (13) 48°03.02′ N. lat., 125°36.24′ W. long.; (14) 48°01.75′ N. lat., 125°37.42′ W. long.; (15) 48°01.39′ N. lat., 125°39.42′ W. long.; (16) 47°57.08′ N. lat., 125°36.51′ W. long.; (17) 47°55.20′ N. lat., 125°36.62′ W. long.; (18) 47°54.33′ N. lat., 125°34.98′ W. long.; (19) 47°54.73′ N. lat., 125°31.95′ W. long.; (20) 47°56.39′ N. lat., 125°30.22′ W. long.; (21) 47°55.86′ N. lat., 125°28.54′ W. long.; (22) 47°58.07′ N. lat., 125°25.72′ W. long.; (23) 48°00.81′ N. lat., 125°24.39′ W. long.; (24) 48°01.81′ N. lat., 125°23.76′ W. long.; (25) 48°02.16′ N. lat., 125°22.71′ W. long.; (26) 48°03.46′ N. lat., 125°22.01′ W. long.; (27) 48°04.21′ N. lat., 125°20.40′ W. long.; (28) 48°03.15′ N. lat., 125°19.50′ W. long.; (29) 48°01.92′ N. lat., 125°18.69′ W. long.; (30) 48°00.85′ N. lat., 125°20.02′ W. long.; (31) 48°00.12′ N. lat., 125°20.04′ W. long.; (32) 47°58.18′ N. lat., 125°18.78′ W. long.; (33) 47°58.24′ N. lat., 125°17.26′ W. long.; (34) 47°52.47′ N. lat., 125°15.30′ W. long.; (35) 47°52.13′ N. lat., 125°12.95′ W. long.; (36) 47°50.60′ N. lat., 125°10.65′ W. lo… | ||||
| 50:50:13.0.1.1.1.3.1.26 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.75 Essential Fish Habitat (EFH). | FWS | [71 FR 27416, May 11, 2006. Redesignated at 75 FR 60995, Oct. 1, 2010; 76 FR 53836, Aug. 30, 2011] | Essential fish habitat (EFH) is defined as those waters and substrate necessary to fish for spawning, breeding, feeding or growth to maturity (16 U.S.C. 1802 (10)). EFH for Pacific Coast Groundfish includes all waters and substrate within areas with a depth less than or equal to 3,500 m (1,914 fm) shoreward to the mean higher high water level or the upriver extent of saltwater intrusion (defined as upstream and landward to where ocean-derived salts measure less than 0.5 parts per thousand during the period of average annual low flow). Seamounts in depths greater than 3,500 m (1,914 fm) are also included due to their ecological importance to groundfish. Geographically, EFH for Pacific Coast groundfish includes both a large band of marine waters that extends from the Northern edge of the EEZ at the U.S. border with Canada to the Southern edge of the EEZ at the U.S. border with Mexico, and inland within bays and estuaries. The seaward extent of EFH is consistent with the westward edge of the EEZ for areas approximately north of Cape Mendocino. Approximately south of Cape Mendocino, the 3500 m depth contour and EFH is substantially shoreward of the seaward boundary of the EEZ. There are also numerous discrete areas seaward of the main 3500 m depth contour where the ocean floor rises to depths less than 3500 m and therefore are also EFH. The seaward boundary of EFH and additional areas of EFH are defined by straight lines connecting a series of latitude and longitude coordinates in §§ 660.76 through 660.79. (a) The seaward boundary of EFH, with the exception of the areas in paragraphs (b) through (qq), is bounded by the EEZ combined with a straight line connecting all of the following points in the order stated: (1) 40°18.17′ N. lat., 128°46.72′ W. long.; (2) 40°17.33′ N. lat., 125°58.62′ W. long.; (3) 39°59.10′ N. lat., 125°44.13′ W. long.; (4) 39°44.99′ N. lat., 125°41.63′ W. long.; (5) 39°29.98′ N. lat., 125°23.86′ W. long.; (6) 39°08.46′ N. lat., 125°38.17′ W. long.; (7) 38°58.71′ N. lat., 125°22.33′ W. lo… | ||||
| 50:50:13.0.1.1.1.3.1.27 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.76 Coastwide EFHCAs. | FWS | [84 FR 63974, Nov. 19, 2019] | (a) General. EFHCAs are defined at § 660.11. The boundaries of areas designated as EFHCAs are defined by straight lines connecting a series of latitude and longitude coordinates and other regulatory boundaries. This paragraph provides coordinates outlining the boundaries of the coastwide EFHCA. Coordinates outlining the boundaries of EFHCAs off the coasts of Washington, Oregon, and California are provided in §§ 660.77, 660.78, and 660.79, respectively. Fishing activity that is prohibited or permitted within a particular EFHCA is detailed at subparts C through G of this part. (b) Seaward of the 700-fm (1280-m) contour. This area includes all waters designated as EFH within the West Coast EEZ west of a line approximating the 700-fm (1280-m) depth contour which is defined by straight lines connecting all of the following points in the order stated: (1) 48°06.97′ N lat., 126°02.96′ W long.; (2) 48°00.44′ N lat., 125°54.96′ W long.; (3) 47°55.96′ N lat., 125°46.51′ W long.; (4) 47°47.21′ N lat., 125°43.73′ W long.; (5) 47°42.89′ N lat., 125°49.58′ W long.; (6) 47°38.18′ N lat., 125°37.26′ W long.; (7) 47°32.36′ N lat., 125°32.87′ W long.; (8) 47°29.77′ N lat., 125°26.27′ W long.; (9) 47°28.54′ N lat., 125°18.82′ W long.; (10) 47°19.25′ N lat., 125°17.18′ W long.; (11) 47°08.82′ N lat., 125°10.01′ W long.; (12) 47°04.69′ N lat., 125°03.77′ W long.; (13) 46°48.38′ N lat., 125°18.43′ W long.; (14) 46°41.92′ N lat., 125°17.29′ W long.; (15) 46°27.49′ N lat., 124°54.36′ W long.; (16) 46°14.13′ N lat., 125°02.72′ W long.; (17) 46°09.53′ N lat., 125°04.75′ W long.; (18) 45°46.64′ N lat., 124°54.44′ W long.; (19) 45°40.86′ N lat., 124°55.62′ W long.; (20) 45°36.50′ N lat., 124°51.91′ W long.; (21) 44°55.69′ N lat., 125°08.35′ W long.; (22) 44°49.93′ N lat., 125°01.51′ W long.; (23) 44°46.93′ N lat., 125°02.83′ W long.; (24) 44°41.96′ N lat., 125°10.64′ W long.; (25) 44°28.31′ N lat., 125°11.42′ W long.; (26) 43°58.37′ N lat., 125°02.93′ W long.; (27) 43°52.74′ N lat., 125°05.58′ W long.; (28) … | ||||
| 50:50:13.0.1.1.1.3.1.28 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.77 EFHCAs off the Coast of Washington. | FWS | [84 FR 63975, Nov. 19, 2019] | (a) General. Boundary line coordinates for EFHCAs off Washington are provided in this section. Fishing activity that is prohibited or permitted within the EEZ in a particular area designated as a groundfish EFHCAs is detailed at §§ 660.12, 660.112, 660.130, 660.212, 660.230, 660.312, 660.330, and 660.360. (b) Olympic 2. The boundary of the Olympic 2 EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 48°21.46′ N lat., 124°51.61′ W long.: (1) 48°21.46′ N lat., 124°51.61′ W long.; (2) 48°17.00′ N lat., 124°57.18′ W long.; (3) 48°06.13′ N lat., 125°00.68′ W long.; (4) 48°06.66′ N lat., 125°06.55′ W long.; (5) 48°08.44′ N lat., 125°14.61′ W long.; (6) 48°22.57′ N lat., 125°09.82′ W long.; (7) 48°21.42′ N lat., 125°03.55′ W long.; (8) 48°22.99′ N lat., 124°59.29′ W long.; and (9) 48°23.89′ N lat., 124°54.37′ W long. (c) Biogenic 1. The boundary of the Biogenic 1 EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 47°29.97′ N lat., 125°20.14′ W long.: (1) 47°29.97′ N lat., 125°20.14′ W long.; (2) 47°30.01′ N lat., 125°30.06′ W long.; (3) 47°40.09′ N lat., 125°50.18′ W long.; (4) 47°47.27′ N lat., 125°50.06′ W long.; (5) 47°47.00′ N lat., 125°24.28′ W long.; (6) 47°39.53′ N lat., 125°10.49′ W long.; and (7) 47°30.31′ N lat., 125°08.81′ W long. (d) Biogenic 2. The boundary of the Biogenic 2 EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 47°08.77′ N lat., 125°00.91′ W long.: (1) 47°08.77′ N lat., 125°00.91′ W long.; (2) 47°08.82′ N lat., 125°10.01′ W long.; (3) 47°20.01′ N lat., 125°10.00′ W long.; and (4) 47°20.00′ N lat., 125°01.25′ W long. (e) Quinault Canyon. The boundary of the Quinault Canyon EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 47°17.00′ N lat., 125°15.63′ W long.: (1) 47°17.00′ N lat., 125°15.63′ W long.;… | ||||
| 50:50:13.0.1.1.1.3.1.29 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.78 EFHCAs off the Coast of Oregon. | FWS | [84 FR 63976, Nov. 19, 2019, as amended at 88 FR 83848, Dec. 1, 2023] | (a) General. Boundary line coordinates for EFHCAs off Oregon are provided in this section. Fishing activity that is prohibited or permitted within the EEZ in a particular area designated as a groundfish EFHCA is detailed at §§ 660.12, 660.112, 660.130, 660.212, 660.230, 660.312, 660.330, and 660.360. (b) Astoria Deep. The boundary of the Astoria Deep EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 46°03.00′ N lat., 124°57.36′ W long.: (1) 46°03.00′ N lat., 124°57.36′ W long.; (2) 46°05.37′ N lat., 125°02.88′ W long.; (3) 46°09.53′ N lat., 125°04.75′ W long.; (4) 46°14.13′ N lat., 125°02.72′ W long.; (5) 46°14.79′ N lat., 125°02.31′ W long.; (6) 46°08.28′ N lat., 125°00.20′ W long.; and (7) 46°05.74′ N lat., 124°55.32′ W long. (c) Thompson Seamount. The boundary of the Thompson Seamount EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 46°06.93′ N lat., 128°39.77′ W long.: (1) 46°06.93′ N lat., 128°39.77′ W long.; (2) 46°06.76′ N lat., 128°39.60′ W long.; (3) 46°07.80′ N lat., 128°39.43′ W long.; (4) 46°08.50′ N lat., 128°34.39′ W long.; (5) 46°06.76′ N lat., 128°29.36′ W long.; (6) 46°03.64′ N lat., 128°28.67′ W long.; (7) 45°59.64′ N lat., 128°31.62′ W long.; (8) 45°56.87′ N lat., 128°33.18′ W long.; (9) 45°53.92′ N lat., 128°39.25′ W long.; (10) 45°54.26′ N lat., 128°43.42′ W long.; (11) 45°56.87′ N lat., 128°45.85′ W long.; (12) 46°00.86′ N lat., 128°46.02′ W long.; (13) 46°03.29′ N lat., 128°44.81′ W long.; and (14) 46°06.24′ N lat., 128°42.90′ W long. (d) Astoria Canyon. The boundary of the Astoria Canyon EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 46°06.48′ N lat., 125°05.46′ W long.: (1) 46°06.48′ N lat., 125°05.46′ W long.; (2) 46°03.00′ N lat., 124°57.36′ W long.; (3) 46°02.28′ N lat., 124°57.66′ W long.; (4) 46°01.92′ N lat., 125°02.46′ W long.; (5) 45°48.72′ N … | ||||
| 50:50:13.0.1.1.1.3.1.3 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.12 General groundfish prohibitions. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 78374, Dec. 15, 2010; 76 FR 27529, May 11, 2011; 76 FR 53834, Aug. 30, 2011; 76 FR 74733, Dec. 1, 2011; 78 FR 587, Jan. 3, 2013; 78 FR 68767, Nov. 15, 2013; 80 FR 22279, Apr. 21, 2015; 80 FR 71980, Nov. 18, 2015; 80 FR 77270, Dec. 14, 2015; 81 FR 36807, June 8, 2016; 81 FR 84425, Nov. 23, 2016; 84 FR 32098, July 5, 2019; 84 FR 63973, Nov. 19, 2019; 86 FR 10867, Feb. 23, 2021; 87 FR 59728, Oct. 3, 2022; 88 FR 81358, Nov. 22, 2023; 88 FR 83840, Dec. 1, 2023; 89 FR 101523, Dec. 16, 2024; 90 FR 57719, Dec. 12, 2025] | In addition to the general prohibitions specified in § 600.725 of this chapter, it is unlawful for any person to: (a) General. (1) Retain any prohibited or protected species caught by means of fishing gear authorized under this subpart, unless otherwise authorized. Except as otherwise authorized, prohibited and protected species must be returned to the sea as soon as practicable with a minimum of injury when caught and brought on board. (2) Falsify or fail to affix and maintain vessel and gear markings as required by § 660.20 or § 660.219, subpart E or § 660.319, subpart F. (3) Fish for groundfish in violation of any terms or conditions attached to an EFP under § 600.745 of this chapter or § 660.30, subpart C of this part. (4) Fish for groundfish using gear not authorized in subparts C through G of this part or in violation of any terms or conditions attached to an EFP under § 660.30, subpart C of this part or part 600 of this chapter. (5) Take and retain, possess, or land more groundfish than specified under § 660.50, § 660.55, § 660.60 of subpart C, or subpart D through G of this part, or under an EFP issued under § 660.30, subpart C of this part, or part 600 of this chapter. (6) Take and retain, possess, or land more than a single cumulative limit of a particular species, per vessel, per applicable cumulative limit period, except for sablefish taken in the primary limited entry, fixed gear sablefish season from a vessel authorized to fish in that season, as described at § 660.231, subpart E. (7) Take and retain, possess, or land groundfish in excess of the landing limit for the open access fishery without having a valid limited entry permit for the vessel affixed with a gear endorsement for the gear used to catch the fish. (8) Fail to sort, prior to the first weighing after offloading, those groundfish species or species groups for which there is a trip limit, size limit, scientific sorting designation, quota, harvest guideline, ACT, ACL or OY, if the vessel fished or landed in an area during a time … | ||||
| 50:50:13.0.1.1.1.3.1.30 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.79 EFHCAs off the Coast of California. | FWS | [84 FR 63979, Nov. 19, 2019, as amended at 88 FR 83848, Dec. 1, 2023] | (a) General. Boundary line coordinates for EFHCA off California are provided in this section. Fishing activity that is prohibited or permitted within the EEZ in a particular area designated as a groundfish EFHCA is detailed at §§ 660.12, 660.112, 660.130, 660.212, 660.230, 660.312, 660.330, and 660.360. (b) Brush Patch. The boundary of the Brush Patch EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 41°51.03′ N lat., 124°48.65′ W long.: (1) 41°51.03′ N lat., 124°48.65′ W long.; (2) 41°51.98′ N lat., 124°51.00′ W long.; (3) 41°53.63′ N lat., 124°53.12′ W long.; (4) 41°55.22′ N lat., 124°54.50′ W long.; (5) 41°57.16′ N lat., 124°54.87′ W long.; (6) 41°59.16′ N lat., 124°52.89′ W long.; (7) 41°58.93′ N lat., 124°51.25′ W long.; (8) 41°57.98′ N lat., 124°50.42′ W long.; (9) 41°54.50′ N lat., 124°49.72′ W long.; (10) 41°52.66′ N lat., 124°47.85′ W long.; and (11) 41°51.24′ N lat., 124°47.23′ W long. (c) Trinidad Canyon. The boundary of the Trinidad Canyon EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 41°07.81′ N lat., 124°51.29′ W long.: (1) 41°07.81′ N lat., 124°51.29′ W long.; (2) 41°14.52′ N lat., 124°52.67′ W long.; (3) 41°17.66′ N lat., 124°54.31′ W long.; (4) 41°18.37′ N lat., 124°45.50′ W long.; (5) 41°17.60′ N lat., 124°43.42′ W long.; and (6) 41°09.44′ N lat., 124°43.11′ W long. (d) Mad River Rough Patch. The boundary of the Mad River Rough Patch EFHCA is defined by straight lines connecting all of the following points in the order stated and connecting back to 40°53.66′ N lat., 124°26.68′ W long.: (1) 40°53.66′ N lat., 124°26.68′ W long.; (2) 40°54.49′ N lat., 124°28.22′ W long.; (3) 40°54.88′ N lat., 124°28.54′ W long.; (4) 40°57.27′ N lat., 124°29.10′ W long.; (5) 40°57.37′ N lat., 124°28.96′ W long.; (6) 40°57.27′ N lat., 124°28.34′ W long.; (7) 40°54.56′ N lat., 124°26.25′ W long.; and (8) 40°54.13′ N lat., 124°26.27′ W long. (e) … | ||||
| 50:50:13.0.1.1.1.3.1.4 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.13 Recordkeeping and reporting. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 78374, Dec. 15, 2010; 76 FR 74733, Dec. 1, 2011; 81 FR 84425, Nov. 23, 2016; 83 FR 62275, Dec. 3, 2018; 83 FR 66637, Dec. 27, 2018; 84 FR 31158, June 28, 2019; 84 FR 32098, July 5, 2019; 85 FR 35600, June 11, 2020; 86 FR 10867, Feb. 23, 2021; 87 FR 59713, 59728, Oct. 3, 2022; 87 FR 74328, Dec. 5, 2022; 88 FR 12867, Mar. 1, 2023; 88 FR 83840, Dec. 1, 2023; 89 FR 101522-101523, Dec. 16, 2024; 90 FR 15414, Apr. 11, 2025] | (a) This subpart recognizes that catch and effort data necessary for implementing the PCGFMP are collected by the States of Washington, Oregon, and California under existing state data collection requirements. (1) Trawl logbook. In the absence of a state trawl logbook requirement based on the port of landing, the authorized representative of the commercial trawl fishing vessel registered to a limited entry permit with a trawl gear endorsement participating in the Shorebased IFQ Program groundfish trawl fisheries must keep and submit a complete and accurate record of fishing activities in the trawl logbook form. The following requirements apply: (i) The authorized representative of the vessel must keep the trawl logbook form on board the vessel while engaged in, or returning from, all Shorebased IFQ Program trips using groundfish trawl gear, and must immediately surrender the logbook form upon demand to NMFS or other authorized officers. (ii) The authorized representative of the vessel must complete the trawl logbook form on all Shorebased IFQ Program trips using groundfish trawl gear, with all available information, except for information not yet ascertainable, prior to entering port. The logbook form must be completed as soon as the information becomes available. The information on the logbook form will include at a minimum: Vessel name, vessel trip start and end dates, crew size, tow start, tow completion, location of tow, average depth of catch, net type, target strategy, and estimated retained pounds by species. (iii) The authorized representative of the vessel must deliver the NMFS copy of the trawl logbook form by mail or in person to NMFS or its agent. The authorized representative of the vessel must transmit the logbook form on or before the 10th day of each month following the month to which the records pertain. (iv) The authorized representative of the vessel responsible for submitting the trawl logbook forms must maintain a copy of all submitted logbooks for up to three years after the fishing a… | ||||
| 50:50:13.0.1.1.1.3.1.5 | 50 | Wildlife and Fisheries | VI | 660 | PART 660—FISHERIES OFF WEST COAST STATES | C | Subpart C—West Coast Groundfish Fisheries | § 660.14 Vessel Monitoring System (VMS) requirements. | FWS | [75 FR 60897, Oct. 1, 2010, as amended at 75 FR 78374, Dec. 15, 2010; 76 FR 74733, Dec. 1, 2011; 85 FR 35600, June 11, 2020; 87 FR 11599, Mar. 2, 2022; 88 FR 83841, Dec. 1, 2023; 89 FR 101524, Dec. 16, 2024] | (a) What is a VMS? A VMS consists of a NMFS OLE type-approved mobile transceiver unit that automatically determines the vessel's position and transmits it to a NMFS OLE type-approved communications service provider. The communications service provider receives the transmission and relays it to NMFS OLE. (b) Who is Required to Have a VMS? The following vessels are required to install a NMFS OLE type-approved mobile transceiver unit and to arrange for a NMFS OLE type-approved communications service provider to receive and relay transmissions to NMFS OLE prior to fishing: (1) Any vessel registered for use with a limited entry “A” endorsed permit ( i.e. , not an MS permit) that fishes in state or Federal waters seaward of the baseline from which the territorial sea is measured off the States of Washington, Oregon or California (0-200 nm offshore). (2) Any vessel that uses non-groundfish trawl gear to fish in the EEZ. (3) Any vessel that uses open access gear to take and retain, or possess groundfish in the EEZ or land groundfish taken in the EEZ. (c) How are Mobile Transceiver Units and Communications Service Providers Approved by NMFS OLE? (1) NMFS OLE will publish type-approval specifications for VMS components in the Federal Register or notify the public through other appropriate media. (2) Mobile transceiver unit manufacturers or communication service providers will submit products or services to NMFS OLE for evaluation based on the published specifications. (3) NMFS OLE may publish a list of NMFS OLE type-approved mobile transceiver units and communication service providers for the Pacific Coast groundfish fishery in the Federal Register or notify the public through other appropriate media. As necessary, NMFS OLE may publish amendments to the list of type-approved mobile transceiver units and communication service providers in the Federal Register or through other appropriate media. A list of VMS transceivers that have been type-approved by NMFS OLE may be mailed to the permit owner's address … |
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CREATE TABLE cfr_sections (
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title_number INTEGER,
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chapter TEXT,
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