<CFRTITLE> <LRH>21 CFR Ch. I (4-1-97 Edition)</LRH> <RRH>Food and Drug Administration, HHS</RRH> <TITLEHD> <PRTPAGE P="1"/> <HD SOURCE="HED">Title 21—Food and Drugs</HD> (This book contains parts 100 to 169) </TITLEHD> <CFRTOC> <PTHD> <E T="03">Part</E> </PTHD> <CHAPTI> <SUBJECT> <E T="04">chapter i</E>—Food and Drug Administration, Department of Health and Human Services (Continued)</SUBJECT> <PG>100</PG> </CHAPTI> <CROSSREF> <HD SOURCE="HED">Cross References: </HD> Food Safety and Inspection Service, Meat and Poultry Inspection, Department of Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III. Federal Trade Commission: See Commercial Practices, 16 CFR chapter I. United States Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chapter I. Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury: See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I. </CROSSREF> </CFRTOC> </CFRTITLE> <CHAPTER> <TOC/> <LRH>21 CFR Ch. I (4-1-97 Edition)</LRH> <RRH>Food and Drug Administration, HHS</RRH> </CHAPTER>

CODE OF FEDERAL REGULATIONS21 Food and Drugs PARTS 100 TO 169 Revised as of April 1, 1997

CONTAINING

A CODIFICATION OF DOCUMENTS

OF GENERAL APPLICABILITY

AND FUTURE EFFECT

AS OF APRIL 1, 1997 With Ancillaries

Published by

the Office of the Federal Register

National Archives and Records

Administration

as a Special Edition of

the Federal Register

ARCHIVES.LI U.S. GOVERNMENT PRINTING OFFICE WASHINGTON : 1997

For sale by U.S. Government Printing Office

Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328

Table of Contents Page Explanation v Title 21: Chapter I—Food and Drug Administration, Department of Health and Human Services (Continued) 3 Finding Aids: Material Approved for Incorporation by Reference 535 Table of CFR Titles and Chapters 543 Alphabetical List of Agencies Appearing in the CFR 559 List of CFR Sections Affected 569

Cite this Code:CFR

To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 100.1 refers to title 21, part 100, section 1. Explanation

The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.

Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows:

Title 1 through Title 16

as of January 1

Title 17 through Title 27

as of April 1

Title 28 through Title 41

as of July 1

Title 42 through Title 50

as of October 1

The appropriate revision date is printed on the cover of each volume.

LEGAL STATUS

The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule.

To determine whether a Code volume has been amended since its revision date (in this case, April 1, 1997), consult the “List of CFR Sections Affected (LSA),” which is issued monthly, and the “Cumulative List of Parts Affected,” which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

Each volume of the Code contains amendments published in the Federal Register since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut-off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text.

OMB CONTROL NUMBERS

The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal agencies to display an OMB control number with their information collection request. Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements.

OBSOLETE PROVISIONS

Provisions that become obsolete before the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on a given date in the past by using the appropriate numerical list of sections affected. For the period before January 1, 1986, consult either the List of CFR Sections Affected, 1949-1963, 1964-1972, or 1973-1985, published in seven separate volumes. For the period beginning January 1, 1986, a “List of CFR Sections Affected” is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regulations in the Federal Register by referring to materials already published elsewhere. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law.

What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are:

(a) The incorporation will substantially reduce the volume of material published in the Federal Register.

(b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process.

Properly approved incorporations by reference in this volume are listed in the Finding Aids at the end of this volume.

What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed in the Finding Aids of this volume as an approved incorporation by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, Washington DC 20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR Index and Finding Aids. This volume contains the Parallel Table of Statutory Authorities and Agency Rules (Table I), and Acts Requiring Publication in the Federal Register (Table II). A list of CFR titles, chapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume.

An index to the text of “Title 3—The President” is carried within that volume.

The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the “Contents” entries in the daily Federal Register.

A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

There are no restrictions on the republication of material appearing in the Code of Federal Regulations.

INQUIRIES

For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency's name appears at the top of odd-numbered pages.

For inquiries concerning CFR reference assistance, call 202-523-5227 or write to the Director, Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408.

SALES

The Government Printing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call 202-512-1800, M-F, 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2233, 24 hours a day. For payment by check, write to the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. For GPO Customer Service call 202-512-1803.

Raymond A. Mosley, Director, Office of the Federal Register. April 1, 1997. THIS TITLE

Title 21—Food and Drugs is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The first eight volumes, containing parts 1-1299, comprise Chapter I—Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II—Drug Enforcement Administration, Department of Justice, and Chapter III—Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 1997.

Redesignation tables for Chapter I—Food and Drug Administration appear in the Finding Aids section for the volumes containing parts 170-199 and 500-599.

For this volume, Kenneth R. Payne was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.

CFRORDR.FRM <CFRTITLE> <LRH>21 CFR Ch. I (4-1-97 Edition)</LRH> <RRH>Food and Drug Administration, HHS</RRH> <TITLEHD> <PRTPAGE P="1"/> <HD SOURCE="HED">Title 21—Food and Drugs</HD> (This book contains parts 100 to 169) </TITLEHD> <CFRTOC> <PTHD> <E T="03">Part</E> </PTHD> <CHAPTI> <SUBJECT> <E T="04">chapter i</E>—Food and Drug Administration, Department of Health and Human Services (Continued)</SUBJECT> <PG>100</PG> </CHAPTI> <CROSSREF> <HD SOURCE="HED">Cross References: </HD> Food Safety and Inspection Service, Meat and Poultry Inspection, Department of Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III. Federal Trade Commission: See Commercial Practices, 16 CFR chapter I. United States Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chapter I. Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury: See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I. </CROSSREF> </CFRTOC> </CFRTITLE> <CHAPTER> <TOC/> <LRH>21 CFR Ch. I (4-1-97 Edition)</LRH> <RRH>Food and Drug Administration, HHS</RRH> </CHAPTER> CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—CONTINUED

(Parts 100 to 169)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION Part Page 100 General 5 101 Food labeling 10 102 Common or usual name for nonstandardized foods 154 104 Nutritional quality guidelines for foods 161 105 Foods for special dietary use 165 106 Infant formula quality control procedures 167 107 Infant formula 173 108 Emergency permit control 182 109 Unavoidable contaminants in food for human consumption and food-packaging material 192 110 Current good manufacturing practice in manufacturing, packing, or holding human food 198 111 Current good manufacturing practice for dietary supplements 207 113 Thermally processed low-acid foods packaged in hermetically sealed containers 208 114 Acidified foods 234 123 Fish and fishery products 240 129 Processing and bottling of bottled drinking water 248 130 Food standards: General 253 131 Milk and cream 260 133 Cheeses and related cheese products 290 135 Frozen desserts 342 136 Bakery products 350 137 Cereal flours and related products 354 139 Macaroni and noodle products 369 145 Canned fruits 380 146 Canned fruit juices 420 150 Fruit butters, jellies, preserves, and related products 434 152 Fruit pies 442 155 Canned vegetables 444 156 Vegetable juices 466 158 Frozen vegetables 469 160 Eggs and egg products 472 161 Fish and shellfish 477 163 Cacao products 493 164 Tree nut and peanut products 501 165 Beverages 505 166 Margarine 518 168 Sweeteners and table sirups 521 169 Food dressings and flavorings 525 Editorial Note:

For nomenclature changes to chapter I see 59 FR 14366, Mar. 28, 1994.

21 CFR Ch. I (4-1-97 Edition) FINDING AIDS

A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually.

Material Approved for Incorporation by Reference

Table of CFR Titles and Chapters

Alphabetical List of Agencies Appearing in the CFR

List of CFR Sections Affected

Title 21—Food and Drugs Material Approved for Incorporation by Reference Material Approved for Incorporation by Reference (Revised as of April 1, 1997)

The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 CFR Part 51 the incorporation by reference of the following publications. This list contains only those incorporations by reference effective as of the revision date of this volume. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see the preliminary pages of this volume.

21 CFR CHAPTER I (PARTS 100 TO 169) FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR American Public Health Association 1015 15th St., NW, Washington, DC 20005 Standard Methods for the Examination of Water and Wastewater, 15th Ed. (1980), “Methods For Organochlorine Pesticides Industrial Effluents” 165.110(b)(4) Standard Methods for the Examination of Water and Wastewater, 15th Ed. (1980) “Methods for Chlorinated Phenoxy Acid Herbicides in Industrial Effluents” 165.110(b)(4) American Society for Testing and Materials 1916 Race St. Philadelphia, PA 19103 NOTE: The following ASTM standards are available from University Microfilm International, 300 N. Zeeb Rd., Ann Arbor, MI 48106. ASTM D 2036-91, Standard Test Methods for Cyanides in Water 165.110(b)(4)(iii) (E)(7)(iv) ASTM D 3697-92, Standard Test Method for Antimony in Water 165.110(b)(4)(iii) (E)(1)(iv) ASTM E 11-70 Table 1, Annual Book of ASTM Standards, Part 30 (1972) 137.105(a) AOAC International (Association of Official Analytical Chemists) 481 N. Frederick Ave. Suite 500, Gaithersburg, MD 20877-2417 Official Methods of Analysis, 16th Ed. (1995) 101.81(c) Official Methods of Analysis, 15th Ed. (1990) 101.9(c)(7)(ii); (g)(2); 155.120(b)(2)(i); 163.5(b) Official Methods of Analysis, 14th Ed., 1984, including the 4th Supplement (1988) 168.122(d) Official Methods of Analysis, 14th Ed., 1984 101.100(a); 130.9; 160.145 Official Methods of Analysis, 13th Ed., 1980 101.9; 101.25(e)(3); 102.23; 102.33(b); 105.65(c)(4)(i); 106.30(b)(3)(i), (ii); 114.90; 131.110; 131.111(f); 131.112(e); 131.115; 131.120; 131.122; 131.123; 131.125; 131.127; 131.130; 131.132; 131.135; 131.136(f); 131.138(e); 131.143; 131.144(f); 131.146(e); 131.147; 131.149; 131.150; 131.155; 131.157; 131.160; 131.162; 131.170(f); 131.180; 131.185; 131.187; 131.200(d); 131.203(d); 131.206(d); 133.5; 135.110; 135.130; 136.110; 136.160; 137.105; 137.180; 137.190; 137.200; 137.211; 137.230; 137.250; 137.270; 137.300; 139.110; 139.150; 145.110; 145.135; 145.145; 146.113; 146.114; 146.120; 146.132(a)(1); 146.185; 150.110; 150.140; 150.160; 155.3; 155.130; 155.170(b)(1)(vi); 156.3; 160.180; 161.145; 161.173; 161.175; 161.190; 163.111; 163.112; 164.150; 166.110; 168.111; 168.120; 168.122; 169.3 Official Methods of Analysis, 12th Ed., 1975 163.110; 163.5(a) NOTE: The following materials are available through the Food and Drug Administration at the addresses indicated. Division of Food Chemistry and Technology, Center for Food Safety and Applied Nutrition (HFF-210), Food and Drug Administration 200 C St. SW., Washington, DC 20204 Analytical Methodology for Polychlorinated Biphenyls (June 1979) 109.30 Comparative Anatomy and Systematics of the Tunas, “Gennus Thunnus” Fishery Bulletin Vol. 66, No. 1, (1967) pp. 65-130 161.190(a)(2) Comparison of the Bluefin tuna, Gennus Thunnus—Bureau of Marine Fisheries, Fish Bulletin No. 77, 1950 161.190(a)(2) “Descriptive Study of Certain Tuna-Like Fishes,” by H.C. Godsil, State of California, Department of Fish and Game, Fish Bulletin No. 97 161.190(a)(2) Systematic Study of the Pacific Tunas, Fish Bulletin No. 60, (1944) 161.190(a)(2) Test procedures for Determination of Permeability of Food Packaging, Inner Wraps (September 1976, revised May 1983) 109.30 Methods for Chemical Analysis of Water and Wastes, Environmental Monitoring and Support Laboratory, EPA-600/4-82-055, March 1983, U.S. Environmental Protection Agency 103.35(d)(1)(ii) Interim Radiochemical Methodology for Drinking Water, Environmental Monitoring and Support Laboratory, EPA 600-4-75-008 (Revised), March 1976, EPA 103.35(e)(2) Standard Methods for the Examination of Water and Wastewater (15th Ed.) (1980) 103.35(b), (c), (d)(1)(ii), and (e)(2) Center for Food Safety and Applied Nutrition (HFF-260), Food and Drug Administration 200 C St. SW., Washington, DC 20204 “Energy Value of Foods—Basis and Derivation” USDA Handbook No. 74, 1955 101.9(c)(3) USDA Handbook 74, “Energy Value of Foods ... Basis and Derivation” (Slightly Revised 1973), A. L. Merrill and B. K. Watt 101.9(c)(1)(i)(A), (c)(1)(i)(B), (c)(1)(i)(C), (c)(1)(i)(E) and (c)(6) “Folic Acid Activity of Some Milk Foods for Babies,” Journal of Dairy Research 35:85-90 (1968) 102.23(c)(5) Journal of the Optical Society of America, Vol. 33, p. 406 (1943) 161.190(a)(7)(iii) “Identification of Low Caries Risk Dietary Components”, by Thomas N. Imfeld, in Monographs in Oral Science, Vol. II, Karger, Basel, Switzerland, 1983 101.80(c)(2) “Protein Quality Evaluation, Sections 5.4.1, 7.2.1 and 8.00, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, 1990 101.9(c)(7)(ii)(B) “Total Dietary Fiber in Foods, Enzymatic Gravimetric Method, First Action,” Journal of the Association of Official Analytical Chemists 68:399, 1985, as amended at 69:370, 1986 101.9 National Technical Information Service U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161 Methods for Chemical Analysis of Water and Wastes, U.S. EPA Environmental Monitoring and Support Laboratory, EPA/600/4-79-020, March 1983: Method 220.1—Atomic Absorption; direct aspiration 103.35(d)(3) Method 220.2—Atomic Absorption; furnace technique 103.35(d)(3) Method 239.2—Atomic Absorption; furnace technique 103.35(d)(3) Methods for the Determination of Metals in Environmental Samples, Office of Research and Development, (EPA/600/4-91/010, June 1991: Method 200.7—Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry, Rev. 3.3, April 1991 103.35(d)(3) Method 200.8—Determination of Trace Elements in Water and Wastes by Industively Coupled Plasma—Mass Spectrometry, Rev. 4.4, April 1991 103.35(d)(3) Method 200.9—Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry, Rev. 1.2, April 1991 103.35(d)(3) Methods for the Determination of Organic Compounds in Drinking Water, Office of Research and Development, Environmental Monitoring Systems Laboratory, EPA/600/4-88/039, December 1988: Method 502.1—Volatile Halogenated Organic Compounds in Water by Purge and Trap Gas Chromatography 103.35(d)(3) Method 502.2—Volatile Organic Compounds in Water by Purge and Trap Capillary Column Gas Chromatography with Photoionization and Electrolytic Conductivity Detectors in Series 103.35(d)(3) Method 503.1—Volatile Aromatic and Unsaturated Organic Compounds in Water by Purge and Trap Gas Chromatography 103.35(d)(3) Method 524.1—Measurement of Purgeable Organic Compounds in Water by Packed Column Gas Chromatography/Mass Spectrometry 103.35(d)(3) Method 524.2—Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry 103.35(d)(3) The Determination of Inorganic Anions in Water by Ion Chromatography—Method 300.0, EPA, EMSL (EPA/600/4-84/017, March 1984 103.35(d)(3)(v)(E)(3) Environmental Protection Agency, Environmental Monitoring and Support Laboratory (EMSL), Cincinnati, OH 45258, available from the National Technical Information Service, U.S. Department of Commerce Port Royal Rd., Springfield, VA 22161 Interim Radiochemical Methodology For Drinking Water (600/4-75-008), Revised March 1976 165.110(b)(5)(ii) Methods for Chemical Analysis of Water and Wastes (EPA-600/4-79-020), March 1983: Method 204.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (1)(i) Method 208.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (2)(i) Method 208.1—Atomic Absorption; direct aspiration 165.110(b)(4)(iii)(E) (2)(ii) Method 210.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (3)(i) Method 213.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (4)(i) Method 218.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (5)(i) Method 245.1—Manual cold vapor technique 165.110(b)(4)(iii)(E) (9)(i) Method 245.2—Automated cold vapor technique 165.110(b)(4)(iii)(E) (9)(ii) Method 249.1—Atomic Absorption; direct aspiration 165.110(b)(4)(iii)(E) (10)(i) Method 249.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (10)(ii) Method 353.3—Spectrophotometric, cadmium reduction 165.110(b)(4)(iii)(E) (11)(i), (E)(11)(iv) Method 353.2—Colorimetric automated, cadmium reduction 165.110(b)(4)(E) (11)(ii); (E)(11)(iii) Method 300.0—The Determination of Inorganic Anions in Water by Ion Chromatography 165.110(b)(4)(iii) (11)(iii) Method 353.1—Colorimetric automated, hydrazine reduction 165.110(b)(4)(iii)(E) (11)(iv); (E) (11)(ii) Method 270.2—Atomic Absorption, furnace technique 165.110(b)(4)(iii)(E) (12)(i) Method 270.3—Atomic Absorption, gaseous hydride 165.110(b)(4)(iii)(E) (12)(ii) Method 279.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (13)(i) Method 202.1—Atomic Absorption technique; direct aspiration 165.110(b)(4)(iii)(G) (1)(i) Method 202.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(G) (1)(ii) Method 272.1—Atomic Absorption; direct aspiration 165.110(b)(4)(iii)(G) (2)(i) Method 272.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(G) (2)(ii) Method 375.1—Colorimetric, Automated, Chloromilate 165.110(b)(4)(iii)(G) 3)(ii) Method 375.3—Gravimetric 165.110(b)(4)(iii)(G) (3)(iii) Method 375.4—Turbidimetric 165.110(b)(4)(iii)(G) (3)(iv) Method 220.2—Atomic Absorption; furnace technique 165.110(b)(4)(iii)(E) (6)(i) Method 220.1—Atomic Absorption; direct aspiration 165.110(b)(4)(iii)(E) (6)(ii) Method 335.1—Tritrimetric; Spectrophometric 165.110(b)(4)(iii)(E) (7)(i) Method 335.2—Tritrimetric; Spectrophotometric 165.110(b)(4)(iii)(E) (7)(ii) Method 335.3—Colorimetric; Automated UV 165.110(b)(4)(iii)(E) (7)(iii) Method 239.2—Atomic Absorption; furnace technique 165.110(b)(4)(E) (8)(i) Methods for the Determination of Organic Compounds in Drinking Water (EPA/600/4-88/039), December 1988: Method 502.1—Volatile Halogenated Organic Compounds in Water by Purge and Trap Gas Chromatography, Rev. 2.0, 1989 165.110(b)(4)(iii) (F)(1) Method 502.2—Volatile Organic Compounds in Water by Purge and Trap Capillary Column Gas Chromatography with Photoionization and Electrolytic Conductivity Detectors in Series, Rev. 2.0, 1989 165.110(b)(4)(iii) (F)(2) Method 503.1—Volatile Aromatic and Unsaturated Organic Compounds in Water by Purge and Trap Gas Chromatography, Rev. 2.0, 1989 165.110(b)(4)(iii) (F)(3) Method 524.1—Measurement of Purgeable Organic Compounds in Water by Packed Column Gas Chromatography/Mass Spectrometry, Rev. 3.0, 1989 165.110(b)(4)(iii) (F)(4) Method 524.2—Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry, Rev. 3.0, 1989 165.110(b)(4)(iii) (F)(5) Method 504—1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-Chloropropane (DBCP) in Water by Microextraction and Gas Chromatography, Rev. 2.0, 1989 165.110(b)(4)(iii) (F)(6) Method 505—Analysis of Organohalide Pesticides and Commercial Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and Gas Chromatography, Rev. 2.0, 1989 165.110(b)(4)(iii) (F)(7) Method 507—Determination of Nitrogen- and Phosphorus-Containing Pesticides in Water by Gas Chromatography with a Nitrogen-Phosphorus Detector, Rev. 2.0, 1989 165.110(b)(4)(iii) (F)(9) Method 508—Determination of Chlorinated Pesticides in Water by Gas Chromatography with an Electron Capture Detector, Rev. 3.0, 1989 165.110(b)(4)(iii) (F)(10) Method 508A—Screening for Polychlorinated Biphenyls by Perchlorination and Gas Chromatography, Rev. 1.0, 1989 165.110(b)(4)(iii) (F)(11) Method 515.1—Determination of Chlorinated Acids in Water by Gas Chromatography with an Electron Capture Detector, Rev. 5.0, May 1991 165.110(b)(4)(iii) (F)(12) Method 525.1—Determination of Organic Compounds in Drinking Water by Liquid-Solid Extraction and Capillary Column Gas Chromatography/Mass Spectrometry, Rev. 2.2, May 1991 165.110(b)(4)(iii) (F)(13) Method 531.1—Measurement of N-Methylcarbamoyloximes and N-Methylycarbamates in Water by Direct Aqueous Injection HPLC with Post Column Derivatization, Rev. 3.0, 1989 165.110(b)(4)(iii) (F)(14) “Methods for the Determination of Organic Compounds in Drinking Water”, Office of Research and Development, EMSL, EPA/600/4-88-039, December, 1988, Supplement 1, July, 1990 Method 506—“Determination of Phthalate and Adipate Esters in Drinking Water by Liquid-Liquid Extraction or Liquid-Solid Extraction and Gas Chromatography with Photoionization Detection” 165.110(b)(4)(iii) (F)(8) Method 547—“Determination of Glyphosate in Drinking Water by Direct-Aqueous-Injection HPLC, Post-Column Derivatization, and Fluorescence Detection” 165.110(b)(4)(iii) (F)(15) Method 548—“Determination of Endothall in Drinking Water by Aqueous Derivatization, Liquid-Solid Extraction, and Gas Chromatography with Electron-Capture Detection” 165.110(b)(4)(iii)(F) (16) Method 549—“Determination of Diquat and Paraquat in Drinking Water by Liquid-Solid Extraction and HPLC with Ultraviolet Detection” 165.110(b)(4)(iii) (F)(17) Method 550—“Determination of Polycyclic Aromatic Hydrocarbons in Drinking Water by Liquid-Liquid Extraction and HPLC with Coupled Ultraviolet and Fluorescence Detection” 165.110(b)(4)(iii) (F)(18) Method 550.1—“Determination of Polycyclic Aromatic Hydrocarbons in Drinking Water by Liquid-Solid Extraction and HPLC with Coupled Ultraviolet and Fluorescence Detection” 165.110(b)(4)(iii) (F)(19) Method 1613—“Tetra-through Octa-Chlorinated Dioxins and Furans by Isotope Dilution HRGC/HRMS”, Revision A, 1990, EPA, Office of Water Regulations and Standards 165.110(b)(4)(iii) (F)(20) Environmental Protection Agency, Office of Research and Development, Washington, DC 20460, available from the National Technical Information Service, U.S. Department of Commerce Port Royal Rd., Springfield, VA 22161 Methods for Determination of Metals in Environmental Samples (EPA/600/4-91/010), June 1991: Method 200.7—Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry 165.110(b)(4)(iii)(E) (2)(iii), (E)(3)(ii), (E)(4)(ii), (E)(5)(iii), (E)(6)(iii), (E)(10)(iii), (G)(1)(iii), (G)(2)(iii) Method 200.8—Determination of Trace Elements in Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry, Rev. 4.4, April 1991 165.110(b)(4) (iii)(E) (2)(iii), (E)(3)(ii), (E)(4)(ii), (E)(5)(ii), (E)(6)(iii), (E)(6) (iv), (E)(8)(ii), (E)(10)(iii), (E)(13)(ii), (G)(1)(iv), (G)(2)(iv) Method 200.9—Determination of Trace Elements in Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry, Rev. 1.2, April 1991 165.110(b)(4)(iii)(E) (1)(iii), (E)(3)(iv), (E)(6)(v), (E)(8)(iii), (E)(13)(iii), (G)(1)(v), (G)(2)(v) United States Pharmacopeial Convention 12601 Twinbrook Pkwy, Rockville, MD 20852 United States Pharmacopeia, 23d Revision, dated January, 1995 165.110(a)(2) Chap. Table of CFR Titles and Chapters (Revised as of April 1, 1997) Title 1—General Provisions I Administrative Committee of the Federal Register (Parts 1—49) II Office of the Federal Register (Parts 50—299) IV Miscellaneous Agencies (Parts 400—500) Title 2—[Reserved] Title 3—The President I Executive Office of the President (Parts 100—199) Title 4—Accounts I General Accounting Office (Parts 1—99) II Federal Claims Collection Standards (General Accounting Office—Department of Justice) (Parts 100—299) Title 5—Administrative Personnel I Office of Personnel Management (Parts 1—1199) II Merit Systems Protection Board (Parts 1200—1299) III Office of Management and Budget (Parts 1300—1399) IV Advisory Committee on Federal Pay (Parts 1400—1499) V The International Organizations Employees Loyalty Board (Parts 1500—1599) VI Federal Retirement Thrift Investment Board (Parts 1600—1699) VII Advisory Commission on Intergovernmental Relations (Parts 1700—1799) VIII Office of Special Counsel (Parts 1800—1899) IX Appalachian Regional Commission (Parts 1900—1999) XI Armed Forces Retirement Home (Part 2100) XIV Federal Labor Relations Authority, General Counsel of the Federal Labor Relations Authority and Federal Service Impasses Panel (Parts 2400—2499) XV Office of Administration, Executive Office of the President (Parts 2500—2599) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199) XXII Federal Deposit Insurance Corporation (Part 3201) XXIII Department of Energy (Part 3301) XXIV Federal Energy Regulatory Commission (Part 3401) XXVI Department of Defense (Part 3601) XXVIII Department of Justice (Part 3801) XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199) XXXIII Overseas Private Investment Corporation (Part 4301) XXXV Office of Personnel Management (Part 4501) XL Interstate Commerce Commission (Part 5001) XLI Commodity Futures Trading Commission (Part 5101) XLII Department of Labor (Part 5201) XLIII National Science Foundation (Part 5301) XLV Department of Health and Human Services (Part 5501) XLVI Postal Rate Commission (Part 5601) XLVII Federal Trade Commission (Part 5701) XLVIII Nuclear Regulatory Commission (Part 5801) L Department of Transportation (Part 6001) LII Export-Import Bank of the United States (Part 6201) LIII Department of Education (Parts 6300—6399) LIV Environmental Protection Agency (Part 6401) LVII General Services Administration (Part 6701) LVIII Board of Governors of the Federal Reserve System (Part 6801) LIX National Aeronautics and Space Administration (Part 6901) LX United States Postal Service (Part 7001) LXI National Labor Relations Board (Part 7101) LXII Equal Employment Opportunity Commission (Part 7201) LXIII Inter-American Foundation (Part 7301) LXV Department of Housing and Urban Development (Part 7501) LXVI National Archives and Records Administration (Part 7601) LXIX Tennessee Valley Authority (Part 7901) LXXI Consumer Product Safety Commission (Part 8101) LXXIV Federal Mine Safety and Health Review Commission (Part 8401) LXXVI Federal Retirement Thrift Investment Board (Part 8601) LXXVII Office of Management and Budget (Part 8701) Title 6—[Reserved] Title 7—Agriculture Subtitle A—Office of the Secretary of Agriculture (Parts 0—26) Subtitle B—Regulations of the Department of Agriculture I Agricultural Marketing Service (Standards, Inspections, Marketing Practices), Department of Agriculture (Parts 27—209) II Food and Consumer Service, Department of Agriculture (Parts 210—299) III Animal and Plant Health Inspection Service, Department of Agriculture (Parts 300—399) IV Federal Crop Insurance Corporation, Department of Agriculture (Parts 400—499) V Agricultural Research Service, Department of Agriculture (Parts 500—599) VI Natural Resources Conservation Service, Department of Agriculture (Parts 600—699) VII Farm Service Agency, Department of Agriculture (Parts 700—799) VIII Grain Inspection, Packers and Stockyards Administration (Federal Grain Inspection Service), Department of Agriculture (Parts 800—899) IX Agricultural Marketing Service (Marketing Agreements and Orders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999) X Agricultural Marketing Service (Marketing Agreements and Orders; Milk), Department of Agriculture (Parts 1000—1199) XI Agricultural Marketing Service (Marketing Agreements and Orders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600—1699) XVII Rural Utilities Service, Department of Agriculture (Parts 1700—1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Department of Agriculture (Parts 1800—2099) XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800—2899) XXIX Office of Energy, Department of Agriculture (Parts 2900—2999) XXX Office of Finance and Management, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII [Reserved] XXXIII Office of Transportation, Department of Agriculture (Parts 3300—3399) XXXIV Cooperative State Research, Education, and Extension Service, Department of Agriculture (Parts 3400—3499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500—3599) XXXVI National Agricultural Statistics Service, Department of Agriculture (Parts 3600—3699) XXXVII Economic Research Service, Department of Agriculture (Parts 3700—3799) XXXVIII World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts 4200—4299) Title 8—Aliens and Nationality I Immigration and Naturalization Service, Department of Justice (Parts 1—499) Title 9—Animals and Animal Products I Animal and Plant Health Inspection Service, Department of Agriculture (Parts 1—199) II Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agriculture (Parts 200—299) III Food Safety and Inspection Service, Meat and Poultry Inspection, Department of Agriculture (Parts 300—599) Title 10—Energy I Nuclear Regulatory Commission (Parts 0—199) II Department of Energy (Parts 200—699) III Department of Energy (Parts 700—999) X Department of Energy (General Provisions) (Parts 1000—1099) XI United States Enrichment Corporation (Parts 1100—1199) XV Office of the Federal Inspector for the Alaska Natural Gas Transportation System (Parts 1500—1599) XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799) Title 11—Federal Elections I Federal Election Commission (Parts 1—9099) Title 12—Banks and Banking I Comptroller of the Currency, Department of the Treasury (Parts 1—199) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399) IV Export-Import Bank of the United States (Parts 400—499) V Office of Thrift Supervision, Department of the Treasury (Parts 500—599) VI Farm Credit Administration (Parts 600—699) VII National Credit Union Administration (Parts 700—799) VIII Federal Financing Bank (Parts 800—899) IX Federal Housing Finance Board (Parts 900—999) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XIV Farm Credit System Insurance Corporation (Parts 1400—1499) XV Thrift Depositor Protection Oversight Board (Parts 1500—1599) XVII Office of Federal Housing Enterprise Oversight, Department of Housing and Urban Development (Parts 1700—1799) XVIII Community Development Financial Institutions Fund, Department of the Treasury (Parts 1800—1899) Title 13—Business Credit and Assistance I Small Business Administration (Parts 1—199) III Economic Development Administration, Department of Commerce (Parts 300—399) Title 14—Aeronautics and Space I Federal Aviation Administration, Department of Transportation (Parts 1—199) II Office of the Secretary, Department of Transportation (Aviation Proceedings) (Parts 200—399) III Commercial Space Transportation, Federal Aviation Administration, Department of Transportation (Parts 400—499) V National Aeronautics and Space Administration (Parts 1200—1299) Title 15—Commerce and Foreign Trade Subtitle A—Office of the Secretary of Commerce (Parts 0—29) Subtitle B—Regulations Relating to Commerce and Foreign Trade I Bureau of the Census, Department of Commerce (Parts 30—199) II National Institute of Standards and Technology, Department of Commerce (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Export Administration, Department of Commerce (Parts 700—799) VIII Bureau of Economic Analysis, Department of Commerce (Parts 800—899) IX National Oceanic and Atmospheric Administration, Department of Commerce (Parts 900—999) XI Technology Administration, Department of Commerce (Parts 1100—1199) XIII East-West Foreign Trade Board (Parts 1300—1399) XIV Minority Business Development Agency (Parts 1400—1499) Subtitle C—Regulations Relating to Foreign Trade Agreements XX Office of the United States Trade Representative (Parts 2000—2099) Subtitle D—Regulations Relating to Telecommunications and Information XXIII National Telecommunications and Information Administration, Department of Commerce (Parts 2300—2399) Title 16—Commercial Practices I Federal Trade Commission (Parts 0—999) II Consumer Product Safety Commission (Parts 1000—1799) Title 17—Commodity and Securities Exchanges I Commodity Futures Trading Commission (Parts 1—199) II Securities and Exchange Commission (Parts 200—399) IV Department of the Treasury (Parts 400—499) Title 18—Conservation of Power and Water Resources I Federal Energy Regulatory Commission, Department of Energy (Parts 1—399) III Delaware River Basin Commission (Parts 400—499) VI Water Resources Council (Parts 700—799) VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399) Title 19—Customs Duties I United States Customs Service, Department of the Treasury (Parts 1—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) Title 20—Employees' Benefits I Office of Workers' Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399) III Social Security Administration (Parts 400—499) IV Employees' Compensation Appeals Board, Department of Labor (Parts 500—599) V Employment and Training Administration, Department of Labor (Parts 600—699) VI Employment Standards Administration, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans' Employment and Training, Department of Labor (Parts 1000—1099) Title 21—Food and Drugs I Food and Drug Administration, Department of Health and Human Services (Parts 1—1299) II Drug Enforcement Administration, Department of Justice (Parts 1300—1399) III Office of National Drug Control Policy (Parts 1400—1499) Title 22—Foreign Relations I Department of State (Parts 1—199) II Agency for International Development, International Development Cooperation Agency (Parts 200—299) III Peace Corps (Parts 300—399) IV International Joint Commission, United States and Canada (Parts 400—499) V United States Information Agency (Parts 500—599) VI United States Arms Control and Disarmament Agency (Parts 600—699) VII Overseas Private Investment Corporation, International Development Cooperation Agency (Parts 700—799) IX Foreign Service Grievance Board Regulations (Parts 900—999) X Inter-American Foundation (Parts 1000—1099) XI International Boundary and Water Commission, United States and Mexico, United States Section (Parts 1100—1199) XII United States International Development Cooperation Agency (Parts 1200—1299) XIII Board for International Broadcasting (Parts 1300—1399) XIV Foreign Service Labor Relations Board; Federal Labor Relations Authority; General Counsel of the Federal Labor Relations Authority; and the Foreign Service Impasse Disputes Panel (Parts 1400—1499) XV African Development Foundation (Parts 1500—1599) XVI Japan-United States Friendship Commission (Parts 1600—1699) XVII United States Institute of Peace (Parts 1700—1799) Title 23—Highways I Federal Highway Administration, Department of Transportation (Parts 1—999) II National Highway Traffic Safety Administration and Federal Highway Administration, Department of Transportation (Parts 1200—1299) III National Highway Traffic Safety Administration, Department of Transportation (Parts 1300—1399) Title 24—Housing and Urban Development Subtitle A—Office of the Secretary, Department of Housing and Urban Development (Parts 0—99) Subtitle B—Regulations Relating to Housing and Urban Development I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199) II Office of Assistant Secretary for Housing-Federal Housing Commissioner, Department of Housing and Urban Development (Parts 200—299) III Government National Mortgage Association, Department of Housing and Urban Development (Parts 300—399) V Office of Assistant Secretary for Community Planning and Development, Department of Housing and Urban Development (Parts 500—599) VI Office of Assistant Secretary for Community Planning and Development, Department of Housing and Urban Development (Parts 600—699) [Reserved] VII Office of the Secretary, Department of Housing and Urban Development (Housing Assistance Programs and Public and Indian Housing Programs) (Parts 700—799) VIII Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development (Section 8 Housing Assistance Programs and Section 202 Direct Loan Program) (Parts 800—899) IX Office of Assistant Secretary for Public and Indian Housing, Department of Housing and Urban Development (Parts 900—999) X Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development (Interstate Land Sales Registration Program) (Parts 1700—1799) XII Office of Inspector General, Department of Housing and Urban Development (Parts 2000—2099) XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development (Parts 3200—3899) XXV Neighborhood Reinvestment Corporation (Parts 4100—4199) Title 25—Indians I Bureau of Indian Affairs, Department of the Interior (Parts 1—299) II Indian Arts and Crafts Board, Department of the Interior (Parts 300—399) III National Indian Gaming Commission, Department of the Interior (Parts 500—599) IV Office of Navajo and Hopi Indian Relocation (Parts 700—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900) VI Office of the Assistant Secretary-Indian Affairs, Department of the Interior (Part 1001) VII Office of the Special Trustee for American Indians, Department of the Interior (Parts 1200—1299) Title 26—Internal Revenue I Internal Revenue Service, Department of the Treasury (Parts 1—799) Title 27—Alcohol, Tobacco Products and Firearms I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury (Parts 1—299) Title 28—Judicial Administration I Department of Justice (Parts 0—199) III Federal Prison Industries, Inc., Department of Justice (Parts 300—399) V Bureau of Prisons, Department of Justice (Parts 500—599) VI Offices of Independent Counsel, Department of Justice (Parts 600—699) VII Office of Independent Counsel (Parts 700—799) Title 29—Labor Subtitle A—Office of the Secretary of Labor (Parts 0—99) Subtitle B—Regulations Relating to Labor I National Labor Relations Board (Parts 100—199) II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299) XII Federal Mediation and Conciliation Service (Parts 1400—1499) XIV Equal Employment Opportunity Commission (Parts 1600—1699) XVII Occupational Safety and Health Administration, Department of Labor (Parts 1900—1999) XX Occupational Safety and Health Review Commission (Parts 2200—2499) XXV Pension and Welfare Benefits Administration, Department of Labor (Parts 2500—2599) XXVII Federal Mine Safety and Health Review Commission (Parts 2700—2799) XL Pension Benefit Guaranty Corporation (Parts 4000—4999) Title 30—Mineral Resources I Mine Safety and Health Administration, Department of Labor (Parts 1—199) II Minerals Management Service, Department of the Interior (Parts 200—299) III Board of Surface Mining and Reclamation Appeals, Department of the Interior (Parts 300—399) IV Geological Survey, Department of the Interior (Parts 400—499) VI Bureau of Mines, Department of the Interior (Parts 600—699) VII Office of Surface Mining Reclamation and Enforcement, Department of the Interior (Parts 700—999) Title 31—Money and Finance: Treasury Subtitle A—Office of the Secretary of the Treasury (Parts 0—50) Subtitle B—Regulations Relating to Money and Finance I Monetary Offices, Department of the Treasury (Parts 51—199) II Fiscal Service, Department of the Treasury (Parts 200—399) IV Secret Service, Department of the Treasury (Parts 400—499) V Office of Foreign Assets Control, Department of the Treasury (Parts 500—599) VI Bureau of Engraving and Printing, Department of the Treasury (Parts 600—699) VII Federal Law Enforcement Training Center, Department of the Treasury (Parts 700—799) VIII Office of International Investment, Department of the Treasury (Parts 800—899) Title 32—National Defense Subtitle A—Department of Defense I Office of the Secretary of Defense (Parts 1—399) V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799) VII Department of the Air Force (Parts 800—1099) Subtitle B—Other Regulations Relating to National Defense XII Defense Logistics Agency (Parts 1200—1299) XVI Selective Service System (Parts 1600—1699) XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499) XXVII Office for Micronesian Status Negotiations (Parts 2700—2799) XXVIII Office of the Vice President of the United States (Parts 2800—2899) XXIX Presidential Commission on the Assignment of Women in the Armed Forces (Part 2900) Title 33—Navigation and Navigable Waters I Coast Guard, Department of Transportation (Parts 1—199) II Corps of Engineers, Department of the Army (Parts 200—399) IV Saint Lawrence Seaway Development Corporation, Department of Transportation (Parts 400—499) Title 34—Education Subtitle A—Office of the Secretary, Department of Education (Parts 1—99) Subtitle B—Regulations of the Offices of the Department of Education I Office for Civil Rights, Department of Education (Parts 100—199) II Office of Elementary and Secondary Education, Department of Education (Parts 200—299) III Office of Special Education and Rehabilitative Services, Department of Education (Parts 300—399) IV Office of Vocational and Adult Education, Department of Education (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) VI Office of Postsecondary Education, Department of Education (Parts 600—699) VII Office of Educational Research and Improvement, Department of Education (Parts 700—799) XI National Institute for Literacy (Parts 1100—1199) Subtitle C—Regulations Relating to Education XII National Council on Disability (Parts 1200—1299) Title 35—Panama Canal I Panama Canal Regulations (Parts 1—299) Title 36—Parks, Forests, and Public Property I National Park Service, Department of the Interior (Parts 1—199) II Forest Service, Department of Agriculture (Parts 200—299) III Corps of Engineers, Department of the Army (Parts 300—399) IV American Battle Monuments Commission (Parts 400—499) V Smithsonian Institution (Parts 500—599) VII Library of Congress (Parts 700—799) VIII Advisory Council on Historic Preservation (Parts 800—899) IX Pennsylvania Avenue Development Corporation (Parts 900—999) XI Architectural and Transportation Barriers Compliance Board (Parts 1100—1199) XII National Archives and Records Administration (Parts 1200—1299) XIV Assassination Records Review Board (Parts 1400—1499) Title 37—Patents, Trademarks, and Copyrights I Patent and Trademark Office, Department of Commerce (Parts 1—199) II Copyright Office, Library of Congress (Parts 200—299) IV Assistant Secretary for Technology Policy, Department of Commerce (Parts 400—499) V Under Secretary for Technology, Department of Commerce (Parts 500—599) Title 38—Pensions, Bonuses, and Veterans' Relief I Department of Veterans Affairs (Parts 0—99) Title 39—Postal Service I United States Postal Service (Parts 1—999) III Postal Rate Commission (Parts 3000—3099) Title 40—Protection of Environment I Environmental Protection Agency (Parts 1—799) V Council on Environmental Quality (Parts 1500—1599) Title 41—Public Contracts and Property Management Subtitle B—Other Provisions Relating to Public Contracts 50 Public Contracts, Department of Labor (Parts 50-1—50-999) 51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51-1—51-99) 60 Office of Federal Contract Compliance Programs, Equal Employment Opportunity, Department of Labor (Parts 60-1—60-999) 61 Office of the Assistant Secretary for Veterans Employment and Training, Department of Labor (Parts 61-1—61-999) Subtitle C—Federal Property Management Regulations System 101 Federal Property Management Regulations (Parts 101-1—101-99) 105 General Services Administration (Parts 105-1—105-999) 109 Department of Energy Property Management Regulations (Parts 109-1—109-99) 114 Department of the Interior (Parts 114-1—114-99) 115 Environmental Protection Agency (Parts 115-1—115-99) 128 Department of Justice (Parts 128-1—128-99) Subtitle D—Other Provisions Relating to Property Management [Reserved] Subtitle E—Federal Information Resources Management Regulations System 201 Federal Information Resources Management Regulation (Parts 201-1—201-99) [Reserved] Subtitle F—Federal Travel Regulation System 301 Travel Allowances (Parts 301-1—301-99) 302 Relocation Allowances (Parts 302-1—302-99) 303 Payment of Expenses Connected with the Death of Certain Employees (Parts 303-1—303-2) 304 Payment from a Non-Federal Source for Travel Expenses (Parts 304-1—304-99) Title 42—Public Health I Public Health Service, Department of Health and Human Services (Parts 1—199) IV Health Care Financing Administration, Department of Health and Human Services (Parts 400—499) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1999) Title 43—Public Lands: Interior Subtitle A—Office of the Secretary of the Interior (Parts 1—199) Subtitle B—Regulations Relating to Public Lands I Bureau of Reclamation, Department of the Interior (Parts 200—499) II Bureau of Land Management, Department of the Interior (Parts 1000—9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000—10005) Title 44—Emergency Management and Assistance I Federal Emergency Management Agency (Parts 0—399) IV Department of Commerce and Department of Transportation (Parts 400—499) Title 45—Public Welfare Subtitle A—Department of Health and Human Services, General Administration (Parts 1—199) Subtitle B—Regulations Relating to Public Welfare II Office of Family Assistance (Assistance Programs), Administration for Children and Families, Department of Health and Human Services (Parts 200—299) III Office of Child Support Enforcement (Child Support Enforcement Program), Administration for Children and Families, Department of Health and Human Services (Parts 300—399) IV Office of Refugee Resettlement, Administration for Children and Families Department of Health and Human Services (Parts 400—499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500—599) VI National Science Foundation (Parts 600—699) VII Commission on Civil Rights (Parts 700—799) VIII Office of Personnel Management (Parts 800—899) X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII ACTION (Parts 1200—1299) XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission on Fine Arts (Parts 2100—2199) XXII Christopher Columbus Quincentenary Jubilee Commission (Parts 2200—2299) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400—2499) XXV Corporation for National and Community Service (Parts 2500—2599) Title 46—Shipping I Coast Guard, Department of Transportation (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) IV Federal Maritime Commission (Parts 500—599) Title 47—Telecommunication I Federal Communications Commission (Parts 0—199) II Office of Science and Technology Policy and National Security Council (Parts 200—299) III National Telecommunications and Information Administration, Department of Commerce (Parts 300—399) Title 48—Federal Acquisition Regulations System 1 Federal Acquisition Regulation (Parts 1—99) 2 Department of Defense (Parts 200—299) 3 Department of Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299) 13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management Federal Employees Health Benefits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800—1899) 19 United States Information Agency (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400—2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999) 34 Department of Education Acquisition Regulation (Parts 3400—3499) 35 Panama Canal Commission (Parts 3500—3599) 44 Federal Emergency Management Agency (Parts 4400—4499) 51 Department of the Army Acquisition Regulations (Parts 5100—5199) 52 Department of the Navy Acquisition Regulations (Parts 5200—5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement (Parts 5300—5399) 54 Defense Logistics Agency, Department of Defense (Part 5452) 57 African Development Foundation (Parts 5700—5799) 61 General Services Administration Board of Contract Appeals (Parts 6100—6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300—6399) 99 Cost Accounting Standards Board, Office of Federal Procurement Policy, Office of Management and Budget (Parts 9900—9999) Title 49—Transportation Subtitle A—Office of the Secretary of Transportation (Parts 1—99) Subtitle B—Other Regulations Relating to Transportation I Research and Special Programs Administration, Department of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299) III Federal Highway Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Transportation (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999) X Surface Transportation Board, Department of Transportation (Parts 1000—1399) Title 50—Wildlife and Fisheries I United States Fish and Wildlife Service, Department of the Interior (Parts 1—199) II National Marine Fisheries Service, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 200—299) III International Fishing and Related Activities (Parts 300—399) IV Joint Regulations (United States Fish and Wildlife Service, Department of the Interior and National Marine Fisheries Service, National Oceanic and Atmospheric Administration, Department of Commerce); Endangered Species Committee Regulations (Parts 400—499) V Marine Mammal Commission (Parts 500—599) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600—699) CFR Index and Finding Aids Subject/Agency Index List of Agency Prepared Indexes Parallel Tables of Statutory Authorities and Rules Acts Requiring Publication in the Federal Register List of CFR Titles, Chapters, Subchapters, and Parts Alphabetical List of Agencies Appearing in the CFR Alphabetical List of Agencies Appearing in the CFR (Revised as of April 1, 1997) Agency CFR Title, Subtitle or Chapter ACTION 45, XII Administrative Committee of the Federal Register 1, I Advanced Research Projects Agency 32, I Advisory Commission on Intergovernmental Relations 5, VII Advisory Committee on Federal Pay 5, IV Advisory Council on Historic Preservation 36, VIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Animal and Plant Health Inspection Service 7, III; 9, I Commodity Credit Corporation 7, XIV Cooperative State Research, Education, and Extension Service 7, XXXIV Economic Research Service 7, XXXVII Energy, Office of 7, XXIX Environmental Quality, Office of 7, XXXI Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 4 Federal Crop Insurance Corporation 7, IV Finance and Management, Office of 7, XXX Food and Consumer Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Forest Service 36, II Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Information Resources Management, Office of 7, XXVII Inspector General, Office of 7, XXVI National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI Natural Resources Conservation Service 7, VI Operations, Office of 7, XXVIII Rural Business-Cooperative Service 7, XVIII, XLII Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force Department 32, VII Federal Acquisition Regulation Supplement 48, 53 Alaska Natural Gas Transportation System, Office of the Federal Inspector 10, XV Alcohol, Tobacco and Firearms, Bureau of 27, I AMTRAK 49, VII American Battle Monuments Commission 36, IV Animal and Plant Health Inspection Service 7, III; 9, I Appalachian Regional Commission 5, IX Architectural and Transportation Barriers Compliance Board 36, XI Arctic Research Commission 45, XXIII Armed Forces Retirement Home 5, XI Arms Control and Disarmament Agency, United States 22, VI Army Department 32, V Engineers, Corps of 33, II; 36, III Federal Acquisition Regulation 48, 51 Assassination Records Review Board 36, XIV Benefits Review Board 20, VII Bilingual Education and Minority Languages Affairs, Office of 34, V Blind or Severely Disabled, Committee for Purchase From People Who Are 41, 51 Board for International Broadcasting 22, XIII Census Bureau 15, I Central Intelligence Agency 32, XIX Child Support Enforcement, Office of 45, III Children and Families, Administration for 45, II, III, IV, X Christopher Columbus Quincentenary Jubilee Commission 45, XXII Civil Rights, Commission on 45, VII Civil Rights, Office for 34, I Coast Guard 33, I; 46, I; 49, IV Commerce Department 44, IV Census Bureau 15, I Economic Affairs, Under Secretary 37, V Economic Analysis, Bureau of 15, VIII Economic Development Administration 13, III Emergency Management and Assistance 44, IV Export Administration, Bureau of 15, VII Federal Acquisition Regulation 48, 13 Fishery Conservation and Management 50, VI Foreign-Trade Zones Board 15, IV International Trade Administration 15, III; 19, III National Institute of Standards and Technology 15, II National Marine Fisheries Service 50, II, IV National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI National Telecommunications and Information Administration 15, XXIII; 47, III National Weather Service 15, IX Patent and Trademark Office 37, I Productivity, Technology and Innovation, Assistant Secretary for 37, IV Secretary of Commerce, Office of 15, Subtitle A Technology, Under Secretary for 37, V Technology Administration 15, XI Technology Policy, Assistant Secretary for 37, IV Commercial Space Transportation 14, III Commodity Credit Corporation 7, XIV Commodity Futures Trading Commission 5, XLI; 17, I Community Planning and Development, Office of Assistant Secretary for 24, V, VI Community Services, Office of 45, X Comptroller of the Currency 12, I Construction Industry Collective Bargaining Commission 29, IX Consumer Product Safety Commission 5, LXXI; 16, II Cooperative State Research, Education, and Extension Service 7, XXXIV Copyright Office 37, II Cost Accounting Standards Board 48, 99 Council on Environmental Quality 40, V Customs Service, United States 19, I Defense Contract Audit Agency 32, I Defense Department 5, XXVI; 32, Subtitle A Advanced Research Projects Agency 32, I Air Force Department 32, VII Army Department 32, V; 33, II; 36, III, 48, 51 Defense Intelligence Agency 32, I Defense Logistics Agency 32, I, XII; 48, 54 Defense Mapping Agency 32, I Engineers, Corps of 33, II; 36, III Federal Acquisition Regulation 48, 2 Navy Department 32, VI; 48, 52 Secretary of Defense, Office of 32, I Defense Contract Audit Agency 32, I Defense Intelligence Agency 32, I Defense Logistics Agency 32, XII; 48, 54 Defense Mapping Agency 32, I Defense Nuclear Facilities Safety Board 10, XVII Delaware River Basin Commission 18, III Drug Enforcement Administration 21, II East-West Foreign Trade Board 15, XIII Economic Affairs, Under Secretary 37, V Economic Analysis, Bureau of 15, VIII Economic Development Administration 13, III Economic Research Service 7, XXXVII Education, Department of 5, LIII Bilingual Education and Minority Languages Affairs, Office of 34, V Civil Rights, Office for 34, I Educational Research and Improvement, Office of 34, VII Elementary and Secondary Education, Office of 34, II Federal Acquisition Regulation 48, 34 Postsecondary Education, Office of 34, VI Secretary of Education, Office of 34, Subtitle A Special Education and Rehabilitative Services, Office of 34, III Vocational and Adult Education, Office of 34, IV Educational Research and Improvement, Office of 34, VII Elementary and Secondary Education, Office of 34, II Employees' Compensation Appeals Board 20, IV Employees Loyalty Board 5, V Employment and Training Administration 20, V Employment Standards Administration 20, VI Endangered Species Committee 50, IV Energy, Department of 5, XXIII; 10, II, III, X Federal Acquisition Regulation 48, 9 Federal Energy Regulatory Commission 5, XXIV; 18, I Property Management Regulations 41, 109 Energy, Office of 7, XXIX Engineers, Corps of 33, II; 36, III Engraving and Printing, Bureau of 31, VI Enrichment Corporation, United States 10, XI Environmental Protection Agency 5, LIV; 40, I Federal Acquisition Regulation 48, 15 Property Management Regulations 41, 115 Environmental Quality, Office of 7, XXXI Equal Employment Opportunity Commission 5, LXII; 29, XIV Equal Opportunity, Office of Assistant Secretary for 24, I Executive Office of the President 3, I Administration, Office of 5, XV Environmental Quality, Council on 40, V Management and Budget, Office of 25, III, LXXVII; 48, 99 National Drug Control Policy, Office of 21, III National Security Council 32, XXI; 47, 2 Presidential Documents 3 Science and Technology Policy, Office of 32, XXIV; 47, II Trade Representative, Office of the United States 15, XX Export Administration, Bureau of 15, VII Export-Import Bank of the United States 5, LII; 12, IV Family Assistance, Office of 45, II Farm Credit Administration 5, XXXI; 12, VI Farm Credit System Insurance Corporation 5, XXX; 12, XIV Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 1 Federal Aviation Administration 14, I Commercial Space Transportation 14, III Federal Claims Collection Standards 4, II Federal Communications Commission 5, XXIX; 47, I Federal Contract Compliance Programs, Office of 41, 60 Federal Crop Insurance Corporation 7, IV Federal Deposit Insurance Corporation 5, XXII; 12, III Federal Election Commission 11, I Federal Emergency Management Agency 44, I Federal Acquisition Regulation 48, 44 Federal Employees Group Life Insurance Federal Acquisition Regulation 48, 21 Federal Employees Health Benefits Acquisition Regulation 48, 16 Federal Energy Regulatory Commission 5, XXIV; 18, I Federal Financial Institutions Examination Council 12, XI Federal Financing Bank 12, VIII Federal Highway Administration 23, I, II; 49, III Federal Home Loan Mortgage Corporation 1, IV Federal Housing Enterprise Oversight Office 12, XVII Federal Housing Finance Board 12, IX Federal Inspector for the Alaska Natural Gas Transportation System, Office of 10, XV Federal Labor Relations Authority, and General Counsel of the Federal Labor Relations Authority 5, XIV; 22, XIV Federal Law Enforcement Training Center 31, VII Federal Maritime Commission 46, IV Federal Mediation and Conciliation Service 29, XII Federal Mine Safety and Health Review Commission 5, LXXIV; 29, XXVII Federal Pay, Advisory Committee on 5, IV Federal Prison Industries, Inc. 28, III Federal Procurement Policy Office 48, 99 Federal Property Management Regulations 41, 101 Federal Property Management Regulations System 41, Subtitle C Federal Railroad Administration 49, II Federal Register, Administrative Committee of 1, I Federal Register, Office of 1, II Federal Reserve System 12, II Board of Governors 5, LVIII Federal Retirement Thrift Investment Board 5, VI, LXXVI Federal Service Impasses Panel 5, XIV Federal Trade Commission 5, XLVII; 16, I Federal Transit Administration 49, VI Federal Travel Regulation System 41, Subtitle F Finance and Management, Office of 7, XXX Fine Arts, Commission on 45, XXI Fiscal Service 31, II Fish and Wildlife Service, United States 50, I, IV Fishery Conservation and Management 50, VI Food and Drug Administration 21, I Food and Consumer Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Foreign Assets Control, Office of 31, V Foreign Claims Settlement Commission of the United States 45, V Foreign Service Grievance Board 22, IX Foreign Service Impasse Disputes Panel 22, XIV Foreign Service Labor Relations Board 22, XIV Foreign-Trade Zones Board 15, IV Forest Service 36, II General Accounting Office 4, I, II General Services Administration 5, LVII Contract Appeals, Board of 48, 61 Federal Acquisition Regulation 48, 5 Federal Property Management Regulations System 41, 101, 105 Federal Travel Regulation System 41, Subtitle F Payment From a Non-Federal Source for Travel Expenses 41, 304 Payment of Expenses Connected With the Death of Certain Employees 41, 303 Relocation Allowances 41, 302 Travel Allowances 41, 301 Geological Survey 30, IV Government Ethics, Office of 5, XVI Government National Mortgage Association 24, III Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Great Lakes Pilotage 46, III Harry S. Truman Scholarship Foundation 45, XVIII Health and Human Services, Department of 5, XLV; 45, Subtitle A Child Support Enforcement, Office of 45, III Children and Families, Administration for 45, II, III, IV, X Community Services, Office of 45, X Family Assistance, Office of 45, II Federal Acquisition Regulation 48, 3 Food and Drug Administration 21, I Health Care Financing Administration 42, IV Human Development Services, Office of 45, XIII Indian Health Service 25, V Inspector General (Health Care), Office of 42, V Public Health Service 42, I Refugee Resettlement, Office of 45, IV Health Care Financing Administration 42, IV Housing and Urban Development, Department of 5, LXV; 24, Subtitle B Community Planning and Development, Office of Assistant Secretary for 24, V, VI Equal Opportunity, Office of Assistant Secretary for 24, I Federal Acquisition Regulation 48, 24 Federal Housing Enterprise Oversight, Office of 12, XVII Government National Mortgage Association 24, III Housing—Federal Housing Commissioner, Office of Assistant Secretary for 24, II, VIII, X, XX Inspector General, Office of 24, XII Public and Indian Housing, Office of Assistant Secretary for 24, IX Secretary, Office of 24, Subtitle A, VII Housing—Federal Housing Commissioner, Office of Assistant Secretary for 24, II, VIII, X, XX Human Development Services, Office of 45, XIII Immigration and Naturalization Service 8, I Independent Counsel, Office of 28, VII Indian Affairs, Bureau of 25, I, V Indian Affairs, Office of the Assistant Secretary 25, VI Indian Arts and Crafts Board 25, II Indian Health Service 25, V Information Agency, United States 22, V Federal Acquisition Regulation 48, 19 Information Resources Management, Office of 7, XXVII Information Security Oversight Office, National Archives and Records Administration 32, XX Inspector General Agriculture Department 7, XXVI Health and Human Services Department 42, V Housing and Urban Development Department 24, XII Institute of Peace, United States 22, XVII Inter-American Foundation 5, LXIII; 22, X Intergovernmental Relations, Advisory Commission on 5, VII Interior Department Endangered Species Committee 50, IV Federal Acquisition Regulation 48, 14 Federal Property Management Regulations System 41, 114 Fish and Wildlife Service, United States 50, I, IV Geological Survey 30, IV Indian Affairs, Bureau of 25, I, V Indian Affairs, Office of the Assistant Secretary 25, VI Indian Arts and Crafts Board 25, II Land Management, Bureau of 43, II Minerals Management Service 30, II Mines, Bureau of 30, VI National Indian Gaming Commission 25, III National Park Service 36, I Reclamation, Bureau of 43, I Secretary of the Interior, Office of 43, Subtitle A Surface Mining and Reclamation Appeals, Board of 30, III Surface Mining Reclamation and Enforcement, Office of 30, VII Internal Revenue Service 26, I International Boundary and Water Commission, United States and Mexico, United States Section 22, XI International Development, Agency for 22, II Federal Acquisition Regulation 48, 7 International Development Cooperation Agency, United States 22, XII International Development, Agency for 22, II; 48, 7 Overseas Private Investment Corporation 5, XXXIII; 22, VII International Fishing and Related Activities 50, III International Investment, Office of 31, VIII International Joint Commission, United States and Canada 22, IV International Organizations Employees Loyalty Board 5, V International Trade Administration 15, III; 19, III International Trade Commission, United States 19, II Interstate Commerce Commission 5, XL James Madison Memorial Fellowship Foundation 45, XXIV Japan-United States Friendship Commission 22, XVI Joint Board for the Enrollment of Actuaries 20, VIII Justice Department 5, XXVIII; 28, I Drug Enforcement Administration 21, II Federal Acquisition Regulation 48, 28 Federal Claims Collection Standards 4, II Federal Prison Industries, Inc. 28, III Foreign Claims Settlement Commission of the United States 45, V Immigration and Naturalization Service 8, I Offices of Independent Counsel 28, VI Prisons, Bureau of 28, V Property Management Regulations 41, 128 Labor Department 5, XLII Benefits Review Board 20, VII Employees' Compensation Appeals Board 20, IV Employment and Training Administration 20, V Employment Standards Administration 20, VI Federal Acquisition Regulation 48, 29 Federal Contract Compliance Programs, Office of 41, 60 Federal Procurement Regulations System 41, 50 Labor-Management Relations and Cooperative Programs, Bureau of 29, II Labor-Management Programs, Office of 29, IV Mine Safety and Health Administration 30, I Occupational Safety and Health Administration 29, XVII Pension and Welfare Benefits Administration 29, XXV Public Contracts 41, 50 Secretary of Labor, Office of 29, Subtitle A Veterans' Employment and Training, Office of the Assistant Secretary for 41, 61; 20, IX Wage and Hour Division 29, V Workers' Compensation Programs, Office of 20, I Labor-Management Relations and Cooperative Programs, Bureau of 29, II Labor-Management Programs, Office of 29, IV Land Management, Bureau of 43, II Legal Services Corporation 45, XVI Library of Congress 36, VII Copyright Office 37, II Management and Budget, Office of 5, III, LXXVII; 48, 99 Marine Mammal Commission 50, V Maritime Administration 46, II Merit Systems Protection Board 5, II Micronesian Status Negotiations, Office for 32, XXVII Mine Safety and Health Administration 30, I Minerals Management Service 30, II Mines, Bureau of 30, VI Minority Business Development Agency 15, XIV Miscellaneous Agencies 1, IV Monetary Offices 31, I National Aeronautics and Space Administration 5, LIX; 14, V Federal Acquisition Regulation 48, 18 National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI National Archives and Records Administration 5, LXVI; 36, XII Information Security Oversight Office 32, XX National Bureau of Standards 15, II National Capital Planning Commission 1, IV National Commission for Employment Policy 1, IV National Commission on Libraries and Information Science 45, XVII National and Community Service, Corporation for 45, XXV National Council on Disability 34, XII National Credit Union Administration 12, VII National Drug Control Policy, Office of 21, III National Foundation on the Arts and the Humanities 45, XI National Highway Traffic Safety Administration 23, II, III; 49, V National Indian Gaming Commission 25, III National Institute for Literacy 34, XI National Institute of Standards and Technology 15, II National Labor Relations Board 29, I National Marine Fisheries Service 50, II, IV National Mediation Board 29, X National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI National Park Service 36, I National Railroad Adjustment Board 29, III National Railroad Passenger Corporation (AMTRAK) 49, VII National Science Foundation 5, XLIII; 45, VI Federal Acquisition Regulation 48, 25 National Security Council 32, XXI National Security Council and Office of Science and Technology Policy 47, II National Telecommunications and Information Administration 15, XXIII; 47, III National Transportation Safety Board 49, VIII National Weather Service 15, IX Natural Resources Conservation Service 7, VI Navajo and Hopi Indian Relocation, Office of 25, IV Navy Department 32, VI Federal Acquisition Regulation 48, 52 Neighborhood Reinvestment Corporation 24, XXV Nuclear Regulatory Commission 5, XLVIII; 10, I Federal Acquisition Regulation 48, 20 Occupational Safety and Health Administration 29, XVII Occupational Safety and Health Review Commission 29, XX Offices of Independent Counsel 28, VI Operations Office 7, XXVIII Overseas Private Investment Corporation 5, XXXIII; 22, VII Panama Canal Commission 48, 35 Panama Canal Regulations 35, I Patent and Trademark Office 37, I Payment From a Non-Federal Source for Travel Expenses 41, 304 Payment of Expenses Connected With the Death of Certain Employees 41, 303 Peace Corps 22, III Pennsylvania Avenue Development Corporation 36, IX Pension and Welfare Benefits Administration 29, XXV Pension Benefit Guaranty Corporation 29, XL Personnel Management, Office of 5, I, XXXV; 45, VIII Federal Acquisition Regulation 48, 17 Federal Employees Group Life Insurance Federal Acquisition Regulation 48, 21 Federal Employees Health Benefits Acquisition Regulation 48, 16 Postal Rate Commission 5, XLVI; 39, III Postal Service, United States 5, LX; 39, I Postsecondary Education, Office of 34, VI President's Commission on White House Fellowships 1, IV Presidential Commission on the Assignment of Women in the Armed Forces 32, XXIX Presidential Documents 3 Prisons, Bureau of 28, V Productivity, Technology and Innovation, Assistant Secretary 37, IV Public Contracts, Department of Labor 41, 50 Public and Indian Housing, Office of Assistant Secretary for 24, IX Public Health Service 42, I Railroad Retirement Board 20, II Reclamation, Bureau of 43, I Refugee Resettlement, Office of 45, IV Regional Action Planning Commissions 13, V Relocation Allowances 41, 302 Research and Special Programs Administration 49, I Rural Business-Cooperative Service 7, XVIII, XLII Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII Saint Lawrence Seaway Development Corporation 33, IV Science and Technology Policy, Office of 32, XXIV Science and Technology Policy, Office of, and National Security Council 47, II Secret Service 31, IV Securities and Exchange Commission 17, II Selective Service System 32, XVI Small Business Administration 13, I Smithsonian Institution 36, V Social Security Administration 20, III; 48, 23 Soldiers' and Airmen's Home, United States 5, XI Special Counsel, Office of 5, VIII Special Education and Rehabilitative Services, Office of 34, III Special Trustee for American Indians, Office of 25, VII State Department 22, I Federal Acquisition Regulation 48, 6 Surface Mining and Reclamation Appeals, Board of 30, III Surface Mining Reclamation and Enforcement, Office of 30, VII Surface Transportation Board 49, X Susquehanna River Basin Commission 18, VIII Technology Administration 15, XI Technology Policy, Assistant Secretary for 37, IV Technology, Under Secretary for 37, V Tennessee Valley Authority 5, LXIX; 18, XIII Thrift Depositor Protection Oversight Board 12, XV Thrift Supervision Office, Department of the Treasury 12, V Trade Representative, United States, Office of 15, XX Transportation, Department of 5, L Coast Guard 33, I; 46, I; 49, IV Commercial Space Transportation 14, III Contract Appeals, Board of 48, 63 Emergency Management and Assistance 44, IV Federal Acquisition Regulation 48, 12 Federal Aviation Administration 14, I Federal Highway Administration 23, I, II; 49, III Federal Railroad Administration 49, II Federal Transit Administration 49, VI Maritime Administration 46, II National Highway Traffic Safety Administration 23, II, III; 49, V Research and Special Programs Administration 49, I Saint Lawrence Seaway Development Corporation 33, IV Secretary of Transportation, Office of 14, II; 49, Subtitle A Surface Transportation Board 49, X Transportation, Office of 7, XXXIII Travel Allowances 41, 301 Treasury Department 5, XXI; 17, IV Alcohol, Tobacco and Firearms, Bureau of 27, I Community Development Financial Institutions Fund 12, XVIII Comptroller of the Currency 12, I Customs Service, United States 19, I Engraving and Printing, Bureau of 31, VI Federal Acquisition Regulation 48, 10 Federal Law Enforcement Training Center 31, VII Fiscal Service 31, II Foreign Assets Control, Office of 31, V Internal Revenue Service 26, I International Investment, Office of 31, VIII Monetary Offices 31, I Secret Service 31, IV Secretary of the Treasury, Office of 31, Subtitle A Thrift Supervision, Office of 12, V Truman, Harry S. Scholarship Foundation 45, XVIII United States and Canada, International Joint Commission 22, IV United States and Mexico, International Boundary and Water Commission, United States Section 22, XI United States Enrichment Corporation 10, XI Utah Reclamation Mitigation and Conservation Commission 43, III Veterans Affairs Department 38, I Federal Acquisition Regulation 48, 8 Veterans' Employment and Training, Office of the Assistant Secretary for 41, 61; 20, IX Vice President of the United States, Office of 32, XXVIII Vocational and Adult Education, Office of 34, IV Wage and Hour Division 29, V Water Resources Council 18, VI Workers' Compensation Programs, Office of 20, I World Agricultural Outlook Board 7, XXXVIII 21 CFR Ch. I (4-1-97 Edition) List of CFR Sections Affected List of CFR Sections Affected

All changes in this volume of the Code of Federal Regulations which were made by documents published in the Federal Register since January 1, 1986, are enumerated in the following list. Entries indicate the nature of the changes effected. Page numbers refer to Federal Register pages. The user should consult the entries for chapters and parts as well as sections for revisions.

For the period before January 1, 1986, see the “List of CFR Sections Affected, 1949-1963, 1964-1972, and 1973-1985,” published in seven separate volumes.

1986 21 CFR 51 FR Page Chapter I Mandatory compliance date 1-1-89 34085 101Authority citation revised; section authority citations removed 25017 101.100(a)(4) added 25017 101Appendix A added 25017 107.50 (Subpart C)OMB number 6106 110Revised 22475 118Removed 22481 123Removed 41616 131.110(b), (c)(1), and (e)(1)(i) eff. 1-5-87 40314 131.135(b), (c)(1), and (3), and (e)(1)(ii) eff. 1-5-87 40314 131.143(b), (c)(1) and (3), and (e)(1)(i) eff. 1-5-87 40314 133Authority citation revised 30210 133.146(b)(2) revised 30210 Effective date confirmed 42088 145.170(b) revision effective date confirmed 11434 160Authority citation revised 11435 160.145(a) revised; (c) redesignated as (d); new (c) and (e) added 11435 Eff. 7-1-87 25362 1987 21 CFR 52 FR Page Chapter I 101Authority citation corrected 6971 101.9(c)(3) amended 28691 131Stay terminated 29509 Technical correction 31123 1988 21 CFR 53 FR Page Chapter I Uniform compliance date 1-1-91 44861 101.2(d)(2) introductory text revised 16068 133.155Revised 3743 133.155Effective date confirmed 37752 133.156Revised 3743 133.156Effective date confirmed 37752 1989 21 CFR 54 FR Page Chapter I 100Authority citation revised; sectional authority citation removed 39632 101Authority citation revised 39632 101.9(a)(2), (c)(4), and (8) (i) and (ii) amended 24891 101.22(a)(3) amended 24891 101.25(e)(3) amended 24891 101.29Authority citation removed 39632 102Authority citation revised 39632 102.23(c) (1) and (5) amended 24891 103Authority citation revised 400 Effective date confirmed 38514 Authority citation revised 39632 Technical correction 41363 103.35(a)(1) amended 400 Effective date confirmed 18651 (b) introductory text amended 24891 Authority citation removed 39632 104Authority citation revised 39632 105Authority citation revised; sectional authority citations removed 39633 106Authority citation revised 39633 106.30(c)(2) amended 24891 106.120(a) and (b) amended 24891 107Technical correction 6804 Authority citation revised 39633 107.200—107.280 (Subpart E)Added 4008 108Effective date confirmed 38514 Authority citation revised 39633 Technical correction 41363 108.5(a)(1) amended 24891 108.25(c) (1) and (2) and (h) amended 24891 108.35(c)(1), (2) introductory text and (ii), and (j)(1) amended 24891 109Effective date confirmed 38514 Authority citation revised 39633 Technical correction 41363 109.30(c) and (d) amended 24892 Authority citation removed 39633 110Authority citation revised 39633 110.10(b)(4) amended 24892 110.35(b)(1) introductory text amended 24892 113Authority citation revised 39633 114Authority citation revised 39633 114.90(a)(4)(ii) amended 24892 129Authority citation revised 39633 130Authority citation revised 39633 130.17(c) introductory text amended 24892 131Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39633 Technical correction 41363 131.110(d) introductory text amended 24892 131.111(f) introductory text amended 24892 131.112(e) introductory text amended 24892 131.115(d) introductory text amended 24892 131.120(c) amended 24892 131.122(c) amended 24892 131.123(d) introductory text amended 24892 131.125(c) introductory text amended 24892 131.127(d) introductory text amended 24892 131.130(d) introductory text amended 24892 131.132(d) introductory text amended 24892 131.135(d) introductory text amended 24893 131.136(f) introductory text amended 24893 131.138(e) introductory text amended 24893 131.143(d) introductory text amended 24893 131.144(f) introductory text amended 24893 131.146(e) introductory text amended 24893 131.147(d) introductory text amended 24893 131.149(c) introductory text amended 24893 131.150(c) amended 24893 131.155(c) amended 24893 131.157(c) amended 24893 131.160(c) introductory text amended 24893 131.162(c) introductory text amended 24893 131.170(f) introductory text amended 24893 131.180(c) amended 24893 131.185(c) introductory text amended 24893 131.187(c) introductory text amended 24893 131.200(e) introductory text amended 24893 131.203(e) introductory text amended 24893 131.206(e) introductory text amended 24893 133Technical correction 37531, 41363 Effective date confirmed 38514 Authority citations revised; sectional authority citations removed 39633 133.5Introductory text amended 24893 133.106(a)(1) amended; (a)(2) removed; (a)(3) redesignated as (a)(2) 32052 133.108Revised 32052 (d)(2) corrected 35756 133.109Revised 32053 133.127Revised 32053 133.133Revised 32053 133.134Revised 32053 133.136Revised 32054 133.137Revised 32054 133.140Revised 32054 133.141Revised 32054 133.144Revised 32055 133.145Revised 32056 133.146Revised 32056 (d)(3)(iii) and (4)(i) corrected 35756 133.153Revised 32056 133.160Revised 32057 (a) and (d)(1) corrected 35756 (d)(1) corrected 37531 133.161Revised 32057 133.162Revised 32057 133.164Revised 32058 133.179(f)(11) added; eff. 4-10-89 6121 Effective date confirmed 22741 133.184Revised 32058 133.186Revised 32058 133.190Revised 32059 135Effective date confirmed 38514 Authority citations revised; sectional authority citations removed 39633 Technical correction 41363 135.110(d) amended 24894 135.130(c) introductory text amended 24894 136Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39633 Technical correction 41363 136.110(d) amended 24894 136.160(a)(5) amended 24894 137Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39633 Technical correction 41363 137.105(a) introductory text amended 24894 137.180(c) introductory text amended 24894 137.190Amended 24894 137.195Amended 24894 137.200(c)(1) amended 24894 137.211(b)(2) amended 24894 137.230(b)(2) amended 24894 137.250(b)(1) introductory text and (2) amended 24894 137.270(b) introductory text amended 24894 137.300(b)(2) amended 24894 137.350(e) amended 24894 139Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39633 Technical correction 41363 139.110(a)(5) amended 24894 139.117(a)(2) introductory text amended 24894 139.150(a) concluding text amended 24894 145Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39633 Technical correction 41363 145.3(m) amended 24894 145.110(a)(1) amended 24894 145.125(b)(2)(ii) amended 24894 145.135(b)(1)(i) amended 24895 145.145(a)(3)(iii) introductory text amended 24895 146Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39633 Technical correction 41363 146.113(a) amended 24895 146.114(a)(1) amended 24895 146.120(a) amended 24895 146.185(b)(2)(i) amended 24895 150Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39633 Technical correction 41363 150.110(d)(3) amended 24895 150.140(d)(3) amended 24895 150.160(d)(5) amended 24895 152Authority citation revised 39633 152.126Authority citation revised 39633 155Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39634 Technical correction 41363 155.3(a) and (e) amended 24895 155.120(b)(2)(i) amended 24895 155.130(b)(2)(i) amended 24895 155.170(b)(1)(vi) amended 24895 156Authority citation revised 24895 Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39634 Technical correction 41363 156.3(b) amended 24895 158Authority citation revised; sectional authority citations removed 39634 160Effective date confirmed 38514 Authority citation revised 39634 Technical correction 41363 160.145(c)(2) amended 24895 160.180Amended 24895 Authority citation removed 39634 161Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39634 Technical correction 41363 161.145(c)(3) amended 24895 161.173(c)(1) amended 24896 161.175(g)(1)(v) amended 24896 161.190(a)(2), (7) introductory text and (iii) amended 24896 163Effective date confirmed 38514 Authority citation revised; sectional authority citation removed 39634 Technical correction 41363 163.110(a) amended 24896 163.111(a) concluding text amended 24896 163.112(a) concluding text amended 24896 164Effective date confirmed 38514 Authority citation revised 39634 Technical correction 41363 164.150(a) amended 24896 Authority citation removed 39634 165Removed 400 165.175Effective date confirmed 18651 166Authority citation revised 24896 Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39634 Technical correction 41363 166.110(a) introductory text amended 24896 168Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39634 Technical correction 41363 168.111(d) introductory text amended 24896 168.120(d) introductory text amended 24896 168.122(d)(1) introductory text amended 24896 169Effective date confirmed 38514 Authority citation revised; sectional authority citations removed 39634 Technical correction 41363 169.3(b) amended 24896 1990 21 CFR 55 FR Page Chapter I 101.4(a) redesignated as (a)(1); (a)(2) added 17433 102.47Revised 45797 109Subpart C heading redesignated as Subpart D; new Subpart C heading added 20785 Subpart D heading redesignated from Subpart C 20785 109.4(c) redesignated as (d); heading, (b), and new (d) revised; new (c) added 20785 109.6(c) and (d) redesignated as (d) and (e); (a), new (d) and (e) revised; new (c) added 20785 109.7(b) revised 20785 109.8Removed 20786 133Effective date confirmed 2510 Technical correction 6876 133.127(a) amended 51409 133.138(b)(3)(iv) revised eff. 4-30-90 6795 Regulation at 55 FR 6795 confirmed 48107 133.195(b)(3)(iv) revised eff. 4-30-90 6795 Regulation at 55 FR 6795 confirmed 48107 133.196Revised eff. 4-30-90 6795 Regulation at 55 FR 6795 confirmed 48107 161.190(a)(2), (4)(i) and (8)(vi) revised; (a)(6)(ix) added 45797 168.122(b)(1) and (3), and (d) revised eff. 4-10-90 8459 Regulation at 55 FR 8458 effective date confirmed 28019 1991 21 CFR 56 FR Page Chapter I 101.42—101.45 (Subpart C)Added 60890 106.100Revised; eff. 4-22-92 66571 161.190(a)(2) corrected 6263 1992 21 CFR 57 FR Page Chapter I 101Technical correction 10522 101.42—101.45 (Subpart C)Technical correction 8174 106.100Technical correction 6352 (k)(6) corrected 7435 146.135(a) revised 57667 146.140(a) amended 57667 146.141(a) amended 57667 146.146(a) amended 57667 146.151(a) amended 57667 155Technical correction 37591 155.120(a)(3)(xiii) and (a)(3)(xiv) redesignated as (a)(3)(xiv) and (a)(3)(xv); new (a)(3)(xiii) added; (b)(2)(i) revised 34245 169Technical correction 37591 169.140(a) and (e) revised 34246 1993 21 CFR 58 FR Page Chapter I 100Implementation at 57 FR 56347 revoked 2066 Implementation; eff. 5-8-94 2070 Authority citation revised 2467 Regulatory impact analysis statement 2927 Technical correction 17096 100.1 (Subpart A)Added 2468 100.2Added 2460 (d), (f), (g), and (h) introductory text corrected 17097 100.100 (Subpart F)Added 27933, 64136 101Implementation at 57 FR 56347 revoked 2066 Implementation; eff. 5-8-94 2070 Regulatory impact analysis statement 2927 Technical correction 17085, 17096, 17099 17100, 17101, 17102, 17343, 19876, 59657 Clarification 44033 101.2(b) and (f) revised; eff. 5-8-94 44030 101.3(e)(4)(ii) revised; eff. 5-8-94 2227 101.4(a)(1) and (b)(2)(i) revised; eff. 5-8-93 2875 (b)(20) through (22), (d), (e) and (f) added, eff. 5-8-94 2875 101.6Removed; eff. 5-8-94 2875 Removal at 58 FR 2850 effective date corrected to 5-8-93 17103 101.8(a) revised; eff. 5-8-94 2291 101.9Revised; eff. 2-14-94 2175 (b) revised; eff. 5-8-94 2291 (c)(7)(iii), (8)(iv) and (9) added; eff. 5-8-94 2227 (k)(1) added; eff. 2-14-94 2533 (b)(5)(iv) and (b)(7) corrected; eff. 5-8-94 17086 (k)(1) addition at 58 FR 2478 effective date corrected to 5-8-94 17097 (c)(8)(iv) corrected 17104 Regulation at 58 FR 2175 effective date corrected to 5-8-94 17328 (c)(1)(i)(A), (6)(iii), (7)(ii), (8)(i), (ii), (B), (d)(8), (9)(i), (ii) and (iii) corrected 17328 (d)(12) sample label correctly revised 17329 (e) introductory text corrected; (e)(5) sample label correctly revised 17330 (f)(2)(ii), (iv), (g)(8), (9), (h)(3)(iv), (j)(4) and (13)(ii)(A) corrected; (j)(13)(ii)(A) sample label correctly revised 17331 (b) revised; eff. 5-8-94 44048 (a) introductory text and (d) amended; (c)(1)(i), (2), (8)(vi), (d)(1)(ii)(D), (iii), (7), (11), (e)(5) sample label, (f)(4), (5), (j)(1)(i), (2)(i), (ii), (iii), (j)(3)(v), (4), (5)(ii), (10), (13)(i), (ii)(A), (B), (C), (14) and (15)(iii) revised; (j)(2)(iv) redesignated as (j)(2)(v); (d)(13), (14) and new (j)(2)(iv) added; eff. 5-8-94 44076 (j)(13)(ii)(A)(1) and (B) corrected 59363 (b)(2)(G) corrected 60109 101.10Revised; eff. 2-14-95 2410 Regulation at 58 FR 2410 eff. date corrected in part to 5-8-94 and 5-8-95 17341 101.12 (Subpart A)Added; eff. 5-8-94 2293 (a)(4) and (b) table 1 corrected 17086 (b) table 2 correctly revised 17087 (h)(11)(i) corrected 17091 Revised; eff. 5-8-94 44051 (b) Table 2 corrected 60109 101.13Revised; eff. 2-14-94 2410 (q)(5) revised; eff. 2-14-95 2410 101.13Regulation at 58 FR 2410 effective date corrected in part to 5-8-94 and 5-8-95 17341 (i)(1), (2), (3), (j)(2)(i), (m)(1)(ii), and (p)(1) corrected; effective 5-8-94 17342 (q)(5)(i) corrected; eff. 5-8-95 17342 (b)(4) added; (d)(2), (f), (g) introductory text, (1), (i)(2), (j)(1)(ii)(B), (l)(1)(ii) introductory text, (m)(1)(ii) introductory text and (q)(2) revised; (h)(1) amended; eff. 5-8-94 44030 101.14Added; eff. 5-8-93 2533 (d)(2)(vii)(B) and (3) added; eff. 5-8-94 2533 (d)(2)(vii)(A) and (B) corrected 17097 (e)(6) revised 44038 101.22(h)(7) added; eff. 5-8-94 2875 (k) added; eff. 5-8-93 2875 101.25Removed; eff. 2-14-94 2413 Regulation at 58 FR 2413 effective date corrected to 5-8-94 17341 101.30Added; eff. 5-8-93 2925 (e)(2) and (l) revised; (h)(1) table amended 44063 (m) added 49192 101.35Removed; eff. 5-8-94 2876 101.54—101.69 (Subpart D)Added; eff. 2-14-94 2413 Regulation at 58 FR 2413 effective date corrected to 5-8-94 17341 101.54(a), (b)(1), (e)(1)(i), (iii)(A) and (2)(i) corrected; eff. 5-8-94 17342 101.56(a) introductory text, (3), (d)(2) and (g) corrected; eff. 5-8-94 17342 101.60(b)(2)(i), (ii), and (iii) redesignated as (b)(2)(i)(A), (B) and (b)(2)(ii); (b)(2) introductory text, new (b)(2)(i)(B), (b)(4)(ii)(A), (b)(5)(ii)(A), (c)(4)(ii)(A) and (5)(ii)(A) corrected; eff. 5-8-94 17342 (a) introductory text, (b)(1)(i) and (c)(1)(i) revised; (b)(2)(i)(B) amended; eff. 5-8-94 44031 101.61(a), (b)(2), (3), (4), (5), (6)(ii)(A) and (7)(ii)(A) corrected; eff. 5-8-94 17342 (a) introductory text and (b)(1)(i) revised; (b)(2)(i)(B) and (b)(4)(i)(B) amended; eff. 5-8-94 44032 101.62(b)(2), (3), (4)(ii)(A), (5)(ii)(A), (6)(ii), (c) introductory text, (4) introductory text, (4)(ii)(A), (5)(ii)(A) and (d)(1)(ii) corrected; eff. 5-8-94 17342 (d)(2)(ii)(B), (d)(4) introductory text and (4)(i) corrected; eff. 5-8-94 17343 (b)(1)(i), (c)(1)(i), (d)(1)(i)(A), (d)(1)(ii)(A), (e)(1) and (2) revised; (b)(2)(i)(B), (d)(1)(i) introductory text, (d)(1)(ii) introductory text, (d)(2)(ii) introductory text, (d)(2)(ii), (A), (d)(2)(iv) introductory text, (d)(2)(iv)(A), (d)(4)(i) introductory text and (d)(4)(ii) introductory text amended; eff. 5-8-94 44032 (b)(2)(i)(B), (d)(1)(i), (ii), (d)(2)(ii), (ii)(A), (iv), (iv)(A), (d)(4)(i) and (ii) corrected; eff. 5-8-94 60105 101.65(b) and (c)(3) corrected; eff. 5-8-94 17343 101.67Added; eff. 5-8-94 2455 101.69(m)(1), (n)(1) and (o)(1) corrected; eff. 5-8-94 17343 (m)(1), (n)(1) and (o)(1) amended; (m)(1)(E), (n)(1)(C) and (o)(1)(C) added; eff. 5-8-94 44033 101.70—101.71 (Subpart E)Added; eff. 5-8-93 2534 101.70(f) corrected 17097 101.71(a) added; eff. 5-8-93 2548 (b) added; eff. 5-8-93 2578 (c) added; eff. 5-8-93 2620 (d) added; eff. 5-8-93 2639 (e) added; eff. 5-8-93 2664 (f) added; eff. 5-8-93 2714 (b) correctly designated 17100 101.72Added; eff. 5-8-93 2676 (c)(2)(ii)(C) corrected 17101 101.73Added; eff. 5-8-93 2801 Heading and tables 1 and 2 corrected; eff. 5-8-94 17343 Table 2 corrected; eff. 5-8-94 17344, 17345, 17346 101.74Added; eff. 5-8-93 2836 (b)(3) corrected; eff. 5-8-93 17100 101.75Added; eff. 5-8-93 2757 101.76Added; eff. 5-8-93 2548 101.77Added; eff. 5-8-93 2578 101.78Added; eff. 5-8-93 2639 101.95 (Subpart F)Added; eff. 2-14-94 2426 (Subpart F)Regulation at 58 FR 2426 effective date corrected to 5-8-94 17341 101.100—101.108 (Subpart F)Redesignated as subpart G; eff. 2-14-94 2426 Regulation at 58 FR 2426 effective date corrected to 5-8-94 17341 101.100(d) introductory text revised; eff. 2-14-94 2188 (a)(2) revised; eff. 5-8-94 2876 Regulation at 58 FR 2189 effective date corrected to 5-8-94 17328 101Appendix B added; eff. 2-14-94 2189 Regulation at 58 FR 2188 effective date corrected to 5-8-94 17328 Appendix B corrected 17332, 17333 102Technical correction 17103 102.22Added; eff. 5-8-94 2876 102.30Removed; eff. 5-8-94 2926 102.32Removed; eff. 5-8-94 2926 102.33Revised; eff. 5-8-94 2926 (c) corrected 17103 (g) redesignated as (g)(1); (g)(2) added; eff. 5-8-94 44063 103.35(d)(3) added; eff. 7-6-93 381 104Technical correction 17104 104.20(a) amended; (c)(1) and (d)(3) revised; eff. 5-8-94 2228 105Implementation at 57 FR 56347 revoked 2066 Implementation; eff. 5-8-94 2070 Regulatory impact analysis statement 2927 Technical correction 17096, 17104 Clarification 44033 105.66Revised; eff. 5-8-94 2430 130Implementation at 57 FR 56347 revoked 2066 Implementation; eff. 5-8-94 2070 Regulatory impact analysis statement 2927 Technical correction 17096, 17103, 17105 Clarification 44033 130.3(e) added; eff. 5-8-93 2876 130.9Added; eff. 5-8-93 2876 130.10Added; eff. 5-8-94 2446 130.11Added; eff. 5-8-93 2876 131Technical correction 17105 131.110(f) revised; eff. 5-8-93 2890 131.111(h) revised; eff. 5-8-93 2890 131.112(g) revised; eff. 5-8-93 2890 131.115(f) revised; eff. 5-8-93 2890 131.120(e) revised; eff. 5-8-93 2890 131.122(e) revised; eff. 5-8-93 2890 131.123(f) revised; eff. 5-8-93 2890 131.125(e) revised; eff. 5-8-93 2890 131.127(f) revised; eff. 5-8-93 2890 131.130(f) revised; eff. 5-8-93 2890 131.132(f) revised; eff. 5-8-93 2890 131.135(f) revised; eff. 5-8-93 2890 131.136(h) revised; eff. 5-8-93 2890 131.138(g) revised; eff. 5-8-93 2891 131.143(f) revised; eff. 5-8-93 2891 131.144(h) revised; eff. 5-8-93 2891 131.146(g) revised; eff. 5-8-93 2891 131.147(f) revised; eff. 5-8-93 2891 131.149(e) revised; eff. 5-8-93 2891 131.150(e) revised; eff. 5-8-93 2891 131.155(e) revised; eff. 5-8-93 2891 131.157(e) revised; eff. 5-8-93 2891 131.160(e) revised; eff. 5-8-93 2891 131.162(e) revised; eff. 5-8-93 2891 131.170(h) revised; eff. 5-8-93 2891 131.180(e) revised; eff. 5-8-93 2891 131.185(e) revised; eff. 5-8-93 2891 131.187(e) revised; eff. 5-8-93 2891 131.200(g) revised; eff. 5-8-93 2891 131.203(g) revised; eff. 5-8-93 2891 131.206(g) revised; eff. 5-8-93 2891 133.102(e) revised; eff. 5-8-93 2891 133.103Revised; eff. 5-8-93 2892 133.104Revised; eff. 5-8-93 2892 133.106(d) introductory text revised; eff. 5-8-93 2892 133.108(d) introductory text revised; eff. 5-8-93 2892 (d) introductory text corrected 17105 133.111(f) revised; eff. 5-8-93 2892 133.113(d) introductory text revised; eff. 5-8-93 2892 133.118(f) added; eff. 5-8-93 2892 133.121Introductory text revised; eff. 5-8-93 2892 133.123(f) introductory text revised; eff. 5-8-93 2892 133.124(h) revised; eff. 5-8-93 2892 133.125(a) introductory text revised; eff. 5-8-93 2892 133.127(d) revised; eff. 5-8-93 2892 133.128(e) revised; eff. 5-8-93 2892 133.129(e) revised; eff. 5-8-93 2892 133.131Introductory text revised; eff. 5-8-93 2892 133.133(d) introductory text revised; eff. 5-8-93 2892 133.134(d) introductory text revised; eff. 5-8-93 2893 133.136(d) introductory text revised; eff. 5-8-93 2893 133.138(d) introductory text revised; eff. 5-8-93 2893 133.140(c) revised; eff. 5-8-93 2893 133.141(d) introductory text revised; eff. 5-8-93 2893 133.144(d) introductory text revised; eff. 5-8-93 2893 133.146(e) introductory text revised; eff. 5-8-93 2893 133.147(e) revised; eff. 5-8-93 2893 133.148(f) introductory text revised; eff. 5-8-93 2893 133.149(d) introductory text revised; eff. 5-8-93 2893 133.150(f) introductory text revised; eff. 5-8-93 2893 133.152(d) introductory text revised; eff. 5-8-93 2893 133.153(d) introductory text revised; eff. 5-8-93 2893 133.154Revised; eff. 5-8-93 2893 133.155(d) introductory text revised; eff. 5-8-93 2893 133.156(d) introductory text revised; eff. 5-8-93 2893 133.158Revised; eff. 5-8-93 2894 133.160(d) introductory text revised; eff. 5-8-93 2894 133.162(d) introductory text revised; eff. 5-8-93 2894 133.164(d) introductory text revised; eff. 5-8-93 2894 133.165(e) revised; eff. 5-8-93 2894 133.167Introductory text revised; eff. 5-8-93 2894 133.168(a) introductory text revised; eff. 5-8-93 2894 133.169(g) revised; eff. 5-8-93 2894 133.170(a) introductory text revised; eff. 5-8-93 2894 133.171Introductory text revised; (f) removed; eff. 5-8-93 2894 133.173(h) revised; eff. 5-8-93 2894 133.174(a) introductory text revised; eff. 5-8-93 2894 133.175Revised; eff. 5-8-93 2894 133.176(a) introductory text revised; eff. 5-8-93 2894 133.178(d) revised; eff. 5-8-93 2894 133.179(i) revised; eff. 5-8-93 2895 133.180(a) introductory text revised; eff. 5-8-93 2895 133.181(d) introductory text revised; eff. 5-8-93 2895 133.182(f) added; eff. 5-8-93 2895 133.183(f) introductory text revised; eff. 5-8-93 2895 133.184(d) introductory text revised; eff. 5-8-93 2895 133.185(d) introductory text revised; eff. 5-8-93 2895 133.186(d) revised; eff. 5-8-93 2895 133.187(g) added; eff. 5-8-93 2895 133.188(g) added; eff. 5-8-93 2895 133.189(e) added; eff. 5-8-93 2895 133.190(d) introductory text revised; eff. 5-8-93 2895 133.191Revised; eff. 5-8-93 2895 133.193(a) revised; eff. 5-8-93 2895 133.195(d) introductory text; eff. 5-8-93 2895 135Technical correction 17103, 17105 135.110(f) revised; eff. 5-8-93 2896 135.115(d) revised; eff. 5-8-93 2896 135.120(a) introductory text; eff. 5-8-93 2896 135.130(e) revised; eff. 5-8-93 2896 135.140(i) revised; eff. 5-8-93 2896 135.160(a) revised; eff. 5-8-93 2876 136Technical correction 17103 136.110(f) revised; eff. 5-8-93 2877 137Technical correction 17103 137.105(b)(1) revised; eff. 5-8-93 2877 137.155Revised; eff. 5-8-93 2877 137.160Revised; eff. 5-8-93 2877 137.165Introductory text revised; eff. 5-8-93 2877 137.170(a) revised; eff. 5-8-93 2877 137.175Introductory text revised; eff. 5-8-93 2877 137.180(b) revised; eff. 5-8-93 2877 137.185Introductory text revised; eff. 5-8-93 2877 137.200(b)(1) revised; eff. 5-8-93 2877 137.205Revised; eff. 5-8-93 2877 137.225Revised; eff. 5-8-93 2877 137.235(c) added; eff. 5-8-93 2877 137.260(c) added; eff. 5-8-93 2878 137.270(c) added; eff. 5-8-93 2878 137.305(b)(1) revised; eff. 5-8-93 2878 137.350(g) added; eff. 5-8-93 2878 139Technical correction 17103 139.110(g) added; eff. 5-8-93 2878 139.115(a) introductory text; eff. 5-8-93 2878 139.117(e) revised; eff. 5-8-93 2878 139.120(a) introductory text revised; eff. 5-8-93 2878 139.121(a) introductory text revised; eff. 5-8-93 2878 139.122(a) introductory text revised; eff. 5-8-93 2878 139.125(a) introductory text revised; eff. 5-8-93 2878 139.135(a) revised; eff. 5-8-93 2878 139.138(a) introductory text revised; eff. 5-8-93 2878 139.140(a) introductory text revised; eff. 5-8-93 2878 139.150(i) added; eff. 5-8-93 2879 139.155(a) introductory text revised; eff. 5-8-93 2879 139.160(a) revised; eff. 5-8-93 2879 139.165(a) revised; eff. 5-8-93 2879 139.180(a) revised; eff. 5-8-93 2879 145Technical correction 17103 145.110(a)(4) revised; eff. 5-8-93 2879 145.115(a)(4)(iv) revised; eff. 5-8-93 2879 145.116(b)(2) revised; eff. 5-8-93 2879 145.120(a)(5)(iv) revised; eff. 5-8-93 2879 145.125(a)(4)(iv) revised; eff. 5-8-93 2879 145.126(b)(2) revised; eff. 5-8-93 2879 145.130(d)(4) revised; eff. 5-8-93 2879 145.131(b)(2) revised; eff. 5-8-93 2880 145.134(f) added; eff. 5-8-93 2880 145.135(a)(4)(iv) revised; eff. 5-8-93 2880 145.136(b)(2) revised; eff. 5-8-93 2880 145.140(d)(4) revised; eff. 5-8-93 2880 145.145(a)(4)(iii) revised; eff. 5-8-93 2880 145.170(a)(4)(iv) revised; eff. 5-8-93 2880 145.171(b)(2) revised; eff. 5-8-93 2880 145.175(a)(4)(iv) revised; eff. 5-8-93 2880 145.176(b)(2) revised; eff. 5-8-93 2880 145.180(a)(5)(iii) revised; eff. 5-8-93 2880 145.181(b)(2) revised; eff. 5-8-93 2880 145.185(a)(4)(iv) revised; eff. 5-8-93 2880 145.190(c)(4) revised; eff. 5-8-93 2880 146Technical correction 17103 146.113(h) added; eff. 5-8-93 2881 146.114(a)(3)(ii) revised; eff. 5-8-93 2881 146.120(c) revised; eff. 5-8-93 2881 146.121(f) added; eff. 5-8-93 2881 146.126(c) revised; eff. 5-8-93 2881 146.132(a)(3)(iii) revised; 5-8-93 2881 146.140(g) added; eff. 5-8-93 2881 146.141(f) added; eff. 5-8-93 2881 146.145(f) added; eff. 5-8-93 2881 146.146(g) added; eff. 5-8-93 2881 146.148(a) revised; eff. 5-8-93 2881 146.150(a) revised; eff. 5-8-93 2881 146.152(d) revised; 5-8-93 2881 146.153(a) revised; eff. 5-8-93 2881 146.154(d) revised; eff. 5-8-93 2882 146.185(a)(3) revised; eff. 5-8-93 2882 146.187(d) added; eff. 5-8-93 2882 150Technical correction 17103 150.110(e)(1) introductory text revised; (e)(2)(ii) removed; eff. 5-8-93 2882 150.140(e)(2) introductory text revised; eff. 5-8-93 2882 150.141(h) added; eff. 5-8-93 2882 150.160(e)(2) introductory text revised; eff. 5-8-93 2882 150.161(h) added; eff. 5-8-93 2882 152Technical correction 17103 152.126(a)(4)(i) revised; eff. 5-8-93 2882 155.3Regulation at 48 FR 3954 effective date confirmed 16771 155.120(a)(5) revised; eff. 5-8-93 2882 155.130(a)(5) revised; eff. 5-8-93 2882 155.131(a)(1) revised; eff. 5-8-93 2882 155.170(a)(4) revised; eff. 5-8-93 2882 155.172(a) introductory text revised; eff. 5-8-93 2883 155.190(a)(6) revised; eff. 5-8-93 17103 155.191(a)(3)(iv) revised; eff. 5-8-93 2883 Regulation at 48 FR 3954 and 49 FR 15073 effective date confirmed 16771 (a)(3)(iv) corrected 17104 155.192Removal at 48 FR 3956 effective date confirmed 16771 155.194(a)(3)(iii) revised; eff. 5-8-93 2883 Regulation at 48 FR 3956 and 49 FR 15073 effective date confirmed 16771 155.200(h) revised; eff. 5-8-93 2883 155.201(a)(4)(ii) revised; eff. 5-8-93 2883 156Technical correction 17103 156.3 (Subpart A)Regulation at 48 FR 3956 effective date confirmed 16771 156.145(a)(2)(ii) revised; eff. 5-8-93 2883 Regulation at 48 FR 3957 effective date confirmed 16771 156.147Removal at 48 FR 3958 effective date confirmed 16771 158Technical correction 17103 158.170(a)(4) revised; eff. 5-8-93 2883 160Technical correction 17103 160.105(e) added; eff. 5-8-93 2883 160.110(d) added; eff. 5-8-93 2883 160.115Existing text designated as (a); (b) added; eff. 5-8-93 2883 160.140(c) added; eff. 5-8-93 2883 160.145(f) added; eff. 5-8-93 2883 160.150(c) added; eff. 5-8-93 2883 160.180Existing text designated as (a); (b) added; eff. 5-8-93 2883 160.185(e) added; eff. 5-8-93 2883 160.190Existing text designated as (a); (b) added; eff. 5-8-93 2884 161Technical correction 17103 161.145(a)(4) added; eff. 5-8-93 2884 161.170(a)(5)(iii) revised; eff. 5-8-93 2884 161.173(a)(5)(ix) revised; eff. 5-8-93 2884 161.175(i) added; eff. 5-8-93 2884 161.190(a)(6)(ii) through (viii) and (8)(vi) revised; (a)(6)(ix) removed; eff. 5-8-93 2884 163Technical correction 17103 Revised 29529 163.110(c) added; eff. 5-8-93 2884 163.111(c) added; eff. 5-8-93 2884 163.112(c) added; eff. 5-8-93 2885 163.113Revised; eff. 5-8-93 2885 163.114Revised; eff. 5-8-93 2885 163.117(a) revised; eff. 5-8-93 2885 163.123(i) added; eff. 5-8-93 2885 163.130(f) added; eff. 5-8-93 2885 163.135(c) added; eff. 5-8-93 2885 163.140(c) added; eff. 5-8-93 2885 163.145(c) added; eff. 5-8-93 2885 163.150(d) added; eff. 5-8-93 2885 163.153(c) added; eff. 5-8-93 2885 163.155(c) added; eff. 5-8-93 2885 164Technical correction 17103 164.110(e) introductory text and (f) revised; (e)(3) and (4) removed; eff. 5-8-93 2885 164.150(e) revised; eff. 5-8-93 2886 166Technical correction 17103 166.110(d) revised; eff. 5-8-93 2886 (a) introductory text amended; (b)(4) revised 21649 168Technical correction 17103, 17105 168.110(b) revised; eff. 5-8-93 2886 168.111(c) revised; eff. 5-8-93 2886 168.130(d) revised; eff. 5-8-93 2886 168.140(d) revised; eff. 5-8-93 2896 168.160(d) revised; eff. 5-8-93 2886 168.180(d)(1) revised; eff. 5-8-93 2886 169Technical correction 17103 169.115(e) revised; eff. 5-8-93 2886 169.140(f) revised; eff. 5-8-93 2886 169.150(g) revised; eff. 5-8-93 2886 169.175(c) added; eff. 5-8-93 2886 169.176(a) revised; eff. 5-8-93 2886 169.177(a) revised; eff. 5-8-93 2886 169.178(a) revised; eff. 5-8-93 2886 169.179(d) added; eff. 5-8-93 2887 169.180(a) revised; eff. 5-8-93 2887 169.181(a) revised; eff. 5-8-93 2887 169.182(a) revised; eff. 5-8-93 2887 1994 21 CFR 59 FR Page Chapter I Chapter INomenclature change 14366 100.100 (Subpart F)Regulation at 58 FR 27933 removed 537 101Date of application 350 Clarification 15049 Notice 28480 101.9(d)(3)(ii), (h)(2) and (j)(6) revised; eff. 7-5-95 371 Regulation at 59 FR 371 eff. date corrected to 7-1-95 24039 (c)(1)(i) revised 62317 101.12(b) Table 2 amended; eff. 7-5-95 371 Regulation at 59 FR 371 eff. date corrected to 7-1-95; Table 2 amended; eff. 7-1-95 24039 101.13(a), (i) introductory text, (j)(1)(i)(A), (B) and (n) revised; (b)(5) added; (c) amended; eff. 7-1-95 393 (j)(1)(i)(B) corrected 15051 101.14(a)(2), (b)(3)(i), (d)(1), (3), (e) introductory text, (6) and (g) revised; (a)(4) added; eff. 7-5-94 425 Regulation at 59 FR 425 eff. date corrected to 7-1-94; (e)(6) corrected 15050 101.36Added; eff. 7-5-95 373 Regulation at 59 FR 371 eff. date corrected to 7-1-95; (b)(4) introductory text, (vi), (c)(10) and (g) amended; eff. 7-1-95 24039 101.54(a)(3), (b)(1), (c)(1) and (e)(1) introductory text revised; eff. 5-8-94 394 (b)(1) corrected 15051 101.60(c)(4) and (5) redesignated as (c)(5) and (6); (a)(2), (3) and new (c)(5) introductory text revised; (a)(4) and new (c)(4) added; eff. 7-1-95 394 101.61(a)(3) revised; eff. 7-1-95 394 101.62(a)(2) and (3) revised; (a)(4) added; eff. 7-1-95 394 101.65(a)(3), (b)(3) and (4) revised; eff. 7-1-95 394 (d)(2), (3) and (4) added 24249 (d)(2)(ii)(A), (C)(1), (iv), (3)(ii)(A), (C)(1) and (iii) corrected 50828 101.70(f) amended; eff. 7-5-94 425 Regulation at 59 FR 426 eff. date corrected to 7-1-94 15050 101.71(c) removed; (d), (e) and (f) redesignated as (c), (d) and (e); eff. 7-1-94 434 Introductory text revised; eff. 7-1-94 437 101.79Added; eff. 7-1-94 434 101.108(c) amended 14364 103.35(d)(1)(i) table amended; (d)(3) introductory text revised; (d)(3)(i) and (v) added 26937 (d)(1)(i) table, (i) table and (ii) table amended; (d)(3) introductory text, (v) introductory text and (vi) revised; (d)(3)(iii), (iv), (v)(A) through (F) and (vii) added; eff. 5-30-95 61535 105Clarification 15049 109Authority citation revised 1641 109.16Added; eff. 7-13-94 1641 109.30(b), (c) and (d) amended 14364 130Clarification 15049 130.17(c) introductorytext amended 15051 131Authority citation revised 17691 131.130(a) revised 17691 Regulation at 59 FR 17691 confirmed 32078 135Authority citation revised 47079 135.110(a)(1) and (b) revised; (d), (e) and (f) redesignated as (e), (f) and (g); new (d) and (f)(7) added; eff. 9-14-95 47079 Regulation at 59 FR 47079 effective date confirmed 64571 135.115(a) revised; (c) text redesignated as (c)(1); new (c)(2) added; eff. 9-14-95 47080 Regulation at 59 FR 47080 effective date confirmed 64571 135.120Removed; eff. 9-14-95 47080 Regulation at 59 FR 47080 effective date confirmed 64571 135.125Removed; eff. 9-14-95 47080 Regulation at 59 FR 47080 effective date confirmed 64571 155.190(a)(3)(iv) amended 15051 155.200(g) amended 15052 166Authority citation revised 26939 166.110(a) introductory text heading and (c) heading added; (a)(1) revised; (b) heading and (d) heading amended 26939 1995 21 CFR 60 FR Page 101Notice 7711 Authority citation revised 67174 101.2(d)(1) revised 17205 101.3(e)(4)(ii) revised; eff. 1-1-97 67174 101.9(i) revised; (j)(17) revised 17205 (j)(17) corrected 30788 (c)(8)(iv) revised; eff. 1-1-97 67174 101.13(j)(2)(iv)(B) revised 17205 101.36(b)(3) introductory text, (i), (ii), (4) introductory text and (vi) revised; eff. 1-1-97 67175 101.54(e)(1)(iii)(B) and (2)(iii)(B) revised 17206 101.56(b)(3)(ii), (c)(1)(ii)(B), (2)(ii)(B) and (g) amended 17206 101.60(b)(4)(ii)(B), (5)(ii)(B), (c)(4)(ii)(B) and (5)(ii)(B) revised 17206 101.61(b)(6)(ii)(B), (7)(ii)(B) and (c)(2)(iii) revised 17206 101.62(b)(4)(ii)(B), (5)(ii)(B), (c)(4)(ii)(B), (5)(ii)(B), (d)(1)(ii)(F)(2), (2)(iii)(E)(2), (iv)(E)(2), (4)(i)(C)(2), (ii)(D)(2), (5)(i)(C)(2) and (ii)(D)(2) revised 17207 102.50Table revised 34460 103.35Removed; eff. 5-13-96 57123 123Added; eff. 12-18-97 65197 129.35(a)(3)(ii) and (iii) revised; (a)(4) added; eff. 5-13-96 57123 129.80(g) introductory text revised; eff. 5-13-96 57124 146.113Removed 56514 165Added; eff. 5-13-96 57124 165.110(a)(2)(v) and (b)(4)(i)(C)(4) corrected; eff. 5-13-96 66495 1996 21 CFR 61 FR Page 100.120Removed 27778 100.130Removed 27778 100.135Removed 27778 100.140Removed 27778 100.145Removed 27778 100.150Removed 27778 100.160Removed 27778 101Technical correction 21074 Request denial 37502 Authority citation revised 43446 101.9(c)(8)(v) amended; eff. 4-19-96 8779 (c)(7)(ii) and (g)(9) amended 14479 (j)(1)(i) revised; (j)(18) added 40978 101.10Revised; eff. 5-2-97 40332 101.13(j)(1)(i)(B) amended 11731 (q)(5) introductory text revised; eff. 5-2-97 40332 (b) introductory text and (q)(5) introductory text correctly revised; eff. 5-2-97 67452 101.14(d)(2)(vii)(B) and (3) introductory text revised; (d)(3)(i) added; eff. 5-2-97 40332 101.17(c) revised; interim 20100 101.33Removed 27779 101.36(b)(3)(v) amended; eff. 4-19-96 8779 (b)(3)(ii) corrected 10280 (f) revised 40979 101.43(a)(1), (2) and (3) revised; eff. 8-18-97 42759 101.44(c) revised; eff. 8-18-97 42760 101.45(c) and (i) amended 14479 Revised; eff. 8-18-97 42760 101.54(e)(1) introductory text and (2) introductory text amended 11731 101.62(b)(1) introductory text revised; eff. 1-1-98 59001 101.79Revised; eff. 4-19-96 8779 (b)(3) corrected 43119, 48529 Clarification 49964 (b)(3) corrected; CFR correction 55567 101.80Added; eff. 1-1-98 43446 101.103Removed 27779 101Appendixes C and D added; eff. 8-18-97 42761 102.23(c)(5) amended 14479 103Removed 27779 103.35(b), (d)(3)(v) introductory text, (A)(3), (E)(3), (G)(3) and (vi) amended 14479 104.19Removed 27779 105.67Removed 27779 Regulation at 61 FR 27779 eff. date confirmed 48963 105.69Removed 27779 Regulation at 61 FR 27779 eff. date confirmed 48963 106.120(a) and (b) amended 14479 107.50(e)(1) and (2) amended 14479 107.240(b) amended 14479 107.250Introductory text amended 14479 108.5(a)(1) amended 14479 108.25(c)(1) and (2) amended 14479 108.35(c)(1), (2) introductory text, (ii) and (g) amended 14480 109.5Removed 27779 109.30(b) and (d) amended 14480 110.110(e) amended 14480 114.3(b) amended 14245 123Meetings 9100 131.122Removed; eff. 1-1-98 59002 131.123Removed; eff. 1-1-98 59002 131.132Removed; eff. 1-1-98 59002 131.135Effective date note reinstated; CFR correction 48405 Removed; eff. 1-1-98 59002 131.136Removed; eff. 1-1-98 59002 131.138Removed; eff. 1-1-98 59002 131.143Effective date note reinstated; CFR correction 48405 Removed; eff. 1-1-98 59002 131.144Removed; eff. 1-1-98 59002 131.146Removed; eff. 1-1-98 59002 131.149(a) amended; eff. 1-1-98 59002 131.185Removed; eff. 1-1-98 59002 131.187Removed; eff. 1-1-98 59002 133.131Removed; eff. 1-1-98 59002 136Technical correction 40513 Clarification 46714 136.115(a)(1) revised; eff. 1-1-98 8796 (a)(3) amended 14245 137Technical correction 40513 Clarification 46714 137.165(a) revised; eff. 1-1-98 8796 137.185(a) revised; eff. 1-1-98 8796 137.230Removed 27779 137.235(a)(1) revised; eff. 1-1-98 8796 Removed 27779 137.240Removed 27779 137.245Removed 27779 137.260(a)(1) revised; eff. 1-1-98 8796 137.305(a)(1) revised; eff. 1-1-98 8796 137.350(a)(1) revised; eff. 1-1-98 8796 139Technical correction 40513 Clarification 46714 139.115(a)(1) revised; eff. 1-1-98 8797 139.122(a)(3) amended; eff. 1-1-98 8797 139.155(a)(1) revised; eff. 1-1-98 8797 161.131Removed 27779 161.132Removed 27779 161.133Removed 27779 161.134Removed 27779 161.135Removed 27779 161.137Removed 27779 161.138Removed 27779 161.139Removed 27779 161.140Removed 27779 161.190(a)(7)(iii) amended 14480 164.150(c) revised 9325 165.110(b)(4)(i)(A) table and (iii)(A) through (D) amended; (b)(4)(iii)(E), (F) and (G) revised; eff. 9-23-96 13264 (a)(2)(iv), (vii), (2), (b)(4)(i)(C), (iii)(E) introductory text, (2)(iii), (6)(iii), (11)(iii) and (F) amended 14480 1997 (Regulations published from January 1, 1997, through April 1, 1997) 21 CFR 62 FR Page 101Authority citation revised 3600, 15342 101.9(j)(4) amended 15342 101.11Removed 3792 101.17(e) added; eff. 7-15-97 2249 101.60(c)(6) amended 15342 101.65(d)(2)(ii)(C) and (4)(ii)(B) stayed; eff. 4-1-97 through 1-1-00 15391 101.72(c)(2)(ii)(A) amended 15342 101.81Added 3600 (c)(2)(i)(C), (iii)(A), (e)(1) and (2) revised 15344 101.108(a) and (b) amended 15342 102.33(c) and (d) amended 15343 111Added; eff. 7-15-97 2249 131Denial of request for hearing and confirmation of effective date 8163 133Denial of request for hearing and confirmation of effective date 8163 165.110(b)(5) reinstated; CFR correction 2266 ○