CODE OF FEDERAL REGULATIONS21 Food and Drugs PARTS 800 TO 1299 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

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 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 627 Table of CFR Titles and Chapters 629 Alphabetical List of Agencies Appearing in the CFR 645 List of CFR Sections Affected 655

Cite this Code:CFR

To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 800.10 refers to title 21, part 800, section 10. 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.

(c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51.

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.

The Table of Exempt Prescription Products to part 1308 appears in the volume containing part 1300-end.

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, Gregory R. Walton 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> <P>(This book contains Parts 800 to 1299) </P> </TITLEHD> <CFRTOC> <PTHD>Part</PTHD> <CHAPTI> <SUBJECT> <E T="04">chapter i</E>—Food and Drug Administration, Department of Health and Human Services (Continued)</SUBJECT> <PG>800</PG> </CHAPTI> <CROSSREF> <HD SOURCE="HED">Cross References: </HD> <P>Food Safety and Inspection Service, Department of Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III.</P> <P>Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.</P> <P>U.S. Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I.</P> <P>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.</P> </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) SUBCHAPTER H—MEDICAL DEVICES Part Page 800 General 5 801 Labeling 13 803 Medical device reporting 36 804 Medical device distributor reporting 51 805 Cardiac pacemaker registry 57 807 Establishment registration and device listing for manufacturers and distributors of devices 59 808 Exemptions from Federal preemption of State and local medical device requirements 74 809 In vitro diagnostic products for human use 84 810 Medical device recall authority (Eff. May 19, 1997) 90 812 Investigational device exemptions 96 813 [Reserved] 814 Premarket approval of medical devices 111 820 Quality system regulation (Eff. June 1, 1997) 133 821 Medical device tracking requirements 154 860 Medical device classification procedures 160 861 Procedures for performance standards development 172 862 Clinical chemistry and clinical toxicology devices 176 864 Hematology and pathology devices 207 866 Immunology and microbiology devices 225 868 Anesthesiology devices 259 870 Cardiovascular devices 278 872 Dental devices 297 874 Ear, nose, and throat devices 319 876 Gastroenterology-urology devices 329 878 General and plastic surgery devices 344 880 General hospital and personal use devices 355 882 Neurological devices 372 884 Obstetrical and gynecological devices 386 886 Opthalmic devices 403 888 Orthopedic devices 424 890 Physical medicine devices 444 892 Radiology devices 459 895 Banned devices 470 897 Cigarettes and smokeless tobacco (Eff. August 28, 1997) 476 SUBCHAPTER I—MAMMOGRAPHY QUALITY STANDARDS ACT 900 Mammography 481 SUBCHAPTER J—RADIOLOGICAL HEALTH 1000 General 492 1002 Records and reports 501 1003 Notification of defects or failure to comply 510 1004 Repurchase, repairs, or replacement of electronic products 513 1005 Importation of electronic products 515 1010 Performance standards for electronic products: general 519 1020 Performance standards for ionizing radiation emitting products 524 1030 Performance standards for microwave and radio frequency emitting products 553 1040 Performance standards for light-emitting products 556 1050 Performance standards for sonic, infrasonic, and ultrasonic radiation-emitting products 580 SUBCHAPTER K[RESERVED] SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION 1210 Regulations under the Federal Import Milk Act 584 1220 Regulations under the Tea Importation Act 587 1230 Regulations under the Federal Caustic Poison Act 596 1240 Control of communicable diseases 602 1250 Interstate conveyance sanitation 611 1251-1269 [Reserved] 1270 Human tissue intended for transplantation 621 1271-1299 [Reserved] 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 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 800 TO 1299) FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR American College of Radiology, Committee on Quality Assurance in Mammography, Mammography Accreditation Program 1891 Preston White Dr., Reston, VA 22091-5431 Mammography Quality Control: Radiologist's Manual, Radiologic Technologists's Manual, Medical Physicist's Manual, 1992 edition 900.12(d) Mammography Quality Control Manual, 1994 edition 900.12(d) American Society for Testing and Materials 1916 Race St. Philadelphia, PA 19103 ASTM D 412-68 Standard Method of Tension Testing of Vulcanized Rubber 801.410 ASTM D 1415-68 Test for International Hardness of Vulcanized Rubber 801.410 ASTM D 3492-83 Standard Specification for Rubber Contraceptives (Condoms) 801.430(f)(2) American National Standards Institute 1430 Broadway, NY, NY 10018 ANSI C81.10-1976 Specifications for Electric Lamp Bases and Holders-Screw Shall Types 1040.20(c) ANSI S3.22-1987 Specification of Hearing Aid Characteristics (ASA 70-1987) 801.420(c)(4) 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— 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 (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 807Authority citation revised 33032 807.31(c) revised 33033 814Added 26364 Technical correction 34589 Authority citation revised 43344 814.15(b) heading correctly revised 40415 Amended (OMB number) 43344 814.20(b)(3)(v) introductory text corrected 40415 Amended (OMB number) 43344 814.39Amended (OMB number) 43344 814.82Amended (OMB number) 43344 814.84Amended (OMB number) 43344 868Authority citation revised 40388 868.5795Added 40388 868.5800Added 40389 874Added 40389 882Authority citation revised 12101 882.5830(c) added 12101 Technical correction 15883 884Authority citation revised 16649, 39845 884.1600(c) added 39845 884.5360(d) added 16649 1987 21 CFR 52 FR Page Chapter I 805Added 27763 862Added 16122 862.1385(a) corrected 29468 862.3750(b) corrected 48623 864Authority citation revised; section authority citations removed 17732 864.1Revised 17732 864.3Added 17732 864.5220(c) added 17733 864.5680(c) added 17733 864.7250(c) added 17733 864.7300(c) added 17733 864.9205(c) added 17733 864.9245(c) added 17733 866Authority citation revised; section authority citations removed 17733 866.1Revised 17733 866.3Added 17733 (b) and (c) corrected 22577 866.2420(c) added 17734 866.3290(c) added 17734 866.3305(c) added 17734 866.3510(c) added 17734 866.6010(c) added 17734 868Authority citation revised; section authority citations removed 17734 868.1Revised 17734 868.3Added 17734 868.1120(c) added 17735 (c) corrected 22577 868.1150(c) added 17735 868.1170(c) added 17735 868.1200(c) added 17735 868.2450(c) added 17735 868.2500(c) added 17735 868.5400(c) added 17735 868.5610(c) added 17735 870Authority citation revised; section authority citations removed 17735 870.1Revised 17735 870.3Added 17735 870.1025(c) added 17736 870.1350(c) added 17736 870.1360(c) added 17736 870.3300(c) added 17736 870.3375(c) added 17736 870.3450(c) added 17736 870.3535(c) added 17736 870.3545(c) added 17736 870.3600(c) added 17736 870.3610(c) added 17736 870.3620(c) added 17736 870.3680(c) added 17736 870.3700(c) added 17736 870.3710(c) added 17736 870.3800(c) added 17736 870.3850(c) added 17736 870.3925(c) added 17737 (c) revised; eff. 12-9-87 18163 (c) corrected 23137 870.4230(c) added 17737 870.4260(c) added 17737 870.4320(c) added 17737 870.4350(c) added 17737 870.4360(c) added 17737 870.5200(c) added 17737 870.5225(c) added 17737 870.5300(c) added 17737 870.5550(c) added 17737 872Added 30097 872.3680(a) corrected 34456 872.6080(a), (b), and (c) corrected 49250 874.9Added 32111 874.1100Correctly designated 18495 (b) revised 32111 874.3540(b) revised 32111 874.4420(b) revised 32111 874.5800(b) revised 32111 876Authority citation revised; section authority citations removed 17737 876.1Revised 17737 (d) corrected 22577 876.3Added 17737 876.3350(c) added 17738 876.3630(c) added 17738 876.3750(c) added 17738 876.4480(c) added 17738 876.5220(c) added 17738 876.5270(c) added 17738 876.5280(c) added 17738 876.5540(c) added 17738 876.5860(c) added 17738 876.5870(c) added 17738 876.5955(c) added 17738 880Authority citation revised; section authority citations removed 17738 880.1Revised 17738 880.3Added 17738 880.5130(c) added 17739 880.5760(c) added 17739 882Authority citation revised; section authority citations removed 17739 882.1Revised 17739 882.3Added 17739 882.1790(c) added 17739 882.1825(c) added 17740 882.5150(c) added 17740 882.5800(c) added 17740 882.5840(c) added 17740 882.5850(c) added 17740 882.5860(c) added 17740 882.5940(c) added 17740 882.5950(c) added 17740 884Authority citation revised; section authority citations removed 17740 884.1Revised 17740 884.3Added 17740 884.1060(c) added 17741 884.1100(c) added 17741 884.1185(c) added 17741 884.2050(c) added 17741 884.2620(c) added 17741 884.2685(c) added 17741 884.4100(c) added 17741 884.4150(c) added 17741 884.4250(c) added 17741 884.4270(c) added 17741 884.5050(c) added 17741 884.5225(c) added 17741 884.5380(c) added 17741 (c) revised 36883 Technical correction 38171 884.5940(c) added 17741 886Added 33355 888Added 33702 Technical correction 36863 890Authority citation revised; section authority citations removed 17741 890.1Revised 17741 890.3Added 17741 890.3610(c) added 17742 890.3890(c) added 17742 (c) corrected 22577 890.5275(c) added 17742 890.5290(c) added 17742 890.5300(c) added 17742 890.5525(c) added 17742 890.5860(c) added 17742 1240Authority citation revised 29514 1240.61Added 29514 1988 21 CFR 53 FR Page Chapter I Uniform compliance date 1-1-91 44861 800Authority citation revised; section authority citations removed 11252 800.12Second (c) removed 11252 803.33(b) amended 11252 807.22(a) amended 11252 807.35(b) amended 11252 807.37(a) and (b)(2) amended 11252 807.90(a) amended 11252 807.95(c)(1) amended 11252 808.87(a) amended 11252 808.98(a) revised 35314 809.5(a)(1), (2), (3), and (4) and (b) amended 11252 812.2(e) amended 11252 812.19Amended 11252 812.20(b)(9) and (d) amended 11252 812.38(d) amended 11253 813.20(a) amended 11253 813.38(b) and (c) amended 11253 813.119(e)(2) amended 11253 813.160(a) introductory text amended 11253 820.1(d) amended 11253 820.3(f) amended 11253 860.7(g)(4) amended 11253 860.123(b)(1) amended 11253 861.32(b) and (c)(5) amended 11253 862.9Added 21448 862.1190(b) corrected 11645 (b) revised 21449 862.1210(b) revised 21449 862.1255(b) revised 21449 862.1290(b) revised 21449 862.1295(b) corrected 11645 862.1305(b) revised 21449 862.1320(b) revised 21449 862.1365(b) revised 21449 862.1380(b) revised 21449 862.1420(b) revised 21449 862.1470(b) revised 21449 862.1490(b) revised 21449 862.1515(b) revised 21449 862.1565(b) revised 21449 862.1575(b) revised 21449 862.1640(b) revised 21449 862.1670(b) revised 21449 862.1680(b) corrected 11645 862.1695Redundant printing correctly removed 11645 862.1700Redundant printing correctly removed 11645 862.1705Redundant printing correctly removed 11645 862.1720(b) corrected 11645 (b) revised 21449 862.1815(b) revised 21449 862.2100(b) revised 21449 862.3750(b) revised 21450 862.3850(b) revised 21450 Technical correction 25050 864.9050(a) amended 11253 864.9160(a) amended 11253 866Technical correction 16837 866.5240(a) amended 11253 866.5890(a) amended 11253 876Technical correction 16837 876.5830(a) amended 11253 878Added 23872 882.5840(c) revised 48621 884.2980Added 1566 Technical correction 5080 884.2982Added 1566 Technical correction 5080 886.9Added 35603 886.1040(b) revised 35603 886.1140(b) revised 35603 886.1150(b) revised 35603 (b) corrected 40825 886.1170(b) revised 35603 886.1190(b) revised 35603 886.1200(b) revised 35604 886.1270(b) revised 35604 886.1320(b) revised 35604 886.1330(b) revised 35604 886.1350(b) revised 35604 886.1375(b) revised 35604 886.1380(b) revised 35604 886.1390(b) revised 35604 886.1395(b) revised 35604 886.1400(b) revised 35604 886.1410(b) revised 35604 886.1415(b) revised 35604 886.1420(b) revised 35604 886.1460(b) revised 35605 886.1500(b) revised 35605 886.1605(b) revised 35605 886.1650(b) revised 35605 886.1655(b) revised 35605 886.1660(b) revised 35605 886.1665(b) revised 35605 886.1700(b) revised 35605 886.1770(b) revised 35605 886.1790(b) revised 35605 (b) corrected 40825 886.1800(b) revised 35605 886.1810(b) revised 35605 886.1840(b) revised 35605 Heading corrected 40825 886.1860(b) revised 35606 886.1870(b) revised 35606 886.1880(b) revised 35606 886.1905(b) revised 35606 886.1910(b) revised 35606 886.4230(b) revised 35606 886.4335(b) revised 35606 886.4350(b) revised 35606 886.4360(b) revised 35606 886.4392Added 38947 886.4445(b) revised 35606 886.4570(b) revised 35606 886.4770(b) revised 35606 886.4855(b) revised 35606 886.5120(b) revised 35607 886.5420(b) revised 35607 886.5540(b) revised 35607 886.5600(b) revised 35607 886.5800(b) revised 35607 886.5810(b) revised 35607 886.5840(b) revised 35607 886.5844(b) revised 35607 886.5870(b) revised 35607 886.5910(b) revised 35607 886.5915(b) revised 35607 888.9Added 52953 888.4200(b) revised 52953 888.4210(b) revised 52953 888.4220(b) revised 52954 888.4230(b) revised 52954 888.5890(b) revised 52954 888.5940(b) revised 52954 888.5980(b) revised 52954 892Added 1567 Technical correction 5080 895Technical correction 16837 895.21(d)(1) amended 11254 1002Technical correction 16837 1002.7Nomenclature change 11254 1002.10Introductory text amended 11254 1002.20(a) and (b) introductory text and (5) amended 11254 1002.31(c) amended 11254 1002.41(a)(1) amended 11254 1002.50(a) introductory text and (b) amended 11254 1002.51Amended 11254 1005.11Amended 11254 1005.25(b) and (c) amended 11254 1010Authority citation revised 52683 1010.2(c) and (d) amended 11254 1010.3(a)(1) and (2)(i), (b), and (c) amended 11254 1010.4(a) introductory text, (b)(1)(viii), (c)(1) and (3) amended 11254 (a) revised; (c)(2) removed; (c)(3) and (4) redesignated as (c)(2) and (3) 52683 1010.5(a) introductory text, (b), (c)(12), and (e)(1) and (2) amended 11254 1010.13Amended 11254 1020.30(c) and (d) introductory text and (3)(ii) amended 11254 1020.32(a)(1) amended 11254 1030Authority citation revised 11254 1030.10(c)(4)(iv), (5)(iv), and (6)(iii), (iv) introductory text and (d) amended 11254 1040.30(c)(1)(ii) amended 11254 1050Authority citation revised 11255 1050.10(d)(5) amended 11255 1989 21 CFR 54 FR Page Chapter I 800Authority citation revised 39640 801Authority citation revised; sectional authority citations removed 39640 801.420(c)(4) amended; eff. 6-19-90 52396 801.430(e) and (f) redesignated as (g) and (h); (b), (d) introductory text, (2), (3) and (4), new (g), and new (h) revised; new (e) and new (f) added 43771 803Authority citation revised 39640 805Authority citation revised 39640 807Authority citation revised; sectional authority citations removed 39640 808Authority citation revised 39640 809Authority citation revised; sectional authority citations removed 39640 812Authority citation revised; sectional authority citations removed 39640 813Authority citation revised; sectional authority citations removed 39641 814Authority citation revised 39641 820Authority citation revised 39641 860Authority citation revised 39641 861Authority citation revised 39641 861.26Authority citation removed 39641 862Authority citation revised 39641 862.1113Added 30206 864Authority citation revised 39641 864.9Added 25043 Effective date added 26958 864.1850(b) revised 25044 Effective date added 26958 864.2220(b) revised 25044 Effective date added 26958 864.2240(b) revised 25044 Effective date added 26958 864.2260(b) revised 25044 Effective date added 26958 864.2360(b) revised 25044 Effective date added 26958 864.2800(b) revised 25044 Effective date added 26958 864.2875(b) revised 25044 Effective date added 26958 864.3010(b) revised 25044 Effective date added 26958 864.3250(b) revised 25044 Effective date added 26958 Revised 47206 864.3300(b) revised 25044 Effective date added 26958 864.3400(b) revised 25044 Effective date added 26958 864.3600(b) revised 25044 Effective date added 26958 864.3800(b) revised 25044 Effective date added 26958 864.3875(b) revised 25045 Effective date added 26958 864.4010(b) revised 25045 Effective date added 26958 864.4400(b) revised 25045 Effective date added 26958 864.5800(b) revised 25045 Effective date added 26958 864.5850(b) revised 25045 Effective date added 26958 864.6150(b) revised 25045 Effective date added 26958 864.6160(b) revised 25045 Effective date added 26958 864.6600(b) revised 25045 Effective date added 26958 864.6700(b) revised 25045 Effective date added 26958 864.8200(b) revised 25045 Effective date added 26958 864.8540(b) revised 25045 Effective date added 26958 866Authority citation revised 39641 866.9Added 25045 Effective date added 26958 866.2050(b) revised 25045 Effective date added 26958 866.2170(b) revised 25045 Effective date added 26958 866.2300(b) revised 25046 Effective date added 26958 866.2320(b) revised 25046 Effective date added 26958 866.2330(b) revised 25046 Effective date added 26958 866.2350(b) revised 25046 Effective date added 26958 866.2360(b) revised 25046 Effective date added 26958 866.2450(b) revised 25046 Effective date added 26958 866.2480(b) revised 25046 Effective date added 26958 866.2500(b) revised 25046 Effective date added 26958 866.2560(b) revised 25046 Effective date added 26958 866.2580(b) revised 25046 Effective date added 26958 866.3010(b) revised 25046 Effective date added 26958 866.3020(b) revised 25046 Effective date added 26958 866.3035(b) revised 25046 Effective date added 26958 866.3065(b) revised 25046 Effective date added 26958 866.3125(b) revised 25046 Effective date added 26958 866.3205(b) revised 25046 Effective date added 26958 866.3250(b) revised 25046 Effective date added 26958 866.3255(b) revised 25046 Effective date added 26958 866.3270(b) revised 25046 Effective date added 26958 866.3330(b) revised 25047 Effective date added 26958 866.3340(b) revised 25047 Effective date added 26958 866.3400(b) revised 25047 Effective date added 26958 866.3410(b) revised 25047 Effective date added 26958 866.3470(b) revised 25047 Effective date added 26958 866.3490(b) revised 25047 Effective date added 26958 866.3520(b) revised 25047 Effective date added 26958 866.3630(b) revised 25047 Effective date added 26958 866.3700(b) revised 25047 Effective date added 26958 866.4500(b) revised 25047 Effective date added 26958 866.4520(b) revised 25047 Effective date added 26958 866.4540(b) revised 25047 Effective date added 26958 866.4600(b) revised 25047 Effective date added 26958 866.4830(b) revised 25047 Effective date added 26958 866.4900(b) revised 25047 Effective date added 26958 866.5800(b) revised 25047 Effective date added 26958 868Authority citation revised 39641 868.9Added 25047 Effective date added 26958 868.1030(b) revised 25048 Effective date added 26958 868.1930(b) revised 25048 Effective date added 26958 868.1965(b) revised 25048 Effective date added 26958 868.2480Added 27160 868.5220(b) revised 25048 Effective date added 26958 868.5280(b) revised 25048 Effective date added 26958 868.5365(b) revised 25048 Effective date added 26958 868.5420(b) revised 25048 Effective date added 26958 868.5560(b) revised 25048 Effective date added 26958 868.5760(b) revised 25048 Effective date added 26958 868.6100(b) revised 25048 Effective date added 26958 868.6175(b) revised 25048 Effective date added 26958 868.6225(b) revised 25048 Effective date added 26958 868.6700(b) revised 25049 Effective date added 26958 870Authority citation revised 39641 870.9Added 25049 Effective date added 26958 870.3730(b) revised 25049 Effective date added 26958 870.4200(b) revised 25049 Effective date added 26958 870.4500(b) revised 25049 Effective date added 26958 872Authority citation revised 39641 872.9Added 13829 872.1730(b) revised 13830 872.1905(b) revised 13830 872.3080(b) revised 13830 872.3110(b) revised 13830 872.3140(b) revised 13830 872.3150(b) revised 13830 872.3220(b) revised 13830 872.3830(b) revised 13830 872.3840(b) revised 13830 872.3850(b) revised 13830 872.4565(b) revised 13830 872.6010(b) revised 13830 872.6050(b) revised 13830 872.6200(b) revised 13830 872.6290(b) revised 13831 872.6390(b) revised 13831 872.6570(b) revised 13831 872.6650(b) revised 13831 872.6670(b) revised 13831 872.6855(b) revised 13831 872.6870(b) revised 13831 872.6880(b) revised 13831 874Authority citation revised 39641 876Authority citation revised 39641 876.9Added 25049 Effective date added 26958 876.4370(b)(2) revised 25049 Effective date added 26958 876.4530(b) revised 25049 Effective date added 26958 876.4560(b) revised 25049 Effective date added 26958 876.4730(b) revised 25049 Effective date added 26958 876.4890(b)(2) revised 25050 Effective date added 26958 876.5030(b) revised 25050 Effective date added 26958 876.5820(b)(2) revised 25050 Effective date added 26958 876.5900(b) revised 25050 Effective date added 26958 876.5920(b) revised 25050 Effective date added 26958 878Authority citation revised 39641 878.9Added 13827 (b) corrected 16438-T 878.1800(b) revised 13827 878.3250(b) revised 13827 878.3910(b) revised 13827 878.3925(b) revised 13827 878.4160(b) revised 13827 878.4800(b) revised 13827 878.4830Added 50738 878.4950(b) revised 13828 878.5900(b) revised 13828 880Authority citation revised 39641 880.9Added 25050 Effective date added 26958 880.5110(b) revised 25050 Effective date added 26958 880.5120(b) revised 25050 Effective date added 26958 880.5510(b) revised 25050 Effective date added 26958 880.6150(b) revised 25050 Effective date added 26958 880.6175Removed 47206 880.6250(b) revised; eff. 4-13-89 1604 Technical correction 6804 880.6280(b) revised 25050 Effective date added 26958 880.6970(b) revised 25050 Effective date added 26958 882Authority citation revised 39641 882.9Added 25051 Effective date added 26958 882.1200(b) revised 25051 Effective date added 26958 882.1500(b) revised 25051 Effective date added 26958 882.1525(b) revised 25051 Effective date added 26958 882.1700(b) revised 25051 Effective date added 26958 882.1750(b) revised 25051 Effective date added 26958 882.4215(b) revised 25051 Effective date added 26958 882.4650(b) revised 25051 Effective date added 26958 884Authority citation revised 39641 884.9Added 25051 Effective date added 26958 884.2900(b) revised 25052 Effective date added 26958 884.4520(b) revised 25052 Effective date added 26958 884.5920(b) revised 25052 Effective date added 26958 886Authority citation revised 39641 888Authority citation revised 39641 888.3353Added 48239 (a) corrected 51342 890Authority citation revised 39641 890.9Added 25052 Effective date added 26958 890.3700(b) revised 25052 Effective date added 26958 890.5125(b) revised 25052 Effective date added 26958 892Authority citation corrected 6804 Authority citation revised 39641 892.9Added 13831 892.1000Added 5078 892.1370(b) revised 13832 892.1380(b) revised 13832 892.1400(b) revised 13832 892.1420(b) revised 13832 895Authority citation revised 39641 895.101Authority citation removed 39641 1000Authority citation revised 39642 1000.50Authority citation removed 39641 1002Authority citation revised; sectional authority citations removed 39642 1003Authority citation revised; sectional authority citations removed 39642 1004Authority citation revised 39642 1005Authority citation revised; sectional authority citations removed 39642 1010Authority citation revised; sectional authority citations removed 39642 1020Authority citation revised 39642 1020.33Authority citation removed 39642 1030Authority citation revised 39642 1040Authority citation revised 39642 1040.30Authority citation removed 39642 1050Authority citation revised 39642 1210Authority citation revised 39642 1220Authority citation revised 39642 1220.40Authority citation removed 39642 1230Authority citation revised 39642 1240Cross-references revised 24900 Authority citation revised 39642 1240.10(f) amended 24900 1240.62(c)(1)(i) through (v) and (2) amended 24900 1240.70(a) revised 24900 1250Cross-references revised 24900 Authority citation revised 39642 1250.51(d), (f)(1), (2), (3) introductory text, and (4)(i) and (iii) amended 24900 1990 21 CFR 55 FR Page Chapter I 800.20Added 51256 801Policy statement 7491 Technical correction 10347 801.420Technical correction 548 801.430(f)(2) amended; (f)(2) figure 1 revised 17600 803.33(b) amended 11168 807.22(a) amended 11169 807.37(a) and (b)(2) amended 11169 807.90(a) revised 11169 812.19Amended 11169 813.20(a) amended 11169 814.20(h) amended 11169 820.1(d) amended 11169 860.123(b)(1) amended 11169 864.5220(b) and (c) revised 23511 872.3100Added 48439 872.3530Added 48439 872.4200Added 48439 872.4620Added 48439 872.6250Added 48439 872.6475Added 48439 872.6510Added 48439 872.6640Added 48439 872.6710Added 48439 872.6865Added 48440 874.1070Added 48440 874.1800Added 48440 874.4750Added 48440 874.4770Added 48440 874.5300Added 48440 874.5550Added 48440 878.4635Added 48440 878.4700Added 48440 878.4820Added 48440 878.4960Added 48440 884.2980(a) added 48440 884.2982(a) revised 48441 886.1050Added 48441 886.1070Added 48441 886.1090Added 48441 886.1120Added 48441 886.1140Revised 48441 886.1160Added 48441 886.1250Revised 48441 886.1290Added 48441 886.1300Added 48441 886.1340Added 48441 886.1350Revised 48441 886.1425Added 48442 886.1430Added 48442 886.1435Added 48442 886.1450Added 48442 886.1605Revised 48442 886.1680Added 48442 886.1690Added 48442 886.1700Revised 48442 886.1780Revised 48442 (a) corrected 51799 886.1810Revised 48442 886.1860Revised 48442 886.1870Revised 48442 886.1910Revised 48442 (a) corrected 51799 886.1940Added 48443 886.1945Revised 48443 886.4070Revised 48443 (a) corrected 51799 886.4250Revised 48443 886.4335Revised 48443 886.4370Revised 48443 886.4855Revised 48443 886.5820Added 48443 886.5900Revised 48443 886.5915Revised 48443 888.1500Added 48443 888.5960Added 48443 892.1100Added 48443 892.1110Added 48444 892.1130Added 48444 892.1300Added 48444 892.1320Added 48444 892.1330Added 48444 892.1350Added 48444 892.1410Added 48444 892.1640Added 48444 892.1890Added 48444 892.1900Added 48444 892.1970Added 48444 1220.40(a) revised 33671 Correctly designated 34797 1991 21 CFR 56 FR Page Chapter I 801Policy statement corrected 2677 812Clarification 29177 Regulation at 29177 corrected 32241 Extension of applicability 35815 878Technical corrections 36871 878.3540(c) revised 14627 878.4493Added 47151 878.5000Added 24685 878.5010Added 24685 878.5020Added 24685 1020Authority citation revised 36098 1020.33(f)(2)(ii) removed; (f)(2)(iii) redesignated as (f)(2)(ii) 36098 1220.40(a) revised 50250 1992 21 CFR 57 FR Page Chapter I 807.3(n) through (q) added; interim 18066 Regulation at 57 FR 18066 stayed 23059 807.87(h) redesignated as (k); new (h), (i) and (j) added; interim 18066 Regulation at 57 FR 18066 stayed 23059 (i)(2) corrected 29354 807.92Added; interim 18066 Regulation at 57 FR 18066 stayed 23059 807.93Added; interim 18067 Regulation at 57 FR 18067 stayed 23059 807.94Added; interim 18067 Regulation at 57 FR 18067 stayed 23059 807.95(c)(3) removed; (d) redesignated as (e); new (d) added; interim 18067 Regulation at 57 FR 18067 stayed 23059 807.100Added 58403 812Extension of applicability 12875, 29001 814.44(a) revised 58403 821Added 22967 860.3(c)(1) amended; (c)(2) and (3) revised 58403 860.84(a) amended 58404 860.120(c) amended 58404 860.130(e) and (f) amended; (c) through (f) redesignated as (d) through (g); new (c) added 58404 860.134Heading, (a) introductory text, and (b)(3) revised 58404 861Authority citation revised 58404 861.1(a) and (b) revised 58404 861.20Revised 58404 861.22Removed 58405 861.24(a) introductory text and (b) revised 58405 861.26Removed 58405 861.28Removed 58405 861.30Revised 58405 861.32Removed 58405 861.36(c) amended 58405 861.38(b)(2) revised 58405 895.20Amended 58405 895.21(b), (d)(4) and (8) revised 58405 895.30(c) and (d) amended 58405 1220.40(a) revised 38771 1240.3(i) through (p) redesignated as (k) through (r); new (i) and new (j) added 57344 1240.61(a) revised 57344 1993 21 CFR 58 FR Page Chapter I 804Opportunity for comment 46514 Added 46519 807Opportunity for comment 46514 Heading and authority citation revised 46522 807.3(d)(2) and (g) revised; (e)(3) and (4) amended; (e)(5) added 46522 807.20(a)(4) revised; (c) and (d) added 46522 807.21Revised 46522 807.22(a) and (c) revised 46522 807.25(b) revised 46523 807.65(e) revised; (g) removed 46523 821Opportunity for comment 43442 Revised 43447 Authority citation revised 43455 Regulation at 58 FR 43447 and 43455 comment period extended 48599 Technical correction 52440 821.20(b)(1) table and (c) table amended 43455 864.5680(b) revised; (c) removed 51571 874.4490Revised 29534 878Authority citation revised 57558 878.5030Added 57558 888.3358Added 3228 890.3450Removed 29535 900 (Subchapter I)Added; interim 67562 900.10—900.14 (Subpart B)Added; interim 67570 1020Authority citation revised 26396 1020.30Revised; eff. in part 5-3-94 26396 1020.31Revised; eff. in part 5-3-94 26401 (c)(2) corrected 31067 1020.32Revised 26404 1220.40(a) revised 64137 1270Added; interim 65520 1994 21 CFR 59 FR Page Chapter I Nomenclature changes 14366 807.3(n) amended; (o) and (q) revised 64295 807.87(i)(2) and (j) amended 64295 807.92(a) introductory text, (3) through (6) and (b) amended; (d) added 64295 807.93Revised 64295 807.94Revised 64296 807.95(d) revised 64296 808.20(b) amended 14365 812Notice of applicability 52078 821.2(b) introductory text amended 31138 821.20(c)table corrected 15052 864.5350(b) revised 63007 864.7660(b) revised 63007 864.7675(b) revised 63007 864.7900(b) revised 63007 864.8500(b) revised 63007 866.5170(b) revised 63007 866.5220(b) revised 63007 866.5230(b) revised 63007 866.5360(b) revised 63007 866.5370(b) revised 63007 866.5540(b) revised 63007 866.5700(b) revised 63007 868.5340(b) revised 63007 868.5350(b) revised 63007 870.1875(a)(2) revised 63007 872.1500(b) revised 63007 872.1820(b) revised 63008 872.3100(b) amended 63008 872.3130(b) revised 63008 872.3165(b) revised 63008 872.3240(b) revised 63008 872.3285(b) revised 63008 872.3330(b) revised 63008 872.3350(b) revised 63008 872.3360(b) revised 63008 872.3410(b) revised 63008 872.3450(b) revised 63008 872.3490(b) revised 63008 872.3520(b) revised 63008 872.3530(b) revised 63008 872.3580(b) revised 63008 872.3670(b) revised 63008 872.3900(b) revised 63008 872.3910(b) revised 63008 872.3940Added 65478 872.3950Added 65478 872.3960Added 65478 872.3970Added 65478 872.4130(b) revised 63008 872.4535(b) revised 63008 872.4620(b) revised 63008 872.4730(b) revised 63008 872.5410(b) revised 63009 872.5525(b) revised 63009 872.5550(b)(1) revised 63009 872.6030(b) revised 63009 872.6140(b) revised 63009 872.6250(b) revised 63009 872.6300(b) revised 63009 872.6475(b) revised 63009 872.6510(b) revised 63009 872.6640(b) revised 63009 872.6865(b) revised 63009 872.6890(b) revised 63009 874.3375(b) revised 63009 874.4750(b) revised 63009 874.5220(b) revised 63009 874.5800(b) revised 63009 876.5970(b) revised 63010 878.1800(b) revised 63010 878.3750(b) revised 63010 878.3800(b) revised 63010 878.3900(b) revised 63010 878.4100(b) revised 63010 878.4380(b) revised 63010 878.4440(b) revised 63010 878.4470(b) revised 63010 878.4635(b) revised 63010 878.4660(b) revised 63010 878.4700(b) revised 63010 878.4730(b) revised 63010 878.4800(b) revised 63010 878.4930(b) revised 63010 878.4950(b) revised 63010 878.5900(b) revised 63010 880.2400(b) revised 63010 880.2720(b)(1) revised 63011 880.5180(b) revised 63011 880.5210(b) revised 63011 880.5240(b) revised 63011 880.5630(b) revised 63011 880.5740(b) revised 63011 880.5780(b)(2) revised 63011 880.5950(b) revised 63011 880.6060(b) revised 63011 880.6150(b) revised 63011 880.6190(b) revised 63011 880.6900(b) revised 63011 882.1430(b) revised 63011 882.1700(b) revised 63011 882.1925(b) revised 63011 882.4030(b) revised 63011 882.4125(b) revised 63012 882.4190(b) revised 63012 882.4200(b) revised 63012 882.4215(b) revised 63012 882.4440(b) revised 63012 882.4500(b) revised 63012 882.4525(b) revised 63012 882.4535(b) revised 63012 882.4600(b) revised 63012 882.4900(b) revised 63012 884.5320Added 67187 886.1040(b) revised 63012 886.1050(b) revised 63012 886.1070(b) revised 63012 886.1090(b) revised 63012 886.1140(b) revised 63012 886.1160(b) revised 63012 886.1250(b) revised 63012 886.1290(b) revised 63012 886.1340(b) revised 63012 886.1350(b) revised 63012 886.1425(b) revised 63013 886.1430(b) revised 63013 886.1435(b) revised 63013 886.1450(b) revised 63013 886.1660(b) revised 63013 886.1680(b) revised 63013 886.1690(b) revised 63013 886.1700(b) revised 63013 886.1810(b) revised 63013 886.1860(b) revised 63013 886.1870(b) revised 63013 886.1910(b) revised 63013 886.1945(b) revised 63013 886.4250(b) revised 63013 886.4350(b) revised 63013 886.4360(b) revised 63013 886.4570(b) revised 63013 886.4750(b) revised 63014 886.4855(b) revised 63014 886.5820(b) revised 63014 886.5840(b) revised 63014 886.5842(b) revised 63014 886.5844(b) revised 63014 886.5900(b) revised 63014 886.5915(b) revised 63014 886.5916(b) and (c) revised; eff. 4-4-94 10284 886.5925(b) and (c) revised; eff. 4-4-94 10284 888.4200(b) revised 63014 888.4210(b) revised 63014 888.4230(b) revised 63014 888.4540(b) revised 63014 888.5940(b) revised 63014 890.1175(b) revised 63014 890.3100(b) revised 63014 890.3750(b) revised 63014 890.3920(b) revised 63014 890.3940(b) revised 63015 890.5765(b) revised 63015 892.1130(b) revised 63015 892.1350(b) revised 63015 892.1640(b) revised 63015 892.5740(b) revised 63015 900Workshop 53586 Technical correction 60051 900.2(f) corrected 6899 (e) revised; (r) and (s) added; interim 49812 900.12(d)(1) corrected 6899 (d)(1)(i) revised; interim 49812 900.18Added; interim 49812 1010.4(b) introductory text amended 14365 1010.5(c) introductory text amended 14365 1020.30(b) amended 26403 1020.32(d) revised; (e) through (h) redesignated as (f) through (i); new (e) added 26404 1030.10(c)(6)(iv) amended 14365 1220.40(a) revised 35253 1240.62(e) amended 14366 1250.51(f)(4)(ii) amended 14366 1270Workshop 29950 1995 21 CFR 60 FR Page Chapter I 803Revised; eff. 4-11-96 63597 807.3(r) added; eff. 4-11-96 63606 807.20(a)(6) added; eff. 4-11-96 63606 807.22(a) revised; eff. 4-11-96 63606 807.40Revised; eff. 4-11-96 63606 862.2310(b) revised 38899 862.2320(b) revised 38900 862.2485(b) revised 38900 862.2720(b) revised 38900 862.2800(b) revised 38900 862.2920(b) revised 38900 866Compliance date extension 54942 866.2560(b) revised 38482 872.3740(b) revised 38900 872.3810(b) revised 38900 872.6100(b) revised 38900 876Authority citation revised 17216 876.3750(c) revised 17216 882.5800(c) revised 43969 886.4350(b) corrected 15872 892.1990Added 36639 900Technical correction 3451 1000Authority citation revised 48380 1000.3Revised 48380 1002Authority citation revised 48382 1002.1Revised 48382 1002.2Removed 48385 1002.3Revised 48385 1002.7Introductory text and (b) amended; (c) added 48385 1002.10—1002.13 (Subpart B)Revised 48386 1002.20(c) amended 48386 1002.30(a) introductory text amended; (a)(5) added 48386 1002.31(c) amended 48386 1002.40(a) revised 48386 1002.50Revised 48387 1002.61 (Subpart G)Removed 48387 1220.40(a) revised 29987 1240.3(r) revised; (s), (t) and (u) added; eff. 12-18-97 65201 1240.60Heading revised; existing text designated as (a) and amended; (b), (c) and (d) added; eff. 12-18-97 65202 1270Workshop 27406 1996 21 CFR 61 FR Page Chapter I 801.63Added; interim 20101 801.126Added; eff. 8-28-97 44615 801.403Removed 37683 801.408Removed 37683 801.425Removed; interim 20101 801.427Removed 37683 801.433Added; interim 20101 803Regulation at 60 FR 63597 eff. date delayed to 7-31-96 16043 803.3(n)(4) stayed 38347 803.19(f) and (g) added; eff. 8-28-97 44615 803.55(b)(9) and (10) stayed 39869 803.57Stayed 38347 803.58Stayed 38347 804.25(c) added; eff. 8-28-97 44615 804.30Removed 38347 807Technical correction 47550 807.3Regulation at 60 FR 63606 eff. date delayed to 7-31-96 16043 (r) stayed 38347 807.20Regulation at 60 FR 63606 eff. date delayed to 7-31-96 16043 (a)(6) stayed 38347 807.22Regulation at 60 FR 63606 eff. date delayed to 7-31-96 16043 807.40Regulation at 60 FR 63606 eff. date delayed to 7-31-96 16043 Stayed 38347 807.65(j) added; eff. 8-28-97 44615 808Authority citation revised 52654 808.1(d)(10) added; eff. 6-1-97 52654 810Added; eff. 5-19-97 59018 812Authority citation revised 52654 812.1(a) amended; eff. 6-1-97 52654 812.20(a)(1) revised; (a)(4) added 51530 812.35(a) amended 51531 812.38(b)(4) added 51531 812.47Added 51531 812.140(a)(3) introductory text revised; (a)(3)(i) amended 57280 814Authority citation revised 51531 814.3(k) and (l) added 15190 (m) and (n) added 33244 814.9(d) redesignated as (d)(1); (d)(2) added 51531 814.47Added 15190 814.100—814.126 (Subpart H)Added 33244 814.102Stayed 55741 814.104Stayed 55741 814.106Stayed 55741 814.108Stayed 55741 814.110(a) stayed 55741 814.112(b) stayed 55741 814.116(b) stayed 55741 814.118(d) stayed 55741 814.120(b) stayed 55741 814.124(b) stayed 55741 814.126(b)(1) stayed 55741 820Technical correction 47550 Revised; eff. 6-1-97 52654 820.1(f) added; eff. 8-28-97 44615 862.2230(b) revised 1119 866.2160(b) revised 1119 866.3720(b) revised 1119 866.5520(b) revised 1119 866.5530(b) revised 1119 866.5860(b) revised 1119 868.1100(b) revised 1119 868.1575(b) revised 1119 868.1870(b) revised 1119 868.1975(b) revised 1119 868.2300(b) revised 1119 868.2320(b) revised 1119 868.2340(b) revised 1119 868.2350(b) revised 1119 868.2610(b) revised 1119 868.2620(b) revised 1119 868.2700(b) revised 1119 868.2875(b) revised 1119 868.2885(b) revised 1119 868.2900(b) revised 1120 868.5100(b) revised 1120 868.5110(b) revised 1120 868.5240(b) revised 1120 868.5300(b) revised 1120 868.5310(b) revised 1120 868.5320(b) revised 1120 868.5375(b) revised 1120 868.5400(c) revised 50706 868.5460(b) revised 1120 868.5530(b) revised 1120 868.5540(b) revised 1120 868.5550(b) revised 1120 868.5570(b) revised 1120 868.5580(b) revised 1120 868.5590(b) revised 1120 868.5600(b) revised 1120 868.5770(b) revised 1120 868.5780(b) revised 1120 868.5790(b) revised 1120 868.5810(b) revised 1120 868.5820(b) revised 1120 868.5860(b) revised 1120 868.5975(b) revised 1120 868.5995(b) revised 1120 868.6400(b) revised 1121 868.6820(b) revised 1121 868.6885(b) revised 1121 870.1350(c) revised 50706 870.1360(c) revised 50706 870.2390(b) revised 1121 870.2600(b) revised 1121 870.2620(b) revised 1121 870.2640(b) revised 1121 870.2810(b) revised 1121 870.3650(b) revised 1121 870.3670(b) revised 1121 870.3690(b) revised 1121 870.3850(c) revised 50706 870.3935(b) revised 1121 870.3945(b) revised 1121 870.5300(c) revised 50706 872.1840(b) revised 1121 872.1850(b) revised 1121 872.3400(c) revised 50706 872.3420(c) revised 50707 872.3480(c) revised 50707 872.3500(c) revised 50707 872.3560(c) revised 50707 872.3820(c) revised 50707 872.4630(b) revised 1121 872.6390(b) revised 1121 874.1060(b) revised 1121 874.1080(b) revised 1121 874.4140(b) revised 1122 874.4175(b) revised 1122 874.4350(b) revised 1122 874.4770(b) revised 1122 876Authority citation revised 1122, 50707 876.1075(b) revised 1122 876.1400(b) revised 1122 876.1500(b) revised 1122 876.1800(b) revised 1122 876.4590(b) revised 1122 876.4890(b) revised 1122 876.5090(b) revised 1122 876.5130(b) revised 1122 876.5220(c) revised 50707 876.5270(c) revised 50707 876.5450(b) revised 1122 876.5520(b) revised 1122 876.5540(b)(3) revised; (b)(4) added 1122 878.4450(b) revised 1123 878.4810(b) revised 1123 878.5350(b) revised 1123 878.5910(b) revised 1123 880.2720(b) revised 1123 880.2900(b) revised 1123 880.5560(b) revised 1123 880.5580Added 64617 880.5760(c) revised 50708 880.6320(b) revised 1123 880.6760Revised; eff. 9-3-96 8439 882.1410(b) revised 1123 882.1825(c) revised 50708 882.4325(b) revised 1123 882.5150(c) revised 50708 882.5850(c) revised 50708 884.1550Revised 1123 884.1640(b) revised 1123 884.1690(b) revised 1123 884.1700(b) revised 1124 884.1720(b) revised 1124 884.1730(b) revised 1124 884.2620(c) revised 50708 884.2685(c) revised 50708 884.4250(c) revised 50708 884.4270(c) revised 50708 884.4530(b) revised 1124 884.5050(c) revised 50709 884.5150(b) revised 1124 884.5225(c) revised 50709 884.5425(b) revised 67714 884.5435(b) revised 67714 884.5900(b) revised 1124 886.1405(b) revised 1124 886.1750(b) revised 1124 886.1760(b) revised 1124 886.3200Revised 1124 888.1100(b) revised 1124 888.3000(b) revised 1124 888.3120(c) revised 50709 888.3180(c) revised 50709 888.3200(c) revised 50709 888.3210(c) revised 50709 888.3220(c) revised 50709 888.3300(c) revised 50709 888.3310(c) revised 50710 888.3370(c) revised 50710 888.3380(c) revised 50710 888.3480(c) revised 50710 888.3540(c) revised 50710 888.3550(c) revised 50710 888.3570(c) revised 50710 888.3580(c) revised 50711 888.3640(c) revised 50711 888.3680(c) revised 50711 888.3790(c) revised 50711 888.5960(b) revised 1125 890.1575(b) revised 1125 890.1600(b) revised 1125 890.1615(b) revised 1125 890.3175(b) revised 1125 890.3610(c) revised 50711 890.3760(b) revised 1125 890.3910Revised; eff. 9-3-96 8439 890.5380(b) revised 1125 890.5410(b) revised 1125 890.5660(b) revised 1125 890.5925(b) revised 1125 890.5940(b) revised 1125 890.5950(b) revised 1125 890.5975(b) revised 1125 892.1700(b) revised 1125 892.1760(b) revised 1125 892.1770(b) revised 1125 892.1830(b) revised 1125 892.1880(b) revised 1125 892.5780(b) revised 1125 892.6500(b) revised 1125 897Added; eff. 8-28-97 44615 897.14Eff. in part 2-28-97 44616 897.34Eff. in part 2-28-98 44617 Regulation at 61 FR 44617 eff. date corrected to 8-28-98 47550 1000.3Figure 1 correctly revised 13422 1002.1Table 1 correctly revised 13423 1002.3Corrected 13424 1240Meetings 9100 1250.51(d) amended 14481 1997 (Regulations published from January 1, 1997, through April 1, 1997) 21 CFR 62 FR Page Chapter I 803.1(a) revised; eff. 5-19-97 13306 803.57Revised; eff. 5-19-97 13306 804.30Added; eff. 5-19-97 13306 812.2(c)(8) removed 4165 (c) introductory text revised; eff. 5-13-97 12096 812.119Added; eff. 5-13-97 12096 813Removed 4165 872.6730(c) revised 2902 ○