Explanation The Code of Federal Regulations is a codification of the general and perma nent 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 int chapters which usually bear the name of the issuing agency. Each chapter i further subdivided into parts covering specific regulatory areas. ISSUE DATES 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................. Title 17 through Title 27. Title 28 through Title 41.......... Title 42 through Title 50............. as of January ....as of April as of October 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 (4 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of th 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 o the Federal Register. These two publications must be used together to deter mine 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, 1989), 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. Thes two lists will identify the Federal Register page number of the latest amend ment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg ister 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 Federa Register and date of publication. Publication dates and effective dates are usual ly not the same and care must be exercised by the user in determining th actual effective date. In instances where the effective date is beyond the cut-of 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 date certain for expiration, an appropriate note will be inserted following the OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal agen- cies to display an OMB control number with their information collection re- quest. 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 require- 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, 1973, consult either the List of CFR Sections Affected, 1949-1963, or 1964-1972, published in three separate volumes. For the period beginning January 1, 1973, a "List of CFR Sections What is incorporation by reference? Incorporation by reference was estab- lished by statute and allows Federal agencies to meet the requirement to pub- lish regulations in the Federal Register by referring to materials already pub- lished 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 What is a proper incorporation by reference? The Director of the Federal lished 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 Properly approved incorporations by reference in this volume are listed in the What if the material incorporated by reference cannot be found? If you have CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate III). A list of CFR Titles, Chapters, and Parts and an alphabetical lis cies publishing in the CFR are also included in this volume. An index to the text of "Title 3-The President" is carried wi The Federal Register Index is issued monthly in cumulative form. 7 is based on a consolidation of the "Contents" entries in the daily Fede A List of CFR Sections Affected (LSA) is published monthly, key revision dates of the 50 CFR titles. For a summary, legal interpretation, or other explanation of any regu this volume, contact the issuing agency. Inquiries concerning editing pr OBSOLETE PROVISIONS Provisions that become o volumes. For the period beg lished by statute and allows F lish regulations in the Federal lished elsewhere. For an incorp Register must approve it. The l the material is treated as if it w U.S.C. 552(a)). This material, lik、 Register will approve an incorpor. (b) The matter incorporated is (c) The incorporating document. Properly approved incorporations What if the material incorporated any problem locating or obtaining a of this volume as an approved inco agency that issued the regulation co tacting the agency, you find the m CFR INDEXES AND TABULAR GUIM A subject index to the Code of Fede THIS TITLE Title 21-Food and Drugs is composed of nine volumes. The parts in volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 299, 300–499, 500–599, 600–799, 800–1299 and 1300-End. The first eight volu containing Parts 1-1299, comprise Chapter I-Food and Drug Administra Department of Health and Human Services. The ninth volume, containing 1300 to End, includes Chapter II-Drug Enforcement Administration, De ment of Justice. The contents of these volumes represent all current regula codified under this title of the CFR as of April 1, 1989. The Table of Excepted Prescription Drugs to Part 1308 appears in the vol containing Part 1300-End. Redesignation tables for Chapter I-Food and Drug Administration appe the Finding Aids section of the first eight volumes. For this volume, Ina C. Masters was Chief Editor. The Code of Federal K lations publication program is under the direction of Richard L. Claypoole sisted by Ruth C. Pontius. |