Rules for USFDA

1. CODE OF FEDERAL
REGULATION
D R . T E J A S B P A T E L
F A C U L T Y O F P H A R M A C Y,
D H A R M S I N H D E S A I U N I V E R S I T Y

2. CODE OF FEDERAL REGULATIONS
• The regulations first published in the Federal Register on a daily
basis are then codified in the Code of Federal Regulations.
• The regulations that are published chronologically in the Federal
Register are codified and arranged by title, then by chapter (one
agency’s regulations) and finally by subject in the CFR.
• The CFR is divided into 50 titles, just like the USCA
–Some titles covering the same subjects are numbered the same
in the CFR and in the USCA; others are not.
• Each title is divided into chapters, subchapters, parts, and
sections.
• A regulation is cited by title, part, and section, e.g.,
14 CFR 121.313 (Title 14, Part 121, Section 313)

3. CODE OF FEDERAL REGULATIONS
• The soft-cover volumes of the CFR are issued each year in sets on a
staggered, quarterly basis:
– Titles 1– 6 are current through January 1
– Titles 17 – 27 are current through April 1
– Titles 29 – 41 are current through July 1
– Titles 42 – 50 are current through October 1
• Each new set contains the text of all regulations in force as of the current
through date. New regulations are merged with, and revoked regulations
are deleted from, the previous set of regulations.
• The color of each set of volumes is changed every year; a current full set
may contain different colored volumes, depending on the time of the year.
• Title 3, which contains Presidential Proclamations and Executive Orders, is
always white.

4. RESEARCH TOOLS IN EACH VOLUME OF
THE CFR
• Table of Contents listing all material within the book: titles, subtitles,
chapters, subchapter(s), parts, and sections
– Subtitles are referenced to page numbers
• Material Approved for Incorporation by Reference ,which is regulatory
material not published in the Federal Register or CFR
– Has force of law as if it were published in the Federal Register and CFR
– Mostly technical standards, state law, and regulations
• Table of CFR Titles and Chapters
• Redesignation Tables to help trace new location of parts and sections of a
regulation
• List of CFR Sections Affected in the volume

5. TABLE OF CONTENTS
• At the beginning of each print issue
• Documents are listed by agencies in alphabetical order
– Cross-referenced from Cabinet departments to subordinate agencies
– Each agency document is arranged by category
• Rules
• Proposed Rules
• Notices
• Presidential documents are arranged as follows:
– Executive Orders
– Proclamations
– Determinations/Memoranda

6. • CFR titles are broken down by Chapter, Subchapter, and Part.
• Immediately preceding each part is a Table of Contents for the
individual regulations contained within that part.
121.313
Subchapter D
Part 121
Title 14
Chapter 1
Parts 60-139

7. • Regulation 121.313
• Paragraph (f) discusses requirements for the door to the flight-crew
compartment.
Title 14
Parts 60-139
121.313

8. • Material Approved for Incorporation by Reference is regulatory material not
published in the Federal Register or CFR
• Has force of law as if were published in the Federal Register and CFR
• Mostly technical standards, state law, and regulations
Material Approved
for Incorporation
by Reference Title 14
Parts 60-139

9. • Table of CFR Titles and Chapters
• Redesignation Tables to help trace new location of parts and sections of
a regulation
Table of CFR Titles and Chapters
Redesignation Table
Title 14
Parts 60-139

10. • List of CFR Sections Affected in each volume indicates the type of
change that was made.
List of CFR Sections Affected
Title 14
Parts 60-139

11. ACCESS TO THE CFR:
INDEX AND FINDING AIDS
• CFR Index and Finding Aids is single volume
• Revised annually
• Index with subject entries and agency names in one listing
• Since 1980, a thesaurus has assured that all agencies use the
same terminology for subject headings
• Parallel Table of Authorities and Rules
• List of Agency-Prepared Indexes Appearing in Individual CFR
Volumes

12. • Subject entries and agency names are in one listing
• Access by subject or agency
• References CFR title and part numbers, not individual regulations
Index and Finding
Aids Volume
Index
14 CFR 121

13. • The List of Agency-Prepared Indexes provides information on how to
locate agency indexes in various CFR volumes.
• The Parallel Table of Authorities shows where regulations promulgated
under statute or Executive Order have been placed in the CFR.
Index and Finding
Aids Volume
List of Agency-Prepared
Indexes Appearing in
Individual CFR Volumes
USCA Authorities

14. • The list of CFR Titles, Chapters, Subchapters, and Parts provides an outline of the CFR
organization.
List of CFR Titles, Chapters,
Subchapters, and Parts
14 CFR 121
Index and Finding
Aids Volume

15. UPDATING REGULATIONS IN PRINT
• LSA: List of CFR Sections Affected
– Issued monthly
– Indicates final and proposed changes made since the last publication of
the CFR set
• CFR Parts Affected
– In each volume of the Code of Federal Regulations
– Incorporated in the cumulative list in the Reader Aids section
• CFR Parts Affected in this Issue
– In each daily issue of the Federal Register

16. • The Alphabetical List of Agencies Appearing in the CFR is
another means of accessing the regulations.
Alphabetical List of Agencies
Appearing in the CFR
Index and Finding
Aids Volume