A REPORT

ON
Project Work
Federal Register and Code of Federal Regulatory

Submitted in Partial Fulfillment of the Requirements for

the Degree of

Bachelor of Pharmacy
by
Monica Arora
B. Pharm. IV Year, VIII Semester
(Roll no. 2000560500056)
Faculty of Pharmacy
BBDNIIT, Lucknow

to the
Faculty of Pharmacy
Dr. A. P. J. Abdul Kalam Technical University, Lucknow
(Formerly Uttar Pradesh Technical University, Lucknow)
2023-2024
 CERTIFICATE

This is to certify that Monica Arora (ROLLNO. 2000560500056) has carried out the Project
work in Pharmaceutical Regulatory Science “Federal Register and Code of Federal
Regulatory” for the award of Bachelor of Pharmacy from Dr. A.P.J. ABDUL KALAM
TECHNICAL UNIVERSITY, LUCKNOW under my supervision. This report embodies
result of original work and report are carried out by the student and the content of the report
do not form the basis for the award of any other degree to the candidate or to anybody else
from this or any other university/institution.

Mr. Vishwambhar Mishra

Associate Professor,

BBDNIIT, LUCKNOW

Date:
 DECLARATION

I hereby declare that the project work mentioned in this report was carried out by me on the
“Federal Register and Code of Federal Regulatory”.

Date: Monica Arora

Roll No. 2000560500056

B.Pharm. IV Year, VIII semester,

BBDNIIT, LUCKNOW.
 ACKNOWLEDGEMENT

I sincerely appreciate the almighty God for his graces, strength, sustenance and above all, his
faithfulness and love from the beginning of my academic life up to this doctoral level. His
benevolence has made me excel and successful in all my academic pursuits.

I thank Prof. (Dr.) Shailendra K. Saraf, Director of Pharmacy, Babu Banarasi Das
Northern India Institute of Technology for providing me the opportunity to embark on this
project.

I sincerely thank Mr. Vishwambhar Mishra, Associate Professor for their able guidance and
encouragement in carrying out this project work. Their untiring cooperation, sincere, guidance,
previous advice and endless inspiration allowed me to prepare my Report.

Monica Arora

Roll no. 2000560500056

B.pharm IV Year VIII Semester

BBDNIIT, Lucknow
 TABLE OF CONTENT

S.NO CONTENTS PAGE NO.

1. Introduction 1-10

1.1. Code of Federal Regulations – Table of Contents 11-22

1.2. Overview of Code of Federal Regulations Titles 23-31

1.3. Electronic Code of Federal Regulations (e-CFR) 32-33

1.4. Federal Regulations : FR vs CFR 34-35

1.5. Code of Federal Regulations in Pharma 36

2. Materials and Methods 37

3. Summary 38-39

4. Conclusion 40

5. References 41
 INTRODUCTION

1. INTRODUCTION

Overview of Federal Register:

It is an official daily publication for rules, proposed rules and

notices of Federal agencies and organizations as well as
executive orders and others presidential documents. Published
by the Office of the Federal Register, National Archives and
Records Administration (NARA), the Federal Register is the
official daily publication for rules, proposed rules, and notices of Federal agencies and
organizations, as well as executive orders and other presidential documents. The Federal
Register is updated daily by 6 a.m. and is published Monday through Friday, except Federal
holidays.

The Federal Register is the official daily publication for Presidential Documents, Executive
Orders, proposed, interim, and final rules and regulations, and notices by Federal Agencies, as
well as notices of hearings, decisions, investigations, and committee meetings. The Federal
Register has been published by the National Archives and Records Administration since 1936
and consists of several distinct parts. A citation to the Federal Register–for example “77 Fed.
Reg. 58945 (Sept. 25, 2012)”–gives you several pieces of information, including the volume
number (in this example, the citation refers you to volume 77), the page number of that volume
(here, page number 58945), and the date of the issue of the Federal Register where the
publication appears (here, September 25th, 2012). The Law Library of Congress blog provides
a Beginner's Guide that may be of assistance with your research in the Federal Register. This
Federal Register collection includes volumes 1-58 (1936-1993). Please note that two different
bound editions of the Federal Register for 1936-1938 (volumes 1-3) were published;

Fig.1: Citation of Federal Register

Faculty of Pharmacy, BBDNIIT, Lucknow 1

 INTRODUCTION

Historical Development of the Federal Register:

In earlier times U.S. Executive branch agencies and the Office of the President would each
publish their own regulations in various separate publications, be they gazettes, bulletins,
rulings, digests, pamphlets, notices, codes, certificates, orders, and the like. This profusion of
authoritative documents, especially as agency regulations began to mushroom in the 1930’s,
made it extremely difficult for the public to determine where a U.S. regulation could be found,
when it was issued and whether it had been altered or revoked. The U.S. Department of Justice
itself had a difficult time determining the status of regulations as became embarrassingly
apparent when the Department had to acknowledge before the Supreme Court that an Executive
order it was trying to enforce had been inadvertently revoked.2 To remedy this situation
Congress, in 1935, passed the Federal Register Act, which empowered the Archivist of the
United States to establish a division within the National Archives to be responsible, with the
Government Publishing Office, for the publication of a daily Federal Register under the
authority of a newly established Administrative Committee of the Federal Register.3

The Federal Register Act requires that the Federal Register, begun on March 14, 1936, be the
Federal government’s comprehensive vehicle for publishing all agency promulgated rules and
regulations as well as all Presidential proclamations and executive orders or other such
documents that the President determines has general applicability and legal effect or as may be
required by Act of Congress. Other documents, such as notices of meetings, agency collection
activities, applications, and policy statements may be included as well. However, the law does
not permit the publication of comments or news items in the Federal Register.4 After the
enactment of the Administrative Procedures Act in 1946, notices of proposed rulemaking are
now also required to be published.5 The proposed rules are to be accompanied by a description
of the subject and issues involved and from 1947 to 1972 these descriptions in the preamble to
the proposed rules were about the only place to find an explanation or rationale for a rule.

Beginning in the 1960s finalized rules began to be accompanied in the Federal Register by
brief explanations, usually just after the text of the rule, but it was not until 1973 that final rules
were required by the Administrative Committee of the Federal Register to have in their
preamble to the rule a statement summarizing the general subject matter of the rule.6 A rule
effective on April 1, 1977, requires that comments to proposed rules and answers to them be
summarized in the preamble before the rule and it also requires that agencies submit their final
and proposed rules with specific preamble heading material. The preamble information
published in the Federal Register to a proposed or final rule is the primary published source for
its “regulatory history” and one of the few means to determine “regulatory intent

What is Available in Federal Register:

 Volumes 60 (1995) to present: Available for download as an entire issue (in PDF and
XML formats) or as smaller sections (in PDF and text formats).
 View the Table of Contents for the most recent issue or for previous issues by clicking
the TOC button for specific issues in browse. Sign up for a free email subscription of
the daily Table of Contents.

Faculty of Pharmacy, BBDNIIT, Lucknow 2

 INTRODUCTION

 XML files can be downloaded in bulk as a zip file by the year (volume) or month in the
Bulk Data Repository. Information on the legal status, authenticity, and schema of the
Federal Register XML renditions can be found in the User Guide Document - Federal
Register XML Rendition.
 Volumes 59 (1994) and older are digitized versions of historical issues of the Federal
Register being made available as full issue PDF only and smaller sections available in
text format only.
 The Federal Register Index and List of CFR Sections Affected (LSA) are available on
www.govinfo.gov as separate publications. www.govinfo.gov provides a tool to easily
find CFR Parts Affected from the Federal Register.
 To find a more recent, unofficial issue of the Federal Register, view the Public Inspection
issue online at www.federalregister.gov, a service of the National Archives and Records
Administration’s Office of the Federal Register.
 You may be able to find new rules and regulations on an agency's website before it is
published in the Federal Register, but this is not considered the official version and the
effective date is generally based on when it is published in the Federal Register.

Organization of Federal Register:

1. Table of Contents and Preliminary Pages-

This section of the Federal Register contains a comprehensive alphabetical listing by agency
name of all documents in the issue. Under each agency, the documents are arranged by
classification- Rules, Proposed Rules, or Notices. Each entry includes the page number where
the document begins and a brief description of the document.
If Presidential Documents appear in the Federal Register they are listed in alphabetical order in
the Contents under the heading "Presidential Documents". Appearing at the end of the Contents
is a list of separate parts published in the issue, if applicable. The documents appearing in the
separate part are also listed under the agency in the table of contents.
Also appearing in the preliminary pages (Contents Section) of each day's Federal Register is a
list of the CFR Parts Affected in This Issue The Reader Aids section of the Federal Register is
designed to help the reader find specific information in the Federal Register system, as
distinguished from the finding aids in the preliminary pages (Contents section) which are more
oriented to one particular issue of the Federal Register.

2. Rules and Regulations Section-

This section of the Federal Register contains final rules and regulations: regulatory documents
having general applicability and legal effect. Most rules are keyed to and codified in the Code
of Federal Regulations (CFR). A document which amends text must include the changes to the
CFR and state the effective date for any change.
Each document begins with a heading that includes the name of the issuing agency (and sub
agency if appropriate), the CFR title and part(s) affected, and a brief description of the specific
subject of the document. In some cases an agency includes a docket number, which identifies
the document within the agency's internal filing system. A Regulation Identifier Number (RIN)
may also be included. This section also contains interim rules that are issued without prior

Faculty of Pharmacy, BBDNIIT, Lucknow 3

 INTRODUCTION

notice and are effective immediately; the interim rule is designed to respond to an emergency
situation. Additionally, this section includes documents that have no regulatory text and do not
amend the CFR, but either affect the agency's handling of its regulations or are of continuing
interest to the public in dealing with an agency. In this category are general policy statements
and interpretations of agency regulations. The terms "rules" and "regulations" have the same
meaning within the Federal Register publication system.

3. Proposed Rules Section-

This section of the Federal Register contains notices to the public of the proposed issuance of
rules and regulations. The purpose of these notices is to give interested persons an opportunity
to participate in the rule making prior to the adoption of the final rules.
Many proposed rules are documents that suggest changes to agency regulations in the Code of
Federal Regulations (CFR) and request public comment on those suggested changes. This
section also contains documents relating to previously published proposed rules, extending the
comment period, announcing a public hearing, making available supplemental information,
withdrawing a proposed rule, or correcting a previously published proposed rule.
This section includes advanced notices of proposed rulemaking, which describe a problem or
situation and the anticipated regulatory action of the agency and seek public response
concerning the necessity for regulation and the adequacy of the agency's anticipated regulatory
action. Additionally, many agencies voluntarily publish proposed changes to procedural rules,
interpretative rules and agency policies to gather public comments.

4. Notices Section-
This section of the Federal Register contains documents other than rules or proposed rules that
are applicable to the public. Notices of hearings and investigations, committee meetings,
agency decisions and rulings, delegations of authority, issuances or revocation of licenses, grant
application deadlines, availability of environmental impact statements, filing of petitions and
applications, and agency statements of organization and functions are examples of documents
appearing in this section.

5. Presidential Documents Section-

This section of the Federal Register contains documents signed by the President and submitted
to the Office of the Federal Register for publication. Presidential documents include
Proclamations and Executive Orders, as well as other documents such as determinations, letters,
memorandums, and reorganization plans. The documents are compiled annually in title 3 of the
Code of Federal Regulations (CFR).

6. Sunshine Act Meetings-

This section of the Federal Register contains notices of meetings published under the
"Government in the Sunshine Act".
In recognition of the public's right to the fullest possible information about the Federal
decision-making process, the Government in the Sunshine Act requires that meetings of
Government agencies be open to the public, with certain specified exceptions. The Act also
requires that public announcement be made in the Federal Register of the time, place, and

Faculty of Pharmacy, BBDNIIT, Lucknow 4

 INTRODUCTION

subject matter of the meeting, the name and telephone number of the agency official to contact
for more information, and whether the meeting is open or closed to the public.

7. Reader Aids-
This section of the Federal Register is designed to help the reader find specific information in
the Federal Register system, as distinguished from the finding aids in the preliminary pages
(Contents section) which are more oriented to one particular issue of the Federal Register.
 Information and Assistance. Appearing first is the listing of Office of the Federal Register
telephone numbers to call for specific information.
 Federal Register Pages and Dates. This is a table of the inclusive page numbers and
corresponding dates for the current month's Federal Register.
 CFR Parts Affected During the Current Month. This is a cumulative list of Code of Federal
Regulations (CFR) parts affected by rules and proposed rules published in the Federal Register
during the current month.

8. Corrections Section-
This section of the Federal Register contains editorial corrections of previously published
Presidential, Rule, Proposed Rule, and Notice documents. These corrections are prepared by the
Office of the Federal Register to correct typographical or clerical errors made in the printing of
the Federal Register. Agency prepared corrections are issued as signed documents and appear in
the appropriate document categories elsewhere in the issue.

Searching the Federal Register :

Please note the difference in searching and browsing the more recent volumes (Volume 60 to
present) versus the older, digitized volumes (Volume 59 and older). Also, Volume 59 (1994)
has entire issues available in PDF format only, and smaller sections available in text format
only.

Searching the More Recent Volumes (Volume 60 to present)

Search options are available by clicking the orange SEARCH button in the top right of any page
across the site.

Basic Search – Use keywords, search operators, and metadata fields in the single search box.

 Search over just the Federal Register by adding collection:fr to your Basic Search query.
 Combine fields for targeted searches. For example, use Basic Search to find final rules issued in
the Federal Register by the Social Security Administration since 2015.

Advanced Search – Click to select a date or date range, collection, and up to 5 fields to search
in.

 Select Federal Register under Refine by Collection first! Then, fields custom to the Federal
Register will populate automatically in the box under Search In.

Faculty of Pharmacy, BBDNIIT, Lucknow 5

 INTRODUCTION

 Combine fields for targeted searches. For example, use Advanced Search to find final rules
issued in the Federal Register by the Social Security Administration since 2015.

Citation Search – Click to retrieve a single FR document in PDF format if you know the Year
(Volume) and Page Number of the document.
Browse – Click to browse FR issues by year, month, and day.

Link Service – Click to easily construct links to an FR document if you know the FR Doc
Number or volume and page numbers.

Search Tip
In Basic and Advanced Search, only the smaller sections of
the FR will display in results for Volumes that have
smaller sections available (Volume 59, 1994 to present). If
you want to see the entire issue, do one of the following:

 From Basic Search Results, click Details next to any

result, click the Document in Context tab, then see
options next to View Entire Issue.
 From FR Browse, expand sections to see options next
to View Entire Issue
 From Browse by Date, select a date or date range to
see a list of entire FR issues that meet that criteria

Searching the Digitized Volumes (Volume 59 and earlier):

The historic digitized issues (Volume 59 and earlier) are being added to the current Federal
Register collection. There are several differences between how you can access the digitized
issues and how you can access the more recent issues:

 Digitized Federal Register issues are available for full-text searching. Some metadata fields can
be used to craft specific searches using the basic or advanced search. Searchable metadata fields
for the digitized issues (Volume 59 and earlier) are: Full-Text, Branch, Category, Dates,
Government Author, Issue, SuDoc Class Number, Title, and Volume. Additional fields are
available for searching the more recent volumes.
 Digitized Federal Register issues (Volume 59 and earlier) are available to browse and download
at the issue level while the more recent issues are available at the article level.
 Digitized Federal Register issues (Volume 59 and earlier) are searchable using the citation
search feature.

Unified Agenda:

The Unified Agenda, as published in the Federal Register, is available on a separate page on
govinfo. The complete Unified Agenda is available to the public at Reginfo.gov.

Faculty of Pharmacy, BBDNIIT, Lucknow 6

 INTRODUCTION

The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda)
provides uniform reporting on the actions administrative agencies plan to issue in the near and
long term. Each edition of the Unified Agenda includes regulatory agendas from Federal
entities that currently have regulations under development or review. Agencies of the United
States Congress are not included.

The Unified Agenda is compiled by the Regulatory Information Service Centre, a component of
the U.S. General Services Administration, in cooperation with the Office of Management and
Budget's Office of Information and Regulatory Affairs. Applicable agendas are then published
by the Office of the Federal Register, National Archives and Records Administration (NARA)
in the Federal Register. The Regulatory Information Service Centre assigns a Regulation
Identifier Number (RIN) to identify each regulatory action listed in the Unified Agenda.

Overview of Code of Federal Regulations (CFR):

The code of Federal regulations (CFR) is the codifications of the general and permanent rules
and regulations (sometimes called administrative law) published in
the Federal Register by the executive departments and agencies of
the Federal Governments of united states.
The CFR is divided into 50 titles that represent broad areas
subjects to Federal Regulations.
Each title is further divided into chapters, subchapters, parts and
sections.
A regulation is cited by title, part and section, e.g. 14CFR 121.313
(Title 14, Part 121, section 313).
Soft cover volumes of the CFR are issued each year.
• Titles 1-16 are updated as of January 1.
• Titles 17-27 are updated as of April 1.
• Titles 29-41 are updated as of July 1.
• Titles 42-50 are updated as of October 1.

The online CFR is a joint project authorized by the publisher, the National Archives and
Records Administration's (NARA) Office of the Federal Register (OFR), and the Government
Publishing Office (GPO) to provide the public with enhanced access to Government
information.

Faculty of Pharmacy, BBDNIIT, Lucknow 7

 INTRODUCTION

Historical Development of the Code of Federal Regulations

The Federal Register Act originally provided, within six months, for a complete compilation of
all existing regulations promulgated prior to the first publication of the Federal Register.
However, this was deemed inefficient, and so instead of a “compilation” of existing regulations,
the Federal Register Act was amended in 1937 to provide a “codification” of all regulations
every five years. A six member Codification Board was established which determined the
precise structure of the new Code of Federal Regulations (CFR). A similar organization to the
United States Code (USC) was followed by the Board so that a majority of the 50 titles to the
CFR (some held in reserve) have similar alphabetically arranged subject categories and title
numbers to that of the 50 titles in the USC.

The first edition of the CFR was published in 1938 and included all finalized regulations that
were published in the Federal Register from March 14, 1936 to June 1, 1938 as well as those
agency regulations deposited with the Archivist, and still in effect, that may have been
published by the agencies before March 14, 1936. Source notes in the first edition of the CFR
are to pages in the rebound edition (1936-1938) of the Federal Register, not to the original
pages in the daily edition.

In 1949, the second edition of the Code of Federal Regulations was finally published. It
included all the regulations still in effect as of January 1, 1949. However, there were some
additional regulations added that were not published in the Federal Register.

After considerable discussion on the best way to proceed, beginning in 1963 for some titles and
for all titles in 1967, the Office of the Federal Register (OFR) began publishing yearly revisions
to the titles of the CFR, effective on January 1 of each year. The new books were bound in soft
covered, dark blue paper stock, but beginning in 1970 each annual edition of the CFR has a
different colour on its outside binding. If there are no changes to regulations in certain books
then a coloured paper stock is issued so it can be used to cover the older edition. Although
ponderous in size, an annual republication of the CFR in soft bound books, instead of a through
cumulative supplements or loose-leafs allows the researcher to determine how a regulation read
on any given date.

Soon, however, it became apparent to the OFR that revising the entire Code of Federal
Regulations, at the same time, was administratively unmanageable. So beginning on October 1,
1972, the OFR has divided the titles of the CFR into four groups with each group being revised
in staggered quarters of the year. Titles 1-16 are revised effectively on January 1 of each year.
Titles 17-27 are revised effectively on April 1 of each year. Titles 28-41 are revised effectively
on July 1 of each year, and titles 42-50 are revised effectively on October 1 of each year.

Faculty of Pharmacy, BBDNIIT, Lucknow 8

 INTRODUCTION

Availability of CFR:
 govinfo currently contains titles from 1996 to the present. CFR volumes are added
concurrent with the release of the paper editions. When revised CFR volumes are
added, the prior editions remain on govinfo as a historical set.
 Bulk data downloads of Code of Federal Regulations XML files are available to the
general public via Data.gov and GPO's Bulk Data Repository. Information on the legal
status, authenticity, and schema of the Code of Federal Regulations XML..
 To see more recently updated titles of the CFR, visit the electronic Code of Federal
Regulations (e-CFR), a regularly updated, unofficial editorial compilation of CFR
material and Federal Register amendments. The e-CFR is updated on a daily basis.
 To see a cumulative list of CFR sections that have been changed at any time since each
CFR title was last updated, view the List of CFR Sections Affected (LSA).
 To find final and proposed rules that affect the CFR and have been published in the
Federal Register within the past 24 hours, week, month, or within a specific date range,
browse the CFR Parts Affected from the Federal Register.

Importance of CFR:
All Federal departments and agencies produce CFRs so that the public and government
officials are aware of the changes in regulations and also they get updates on literally every
subject that the Federal government has jurisdiction to manage. These constantly updated
Federal regulations can unfold fantastic opportunities for the general public. CFRs are updated
on a routine basis upon new Federal legislation changes in economic or social objectives.

Searching the Code of Federal Regulations:

You can find and search the Code of Federal Regulations by:
 Using Basic Search for keyword and metadata fielded searches,
 Using Advanced Search; fields specific to the CFR will display after you select Code of
Federal Regulations in the Refine by Collection column,
 Using Citation Search to retrieve a single Code of Federal Regulations document in PDF
format if you know the Volume and Page of the document,
 Refining search results by clicking on links in the Refine Your Search panel on the left hand
side of the page (the sections under Refine Your Search correspond to the metadata available
for the documents), and
 Browsing the Code of Federal Regulations browse page.

General govinfo Search Tips:

Search by Citation- For example, 7 CFR 1951.7 from 2016.
 Using Basic Search, enter: collection:cfr and citation:"7 CFR 1951.7" and
publishdate:2016
 Using Advanced Search, select Code of Federal Regulations under Refine by
Collection, then under Search In select Citation in the first box and enter “7 CFR
1951.7" in the second box

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 INTRODUCTION

 Using Citation Search, select Code of Federal Regulations from Select Collection box,
select 2016 from Select Year box, select 7 from Select Title Number box, and then
enter 1951 in the Part field and 7 in Section box.

Search by Title Number- For example, CFR documents from Title 7.

 Using Basic Search, enter: collection:cfr and cfrtitlenum:7
 Using Advanced Search, select Code of Federal Regulations under Refine by
Collection, then under Search In select CFR Title Number in the first box and enter 7
in the second box.
Search by Title and Part Number- CFR documents from Title 7, Part 1951.
 Using Basic Search, enter: collection:cfr and cfrtitlenum:7 and cfrpartnum:1951.
 Using Advanced Search, select Code of Federal Regulations under Refine by
Collection, then under Search In select CFR Title Number in the first box, enter 7 in
the second box, click + Additional Criteria, select CFR Part Number from the
resulting box, and enter 1951 in the next box.

Search by Keyword- For example, Code of Federal Regulations documents with “emissions”
in the full text of the publication.
 Using Basic Search, enter: emissions and collection:cfr
 Using Advanced Search, select Code of Federal Regulations under Refine by
Collection, then under Search In enter emissions in the second box.

Organization of Code of Federal Regulations:

The CFR is divided into 50 titles that represent broad areas subject to Federal regulations. Each
title is divided into chapters, which usually bear the name of the issuing agency. Each chapter
is further subdivided into parts that cover specific regulatory areas. Large parts may be
subdivided into subparts. All parts are organized in sections, and most citations to the CFR
refer to material at the section level.

Fig. 2: Citation of Code of Federal Regulations

Faculty of Pharmacy, BBDNIIT, Lucknow 10

 CODE OF FEDERAL REGULATIONS -TABLE OF CONTENTS

1.1 CODE OF FEDERAL REGULATIONS - TABLE OF CONTENTS

S.No. Title No. Name of Title

Title 1 General Provision

Chapter I Administrative Committee of the Federal Register
1. Chapter II Office of the Federal Register
Chapter III Administrative Conference of the United States
Chapter IV Miscellaneous Agencies
Chapter V [Reserved]
Chapter VI National Capital Planning Commission

Title 2 Grants and Agreements

2. Subtitle A Office of Management and Budget Guidance for
Grants and Agreements
Chapter I Office of Management and Budget Government
wide Guidance for Grants and Agreements
Chapter II Office of Management and Budget Guidance

3. Title 3 The President

Chapter I Executive Office of the President
Part 100 Standards of Conduct
Part 101 Public Information Provisions of the
Administrative Procedures Act
Part 102 Enforcement of Non discrimination on the Basis of
Handicap in Programs or Activities Conducted by the
Executive Office of the President
Part 103-109 [Reserved]

4. Title 4 Accounts
Chapter I Government Accountability Office
Subchapter A Personnel System
Subchapter B General Procedures
Subchapter C-D [Reserved]
Subchapter E Standardization Fiscal Procedures
Subchapter F Records
Subchapter G [Reserved]

5. Title 5 Administrative Personnel

Chapter I Office of Personnel Management
Subchapter A Civil Service Rules
Subchapter B Civil Service Regulations
Subchapter C Regulations Governing Employees of the
Office of Personnel Management
Chapter II Merit System Protection Board
Subchapter A Organization and Procedures
Chapter III Office of Management and Budget
Subchapter A Administrative Procedures

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 CODE OF FEDERAL REGULATIONS -TABLE OF CONTENTS

Subchapter B OMB Directives

Subchapter C Joint Regulations with the Office of Personnel
Management
Chapter IV Office of Personnel Management and Office of the
Director of National Intelligence
Chapter V The International Organization Employees Loyalty
Board
Chapter VI Federal Retirement Thrift Investment Board
Chapter VIII Office of Special Counsel
Chapter IX Appalachian Regional Commission
Chapter XI Armed Forces Retirement Home

6. Title 6 Domestic Security

Chapter I Department of Homeland Security, Office of the
Secretary
Chapter X Privacy and Civil Liberties Oversight Board

7. Title 7 Agriculture
Subtitle A Office of the Secretary of Agriculture
Subtitle B Regulations of the Department

8. Title 8 Aliens and Nationality

Chapter I Department of Homeland Security
Subchapter A General Provisions
Subchapter B Immigration Regulations
Subchapter C Nationality Regulations
Chapter V Executive Office of Immigration Review,
Department of Justice
Subchapter A General Provisions
Subchapter B Immigration Regulations
Subchapter C Nationality Regulations

9. Title 9 Animals and Animal Products

Chapter I Animal and Plant Health Inspection Service,
Department of Agriculture
Chapter II Agricultural Marketing Service (Fair Trade
Practices Programs), Department of Agriculture
Chapter III Food Safety and Inspection Service, Department
of Agriculture

10. Title 10 Energy

Chapter I Nuclear Regulatory Commission
Chapter II Department of Energy
Subchapter A Oil
Subchapter B Climate Change
Subchapter C [Reserved]
Subchapter D Energy Conservation
Subchapter E Alternate Fuels

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 CODE OF FEDERAL REGULATIONS -TABLE OF CONTENTS

Subchapter H Assistance Regulations

Subchapter I Sales Regulation
Chapter III Department of Energy
Chapter X Department of Energy (General Provisions)
Chapter XIII Nuclear Waste Technical Review Board
Chapter XVII Defence Nuclear Facilities Safety Board
Chapter XVIII Northeast Interstate Low-Level Radioactive
Waste Commission

11. Title 11 Federal Elections

Chapter I Federal Election Commission
Subchapter A General
Subchapter B Administrative Regulations
Subchapter D [Reserved]
Subchapter E Presidential Election Campaign Fund:
Presidential Election Campaign
Chapter II Election Assistance Commission

12. Title 12 Banks and Banking

Chapter II Federal Reserve System
Chapter III Federal Deposit Insurance Corporation
Chapter IV Export- Import Bank of the United Sales
Chapter V [Reserved]
Chapter VI Farm Credit Administration
Subchapter A Administrative Provisions
Subchapter B Farm Credit System
Chapter VIII Federal Financing Bank
Chapter IX [Reserved]
Chapter X Consumer Financial Protection Bureau
Chapter XI Federal Financial Institution Examination Council
Chapter XII Federal Housing Finance Agency

13. Title 13 Business Credit and Assistance

Chapter I Small Business Administration
Chapter III Economic Development Administration,
Department of Commerce
Chapter IV Emergency Steel Guarantee Loan Board
Chapter V Emergency Oil and Gas Guaranteed Loan Board

14. Title 14 Aeronautics and Space

Chapter I Federal Aviation Administration, Department of
Transportation
Chapter II Office of the Secretary, Department of
Transportation( Aviation Proceedings)
Subchapter A Economic Regulations
Subchapter B Procedural Regulations
Subchapter C [Reserved]
Subchapter D Special Regulations

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 CODE OF FEDERAL REGULATIONS -TABLE OF CONTENTS

Subchapter E Organizations
Subchapter F Policy Statements
Chapter III Commercial Space Transportation, Federal
Aviation Administration, Department of Transportation
Chapter V National Aeronautics and Space Administration
Chapter VI Air Transportation System Stabilization
Subchapter A Office of Management and Budget
Subchapter B Air Transportation Stabilization Board

15. Title 15 Commerce and Foreign Trade

Subtitle A Office of the Secretary of Commerce
Subtitle B Regulations Relating to Commerce and Foreign
Trade
Subtitle C Regulations Relating to Foreign Trade Agreements
Subtitle D- Regulations Relating to Telecommunication and
Information [Reserved]

16. Title 16 Commercial Practices

Chapter I Federal Trade Commission
Subchapter A Organization, Procedure and Rules of
Practices
Subchapter B Guides and Trade Practice Rules
Subchapter D Trade Regulations Rules
Chapter II Consumer Product Safety Commission
Subchapter A General
Subchapter B Consumer Product Safety Act Regulations
Subchapter C Federal Hazardous Substances Act
Regulations
Subchapter D Flammable Fabrics Act Regulations
Subchapter E Poison Prevention Packaging Act of 1970
Regulations
Subchapter F Refrigerator Safety Act Regulations

17. Title 17 Commodity and Securities Exchanges

Chapter I Commodity Future Trading Commission
Chapter II Securities and Exchange Commission
Chapter IV Department of the Treasury
Subchapter A Regulations Under Section 15C of the
Securities Exchange Act of 1934
Subchapter B Regulations Under Title II of the Government
Securities Act of 1986

18. Title 18 Conservation of Power and Water Resources

Chapter I Federal Energy Regulatory Commission,
Department of Energy
Chapter III Delaware River Basin in Commission
Subchapter A Administrative Manual
Subchapter B Special Regulations

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Chapter VI Water Resources Council

Chapter VIII Susquehanna River Basin Commission
Chapter XIII Tennessee Valley Authority

19. Title 19 Custom Duties

Chapter I U.S. Customs and Border Protection, Department of
Homeland Security, Department of the Treasury
Chapter II United States International Trade Commission
Subchapter A General
Subchapter B Nonadjudicative Investigations
Subchapter C Investigation of Unfair Practices Import Trade
Subchapter D Special Provisions
Chapter III International Trade Administration, Department of
Commerce

20. Title 20 Employees Benefits

Chapter I Office of Workers Compensation Programs,
Department of Labor
Chapter II Railroad Retirement Board
Chapter V Employment and Training Administration,
Department of Labor
Chapter VI Office of Workers Compensation Programs,
Department of Labor
Chapter VII Benefits Review Board, Department of Labor
Chapter VIII Joint Board for the Enrolment of Actuaries

21. Title 21 Food and Drugs

Chapter I Food and Drug Administration, Department of
Health and Human Services
Subchapter A General
Subchapter B Food for Human Consumption
Subchapter C Drugs: General
Subchapter D Drugs for Human Use
Subchapter E Animal Drugs, Feeds and Related Products
Subchapter F Biologics
Subchapter G Cosmetics
Subchapter J Radiological Health
Chapter II Drug Enforcement Administration, Department of
Justice
Chapter III Office of National Drug Control Policy

22. Title 22 Foreign Relations

Chapter I Department of State
Chapter II Agency for International Development
Chapter III Peace Corps
Chapter V United States Agency for Global Media
Chapter IX Foreign Service Grievance Board
Chapter X Inter- American Foundation

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Chapter XII United States International Development

Cooperation Agency
Chapter XIII Millennium Challenge Corporation
Chapter XV African Development Foundation
Chapter XVII United States Institute of Peace

23. Title 23 Highways

Chapter I Federal Highway Administration, Department of
Transportation
Subchapter A General Management and Administration
Subchapter B Payment Procedures
Subchapter C Civil Rights
Subchapter D National Highway Institute
Subchapter E Planning and Research
Subchapter H Right- of- Way and Environment
Subchapter I Public Transportation
Subchapter J Highway Safety
Subchapter K Intelligent Transportation Systems
Chapter II National Highway Traffic Safety Administration
and Federal Highway Administration, Department of
Transportation

24. Title 24 Housing and Urban Development

Subtitle A Office of the Secretary, Department of Housing and
Urban Development
Subtitle B Regulations Relating to Housing and Urban
Development

25. Title 25 Indians

Chapter I Bureau of Indian Affairs, Department of the Interior
Chapter III Indian Arts and Crafts Board, Department of the
Interior
Chapter III National Indian Gaming Commission, Department
of the Interior
Chapter IV The Office of Navajo and Hopi Indian Relocation

26. Title 26 Internal Revenue

Chapter I Internal Revenue Service, Department of the
Treasury
Subchapter A Income Tax
Subchapter B Estate and Gift Taxes
Subchapter C Employment Taxes and Collection of Income
Tax at Source
Subchapter D Miscellaneous Excise Taxes
Subchapter E [Reserved]
Subchapter F Procedure and Administration
Subchapter G Regulation Under Tax Convention
Subchapter H Internal Revenue Practice

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27. Title 27 Alcohol, Tobacco Products and Firearms

Chapter I Alcohol and Tobacco Tax and Trade Bureau,
Department of the Treasury
Subchapter A Alcohol
Subchapter B Tobacco
Subchapter C Firearms
Subchapter D-E [Reserved]
Subchapter F Procedures and Practices
Subchapter G-L [Reserved]
Subchapter M Alcohol, Tobacco and Other Excise Taxes
Chapter II Bureau of Alcohol, Tobacco, Firearms and
Explosives, Department of Justice
Subchapter A [Reserved]
Subchapter B Firearms and Ammunition
Subchapter C Explosives

28. Title 28 Judicial Administration

Chapter I Department of Justice
Chapter III Federal Prison Industries, Inc; Department of
Justice
Chapter V Bureau of Prisons, Department of Justice
Chapter VI Office of Independent Counsel, Department of
Justice
Chapter VII Office of Independent Counsel
Chapter IX National Crime Prevention and Privacy Compact
Council
Chapter XI Department of Justice and Department of State

29. Title 29 Labor

Subtitle A Office of the Secretary of Labor
Subtitle B Regulation Relating to Labor
Chapter I National Labor Relations Board
Chapter II Office of Labor- Management Standards,
Department of Labor
Chapter III National Railroad Adjustment Board
Chapter IV Office of Labor- Management Standards,
Department of Labor
Chapter V Wage and Hour Division, Department of Labor

30. Title 30 Mineral Resources

Chapter I Mine Safety and Health Administration, Department
of Labor
Chapter II Bureau of Safety and Environmental Enforcement,
Department of the Interior
Subchapter A Minerals Revenue Management
Subchapter B Offshore
Subchapter C Appeals

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Chapter IV Geological Survey, Department of the Interior

31. Title 31 Money and Finance : Treasury

Subtitle A Office of the Secretary of the Treasury
Subtitle B Regulations Relating to Money and Finance
Chapter I Monetary Offices, Department of the Treasury
Chapter II Fiscal Service, Department of the Treasury
Chapter IV Secret Service, Department of the Treasury
Chapter V Office of Foreign Assets Control, Department of
the Treasury
Chapter VI Bureau of Engraving and Printing,

32. Title 32 National Defence

Subtitle A Department of Defence
Chapter I Office of the Secretary of Defence
Chapter V Department of the Army
Chapter VI Department of the Navy
Chapter VII Department of the Air Force
Subtitle B Other Regulations Relating to National Defence

33. Title 33 Navigation and Navigable Waters

Chapter I Coast Guard, Department of Homeland Security
Chapter II Corps of Engineers, Department of the Army,
Department of the Defence
Chapter IV Great Lakes St. Lawrence Seaway Development
Corporation, Department of Transportation

34. Title 34 Education

Subtitle A Office of the Secretary, Department of Education
Subtitle B Regulations of the Offices of the Department of
Education
Chapter I Office for Civil Rights, Department of Education
Chapter II Office of Elementary and Secondary Education,
Department of Education
Chapter III Office of Special Education and Rehabilitative
Services, Department of Education
Chapter IV Office of Career, Technical, and Adult
Education, Department of Education
Chapter V [Reserved]
Subtitle C Regulations Relating to Education
35. Title 35 Reserved

36. Title 36 Parks, Forests, and Public Property

Chapter I National Park Service, Department of the Interior
Chapter II Forest Service, Department of Agriculture
Chapter III Corps of Engineer, Department of Army
Chapter IV American Battle Monuments Commission
Chapter V Smithsonian Institution

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Chapter VI [Reserved]
Chapter VII Library of Congress
Chapter VIII Advisory Council on Historic Preservation
Chapter X Presidio Trust
Chapter XI Architectural and Transportation Barriers
Compliance Board
Chapter XII National Archives and Records Administration
Chapter XV Oklahoma City National Memorial Trust

37. Title 37 Patents, Trademarks, and Copyright

Chapter I United States Patents and Trademark Office,
Department of Commerce
Subchapter A General
Subchapter B Administration
Subchapter C Protection of Foreign Mask Works
Chapter II U.S. Copyright Office, Library of Congress
Chapter III Copyright Royalty Board and Procedures
Subchapter A General Provisions
Subchapter B Copyright Royalty Judges Rules and
Procedures
Subchapter C Submission of Royalty Claims
Chapter IV National Institute of Standards and Technology,
Department of Commerce
Chapter V [Reserved]

38. Title 38 Pensions, Bonuses, and Veterans Relief

Chapter I Department of Veterans Affairs
Chapter II Armed Forces Retirement Home

39. Title 39 Postal Service

Chapter I United States Postal Services
Subchapter A The Board of Governor of the U.S. Postal
Service
Subchapter B International Mail
Subchapter C Post Office Service [Domestic Mail]
Subchapter D Organization and Administration
Subchapter E Personnel
Chapter III Postal Regulatory Commission
Subchapter A The Commission
Subchapter B Seeking Information from the Commission
Subchapter C General Rules of Practice for Proceedings
Before the Commission

40. Title 40 Protection Environment

Chapter I Environment Protection Agency
Chapter IV Environment Protection Agency and Department
of Justice
Chapter V Council on Environment Quality

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Subchapter A National Environmental Policy Act

Subchapter B Administrative Procedures and Operations
Chapter VI Chemical Safety and Hazard Investigation Board
Chapter VII Environment Protection Agency and Department
OF Defence
Chapter VIII Gulf Coast Ecosystem Restoration Council
Chapter IX Federal Permitting Improvement Steering Council

41. Title 41 Public Contracts and Property Management

Subtitle A Federal Procurement Regulations System [Note]
Subtitle B Other Provisions Relating to Public Contracts
Subtitle C Federal Property Management Regulation System
Subtitle D Federal Acquisition Supply Chain Security
Subtitle E Reserved
Subtitle F Federal Travel Regulation System

42. Title 42 Public Health

Chapter I Public Health Service, Department of Health and
Human Services
Chapter II-III Reserved
Chapter IV Centres for Medicare & Medicaid Services,
Department of Health and Human Services
Subchapter A General Provisions
Subchapter B Medicare Program
Subchapter C Medical Assistance Program
Subchapter D State Children’s Health Insurance Programs
(SCHIPs)
Subchapter E Programs of All- Inclusive Care for the
Elderly (PACE)
Subchapter F Quality Improvement Organizations
Subchapter G Standard and Certifications
Subchapter H Health Care Infrastructure and Model
Subchapter I Basic Health Programs
Chapter V Office of Inspector General- Health Care,
Department of Health and Human Services
Subchapter A General Provisions
Subchapter B OIG Authorities

43. Title 43 Public Lands: Interior

Subtitle A Office of the Secretary of the Interior
Subtitle B Regulations Relating to Public Lands
Chapter I Bureau of Reclamation, Department of the Interior
Chapter II Bureau of Land Management, Department of the
Interior
Chapter III Utah Reclamation Mitigation and Conservative
Commission

44. Title 44 Emergency Management and Assistance

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Chapter I Federal Emergency Management Agency,

Department of Homeland Security
Subchapter A General
Subchapter B Insurance and Hazard Mitigation
Subchapter C Fire Prevention and Control
Subchapter D Disaster Assistance
Subchapter E Fire Assistance
Subchapter F Preparedness
Chapter IV Department of Commerce and Department of
Transportation

45. Title 45 Public Welfare

Subtitle A Department of Health and Human Services
Subchapter A General Administration
Subchapter B Requirements Relating to Health Care Access
Subchapter C Administrative Data Standards and Related
Requirements
Subchapter D Health Information Technology
Subchapter E Price Transparency
Subtitle B Regulations Relating to Public Welfare

46. Title 46 Shipping

Chapter I Coast Guard, Department of Homeland Security
Chapter II Maritime Administration, Department of
Transportation
Chapter III Coast Guard ( Great Lakes Pilotage), Department
of Homeland Security
Chapter IV Federal Maritime Commission
Subchapter A General and Administrative Provisions
Subchapter B Regulations Affecting Ocean Shipping in
Foreign Commerce
Subchapter C Regulations and Actions to Address
Restrictive Foreign Maritime Practices
Subchapter D Reserved

47. Title 47 Telecommunication

Chapter I Federal Communication Commission
Subchapter A General
Subchapter B Common Carrier Services
Subchapter C Broadcast Radio Services
Subchapter D Safety and Special Radio Services
Chapter II Office of Science and Technology Policy and
National Security Council
Chapter III National Telecommunication and Information
Administration, Department of Commerce
Chapter IV National Highway Traffic Safety Administration,
Department of Transportation
Chapter V The First Responder Network Authority

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Subchapter A National Telecommunication and Information

Administration Regulations
Subchapter B

48. Title 48 Federal Acquisition Regulation System

Chapter 1 Federal Acquisition Regulation
Chapter 2 Health and Human Service
Chapter 3 Department of Agriculture
Chapter 4 General Service Administration
Chapter 5 General Services Administration
Chapter 6 Department of State
Chapter 7 Agency for International Development
Chapter 8 Departments of Veterans Affairs
Chapter 9 Department of Energy
Chapter 10 Department of Treasury
Chapter 11 Department of the Interior
Chapter 12 Department of Housing and Urban Development
Chapter 13 Department of Homeland Security

49. Title 49 Transportation

Subtitle A Office of the Secretary of Transportation
Subtitle B Other Regulations Relating to Transportation

50. Title 50 Wildlife and Fisheries

Chapter I United States Fish and Wildlife Service, Department
of the Interior
Subchapter A General Provisions
Subchapter B Taking Possession, Transportation, Sale,
Purchase Barter, Exportation and Importance of Wildlife
Subchapter C The National Wildlife Refuge System
Subchapter D Reserved
Subchapter E Management of Fisheries Conservation Areas
Subchapter F Financial Assistance
Subchapter G Miscellaneous Provisions
Subchapter H National Wildlife Monuments
Chapter II National Marine Fisheries Service, National
Oceanic and Atmospheric Administration, Department of
Commerce
Chapter III International Fishing and Related Activities
Chapter IV Joint Regulations, Endangered Species Committee
Regulations
Subchapter A
Subchapter B Reserved
Subchapter C Endangered Species Exemption Process
Chapter V Marine Mammal Commission
Chapter VI Fishery Conservative and Management

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

1.2 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

All Code of Federal Regulations Titles are

available in digital and printed form and can
be referenced online using the Electronic
Code of Federal Regulations (e-CFR).

TITLE 1 GENERAL PROVISIONS

Title1 of the Code of Federal

Regulations (1 CFR), titled General Provisions, is a United States federal government
regulation.
Title 1 comprises one volume, further divided into four chapters. As of the revision of January
1, 2012, the Title includes regulations on the Administrative Committee of the Federal
Register ) and the Office of the Federal Register , which are responsible for preparing
the Federal Register and associated publications, including the Code of Federal Regulations.
Chapter 1: Administrative Committee of the Federal Register
Chapter 1 states that, in addition to setting forth the policies, procedures, and delegations
under which the Administrative Committee of the Federal Register carries out its general
responsibilities under chapter 15 of title 44 of the United States Code, its purpose is "to inform
the public of the nature and uses of Federal Register publications.".
Chapter 2: Office of the Federal Register
Chapter 2 concerns the incorporation by reference of outside documents into the Federal
Register, thereby making them a part of the Federal Register. Regulations include the
circumstances under which the Director of the Federal Register will approve incorporation,
how to request approval, which publications are eligible, the proper language for citing
incorporated publications, and how to change or remove incorporations .
Chapter 3: Administrative Conference of the United States
Chapter 3 addresses the Administrative Conference of United States (ACUS), an independent
agency established by the Administrative Conference Act. The CFR states that the purposes of
the ACUS are to facilitate cooperation between the federal government and the general public
to ensure that regulations are most effective and infringe on private rights the least. The ACUS
also exists to "improve the use of science" and "reduce unnecessary litigation" in the regulatory
process.
Chapter 4: Miscellaneous Agencies
Generally, the regulations in this chapter concern specific activities of the named agencies
pursuant to laws enacted by Congress.

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

TITLE 2 GRANTS AND AGREEMENTS

Title 2 of the Code of Federal Regulations (2 CFR), titled Grants and Agreements, is a United
States federal-government regulation. As of the January 1, 2022 revision, Title 2 comprises two
subtitles: Subtitle A, Office of Management and Budget Guidance for Grants and Agreements,
and Subtitle B, Federal Agency Regulations for Grants and Agreements.

TITLE 3 THE PRESIDENT

CFR Title 3 – The President is one of 50 titles composing the United States Code of Federal
Regulations (CFR) and contains the principal set of rules and regulations issued by federal
agencies regarding the Executive Office of the President of the United States.
TITLE 4 ACCOUNTS

CFR Title 4 – Accounts is one of 50 titles composing the United States Code of Federal
Regulations (CFR) and contains the principal set of rules and regulations issued by federal
agencies regarding accounts.
TITLE 5 ADMINISTRATIVE PERSONNEL

CFR Title 5 – Administrative Personnel is one of fifty titles comprising the United States Code
of Federal Regulations (CFR), containing the principal set of rules and regulations issued by
federal agencies regarding administrative personnel.

TITLE 6 DOMESTIC SECURITY

CFR Title 6 – Domestic Security is one of the 50 titles composing the United States Code of
Federal Regulations (CFR) and contains the principal set of rules and regulations issued by
federal agencies regarding domestic security.

TITLE 7 AGRICULTURE

CFR Title 7 – Agriculture is one of 50 titles comprising the United States Code of Federal
Regulations (CFR) and contains the principal set of rules and regulations issued by federal
agencies regarding agriculture.

TITLE 8 ALIENS AND NATIONALITY

CFR Title 8 – Aliens and Nationality is one of fifty titles composing the United States Code of
Federal Regulations (CFR), containing the principal set of rules and regulations issued by
federal agencies regarding aliens and nationality. It is available in digital and printed form, and
can be referenced online using the Electronic Code of Federal Regulations (e-CFR).

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

TITLE 9 ANIMALS AND ANIMAL PRODUCTS

CFR Title 9 – Animals and Animal Products is one of 50 titles composing the United States
Code of Federal Regulations (CFR) and contains the principal set of rules and regulations
issued by federal agencies regarding animals and animal products

TITLE 10 ENERGY

Title 10 of the Code of Federal Regulations is one of 50 titles composing the United States
Code of Federal Regulations (CFR) and contains the principal set of rules and regulations
issued by federal agencies regarding nuclear energy.

TITLE 11 FEDERAL ELECTIONS

CFR Title 11 – Federal Elections is one of 50 titles composing the United States Code of
Federal Regulations (CFR) and contains the principal set of rules and regulations issued by
federal agencies regarding federal elections.

TITLE 12 BANKS AND BANKING

FR Title 12 – Banks and Banking is one of 50 titles composing the United States Code of
Federal Regulations (CFR) and contains the principal set of rules and regulations issued by
federal agencies regarding banks and banking.

TITLE 13 BUSINESS CREDIT AND ASSISTANCE

CFR Title 13 – Business Credit and Assistance is one of 50 titles composing the United States
Code of Federal Regulations (CFR) and contains the principal set of rules and regulations
issued by federal agencies regarding business credit and assistance

TITLE 14 AERONAUTICS AND SPACE

Title 14 CFR – Aeronautics and Space is one of the fifty titles that make up the United States
Code of Federal Regulations (CFR). Title 14 is the principal set of rules and regulations
(sometimes called administrative law) issued by the Department of Transportation and Federal
Aviation Administration, federal agencies of the United States which oversee Aeronautics and
Space. This title is available in digital and printed form, and can be referenced online using the
Electronic Code of Federal Regulations (e-CFR).

TITLE 15 COMMERCE AND FOREIGN TRADE

Title 15 is the portion of the Code of Federal Regulations that governs Commerce and Foreign
Trade within the United States. It is available in digital or printed form. Title 15 comprises
three volumes, and is divided into four Subtitles:

Subtitle A — Office of the Secretary of Commerce

Subtitle B — Regulations Relating to Commerce and Foreign Trade

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

Subtitle C — Regulations Relating to Foreign Trade Agreements

Subtitle D — Regulations Relating to Telecommunications and Information.

TITLE 16 COMMERCIAL PRACTICES

CFR Title 16 – Commercial Practices is one of fifty titles comprising the United States Code of
Federal Regulations (CFR), containing the principal set of rules and regulations issued by
federal agencies regarding commercial practices.

TITLE 17 COMMODITY AND SECURITIES EXCHANGES

CFR Title 17 – Commodity and Securities Exchanges is one of 50 titles composing the United
States Code of Federal Regulations (CFR) and contains the principal set of rules and
regulations issued by federal agencies regarding commodity and securities exchanges.

TITLE 18 CONSERVATION OF POWER AND WATER RESOURCES

CFR Title 18 – Conservation of Power and Water Resources is one of 50 titles composing the
United States Code of Federal Regulations (CFR) and contains the principal set of rules and
regulations issued by federal agencies regarding the conservation of power and water
resources.

TITLE 19 CUSTOM DUTIES

CFR Title 19 – Customs Duties is one of fifty titles comprising the United States Code of
Federal Regulations (CFR), containing the principal set of rules and regulations issued by
federal agencies regarding customs duties

TITLE 20 EMPLOYEES BENEFITS

CFR Title 20 – Employees' Benefits is one of 50 titles composing the United States Code of
Federal Regulations (CFR) and contains the principal set of rules and regulations issued by
federal agencies regarding employees' benefits.

TITLE 21 FOOD AND DRUGS

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within
the United States for the Food and Drug Administration (FDA), the Drug Enforcement
Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

It is divided into three chapters:

Chapter I — Food and Drug Administration
Chapter II — Drug Enforcement Administration
Chapter III — Office of National Drug Control Policy

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

TITLE 22 FOREIGN RELATIONS

CFR Title 22 – Foreign Relations is one of fifty titles comprising the United States Code of
Federal Regulations (CFR), containing the principal set of rules and regulations issued by
federal agencies regarding foreign relations.

TITLE 23 HIGHWAYS

CFR Title 23 - Highways is one of fifty titles comprising the United States Code of Federal
Regulations (CFR), containing the principal set of rules and regulations issued by federal
agencies regarding highways.

TITLE 24 HOUSING AND URBAN DEVELOPMENT

CFR Title 24 - Housing and Urban Development is one of fifty titles comprising the United
States Code of Federal Regulations (CFR), containing the principal set of rules and regulations
issued by federal agencies regarding housing and urban development.

TITLE 25 INDIANS

Title 25 is the portion of the Code of Federal Regulations that governs Government-to-
Government relations with Native American tribes within the United States. It is available in
digital or printed form.

TITLE 26 INTERNAL REVENUE

Treasury Regulations are the tax regulations issued by the United States Internal Revenue
Service (IRS), a bureau of the United States Department of the Treasury. These regulations are
the Treasury Department's official interpretations of the Internal Revenue Code and are one
source of U.S. federal income tax law.

TITLE 27 ALCOHOL, TOBACCO PRODUCTS AND FIREARMS

CFR Title 27 – Alcohol, Tobacco Products and Firearms is one of 50 titles composing the
United States Code of Federal Regulations (CFR) and contains the principal set of rules and
regulations issued by federal agencies regarding alcohol, tobacco products, and firearms

TITLE 28 JUDICIAL ADMINISTRATION

CFR Title 28 - Judicial Administration is one of fifty titles comprising the United States Code
of Federal Regulations (CFR), containing the principal set of rules and regulations issued by
federal agencies regarding judicial administration.

TITLE 29 LABOR

CFR Title 29 - Labor is one of fifty titles comprising the United States Code of Federal
Regulations (CFR), containing the principal set of rules and regulations issued by federal
agencies regarding labor.

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

TITLE 30 MINERAL RESOURCES

CFR Title 30 - Mineral Resources is one of fifty titles comprising the United States Code of
Federal Regulations (CFR), containing the principal set of rules and regulations issued by
federal agencies regarding national mineral resources

TITLE 31 MONEY AND FINANCE: TRASURY

CFR Title 31 - Money and Finance: Treasury is one of fifty titles comprising the United States
Code of Federal Regulations (CFR). Title 31 is the principal set of rules and regulations issued
by federal agencies of the United States regarding money, finance, and the treasury.

TITLE 32 NATIONAL DEFENCE

CFR Title 32 – National Defence is one of 50 titles composing the United States Code of
Federal Regulations (CFR). Title 32 is the principal set of rules and regulations issued by
federal agencies of the United States regarding national defence

TITLE 33 NAVIGATION AND NAVIGABLE WATERS

Title 33 is the portion of the Code of Federal Regulations that governs Navigation and
Navigable Waters within the United States. It is available in digital or printed form. Title 33
and Title 46 of the Code of Federal Regulations are usually consulted by Classification
societies, engineering firms, deck officers on oceangoing vessels, and marine engineers.

It is divided into three chapters:

Chapter I — United States Coast Guard,
Chapter II — Army Corps of Engineers,
Chapter IV[sic.] — Saint Lawrence Seaway Development Corporation.

TITLE 34 EDUCATION

CFR Title 34 - Education is one of fifty titles comprising the United States Code of Federal
Regulations (CFR). Title 34 is the principal set of rules and regulations issued by federal
agencies of the United States regarding education.

TITLE 35 [RESERVED]

Title 35 of the Code of Federal Regulations (35 CFR) was a United States federal government
regulation on the Panama Canal. The U.S. controlled the Panama Canal Zone from 1904 to
1999. The Torrijos–Carter Treaties provided for handover to Panama. After a period of joint
American–Panamanian control, the canal was taken over by the Panamanian government in
1999, and is now operated by the Panama Canal Authority, a Panamanian government agency.
Title 35 title last appeared in the 2000 revision of the CFR, and has since been withdrawn.

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

TITLE 36 PARKS, FORESTSAND PUBLIC PROPERTY

CFR Title 36 - Parks, Forests, and Public Property is one of fifty titles comprising the United
States Code of Federal Regulations (CFR). Title 36 is the principal set of rules and regulations
issued by federal agencies of the United States regarding parks, forests, and public property.

TITLE 37 PATENTS, TRADEMARKS AND COPYRIGHTS

CFR Title 37 - Patents, Trademarks, and Copyrights is one of fifty titles comprising the United
States Code of Federal Regulations (CFR). Title 37 is the principal set of rules and regulations
issued by federal agencies of the United States regarding patents, trademarks, and copyrights.

TITLE 38 PENSIONS, BONUSES AND VETERANS’ RELIEF

CFR Title 38 - Pensions, Bonuses, and Veterans' Relief is one of fifty titles comprising the
United States Code of Federal Regulations (CFR). Title 38 is the principal set of rules and
regulations issued by federal agencies of the United States regarding pensions, bonuses, and
veterans' relief.

TITLE 39 POSTAL SERVICE

CFR Title 39 - Postal Service is one of fifty titles comprising the United States Code of Federal
Regulations (CFR). Title 39 is the principal set of rules and regulations issued by federal
agencies of the United States regarding postal service.

TITLE 40 PROTECTION OF ENVIRONMENT

Title 40 is a part of the United States Code of Federal Regulations. Title 40 arranges mainly
environmental regulations that were promulgated by the US Environmental Protection Agency
(EPA), based on the provisions of United States laws (statutes of the U.S. Federal Code). Parts
of the regulation may be updated annually on July 1.

TITLE 41 PUBLIC CONTRACTS AND PROPERTY MANAGEMENT

Title 41 of the Code of Federal Regulations ("CFR"), titled Public Contracts and Property
Management, is the portion of the CFR that governs federal government public contracts
within the United States. It is available in digital or printed form. Title 41 comprises four
volumes, and is divided into six Subtitles. Only three of the Subtitles are currently in use, the
others being either obsolesced (Subtitle A) or reserved for future use (Subtitles D and E).

TITLE 42 PUBLIC HEALTH

CFR Title 42 - Public Health is one of fifty titles comprising the United States Code of Federal
Regulations (CFR). Title 42 is the principal set of rules and regulations issued by federal
agencies of the United States regarding public health.

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

TITLE 43 PUBLIC LANDS: INTERIOR

CFR Title 43 - Public Lands: Interior is one of fifty titles comprising the United States Code of
Federal Regulations (CFR). Title 43 is the principal set of rules and regulations issued by
federal agencies of the United States regarding public lands under the jurisdiction of the
Department of the Interior.

TITLE 44 EMERGENCY MANAGEMENT AND ASSISTANCE

CFR Title 44 – Emergency Management and Assistance is one of 50 titles in the United States
Code of Federal Regulations (CFR). Title 44 is the principal set of rules and regulations issued
by federal agencies of the United States regarding emergency management and assistance.

TITLE 45 PUBLIC WELFARE

CFR Title 45 - Public Welfare is one of fifty titles comprising the United States Code of
Federal Regulations (CFR). Title 45 is the principal set of rules and regulations issued by
federal agencies of the United States regarding public welfare. Section 46 regards the
protection of human subjects, though it does not protect undocumented immigrants in the US.

TITLE 46 SHIPPING

Title 46 is the portion of the Code of Federal Regulations that governs shipping within the
United States for the United States Coast Guard, the United States Maritime Administration,
and the United States Maritime Commission. It is available in digital or printed form. Title 46
and Title 33 of the Code of Federal Regulations are usually consulted by Classification
societies, engineering firms, deck officers on oceangoing vessels, and marine engineers.

It is divided into four chapters:

Chapter I — United States Coast Guard,
Chapter II — United States Maritime Administration,
Chapter III — United States Coast Guard (Great Lakes Pilotage), and
Chapter IV — United States Maritime Commission.

TITLE 47 TELECOMMUNICATION

The Code of Federal Regulations, Telecommunications, containing the U.S. federal regulations
for telecommunications can be found under Title 47 of the United States Code of Federal
Regulations.

TITLE 48 FEDERAL ACQUISTION REGULATIONS SYSTEMS

Title 48 of the Code of Federal Regulations contains regulations concerning government

procurement in the United States.

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 OVERVIEW OF CODE OF FEDERAL REGULATIONS TITLES

TITLE 49 TRANSPORTATION

CFR Title 49 - Transportation is one of fifty titles comprising the United States Code of
Federal Regulations (CFR). Title 49 is the principal set of rules and regulations (sometimes
called administrative law) issued by the Departments of Transportation and Homeland
Security, federal agencies of the United States regarding transportation and transportation-
related security.

TITLE 50 WILDLIFE AND FISHERIES

CFR Title 50 - Wildlife and Fisheries is one of fifty titles comprising the United States Code of
Federal Regulations (CFR). Title 50 is the principal set of rules and regulations issued by
federal agencies of the United States regarding wildlife and fisheries. Maintained by the Office
of the Federal Register, it is available in digital and printed form, and can be referenced online
the Electronic Code of Federal Regulations (e-CFR).

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 ELECTRONIC CODE OF FEDERAL REGULATIONS (e-CFR)

1.3 ELECTRONIC CODE OF FEDERAL REGULATIONS (e-CFR)

The Electronic Code of Federal Regulations (e-CFR) is a web version of the Code of Federal
Regulations (CFR) that we update daily to better reflect its current status. The e-CFR is an
editorial compilation of CFR material and amendments published in the daily Federal Register.

The Administrative Committee of the Federal Register (ACFR) has authorized the National
Archives and Records Administration’s Office of the Federal Register (OFR) and the
Government Publishing Office (GPO) to develop and maintain the e-CFR as an informational
resource. The OFR/GPO partnership is committed to presenting accurate and reliable
regulatory information on the e-CFR with the objective of eventually establishing the e-CFR as
a publication officially recognized by the ACFR.

While we try to ensure that the material on the e-CFR is accurate, those relying on it for legal
research should verify their results against the most current official edition of the CFR, the
daily Federal Register, and the List of CFR Sections Affected (LSA), available online at
www.federalregister.gov and www.govinfo.gov. For complete information about, and access
to, our official publications and services, go to the OFR’s website on www.archives.gov.

USING THE e-CFR POINT-IN-TIME SYSTEM

Getting Started:

The Electronic Code of Federal Regulations (e-CFR) provides a way of exploring the Code of
Federal Regulations as it exists today and at points in time back to January 2017. The e-CFR
allows you to:

 browse the Code of Federal Regulations as it existed at any point in time.

 compare the regulations as they existed on any two dates
 view a timeline of how the CFR content has changed
 search for specific terms
 subscribe to changes in the regulations
The e-CFR is not an official legal edition of the CFR. Understanding the e-CFR explains its
status and the editorial process.

Code of Federal Regulations

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules
published in the Federal Register by the departments and agencies of the Federal Government.
It is divided into 50 titles representing broad areas subject to federal regulation.
The e-CFR is not an official legal edition of the CFR. Understanding the e-CFR explains its
status and the editorial process.

Faculty of Pharmacy, BBDNIIT, Lucknow 32

 ELECTRONIC CODE OF FEDERAL REGULATIONS (e-CFR)

Digging Deeper
Navigating to Content of Interest:
 Go to CFR Reference
 Table of Contents
 Browsing
 Searching
Reading e-CFR Content:
 In-Page Table of Contents
 Finding Citations
 Paragraph Indentation
e-CFR
Changes Through Time:
 Timeline of Changes to a Part/Section
 Viewing Historical Content
 Comparing Changes through Time
 Recent Changes
 Subscribing to Changes

Navigating to Content of Interest:

Each title in the CFR is organized hierarchically – for example a title may be divided into
chapters, parts, subparts, sections and appendices. Each level of hierarchy provides some
context about the content contained in it and is useful in understanding the broader purpose of
the content.

Reading e-CFR Content:

There is a single section of e-CFR. The main content is shown in the centre of the page. It
includes the title of the section, § 578.5 Inflationary adjustment of civil penalties, the text of the
content.

e- CFR Changes through time:

Timeline views allow you to compare changes to e-CFR content across time. When viewing
content, the timeline utility menu item on the left side of the document will allow you to view
all changes to the content within the system.

Agencies in e-CFR

With the exception of published content, references to agencies in eCFR.gov are non-official,
editorial supplements to the Code of Federal Regulations. These references are derived from
CFR chapter headings but may have been modified to help identify the agency .

Faculty of Pharmacy, BBDNIIT, Lucknow 33

 FEDERAL REGULATIONS: FR vs CFR

1.4 FEDERAL REGULATIONS: FR vs CFR

The Federal Register is the chronological publication of proposed regulations, final regulations,
and related materials. The Code of Federal Regulations (CFR) is a subject arrangement of
regulations. A regulation will be published first in the Federal Register and will later be
included in the appropriate volume of the CFR.

Like Congressional legislative history, the regulatory history recorded in the Federal Register
can be invaluable to researchers interested in the intent of lawmakers and the purpose of
regulations.

Federal Register Code of Federal Regulations

 Notices of proposed rulemaking  Final Rules

 Proposed new rules and
regulations
 Rationale, statutory basis, and
goals of proposed rules and
regulations
 Final Rules
 Changes to existing rules
 Notices of meetings and
adjudicatory proceedings
 Presidential documents (Executive
orders, proclamations,
administrative orders, etc.)
Table 1: Comparison of Federal Register and Code of Federal Regulations

FEDERAL REGISTER
 Publication Schedule and Contents:
Published every weekday, except on federal holidays.
Each daily issue of the printed Federal Register is organized into four categories:
 Presidential Documents (executive orders and proclamations)
 Rules and Regulations (including policy statements and interpretations of rules by federal
agencies)
 Proposed Rules (including petitions to agencies from the public)
 Notices (such as scheduled hearings and meetings open to the public and grant applications)

 Where to Find:
The Federal Register is available in several different places, in both microform and electronic
format.
Federal Register (Office of the Federal Register)
Official website of the Office of the Federal Register, current issue available daily.
Federal Register (GovInfo) Daily electronic version of the Federal Register, from the U.S.
Government Printing Office's GovInfo website.
Federal Register Library (Hein Online)

Faculty of Pharmacy, BBDNIIT, Lucknow 34

 FEDERAL REGULATIONS: FR vs CFR

Full-text PDF of every Federal Register, from Vol. 1 (1936) through the most current issue.
Federal Register (Lexis Advance)
Searchable database of current and historical issues of the Federal Register.
Federal Register (Westlaw)
Searchable database of current and historical issues of the Federal Register.

 Additional Information:
Federal Register: Reader Aids
Educational articles, tutorials, and videos increase your understanding of the Federal Register
publication system and improve your FederalRegister.gov skills.
Federal Register Tutorial: What it Is and How to Use it.
Workshop by the National Archives and Records Administration covering the historical
background and legal basis of the FR/CFR publication system, as well as the regulatory process
and organization of the publications.

CODE OF FEDERAL REGULATIONS

 Publication Schedule and Contents:

The Code of Federal Regulations is the annual codification of all the general and permanent
rules published in the Federal Register, arranged by subject.

The CFR is divided into 50 titles, and those 50 titles are split into four sections. Each of those
sections is updated once a year according to the following schedule:

Titles 1–16 are updated as of January 1

Titles 17–27 are updated as of April 1
Titles 28–41 are updated as of July 1
Titles 42–50 are updated as of October 1

 Where to Find:
The Code of Federal Regulations consists of primary Federal law. As
such, it is accessible in several locations, in both electronic and print
format.
Code of Federal Regulations (GovInfo)
Updated and maintained by the GPO, PDFs attached to each section are
the official version of the CFR.
Code of Federal Regulations (e-CFR)
Unofficial editorial compilation of CFR materials from the Federal
Register. Usually the most current version of the CFR.
Code of Federal Regulations (Hein)
Users can browse by year, title, binding, indexes and finding aids, and
lists/compilations of sections affected.
Code of Federal Regulations (Lexi)

Faculty of Pharmacy, BBDNIIT, Lucknow 35

 CODE OF FEDERAL REGULATIONS IN PHARMA

1.5 CODE OF FEDERAL REGULATIONS IN PHARMA

What is the CFR in Pharma?

The Code of Federal Regulations (CFR) is a comprehensive collection of the rules and
regulations issued by federal agencies of the United States. It serves as the official text of
federal regulations and plays a crucial role in ensuring that the operations and actions of the
government are transparent and accessible to the public. Established to codify the general and
permanent rules published in the.

Importance of CFR in pharmaceutical?

The CFR's significance cannot be overstated. It provides a legal framework that governs the
operation of government agencies, ensuring that their actions are in compliance with
established statutes. This framework is vital for maintaining transparency, as it allows the
public to understand the regulations that impact their lives and businesses. Moreover, the CFR
promotes standardization and consistency across federal regulations, facilitating compliance
and simplifying the regulatory landscape for all stakeholders.

Roles of the CFR in pharmaceutical industry

As a compilation of all federal regulations, the CFR serves several critical roles. It acts as a
reference point for individuals, businesses, government entities, and legal professionals,
offering guidance on the regulatory requirements applicable to various activities and sectors.
The CFR is regularly updated to reflect changes in regulations, ensuring that the compilation
remains current and relevant. This dynamic process involves the revision and publication of
new rules, amendments, and repeals, keeping the public informed and engaged with the
regulatory environment.

Functions of the CFR

The organizational structure of the CFR is designed for ease of navigation and comprehension.
It is divided into 50 titles that represent broad areas subject to federal regulation, such as
transportation, labor, and environmental protection. Each title is further subdivided into
chapters, parts, and sections that detail specific regulations and their applications..
Additionally, the CFR is accessible to the public through various means, including online
databases and printed volumes, providing valuable resources for understanding federal
regulations.

Faculty of Pharmacy, BBDNIIT, Lucknow 36

 MATERIALS AND METHODS

2. MATERIALS AND METHODS

Materials:

1. Official Websites:
 Archives.gov: Provided historical documents and archives related to the Federal Register
and the Code of Federal Regulations (CFR). Offered context on the evolution of regulatory
frameworks.
 Govinfo.gov: A source for accessing official publications from all three branches of the
U.S. government. Used to retrieve the Federal Register, CFR, and other regulatory
documents.

2. Books:
 Regulatory Science by Bigoniya Papiya: Provided a comprehensive foundation on the
principles, practices, and methodologies of regulatory science. Used for theoretical
frameworks and detailed explanations of regulatory processes.
 USFDA (U.S. Food and Drug Administration): Essential for understanding current
regulations, guidelines, and updates in the pharmaceutical industry. Used to access official
documents, regulatory news, and compliance guidelines.

Methods:

1. Literature Review:

 Comprehensive review of research and review articles from Elsevier and other sources.
 Summarized findings from multiple studies to provide a well-rounded understanding of
regulatory science.
 Emphasized the evolution and current status of the Federal Register and CFR.

2. Data Collection:

 Collected data from articles, books, and official documents.

 Systematically organized information to address specific aspects of the Federal Register
and CFR.
 Ensured data integrity and reliability by using verified and authoritative sources.

3. Compilation and Reporting:

 Compiled findings from various sources into a cohesive report.

 Presented data in a structured format to highlight significant aspects of pharmaceutical
regulatory science.
 Summarized key points from research articles, official documents, and the book by
Bigoniya Papiya.

Faculty of Pharmacy, BBDNIIT, Lucknow 37

 SUMMARY

3. SUMMARY

The Federal Register and the Code of Federal Regulations (CFR) are essential components of
the U.S. federal government's regulatory infrastructure, serving as vital resources for
understanding and navigating the complex web of regulations that govern various aspects of
American life. While both publications are interconnected and serve complementary purposes,
they each have distinct functions and characteristics.

The Federal Register, established in 1936, is the official daily publication for rules, proposed
rules, and notices of federal agencies and organizations. It serves as a public forum for the
dissemination of information about government actions and regulatory initiatives. In addition
to rules and notices issued by federal agencies, the Federal Register also includes executive
orders, proclamations, and other presidential documents. This comprehensive publication
provides transparency and accountability in the regulatory process by ensuring that citizens,
businesses, and other stakeholders have access to information about proposed and final
regulatory actions.

One of the primary objectives of the Federal Register is to facilitate public participation in the
rulemaking process. By publishing proposed rules and solicitations for public comments,
agencies solicit feedback from interested parties, including individuals, businesses, advocacy
groups, and other stakeholders. This public input helps inform the development of regulations
and ensures that regulatory decisions are based on a diverse range of perspectives and
expertise.

In contrast, the Code of Federal Regulations (CFR) is a codification of the general and
permanent rules published in the Federal Register by the executive departments and agencies of
the federal government. It provides a systematic and organized compilation of federal
regulations, organized into 50 titles representing broad areas subject to federal regulation.
These titles cover a wide range of topics, including agriculture, commerce and trade, energy,
environment, health and human services, transportation, and more.

Unlike the Federal Register, which publishes individual rules and notices as they are issued, the
CFR consolidates and organizes these regulations into a cohesive framework. Each title of the
CFR represents a specific subject area, with chapters, subchapters, parts, and sections detailing
the regulatory requirements applicable to that area. This organizational structure makes it easier
for individuals, businesses, attorneys, regulators, and other stakeholders to locate and
understand the relevant regulations governing their activities.

The CFR is updated annually through a process known as "rolling revision," wherein
individual titles are revised on a staggered schedule to incorporate new regulations,
amendments, and editorial changes. This ensures that the CFR remains current and reflects the

Faculty of Pharmacy, BBDNIIT, Lucknow 38

 SUMMARY

latest regulatory developments. Additionally, the CFR is available in both print and electronic
formats, with online versions offering search functionality and hyperlinks for enhanced
navigation and accessibility

Together, the Federal Register and the CFR play crucial roles in the U.S. regulatory process,
promoting transparency, accountability, and accessibility. By providing comprehensive
information about federal regulations and facilitating public participation, these publications
help ensure that regulatory decisions are informed, fair, and consistent with the public
interestThe Federal Register and the Code of Federal Regulations (CFR) are two essential
components of the United States federal government's regulatory system. Both play crucial
roles in informing the public about government actions and regulations, but they serve different
purposes.

Together, the Federal Register and the CFR form the backbone of the federal regulatory system
in the United States. They ensure that government actions are transparent, accessible, and
enforceable, thereby promoting accountability and the rule of law. By providing a centralized
repository of regulatory information, these two publications facilitate public participation in the
regulatory process, allowing individuals, businesses, and organizations to understand their
rights and obligations under federal law.

In summary, while the Federal Register serves as the official record of federal government
actions and decisions, the Code of Federal Regulations organizes and codifies the general and
permanent rules issued by federal agencies, making them readily accessible to the public. Both
publications play essential roles in promoting transparency, accountability, and public
participation in the federal regulatory process, thereby contributing to the effective functioning
of the U.S. government.

Faculty of Pharmacy, BBDNIIT, Lucknow 39

 CONCLUSION

4. CONCLUSION

In conclusion, the Federal Register serves as the official daily publication for rules, proposed
rules, and notices of Federal agencies and organizations. It provides transparency and
accountability in government actions, allowing citizens and businesses to stay informed and
participate in the regulatory process. Meanwhile, the Code of Federal Regulations (CFR)
compiles all currently enforced regulations into a structured format, making it easier for users
to find and understand regulatory requirements. Together, these resources play a crucial role in
maintaining the rule of law and facilitating the functioning of the federal government.

The Federal Register and the Code of Federal Regulations (CFR) are foundational elements of
the regulatory framework in the United States, serving as vital resources for government
transparency, accountability, and regulatory compliance. These two publications play distinct
yet complementary roles in the administration of federal regulations, providing a
comprehensive record of government actions and codifying enforceable rules and
requirements.

One of the key functions of the Federal Register is to provide a centralized repository for all
federal regulations and regulatory activities. This includes not only new regulations but also
amendments, revisions, and withdrawals of existing rules, as well as announcements of public
meetings, hearings, and comment periods. By consolidating this information into a single
publication, the Federal Register enables individuals and organizations to stay informed about
the latest developments in federal regulation and to track the progress of specific rulemakings
affecting their interests.

Moreover, the Federal Register serves as an essential tool for legal research and compliance. Its
searchable database allows users to access historical and current documents, facilitating the
identification and understanding of regulatory requirements. Attorneys, compliance officers,
government officials, researchers, and members of the public rely on the Federal Register to
ascertain the legal status and effect of federal regulations, enabling them to navigate the
complexities of regulatory compliance and enforcement.

While the Federal Register provides a record of regulatory actions and notices, the Code of
Federal Regulations (CFR) serves as the codified compilation of all currently enforced
regulations issued by federal agencies. The CFR is organized by subject matter into fifty titles,
each covering a specific area of federal regulation, such as agriculture, commerce, energy,
environment, and transportation. Within each title, regulations are further categorized by
agency and sequentially numbered for ease of reference.

The CFR is regularly updated to incorporate new regulations, revisions, and amendments
published in the Federal Register, ensuring that it accurately reflects the current state of federal
law. As such, it serves as the authoritative source for understanding and complying with federal
regulations across various industries and sectors. Businesses, professionals, government
agencies, and individuals consult.

Faculty of Pharmacy, BBDNIIT, Lucknow 40

 REFERENCES

5. REFERENCES
WEBSITES:

1. https://www.archives.gov/federal-register

2. https://www.govinfo.gov/app/collection/fr

3. https://www.loc.gov/collections/federal-register/about-this-collection/

4. https://www.ecfr.gov/reader-aids/using-ecfr/getting-started/

5. https://www.govinfo.gov/help/cfr

6. https://www.ddregpharma.com/what-is-the-code-of-federal-regulations

7. https://guides.library.txstate.edu/CFR

8. https://www.llsdc.org/fr-cfr-research-guide

9. https://libguides.law.umich.edu/c.php?g=1005584&p=7284939

10. https://www.federal register.gov

11. https://www.law.cornell.edu/cfr/text

BOOK:

 Bigoniya papiya, drug regulatory affairs, published by CBS Publishers & distributors
Pvt. Ltd, Page no 7-8

Faculty of Pharmacy, BBDNIIT, Lucknow 41