This article provides an overview of federal administrative processes as they relate to the regulatory professional. The author reviews and emphasizes the importance of understanding the impact of the administrative process on federally regulated industry, with a focus on federal administrative law under the Administrative Procedures Act
). She reviews the APA
impact on federal agencies, particularly on the United States Food and Drug Administration (FDA), which must adhere to the Act’s
prescribed provisions in terms of legal procedures when publishing proposed rules which includes public participation in the rulemaking process by submitting comments about a proposed rule.
The Federal Register
The Federal Register
can be regarded as the “daily newspaper” of the federal government. It is, in fact, a legal newspaper published every business day by the National Archives and Records Administration (NARA) and serves as the government’s official daily publication for rules, proposed rules and notices by federal agencies, including FDA and the US Department of Agriculture (USDA), among others.
The Code of Federal Regulations (CFR)
For regulatory professionals, the CFR is critically important as it is a compilation of the general and permanent rules published in the Federal Register
by agencies of the federal government. The published regulations are organized by subject area and assigned a title number. For example, Title 21 CFR concerns food and drugs. Every title is divided into chapters and each chapter is subdivided into parts that cover specific regulatory areas. Practical food and drug law-related examples from the Federal Register
and the CFR are listed. Both the Federal Register
and the CFR are important in the practice of food and drug law. Volume II of the CFR, which is the focus of this article, contains an administrative law backgrounder detailing the specifics of administrative law because FDA simultaneously acts as a regulator of federal law, a “watchdog” and a facilitator.
The Federal Register and Code of Federal Regulations
Federal Register: Comments, Petitions, Proposed and Final Rules
As one result of the New Deal Legislation in the 1930s, Congress delegated more responsibility to federal agencies, permitting them to develop and issue detailed regulations. While no centralized system existed prior to that time, on 26 July 1935 Congress passed the Federal Register Ac
) (44 USC Chapter 15). The Act
instituted a uniform system for handling agency regulations, including the filing of documents with the Office of the Federal Register,
posting of documents for public inspection, publication of documents in the Federal Register
(after a 1937 amendment) and a permanent codification of rules in the Code of Federal Regulations. The legal effect of publication in the Federal Register
gives official notice of a document and its contents, establishes the text as the copy of the original document, provides the date when the regulation was issued and provides evidence of the document acceptable to a court of law commonly known as prima facie
evidence. One of the most important additions to the Federal Register
system was implemented through the Administrative Procedures Act
). Enacted in 1946 (5 USC section 551 et seq.) by which the APA permits public participation in the rulemaking process by submitting comments about a proposed rule.
As 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, documents published in the Federal Register
are cited or referenced by volume and page number. Proposed rules and final rules are drafted as agency documents and submitted to the Office of the Federal Register
. The documents are then edited to conform to a specific style and then published in the Federal Register
. The Federal Register
includes any announcements related to agency matters, such as the request for comments on particular issues. Even proposed amendments to an initially proposed rule must appear, as well as any notices regarding a comment period extension.
Submission of Comments to Proposed Regulations and Submission of Petitions
FDA publishes rules that establish or modify how the agency regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, tobacco products, dietary supplements and medical devices. FDA rules have considerable impact on public health, industry and the economy. These rules are not created arbitrarily, nor are they created in a “vacuum.” FDA gathers public comments on proposed rules and stakeholder are able to submit petitions.
when FDA plans to issue a new regulation or revise an existing regulation, an announcement appears in the Federal Register
on the day the public comment period begins. Published every weekday, the Federal Register
is available at many public and college libraries as well as on the FDA website. Issues open to public comment often are reported by the news media and can be found at regulations.gov
In the Federal Register
, the “notice of proposed rulemaking” describes the planned regulation and provides background on the issue. It also gives the address for submitting written comments and the name of the person to contact for more information. Also noted is the “comment period,” which specifies how long the agency will accept public comments. Usually the file or docket stays open for comments for at least 60 days, although some comment periods are longer and can be extended.
several recommendations to consider for comment submission include:
- Clearly indicating your position about the proposed rule and why you take that position. FDA regulatory decisions are based largely on law and science, and agency reviewers look for reasoning, logic, and good science in comments they evaluate.
- Refer to the docket number, listed in Federal Register notice.
- Include a copy of articles or other references that support your comments.
- Only relevant material should be submitted. If an article or reference is in a foreign language, it must be accompanied by an English translation and verified to be accurate. A copy of the original publication should accompany translations.
- To protect privacy when submitting medical information, delete names or other information that could identify patients.
- Comments must be postmarked, electronically submitted or delivered in person by the last day of the comment period. When a comment is received, it is logged in, numbered and placed in a file for that docket. It then becomes a public record and is available for anyone to examine at regulations.gov.
another means to influence FDA is to petition the agency to issue, change or cancel a regulation or to take some other action. The agency receives hundreds of petitions on an annual basis. Petitions require careful preparation by the submitter. FDA expends considerable resources processing petitions. Individuals sometimes submit petitions; however, most come from regulated industry or consumer groups. For example, a drug company might request a change in labeling for one of its products, a food company might ask that its product be exempted from some provision of a regulation or a consumer group might petition FDA.
Submission of Petitions
- Action requested—What rule, order or other administrative action does the petitioner want FDA to issue, amend or revoke?
- Statement of grounds—The factual and legal grounds for the petition, including all supporting material, as well as information known to the petitioner that may be unfavorable to the petitioner’s position.
- Environmental impact—This information is generally required if the petition requests approval of food or color additives, drugs, biological products, animal drugs or certain medical devices or for a food to be categorized as Generally Recognized As Safe (GRAS). Procedures for preparing environmental impact statements can be found in Title 21, Part 25 of the Code of Federal Regulations. If an environmental impact statement is not required, petitions should include a statement to that effect.
- The following official certification statement—“The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition.”
- Identifying information—The petition must be signed and include contact information.
Ultimately, FDA decides whether to grant a petition or not. Agency staffers evaluate the petition, a process that may take several weeks or more than a year, depending on the issue’s complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied with FDA’s determination, the petitioner can take the matter to court. (See Title 21 of the Code of Federal Regulations, Sections 10.30, 10.33 and 10.35.) Besides accepting public comments and petitions, FDA also schedules public meetings and hearings to discuss and explain its proposals. These meetings and hearings are usually held with industry representatives or consumer groups; however, anyone may attend and, with advance notice, comment on a proposal. Meetings are held in the Washington, DC, area, as well as at a variety of locations through-out the United States. Public meetings are announced in the Federal Register
Illustration of a Proposed Rule
Banned Devices—Powdered Surgeon’s Gloves
81 FR 15173
FDA, US Department of Health and Human Services (HHS)
Action: Proposed Rule
. Banned Devices; Proposal To Ban Powdered Surgeon's Gloves (21 CFR 878.4460), Powdered Patient Examination Gloves (21 CFR 880.6250) and Absorbable Powder for Lubricating a Surgeon’s Glove (21 CFR 878.4480).
Proposed Rule Summary:
FDA issued a proposed rule 22 March 2016 to ban the following devices:
- powdered surgeon’s gloves
- powdered patient examination gloves
- absorbable powder for lubricating a surgeon’s glove
The proposed rule would apply to all powdered gloves except powdered radiographic protection gloves. The reason the proposed rule banned these medical device products is because of the unreasonable and substantial risk of illness or injury they posed and the risk cannot be corrected or eliminated by labeling or a change in labeling. The gloves include powdered natural rubber latex surgeon's gloves, powdered synthetic latex surgeon's gloves, powdered natural rubber latex patient examination gloves, powdered synthetic patient examination gloves and absorbable powder for lubricating a surgeon's glove. 21 USC section 360f authorizes FDA to ban by regulation any device intended for human use if FDA finds, based on all available data and information, that such device presents a “substantial deception” or an “unreasonable and substantial risk of illness or injury,” which cannot be, or has not been, corrected or eliminated by labeling or a change in labeling.
non-powdered gloves are not included, and FDA is unaware of any powdered radiographic protection gloves currently in the marketplace.
final rule. The above proposed rule became final
and effective on 18 January 2017.
FDA has determined that powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove present an unreasonable and substantial risk of illness or injury and the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices. This rule became effective on 18 January 2017. See docket as follows:
19 December 2016
21 CFR Parts 878, 880 and 895
Federal Register Number:
Code of Federal Regulations—Rule Codification
Once published in the Federal Register
, the regulation is codified as a final rule in the Code of Federal Regulations (CFR). The CFR is the codification of the general and permanent rules published in the Federal Register
by the executive departments and agencies of the federal government. The CFR is divided into “Titles” representing broad subject areas of federal regulation. For example, food and drug matters appear under Title 21 of the CFR. USDA regulations appear under Titles 7 and 9.
In terms of codification, it is helpful to make a parallel comparison between the publication process by Congress and regulations created by Federal agencies. Legislation is initially published as “slip law.” This means the Office of the Federal Register prints the law in pamphlet form on an annual basis. The United States statutes at-large are a compilation in chronological order of all private and public laws of a Congressional session. The law is then codified in the United States Code and arranged by subject. Proposed and final rules are submitted to the Office of the Federal Register
and published in the Federal Register
. Volume 1 started in 1936 and there are modifications with each calendar year.
Final Rules Under Section 4205 Vending Machines and Restaurant Menus Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
A final rule was issued 1 December 2014 to assist consumers by requiring the availability of point-of-purchase nutrition caloric information prior to purchasing the food item. (Proposed Rule: 6 April 2011).
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
The purpose of the final rule also published 1 December 2014 is to implement the menu labeling provisions of the Affordable Care Act
compliance for caloric disclosure restaurants was delayed until 7 May 2018 and 26 July 2018 for vending machines. Trade associations requested an extension due to front-of-package font size requirements for certain foods sold from glass-front vending machines.
Direct Final Rule Illustrations
Similar to other administrative agencies, FDA has resorted to companion publication of a direct final rule along with the proposed rule. Recognized as a “direct final rule,” this procedure is usually reserved for rules which the agency views as noncontroversial. In theory, the concept is a sound policy if it works. Yet, as the example below illustrates, this is not always the case. Sometimes a rule can be withdrawn due to adverse comments. In this situation, the direct final rule was published at the same time as the proposed rule.
Section 920 of FDAAA
added new Section 505(t) to the Federal Food, Drug, and Cosmetic Act
) (21 USC 355(t)) (P.L. 110-85, 121 Stat. 823, 27 September 2007). This section mandated FDA:
“Publish on its Internet site a complete list of all authorized generic drugs and included in an annual report submitted to the agency after 1 January 1999, consisting of the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market.”
FDA amended its regulations in a direct final rule, requiring the holder of a New Drug Application (NDA) to provide information regarding authorized generic drugs in an annual report. However, the direct final rule was withdrawn due to significant adverse comments received. (74 Fed. Reg. 6541, 2/10/09).
Similarly, the Center for Tobacco Products Regulation announced FDA withdrew the following direct final rule.
Action: Direct Final Rule; Withdrawal
FDA published in the Federal Register
on 8 August 2016 a direct final rule regarding procedures for refusing to accept premarket tobacco product submissions. The comment period closed 24 October 2016. FDA withdrew the direct final rule because the agency received significant adverse comments. FDA intends to consider the comments received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (8 August 2016).
the direct final rule published at 81 FR 52329 (8 August 2016), withdrawn effective 16 November 2016.
Instructions for Submitting Citizen Petitions (CPs) Electronically
This article has provided an overview of the federal administrative processes as related to the regulatory professional. The importance of understanding the impact of the administrative process on the regulated industry is critical. Equally critical is the impact the federal rules and regulations can exert on the regulated industry. Yet, due process is provided to industry as the regulatory affairs professional has the unique opportunity to comment and submit petitions as it relates to the company the professional represents.
About the Author
Roseann B. Termini, EdM, JD,
has more than 30 years of extensive experience in food and drug law. As a featured speaker and course director, Termini frequently presents food and drug law topics and has published a broad array of specialized food, drug and related law issues in addition to her Food and Drug Law
books. Her expertise entails an appellate clerkship, sole corporate counsel, regulatory attorney and senior deputy attorney general and online instruction of food and drug law. Termini initiated the inaugural online food and drug law courses at Delaware Law School, Widener University and direct-to-consumer promotion at St. Joseph’s University executive program. In addition to her professional association committee appointments, she served on the President’s Council at Immaculata University, the Justinian Society and was chair of a Food and Drug Law Institute Committee. She is currently the Co-Chair of the Health Law PA Bar Association and member of the Central Atlantic Association of Food and Drug Law Officials. She can be contacted at firstname.lastname@example.org
this article is from Volume II of Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products (2019). www.fortipublications.com
. It is available from RAPS
©Roseann B. Termini, 2019. All rights reserved.
Termini R B. “Administrative Law Overview.” Regulatory Focus.
August 2019. Regulatory Affairs Professionals Society.