The following information is provided for those readers who want to know how to comment on FDA regulations or file petitions to influence the Agency.

As a regulatory Agency, FDA publishes rules that establish or modify the way that foods, human and veterinary drugs, medical devices and other products are regulated. By law, anyone can participate in the rule-making process by commenting in writing on rules that FDA proposes. FDA allows for public input and carefully considers these comments when it draws up a final rule. One way that FDA gathers public comments is through proposed rules.

When FDA plans to issue a new regulation or revise an existing one, it places an announcement in the Federal Register on the day the public comment period begins. The Federal Register, which is published every weekday, is available at many public libraries and colleges. It is also available on the Internet through the World Wide Web. Two Web addresses that include information from the Federal Register are:

• http://www.access.gpo.gov/su_docs/

• http:/thorplus.lib.purdue.edu/gpo/
  
  

Information on FDA issues that are open for public comment are also available through the Agency's News Page at the following World Wide Web site:

• http://www.fda.gov/opacom/backgrounders/voice.html

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 at least 60 days, although some comment periods have been as short as 10 days or as long as nine months. Weekends and holidays are included in the comment period.

There is no special form to fill out for comments, nor do submitters have to follow a certain style. But, FDA can process comments more effectively if they are presented -- either written legibly or typed -- on 8 1/2-inch by 11-inch paper. The Agency also has the following suggestions for making sure comments have the greatest impact:

• Clearly indicate if you are for or against the proposed rule or some part of it and why. 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 the 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 verified to be accurate. Translations should be accompanied by a copy of the original publication.

• To protect privacy when submitting medical information, delete name or other information that would identify patients.

• Threats, obscenities, profanities, or material defamatory to FDA or the Federal government may be rejected or referred to law enforcement officials.

• Comments must be postmarked or delivered in person by the last day of the comment period.

When FDA receives a comment, 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 in the FDA's reading room (Room 1-23, 12420 Parklawn Drive, Rockville, MD). Under the Freedom of Information Act (FOIA), visitors to the reading room can receive free copies of comments up to 50 pages if their request is for noncommercial use. After that, each page costs 10 cents. People also can send FDA an FOIA request and have copies of comments mailed to them.

Another way to influence the way FDA does business is to petition the Agency to issue, change or cancel a regulation, or to take other action. The Agency receives about 200 petitions yearly.

Petitions require careful preparation by the submitter. FDA spends considerable time and staff resources processing petitions. Individuals sometimes submit petitions, but 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 to tighten regulation of a certain product.

Petitions submitted to FDA must contain:

• 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.

• Certification -- A statement that to the best of the petitioner's knowledge, the petition includes all information relevant to the petition, favorable or not. The petition must be signed and include the petitioner's address and phone number.
  In addition, some petitions may require information on:

• 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 GRAS (generally recognized as safe). Procedures for preparing environmental impact statements can be found in Title 21 of the Code of Federal Regulations, Sections 25.24 and 25.31. If an environmental impact statement is not required, petitions should include a statement to that effect.

• Economic impact -- This information is required only if FDA requests it after review of the petition.

Petitions should be mailed or delivered to: Dockets Management Branch, Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857.

Ultimately, FDA management decides whether to grant a petition. But first, Agency staffers evaluate it, a process that may take several weeks to 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, the petitioner can take the matter to court.

For more information on submitting petitions, consult 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 usually are held with industry representatives or consumer groups, but anyone interested may attend and, with advance notice, may comment on a proposal. Meetings often are held in the Washington, DC area, but sometimes are set in other areas across the country. Meetings for the public to present views are announced in the Federal Register.

Questions about the comment, petition or hearing process should go to the FDA Dockets Management Branch, (301) 443-7542. Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday.

Filing a Freedom of Information Request

Copies of comments on any given issue may be obtained through a Freedom of Information Act (FOIA) request to FDA. The request is best made by letter, specifying exactly what material is sought. Requesters usually should be specific about what comments they want, instead of asking for "all comments" received on a certain proposal, which in some cases can run thousands of pages. (Indexes of comments are available by FOIA request as well.)

FOIA requests should include an address and phone number and be sent to: Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Requests also can be faxed to (301) 443-1726. For more information, call (301) 443-6310.

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Source: May/June 1996 FDA Veterinarian Newsletter Main Index This page produced by GetCVM, a digital spider from SpiderMakers