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Insight Report Vol. 5 No.8
The FDA can be Petitioned and...
You do have a say in the REGULATIONS that affect you.
Every once in a while it is too to know
that you do have a say in what the regulations that the government enacts.
Yeah, your say does count. But you have to know how to put your two-cents
in to be effective. The following was taken from the FDA website and
explains how to make a comment to a new regulation that is published in
the Federal Register and provides a public comment time period. The
following also supplies information on how to petition the FDA to change
or enact new regulations. It is not the most interesting reading but it is
informative.
As a regulatory agency, FDA publishes
rules that establish or modify the way it regulates foods, drugs,
biologics, cosmetics, radiation-emitting electronic products, and medical
devices--commodities close to the daily lives of all Americans. FDA rules
have considerable impact on the nation's health, industries and economy.
These rules are not created arbitrarily or in a vacuum. They are formed
with the public's help.
By law, anyone can participate in the
rule-making process by commenting in writing on rules FDA proposes. FDA
allows plenty of time for public input and carefully considers these
comments when it draws up a final rule.
FDA gathers public comments mainly
through two channels: proposed rules and petitions.
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. Published every
weekday, the Federal Register is available at many public libraries and
colleges, and on the FDA Website.
Issues open
to public comment often are reported by the news media and can also be
found on FDA's Website.
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, though 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.
Here are some other suggestions for
making sure your comment has the greatest possible 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
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 names or other information that would
identify patients.
- 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 FDA's reading
room (Room 1061, 5630 Fishers Lane, 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.
Petitions
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 1061,
5630 Fishers Lane, Rockville, MD 20852.
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, D.C., area, but sometimes are set in other areas across
the country. Meetings for the public to present views are announced in the
Federal Register.
Copies of
comments
on FDA issues are available on the FDA Website.
The next Insight Report – To Be Announced
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