[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Proposed Rules]
[Page 16461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8165]



[[Page 16461]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. 99N-2497]


Citizen Petitions; Actions That Can Be Requested by Petition; 
Denials, Withdrawals, and Referrals for Other Administrative Action; 
Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a 
proposed rule that appeared in the Federal Register of November 30, 
1999 (64 FR 66822). The proposal would have modified the types of 
actions that can be requested through a citizen petition; revised 
certain content requirements for citizen petitions; and permitted the 
agency to refer citizen petitions for other administrative action, seek 
clarification of a petitioner's request, withdraw certain petitions, 
and combine petitions. We proposed these changes to improve the citizen 
petition process by making it more efficient and reducing the backlog 
of pending requests. We believe the proposed rule is no longer needed 
because we have made other improvements to our process for responding 
to citizen petitions.

DATES: The proposed rule is withdrawn on April 4, 2003.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and 
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: FDA's citizen petition regulations at 21 CFR 
10.30 provide a formal means for the public to contact FDA and seek its 
action or response on a particular matter. For example, the petition 
process can be used by a drug company to request a change in the 
approval standards for a generic competitor, a food trade association 
can request that we establish exemptions from certain package labeling 
requirements, or a consumer group can petition us to tighten regulation 
of a particular product. Citizen petitions are submitted to our Dockets 
Management Branch for processing and referral to the appropriate 
office, and our regulations require us to issue a tentative or final 
response within 180 days after receiving the citizen petition.
    While the citizen petition process has benefited both FDA and the 
public, reviewing and responding to citizen petitions is often resource 
intensive and time consuming. We must research the petition, examine 
scientific, medical, legal, and sometimes economic issues, and 
coordinate internal agency review and clearance of the response. 
Petitioners occasionally sue over unfavorable responses or delays in 
issuing a response. This litigation consumes additional resources and 
time.
    Historically, we have received more citizen petitions than we have 
been able to answer. We receive nearly 290 citizen petitions annually, 
and, in most years, the number of incoming citizen petitions exceeded 
the number of responses that we would issue. In the past, the response 
rate was approximately 100 responses per year. This resulted in a 
steadily growing backlog of citizen petitions.
    Faced with a growing backlog of petitions and increasing demands on 
our resources, on November 30, 1999, we proposed to amend our citizen 
petition regulations to make the citizen petition system more efficient 
and responsive (64 FR 66822). The major changes under the proposal 
would:
    [sbull] Limit the types of actions that could be requested through 
a citizen petition to: (1) Requests to issue, amend, or revoke a 
regulation; (2) requests to amend or revoke an order that FDA had 
issued or published; and (3) requests for any other action specifically 
authorized by another FDA regulation.
    [sbull] Revise the content requirements to include a certification 
that, to the petitioner's best knowledge and belief, its citizen 
petition ``includes all information and views on which the petition 
relies, that it is well grounded in fact and is warranted by existing 
laws or regulations, that it is not submitted for any improper purpose, 
such as to harass or to cause unnecessary delay, and that it includes 
representative data and information known to the petitioner which are 
unfavorable to the petition.''
    [sbull] Allow us to refer petitions for other administrative 
action, seek clarification of a petitioner's requests, withdraw certain 
petitions, and combine petitions.
    The preamble to the proposed rule emphasized that, while we were 
redefining the types of actions that could be the subject of a citizen 
petition, interested parties would still have other means of contacting 
or communicating with us.
    We received nearly 20 comments on the proposed rule, with most 
comments opposing the rule in whole or in part. The comments opposed to 
the rule came from industry and public interest groups and stated that 
citizen petitions are a valuable means for communicating with us or for 
allowing public participation in agency actions. They expressed concern 
that the changes would unduly restrict the use of citizen petitions. 
Nonetheless, several comments supported the underlying goal of the 
proposal, and some of its relatively minor changes, pointing to the 
still-unanswered petitions they had submitted earlier as evidence that 
improvements were needed.
    Two comments supported the proposal. These comments agreed with us 
that the proposal would prevent misuse of the citizen petition process 
(particularly with respect to approvals of generic drugs), and they 
suggested additional changes to strengthen the citizen petition 
process.
    As we evaluated the comments, we continued efforts to improve our 
handling of citizen petitions. These efforts have led to a marked 
increase in the number of citizen petition responses, and our current 
annual response rate is equal to, and sometimes even exceeds, the 
number of citizen petitions that we receive. Given this progress, we 
believe that a revision of the citizen petition regulations is not 
warranted at this time. Consequently, we are withdrawing the proposed 
rule.

    Dated: March 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8165 Filed 4-3-03; 8:45 am]
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