[Federal Register Volume 74, Number 45 (Tuesday, March 10, 2009)]
[Notices]
[Pages 10255-10256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4972]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0650]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General
Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
9, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-0183.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
General Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions--(OMB Control
Number 0910-0183)--Extension
The Administrative Procedures Act (5 U.S.C. 553(e)) provides that
every agency shall give an interested person the right to petition for
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30)
sets forth the format and procedures by which an interested person may
submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20) (submission
of documents to Division of Dockets Management), a citizen petition
requesting the Commissioner of Food and Drugs (the Commissioner) to
issue, amend, or revoke a regulation or order, or to take or refrain
from taking any other form of administrative action.
The Commissioner may grant or deny such a petition, in whole or in
part, and may grant such other relief or take other action as the
petition warrants. Respondents are individuals or households, State or
local governments, not-for-profit institutions and businesses or other
for-profit institutions or groups.
[[Page 10256]]
Section 10.33 (21 CFR 10.33) issued under section 701(a) of the
Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)),
sets forth the format and procedures by which an interested person may
request reconsideration of part or all of a decision of the
Commissioner on a petition submitted under 21 CFR 10.25 (initiation of
administrative proceedings). A petition for reconsideration must
contain a full statement in a well-organized format of the factual and
legal grounds upon which the petition relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner. The respondent must submit a petition no later
than 30 days after the decision involved. However, the Commissioner
may, for good cause, permit a petition to be filed after 30 days. An
interested person who wishes to rely on information or views not
included in the administrative record shall submit them with a new
petition to modify the decision. FDA uses the information provided in
the request to determine whether to grant the petition for
reconsideration. Respondents to this collection of information are
individuals of households, State or local governments, not-for-profit
institutions, and businesses or other for-profit institutions who are
requesting from the Commissioner of FDA a reconsideration of a matter.
Section 10.35 (21 CFR 10.35), issued under section 701(a) of the
act, sets forth the format and procedures by which an interested person
may request, in accordance with Sec. 10.20 (submission of documents to
Division of Dockets Management), the Commissioner to stay the effective
date of any administrative action.
Such a petition must do the following: (1) Identify the decision
involved; (2) state the action requested, including the length of time
for which a stay is requested; and (3) include a statement of the
factual and legal grounds on which the interested person relies in
seeking the stay. FDA uses the information provided in the request to
determine whether to grant the petition for stay of action.
Respondents to this information collection are interested persons
who choose to file a petition for an administrative stay of action.
Section 10.85 (21 CFR 10.85), issued under section 701(a) of the
act, sets forth the format and procedures by which an interested person
may request, in accordance with Sec. 10.20 (submission of documents to
Division of Dockets Management), an advisory opinion from the
Commissioner on a matter of general applicability. An advisory opinion
represents the formal position of FDA on a matter of general
applicability. When making a request, the petitioner must provide a
concise statement of the issues and questions on which an opinion is
requested, and a full statement of the facts and legal points relevant
to the request. Respondents to this collection of information are
interested persons seeking an advisory opinion from the Commissioner on
the agency's formal position for matters of general applicability.
In the Federal Register of December 30, 2008 (73 FR 79885), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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10.30 162 3 486 12 5,832
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10.33 4 2 8 10 80
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10.35 7 2 14 10 140
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10.85 2 1 2 16 32
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Total 6,084
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this collection of information are based
on agency records and experience over the past 3 years. In 2007, FDA
received approximately 162 citizen petitions (Sec. 10.30), 4
administrative reconsiderations of action (Sec. 10.33), 7
administrative stays of action (Sec. 10.35), and 2 advisory opinions
(Sec. 10.85).
Dated: March 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4972 Filed 3-9-09; 8:45 am]
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