Document ID: FDA-2008-N-0650-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-03-10T04:00Z

[Federal Register: March 10, 2009 (Volume 74, Number 45)]
[Notices]               
[Page 10255-10256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr09-62]                         

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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 oira_submission@omb.eop.gov. 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]

BILLING CODE 4160-01-S