[Federal Register Volume 71, Number 28 (Friday, February 10, 2006)]
[Notices]
[Pages 7052-7053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0425]


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 March 
13, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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. Under part 10 (21 CFR part 
10), Sec.  10.30 sets forth the format and procedures by which an 
interested person may submit to FDA, in accordance with Sec.  10.20 
(submission of documents to the Division of Dockets Management (DDM)), 
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.
    Section 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 in a 
petition submitted under Sec.  10.25 (initiation of administrative 
proceedings). A petition for reconsideration must contain in a well-
organized format a full statement 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 has been made. 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 or 
households, State or local governments, not-for-profit institutions, 
and businesses or other for-profit institutions who are requesting a 
reconsideration of a matter from the Commissioner.
    Section 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 DDM), the 
Commissioner to stay the effective date of any administrative action.
    Such a petition must provide the following information: (1) The 
decision involved; (2) the action requested, including the length of 
time for which a stay is requested; and (3) a statement

[[Page 7053]]

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 a 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, 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 the DDM), 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 November 16, 2005 (70 FR 69574), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                         Annual Frequency per
       21 CFR Section           No. of Respondents             Response            Total Annual Responses       Hours per Response        Total Hours
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10.30                                            156                          3                        468                         12              5,616
10.33                                             10                          2                         20                         10                200
10.35                                             13                          2                         26                         10                260
10.85                                              2                          1                          2                         16                 32
Total                        .......................  .........................  .........................  .........................              6,108
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1846 Filed 2-9-06; 8:45 am]
BILLING CODE 4160-01-S