[Federal Register: November 16, 2005 (Volume 70, Number 220)]
[Notices]               
[Page 69574-69576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no05-82]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0425]

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements 
contained in existing FDA regulations regarding the general 
administrative procedures for a person to take the following actions: 
Petition the Commissioner of Food and Drugs (the Commissioner) to 
issue, amend, or revoke a rule; file a petition for an administrative 
reconsideration or an administrative stay of action; and request an 
advisory opinion from the Commissioner.

DATES: Submit written or electronic comments on the collection of 
information by January 17, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites

[[Page 69575]]

comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

General Administrative Procedures: Citizen Petitions; Petition for 
Reconsideration or Stay of Action; Advisory Opinions--(21 CFR Part 10) 
(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), a 
citizen petition requesting 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 Division of 
Dockets Management), 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 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 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.
    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                                                                 156                     3                468                 12              5,616
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10.33                                                                  10                     2                 20                 10                200
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10.35                                                                  13                     2                 26                 10                260
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10.85                                                                   2                     1                  2                 16                 32
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Total                                                                                                                                              6,108
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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. Agency 
personnel handling the petitions regarding Sec.  10.30 received 
approximately 156 citizen petitions annually, each required an average 
of 12 hours of preparation time. The agency received approximately 10 
requests annually regarding Sec.  10.33 (administrative reconsideration 
of an action), each required an average of 10 hours of preparation 
time. Regarding Sec.  10.35 (administrative stay of an action), the 
agency received approximately 13 requests annually, each required an 
average of 10 hours of preparation time. Lastly, regarding

[[Page 69576]]

petitions for Sec.  10.85 (advisory opinions), the agency received 
approximately 2 requests annually, each required an average of 16 hours 
of preparation time.

    Dated: November 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22668 Filed 11-15-05; 8:45 am]

BILLING CODE 4160-01-S