[Federal Register Volume 67, Number 131 (Tuesday, July 9, 2002)]
[Notices]
[Pages 45525-45526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17077]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0281]


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 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 September 9, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (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 comments on: (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 No. 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 the Dockets Management Branch), 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, non-for profit institutions and businesses or other 
for-profit institutions or groups.
    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 Sec. 10.25 (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

[[Page 45526]]

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 instructions who are requesting from 
the Commissioner 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 
the Dockets Management Branch), the Commissioner to stay the effective 
date of any administrative action.
    Such a petition must: (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 
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 Dockets Management Branch), 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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                                                                        Annual Frequency per                                  Hours per
                21 CFR Section                   No. of Respondents           Response            Total Annual Responses      Response      Total Hours
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10.30                                                  150                       3                        450                   12          5,400
10.33                                                   10                       1                         10                   10            100
10.35                                                   13                       1                         13                   10            130
10.85                                                    3                       1                          3                   16             48
Total                                                                                                                                       5,678
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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 is based on 
agency records and experience over the past 3 years. Agency personnel 
handling the petitions for Sec. 10.30 estimate 150 (citizen petitions) 
received by the agency annually, each requiring an average of 12 hours 
preparation time. Agency personnel handling the petitions for 
Sec. 10.33 (administrative reconsideration of an action) estimate 10 
requests are received by the agency annually, each requiring an average 
of 10 hours preparation time. Agency personnel handling the petitions 
for Sec. 10.35 (administrative stay of an action) estimate 13 requests 
are received by the agency annually, each requiring an average of 10 
hours preparation time. Agency personnel handling the petitions for 
Sec. 10.85 (advisory opinions) estimate 3 requests are received by the 
agency annually, each requiring an average of 16 hours preparation 
time.

    Dated: June 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-17077 Filed 7-8-02; 8:45 am]
BILLING CODE 4160-01-S