[Federal Register Volume 67, Number 243 (Wednesday, December 18, 2002)]
[Notices]
[Pages 77498-77499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31722]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0281]


Agency Information Collection Activities; Submission for OMB 
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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
January 17, 2003.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: 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 the Dockets Management Branch), a citizen 
petition requesting the Commissioner of Food and Drugs (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 (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

[[Page 77499]]

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 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 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.
    In the Federal Register of July 9, 2002 (67 FR 45525), 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\
----------------------------------------------------------------------------------------------------------------
                                             Annual Frequency per    Total Annual     Hours per
  21 CFR Section      No. of Respondents           Response            Responses      Response      Total Hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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 three requests are received by 
the agency annually, each requiring an average of 16 hours preparation 
time.

    Dated: December 6, 2002.
Margaret M.Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-31722 Filed 12-17-02; 8:45 am]
BILLING CODE 4160-01-S