[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15762-15763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6392]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0627]


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.

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

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 
16, 2012.

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: 202-395-7285, or emailed to [email protected]. 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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, [email protected].

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 FDA (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 or groups.
    Section 10.33 (21 CFR 10.33) issued under section 701(a) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C 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

[[Page 15763]]

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 a reconsideration of a matter.
    Section 10.35 (21 CFR 10.35), issued under section 701(a) of the 
FD&C Act, sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20, 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 
FD&C Act sets forth the format and procedures by which an interested 
person may request, in accordance with Sec.  10.20, 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 accordance with 5 CFR 1320.8(d), FDA published a 60-day notice 
for public comment in the Federal Register of September 7, 2011 (76 FR 
55396), to which the Agency received one comment. However, this comment 
did not address the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
10.30...........................             207               1             207              24           4,968
10.33...........................               4               1               4              10              40
10.35...........................               5               1               5              10              50
10.85...........................               4               1               4              16              64
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,122
----------------------------------------------------------------------------------------------------------------
\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 2010, FDA 
received approximately 207 petitions (Sec.  10.30), 4 administrative 
reconsiderations of action (Sec.  10.33), 5 administrative stays of 
action (Sec.  10.35), and 4 advisory opinions (Sec.  10.85).

    Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6392 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P