Document ID: FDA-2011-N-0624-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2012-03-26T04:00Z

[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17482-17483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7137]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0624]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Notice of 
Participation

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 April 
25, 2012.

[[Page 17483]]

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0191. 
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, Ila.Mizrachi@fda.hhs.gov.

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.

Notice of Participation--21 CFR 12.45 (OMB Control Number 0910-0191)--
Extension

    Section 12.45 (21 CFR 12.45), issued under section 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the 
format and procedures for any interested person to file a petition to 
participate in a formal evidentiary hearing, either personally or 
through a representative. Section 12.45 requires that any person filing 
a notice of participation state their specific interest in the 
proceedings, including the specific issues of fact about which the 
person desires to be heard. This section also requires that the notice 
include a statement that the person will present testimony at the 
hearing and will comply with specific requirements in 21 CFR 12.85, or, 
in the case of a hearing before a Public Board of Inquiry, concerning 
disclosure of data and information by participants (21 CFR 13.25). In 
accordance with Sec.  12.45(e), the presiding officer may omit a 
participant's appearance.
    The presiding officer and other participants will use the collected 
information in a hearing to identify specific interests to be 
presented. This preliminary information serves to expedite the pre-
hearing conference and commits participation.
    The respondents are individuals or households, State or local 
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
    In the Federal Register of September 9, 2011 (76 FR 55918), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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12.45..............................................................               4                1                4                3               12
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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.

    Dated: March 20, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7137 Filed 3-23-12; 8:45 am]
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