Document ID: FDA-2008-N-0652-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-04-06T04:00Z

[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Notices]               
[Page 15496-15497]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ap09-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0652]

 
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 May 6, 
2009.

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: 202-395-6974, or e-mailed 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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug

[[Page 15497]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

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--(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 December 29, 2008 (73 FR 79495), 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\
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  Section 502 of
  the FFD&C Act/         No. of        Annual Frequency     Total Annual        Hours per
  Section 351 of      Respondents        per Response        Responses           Response         Total Hours
   the PHS Act
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12.45                              8                  1                  8                  3                 24
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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 30, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7671 Filed 4-3-09; 8:45 am]

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