Document ID: FDA-2008-N-0652-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
Posted Date: 2008-12-29T05:00Z

[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Notices]               
[Page 79495-79496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de08-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 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 reporting requirements for 
filing a notice of participation with FDA.

DATES: Submit written or electronic comments on the collection of 
information by February 27, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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 these topics: (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.

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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                           No. of         Annual Frequency per      Total Annual        Hours per
                   21 CFR Section                       Respondents             Response             Responses           Response         Total Hours
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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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

[[Page 79496]]

    Dated: December 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30839 Filed 12-24-08; 8:45 am]

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