[Federal Register Volume 67, Number 138 (Thursday, July 18, 2002)]
[Notices]
[Pages 47387-47388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0282]


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 comments on the collection 
of information by September 16, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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: 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: 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: (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

    The regulations in Sec. 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. Section 12.45 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 (21 CFR 
13.25), concerning disclosure of data and information by participants. 
In accordance with Sec. 12.45(e) the presiding officer may omit a 
participant's appearance.

[[Page 47388]]

    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 
prehearing 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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                                   Annual
                       No. of    Frequency    Total      Hours    Total
  21 CFR Section    Respondents     per       Annual      per     Hours
                                  Response  Responses  Response
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12.45                    340           1        340          3    1,020
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\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    The agency bases this estimate past notices filed in which each 
notice of participation filed took an estimated 3 hours to complete.

    Dated: July 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18122 Filed 7-17-02; 8:45 am]
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