[Federal Register Volume 67, Number 250 (Monday, December 30, 2002)]
[Notices]
[Page 79639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32849]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0282]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Notice of Participation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
January 29, 2003.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: 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

    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. 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.
    In the Federal Register of July 18, 2002 (67 FR 47387), 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\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
 21 CFR  Section      Respondents        per Response        Responses           Response         Total  Hours
----------------------------------------------------------------------------------------------------------------
12.45                            340                  1                340                  3              1,020
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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

    Dated: December 20, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32849 Filed 12-27-02; 8:45 am]
BILLING CODE 4160-01-S