[Federal Register Volume 62, Number 152 (Thursday, August 7, 1997)]
[Notices]
[Pages 42561-42562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0323]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 (the PRA).

DATES: Submit written comments on the collection of information by 
September 8, 1997.

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: 
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, rm. 16B-19, Rockville, MD 20857, 
301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(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--Reinstatement)

    Under part 12 (21 CFR part 12) regulations issued under sections 
201-903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-
393), any interested person may participate in a formal evidentiary 
hearing, either personally or through a representative by filing a 
notice of participation under Sec. 12.45. Section 12.45 requires that 
any person filing a notice of participation state the person's 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 
documentary evidence on testimony at the hearing and will comply with 
specific requirements in Sec. 12.85 or, in the case of a hearing before 
a Public Board of Inquiry, in 21 CFR 13.25, concerning disclosure of 
data and information by participants. A participant's appearance can be 
struck by the presiding officer in accordance with Sec. 12.45(e).
    The information obtained is used by the presiding officer and other 
participants in a hearing to identify specific interests to be 
presented. This preliminary information serves to expedite the 
prehearing conference and commits participation.
    The affected 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:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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12.45                                  92               1              92               3             276       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   


[[Page 42562]]

    The agency bases this estimate on fiscal year 1995 data in which 
each notice of participation filed took an estimated 3 hours to 
complete.

    Dated: July 31, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20870 Filed 8-6-97; 8:45 am]
BILLING CODE 4160-01-F