[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Page 64751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31051]



[[Page 64751]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0405]


Agency Information Collection Activities: Proposed Collection; 
Reinstatement

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, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed reinstatement 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 comments on the collection of information by 
February 4, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Peggy R. Wolff, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 
reinstatement 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 listed below.
    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--
Reinstatement)

    Under the 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 
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.   

    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: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31051 Filed 12-5-96; 8:45 am]
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