[Federal Register Volume 64, Number 187 (Tuesday, September 28, 1999)]
[Notices]
[Pages 52330-52331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4069]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Notice of Participation; Extension

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 comments on the collection of information by 
November 29, 1999.

ADDRESSES: 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 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.

[[Page 52331]]

 Notice of Participation--21 CFR 12.45 (OMB Control Number 0910-
0191--Extension)

     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 
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:

                                  Table 1.--Estimated Annual Reporting Burden1
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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                                  30               1              30               3              90
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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 on an average for the period 1996 
through 1998 in which each notice of participation filed took an 
estimated 3 hours to complete.

    Dated: September 22, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-25101 Filed 9-27-99; 8:45 am]
BILLING CODE 4160-01-F