[Federal Register Volume 64, Number 249 (Wednesday, December 29, 1999)]
[Notices]
[Pages 73056-73057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 28, 2000.
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: 
Wendy Taylor, 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

[[Page 73057]]

collection of information to OMB for review and clearance.

 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 to 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
to 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.
     In the Federal Register of September 28, 1999 (64 FR 52330), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
     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: December 22, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-33759 Filed 12-28-99; 8:45 am]
BILLING CODE 4160-01-F