[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
