[Federal Register Volume 64, Number 249 (Wednesday, December 29, 1999)]
[Notices]
[Page 73056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33757]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4068]


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

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 collection of information to OMB for 
review and clearance.

Advisory Opinions--21 CFR 10.85 (OMB Control Number 0910-0193)--
Extension

    Section 10.85 (21 CFR 10.85), issued under section 701(a) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)), 
provides that an interested person may request an advisory opinion from 
the Commissioner of Food and Drugs (the Commissioner) on a matter of 
general applicability. Section 10.85 sets forth the format and 
instructions for making an advisory opinion request. When making a 
request, the petitioner must provide a concise statement of the issues 
and questions on which an opinion is requested and a full statement of 
the facts and legal points relevant to the request. An advisory opinion 
represents the formal position of FDA on a matter of general 
applicability. Respondents to this collection of information are 
parties seeking an advisory opinion from the Commissioner on the 
agency's formal position for matters of general applicability.
    In the Federal Register of September 28, 1999 (64 FR 52329), the 
agency requested comments on the proposed collection of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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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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10.85                                   3               1               3              16              48
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this collection of information is based on 
an average for the period 1996 through 1998 with each advisory opinion 
requiring an estimated 16 hours of preparation time.

    Dated: December 22, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-33757 Filed 12-28-99; 8:45 am]
BILLING CODE 4160-01-F