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

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]

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