Agency Information Collection Activities: Proposed Collection; Comment Request; Advisory Opinions; Extension

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4068]

Agency Information Collection Activities: Proposed Collection;

Comment Request; Advisory Opinions; 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 requirements for parties

seeking an advisory opinion from the Commissioner of Food and Drugs

(the Commissioner).

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

[[Page 52330]]

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.

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 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.

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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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: September 22, 1999.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.

[FR Doc. 99-25100 Filed 9-27-99; 8:45 am]

BILLING CODE 4160-01-F