Agency Information Collection Activities: Proposed Collection; Comment Request; Notice of Participation; Extension

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-4069]

Agency Information Collection Activities: Proposed Collection;

Comment Request; Notice of Participation; 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 reporting requirements for

filing a notice of participation with FDA.

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

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.

[[Page 52331]]

Notice of Participation--21 CFR 12.45 (OMB Control Number 0910-

0191--Extension)

Under part 12 (21 CFR part 12) regulations issued under sections

201-903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-

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.

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: September 22, 1999.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.

[FR Doc. 99-25101 Filed 9-27-99; 8:45 am]

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