Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Participation

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]

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