00-4669. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 March 30, 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.

Filing Objections and Requests for a Hearing on a Regulation or Order

Under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)(2)), within 30 days after publication of a regulation or order, any person adversely affected by such regulations or order may file objections and request a public hearing. The implementing regulations for these statutory requirements are found at 21 CFR 12.22, which sets forth the format and instructions for filing objections and requests for a hearing. Each objection for which a hearing has been requested must be separately numbered and specify with particularity the provision of the regulation or the proposed order objected to. In addition, each objection must include a detailed description and analysis of the factual information to be presented in support of the objection as well as any report or other document relied on, with some exceptions. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis only for the purpose of determining whether a hearing request is justified. The description and analysis do not limit the evidence that may be presented if a hearing is granted. Respondents to this information collection are those parties that may be adversely affected by an order or regulation.

In the Federal Register of October 25, 1999 (64 FR 57467), 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 Burden ¹

21 CFR Section	No. of ­Respondents	Annual ­Frequency per ­Response	Total Annual Responses	Hours per ­Response	Total Hours
12.22	60	1	60	20	1,200
1 There are no capital or operating and maintenance costs associated with this collection of information.

The burden estimate for this collection of information is based on agency data received on this administrative procedure for the past 3 years. Agency personnel responsible for processing the filing of objections and requests for a public hearing on a specific regulation or order, estimate approximately 60 requests are received by the agency annually, with each requiring approximately 20 hours of preparation time.

Dated: February 23, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.