Agency Information Collection Activities; Proposals, Submissions, and Approvals
Federal Register: April 3, 2009 (Volume 74, Number 63)
Notices
Page 15295-15296
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr03ap09-39
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2008-N-0653
Agency Information Collection Activities; Submission for Office of Management and Budget 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 a proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 4, 2009.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0184.
Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794.
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--
(OMB Control Number 0910-0184)--Extension
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)(2)), set forth the instructions for filing objections and requests for a hearing on a regulation or order under Sec. 12.20(d)
(21 CFR 12.20(d)). Objections and requests must be submitted within the time specified in Sec. 12.20(e). Each objection, for which a hearing has been requested, must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis to determine whether a hearing request is justified. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under 21 CFR 12.24 and 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 January 14, 2009 (74 FR 2080), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
FDA estimates the burden of this collection of information as follows:
Page 15296
Table 1--Estimated Annual Reporting Burden\1\
No. of
Annual Frequency
Total Annual
Hours per 21 CFR Section
Respondents
per Response
Responses
Response
Total Hours
12.22
5
1
5
20
100
\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 past filings. Agency personnel, responsible for processing the filing of objections and requests for a public hearing on a specific regulation or order, estimate approximately five requests are received by the agency annually, with each requiring approximately 20 hours of preparation time.
Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
FR Doc. E9-7472 Filed 4-2-09; 8:45 am
BILLING CODE 4160-01-S
