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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket ID: [Docket No. 2006N-0237]

NOTICE: NOTICES

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

DATES: Fax written comments on the collection of information by January 19, 2007.

DOCUMENT 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.

SUMMARY: Agency information collection activities; proposals, submissions, and approvals,

SUPPLEMENTAL INFORMATION

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications(OMB Control Number 09100523)Extension

This regulation relates to agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Public Law 101629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Public Law 107250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any of the following combinations: (1) A drug and a device; (2) a device and a biological; (3) a biological and a drug; or (4) a drug, a device, and a biological. The second purpose of this regulation is to enhance the efficiency of agency management and operations by providing procedures for classifying and determining which agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant's recommendation as to which agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biologicals, and combination products. The respondents will be businesses or other forprofit organizations.

In the Federal Register of June 22, 2006 (71 FR 35916), FDA published a 60day 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 76344]]
Table 1.Estimated Annual Reporting Burden\1\ Annual Frequency per 21 CFR Section No. of Respondents Response Total Annual Responses Hours per Response Total Hours Part 3 43 1 43 24 1,032 \1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E621636 Filed 121906; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Jonna Capezzuto, Office of the Chief Information Officer (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,3018274659.