[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Notices]
[Pages 76343-76344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21636]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0237]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 January 
19, 2007.

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.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of the Chief 
Information Officer (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.

Product Jurisdiction: Assignment of Agency Component for Review of 
Premarket Applications--(OMB Control Number 0910-0523)--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 101-629), and amended 
by the Medical Device User Fee and Modernization Act of 2002 (Public 
Law 107-250), 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 for-profit organizations.
    In the Federal Register of June 22, 2006 (71 FR 35916), 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 76344]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                   Annual Frequency per
               21 CFR Section                 No. of Respondents         Response          Total Annual Responses    Hours per Response     Total Hours
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Part 3                                                         43                     1                         43                    24           1,032
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\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. E6-21636 Filed 12-19-06; 8:45 am]
BILLING CODE 4160-01-S