Document ID: FDA-2009-N-0380-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Product Jurisdiction; Assignment of Agency Component for Review of Premarket Applications
Posted Date: 2010-03-17T04:00Z

[Federal Register: March 17, 2010 (Volume 75, Number 51)]
[Notices]               
[Page 12758-12759]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr10-78]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0380]

 
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.

-----------------------------------------------------------------------

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 April 
16, 2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0523. 
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, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3794, 
Jonnalynn.capezzuto@fda.hhs.gov.

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

[[Page 12759]]

products that are comprised of any combination of the following 
products: (1) A drug and a device; (2) a device and a biological 
product; (3) a biological product and a drug; or (4) a drug, a device, 
and a biological product. 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, biological products, and combination products. The 
respondents will be businesses or other for-profit organizations.
    In the Federal Register of August 25, 2009 (74 FR 42900), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 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
----------------------------------------------------------------------------------------------------------------
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.

    These burden estimates are based on the number of applications FDA 
received over the past 2 fiscal years.

    Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5749 Filed 3-16-10; 8:45 am]
BILLING CODE 4160-01-S