[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42900-42901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20409]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the procedure by which an 
applicant may obtain an assignment or designation determination for 
combination products.

DATES:  Submit written or electronic comments on the collection of 
information by October 26, 2009.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, <a href="/cdn-cgi/l/email-protection#81cbeeefefe0cdf8efefafc2e0f1e4fbfbf4f5eec1e7e5e0afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="a1ebcecfcfc0edd8cfcf8fe2c0d1c4dbdbd4d5cee1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 42901]]

Product Jurisdiction: Assignment of Agency Component for Review of 
Premarket Applications--(OMB Control Number 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 
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.
    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: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9-20409 Filed 8-24-09; 8:45 am]
BILLING CODE 4160-01-S


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>