[Federal Register Volume 78, Number 85 (Thursday, May 2, 2013)]
[Notices]
[Pages 25746-25747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10376]
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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.
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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
[[Page 25747]]
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 either electronic or written comments on the collection
of information by July 1, 2013.
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, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, [email protected].
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.
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 (Pub. L. 101-629), and amended by
the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 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: (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\
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Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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.
These burden estimates are based on the number of applications FDA
received over the past two fiscal years.
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10376 Filed 5-1-13; 8:45 am]
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