[Federal Register Volume 68, Number 120 (Monday, June 23, 2003)]
[Notices]
[Pages 37160-37161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15699]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0222 ]
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 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.
DATES: Submit written or electronic comments on the collection of
information by August 22, 2003.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with
the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
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, 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: (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
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: (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 one
[[Page 37161]]
of the bases for making the assignment or designation decision. Most
information required by the proposed regulation is already required for
premarket applications affecting drugs, devices, biological and
combination products. The respondents will be businesses or other for-
profit organizations.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Response Total Hours
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3 28 1 28 24 672
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15699 Filed 6-20-03; 8:45 am]
BILLING CODE 4160-01-S