[Federal Register: September 15, 2003 (Volume 68, Number 178)]
[Notices]
[Page 53980-53981]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se03-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0222]
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 October
15, 2003.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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
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
[[Page 53981]]
the premarket review and regulation of products that are comprised of
any combination of these components: (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
designed 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 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:
Table 1.--Estimated Annual Reporting Burden \1\
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Annual
21 CFR Part No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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3 28 1 28 24 672
Total .................. ............... .................. .................. 672
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In the Federal Register of Monday, June 23, 2003 (68 FR 37160), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Dated: September 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23509 Filed 9-12-03; 8:45 am]
BILLING CODE 4160-01-S