[Federal Register: June 23, 2003 (Volume 68, Number 120)]
[Page 37160-37161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

                                      Estimated Annual Reporting Burden\1\
                                              Annual Frequency per   Total Annual     Hours per
    21 CFR Section       No. of Respondents         Response           Responses      Response      Total Hours
3                               28                     1                 28             24            672
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: June 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15699 Filed 6-20-03; 8:45 am]