[Federal Register: September 15, 2003 (Volume 68, Number 178)]
[Page 53980-53981]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 
    FDA estimates the burden of this collection of information as 

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

    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]