[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Page 61223]
[FR Doc No: 2016-21228]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0380]

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
6, 2016.

ADDRESSES: 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: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0523.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
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--21 CFR Part 3--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.
    In the Federal Register of January 28, 2016 (81 FR4921), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    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 part                                 Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses      per  response
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3..................................................................              84                1               84               24            2,016
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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 fiscal year.

    Dated: August 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21228 Filed 9-2-16; 8:45 am]
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