[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12500-12501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0913]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 513(g) Request for 
Information

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 April 
8, 2015.

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: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0705. 
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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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.

513(g) Request for Information--(OMB Control Number 0910-0705)--
(Extension)

    Section 513(g) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining the 
Agency's views about the classification and regulatory requirements 
that may be applicable to a particular device. Section 513(g) provides 
that, within 60 days of the receipt of a written request of any person 
for information respecting the class in which a device has been 
classified or the requirements applicable to a device under the FD&C 
Act, the Secretary of Health and Human Services

[[Page 12501]]

shall provide such person a written statement of the classification (if 
any) of such device and the requirements of the FD&C Act applicable to 
the device.
    The guidance document entitled ``Guidance for Industry and Food and 
Drug Administration Staff; FDA and Industry Procedures for Section 
513(g) Requests for Information Under the Federal Food, Drug, and 
Cosmetic Act'' establishes procedures for submitting, reviewing, and 
responding to requests for information respecting the class in which a 
device has been classified or the requirements applicable to a device 
under the FD&C Act that are submitted in accordance with section 513(g) 
of the FD&C Act. FDA does not review data related to substantial 
equivalence or safety and effectiveness in a 513(g) request for 
information. FDA's responses to 513(g) requests for information are not 
device classification decisions and do not constitute FDA clearance or 
approval for marketing. Classification decisions and clearance or 
approval for marketing require submissions under different sections of 
the FD&C Act. Additionally, the FD&C Act, as amended by the FDA 
Amendments Act of 2007 (Public Law 110-85), requires FDA to collect 
user fees for 513(g) requests for information. The guidance document 
entitled ``Guidance for Industry and Food and Drug Administration 
Staff; User Fees for 513(g) Requests for Information'' assists FDA 
staff and regulated industry by describing the user fees associated 
with 513(g) requests. The Medical Device User Fee Cover Sheet (Form FDA 
3601), which accompanies the supplemental material described in this 
information collection, is approved under OMB control number 0910-0511 
and expires April 30, 2016.
    In the Federal Register of July 22, 2014 (79 FR 42517), 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       Total       Average
                  Activity                     Number of    responses per     annual     burden per  Total hours
                                              respondents    respondent     responses     response
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Center for Devices and Radiological Health            114               1          114           12        1,368
 513(g) requests............................
Center for Biologics Evaluation and Research            4               1            4           12           48
 513(g) requests............................
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    Total...................................  ...........  ..............  ...........  ...........        1,416
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents to this collection of information are mostly device 
manufacturers; however, anyone may submit a 513(g) request for 
information. The total number of annual responses is based on the 
average number of 513(g) requests received each year by the Agency.

    Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05358 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P