[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16865-16866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07980]


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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 May 17, 
2018.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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

    This information collection supports Agency regulations and 
accompanying guidance. 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 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. Regulations governing medical device classification procedures 
are codified under 21 CFR part 860.
    The guidance document entitled ``FDA and Industry Procedures for 
Section 513(g) Requests for Information Under the Federal Food, Drug, 
and Cosmetic Act; Guidance for Industry and Food and Drug 
Administration Staff'' 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.

[[Page 16866]]

    Relatedly, the FD&C Act, as amended by the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 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.
    In the Federal Register of November 21, 2017 (82 FR 55381) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received in response to the 
notice.
    We therefore retain the currently approved burden estimate for the 
information collection, which is as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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CDRH 513(g) requests............             114               1             114              12           1,368
CBER 513(g) requests............               4               1               4              12              48
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    Total.......................  ..............  ..............  ..............  ..............           1,416
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\1\ There are no capital costs of operating and maintenance costs associated with this collection off
  information.

    Respondents to the 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: April 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07980 Filed 4-16-18; 8:45 am]
 BILLING CODE 4164-01-P


