[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Notices]
[Pages 2674-2676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
burden estimate for requests for a written statement from FDA regarding 
the classification and regulatory requirements that may be applicable 
to a particular device (513(g) requests).

DATES: Submit either electronic or written comments on the collection 
of information by March 15, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 15, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 15, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your

[[Page 2675]]

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0913 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; 513(g) Request for Information.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including 
each proposed extension of an existing 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 these topics: (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.

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 (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'' \1\ 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.
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    \1\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic.
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    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 ``User Fees for 513(g) Requests for Information; 
Guidance for Industry and Food and

[[Page 2676]]

Drug Administration Staff'' \2\ 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.
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    \2\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513g-requests-information.
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    FDA estimates the burden of this collection of information 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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Center for Devices and                       114               1             114              12           1,368
 Radiological Health 513(g)
 requests.......................
Center for Biologics Evaluation                4               1               4              12              48
 and Research 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: January 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00470 Filed 1-12-21; 8:45 am]
BILLING CODE 4164-01-P