Document ID: FDA-2017-N-4951-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Humanitarian Use Devices
Posted Date: 2020-08-13T04:00Z

[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49379-49381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17716]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4951]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Humanitarian Use Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection requirements for 
humanitarian use devices (HUDs).

DATES: Submit either electronic or written comments on the collection 
of information by October 13, 2020.

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 October 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 13, 2020. 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

[[Page 49380]]

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 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-2017-N-4951 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request: Medical Devices; Humanitarian Use 
Devices.'' 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, 
PRAStaff@fda.hhs.gov.

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.

Medical Devices; Humanitarian Use Devices--21 CFR Part 814

OMB Control Number 0910-0332--Extension

    This collection of information implements the humanitarian use 
devices (HUDs) provision of section 520(m) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(m)) and part 814, subpart H 
(21 CFR part 814, subpart H). Under section 520(m) of the FD&C Act, FDA 
is authorized to exempt an HUD from the effectiveness requirements of 
sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided 
that the device: (1) Is designed to treat or diagnose a disease or 
condition that affects no more than 8,000 individuals in the United 
States; (2) would not be available to a person with a disease or 
condition unless an exemption is granted and there is no comparable 
device other than another HUD approved under this exemption that is 
available to treat or diagnose such disease or condition; and (3) will 
not expose patients to an unreasonable or significant risk of illness 
or injury and the probable benefit to health from the use of the device 
outweighs the risk of injury or illness from its use, taking into 
account the probable risks and benefits of currently available devices 
or alternative forms of treatment.
    Respondents may submit a humanitarian device exemption (HDE) 
application seeking exemption from the effectiveness requirements of 
sections 514 and 515 of the FD&C Act as authorized by section 520(m)(2) 
of the FD&C Act. The information collected will assist FDA in making 
determinations on the following: (1) Whether to grant HUD designation 
of a medical device; (2) whether to exempt an HUD from the 
effectiveness requirements under sections 514 and 515 of the FD&C Act, 
provided that the device meets requirements set forth under section 
520(m) of the FD&C Act; and (3) whether to grant marketing approval(s) 
for the HUD. Failure to collect this information would prevent FDA from 
making a determination on the factors listed previously in this 
document. Further, the collected information would also enable FDA to 
determine whether the holder of an HUD is in compliance with the HUD 
provisions under section 520(m) of the FD&C Act.

[[Page 49381]]

    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; 21 CFR section       Number of      responses per    Total annual   Average  burden    Total hours
                                 respondents       respondent       responses     per  response
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Request for HUD designation--               20                1              20               40             800
 814.102.....................
HDE Application--814.104.....                4                1               4              328           1,312
HDE Amendments and                          20                5             100               50           5,000
 resubmitted HDEs--814.106...
HDE Supplements--814.108.....              116                1             116               80           9,280
Notification of withdrawal of                2                1               2                1               2
 an HDE--814.116(e)(3).......
Notification of withdrawal of                1                1               1                2               2
 IRB approval--814.124(b)....
Periodic reports--                          50                1              50              120           6,000
 814.126(b)(1)...............
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ...............  ..............  ...............          22,396
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                       Number of                        Average  burden
                    Activity; 21 CFR section                         Number of        records per       Total annual          per          Total hours
                                                                   recordkeepers       respondent         records        recordkeeping
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HDE Records--814.126(b)(2).....................................               65                  1               65                 2              130
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                       Number of
                    Activity; 21 CFR section                         Number of      disclosures  per    Total annual    Average  burden    Total hours
                                                                    respondents        respondent       disclosures     per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a)......................               22                  1               22                 1               22
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents in tables 1, 2, and 3 are an average 
based on data for the previous 3 years, i.e., fiscal years 2017 through 
2019. The number of respondents has been adjusted to reflect updated 
respondent data. This has resulted in an overall increase of 5,809 
hours to the total estimated burden. The number of annual reports 
submitted under Sec.  814.126(b)(1) in table 1 reflects 50 respondents 
with approved HUD applications. Under Sec.  814.126(b)(2) in table 2, 
the estimated number of recordkeepers is 65.
    We have also updated the burden estimate consistent with new 
provisions in Sec.  814.104(b)(4)(i)) regarding ``Human Subject 
Protection; Acceptance of Data from Clinical Investigations for Medical 
Devices'' (83 FR 7366; February 21, 2018) (approved under OMB control 
number 0910-0741). Section 814.104 is being amended to address 
submission of data from clinical investigations in a Humanitarian 
Device Exemption (HDE). To the extent the applicant includes data from 
clinical investigations, the applicant will be required to include the 
information and statements as described in Sec.  814.104(b)(4)(i). 
Consistent with our estimate in OMB control number 0910-0741, this 
revision increases our burden estimate for an HDE by 8 hours per 
submission.

    Dated: August 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17716 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P