[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11303-11304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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: Submit written comments (including recommendations) on the 
collection of information by March 26, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0332. 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, 
<a href="/cdn-cgi/l/email-protection#7d2d2f3c2e091c1b1b3d1b191c5315150e531a120b"><span class="__cf_email__" data-cfemail="cf9f9d8e9cbbaea9a98fa9abaee1a7a7bce1a8a0b9">[email protected]</span></a>.

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.

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.
    In the Federal Register of August 13, 2020 (85 FR 49379), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, they 
were not responsive to the four collection of information topics 
solicited.
    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 resubmitted                20               5             100              50           5,000
 HDEs--814.106..................
HDE Supplements--814.108........             116               1             116              80           9,280
Notification of withdrawal of an               2               1               2               1               2
 HDE--814.116(e)(3).............
Notification of withdrawal of                  1               1               1               2               2
 institutional review board
 approval--814.124(b)...........
Periodic reports--814.126(b)(1).              50               1              50             120           6,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          22,396
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 11304]]


                                                   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     recordkeeper       records       recordkeeping
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HDE Records--814.126(b)(2).........................................              62                1               62                2              124
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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
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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 5,803 
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. Based on further review, the estimated 
number of recordkeepers has been adjusted from 65 respondents to 62 
respondents in table 2 to reflect the most current data available. 
Therefore, under Sec.  814.126(b)(2) in table 2, the estimated number 
of recordkeepers is 62.
    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 an 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: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03746 Filed 2-23-21; 8:45 am]
BILLING CODE 4164-01-P


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