[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51993-51995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18271]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 September 23, 2022.

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, 
[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.

[[Page 51994]]

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

OMB Control Number 0910-0332--Revision

    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.
    HUDs approved under an HDE cannot be sold for an amount that 
exceeds the costs of research and development, fabrication, and 
distribution of the device (i.e., for profit), except in narrow 
circumstances. Under section 520(m)(6)(A)(i) of the FD&C Act, an HUD 
approved under an HDE is eligible to be sold for profit if the device 
meets the following criteria: The device is intended for the treatment 
or diagnosis of a disease or condition that occurs in pediatric 
patients or in a pediatric subpopulation, and such device is labeled 
for use in pediatric patients or in a pediatric subpopulation in which 
the disease or condition occurs; or the device is intended for the 
treatment or diagnosis of a disease or condition that does not occur in 
pediatric patients, or that occurs in pediatric patients in such 
numbers that the development of the device for such patients is 
impossible, highly impracticable, or unsafe.
    Section 520(m)(6)(A)(ii) of the FD&C Act, provides that the 
Secretary of Health and Human Services will determine the annual 
distribution number (ADN) for devices that meet the eligibility 
criteria to be permitted to be sold for profit. The Cures Act amended 
the FD&C Act definition of the ADN as the number of devices reasonably 
needed to treat, diagnose, or cure a population of 8,000 individuals in 
the United States.
    Section 520(m)(6)(A)(iii) of the FD&C Act provides that an HDE 
holder immediately notify the Agency if the number of such devices 
distributed during any calendar year exceeds the ADN. Section 
520(m)(6)(C) of the FD&C Act provides that an HDE holder may petition 
to modify the ADN if additional information arises.
    In the Federal Register of April 7, 2022 (87 FR 20429), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Activity/21 CFR section or FD&C     Number of     responses per   Total annual     burden per      Total hours
           Act section              respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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
Pediatric Subpopulation and                    1               1               1             100             100
 Patient Information--515A(a)(2)
 of the FD&C Act (21 U.S.C. 360e-
 1(a)(2)).......................
Exemption from Profit                          1               1               1              50              50
 Prohibition Information--
 520(m)(6)(A)(i) and (ii) of the
 FD&C Act.......................
Request for Determination of                   1               1               1              10              10
 Eligibility Criteria--section
 613(b) of the Food and Drug
 Administration Safety and
 Innovation Act.................
ADN Notification--                             1               1               1             100             100
 520(m)(6)(A)(iii) of the FD&C
 Act............................
ADN Modification--520(m)(6)(C)                 1               1               1             100             100
 of the FD&C Act................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          22,756
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 51995]]


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2).........................................              62                1               62                2              124
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      Activity/21 CFR section                           Number of       disclosures      Total annual   Average  burden    Total hours
                                                                       respondents    per  respondent    disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a)..........................              22                1               22                1               22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
increase of 360 total burden hours and a corresponding increase of five 
total annual responses. For efficiency of Agency operations, we are 
consolidating the related information activity and account for burden 
associated with HDE regulations currently approved in OMB control 
number 0910-0661. As a result, there is an increase in the total number 
of burden hours for this information collection.

    Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18271 Filed 8-23-22; 8:45 am]
BILLING CODE 4164-01-P