Notice2022-18271
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 163 (Wednesday, August 24, 2022)</title>
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[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51993-51995]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18271]
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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, 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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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#c191938092b5a0a7a781a7a5a0efa9a9b2efa6aeb7"><span class="__cf_email__" data-cfemail="c9999b889abda8afaf89afada8e7a1a1bae7aea6bf">[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.
[[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\
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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
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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
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................
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Total....................... .............. .............. .............. .............. 22,756
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\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\
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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 Total annual Average burden Total hours
respondents per 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.
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
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