Notice2022-07376
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices
Primary source
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Published
April 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 67 (Thursday, April 7, 2022)</title>
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[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20429-20431]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07376]
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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 June 6, 2022.
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 June 6, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 6, 2022. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: 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#59090b180a2d383f3f193f3d387731312a773e362f"><span class="__cf_email__" data-cfemail="0f5f5d4e5c7b6e69694f696b6e2167677c21686079">[email protected]</span></a>.
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
[[Page 20430]]
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--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, a 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.
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 or FD&C Number of responses per Total annual Average burden Total hours
act section 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 2 1 2 1 2
an 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--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 20431]]
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.
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: March 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07376 Filed 4-6-22; 8:45 am]
BILLING CODE 4164-01-P
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