Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices, 11303-11304 [2021-03746]
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11303
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
2. Modeling natural history of disease,
specifically methodological
considerations and challenges in
characterizing the natural relationship
between pharmacodynamic markers and
clinical outcomes.
3. Clinical trial simulations based on
disease progression/natural history
models to support drug development
and regulatory decisions.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03727 Filed 2–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4951]
Medical Devices; Humanitarian Use
Devices—21 CFR Part 814
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.
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://
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
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.
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
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Activity/21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Request for HUD designation—814.102 .............................
HDE Application—814.104 ..................................................
HDE Amendments and resubmitted HDEs—814.106 .........
HDE Supplements—814.108 ...............................................
Notification of withdrawal of an HDE—814.116(e)(3) .........
Notification of withdrawal of institutional review board approval—814.124(b) ...........................................................
Periodic reports—814.126(b)(1) ..........................................
20
4
20
116
2
1
1
5
1
1
20
4
100
116
2
40
328
50
80
1
800
1,312
5,000
9,280
2
1
50
1
1
1
50
2
120
2
6,000
Total ..............................................................................
........................
........................
........................
........................
22,396
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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11304
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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 § 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 § 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 § 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
§ 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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Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Rural Health Clinic
COVID–19 Testing Program Data
Collection, OMB No. 0906–0056—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than March 26, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
SUMMARY:
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Health Clinic COVID–19 Testing
Program Data Collection, OMB No.
0906–0056—Extension.
Abstract: This ICR is for continued
approval of the Rural Health Clinic
(RHC) COVID–19 Testing Program Data
Collection. HRSA is proposing to
continue this data collection with no
changes. The current performance
measures are collected electronically in
the RHC COVID–19 Testing Report
(CTR), which funded providers access
via rhccovidreporting.com. RHC
COVID–19 Testing Program Data
Collection supports the HRSA
requirement to monitor and report on
funds distributed under the Paycheck
Protection Program and Health Care
Enhancement Act. Signed into law on
April 24, 2020, the Paycheck Protection
Program and Health Care Enhancement
Act appropriated $225 million to RHCs
to support COVID–19 testing efforts,
expand access to testing in rural
communities, and other related
expenses. On May 20, 2020, HRSA
issued funding as one-time payments to
2,406 RHC organizations based on the
number of certified clinic sites they
operate, providing $49,461.42 per clinic
site (4,549 RHC clinic sites total across
the country).
The RHC CTR collects monthly,
aggregate data from funded
organizations. Funded organizations
provide basic identifying information,
report on the number of and location of
testing sites, indicate how they used the
funds, and report the total number of
patients tested and the number of tests
with a positive result.
Funded organizations must report the
number of patients tested and the
number of positive tests on a monthly
E:\FR\FM\24FEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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) 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,
[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.
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\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 22,396
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 per Total annual Average burden Total hours
respondents 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.
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
