Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Humanitarian Use Devices, 51993-51995 [2022-18271]
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
51993
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2—Continued
Number of
respondents
21 CFR citation
Number of
disclosures
per respondent
Total annual
disclosures
Average burden per
disclosure
Total hours
Part 809 (in vitro diagnostic products for human use) and part 1040 (light-emitting products)
Format and content of labeling for IVDs; 809.10 ....
Advertising and promotional materials for ASRs;
809.30(d).
Labeling of sunlamp products—1040.20(d) .............
1,700
300
6
25
10,200
7,500
80 ..............................
1 ................................
816,000
7,500
30
1
30
10 ..............................
300
322
630
0.1 (6 minutes) ..........
0.1 (6 minutes) ..........
32
63
FD&C Action Section 502(u)
Establishments listing <10 SUDs ............................
Establishments listing >10 SUDs ............................
161
14
2
45
Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells;
Hepatitis B Surface Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling Provisions; Part 809, subpart B: Labeling
Symbols glossary—660.2; antibody to Hepatitis B
surface antigen requirements, 660.28; blood
grouping labeling, 660.35; reagent red blood cell
labeling, 660.45, hepatitis B surface antigen labeling, 660.55; anti-human globulin labeling,
801.15; medical devices labeling and use of
symbols; 809.10, labeling for in vitro diagnostic
products.
3,000
1
3,000
4 ................................
12,000
UDI ...........................................................................
3 5,987
51
4 305,337
0.8833 (53 minutes) ..
269,704
Total ..................................................................
........................
........................
20,752,542
....................................
8,754,765
Part 801, subpart B
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category
may involve fewer respondents.
4 Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer total annual responses.
2 Numbers
3 Maximum
jspears on DSK121TN23PROD with NOTICES
Because many labeling provisions
correspond to specific recordkeeping
requirements, we have accounted for
burden attendant to the provisions
enumerated in table 3 as third-party
disclosures. These figures reflect what
we believe to be the average burden
incurred by respondents to applicable
information collection activities.
We are revising this information
collection to include OMB control
number 0910–0720. Our estimated
burden for the information collection
reflects an overall increase of 579,633
hours and a corresponding increase of
926,823 responses/records. We attribute
this adjustment to the revision of this
information collection to include OMB
control number 0910–0720.
Dated: August 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18275 Filed 8–23–22; 8:45 am]
BILLING CODE 4164–01–P
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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:
FOR FURTHER INFORMATION CONTACT:
Notice.
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,
SUMMARY:
PO 00000
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Fmt 4703
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.
Sfmt 4703
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\24AUN1.SGM
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51994
Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
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
jspears on DSK121TN23PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR section or FD&C Act section
Average
burden per
response
Total annual
responses
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) ..........................................
Pediatric Subpopulation and Patient Information—
515A(a)(2) of the FD&C Act (21 U.S.C. 360e–1(a)(2)) ...
Exemption
from
Profit
Prohibition
Information—
520(m)(6)(A)(i) and (ii) of the FD&C Act ..........................
Request for Determination of Eligibility Criteria—section
613(b) of the Food and Drug Administration Safety and
Innovation Act ...................................................................
ADN Notification—520(m)(6)(A)(iii) of the FD&C Act ..........
ADN Modification—520(m)(6)(C) of the FD&C Act .............
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
1
1
1
100
100
1
1
1
50
50
1
1
1
1
1
1
1
1
1
10
100
100
10
100
100
Total ..............................................................................
........................
........................
........................
........................
22,756
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
51995
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.
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.
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.
[FR Doc. 2022–18271 Filed 8–23–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
[Docket No. FDA–2019–N–0430]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for Quick Turnaround Testing of
Communication Effectiveness
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 September
23, 2022.
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:37 Aug 23, 2022
Jkt 256001
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 0910–0876. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Generic Clearance for Quick
Turnaround Testing of Communication
Effectiveness
OMB Control Number 0910–0876—
Extension
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
helping to ensure the safety and security
of the food supply. It enables FDA to
focus more on preventing food safety
problems rather than relying primarily
on reacting to problems after they occur.
FSMA recognizes the important role
consumers and stakeholders play in
ensuring the safety of the food supply,
which helps ensure that suppliers
produce food that meets U.S. safety
standards.
Occasionally, FDA will need to
communicate with consumers and other
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
stakeholders about immediate health
issues that could affect public health
and safety. This collection of
information allows the use of fast-track
methods of communication such as
quick turnaround surveys, focus groups,
and indepth interviews collected from
consumers and other stakeholders to
communicate FDA issues of immediate
and important public health
significance. We plan on using these
methods of communication to collect
vital public health and safety
information.
For example, these methods of
communication might be used when
there is a foodborne illness outbreak,
food recall, or other situation requiring
expedited FDA food, dietary
supplement, cosmetics, or animal food
or feed communications. So that FDA
may better protect the public health, the
Agency needs quick turnaround
information provided by this collection
of information to help ensure its
messaging has reached the target
audience, has been effective, and, if
needed, to update its communications
during these events.
Respondents to this collection of
information include a wide range of
consumers and other FDA stakeholders
such as producers and manufacturers of
FDA-regulated food and cosmetic
products, dietary supplements, and
animal food and feed. Participation will
be voluntary.
In the Federal Register of April 18,
2022 (87 FR 22906), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although three comments
were received, they were not responsive
to the four collection of information
topics solicited.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\24AUN1.SGM
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]]>Agencies
[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
