Agency Information Collection Request. 30-Day Public Comment Request, 3997-3999 [2023-01196]
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Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
preparedness-and-response/mcm-legalregulatory-and-policy-framework/
emergency-use-authorization.
khammond on DSKJM1Z7X2PROD with NOTICES
III. The Authorizations
Having concluded that the criteria for
the issuance of the following
Authorizations under section 564(c) of
the FD&C Act are met, FDA has
authorized the emergency use of the
following products for diagnosing,
treating, or preventing COVID–19
subject to the terms of each
Authorization. The Authorizations in
their entirety, including any authorized
fact sheets and other written materials,
can be accessed from the FDA web page
entitled ‘‘Emergency Use
Authorization,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow
include Authorizations issued from June
16, 2022, through December 6, 2022,
and we have included explanations of
the reasons for their issuance, as
required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that
have been reissued can be accessed from
FDA’s web page: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
FDA is hereby announcing the
following Authorizations for molecular
diagnostic and antigen tests for COVID–
19, excluding multianalyte tests: 3
• Genabio Diagnostics Inc.’s Genabio
COVID–19 Rapid Self-Test Kit, issued
July 8, 2022;
• Watmind USA’s Speedy Swab Rapid
COVID–19 Antigen Self-Test, issued
July 8, 2022;
• Predicine, Inc.’s Predicine SARS–
CoV–2 RT–PCR Test, issued July 19,
2022;
• Aptitude Medical Systems Inc.’s
Metrix COVID–19 Test, issued
October 18, 2022;
• Nanobiosym Precision Testing
Services’s The Nano Test for COVID–
19, issued November 8, 2022;
• ANP Technologies, Inc.’s NIDS
COVID–19 Antigen Home Test, issued
November 17, 2022;
3 As set forth in the EUAs for these products, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the products may be effective in
diagnosing COVID–19, and that the known and
potential benefits of the products, when used for
diagnosing COVID–19, outweigh the known and
potential risks of such products; and (3) there is no
adequate, approved, and available alternative to the
emergency use of the products.
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• Beijing Hotgen Biotech Co., Ltd.’s
Hotgen COVID–19 Antigen Home
Test, issued November 17, 2022;
• Premier Medical Laboratory Services’s
Diversified Medical Healthcare
SARS–CoV–2 Assay, issued
November 18, 2022;
• CorDx, Inc.’s CorDx COVID–19 Ag
Test, issued November 21, 2022;
• Azure Biotech Inc.’s Fastep COVID–
19 Antigen Home Test, issued
November 21, 2022;
• ACON Laboratories, Inc.’s Flowflex
COVID–19 Antigen Rapid Test, issued
December 6, 2022.
FDA is hereby announcing the
following Authorization for a
multianalyte test:
• Lucira Health, Inc.’s Lucira COVID–19
and Flu Test, issued November 22,
2022.4
FDA is hereby announcing the
following Authorization for a serology
test:
• Diazyme Laboratories, Inc.’s Diazyme
SARS–CoV–2 Neutralizing Antibody
CLIA Kit, issued December 6, 2022.5
In addition, on November 1, 2022,
FDA issued a letter to Developers of
Antigen In Vitro Diagnostics (IVDs)
Authorized for Emergency Use for
Coronavirus Disease 2019 (COVID–19)
as of Today’s Date (November 1, 2022)
for Revisions Related to Serial (Repeat)
Testing for the EUAs of Antigen IVDs.6
4 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19, through the simultaneous
qualitative detection and differentiation of SARS–
CoV–2, influenza A virus, and/or influenza B virus
RNA, and that the known and potential benefits of
the product, when used for diagnosing COVID–19,
outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
5 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing recent or prior infection with SARS–
CoV–2 by identifying individuals with an adaptive
immune response to the virus that causes COVID–
19, and that the known and potential benefits of the
product, when used for such use, outweigh the
known and potential risks of the product; and (3)
there is no adequate, approved, and available
alternative to the emergency use of the product.
6 FDA concluded revisions to the EUAs of the
tests that are within the scope of the November 1,
2022, letter is appropriate to protect the public
health or safety and revised all such EUAs pursuant
to section 564(g)(2)(C) of the FD&C Act, including
to revise the authorized use and to establish the
additional condition set forth in the letter, as
permitted by section 564(e) of the FD&C Act. The
PO 00000
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3997
Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01180 Filed 1–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0945–0003]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 22, 2023.
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 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041. When submitting
comments or requesting information,
please include the document identifier
0945–0003–30D and project title for
reference.
SUMMARY:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
SUPPLEMENTARY INFORMATION:
action is based on the available scientific evidence
on the impact of serial testing on the performance
of SARS–CoV–2 antigen tests. (Refer to:
‘‘Performance of Screening for SARS–CoV–2 using
Rapid Antigen Tests to Detect Incidence of
Symptomatic and Asymptomatic SARS–CoV–2
Infection: findings from the Test Us at Home
prospective cohort study’’ at https://
www.medrxiv.org/content/10.1101/
2022.08.05.22278466v1.) The letter revised all
current EUAs for antigen SARS–CoV–2 IVD devices
as of November 1, 2022, by: (1) revising the
authorized use to be for serial testing at least twice
over 3 days for individuals with symptoms of
COVID–19 and, for tests previously authorized for
testing individuals without symptoms, revising the
authorized use to be for serial testing at least thrice
over 5 days for individuals without symptoms of
COVID–19, (2) establishing a new condition of
authorization regarding updating authorized
labeling, and (3) eliminating a condition of
authorization regarding evaluating clinical
performance to support the serial screening claim.
E:\FR\FM\23JAN1.SGM
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3998
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: HIPAA
Privacy, Security, and Breach
Notification Rules, and Supporting
Regulations Contained in 45 CFR parts
160 and 164.
Type of Collection: Extension
on changes in burden that could result
from the modifications proposed in the
NPRM. On December 2, 2022, OCR
published a second NPRM proposing
additional modifications to the HIPAA
Rules, available at 87 FR 74216. OCR
will also review public comment
received on the 2022 NPRM, and will
update this ICR to reflect the input we
receive on this notice and through the
rulemaking process.
Type of respondent: HIPAA covered
entities, business associates,
individuals, and professional and trade
associations of covered entities and
business associates.
OMB No. 0945–0003: Office for Civil
Rights (OCR)–Health Information
Privacy Division
Abstract: OCR requests approval to
extend this existing, approved
collection for three years without
changing any collection requirements.
No public comments were received. In
2021, OCR published a Notice of
Proposed Rulemaking (NPRM)
proposing modifications to the HIPAA
Rules that would affect the hourly
burdens associated with the HIPAA
Rules. 86 FR 6446. OCR is reviewing
public comment received on the NPRM
about existing burdens associated with
compliance with the HIPAA Rules, and
ESTIMATED ANNUALIZED BURDEN TABLE
Type of respondent
160.204 .........................
Process for Requesting Exception Determinations (states or persons).
Risk Analysis—Documentation [2] .......................
Information System Activity Review—Documentation.
Security Reminders—Periodic Updates ..............
Security Incidents (other than breaches)—Documentation.
Contingency Plan—Testing and Revision ...........
Contingency Plan—Criticality Analysis ................
Maintenance Records ..........................................
Security Incidents—Business Associate reporting of incidents (other than breach) to Covered Entities.
Documentation—Review and Update [3] ............
Individual Notice—Written and E-mail Notice
(drafting) [4].
Individual Notice—Written and E-mail Notice
(preparing and documenting notification).
Individual Notice—Written and E-mail Notice
(processing and sending) [5].
Individual Notice—Substitute Notice (posting or
publishing) [6].
Individual Notice—Substitute Notice (staffing tollfree number) [7].
Individual Notice—Substitute Notice (individuals’
voluntary burden to call toll-free number for information) [8], [9].
Media Notice [10] .................................................
Notice to Secretary (notice for breaches affecting 500 or more individuals).
Notice to Secretary (notice for breaches affecting fewer than 500 individuals) [11].
Business Associate notice to Covered Entity—
500 or more individuals affected.
Business Associate notice to Covered Entity—
Less than 500 individuals affected.
500 or More Affected Individuals (investigating
and documenting breach).
Less than 500 Affected Individuals (investigating
and documenting breach)—affecting 10–499.
Less than 500 Affected Individuals (investigating
and documenting breach)—affecting <10.
Uses and Disclosures—Organizational Requirements.
Uses and Disclosures for Which Individual authorization is required.
Uses and Disclosures for Research Purposes
[12].
164.308 .........................
164.308 .........................
164.308 .........................
164.308 .........................
164.308
164.308
164.310
164.314
.........................
.........................
.........................
.........................
164.316 .........................
164.404 .........................
164.404 .........................
164.404 .........................
164.404 .........................
164.404 .........................
164.404 .........................
164.406 .........................
164.408 .........................
164.408 .........................
164.410 .........................
164.410 .........................
164.414 .........................
khammond on DSKJM1Z7X2PROD with NOTICES
164.414 .........................
164.414 .........................
164.504 .........................
164.508 .........................
164.512 .........................
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Jkt 259001
PO 00000
Frm 00033
Number of
responses per
respondent
Number of
respondents
Section
Fmt 4703
Sfmt 4703
Average
burden hours
per response
[1]
Total burden
hours
1
1
16
16
1,700,000
1,700,000
1
12
10
0.75
17,000,000
15,300,000
1,700,000
1,700,000
12
52
1
5
20,400,000
442,000,000
1,700,000
1,700,000
1,700,000
1,000,000
1
1
12
12
8
4
6
20
13,600,000
6,800,000
122,400,000
240,000,000
1,700,000
58,482
1
1
6
0.5
10,200,000
29,241
58,482
1
0.5
29,241
58,482
1,941
0.008
908,108
2,746
1
1
2,746
2,746
1
3.42
9,391
113,264
1
0.125
14,158
267
267
1
1
1.25
1.25
334
334
58,215
1
1
58,215
20
1
50
1,000
1,165
1
8
9,320
267
1
50
13,350
2,479
1
8
19,832
55,736
1
4
222,944
700,000
1
0.083333333
58,333
700,000
1
1
700,000
113,524
1
0.083333333
9,460
E:\FR\FM\23JAN1.SGM
23JAN1
3999
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Number of
responses per
respondent
Average
burden hours
per response
[1]
Total burden
hours
Type of respondent
164.520 .........................
Notice of Privacy Practices for Protected Health
Information (health plans—periodic distribution
of NPPs by paper mail) [13], [18].
Notice of Privacy Practices for Protected Health
Information (health plans—periodic distribution
of NPPs by electronic mail) [19].
Notice of Privacy Practices for Protected Health
Information (health care providers—dissemination and acknowledgement) [14].
Rights to Request Privacy Protection for Protected Health Information [15].
Access of Individuals to Protected Health Information (disclosures) [16].
Amendment of Protected Health Information (requests).
Amendment of Protected Health Information (denials).
Accounting for Disclosures of Protected Health
Information [17].
100,000,000
1
0.004166667
416,667
100,000,000
1
0.002783333
278,333
613,000,000
1
0.05
30,650,000
20,000
1
0.05
1,000
200,000
1
0.05
10,000
150,000
1
0.083333333
12,500
50,000
1
0.083333333
4,167
5,000
1
0.05
250
..............................................................................
........................
2,070
........................
921,158,940
164.520 .........................
164.520 .........................
164.522 .........................
164.524 .........................
164.526 .........................
164.526 .........................
164.528 .........................
Total .......................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–01196 Filed 1–20–23; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Privacy Act of 1974; System
of Records
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice of a new system of
records.
AGENCY:
In accordance with the
Privacy Act, the Department of Health
and Human Services (HHS) is
establishing a new system of records to
be maintained by the Office of
Infectious Disease and HIV/AIDS Policy
within the Office of the Assistant
Secretary for Health (OASH/OIDP),
System No. 09–90–2101 ‘‘HIV
Prevention Medication Distribution
Records.’’ The new system of records
will consist of records about individual
patients who participate in the Ending
the HIV Epidemic—Pre-Exposure
Prophylaxis Implementation and
Distribution Services Program (PrEP
Program), which will provide donated
HIV prevention medication to patients
in the United States who are at
substantial risk of acquiring the human
immunodeficiency virus (HIV).
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Section
VerDate Sep<11>2014
16:44 Jan 20, 2023
Jkt 259001
In accordance with 5 U.S.C.
552a(e)(4) and (11), this notice is
effective upon publication, subject to a
30-day period in which to comment on
the routine uses, described below.
Please submit any comments by
February 22, 2023.
ADDRESSES: The public should submit
comments on the new system of records
by email to ann.abercrombie@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records may be submitted to Ann
Abercrombie, OASH/OIDP at (202) 401–
9588, or ann.abercrombie@hhs.gov.
SUPPLEMENTARY INFORMATION: Within the
U.S. Department of Health and Human
Services (HHS), the Office of the
Assistant Secretary for Health (OASH)
leads development of agency-wide
public health policy recommendations
and oversees core public health offices,
including the Office of the Surgeon
General and the U.S. Public Health
Service Commissioned Corps, as well as
10 regional health offices across the
nation and 10 presidential and
secretarial advisory committees. The
mission of the Office of Infectious
Disease and HIV/AIDS Policy (OIDP) is
to provide strategic leadership and
management, while encouraging
collaboration, coordination, and
innovation among federal agencies and
stakeholders to reduce the burden of
infectious diseases, including the
human immunodeficiency virus (HIV).
The initiative to End the HIV
Epidemic in the U.S. is part of a
national HIV prevention and control
DATES:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
effort to reduce the number of new HIV
infections by 75% in five years and 90%
in 10 years. A key component of the
initiative is expanding access to HIV
prevention medication for patients who
are at substantial risk of acquiring the
disease. Pursuant to a donation
agreement executed May 8, 2019, a drug
manufacturer, Gilead Sciences, Inc.
(Gilead), donated certain HIV
prevention medication (emtricitabine/
tenofovir disoproxil fumarate and
emtricitabine/tenofovir alafenamide
tablets, collectively referred to as
‘‘Product’’) to HHS for distribution
through the Ending the HIV Epidemic—
Pre-Exposure Prophylaxis (PrEP)
Implementation and Distribution
Services Program (PrEP Program), which
will be administered by OASH/OIDP
subject to the terms of the donation
agreement between Gilead and HHS.
Under the terms of the donation
agreement, Gilead will donate Product
for up to 200,000 individuals each year
up to end of 2030 or earlier. The PrEP
Program, through a contractor engaged
by OASH/OIDP, will issue an
enrollment card or electronic
enrollment confirmation, containing a
unique identification number, to each
qualified eligible patient in the United
States who applies to the program (up
to 200,000 individuals per year). This
will enable the patient to obtain the
Product at no cost, either in person or
by mail, from a participating pharmacy.
The contractor will operate a mail order
pharmacy to acquire the Product from
Gilead and dispense it to patients who
elect to receive the Product by mail. The
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Pages 3997-3999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01196]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0945-0003]
Agency Information Collection Request. 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before February 22,
2023.
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 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041. When submitting comments or requesting information,
please include the document identifier 0945-0003-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of
[[Page 3998]]
information, including any of the following subjects: (1) The necessity
and utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Title of the Collection: HIPAA Privacy, Security, and Breach
Notification Rules, and Supporting Regulations Contained in 45 CFR
parts 160 and 164.
Type of Collection: Extension
OMB No. 0945-0003: Office for Civil Rights (OCR)-Health Information
Privacy Division
Abstract: OCR requests approval to extend this existing, approved
collection for three years without changing any collection
requirements. No public comments were received. In 2021, OCR published
a Notice of Proposed Rulemaking (NPRM) proposing modifications to the
HIPAA Rules that would affect the hourly burdens associated with the
HIPAA Rules. 86 FR 6446. OCR is reviewing public comment received on
the NPRM about existing burdens associated with compliance with the
HIPAA Rules, and on changes in burden that could result from the
modifications proposed in the NPRM. On December 2, 2022, OCR published
a second NPRM proposing additional modifications to the HIPAA Rules,
available at 87 FR 74216. OCR will also review public comment received
on the 2022 NPRM, and will update this ICR to reflect the input we
receive on this notice and through the rulemaking process.
Type of respondent: HIPAA covered entities, business associates,
individuals, and professional and trade associations of covered
entities and business associates.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden hours Total burden
Section respondent respondents responses per per response hours
respondent [1]
----------------------------------------------------------------------------------------------------------------
160.204....................... Process for 1 1 16 16
Requesting
Exception
Determinations
(states or
persons).
164.308....................... Risk Analysis-- 1,700,000 1 10 17,000,000
Documentation
[2].
164.308....................... Information 1,700,000 12 0.75 15,300,000
System Activity
Review--Documen
tation.
164.308....................... Security 1,700,000 12 1 20,400,000
Reminders--Peri
odic Updates.
164.308....................... Security 1,700,000 52 5 442,000,000
Incidents
(other than
breaches)--Docu
mentation.
164.308....................... Contingency 1,700,000 1 8 13,600,000
Plan--Testing
and Revision.
164.308....................... Contingency 1,700,000 1 4 6,800,000
Plan--Criticali
ty Analysis.
164.310....................... Maintenance 1,700,000 12 6 122,400,000
Records.
164.314....................... Security 1,000,000 12 20 240,000,000
Incidents--Busi
ness Associate
reporting of
incidents
(other than
breach) to
Covered
Entities.
164.316....................... Documentation--R 1,700,000 1 6 10,200,000
eview and
Update [3].
164.404....................... Individual 58,482 1 0.5 29,241
Notice--Written
and E-mail
Notice
(drafting) [4].
164.404....................... Individual 58,482 1 0.5 29,241
Notice--Written
and E-mail
Notice
(preparing and
documenting
notification).
164.404....................... Individual 58,482 1,941 0.008 908,108
Notice--Written
and E-mail
Notice
(processing and
sending) [5].
164.404....................... Individual 2,746 1 1 2,746
Notice--Substit
ute Notice
(posting or
publishing) [6].
164.404....................... Individual 2,746 1 3.42 9,391
Notice--Substit
ute Notice
(staffing toll-
free number)
[7].
164.404....................... Individual 113,264 1 0.125 14,158
Notice--Substit
ute Notice
(individuals'
voluntary
burden to call
toll-free
number for
information)
[8], [9].
164.406....................... Media Notice 267 1 1.25 334
[10].
164.408....................... Notice to 267 1 1.25 334
Secretary
(notice for
breaches
affecting 500
or more
individuals).
164.408....................... Notice to 58,215 1 1 58,215
Secretary
(notice for
breaches
affecting fewer
than 500
individuals)
[11].
164.410....................... Business 20 1 50 1,000
Associate
notice to
Covered Entity--
500 or more
individuals
affected.
164.410....................... Business 1,165 1 8 9,320
Associate
notice to
Covered Entity--
Less than 500
individuals
affected.
164.414....................... 500 or More 267 1 50 13,350
Affected
Individuals
(investigating
and documenting
breach).
164.414....................... Less than 500 2,479 1 8 19,832
Affected
Individuals
(investigating
and documenting
breach)--affect
ing 10-499.
164.414....................... Less than 500 55,736 1 4 222,944
Affected
Individuals
(investigating
and documenting
breach)--affect
ing <10.
164.504....................... Uses and 700,000 1 0.083333333 58,333
Disclosures--Or
ganizational
Requirements.
164.508....................... Uses and 700,000 1 1 700,000
Disclosures for
Which
Individual
authorization
is required.
164.512....................... Uses and 113,524 1 0.083333333 9,460
Disclosures for
Research
Purposes [12].
[[Page 3999]]
164.520....................... Notice of 100,000,000 1 0.004166667 416,667
Privacy
Practices for
Protected
Health
Information
(health plans--
periodic
distribution of
NPPs by paper
mail) [13],
[18].
164.520....................... Notice of 100,000,000 1 0.002783333 278,333
Privacy
Practices for
Protected
Health
Information
(health plans--
periodic
distribution of
NPPs by
electronic
mail) [19].
164.520....................... Notice of 613,000,000 1 0.05 30,650,000
Privacy
Practices for
Protected
Health
Information
(health care
providers--diss
emination and
acknowledgement
) [14].
164.522....................... Rights to 20,000 1 0.05 1,000
Request Privacy
Protection for
Protected
Health
Information
[15].
164.524....................... Access of 200,000 1 0.05 10,000
Individuals to
Protected
Health
Information
(disclosures)
[16].
164.526....................... Amendment of 150,000 1 0.083333333 12,500
Protected
Health
Information
(requests).
164.526....................... Amendment of 50,000 1 0.083333333 4,167
Protected
Health
Information
(denials).
164.528....................... Accounting for 5,000 1 0.05 250
Disclosures of
Protected
Health
Information
[17].
---------------------------------------------------------------
Total..................... ................ .............. 2,070 .............. 921,158,940
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2023-01196 Filed 1-20-23; 8:45 am]
BILLING CODE 4153-01-P
