Agency Information Collection Request. 60-Day Public Comment Request, 34905-34907 [2019-15323]
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34905
Federal Register / Vol. 84, No. 139 / Friday, July 19, 2019 / Notices
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2019–15389 Filed 7–18–19; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0945–0003–60D]
Agency Information Collection
Request. 60-Day Public Comment
Request
AGENCY:
ACTION:
Office of the Secretary, HHS.
Notice.
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.
SUMMARY:
Comments on the ICR must be
received on or before September 17,
2019.
DATES:
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0945–0003–
60D, and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
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
ADDRESSES:
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: Office for Civil Rights (OCR)
requests approval to extend this
existing, approved collection without
changing any collecting requirements
while OCR obtains public comment
through a Notice of Proposed
Rulemaking (NPRM) proposing
modifications to the HIPAA Rules that
will affect the hourly burdens associated
with the Rules. When the NPRM is
published, we expect to receive robust
public comment on existing burdens
associated with compliance with the
HIPAA Rules and on changes in burden
that could result from the modifications
proposed in the NPRM. OCR will
update this ICR to reflect the input we
receive on this notice and through the
rulemaking process.
Likely Respondents: HIPAA covered
entities, business associates,
individuals, and professional and trade
associations of covered entities and
business associates.
jbell on DSK3GLQ082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOUR TABLE
Number of
responses per
respondents
Respondents
(if necessary)
45 CFR 160.204: Process for Requesting
Exception Determinations (states or persons).
45 CFR 164.308: Risk Analysis—Documentation.
45 CFR 164.308: Information System Activity Review—Documentation.
45 CFR 164.308: Security Reminders—
Periodic Updates.
45 CFR 164.308: Security Incidents (other
than breaches)—Documentation.
45 CFR 164.308: Contingency Plan—Testing and Revision.
45 CFR 164.308: Contingency Plan—Criticality Analysis.
45 CFR 164.310: Maintenance Records ......
A state’s chief elected official
or designee.
1
1
16
16
Covered entities; business
associates.
Covered entities; business
associates.
Covered entities; business
associates.
Covered entities; business
associates.
Covered entities; business
associates.
Covered entities; business
associates.
Covered entities; business
associates.
Business associates .............
1,700,000
1
10
17,000,000
1,700,000
12
0.75
15,300,000
1,700,000
12
1
20,400,000
1,700,000
52
5
442,000,000
1,700,000
1
8
13,600,000
1,700,000
1
4
6,800,000
1,700,000
12
6
122,400,000
1,000,000
12
20
240,000,000
Covered entities; business
associates.
Covered entities ....................
1,700,000
1
6
10,200,000
58,481
1
0.5
29,241
Covered entities ....................
58,481
1
0.5
29,241
Covered entities ....................
58,481
353
0.008
165,150
Covered entities ....................
2,746
1
1
2,746
Covered entities ....................
2,746
1
5.75
15,790
45 CFR 164.314: Security Incidents—Business Associate reporting of incidents
(other than breach) to Covered Entities.
45 CFR 164.316: Documentation—Review
and Update.
45 CFR 164.404: Individual Notice—Written
and E-mail Notice (drafting).
45 CFR 164.404: Individual Notice—Written
and E-mail Notice (preparing and documenting notification).
45 CFR 164.404: Individual Notice—Written
and E-mail Notice (processing and sending).
45 CFR 164.404: Individual Notice—Substitute Notice (posting or publishing).
45 CFR 164.404: Individual Notice—Substitute Notice (staffing toll-free number).
VerDate Sep<11>2014
18:36 Jul 18, 2019
Jkt 247001
PO 00000
Frm 00057
Fmt 4703
Number of
respondents
Average
burden per
response
Forms
(if necessary)
Sfmt 4703
E:\FR\FM\19JYN1.SGM
19JYN1
Total burden
hours
34906
Federal Register / Vol. 84, No. 139 / Friday, July 19, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOUR TABLE—Continued
45 CFR 164.404: Individual Notice—Substitute Notice (individuals’ voluntary burden to call toll-free number for information).
45 CFR 164.406: Media Notice ....................
45 CFR 164.408: Notice to Secretary (notice for breaches affecting 500 or more individuals).
45 CFR 164.408: Notice to Secretary (notice for breaches affecting <500 individuals).
45 CFR 164.410: Business associate notice
to covered entity—500 or more Affected
Individuals.
45 CFR 164.410: Business associate notice
to covered entity—Less than 500 Affected
Individuals.
45 CFR 164.414: 500 or More Affected Individuals (investigating and documenting
breach).
45 CFR 164.414: Less than 500 Affected
Individuals (investigating and documenting breach)—affecting 10–499.
45 CFR 164.414: Less than 500 Affected
Individuals (investigating and documenting breach)—affecting <10.
45 CFR 164.504: Uses and Disclosures—
Organizational Requirements.
45 CFR 164.508: Uses and Disclosures for
Which Individual authorization is required.
45 CFR 164.512: Uses and Disclosures for
Research Purposes.
45 CFR 164.520: Notice of Privacy Practices for Protected Health Information
(health plans—periodic distribution of
NPPs by paper mail).
45 CFR 164.520: Notice of Privacy Practices for Protected Health Information
(health plans—periodic distribution of
NPPs by electronic mail).
45 CFR 164.520: Notice of Privacy Practices for Protected Health Information
(health care providers—dissemination and
acknowledgement).
45 CFR 164.522: Rights to Request Privacy
Protection for Protected Health Information.
45 CFR 164.524: Access of Individuals to
Protected Health Information (disclosures).
Covered entities ....................
11,326,440
1
0.125
1,415,805
Covered entities ....................
Covered entities ....................
267
267
1
1
1.25
1.25
334
334
Covered entities ....................
58,215
1
1
58,215
Business associates .............
20
1
50
1,000
Business associates .............
1,165
1
8
9,320
Covered entities ....................
267
1
50
13,350
Covered entities ....................
2,479
1
8
19,832
Covered entities ....................
55,736
1
4
222,944
Covered entities ....................
700,000
1
0.083333333
58,333
Covered entities ....................
700,000
1
1
700,000
Covered entities ....................
113,524
1
0.083333333
9,460
Covered entities—health
plans.
100,000,000
1
0.004166667
416,667
Covered entities—health
plans.
100,000,000
1
0.002783333
278,333
Covered entities—health
care providers.
613,000,000
1
0.5
30,650,000
Covered entities—health
care providers, health
plans.
Covered entities—health
care providers, health
plans, clearinghouses.
Covered entities—health
care providers, health
plans, clearinghouses.
Covered entities—health
care providers, health
plans, clearinghouses.
Covered entities—health
care providers, health
plans, clearinghouses.
20,000
1
0.5
1,000
200,000
1
0.5
10,000
150,000
1
0.083333333
12,500
50,000
1
0.083333333
4,167
5,000
1
0.05
250
........................
........................
........................
921,824,027
45 CFR 164.526: Amendment of Protected
Health Information (denials).
45 CFR 164.528: Accounting for Disclosures of Protected Health Information.
Total ...................................................
jbell on DSK3GLQ082PROD with NOTICES
Average
burden per
response
Respondents
(if necessary)
45 CFR 164.526: Amendment of Protected
Health Information (requests).
VerDate Sep<11>2014
18:36 Jul 18, 2019
Jkt 247001
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
...............................................
PO 00000
Frm 00058
Fmt 4703
Sfmt 9990
E:\FR\FM\19JYN1.SGM
19JYN1
Total burden
hours
34907
Federal Register / Vol. 84, No. 139 / Friday, July 19, 2019 / Notices
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2019–15323 Filed 7–18–19; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0001]
Agency Information Collection
Request. 30-Day Public Comment
Request
AGENCY:
ACTION:
Office of the Secretary, HHS.
Notice.
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
SUMMARY:
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 Collections: Application
for Federal Assistance SF–424 Research
and Related Forms.
Type of Collection: Reinstatement
without change.
OMB No. 4040–0002.
Abstract: The SF–424 Research and
Related Forms provide the Federal
grant-making agencies an alternative to
the Standard Form 424 data set and
form. Agencies may use the SF–424
Research and Related Forms for grant
programs not required to collect all the
data that is required on the SF–424 core
data set and form. The IC expires on 10/
31/2019. We are seeking an extension of
this information collection and a threeyear clearance.
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before August 19, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: Ed
Calimag, ed.calimag@hhs.gov or (202)
690–7569. When submitting comments
or requesting information, please
include the document identifier 4040–
0001–30D 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
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
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Forms
Average
burden hours
per response
Total burden
hours
SF–424 R&R Multi-Project Cover ....................................................................
SF424 (R&R ) ..................................................................................................
SBIR/STTR Information ...................................................................................
RR FedNonFed Budget ...................................................................................
Research and Related Senior/Key Person Profile (Expanded) ......................
Research And Related Other Project Information ...........................................
Research & Related Budget ............................................................................
Research & Related Subaward Budget (Total Fed + Non-Fed) Attachment(s) Form ................................................................................................
Research & Related Subaward Budget (Total Fed + Non-Fed) 5 YR 30 ATT
Research & Related Senior/Key Person Profile ..............................................
Research & Related Personal Data ................................................................
Research & Related Multi-Project 10 Year Budget .........................................
Research & Related Budget 10YR ..................................................................
R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT ............................
R&R Subaward Budget Attachment(s) Form 10 YR 30 ATT ..........................
R&R Subaward Budget Attachment(s) Form 10 YR 10 ATT ..........................
R&R Subaward Budget Attachment(s) Form ..................................................
R&R R Multi-Project Subaward Budget Attachment(s) Form 10 YR 30 ATT
1,519
109,455
6,376
0
108,543
37,603
63,909
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1,159
109,455
6,376
0
108,543
37,603
63,909
0
0
695
0
3,847
0
59,767
1,023
0
271
1,023
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0
0
695
0
3,847
0
59,767
1,023
0
271
1,023
Total ..........................................................................................................
394,031
........................
........................
394,031
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2019–15388 Filed 7–18–19; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
[Document Identifier: OS–4040–0004]
Agency Information Collection
Request. 30-Day Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
VerDate Sep<11>2014
18:36 Jul 18, 2019
Jkt 247001
ACTION:
Notice.
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 August 19, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: Ed
Calimag, ed.calimag@hhs.gov or (202)
690–7569. When submitting comments
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
or requesting information, please
include the document identifier 4040–
0004–30D and project title for reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 84, Number 139 (Friday, July 19, 2019)]
[Notices]
[Pages 34905-34907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15323]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0945-0003-60D]
Agency Information Collection Request. 60-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 September 17,
2019.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0945-0003-60D, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, [email protected], or call 202-795-7714.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of 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: Office for Civil Rights (OCR) requests approval to extend
this existing, approved collection without changing any collecting
requirements while OCR obtains public comment through a Notice of
Proposed Rulemaking (NPRM) proposing modifications to the HIPAA Rules
that will affect the hourly burdens associated with the Rules. When the
NPRM is published, we expect to receive robust public comment on
existing burdens associated with compliance with the HIPAA Rules and on
changes in burden that could result from the modifications proposed in
the NPRM. OCR will update this ICR to reflect the input we receive on
this notice and through the rulemaking process.
Likely Respondents: HIPAA covered entities, business associates,
individuals, and professional and trade associations of covered
entities and business associates.
Estimated Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms (if necessary) Respondents (if Number of responses per Average burden Total burden
necessary) respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
45 CFR 160.204: Process for A state's chief 1 1 16 16
Requesting Exception elected
Determinations (states or official or
persons). designee.
45 CFR 164.308: Risk Analysis-- Covered 1,700,000 1 10 17,000,000
Documentation. entities;
business
associates.
45 CFR 164.308: Information Covered 1,700,000 12 0.75 15,300,000
System Activity Review-- entities;
Documentation. business
associates.
45 CFR 164.308: Security Covered 1,700,000 12 1 20,400,000
Reminders--Periodic Updates. entities;
business
associates.
45 CFR 164.308: Security Covered 1,700,000 52 5 442,000,000
Incidents (other than entities;
breaches)--Documentation. business
associates.
45 CFR 164.308: Contingency Covered 1,700,000 1 8 13,600,000
Plan--Testing and Revision. entities;
business
associates.
45 CFR 164.308: Contingency Covered 1,700,000 1 4 6,800,000
Plan--Criticality Analysis. entities;
business
associates.
45 CFR 164.310: Maintenance Covered 1,700,000 12 6 122,400,000
Records. entities;
business
associates.
45 CFR 164.314: Security Business 1,000,000 12 20 240,000,000
Incidents--Business Associate associates.
reporting of incidents (other
than breach) to Covered
Entities.
45 CFR 164.316: Documentation-- Covered 1,700,000 1 6 10,200,000
Review and Update. entities;
business
associates.
45 CFR 164.404: Individual Covered entities 58,481 1 0.5 29,241
Notice--Written and E-mail
Notice (drafting).
45 CFR 164.404: Individual Covered entities 58,481 1 0.5 29,241
Notice--Written and E-mail
Notice (preparing and
documenting notification).
45 CFR 164.404: Individual Covered entities 58,481 353 0.008 165,150
Notice--Written and E-mail
Notice (processing and
sending).
45 CFR 164.404: Individual Covered entities 2,746 1 1 2,746
Notice--Substitute Notice
(posting or publishing).
45 CFR 164.404: Individual Covered entities 2,746 1 5.75 15,790
Notice--Substitute Notice
(staffing toll-free number).
[[Page 34906]]
45 CFR 164.404: Individual Covered entities 11,326,440 1 0.125 1,415,805
Notice--Substitute Notice
(individuals' voluntary
burden to call toll-free
number for information).
45 CFR 164.406: Media Notice.. Covered entities 267 1 1.25 334
45 CFR 164.408: Notice to Covered entities 267 1 1.25 334
Secretary (notice for
breaches affecting 500 or
more individuals).
45 CFR 164.408: Notice to Covered entities 58,215 1 1 58,215
Secretary (notice for
breaches affecting <500
individuals).
45 CFR 164.410: Business Business 20 1 50 1,000
associate notice to covered associates.
entity--500 or more Affected
Individuals.
45 CFR 164.410: Business Business 1,165 1 8 9,320
associate notice to covered associates.
entity--Less than 500
Affected Individuals.
45 CFR 164.414: 500 or More Covered entities 267 1 50 13,350
Affected Individuals
(investigating and
documenting breach).
45 CFR 164.414: Less than 500 Covered entities 2,479 1 8 19,832
Affected Individuals
(investigating and
documenting breach)--
affecting 10-499.
45 CFR 164.414: Less than 500 Covered entities 55,736 1 4 222,944
Affected Individuals
(investigating and
documenting breach)--
affecting <10.
45 CFR 164.504: Uses and Covered entities 700,000 1 0.083333333 58,333
Disclosures--Organizational
Requirements.
45 CFR 164.508: Uses and Covered entities 700,000 1 1 700,000
Disclosures for Which
Individual authorization is
required.
45 CFR 164.512: Uses and Covered entities 113,524 1 0.083333333 9,460
Disclosures for Research
Purposes.
45 CFR 164.520: Notice of Covered 100,000,000 1 0.004166667 416,667
Privacy Practices for entities--healt
Protected Health Information h plans.
(health plans--periodic
distribution of NPPs by paper
mail).
45 CFR 164.520: Notice of Covered 100,000,000 1 0.002783333 278,333
Privacy Practices for entities--healt
Protected Health Information h plans.
(health plans--periodic
distribution of NPPs by
electronic mail).
45 CFR 164.520: Notice of Covered 613,000,000 1 0.5 30,650,000
Privacy Practices for entities--healt
Protected Health Information h care
(health care providers-- providers.
dissemination and
acknowledgement).
45 CFR 164.522: Rights to Covered 20,000 1 0.5 1,000
Request Privacy Protection entities--healt
for Protected Health h care
Information. providers,
health plans.
45 CFR 164.524: Access of Covered 200,000 1 0.5 10,000
Individuals to Protected entities--healt
Health Information h care
(disclosures). providers,
health plans,
clearinghouses.
45 CFR 164.526: Amendment of Covered 150,000 1 0.083333333 12,500
Protected Health Information entities--healt
(requests). h care
providers,
health plans,
clearinghouses.
45 CFR 164.526: Amendment of Covered 50,000 1 0.083333333 4,167
Protected Health Information entities--healt
(denials). h care
providers,
health plans,
clearinghouses.
45 CFR 164.528: Accounting for Covered 5,000 1 0.05 250
Disclosures of Protected entities--healt
Health Information. h care
providers,
health plans,
clearinghouses.
---------------------------------------------------------------
Total................... ................ .............. .............. .............. 921,824,027
----------------------------------------------------------------------------------------------------------------
[[Page 34907]]
Terry Clark,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2019-15323 Filed 7-18-19; 8:45 am]
BILLING CODE 4150-28-P
