60-day FRN

published 60-FRN day 0945-0003.pdf

Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164

60-day FRN

OMB: 0945-0003

Document [pdf]
Download: pdf | pdf
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
[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
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).

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18:36 Jul 18, 2019

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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

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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
[email protected] or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: Ed
Calimag, [email protected] 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
[email protected] or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: Ed
Calimag, [email protected] 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:

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