Agency Information Collection Request. 30-Day Public Comment Request, 51604-51606 [2019-21031]
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51604
Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Notices
Auditorium, Hyattsville, Maryland
20782.
Status: Open.
Purpose: At the November 13–14,
2019 meeting, the Committee will
deliberate draft recommendations for
the HHS Secretary, continue with
activities outlined in the NCVHS 2019
workplan, and hold discussions on
several health data policy topics.
Anticipated action items during this
meeting include a letter that outlines
recommendations to the Secretary
regarding preparations for
implementation of ICD–11 and
accompanying proposed research and
communication agendas developed by
the Committee.
The Subcommittee on Standards will
report on continued progress on the
elements of a Predictability Roadmap in
follow up to its July 2019 visioning
meeting and December 2018 hearing—
including continued focus on the
function and purpose of the Designated
Standards Maintenance Organizations
(DSMOs) in light of changes in the
health care standards environment and
the need for harmonization of
administrative and clinical standards.
The Subcommittee anticipates
continuing discussion and possible
activities in collaboration with the
Office of the National Coordinator for
Health Information and Technology
(ONC) regarding the opportunity for
burden reduction through convergence
of administrative and clinical data
standards using the prior authorization
transaction as a use-case.
The Subcommittee on Privacy,
Confidentiality and Security will lead a
discussion of the full Committee on
assessing priority areas for focus and
activity. The Subcommittee on
Population Health will lead discussion
on the Federal Data Strategy Year One
Action Plan. Finally, the Committee will
consider and discuss its workplan for
calendar year 2020 together with the
NCVHS Strategic Plan.
The times and topics are subject to
change. Please refer to the posted
agenda for any updates.
Contact Person For More Information:
Substantive program information may
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, telephone (301) 458–4715.
Summaries of meetings and a roster of
VerDate Sep<11>2014
19:16 Sep 27, 2019
Jkt 247001
Committee members are available on the
home page of the NCVHS website:
www.ncvhs.hhs.gov, where further
information including an agenda and
instructions to access the broadcast of
the meeting will also be posted.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (770) 488–3210 as soon
as possible.
Dated: September 24, 2019.
Sharon Arnold,
Associate Deputy Assistant Secretary for
Planning and Evaluation, Science and Data
Policy, Office of the Assistant Secretary for
Planning and Evaluation.
[FR Doc. 2019–21074 Filed 9–27–19; 8:45 am]
BILLING CODE 4150–05–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 Information
Collection Request (ICR) must be
received on or before October 30, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0945–0003–New–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
SUMMARY:
PO 00000
Frm 00097
Fmt 4703
Sfmt 4703
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 collection 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. This notice does,
however, make the following revisions
to estimates provided in the 60-day
public comment request, which do not
change the collection requirements: (1)
Lower the estimated number of
individuals who call an entity’s toll-free
number for information after being
affected by a breach requiring substitute
notice to reflect a more realistic estimate
of the proportion of individuals who
choose to call; and (2) correct an error
from the 2016 ICR notice that
underestimated the average number of
individuals affected per breach because
it relied on older breach data. This
notice also incorporates data from the
60-day public comment request which
recognizes for the first time the burdens
resulting from the pre-existing, ongoing
requirements for business associates to
report breaches of PHI to their covered
entities.
We did not receive public comment
on the 60-day public comment request
published on July 19, 2019. 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.
Likely Respondents: HIPAA covered
entities, business associates,
individuals, and professional and trade
associations of covered entities and
business associates.
E:\FR\FM\30SEN1.SGM
30SEN1
51605
Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses per
respondents
Total
burden
hours
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
58,482
1
0.5
29,241
Covered entities .......................
58,482
1
0.5
29,241
Covered entities .......................
58,482
1,941
0.008
908,108
Covered entities .......................
2,746
1
1
2,746
Covered entities .......................
2,746
1
3.42
9,391
Covered entities .......................
113,264
1
0.125
14,158
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
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 Email Notice (drafting).
45 CFR 164.404 Individual Notice—Written and Email Notice (preparing and
documenting notification).
45 CFR 164.404 Individual Notice—Written and Email 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).
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 less than
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 165.512 Uses and Disclosures
for Research Purposes.
VerDate Sep<11>2014
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Number of
respondents
Average
burden per
response
Forms
(if necessary)
Sfmt 4703
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51606
Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Total
burden
hours
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).
45 CFR 164.526 Amendment of Protected
Health Information (requests).
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
0.05
30,650,000
Covered entities—health care
providers, health plans.
20,000
1
0.05
1,000
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.
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
........................
........................
........................
921,158,941
45 CFR 164.528 Accounting for Disclosures of Protected Health Information.
Total ...................................................
..................................................
Debbie Kramer,
HHS Information Collection Reports
Clearance Officer.
[FR Doc. 2019–21031 Filed 9–27–19; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders & Stroke (NINDS); Notice of
Organizational Change
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Neurological Disorders and Stroke
(NINDS) will launch a public
information website and host a webinar
to enable public discussion regarding
NINDS proposal to reorganize the Office
of Communications and Public Liaison
and Office of Scientific Liaison.
DATES: NINDS will launch public
website information at https://
www.ninds.nih.gov/About-NINDS/
Public-Hearing-NINDS-OfficeNeuroscience-Communications-andEngagement-Proposal on October 01,
2019. A public webinar will be held on
SUMMARY:
VerDate Sep<11>2014
19:16 Sep 27, 2019
Jkt 247001
Number of
respondents
Average
burden per
response
Respondents
(if necessary)
45 CFR 164.526 Amendment of Protected
Health Information (denials).
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondents
Forms
(if necessary)
October 17, 2019 at 1:00 p.m. EST. A
recording of the webinar will be posted
no later than October 18, 2019 at 3:00
p.m. EST. Any interested person may
file written comments by sending an
email to NINDSReorgComments@
nih.gov by October 31, 2019. The
statement should include the
individual’s name, and when
applicable, professional affiliation.
NINDS will respond to comments by
email no later than November 07, 2019.
ADDRESSES: The following email address
has been established for questions and/
or comments on the reorganization:
NINDSReorgComments@nih.gov.
FOR FURTHER INFORMATION CONTACT:
Mary Coats, Management Analyst,
National Institute of Neurological
Disorders & Stroke (NINDS),
NINDSReorgComments@nih.gov, 301–
594–4489.
SUPPLEMENTARY INFORMATION: Pursuant
to the NIH Reform Act of 2006 (42
U.S.C. Sec. 281 (d)(4)), NINDS will
launch a public information website at
https://www.ninds.nih.gov/AboutNINDS/Public-Hearing-NINDS-OfficeNeuroscience-Communications-andEngagement-Proposal and host a
webinar to enable public discussion
regarding NINDS proposal to reorganize
the Office of Communications and
Public Liaison and Office of Scientific
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
Liaison. Details of the reorganization
and information regarding the webinar
is available on the Institute’s website at
https://www.ninds.nih.gov/AboutNINDS/Public-Hearing-NINDS-OfficeNeuroscience-Communications-andEngagement-Proposal.
This reorganization will support
efforts to Optimize NIH as it will foster
greater collaboration and sharing of
resources across NINDS.
Dated: September 19, 2019.
Walter J. Koroshetz,
Director, National Institute of Neurological
Disorders and Stroke, National Institutes of
Health.
[FR Doc. 2019–21189 Filed 9–27–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting. The meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
E:\FR\FM\30SEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51604-51606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21031]
-----------------------------------------------------------------------
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 Information Collection Request (ICR) must be
received on or before October 30, 2019.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0945-0003-New-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 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 collection
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. This
notice does, however, make the following revisions to estimates
provided in the 60-day public comment request, which do not change the
collection requirements: (1) Lower the estimated number of individuals
who call an entity's toll-free number for information after being
affected by a breach requiring substitute notice to reflect a more
realistic estimate of the proportion of individuals who choose to call;
and (2) correct an error from the 2016 ICR notice that underestimated
the average number of individuals affected per breach because it relied
on older breach data. This notice also incorporates data from the 60-
day public comment request which recognizes for the first time the
burdens resulting from the pre-existing, ongoing requirements for
business associates to report breaches of PHI to their covered
entities.
We did not receive public comment on the 60-day public comment
request published on July 19, 2019. 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.
Likely Respondents: HIPAA covered entities, business associates,
individuals, and professional and trade associations of covered
entities and business associates.
[[Page 51605]]
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average
Forms (if necessary) Respondents (if Number of responses per burden per Total burden
necessary) respondents respondents 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 58,482 1 0.5 29,241
Notice--Written and Email
Notice (drafting).
45 CFR 164.404 Individual Covered entities 58,482 1 0.5 29,241
Notice--Written and Email
Notice (preparing and
documenting notification).
45 CFR 164.404 Individual Covered entities 58,482 1,941 0.008 908,108
Notice--Written and Email
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 3.42 9,391
Notice--Substitute Notice
(staffing toll-free number).
45 CFR 164.404 Individual Covered entities 113,264 1 0.125 14,158
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 less than
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 165.512 Uses and Covered entities 113,524 1 0.083333333 9,460
Disclosures for Research
Purposes.
[[Page 51606]]
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 0.05 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 0.05 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 0.05 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..................... ................ .............. .............. .............. 921,158,941
----------------------------------------------------------------------------------------------------------------
Debbie Kramer,
HHS Information Collection Reports Clearance Officer.
[FR Doc. 2019-21031 Filed 9-27-19; 8:45 am]
BILLING CODE 4153-01-P
