Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evidence-Based Telehealth Network Program Measures, OMB No. 0906-xxxx-NEW, 44903-44904 [2019-18388]
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44903
Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden hours
Delta States Rural Development Network Program Performance Improvement Measurement System ................
12
1
12
1.66
* 20
Total ..............................................................................
12
........................
12
........................
20
* Number is rounded to the nearest whole number.
HRSA specifically requests comments
on (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.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–18425 Filed 8–26–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Evidence-Based Telehealth
Network Program Measures, OMB No.
0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
SUMMARY:
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than September 26,
2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Evidence-Based Telehealth Network
Program Measures, OMB No. 0906–
xxxx—NEW.
Abstract: This ICR is for a new
approval of measures for the Federal
Office of Rural Health Policy’s Office of
Advancement of Telehealth programs.
Specifically, grants administered in
accordance with the following
legislative statute (ii) Section 711(b) of
the Social Security Act (42 U.S.C.
912(b)), as amended. The purpose of
these programs are to provide grants
that demonstrate how telehealth
programs and networks can improve
access to quality health care services in
rural, frontier, and underserved
communities. These grants will work to:
(a) Expand access to, coordinate, and
improve the quality of health care
services; (b) improve and expand the
training of health care providers; and (c)
expand and improve the quality of
health information available to health
care providers and patients and their
families for decision-making. In
addition, these grants will help HRSA
assess the effectiveness of evidence
based practices with the use of
telehealth for patients, providers, and
payers.
A 60-day notice was published in the
Federal Register on April 08, 2019, vol.
84, No. 67; pp. 13936. There were no
public comments.
Need and Proposed Use of the
Information: The measures will enable
HRSA and HRSA to capture awardeelevel and aggregate data that illustrate
the impact and scope of federal funding
along with assessing these efforts. The
measures cover the principal topic areas
of interest to HRSA including: (a)
Population demographics; (b) access to
health care; (c) cost savings and costeffectiveness; and (d) clinical outcomes.
Likely Respondents: Award recipients
of the Evidence Based Telehealth
Network Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
jspears on DSK3GMQ082PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Evidence-Based Telehealth Network Program Report ........
Telehealth Performance Measurement Report ...................
VerDate Sep<11>2014
20:14 Aug 26, 2019
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Frm 00062
Number of
responses per
respondent
50
50
Fmt 4703
Sfmt 4703
Total
responses
12
1
E:\FR\FM\27AUN1.SGM
600
50
27AUN1
Average
burden per
response
(in hours)
14
5
Total
burden
hours
8,400
250
44904
Federal Register / Vol. 84, No. 166 / Tuesday, August 27, 2019 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
* 50
Number of
responses per
respondent
Total
responses
........................
650
Average
burden per
response
(in hours)
........................
Total
burden
hours
8,650
* There are 50 unique respondents. All respondents will be responding to the two forms.
Maria G. Button,
Director, Division of the Executive Secretariat.
SUMMARY:
and transplantation community
monitored the impact of the
recommendations on provider and
patient perceptions, organ utilization,
and clinical outcomes. HHS conducted
analyses to inform efforts to revise the
Guideline recommendations. In April
2019, the Assistant Secretary for Health
of the Department of Health and Human
Services (HHS) received input from the
Advisory Committee on Blood and
Tissue Safety and Availability
(ACBTSA) regarding revisions to the
Guideline recommendations to reflect
recent epidemiologic trends in clinical
characteristics of deceased organ donors
and scientific advances and
improvements in testing for and
treatment of HIV, HBV, and HCV
infections.
HHS is asking respondents to review
the proposed revisions to the current
Guideline and provide assessments on
updating the Guideline, whether these
changes are achievable in the clinical
setting, or if there are potential barriers
to implementation. In addition, impact
on organ allocation and utilization
should be considered. Other comments
pertinent to these proposed revisions
are welcome.
Since the emergence of the human
immunodeficiency virus (HIV)
epidemic, the U.S. Public Health
Service (PHS) has made
recommendations to reduce the risk of
HIV transmission associated with organ
transplantation.2 3 Historically,
recommendations included identifying
risk factors among organ donors
associated with HIV infection to
minimize risk of potential transmission
to recipients. Recommendations also
included laboratory screening of donors
using anti-HIV antibody testing, with
I. Background
Since implementation of the
Guideline in 2014,1 the organ donation
transplantation. Public health reports (Washington,
DC: 1974). 2013;128(4):247–343.
2 CDC. Guidelines for preventing transmission of
human immunodeficiency virus through
transplantation of human tissue and organs. Centers
for Disease Control and Prevention. MMWR
Recommendations and reports: Morbidity and
mortality weekly report Recommendations and
reports/Centers for Disease Control. 1994;43(RR–
8):1–17.
3 CDC. Testing donors of organs, tissues, and
semen for antibody to human T-lymphotropic virus
type III/lymphadenopathy-associated virus. MMWR
Morbidity and mortality weekly report.
1985;34(20):294.
[FR Doc. 2019–18388 Filed 8–26–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information: Regarding
Revisions to the PHS Guideline for
Reducing Human Immunodeficiency
Virus (HIV), Hepatitis B Virus (HBV),
and Hepatitis C Virus (HCV) Through
Organ Transplantation
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: Request for information; notice.
AGENCY:
jspears on DSK3GMQ082PROD with NOTICES
The Office of the Assistant
Secretary for Health in the Department
of Health and Human Services (HHS)
seeks public comment regarding
proposed revisions to the 2013 PHS
Guideline for Reducing Human
Immunodeficiency Virus (HIV),
Hepatitis B Virus (HBV), and Hepatitis
C Virus (HCV) Through Organ
Transplantation.
DATES: To be assured consideration,
comments must be received at the
address provided below no later than
5:00 p.m. ET on September 26, 2019.
ADDRESSES: Electronic responses are
strongly preferred and may be addressed
to ACBTSA@hhs.gov. Written responses
should be addressed to: U.S.
Department of Health and Human
Services, Mary E. Switzer Building, 330
C Street SW, Room L001, Washington,
DC 20024 Attn: ACBTSA—RFI.
FOR FURTHER INFORMATION CONTACT: Mr.
James Berger, Designated Federal
Official, Office of Infectious Disease and
HIV/AIDS Policy, (202) 795–7608.
SUPPLEMENTARY INFORMATION:
1 Seem DL, Lee I, Umscheid CA, Kuehnert MJ.
PHS guideline for reducing human
immunodeficiency virus, hepatitis B virus, and
hepatitis C virus transmission through organ
VerDate Sep<11>2014
19:12 Aug 26, 2019
Jkt 247001
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
additional testing recommendations
added as technologies such as nucleic
acid testing (NAT) were developed. In
2013, based on donor-derived
transmission events and reports of poor
recipient outcome from hepatitis B
(HBV) and C (HCV) transmission, the
PHS released a revised guideline. The
2013 Guideline added organ donor
screening recommendations for HBV
(hepatitis B surface antigen (HBsAg) and
total antibody to hepatitis B core antigen
(anti-HBc)) and HCV (antibody to
hepatitis C (anti-HCV) and NAT), in
addition to HIV, to reduce the risk of
unintended transmission through
transplantation. This revised Guideline
was enhanced by recommending
specific recipient informed consent and
post-transplant recipient monitoring for
evidence of possible disease
transmission.
Per the 1994 guideline, donors with
risk factors for HIV infection and
transmission to recipients were
designated ‘‘Centers for Disease Control
and Prevention (CDC) High Risk’’
donors. The 2013 Guideline changed
this terminology to ‘‘Increased Risk
Donor (IRD)’’ and recommended HCV
nucleic acid testing (NAT) for all donors
and HIV NAT or p24 antigen testing for
IRD. For living donors, testing was
recommended to be performed as close
as possible to the date of the organ
recovery but at least within 28 days
prior to surgery. For deceased donors,
specimens for testing were to be
obtained before procurement but with
no specific recommendation on the
timing of collection relative to organ
recovery. The term ‘‘Increased Risk’’
was adopted over ‘‘High Risk’’ to convey
the continued but small possibility of
donor-derived disease transmission
from donors with risk factors, even with
use of the more sensitive NAT screening
tests.
The 2013 Guideline specifically
outlines 12 medical or social history
criteria resulting in IRD designation if
these risk factors occurred within the 12
months prior to organ recovery. The 12
criteria are:
1. Sex with a person known or
suspected to have HIV, HBV, or HCV
infection.
E:\FR\FM\27AUN1.SGM
27AUN1
]]>Agencies
[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Pages 44903-44904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18388]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Evidence-Based Telehealth
Network Program Measures, OMB No. 0906-xxxx--NEW
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than September
26, 2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Evidence-Based Telehealth
Network Program Measures, OMB No. 0906-xxxx--NEW.
Abstract: This ICR is for a new approval of measures for the
Federal Office of Rural Health Policy's Office of Advancement of
Telehealth programs. Specifically, grants administered in accordance
with the following legislative statute (ii) Section 711(b) of the
Social Security Act (42 U.S.C. 912(b)), as amended. The purpose of
these programs are to provide grants that demonstrate how telehealth
programs and networks can improve access to quality health care
services in rural, frontier, and underserved communities. These grants
will work to: (a) Expand access to, coordinate, and improve the quality
of health care services; (b) improve and expand the training of health
care providers; and (c) expand and improve the quality of health
information available to health care providers and patients and their
families for decision-making. In addition, these grants will help HRSA
assess the effectiveness of evidence based practices with the use of
telehealth for patients, providers, and payers.
A 60-day notice was published in the Federal Register on April 08,
2019, vol. 84, No. 67; pp. 13936. There were no public comments.
Need and Proposed Use of the Information: The measures will enable
HRSA and HRSA to capture awardee-level and aggregate data that
illustrate the impact and scope of federal funding along with assessing
these efforts. The measures cover the principal topic areas of interest
to HRSA including: (a) Population demographics; (b) access to health
care; (c) cost savings and cost-effectiveness; and (d) clinical
outcomes.
Likely Respondents: Award recipients of the Evidence Based
Telehealth Network Program.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Evidence-Based Telehealth 50 12 600 14 8,400
Network Program Report.........
Telehealth Performance 50 1 50 5 250
Measurement Report.............
-------------------------------------------------------------------------------
[[Page 44904]]
* 50 .............. 650 .............. 8,650
----------------------------------------------------------------------------------------------------------------
* There are 50 unique respondents. All respondents will be responding to the two forms.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-18388 Filed 8-26-19; 8:45 am]
BILLING CODE 4165-15-P
