Request for Information (RFI): Improving Efficiency, Effectiveness, Coordination, and Accountability of HIV and Viral Hepatitis Prevention, Care, and Treatment Programs, 2883-2884 [2019-01695]
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Federal Register / Vol. 84, No. 27 / Friday, February 8, 2019 / Notices
• Description of the proposed pilot
project, including, but not limited to,
the goals, objectives, processes that
will be studied, and evaluation
methods
E. Initiation and Duration of Pilot
Projects
The selected participants should be
ready to start their pilot project within
4 months of receiving a letter of
acceptance from FDA into the program.
The duration of a pilot project should
not exceed 6 months. FDA may consider
a pilot project with a later start date or
longer duration depending on the
proposed goal(s) and objective(s). Each
pilot project is expected to be completed
within the proposed duration time
period. This time period does not
include an additional 30 days for
completion of a final report (see Section
II.G. Reports).
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F. Participation in Pilot Projects
Each participant that is selected into
the program will be responsible for
conducting its pilot project. A group of
entities (e.g., members of the
pharmaceutical distribution supply
chain or other stakeholders, including
trade associations) that partners to
conduct a pilot project will be
considered a single participant for
purposes of the DSCSA Pilot Project
Program. The participant will be
responsible for the funding and
resources necessary to conduct the pilot
project, and for determining each
partner’s role and responsibility in its
pilot project.
Prior to launch of a pilot project, FDA
intends to hold a design strategy
meeting with the selected pilot
participant(s) to review the goal(s) and
objective(s)s for the pilot project and
discuss the project plans and other
pertinent details. FDA also expects pilot
project participants to submit reports on
the progress of their pilot projects to
FDA (see Section II.G. Reports).
Participants should evaluate their pilot
projects using the evaluation methods
they identified during the pilot project
design process.
G. Reports
Each pilot project is expected to be
completed within the proposed duration
time period, and FDA asks that all
participants submit periodic progress
reports to FDA while the pilot project is
being conducted, in addition to
submitting a final report after
completing the pilot project. These
reports will provide insight into the
systems and process needed to comply
with certain DSCSA requirements for
enhanced drug distribution security.
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1. Progress Report(s)
Each pilot project program participant
is expected to provide reports on the
progress of its pilot project to FDA. The
progress reports are intended to capture
the ongoing work during the pilot
project, including but not limited to,
status or results, changes, challenges,
and/or lessons learned. FDA will work
with participants to develop an
appropriate schedule for the submission
of progress reports based on the design
and duration of the pilot project.
Because the duration of a pilot project
should not exceed 6 months, the
frequency of progress reports will vary
based on the length of the individual
pilot project. Pilot projects of relatively
shorter duration may result in shorter
time intervals between progress reports.
For example, FDA may ask for monthly
progress reports for a 6-month pilot
project, however for a 1-month pilot
project, FDA may ask for weekly
progress reports.
2. Final Report
Within 30 to 45 business days of
completing a pilot project, each
participant is expected to provide a final
report to FDA that captures the
description, objectives, methods,
evaluation, costs and key findings, and
lessons learned from the project. Timely
completion of pilot projects and the
final report will support FDA’s DSCSA
implementation, including the statutory
requirements under section 582(j) of the
FD&C Act to consider information from
pilot projects in the development of
guidances for unit-level tracing and
standards for the interoperable data
exchange in section 582(h)(3) and (4) of
the FD&C Act. FDA may also request
that the participants meet with the
Agency upon the completion of their
pilot project or the final report.
H. Final DSCSA Pilot Project Program
Report
To ensure that all supply chain
members benefit from the information
generated by the DSCSA Pilot Project
Program, FDA intends to make the
following information about each pilot
project of the program available to the
public in a final program report: (1) The
names and industry sector(s) of the pilot
project participant(s); (2) the pilot
project’s objectives and evaluation
methods; (3) the duration of the pilot
project; and (4) the key findings and
lessons learned from the pilot project.
FDA intends to post the information
related to the DSCSA Pilot Project
Program and the final program report on
FDA’s website.
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I. Recordkeeping
Any records generated by a
participant while conducting a pilot
project should be maintained in
accordance with the participant’s
normal recordkeeping practices. For
pilot projects that involve partnering
entities, the partnering entities should
decide who is responsible for the
records generated in the course of
conducting the pilot project. FDA
recommends that participants maintain
the progress reports and final report for
its pilot project for at least 1 year after
completion of the pilot project.
III. Paperwork Reduction Act of 1995
This notice contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
this notice was approved under OMB
control number 0910–0859.
Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01561 Filed 2–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information (RFI):
Improving Efficiency, Effectiveness,
Coordination, and Accountability of
HIV and Viral Hepatitis Prevention,
Care, and Treatment Programs
Office of HIV/AIDS and
Infectious Disease Policy, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Both the National HIV/AIDS
Strategy (NHAS) and the National Viral
Hepatitis Action Plan (NVHAP) expire
in 2020. The Department of Health and
Human Services (HHS) Office of HIV/
AIDS and Infectious Disease Policy
(OHAIDP), in collaboration with federal
partners, is leading development of the
next iterations of these two separate and
distinct national strategies. To help
inform the next iterations of the NHAS
and NVHAP, HHS seeks input from
external stakeholders for improving
efficiency, effectiveness, coordination,
and accountability of HIV and viral
hepatitis prevention, care, treatment,
and cure policies, services, and
programs.
DATES: To be assured consideration,
comments must be received at the
SUMMARY:
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08FEN1
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2884
Federal Register / Vol. 84, No. 27 / Friday, February 8, 2019 / Notices
address provided below, no later than
5:00 p.m. ET on March 11, 2019.
ADDRESSES: Electronic responses are
strongly preferred and may be addressed
to HepHIVStrategies@hhs.gov. Written
responses should be addressed to: U.S.
Department of Health and Human
Services, Room L001, 330 C Street SW,
Washington, DC 20024. Attention HIV/
Viral Hepatitis RFI.
FOR FURTHER INFORMATION CONTACT:
Nathan Fecik, MPH regarding HIV or
Corinna Dan, RN, MPH regarding viral
hepatitis, in the Office of HIV/AIDS and
Infectious Disease Policy, (202) 795–
7697.
SUPPLEMENTARY INFORMATION: The
NHAS and NVHAP have served as
roadmaps for the national response to
HIV and viral hepatitis in the United
States. They have been of great value in
establishing and monitoring indicators
of progress toward important national
public health goals, setting expectations,
identifying opportunities for
stakeholder engagement across sectors,
and improving transparency and
accountability. As a nation, we have
made significant progress toward
achieving the goals for both strategies,
but ongoing challenges and disparities
remain.
The NHAS and the NVHAP were
developed with input from nonfederal
stakeholders who are committed to
working toward shared national goals
and aligning efforts across sectors. The
strategies allow flexibility to adapt to:
Scientific advances; changes in the
needs of people with and at-risk for
these infections; emerging threats to our
progress toward eliminating HIV and
viral hepatitis, such as the opioid crisis;
and other factors including social
determinants of health and stigma that
affect the health of people with and at
risk for these infections.
This request for information seeks
public input on improving efficiency,
effectiveness, coordination, and
accountability of HIV and viral hepatitis
prevention, care, treatment, and cure
policies, services, and programs at all
levels and for all types of stakeholders.
The feedback received will inform the
next edition of two separate strategies:
(1) The National HIV/AIDS Strategy;
and (2) the National Viral Hepatitis
Action Plan. Please indicate the national
strategy to which each comment
applies. If submitting comments for both
strategies please submit two separate
responses. Topics of interest include,
but are not limited to, the following:
(1a) What components of the NHAS
do you think should be maintained?
What changes should be made to the
NHAS? This may include changes to the
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17:18 Feb 07, 2019
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structure, goals, and indicators, key
areas of focus and/or populations, and
annual reporting processes by federal
agencies. This may also include areas of
the current strategy that should be
scaled back or areas of the current
strategy that should be expanded or
scaled up.
(1b) What components of the NVHAP
do you think should be maintained?
What changes should be made to the
NVHAP? This may include changes to
the structure, goals, and indicators, key
areas of focus and/or populations, and
annual reporting processes by federal
agencies. This may also include areas of
the current strategy that should be
scaled back or areas of the current
strategy that should be expanded or
scaled up.
(2a) Specific recommendations you
think will improve the efficiency,
effectiveness, accountability, and
impact of the national response to HIV.
(2b) Specific recommendations you
think will improve the efficiency,
effectiveness, accountability, and
impact of the national response to viral
hepatitis.
(3a) What specific actions should the
federal government and others take to
improve the coordination of funding
and delivery of HIV services?
(3b) What specific actions should the
federal government and others take to
improve the coordination of funding
and delivery of viral hepatitis services?
(4a) What monitoring and evaluation
strategies would further improve HIV
prevention, care, and treatment?
(4b) What monitoring and evaluation
strategies would further improve viral
hepatitis prevention, care, and
treatment?
Dated: January 29, 2019.
Tammy R. Beckham,
Director, Office of HIV/AIDS and Infectious
Disease Policy.
[FR Doc. 2019–01695 Filed 2–7–19; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–New]
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
SUMMARY:
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following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before March 11, 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
0937–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: SMARTool
Pilot Replication Project.
Type of Collection: OMB No. 0937–
NEW—Office of the Assistant Secretary
for Health (OASH).
Abstract: The Office of the Assistant
Secretary for Health (OASH), U.S.
Department of Health and Human
Services (HHS), is requesting approval
by OMB of a new information collection
request. OASH is updating the Center
for Relationship Education’s Systematic
Method for Assessing Risk-Avoidance
Tool (SMARTool), a tool for sexual risk
avoidance (SRA) curriculum developers
and implementing organizations (IOs) to
ensure that their SRA curricula are
grounded in evidence. In an effort to
assess the SMARTool’s impact, OASH
aims to conduct a formative evaluation
to (1) provide preliminary evidence on
the effectiveness of SRA curricula that
are aligned with the SMARTool, (2)
derive lessons learned to improve the
implementation of SRA curricula, and
(3) develop and test baseline and followup questionnaires that assess SRA
program effects on the key SMARTool
constructs. The evaluation will be
conducted with an estimated four IOs.
The evaluation will use quantitative and
qualitative methods and will include
both a process evaluation and an
outcome evaluation.
Need and Proposed Use of the
Information: To enhance the rigor of the
evaluation, a comparison group will be
identified for each IO, if possible. This
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]]>Agencies
[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2883-2884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01695]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information (RFI): Improving Efficiency,
Effectiveness, Coordination, and Accountability of HIV and Viral
Hepatitis Prevention, Care, and Treatment Programs
AGENCY: Office of HIV/AIDS and Infectious Disease Policy, Office of the
Assistant Secretary for Health, Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Both the National HIV/AIDS Strategy (NHAS) and the National
Viral Hepatitis Action Plan (NVHAP) expire in 2020. The Department of
Health and Human Services (HHS) Office of HIV/AIDS and Infectious
Disease Policy (OHAIDP), in collaboration with federal partners, is
leading development of the next iterations of these two separate and
distinct national strategies. To help inform the next iterations of the
NHAS and NVHAP, HHS seeks input from external stakeholders for
improving efficiency, effectiveness, coordination, and accountability
of HIV and viral hepatitis prevention, care, treatment, and cure
policies, services, and programs.
DATES: To be assured consideration, comments must be received at the
[[Page 2884]]
address provided below, no later than 5:00 p.m. ET on March 11, 2019.
ADDRESSES: Electronic responses are strongly preferred and may be
addressed to HepHIVStrategies@hhs.gov. Written responses should be
addressed to: U.S. Department of Health and Human Services, Room L001,
330 C Street SW, Washington, DC 20024. Attention HIV/Viral Hepatitis
RFI.
FOR FURTHER INFORMATION CONTACT: Nathan Fecik, MPH regarding HIV or
Corinna Dan, RN, MPH regarding viral hepatitis, in the Office of HIV/
AIDS and Infectious Disease Policy, (202) 795-7697.
SUPPLEMENTARY INFORMATION: The NHAS and NVHAP have served as roadmaps
for the national response to HIV and viral hepatitis in the United
States. They have been of great value in establishing and monitoring
indicators of progress toward important national public health goals,
setting expectations, identifying opportunities for stakeholder
engagement across sectors, and improving transparency and
accountability. As a nation, we have made significant progress toward
achieving the goals for both strategies, but ongoing challenges and
disparities remain.
The NHAS and the NVHAP were developed with input from nonfederal
stakeholders who are committed to working toward shared national goals
and aligning efforts across sectors. The strategies allow flexibility
to adapt to: Scientific advances; changes in the needs of people with
and at-risk for these infections; emerging threats to our progress
toward eliminating HIV and viral hepatitis, such as the opioid crisis;
and other factors including social determinants of health and stigma
that affect the health of people with and at risk for these infections.
This request for information seeks public input on improving
efficiency, effectiveness, coordination, and accountability of HIV and
viral hepatitis prevention, care, treatment, and cure policies,
services, and programs at all levels and for all types of stakeholders.
The feedback received will inform the next edition of two separate
strategies: (1) The National HIV/AIDS Strategy; and (2) the National
Viral Hepatitis Action Plan. Please indicate the national strategy to
which each comment applies. If submitting comments for both strategies
please submit two separate responses. Topics of interest include, but
are not limited to, the following:
(1a) What components of the NHAS do you think should be maintained?
What changes should be made to the NHAS? This may include changes to
the structure, goals, and indicators, key areas of focus and/or
populations, and annual reporting processes by federal agencies. This
may also include areas of the current strategy that should be scaled
back or areas of the current strategy that should be expanded or scaled
up.
(1b) What components of the NVHAP do you think should be
maintained? What changes should be made to the NVHAP? This may include
changes to the structure, goals, and indicators, key areas of focus
and/or populations, and annual reporting processes by federal agencies.
This may also include areas of the current strategy that should be
scaled back or areas of the current strategy that should be expanded or
scaled up.
(2a) Specific recommendations you think will improve the
efficiency, effectiveness, accountability, and impact of the national
response to HIV.
(2b) Specific recommendations you think will improve the
efficiency, effectiveness, accountability, and impact of the national
response to viral hepatitis.
(3a) What specific actions should the federal government and others
take to improve the coordination of funding and delivery of HIV
services?
(3b) What specific actions should the federal government and others
take to improve the coordination of funding and delivery of viral
hepatitis services?
(4a) What monitoring and evaluation strategies would further
improve HIV prevention, care, and treatment?
(4b) What monitoring and evaluation strategies would further
improve viral hepatitis prevention, care, and treatment?
Dated: January 29, 2019.
Tammy R. Beckham,
Director, Office of HIV/AIDS and Infectious Disease Policy.
[FR Doc. 2019-01695 Filed 2-7-19; 8:45 am]
BILLING CODE 4150-28-P
