Request for Information on the Development of the FY 2018 Trans-NIH Plan for HIV-Related Research, 33680-33681 [2016-12578]
Download as PDF
33680
Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices
Place: National Institutes of Health,
Building 35, Conference Room 620/630, 9000
Rockville Pike, Rockville, MD 20852.
Contact Person: Shayla Beckham,
Extramural Support Assistant, Office of
Science Policy, National Institutes of Health,
6705 Rockledge Drive, Room 750, Bethesda,
MD 20892–9606, 301–496–9838, beckhams@
mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
oba.od.nih.gov/rdna/rdna.html, where an
agenda and any additional information for
the meeting will be posted when available.
OMB’s ‘‘Mandatory Information
Requirements for Federal Assistance Program
Announcements’’ (45 FR 39592, June 11,
1980) requires a statement concerning the
official government programs contained in
the Catalog of Federal Domestic Assistance.
Normally NIH lists in its announcements the
number and title of affected individual
programs for the guidance of the public.
Because the guidance in this notice covers
virtually every NIH and Federal research
program in which DNA recombinant
molecule techniques could be used, it has
been determined not to be cost effective or
in the public interest to attempt to list these
programs. Such a list would likely require
several additional pages. In addition, NIH
could not be certain that every Federal
program would be included as many Federal
agencies, as well as private organizations,
both national and international, have elected
to follow the NIH Guidelines. In lieu of the
individual program listing, NIH invites
readers to direct questions to the information
address above about whether individual
programs listed in the Catalog of Federal
Domestic Assistance are affected.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: May 23, 2016.
Carolyn Baum,
Program Specialist, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–12503 Filed 5–26–16; 8:45 am]
BILLING CODE 4140–01–P
sradovich on DSK3TPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information on the
Development of the FY 2018 Trans-NIH
Plan for HIV-Related Research
Through this Request for
Information (RFI), the Office of AIDS
Research (OAR) in the Division of
SUMMARY:
VerDate Sep<11>2014
18:00 May 26, 2016
Jkt 238001
Program Coordination, Planning, and
Strategic Initiatives, National Institutes
of Health (NIH) invites feedback from
investigators in academia, industry,
health care professionals, patient
advocates and health advocacy
organizations, scientific or professional
organizations, federal agencies, and
other interested constituents and the
community on the development of the
fiscal year 2018 Trans-NIH Plan for HIVRelated Research. This plan is designed
to identify and articulate possible future
directions to maximize benefits of
investments in HIV/AIDS research.
DATES: The Office of AIDS Research
Request for Information is open for
public comment for a period of 30 days.
Comments must be received by June 27,
2016 to ensure consideration. After the
public comment period has closed, the
comments received will be considered
in a timely manner by the Office of
AIDS Research in the Division of
Program Coordination, Planning, and
Strategic Initiatives.
ADDRESSES: Submissions may be
electronically to OAR_RFI18@
od.nih.gov.
FOR FURTHER INFORMATION CONTACT:
Questions about this request for
information should be directed to
Shoshana Kahana, Ph.D., Office of AIDS
Research, Division of Program
Coordination, Planning, and Strategic
Initiatives, Office of the Director,
National Institutes of Health, 5601
Fishers Lane, Bethesda, MD 20892,
OAR_RFI18@od.nih.gov, 301–496–0357.
SUPPLEMENTARY INFORMATION: OAR
oversees and coordinates the conduct
and support of all HIV/AIDS research
activities at the NIH. The NIHsponsored HIV/AIDS research program
includes both extramural and
intramural research, buildings and
facilities, research training, and program
evaluation and supports a
comprehensive portfolio of research
representing a broad range of basic,
clinical, behavioral, social science, and
translational research on HIV/AIDS and
its associated coinfections. The NIH
HIV/AIDS research program is
conducted and supported by nearly all
of the NIH Institutes and Centers (ICs).
OAR plans and coordinates research
through the development of an annual
Trans-NIH Plan for HIV-Related
Research (the ‘‘Plan’’) that articulates
the overarching HIV/AIDS research
priorities and serves as the framework
for developing the trans-NIH AIDS
research budget. The Plan provides
information about the NIH’s HIV/AIDS
research priorities to the scientific
community, Congress, community
stakeholders, HIV-affected communities,
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
and the broad public at large. The fiscal
year 2017 Plan was recently distributed
on the OAR Web site: (https://
www.oar.nih.gov/strategic_plan/fy2017/
OARStrategicPlan2017.pdf).
New overarching priorities for HIV/
AIDS research for the next three to five
years were defined in the NIH Director’s
Statement of August 12, 2015 (https://
grants.nih.gov/grants/guide/notice-files/
NOT-OD-15-137.html).
High Priority topics of research for
support include:
(1) Reducing the incidence of HIV/
AIDS (including the development of a
safe and effective vaccine, microbicides,
and pre-exposure prophylaxis
candidates);
(2) Developing the next generation of
HIV therapies with less toxicity, better
safety, and ease of use;
(3) Identifying strategies to cure AIDS;
and
(4) Improving the prevention and
treatment of HIV-associated
comorbidities, coinfections, and
complications.
There also are three cross-cutting
areas associated with these overarching
priorities which include:
(1) Basic research underlying the
basic biology of HIV (e.g., transmission
and pathogenesis; immune dysfunction
and chronic inflammation; host
microbiome and genetic determinants);
(2) Research to reduce health
disparities in the incidence of new HIV
infections or in treatment outcomes of
those living with HIV/AIDS; and
(3) Research training of the workforce
required to conduct high priority HIV/
AIDS research.
Information Requested
OAR is seeking input on the inclusion
of important new and/or emerging areas
of scientific investigation to inform the
development of the fiscal year 2018
Trans-NIH Plan for HIV-Related
Research. The overarching high-priority
areas of research as delineated in NOT–
15–137 will remain unchanged. OAR
would like feedback on those scientific
and research opportunities that refine
the NIH HIV/AIDS research agenda and
optimize the investment of HIV/AIDS
research resources to search for critical
strategies to prevent, treat, and cure
AIDS.
Please provide your perspective on
any of the following topics as they relate
to the development of the fiscal year
2018 Trans-NIH Plan for HIV-Related
Research. Comments can include but are
not limited to the following areas:
1. Emerging strategies and
technologies related to the development,
testing, and production of promising
HIV vaccine candidates (active and
E:\FR\FM\27MYN1.SGM
27MYN1
sradovich on DSK3TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices
passive), and novel adjuvants, including
the coordinated role that mucosal and
systemic immunity play in protection
from viral acquisition and infection.
2. Emerging topics related to the
development, testing, and formulation
of microbicides, pre-exposure
prophylaxis candidates, long acting/
and/or injectable formulations of
antiretroviral treatment candidates (and
related methods of delivery for HIV
treatments) that are less toxic, longer
acting, have fewer side effects and
complications, and easier to take and
adhere to than current regimens.
3. Emerging topics that relate to the
research toward a cure, including the
development of novel approaches and
strategies that could lead to sustained
HIV remission or viral eradication
without the continuing need for
combination antiretroviral therapy,
including studies of HIV persistence,
latency, and reservoir formation.
4. Emerging topics that relate to the
HIV cascade of care, including the
development, testing, and
implementation of integrated
biomedical, behavioral, and social
science strategies to improve HIV testing
and entry into prevention and treatment
services, including linkage, engagement,
and retention in these services for
optimal treatment response.
5. Emerging topics that relate to basic
research underlying the basic biology of
HIV, (e.g., acquisition, transmission and
pathogenesis; viral persistence; immune
dysfunction and chronic inflammation;
host microbiome and genetic
determinants; and pathogenesis of
opportunistic infections, coinfections,
comorbidities, and HIV-related
mortalities.
6. Emerging topics that relate to
reducing health disparities in the
incidence of new HIV infections or in
treatment outcomes of those living with
HIV/AIDS, with a specific focus on
structural, environmental, and
community-level determinants of health
and the interplay of these determinants
in developing strategies to mitigate the
disparities in HIV incidence and access
to HIV preventive and treatment
services,
7. Emerging topics that relate to the
challenges and opportunities that
should be considered for research
training and career development
programs targeting researchers
conducting high priority HIV/AIDS
research.
VerDate Sep<11>2014
18:00 May 26, 2016
Jkt 238001
Please limit responses to <1500
characters. Responses to this RFI Notice
are voluntary. The submitted
information will be reviewed by NIH
staff and may be made available to the
public. Submitted information will not
be considered confidential. This request
is for information and planning
purposes and should not be construed
as a solicitation or as an obligation of
the federal government or the NIH. No
awards will be made based on responses
to this Request for Information. The
information submitted will be analyzed
and may be used in reports or
presentations. Those who respond are
advised that the NIH is under no
obligation to acknowledge receipt of
your comments, or provide comments
on your submission. No proprietary,
classified, confidential and/or sensitive
information should be included in your
response. The NIH and the government
reserve the right to use any nonproprietary technical information in any
future solicitation(s).
Dated: May 20, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–12578 Filed 5–26–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The Clinical Trials
Reporting Program (CTRP) Database
(NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health, has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 11, 2016
(Vol. 81, P. 12914) and allowed 60-days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
33681
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Jose Galvez, MD, Office of the
Director, National Cancer Institute, 9609
Medical Center Drive, Rockville, MD
20852 or call non-toll-free number 240–
276–5206 or Email your request,
including your address to: jose.galvez@
nih.gov. Formal requests for additional
plans and instruments must be
requested in writing.
Proposed Collection: The Clinical
Trials Reporting Program (CTRP)
Database (NCI), 0925–0600, Expiration
Date 05/31/2016—Revision, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The Clinical Trials Reporting
Program (CTRP) is an electronic
resource that serves as a single,
definitive source of information about
all NCI-supported clinical research. This
resource allows the NCI to consolidate
reporting, aggregate information and
reduce redundant submissions.
Information is submitted by clinical
research administrators as designees of
clinical investigators who conduct NCIsupported clinical research. The
designees can electronically access the
CTRP Web site to complete the initial
trial registration. Subsequent to
registration, four amendments and four
study subject accrual updates occur per
trial annually.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The estimated
annualized burden hours are 18,000.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\27MYN1.SGM
27MYN1
Agencies
[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Notices]
[Pages 33680-33681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12578]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information on the Development of the FY 2018 Trans-
NIH Plan for HIV-Related Research
SUMMARY: Through this Request for Information (RFI), the Office of AIDS
Research (OAR) in the Division of Program Coordination, Planning, and
Strategic Initiatives, National Institutes of Health (NIH) invites
feedback from investigators in academia, industry, health care
professionals, patient advocates and health advocacy organizations,
scientific or professional organizations, federal agencies, and other
interested constituents and the community on the development of the
fiscal year 2018 Trans-NIH Plan for HIV-Related Research. This plan is
designed to identify and articulate possible future directions to
maximize benefits of investments in HIV/AIDS research.
DATES: The Office of AIDS Research Request for Information is open for
public comment for a period of 30 days. Comments must be received by
June 27, 2016 to ensure consideration. After the public comment period
has closed, the comments received will be considered in a timely manner
by the Office of AIDS Research in the Division of Program Coordination,
Planning, and Strategic Initiatives.
ADDRESSES: Submissions may be electronically to OAR_RFI18@od.nih.gov.
FOR FURTHER INFORMATION CONTACT: Questions about this request for
information should be directed to Shoshana Kahana, Ph.D., Office of
AIDS Research, Division of Program Coordination, Planning, and
Strategic Initiatives, Office of the Director, National Institutes of
Health, 5601 Fishers Lane, Bethesda, MD 20892, OAR_RFI18@od.nih.gov,
301-496-0357.
SUPPLEMENTARY INFORMATION: OAR oversees and coordinates the conduct and
support of all HIV/AIDS research activities at the NIH. The NIH-
sponsored HIV/AIDS research program includes both extramural and
intramural research, buildings and facilities, research training, and
program evaluation and supports a comprehensive portfolio of research
representing a broad range of basic, clinical, behavioral, social
science, and translational research on HIV/AIDS and its associated
coinfections. The NIH HIV/AIDS research program is conducted and
supported by nearly all of the NIH Institutes and Centers (ICs).
OAR plans and coordinates research through the development of an
annual Trans-NIH Plan for HIV-Related Research (the ``Plan'') that
articulates the overarching HIV/AIDS research priorities and serves as
the framework for developing the trans-NIH AIDS research budget. The
Plan provides information about the NIH's HIV/AIDS research priorities
to the scientific community, Congress, community stakeholders, HIV-
affected communities, and the broad public at large. The fiscal year
2017 Plan was recently distributed on the OAR Web site: (https://www.oar.nih.gov/strategic_plan/fy2017/OARStrategicPlan2017.pdf).
New overarching priorities for HIV/AIDS research for the next three
to five years were defined in the NIH Director's Statement of August
12, 2015 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html).
High Priority topics of research for support include:
(1) Reducing the incidence of HIV/AIDS (including the development
of a safe and effective vaccine, microbicides, and pre-exposure
prophylaxis candidates);
(2) Developing the next generation of HIV therapies with less
toxicity, better safety, and ease of use;
(3) Identifying strategies to cure AIDS; and
(4) Improving the prevention and treatment of HIV-associated
comorbidities, coinfections, and complications.
There also are three cross-cutting areas associated with these
overarching priorities which include:
(1) Basic research underlying the basic biology of HIV (e.g.,
transmission and pathogenesis; immune dysfunction and chronic
inflammation; host microbiome and genetic determinants);
(2) Research to reduce health disparities in the incidence of new
HIV infections or in treatment outcomes of those living with HIV/AIDS;
and
(3) Research training of the workforce required to conduct high
priority HIV/AIDS research.
Information Requested
OAR is seeking input on the inclusion of important new and/or
emerging areas of scientific investigation to inform the development of
the fiscal year 2018 Trans-NIH Plan for HIV-Related Research. The
overarching high-priority areas of research as delineated in NOT-15-137
will remain unchanged. OAR would like feedback on those scientific and
research opportunities that refine the NIH HIV/AIDS research agenda and
optimize the investment of HIV/AIDS research resources to search for
critical strategies to prevent, treat, and cure AIDS.
Please provide your perspective on any of the following topics as
they relate to the development of the fiscal year 2018 Trans-NIH Plan
for HIV-Related Research. Comments can include but are not limited to
the following areas:
1. Emerging strategies and technologies related to the development,
testing, and production of promising HIV vaccine candidates (active and
[[Page 33681]]
passive), and novel adjuvants, including the coordinated role that
mucosal and systemic immunity play in protection from viral acquisition
and infection.
2. Emerging topics related to the development, testing, and
formulation of microbicides, pre-exposure prophylaxis candidates, long
acting/and/or injectable formulations of antiretroviral treatment
candidates (and related methods of delivery for HIV treatments) that
are less toxic, longer acting, have fewer side effects and
complications, and easier to take and adhere to than current regimens.
3. Emerging topics that relate to the research toward a cure,
including the development of novel approaches and strategies that could
lead to sustained HIV remission or viral eradication without the
continuing need for combination antiretroviral therapy, including
studies of HIV persistence, latency, and reservoir formation.
4. Emerging topics that relate to the HIV cascade of care,
including the development, testing, and implementation of integrated
biomedical, behavioral, and social science strategies to improve HIV
testing and entry into prevention and treatment services, including
linkage, engagement, and retention in these services for optimal
treatment response.
5. Emerging topics that relate to basic research underlying the
basic biology of HIV, (e.g., acquisition, transmission and
pathogenesis; viral persistence; immune dysfunction and chronic
inflammation; host microbiome and genetic determinants; and
pathogenesis of opportunistic infections, coinfections, comorbidities,
and HIV-related mortalities.
6. Emerging topics that relate to reducing health disparities in
the incidence of new HIV infections or in treatment outcomes of those
living with HIV/AIDS, with a specific focus on structural,
environmental, and community-level determinants of health and the
interplay of these determinants in developing strategies to mitigate
the disparities in HIV incidence and access to HIV preventive and
treatment services,
7. Emerging topics that relate to the challenges and opportunities
that should be considered for research training and career development
programs targeting researchers conducting high priority HIV/AIDS
research.
Please limit responses to <1500 characters. Responses to this RFI
Notice are voluntary. The submitted information will be reviewed by NIH
staff and may be made available to the public. Submitted information
will not be considered confidential. This request is for information
and planning purposes and should not be construed as a solicitation or
as an obligation of the federal government or the NIH. No awards will
be made based on responses to this Request for Information. The
information submitted will be analyzed and may be used in reports or
presentations. Those who respond are advised that the NIH is under no
obligation to acknowledge receipt of your comments, or provide comments
on your submission. No proprietary, classified, confidential and/or
sensitive information should be included in your response. The NIH and
the government reserve the right to use any non-proprietary technical
information in any future solicitation(s).
Dated: May 20, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-12578 Filed 5-26-16; 8:45 am]
BILLING CODE 4140-01-P