81 FR 33680 - Request for Information on the Development of the FY 2018 Trans-NIH Plan for HIV-Related Research
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 103 (May 27, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 103 (May 27, 2016)
| Page Range | 33680-33681 | |
| FR Document | 2016-12578 |
[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)] [Notices] [Pages 33680-33681] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected], 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: (http://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
![33680 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices
Place: National Institutes of Health, Program Coordination, Planning, and and the broad public at large. The fiscal
Building 35, Conference Room 620/630, 9000 Strategic Initiatives, National Institutes year 2017 Plan was recently distributed
Rockville Pike, Rockville, MD 20852. of Health (NIH) invites feedback from on the OAR Web site: (http://
Contact Person: Shayla Beckham,
investigators in academia, industry, www.oar.nih.gov/strategic_plan/fy2017/
Extramural Support Assistant, Office of
Science Policy, National Institutes of Health, health care professionals, patient OARStrategicPlan2017.pdf).
6705 Rockledge Drive, Room 750, Bethesda, advocates and health advocacy New overarching priorities for HIV/
MD 20892–9606, 301–496–9838, beckhams@ organizations, scientific or professional AIDS research for the next three to five
mail.nih.gov. organizations, federal agencies, and years were defined in the NIH Director’s
Information is also available on the other interested constituents and the Statement of August 12, 2015 (https://
Institute’s/Center’s home page: http:// community on the development of the grants.nih.gov/grants/guide/notice-files/
oba.od.nih.gov/rdna/rdna.html, where an fiscal year 2018 Trans-NIH Plan for HIV- NOT-OD-15-137.html).
agenda and any additional information for Related Research. This plan is designed High Priority topics of research for
the meeting will be posted when available. to identify and articulate possible future support include:
OMB’s ‘‘Mandatory Information directions to maximize benefits of (1) Reducing the incidence of HIV/
Requirements for Federal Assistance Program AIDS (including the development of a
investments in HIV/AIDS research.
Announcements’’ (45 FR 39592, June 11,
1980) requires a statement concerning the DATES: The Office of AIDS Research safe and effective vaccine, microbicides,
official government programs contained in Request for Information is open for and pre-exposure prophylaxis
the Catalog of Federal Domestic Assistance. public comment for a period of 30 days. candidates);
Normally NIH lists in its announcements the Comments must be received by June 27, (2) Developing the next generation of
number and title of affected individual 2016 to ensure consideration. After the HIV therapies with less toxicity, better
programs for the guidance of the public. public comment period has closed, the safety, and ease of use;
Because the guidance in this notice covers comments received will be considered (3) Identifying strategies to cure AIDS;
virtually every NIH and Federal research and
program in which DNA recombinant
in a timely manner by the Office of
AIDS Research in the Division of (4) Improving the prevention and
molecule techniques could be used, it has
Program Coordination, Planning, and treatment of HIV-associated
been determined not to be cost effective or
in the public interest to attempt to list these Strategic Initiatives. comorbidities, coinfections, and
programs. Such a list would likely require ADDRESSES: Submissions may be complications.
several additional pages. In addition, NIH electronically to OAR_RFI18@ There also are three cross-cutting
could not be certain that every Federal od.nih.gov. areas associated with these overarching
program would be included as many Federal priorities which include:
agencies, as well as private organizations, FOR FURTHER INFORMATION CONTACT: (1) Basic research underlying the
both national and international, have elected Questions about this request for basic biology of HIV (e.g., transmission
to follow the NIH Guidelines. In lieu of the information should be directed to and pathogenesis; immune dysfunction
individual program listing, NIH invites Shoshana Kahana, Ph.D., Office of AIDS and chronic inflammation; host
readers to direct questions to the information Research, Division of Program
address above about whether individual microbiome and genetic determinants);
Coordination, Planning, and Strategic (2) Research to reduce health
programs listed in the Catalog of Federal
Initiatives, Office of the Director, disparities in the incidence of new HIV
Domestic Assistance are affected.
National Institutes of Health, 5601 infections or in treatment outcomes of
(Catalogue of Federal Domestic Assistance Fishers Lane, Bethesda, MD 20892,
Program Nos. 93.14, Intramural Research those living with HIV/AIDS; and
Training Award; 93.22, Clinical Research
OAR_RFI18@od.nih.gov, 301–496–0357. (3) Research training of the workforce
Loan Repayment Program for Individuals SUPPLEMENTARY INFORMATION: OAR required to conduct high priority HIV/
from Disadvantaged Backgrounds; 93.232, oversees and coordinates the conduct AIDS research.
Loan Repayment Program for Research and support of all HIV/AIDS research
Generally; 93.39, Academic Research activities at the NIH. The NIH- Information Requested
Enhancement Award; 93.936, NIH Acquired sponsored HIV/AIDS research program OAR is seeking input on the inclusion
Immunodeficiency Syndrome Research Loan includes both extramural and of important new and/or emerging areas
Repayment Program; 93.187, Undergraduate intramural research, buildings and of scientific investigation to inform the
Scholarship Program for Individuals from
facilities, research training, and program development of the fiscal year 2018
Disadvantaged Backgrounds, National
Institutes of Health, HHS) evaluation and supports a Trans-NIH Plan for HIV-Related
comprehensive portfolio of research Research. The overarching high-priority
Dated: May 23, 2016. representing a broad range of basic, areas of research as delineated in NOT–
Carolyn Baum, clinical, behavioral, social science, and 15–137 will remain unchanged. OAR
Program Specialist, Office of Federal Advisory translational research on HIV/AIDS and would like feedback on those scientific
Committee Policy. its associated coinfections. The NIH and research opportunities that refine
[FR Doc. 2016–12503 Filed 5–26–16; 8:45 am] HIV/AIDS research program is the NIH HIV/AIDS research agenda and
BILLING CODE 4140–01–P conducted and supported by nearly all optimize the investment of HIV/AIDS
of the NIH Institutes and Centers (ICs). research resources to search for critical
OAR plans and coordinates research strategies to prevent, treat, and cure
DEPARTMENT OF HEALTH AND through the development of an annual AIDS.
HUMAN SERVICES Trans-NIH Plan for HIV-Related Please provide your perspective on
Research (the ‘‘Plan’’) that articulates any of the following topics as they relate
National Institutes of Health the overarching HIV/AIDS research to the development of the fiscal year
sradovich on DSK3TPTVN1PROD with NOTICES
priorities and serves as the framework 2018 Trans-NIH Plan for HIV-Related
Request for Information on the
for developing the trans-NIH AIDS Research. Comments can include but are
Development of the FY 2018 Trans-NIH
research budget. The Plan provides not limited to the following areas:
Plan for HIV-Related Research
information about the NIH’s HIV/AIDS 1. Emerging strategies and
SUMMARY: Through this Request for research priorities to the scientific technologies related to the development,
Information (RFI), the Office of AIDS community, Congress, community testing, and production of promising
Research (OAR) in the Division of stakeholders, HIV-affected communities, HIV vaccine candidates (active and
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![Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices 33681
passive), and novel adjuvants, including Please limit responses to <1500 information collection that has been
the coordinated role that mucosal and characters. Responses to this RFI Notice extended, revised, or implemented on or
systemic immunity play in protection are voluntary. The submitted after October 1, 1995, unless it displays
from viral acquisition and infection. information will be reviewed by NIH a currently valid OMB control number.
2. Emerging topics related to the staff and may be made available to the Direct Comments to OMB: Written
development, testing, and formulation public. Submitted information will not comments and/or suggestions regarding
of microbicides, pre-exposure be considered confidential. This request the item(s) contained in this notice,
prophylaxis candidates, long acting/ is for information and planning especially regarding the estimated
and/or injectable formulations of purposes and should not be construed public burden and associated response
antiretroviral treatment candidates (and as a solicitation or as an obligation of time, should be directed to the: Office
related methods of delivery for HIV the federal government or the NIH. No of Management and Budget, Office of
treatments) that are less toxic, longer awards will be made based on responses Regulatory Affairs, OIRA_submission@
acting, have fewer side effects and to this Request for Information. The omb.eop.gov or by fax to 202–395–6974,
complications, and easier to take and information submitted will be analyzed Attention: NIH Desk Officer.
adhere to than current regimens. and may be used in reports or
3. Emerging topics that relate to the Comment Due Date: Comments
presentations. Those who respond are
research toward a cure, including the regarding this information collection are
advised that the NIH is under no
development of novel approaches and obligation to acknowledge receipt of best assured of having their full effect if
strategies that could lead to sustained your comments, or provide comments received within 30 days of the date of
HIV remission or viral eradication on your submission. No proprietary, this publication.
without the continuing need for classified, confidential and/or sensitive FOR FURTHER INFORMATION CONTACT: To
combination antiretroviral therapy, information should be included in your obtain a copy of the data collection
including studies of HIV persistence, response. The NIH and the government plans and instruments, or request more
latency, and reservoir formation. reserve the right to use any non- information on the proposed project,
4. Emerging topics that relate to the proprietary technical information in any contact: Jose Galvez, MD, Office of the
HIV cascade of care, including the future solicitation(s). Director, National Cancer Institute, 9609
development, testing, and Medical Center Drive, Rockville, MD
Dated: May 20, 2016.
implementation of integrated 20852 or call non-toll-free number 240–
biomedical, behavioral, and social Lawrence A. Tabak,
276–5206 or Email your request,
science strategies to improve HIV testing Deputy Director, National Institutes of Health.
including your address to: jose.galvez@
and entry into prevention and treatment [FR Doc. 2016–12578 Filed 5–26–16; 8:45 am]
nih.gov. Formal requests for additional
services, including linkage, engagement, BILLING CODE 4140–01–P
plans and instruments must be
and retention in these services for requested in writing.
optimal treatment response. Proposed Collection: The Clinical
5. Emerging topics that relate to basic DEPARTMENT OF HEALTH AND
HUMAN SERVICES Trials Reporting Program (CTRP)
research underlying the basic biology of
Database (NCI), 0925–0600, Expiration
HIV, (e.g., acquisition, transmission and
National Institutes of Health Date 05/31/2016—Revision, National
pathogenesis; viral persistence; immune
Cancer Institute (NCI), National
dysfunction and chronic inflammation; Submission for OMB Review; 30-Day Institutes of Health (NIH).
host microbiome and genetic Comment Request; The Clinical Trials
determinants; and pathogenesis of Need and Use of Information
Reporting Program (CTRP) Database Collection: The Clinical Trials Reporting
opportunistic infections, coinfections, (NCI)
comorbidities, and HIV-related Program (CTRP) is an electronic
mortalities. SUMMARY: Under the provisions of resource that serves as a single,
6. Emerging topics that relate to Section 3507(a)(1)(D) of the Paperwork definitive source of information about
reducing health disparities in the Reduction Act of 1995, the National all NCI-supported clinical research. This
incidence of new HIV infections or in Cancer Institute (NCI), the National resource allows the NCI to consolidate
treatment outcomes of those living with Institutes of Health, has submitted to the reporting, aggregate information and
HIV/AIDS, with a specific focus on Office of Management and Budget reduce redundant submissions.
structural, environmental, and (OMB) a request for review and Information is submitted by clinical
community-level determinants of health approval of the information collection research administrators as designees of
and the interplay of these determinants listed below. This proposed information clinical investigators who conduct NCI-
in developing strategies to mitigate the collection was previously published in supported clinical research. The
disparities in HIV incidence and access the Federal Register on March 11, 2016 designees can electronically access the
to HIV preventive and treatment (Vol. 81, P. 12914) and allowed 60-days CTRP Web site to complete the initial
services, for public comment. No public trial registration. Subsequent to
7. Emerging topics that relate to the comments were received. The purpose registration, four amendments and four
challenges and opportunities that of this notice is to allow an additional study subject accrual updates occur per
should be considered for research 30 days for public comment. The trial annually.
training and career development National Cancer Institute (NCI), OMB approval is requested for 3
programs targeting researchers National Institutes of Health, may not years. There are no costs to respondents
conducting high priority HIV/AIDS conduct or sponsor, and the respondent other than their time. The estimated
sradovich on DSK3TPTVN1PROD with NOTICES
research. is not required to respond to, an annualized burden hours are 18,000.
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Document Created: 2018-02-07 15:10:26
Document Modified: 2018-02-07 15:10:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| 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, [email protected], 301-496-0357. | |
| FR Citation | 81 FR 33680 |
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