83 FR 55377 - Draft Report on Health Research and Development To Stem the Opioid Crisis: A Federal Roadmap; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 214 (November 5, 2018)

Page Range		55377-55378
FR Document		2018-24149

The Office of the Director, National Institutes of Health (NIH), on behalf of the National Science and Technology Council (NSTC); Committee on Science; Fast Track Action Committee on Health Science and Technology Response to the Opioid Crisis (Opioid FTAC), is requesting input on the content of a draft report, ``Health Research and Development to Stem the Opioid Crisis: A Federal Roadmap.''

Federal Register, Volume 83 Issue 214 (Monday, November 5, 2018)

[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Notices]
[Pages 55377-55378]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Health Research and Development To Stem the 
Opioid Crisis: A Federal Roadmap; Request for Comments

AGENCY: National Institutes of Health, HHS.

[[Page 55378]]


ACTION: Notice for public comment.

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SUMMARY: The Office of the Director, National Institutes of Health 
(NIH), on behalf of the National Science and Technology Council (NSTC); 
Committee on Science; Fast Track Action Committee on Health Science and 
Technology Response to the Opioid Crisis (Opioid FTAC), is requesting 
input on the content of a draft report, ``Health Research and 
Development to Stem the Opioid Crisis: A Federal Roadmap.''

DATES: Comments must be submitted on or before December 5, 2018.

ADDRESSES: You may submit comments by email to 
[email protected]. Please include ``Health Research and 
Development to Stem the Opioid Crisis: A Federal Roadmap'' in the 
subject line of the message.
    Instructions: The draft report is available for download at: 
https://www.nih.gov/draft-ftac. Response to this Notice for Public 
Comments is voluntary. Clearly indicate the section and page number, if 
applicable, to which submitted comments pertain. All submissions must 
be in English. Please clearly label submissions as regarding ``Health 
Research and Development to Stem the Opioid Crisis: A Federal 
Roadmap.'' When the final report is issued, relevant comments and the 
commenters' names, along with the commenters' responses, may become 
part of the public record and be made available to view online. NIH 
therefore requests that commenters do not submit business proprietary 
information, copyrighted information, or personally identifiable 
information in response to this Notice for Public Comment. Please note 
that the U.S. Government will not pay for response preparation or for 
the use of any information contained in the response.

FOR FURTHER INFORMATION CONTACT: Sara Brenner, Office of Science and 
Technology Policy, (202) 456-444, or [email protected].

SUPPLEMENTARY INFORMATION: The Opioid FTAC was chartered in December 
2017 to facilitate coordination of health Research and Development 
(R&D) and related Science and Technology (S&T) activities across 
agencies, and with other Administration initiatives, in support of the 
national response to the opioid crisis; facilitate interagency sharing 
of opioid-related health R&D findings, standard-based data and tools, 
and best practices; assess gaps in, and opportunities for 
strengthening, the R&D and related S&T response to the opioid crisis; 
and, identify opportunities to expedite promising and potentially 
groundbreaking R&D efforts to rapidly combat the crisis.
    The draft report builds on the recommendations in the report from 
the President's Commission on Combating Drug Addiction and The Opioid 
Crisis, as well as recommendations from multiple other sources, such as 
the National Academy of Sciences report on Pain Management and the 
Opioid Epidemic, the Interagency Pain Research Coordinating Committee's 
Federal Pain Research Strategy, the National Governors Association 
report on Governor's Recommendations for Federal Action to End the 
Nation's Opioid Crisis, and the Surgeon General's report Facing 
Addiction in America, among others, to identify research and 
development opportunities to coordinate the Federal Government's S&T 
response to the opioid crisis. This notice solicits relevant public 
input on the draft report.
    The report describes:
     Seven areas of R&D: (1) The Biology and Chemistry of 
Opioid Addiction and Pain, (2) Non-Biological Contributors to Opioid 
Addiction, (3) Pain Management, (4) Prevention of Opioid Addiction, (5) 
Treatment of Opioid Addiction and Withdrawal, (6) Overdose Prevention 
and Recovery, and (7) Community Consequences of Opioid Addiction;
     Research recommendations generated by the Opioid FTAC in 
each of these areas;
     An eighth section that includes recommendations on ways to 
enhance Federal interagency coordination as well as coordination with 
non-Federal stakeholders.

    Dated: October 29, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-24149 Filed 11-2-18; 8:45 am]
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Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices 55377

Place: National Institutes of Health, 6701 DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Rockledge Drive, Bethesda, MD 20892 HUMAN SERVICES as amended. The grant applications and
(Telephone Conference Call). the discussions could disclose
Contact Person: Luis Espinoza, Ph.D., National Institutes of Health confidential trade secrets or commercial
Scientific Review Officer, Center for property such as patentable material,
Scientific Review, National Institutes of National Institute on Drug Abuse; and personal information concerning
Health, 6701 Rockledge Drive, Room 4140, Notice of Closed Meeting individuals associated with the grant
MSC 7814, Bethesda, MD 20892, 301–435–
Pursuant to section 10(d) of the applications, the disclosure of which
0952, espinozala@mail.nih.gov.
Federal Advisory Committee Act, as would constitute a clearly unwarranted
This notice is being published less than 15 invasion of personal privacy.
days prior to the meeting due to the timing amended, notice is hereby given of the
limitations imposed by the review and following meeting of the Board of Name of Committee: National Institute on
funding cycle. Scientific Counselors, NIDA. Drug Abuse Special Emphasis Panel
The meeting will be closed to the Identification of Genetic and Genomic
Name of Committee: Center for Scientific Variants by Next-Gen Sequencing in Non-
Review Special Emphasis Panel; The Lasker
public as indicated below in accordance
with the provisions set forth in section human Animal Models (U01).
Clinical Research Scholar Program. Date: November 16, 2018.
Date: November 28, 2018. 552b(c)(6), Title 5 U.S.C., as amended Time: 1:00 p.m. to 3:00 p.m.
Time: 1:00 p.m. to 3:00 p.m. for the review, discussion, and Agenda: To review and evaluate
Agenda: To review and evaluate grant evaluation of individual intramural cooperative agreement applications.
applications. programs and projects conducted by the Place: National Institutes of Health,
Place: National Institutes of Health, 6701 National Institute on Drug Abuse, Neuroscience Center, 6001 Executive
Rockledge Drive, Bethesda, MD 20892 including consideration of personnel Boulevard, Rockville, MD 20852, (Telephone
(Virtual Meeting). qualifications and performance, and the Conference Call).
Contact Person: Gerald L. McLaughlin,
Contact Person: Abdelouahab Aitouche, competence of individual investigators, Ph.D., Scientific Review Officer, Office of
Ph.D., Scientific Review Officer, Center for the disclosure of which would Extramural Policy and Review, National
Scientific Review, National Institutes of constitute a clearly unwarranted Institute on Drug Abuse, NIH, DHHS, 6001
Health, 6701 Rockledge Drive, Room 4222, invasion of personal privacy. Executive Blvd., Room 4238, MSC 9550,
MSC 7814, Bethesda, MD 20892, 301–435– Bethesda, MD 20892–9550, 301–827–5819,
Name of Committee: Board of Scientific
2365, aitouchea@csr.nih.gov. gm145a@nih.gov.
Counselors, NIDA.
Name of Committee: Center for Scientific Date: December 3–4, 2018. Name of Committee: National Institute on
Review Special Emphasis Panel; PAR Panel: Closed: 8:00 a.m. to 5:00 p.m. Drug Abuse Special Emphasis Panel PHASE
Cancer Health Disparities. Agenda: To review and evaluate personal II Interview: NIDA Avant-Garde Award
Date: November 29, 2018. qualifications and performance, and Program for HIV/AIDS and Drug Use
Time: 8:00 a.m. to 5:00 p.m. competence of individual investigators. Research (DP1).
Agenda: To review and evaluate grant Place: Intramural Research Program, Date: December 10, 2018.
applications. National Institute on Drug Abuse, NIH, Johns Time: 8:00 a.m. to 5:00 p.m.
Hopkins Bayview Campus, Baltimore, MD Agenda: To review and evaluate grant
Place: Hilton Washington/Rockville, 1750
21223. applications.
Rockville Pike, Rockville, MD 20852.
Contact Person: Joshua Kysiak, Program Place: Courtyard by Marriott Chevy Chase,
Contact Person: Reigh-Yi Lin, Ph.D., 5520 Wisconsin Avenue, Chevy Chase, MD
Scientific Review Officer, Center for Specialist, Biomedical Research Center,
20815.
Scientific Review, National Institutes of Intramural Research Program, National
Contact Person: Hiromi Ono, Ph.D.,
Health, 6701 Rockledge Drive, Bethesda, MD Institute on Drug Abuse, NIH, DHHS, 251
Scientific Review Officer, Office of
20892, 301–827–6009, lin.reigh-yi@nih.gov. Bayview Boulevard, Baltimore, MD 21224,
Extramural Policy and Review, National
443–740–2465, kysiakjo@nida.nih.gov.
Name of Committee: Center for Scientific Institute on Drug Abuse, National Institutes
Review Special Emphasis Panel; PAR Panel: (Catalogue of Federal Domestic Assistance of Health, DHHS, 6001 Executive Boulevard,
Program Nos.: 93.279, Drug Abuse and Room 4238, MSC 9550, Bethesda, MD 20892,
Cancer Health Disparities.
Addiction Research Programs, National 301–827–5820, hiromi.ono@nih.gov.
Date: November 29–30, 2018.
Institutes of Health, HHS) (Catalogue of Federal Domestic Assistance
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant Dated: October 30, 2018. Program Nos.: 93.279, Drug Abuse and
applications. Natasha M. Copeland, Addiction Research Programs, National
Place: Hilton Washington/Rockville, 1750 Institutes of Health, HHS)
Program Analyst, Office of Federal Advisory
Rockville Pike, Rockville, MD 20852. Committee Policy. Dated: October 30, 2018.
Contact Person: Ola Mae Zack Howard, [FR Doc. 2018–24099 Filed 11–2–18; 8:45 am] Natasha M. Copeland,
Ph.D., Scientific Review Officer, Center for Program Analyst, Office of Federal Advisory
BILLING CODE 4140–01–P
Scientific Review, National Institutes of Committee Policy.
Health, 6701 Rockledge Drive, Room 4192,
[FR Doc. 2018–24101 Filed 11–2–18; 8:45 am]
MSC 7806, Bethesda, MD 20892, 301–451–
DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–P
4467, howardz@mail.nih.gov.
HUMAN SERVICES
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine; National Institutes of Health DEPARTMENT OF HEALTH AND
93.333, Clinical Research; 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
HUMAN SERVICES
National Institute on Drug Abuse;
93.846–93.878, 93.892, 93.893, National Notice of Closed Meetings National Institutes of Health
Institutes of Health, HHS)
Pursuant to section 10(d) of the Draft Report on Health Research and
Dated: October 30, 2018.
Federal Advisory Committee Act, as Development To Stem the Opioid
Natasha M. Copeland, amended, notice is hereby given of the
Program Analyst, Office of Federal Advisory Crisis: A Federal Roadmap; Request
following meetings. for Comments
Committee Policy. The meetings will be closed to the
[FR Doc. 2018–24103 Filed 11–2–18; 8:45 am] public in accordance with the AGENCY: National Institutes of Health,
BILLING CODE 4140–01–P provisions set forth in sections HHS.

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55378 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices

ACTION: Notice for public comment. promising and potentially disaster for the State of Kansas (FEMA–
groundbreaking R&D efforts to rapidly 4403–DR), dated October 19, 2018, and
SUMMARY: The Office of the Director, combat the crisis. related determinations.
National Institutes of Health (NIH), on The draft report builds on the DATES: The declaration was issued
behalf of the National Science and recommendations in the report from the October 19, 2018.
Technology Council (NSTC); Committee President’s Commission on Combating FOR FURTHER INFORMATION CONTACT:
on Science; Fast Track Action Drug Addiction and The Opioid Crisis,
Committee on Health Science and Dean Webster, Office of Response and
as well as recommendations from Recovery, Federal Emergency
Technology Response to the Opioid multiple other sources, such as the
Crisis (Opioid FTAC), is requesting Management Agency, 500 C Street SW,
National Academy of Sciences report on Washington, DC 20472, (202) 646–2833.
input on the content of a draft report, Pain Management and the Opioid
‘‘Health Research and Development to SUPPLEMENTARY INFORMATION: Notice is
Epidemic, the Interagency Pain hereby given that, in a letter dated
Stem the Opioid Crisis: A Federal Research Coordinating Committee’s
Roadmap.’’ October 19, 2018, the President issued
Federal Pain Research Strategy, the a major disaster declaration under the
DATES: Comments must be submitted on National Governors Association report authority of the Robert T. Stafford
or before December 5, 2018. on Governor’s Recommendations for Disaster Relief and Emergency
ADDRESSES: You may submit comments Federal Action to End the Nation’s Assistance Act, 42 U.S.C. 5121 et seq.
by email to opioidsroadmap@ Opioid Crisis, and the Surgeon (the ‘‘Stafford Act’’), as follows:
OSTP.eop.gov. Please include ‘‘Health General’s report Facing Addiction in
America, among others, to identify I have determined that the damage in
Research and Development to Stem the certain areas of the State of Kansas resulting
Opioid Crisis: A Federal Roadmap’’ in research and development opportunities from severe storms, straight-line winds, and
the subject line of the message. to coordinate the Federal Government’s flooding during the period of September 1 to
Instructions: The draft report is S&T response to the opioid crisis. This September 8, 2018, is of sufficient severity
available for download at: https:// notice solicits relevant public input on and magnitude to warrant a major disaster
www.nih.gov/draft-ftac. Response to this the draft report. declaration under the Robert T. Stafford
Notice for Public Comments is The report describes: Disaster Relief and Emergency Assistance
voluntary. Clearly indicate the section • Seven areas of R&D: (1) The Biology Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford
Act’’). Therefore, I declare that such a major
and page number, if applicable, to and Chemistry of Opioid Addiction and disaster exists in the State of Kansas.
which submitted comments pertain. All Pain, (2) Non-Biological Contributors to In order to provide Federal assistance, you
submissions must be in English. Please Opioid Addiction, (3) Pain are hereby authorized to allocate from funds
clearly label submissions as regarding Management, (4) Prevention of Opioid available for these purposes such amounts as
‘‘Health Research and Development to Addiction, (5) Treatment of Opioid you find necessary for Federal disaster
Stem the Opioid Crisis: A Federal Addiction and Withdrawal, (6) assistance and administrative expenses.
Roadmap.’’ When the final report is Overdose Prevention and Recovery, and You are authorized to provide Public
issued, relevant comments and the Assistance in the designated areas and
(7) Community Consequences of Opioid
Hazard Mitigation throughout the State.
commenters’ names, along with the Addiction; Consistent with the requirement that Federal
commenters’ responses, may become • Research recommendations assistance be supplemental, any Federal
part of the public record and be made generated by the Opioid FTAC in each funds provided under the Stafford Act for
available to view online. NIH therefore of these areas; Hazard Mitigation will be limited to 75
requests that commenters do not submit • An eighth section that includes percent of the total eligible costs. Federal
business proprietary information, recommendations on ways to enhance funds provided under the Stafford Act for
copyrighted information, or personally Federal interagency coordination as Public Assistance also will be limited to 75
percent of the total eligible costs, with the
identifiable information in response to well as coordination with non-Federal exception of projects that meet the eligibility
this Notice for Public Comment. Please stakeholders. criteria for a higher Federal cost-sharing
note that the U.S. Government will not Dated: October 29, 2018. percentage under the Public Assistance
pay for response preparation or for the Lawrence A. Tabak, Alternative Procedures Pilot Program for
use of any information contained in the Debris Removal implemented pursuant to
Deputy Director, National Institutes of Health. section 428 of the Stafford Act.
response.
[FR Doc. 2018–24149 Filed 11–2–18; 8:45 am] Further, you are authorized to make
FOR FURTHER INFORMATION CONTACT: Sara
BILLING CODE 4140–01–P changes to this declaration for the approved
Brenner, Office of Science and assistance to the extent allowable under the
Technology Policy, (202) 456–444, or Stafford Act.
OpioidsRoadmap@ostp.eop.gov.
DEPARTMENT OF HOMELAND The Federal Emergency Management
SUPPLEMENTARY INFORMATION: The
SECURITY Agency (FEMA) hereby gives notice that
Opioid FTAC was chartered in pursuant to the authority vested in the
December 2017 to facilitate coordination Federal Emergency Management Administrator, under Executive Order
of health Research and Development Agency 12148, as amended, Paul Taylor, of
(R&D) and related Science and FEMA is appointed to act as the Federal
Technology (S&T) activities across [Internal Agency Docket No. FEMA–4403–
DR; Docket ID FEMA–2018–0001] Coordinating Officer for this major
agencies, and with other Administration disaster.
initiatives, in support of the national The following areas of the State of
Kansas; Major Disaster and Related
response to the opioid crisis; facilitate Kansas have been designated as
Determinations
interagency sharing of opioid-related adversely affected by this major disaster:
health R&D findings, standard-based AGENCY: Federal Emergency
data and tools, and best practices; assess Barber, Clay, Kingman, Kiowa, Marshall,
Management Agency, DHS. Pratt, Rice, and Riley Counties for Public
gaps in, and opportunities for ACTION: Notice. Assistance.
strengthening, the R&D and related S&T All areas within the State of Kansas are
response to the opioid crisis; and, SUMMARY: This is a notice of the eligible for assistance under the Hazard
identify opportunities to expedite Presidential declaration of a major Mitigation Grant Program.

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Document Created: 2018-11-03 00:28:32
Document Modified: 2018-11-03 00:28:32

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
Action		Notice for public comment.
Dates		Comments must be submitted on or before December 5, 2018.
Contact		Sara Brenner, Office of Science and Technology Policy, (202) 456-444, or [email protected]
FR Citation		83 FR 55377

83 FR 55377 - Draft Report on Health Research and Development To Stem the Opioid Crisis: A Federal Roadmap; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 214 (November 5, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health