30756 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Request for Information on the 

HEALing Communities Study: 

Developing and Testing an Integrated 

Approach To Address the Opioid 

Crisis 

AGENCY: National Institutes of Health; 

Substance Abuse and Mental Health 

Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: This Request for Information 

(RFI) is intended to gather broad public 

input on the conduct of a multi-site 

national research effort to develop and 

test approaches for the systematic 

implementation and sustainability of an 

integrated set of evidence-based 

interventions across healthcare, 

behavioral health, justice systems, state 

and local governments, and community 

organizations to prevent and treat 

opioid misuse and Opioid Use Disorders 

(OUD). The goals are to decrease fatal 

and non-fatal overdoses, decrease the 

incidence of OUD and related infectious 

diseases (e.g., Hepatitis C and HIV), 

increase the number of individuals 

receiving medication-assisted treatment 

(MAT), increase the proportion retained 

in treatment beyond 6 months, and 

increase the number of individuals 

receiving needed recovery support 

services. 

DATES: The RFI is open for public 

comment for a period of 21 days. 

Comments must be received by July 20, 

2018 to ensure consideration. 

ADDRESSES: Comments must be 

submitted electronically to the 

following email address: OpioidRFI@

nida.nih.gov. 

FOR FURTHER INFORMATION CONTACT: 

Please direct all inquiries to Redonna K. 

Chandler, Ph.D., National Institute on 

Drug Abuse; Phone: 301–443–1470; 

email: redonna.chandler@nih.gov. 

SUPPLEMENTARY INFORMATION: This RFI is 

for information and planning purposes 

only, and should not be construed as a 

solicitation or an obligation on the part 

of the federal government, the National 

Institutes of Health (NIH), the National 

Institute on Drug Abuse (NIDA), or the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA). 

NIH does not intend to make any 

awards based on responses to this RFI 

or to otherwise pay for the preparation 

of any information submitted or for the 

government’s use of such information. 

Terminology: This RFI is focused on 

the use, misuse, abuse of opioids, and 

OUD. Opioids include prescription and 

illicit opioids, such as heroin, illicitly 

manufactured fentanyl, and related 

analogs. OUD refers to the clinical 

diagnosis defined in the Diagnostic and 

Statistical Manual of Mental Disorders, 

Fifth Edition (DSM–5). 

Problem Statement: Despite the 

availability of multiple effective 

evidence-based interventions and 

practices, most Americans at risk for or 

suffering from an OUD do not receive 

appropriate prevention and treatment 

services. Simultaneously, opioid 

overdose rates continue to increase. 

NIDA, in partnership with SAMHSA, 

is exploring options for conducting a 

multi-site national research effort in up 

to three communities to develop and 

test approaches for the systematic 

implementation and sustainability of an 

integrated set of evidence-based 

interventions across healthcare, 

behavioral health, justice systems, state 

and local governments, and community 

organizations to prevent and treat 

opioid misuse and OUD. The goals are 

to decrease fatal and non-fatal 

overdoses, decrease the incidence of 

OUD and related infectious diseases 

(e.g., Hepatitis C and HIV), increase the 

number of individuals receiving 

medication-assisted treatment (MAT), 

increase the proportion retained in 

treatment beyond 6 months, and 

increase the number of individuals 

receiving needed recovery support 

services. This research would be a part 

of the NIH Helping to End Addiction 

Long-term (HEAL) Initiative (https://

www.nih.gov/research-training/medicalresearch-initiatives/heal-initiative). 

Information Requested: This RFI 

solicits input from the extramural 

research community and public 

stakeholders. NIDA and SAMHSA 

especially seek input on study elements 

such as, but not limited to: 

Study Design: 

• How can ‘‘heavily affected 

communities’’ be defined, including 

geospatial/geopolitical definitions to 

provide consistent boundaries for a 

multi-site study? 

• What research designs might be 

appropriate to accomplish the overall 

goals of the study? 

• How can effect size be estimated 

and what effect size might be expected 

in relation to candidate outcomes: Rates 

of non-fatal and fatal overdose; 

prevalence and incidence of opioid 

misuse, OUD and Hepatitis C; percent of 

patients screened for opioid misuse and 

OUD and who received a brief 

intervention or were referred to 

treatment; percent of patients initiated 

on MAT and retained in medication 

treatment beyond 6 months; rates of 

naloxone distribution and overdose 

reversals; opioid analgesic and 

benzodiazepine prescription rates; and 

implementation of prevention 

programs? 

• What baseline data should be 

captured, what are potential existing 

sources for this data, and what 

challenges might exist with quality of 

existing data? 

• How long would an integrated set of 

evidence-based interventions need to be 

in place before expecting a meaningful 

change in outcomes, and which 

combination of interventions should be 

implemented in communities with 

different characteristics? 

• What confounding variables need to 

be considered? 

• What are potential threats to 

internal and external study validity and 

what strategies could be deployed to 

mitigate threats? 

• Are there particular strategies that 

can help the Coordinating Center 

overcome barriers to the facilitation of 

collaboration and coordination activities 

across Research Centers with regard to 

data harmonization, collection, 

integration, cleaning, analyses, and 

creating datasets for sharing with the 

research community at large? 

Outcomes: 

• What target metrics would be 

feasible for outcomes? Candidate 

outcomes could include, but are not 

limited to those listed above: Rates of 

non-fatal and fatal overdose; prevalence 

and incidence of opioid misuse, OUD 

and Hepatitis C; percent of patients 

screened for opioid misuse and OUD 

and who received a brief intervention or 

were referred to treatment; percent of 

patients initiated on MAT and retained 

in medication treatment beyond 6 

months; rates of naloxone distribution 

and overdose reversals; opioid analgesic 

and benzodiazepine prescription rates; 

and implementation of prevention 

programs? 

• What is the best way to gather 

reliable data related to candidate 

outcomes listed above? 

• What are essential interventions for 

an evidence-based integrated approach 

to opioid prevention and treatment 

services, including policies and 

practices? 

• How could ‘‘evidence-based or 

evidence-informed’’ be defined? 

• How can fidelity to an evidencebased integrated approach to opioid 

prevention and treatment services, 

including policies and practices be 

measured? 

• What strategies and resources 

would be necessary, including training 

and technical assistance, to have 

meaningful penetration of the evidenceVerDate Sep<11>2014 17:58 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1

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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30757 

based integrated approach to opioid 

prevention and treatment services in a 

single community? 

Health Economics: 

• What economic questions should be 

included as part of the study to inform 

systems and policy change? 

Implementation Research: 

• What implementation research 

questions should be included to develop 

best practices for replication in other 

communities impacted by the opioid 

crisis? 

• What data should be collected to 

help develop metrics for determining 

the quality of an integrated approach to 

opioid prevention and treatment 

services, including policies and 

practices? 

• Are there examples of prior 

implementation research studies that 

highlight implementation tools that can 

be used to replicate and scale up 

integrated approaches? 

Infrastructure, Partnerships, 

Collaboration: 

• What research, prevention, and 

treatment infrastructure and 

partnerships are needed to support a 

community-based pragmatic trial 

assessing the impact of an evidencebased integrated approach to opioid 

prevention and treatment services? 

• What is the best approach to 

fostering collaboration and meaningful 

participation between state, county, and 

local governments; community 

stakeholders; medical/clinical service 

providers; and researchers? 

• How do we construct a research 

initiative with the highest likelihood of 

having sustainable prevention and 

treatment services? 

• What data would be of most interest 

to state and community partners? 

Responses to this RFI are voluntary 

and may be submitted anonymously. 

Please do not include any personally 

identifiable or other information that 

you do not wish to make public. 

Proprietary, classified, confidential, or 

sensitive information should not be 

included in responses. Comments 

submitted will be compiled for 

discussion and shared internally with 

NIDA, SAMHSA, NIH program staff, 

and participating leadership across the 

Department of Health and Human 

Services, as appropriate. Any personal 

identifiers (personal names, email 

addresses, etc.) will be removed when 

responses are compiled. 

This RFI is for informational and 

planning purposes only and is not a 

solicitation for applications or an 

obligation on the part of the United 

States Government to provide support 

for any ideas identified in response to 

it. Please note that the United States 

Government will not pay for the 

preparation of any information 

submitted or for use of that information. 

Dated: June 25, 2018. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2018–14031 Filed 6–28–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; T1D NIDDK Review. 

Date: June 29, 2018. 

Time: 9:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Elena Sanovich, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7351, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, 301–594–8886, 

sanoviche@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; RFA–DK–17–021: 

HIRN Consortium on Beta Cell Death and 

Survival Early T1D Biomarkers Discovery in 

Human Pancreas. 

Date: July 23, 2018. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Najma S. Begum, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7349, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–8894, 

begumn@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; T1D Clinical Trials 

Testing Current and Novel Closed Loop 

Systems (R01). 

Date: July 24, 2018. 

Time: 3:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Jason D. Hoffert, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7343, 6707 Democracy Boulevard, 

Bethesda, MD 20817, 301–496–9010, 

hoffertj@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; RFA–DK–17–020: 

Immune System Engineering for Targeted 

Tolerance in Type 1 Diabetes (R01). 

Date: July 25, 2018. 

Time: 11:00 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Dianne Camp, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7013, 6707 Democracy Boulevard, 

Bethesda, MD 20892–2542, 301–594–7682, 

campd@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; SBIR Phase II 

Clinical Trials. 

Date: July 26, 2018. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Thomas A. Tatham, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7021, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–3993, 

tathamt@mail.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; PAR–18–042: 

NIDDK Ancillary Studies (R01). 

Date: July 26, 2018. 

Time: 11:30 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Ann A. Jerkins, Ph.D., 

Scientific Review Officer, Review Branch, 


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