Expired PAR-13-334: Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of PAS-12-122
Related Notices	September 08, 2016 - This PAR has been reissued as PAR-16-430. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) August 11, 2014 - See Notice NOT-DA-14-027. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	PAR-13-334
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
Funding Opportunity Purpose	NIDA grant-funded research programs aiming to develop medications for the treatment of Substance Use Disorders (SUDs) are often hindered by a lack of both human and financial resources. Drug development is a lengthy process that requires a wide range of skill sets. Consequently, individual grantees with the necessary expertise in one area of medications development are often unable to advance a project through the next stage because of a lack of real world experience in the development process and/or the financial resources to advance a medication through the development pipeline in an acceptable timeframe. The purpose of this Funding Opportunity Announcement (FOA) is to support research that advances compounds towards FDA approval by leveraging NIDA funds with the strengths and resources of outside organizations, such as for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, and small businesses. Applications from single entities that possess considerable resources for medications development will also be considered, provided the entity demonstrates a significant resource commitment to the proposed project. A resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material. It is anticipated that in comparison with traditional grant-funded research, strategic alliances will increase the pace at which medications to treat SUDs move through the drug development process. Both the term (up to three years) and budget (up to $2,000,000/year in direct costs) of the grant are consistent with the objective of accelerating the pace of medications development compared to traditional research project grant funding. Project aims can range from the development of a new molecular entity to the expansion of an existing medication’s clinical indication(s). Each project must have a defined entry and exit point in the medications development pathway, with the objective of advancement in the FDA approval process. It is hoped that support for these collaborations will accelerate the rate of medications development for Substance Use Disorders.

Key Dates

Posted Date	August 19, 2013
Open Date (Earliest Submission Date)	February 27, 2014
Letter of Intent Due Date(s)	30 days prior to receipt date
Application Due Date(s)	March 27, 2014, July 28, 2014, March 27, 2015, July28, 2015, March 28, 2016, July 28, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	May 7, 2014, September 7, 2014, May 7, 2015, September 7, 2015, May 7, 2016, September 7, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	June/July 2014, October/November 2014, June/July 2015, October/November 2015, June/July 2016, October/November 2016
Advisory Council Review	October 2014, January 2015, October 2015, January 2016, October 2016, January 2017
Earliest Start Date	December 2014, April 2015, December 2015, April 2016, December 2016, April 2017
Expiration Date	September 8, 2016
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Drug development is a lengthy process that requires teams with a wide range of individual skill sets. Consequently, individual grantees with the necessary expertise in one area of drug development are often unable to advance a project through the next stage of development. Grantees often lack expertise in the drug development process and/or the financial resources to advance a medication through the development pipeline in an acceptable timeframe. Consequently, the National Institute on Drug Abuse (NIDA) is seeking research grant applications which propose the discovery and development of safe and effective medications for the treatment of Substance Use Disorders (SUDs) through the establishment of strategic alliances. That is, leveraging NIDA funds with the expertise and resources of researchers at for profit or non-profit organizations (including, but not limited to, academic institutions, pharmaceutical companies, biotech companies, private or public foundations). NIDA anticipates that through leveraging its resources, Strategic Alliances will accelerate the pace of grant-funded medications development for SUDs. Applications may be focused at any point along the medications development continuum including, but not limited to, the advanced development of new chemical entities (e.g., lead optimization), investigational new drug (IND)-enabling studies (e.g., preclinical toxicology, GMP manufacturing), and Phase I, II or III clinical trials of either a new chemical entity or an already marketed therapeutic. The studies proposed should be directed at advancing a medication to treat SUDs toward FDA approval.

Applications from a single entity (private for-profit, non-profit, or academic) will also be considered, with the entity expected to make a significant resource commitment to the proposed project. A significant resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material.

The development of safe and effective medications for the treatment of SUDs is a public health priority. According to the National Survey of Drug Use and Health (NSDUH) of 2010, an estimated 69.6 million Americans aged 12 or older are current users of tobacco products and 22.6 million Americans aged 12 or older are current drug users (defined as having had used an illicit drug during the last month). Illicit drugs include marijuana, cocaine, heroin, hallucinogens, inhalants as well as the nonmedical use of prescription-type pain relievers, tranquilizers, stimulants, and sedatives. The overall use of illicit drugs has not increased since 2002, but the abuse of prescription opiate analgesics has more than doubled over the past 10 years significantly (P<0.05) higher in both 2009 and 2010 than in every year from 2002 to 2007.

Over the past 20 years, basic research has identified neural substrates and pathways implicated in reward and addiction. However, the application of this basic knowledge to the development of effective medications to treat SUDs has largely been unsuccessful in both preclinical and early clinical stage development, hindered by the costs and high attrition rates of compounds. Later stage clinical development also presents formidable challenges, with prospective SUD medications failing due to lack of efficacy, tolerability and unexpected toxicity, as well as human issues such as difficulties in recruitment, medication compliance and subject loss during the trial and prior to follow up.

While there are medications approved for nicotine and opiate dependence, the efficacy of these drugs is far from ideal. For example, the abstinence rates after 1 year with either nicotine replacement therapy (NRT) or bupropion is about 2 - 8% and 8%, respectively, higher than that achieved with placebo. Moreover, there are currently no FDA approved medications for the treatment of cocaine, methamphetamine, or cannabis use disorders. By providing funds well beyond a traditional research project grant, this Strategic Alliances FOA will accelerate medications development, fostering collaborative ventures of NIDA with other entities such that each makes a significant commitment of resources toward the goal of obtaining FDA approval of safe and effective medications for SUDs. Examples of resources that alliance partners could make include salary support for key study personnel, toxicology and/or analytical assays, providing clinical trial materials, clinical support (e.g., monitoring, site support), and/or statistical analyses.

This FOA encourages, but is not limited to, the following medications development stages:

Lead optimization of new chemical entities identified through assay screens as having promise as

SUD treatments.

Preclinical characterization of pharmacological or biological-based therapies, within appropriate

animal models of behavior, and / or IND enabling studies including toxicity and pharmacokinetic

(PK) / pharmacodynamic (PD) studies.

Clinical Development

Phase I clinical trials (e.g., safety and interaction studies, human laboratory studies assessing

subjective effects of a medication on targeted drug of abuse).

Pilot or proof-of-concept studies to assess efficacy.

Phase II clinical trials to assess efficacy.

Phase III clinical trials for NDA requirements.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html..

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets for direct costs may be up to $2,000,000 per year, but need to reflect the actual needs of the proposed project.
Award Project Period	The maximum period of support is 3 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to: [email protected]

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Director - Strategic Alliances FOA
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover