Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	NIDA Research "Center of Excellence" Grant Program (P50)
Activity Code	P50 Specialized Center
Announcement Type	Reissue of PAR-10-189
Related Notices	October 21, 2015 - This PAR has been reissued as PAR-16-009. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PAR-13-222
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	This Funding Opportunity Announcement (FOA) is to provide support for research Centers that (1) conduct drug abuse and addiction research in any area of NIDA’s mission, (2) have outstanding innovative science, (3) are multidisciplinary, thematically integrated, synergistic, and (4) serve as national resource(s) to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers in the NIDA research fields. It is expected that a Center will transform knowledge in the sciences it is studying. Incremental work should not be the focus of Center activities; rather, new and creative directions are required. The P50 Center of Excellence is expected to support the education, training, and mentoring of new investigators who would be given meaningful roles to play in the Center projects. A goal of this program is to create NIDA Centers that are national community resources for drug abuse research by sharing their findings, their data and their resources to further advance research in this field.

Posted Date	May 6, 2013
Open Date (Earliest Submission Date)	August 25, 2013
Letter of Intent Due Date(s)	30 days prior to the application due date
Application Due Date(s)	September 25, 2013, September 25, 2014, September 25, 2015, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	January 7, 2014, January 7, 2015, January 7, 2016, by 5:00 PM local time of applicant organization.
Scientific Merit Review	February 2014, February 2015, February 2016
Advisory Council Review	May 2014, May 2015, May 2016
Earliest Start Date	Standard dates apply
Expiration Date	October 21, 2015
Due Dates for E.O. 12372	Not Applicable

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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

NIDA supports research center grants to foster an innovative, synergistic and thematically coherent approach to drug abuse and addiction research and to enable studies that would not occur without the climate, facilities and research resources that a research center can uniquely provide. NIDA encourages the application of multiple scientific perspectives and approaches to the problem of addiction to support the highest quality, multidisciplinary programs of innovative research. Through the Centers program, NIDA seeks to encourage outstanding scientists to bring a full range of expertise, approaches, technologies, and creativity to the study of problems related to drug abuse and addiction. Investigative efforts are expected to be broadly based and to encompass a variety of areas, including biological, biomedical, social, behavioral, and/or clinical sciences as well as dissemination sciences to address critical research issues.

NIDA Centers are expected to be scientifically innovative and provide the next generation of ideas and approaches. It is expected that a Center will transform knowledge in the sciences it is studying and be at the cutting edge of science. Incremental work, though valuable, should not be the focus of Center activities.

NIDA Centers are expected to be thematically coherent and demonstrate the highest caliber of multidisciplinary scientific work; there must be an overarching theme that integrates and focuses the Center. Each core and research component should relate to the overall Center theme and to other components of the Center to provide a synergy that leads to creative thinking, novel approaches, innovations, and highly significant findings. Interactions and integration of projects should be clearly evident, so that the Center does not appear to be a collection of independent research projects. There should be linkages among components that result in levels of productivity, quality, and progress that will exceed those expected from combining the individual components in an additive fashion. Linkages may be conceptual, spatial, and/or temporal. Interdependency of the scientific projects may allow for a variety of arrangements, for example, multiple research components sharing a common subject pool managed through a core or a common imaging protocol managed in a core to allow for comparability of data across research projects. The type of integration proposed may be different for different genres of science, including: conceptual integration or sharing of data, instruments, and other resources. Linkages should encourage cross-fertilization of ideas and interactions among investigators that are relevant to the theme. Multidisciplinary research activity is expected across a variety of disciplines or sub-disciplines to bring multiple scientific perspectives and approaches to a research area or question.

From basic animal model research to prevention and treatment, a considerable and growing body of drug abuse literature is finding outcomes that are different in males and females. Effects are often sex/gender-specific and sometimes opposite in males and females. In such cases, failure to test for male-female differences results in conclusion errors. In order to harness the full research and clinical potential of a NIDA P50 Center of Excellence, for projects involving both male and female human subjects, applicants are strongly encouraged to pose gender-based hypotheses and analyze the data for gender differences. For projects involving animal subjects, potential applicants are strongly encouraged to include both males and females, pose sex-based hypotheses, and analyze the data for sex differences. When sex/gender hypotheses and analyses are not proposed, scientific justification should be provided.

In addition, NIDA Research Centers are expected to serve as national research resources in the drug abuse research field to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers in the NIDA research fields. They are expected to attract established and promising investigators into drug abuse research. The P50 Center application is expected to provide opportunities for research training, career development, and mentoring, as well as for effective dissemination of research findings.

A project previously funded as a P20, P30, or P60 NIH grant may be submitted as a new P50 Center by application through this announcement. In order to help the review committee to assess the significance of this transition, the applicant is encouraged to provide information on previous specific aims and highlight scientific accomplishments and the importance and innovation of the findings. This section can be incorporated in the Overall Center Characteristics as preliminary studies.

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/gide/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.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

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://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html 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 for further details.

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 are not limited, but need to reflect the actual needs of the proposed project.
Award Project Period	Applicants may apply for up to five years of support, whether as new or renewal applicationsA Center may be funded for a maximum of two competitive segments.

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.

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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) must maintain an active entity registration (formerly r registration), to be renewed at least annually. Use the SAM.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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.

For purposes of this FOA, the Program Director/Principal Investigator (PD/PI) will be referred to as the Center Director.

An individual who serves as the Center Director of a NIDA P50 Center grant may not concurrently serve as the PD/PI of another NIDA-supported Center. It is expected that the Center Director will commit at least 2.4 person months to Center administration including the administrative core and 1.8 person months to any other core and/or on research component directly supported by the Center grant, for a minimum total of 4.2 person months effort.

Multiple Center Directors are allowed; however, very strong justification for the need of such arrangement is expected to be provided. Also, a Multiple PD/PI Leadership Plan is expected to be provided. When multiple Center Directors are proposed, each one is expected to commit a minimum of 2.4 person months effort.

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

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.

NIDA now limits Centers to a maximum of two competitive segments, each for a maximum of 5 years of support. All new or renewal applications for NIDA Centers should include plans for orderly completion of the Center’s programs and projects within the 5-year project period.

For active NIDA Centers currently in their first competitive segment, only one renewal (and its resubmission if applicable) will be allowed for each award, limiting the total length of support to two competitive segments.

Following 2 funded competitive segments, NIDA will no longer accept an additional renewal, but will accept a new application that is a significant and substantial change in concept and scope when compared to the previously funded renewal.

Investigators and their institutions are expected to follow these guidelines so institutions can submit applications that are eligible to advance in the review process.

NIDA P50 Centers can be renewed once for a maximum of 10 years. Applicants who wish to submit a new application following 10 years of consecutive NIDA P50 funding should reconceptualize their Center before submitting the new application to the FOA and are strongly encouraged to contact their Program Officer at least 6 months before the application due date to discuss the new concepts and to discuss submission as a new NIDA P50 Center.

Scientific judgments to determine the potential continued cutting-edge contributions that another funding period would provide will be made by NIDA staff on a case-by-case basis after carefully considering many factors.

For active NIDA Centers that are currently not in their first competitive segment, NIDA will accept renewal applications from Centers if they have less than 18 months of project support remaining as of the next application due date (September 25, 2013 for non-AIDS applications, January 7, 2014 for AIDS applications) regardless of the number of years of prior project support. These applications should include plans for orderly completion of the Center s programs and projects within the renewal application. A single resubmission will be permitted for these applications.

NIDA will not accept renewal applications that would provide project support in excess of two competitive segments years (i.e., for a third or greater competitive segment) from Centers which have 18 or more months of support remaining prior to the next receipt date( September 25, 2013 for non-AIDS applications, January 7, 2014 for AIDS applications). Grantees in this category should submit plans for orderly completion of the Center s programs and projects to their Project Officer and Grants Management Specialist by the end of the current project period; the annual progress report may be used for this purpose.

Revisions: Applications for Revisions to Center grants will be supported only under the most exceptional circumstances. Revision applications are expected to meet all criteria for a NIDA Center listed above and are expected to contribute to the overall theme of the Center and be clearly linked to other ongoing Center Research Projects in a synergistic fashion. NIDA encourages applicants to consult with NIDA prior to submission of a revision application.

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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]

If preferred, hard copy (paper) letters may be sent to:

Center Grant Applications
Director
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4245, MSC 9550
Bethesda, MD 20892-8401

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Core In ASSIST, select component type Core when preparing the following application components: Research Core Pilot Project Core	12
Project In ASSIST, select component type Project when preparing the following application components: Research Projects	12

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

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall
• Administrative Core: required
• Research Cores: optional
• Pilot Project Core: optional
• Research Projects: minimum of 3 required

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: The following information should be loaded as separate PDF attachments. The filename provided for each attachment will be the name used for the bookmark in the application image.

Center Organizational Structure. Applicants should include a diagram of the organizational structure of the Center. This diagram should demonstrate how the interactions among the Center components will achieve the stated goals of the Center. The diagram should be attached as a PDF titled "Center_Organizational_Structure".

Table of Research Core Utilization. In order to assist the reviewers in determining the relationship between the Research Cores and the Research Projects, a table should be provided that indicates the percentage use of each core relative to the individual projects. The table should be attached as a PDFtitled "Table_of_Research_Core_Utilization".

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Program Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

An individual cannot serve as Center Director of a NIDA P50 Center of Excellence grant while serving as the PI of another NIDA supported research Center.

Multiple Center Directors are allowed; however, very strong justification for the need of such arrangement is expected to be provided

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. Although the average Center director will commit more time to the Center and associated activities than the minimum, it is expected that the Center director will commit at least 2.4 person months effort to Center administration including the administrative core and 1.8 person months effort to any other core and/or on research component directly supported by the Center grant, for a minimum total of 4.2 person months effort. When multiple PIs/Center Directors are proposed, each one is expected to commit a minimum of 2.4 months effort.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Specific Aims are required.

Research Strategy: Each Center application is expected to provide evidence of an environment that promotes the conduct of the highest quality, state-of-the-art research, innovation, and leadership in its areas of investigation. Applicants are expected to demonstrate that the Center is, or would serve as, a significant national scientific research resource soon after its establishment, to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers. For renewals, the application is expected to demonstrate its past success in doing so and how the Center will continue to serve as a national resource.

The application should document availability of appropriate and adequate facilities dedicated to the conduct of administrative, shared resource, and research activities. While all members of the Center need not be located physically in facilities controlled exclusively by the Center, there must be a clearly identifiable physical location for the Center which insures adequate administrative oversight for the Center and associated core units providing shared resources. Much of the shared research environment and many facilities will be located in or funded through the core components. The Overall section should discuss how each core component contributes toward cost-effectiveness and quality control in resource utilization among the research components; how data analytic capacities, database facilities and data resources would be utilized among Center components; and describe the types and quality of shared laboratory and clinical facilities.

All NIDA Centers are expected to clearly demonstrate that they support innovative, rigorous, thematically focused, and productive research that is the result of interacting components of the research program that would not emerge from the mere collection of those individual components. A cadre of experienced, independent and productive investigators should be present with active collaborations in place or planned. These investigators should evidence productivity, stature and leadership, or a potentially strong leadership role, in their respective fields. A broad range of expertise relevant to the Center's goals should be present. Investigative efforts may encompass researchers with primary appointments at the applicant institution as well as at other collaborating sites. Investigators are expected to commit to data sharing and ongoing communications with other investigators in the Center.

Applications should explicitly discuss the integration of work proposed in the application. Further, applications should demonstrate that use of the research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities and research resources that a research Center can uniquely provide. A project previously funded as a P20, P30, or P60 NIH grant may be submitted as a new P50 Center by application through this announcement. In order to help the review committee to assess the significance of this transition, the applicant is encouraged to provide information on previous specific aims and highlight scientific accomplishments and the importance and innovation of the findings. This section can be incorporated in the Overall Center Characteristics as preliminary studies.

For Renewal Applications Only: Include a progress report including a summary of the most significant advances accomplished during the prior period of support. The Progress Report should demonstrate the research environment's conduciveness to productivity by identifying the originally approved specific aims, the progress made on each specific aim, and relevant publications produced in the previous funding period. It is especially important that renewals (1) identify innovative work accomplished by the Center during the current funding period and (2) propose innovative work for the new funding period. Changes in the Specific Aims, including termination of Research Components or Cores, should be described and justified and major findings presented with clear descriptions of the importance of these findings to advances in the field. The application should also address any significant organizational changes, and provide summaries of training activities for junior investigators as well as results of education and dissemination activities. Centers that conduct clinical trials must also provide a summary of recruitment, retention, and safety issues, for each trial conducted.

Progress Report Publication List: Include also a Progress Report Publication List. Cite complete references to appropriate publications and manuscripts accepted for publication that resulted from the work during the prior funding period.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing will extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a Center and is therefore an important criterion in the evaluation and funding of a Center application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

In developing the budget, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigured to maximize efficient resource utilization. The Center is intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.

It is expected that the Center director will commit at least 2.4 person months effort to Center administration including the Administrative Core.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims are required.

Research Strategy: The Administrative Core is expected to have a scientifically and administratively qualified Center Director with responsibility for the scientific, administrative, budgetary, and operational aspects of the Center. The Center Director should be an outstanding, productive, senior researcher, as documented by publications, patents, honors, and similar indices of stature. The Center Director is responsible for overall coordination and development of the Center with the responsibility to provide leadership essential to the success of the Center program, to ensure interaction and collaboration among scientists conducting research, to monitor ongoing research and identify (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources.

The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, to foster synergy, and to support planning and evaluation activities. There should be convincing evidence of the applicant institution's commitment to the Center. Administrative and organizational arrangements should promote joint planning and evaluation activities as well as collaborations and interactions within, between and among programmatic elements of the center. This should include: (a) an overall programmatic structure that effectively promotes scientific interactions, provides for internal quality control of research and publications, generation of future grant applications, and also takes maximum advantage of the Center’s drug abuse research capability (the description of these attributes is particularly important when there are multiple participating institutions in the Center); (b) an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources; (c) the use of an external advisory structure that is charged to provide appropriate and objective advice and evaluation, as needed, to the Center Director ; (d) an internal advisory, decision-making, and priority setting process to support the activities of the Center; and (e) appropriate criteria and processes for determining and sustaining individual participation in the Center based on productivity, research direction, and overall contribution.

To promote information sharing, to facilitate collaboration, and to address issues of common concern among NIDA research Centers, NIDA may ask Center Directors to participate in meetings on an as-needed basis.

Education Activities: As part of serving as a national resource, a NIDA P50 Center is expected to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing will extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a Center and is therefore an important criterion in the evaluation and funding of a Center application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Core)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each Research Core is expected to have a director who is scientifically and administratively well qualified, with responsibility for the scientific, administrative, budgetary, and operational aspects of the core and for coordination with the Center Director and other core/project directors

Budget (Research Core)

In developing the budget for Center Core Components, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigured to maximize efficient resource utilization. The Center is intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.

It is expected that the Core director will make a substantial commitment of time and effort to the Core, at least 1.8 person months effort to administrative and research-related activities directly supported by the Core

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims are required.

Research Strategy: A Research Core can be a laboratory, a facility, a service, or other shared resource that supports other Center components in their activities. Research Cores are expected to support two or more Research Components and each Research Core should be clearly described in terms of the services and resources to be provided to other Center components. Issues to be addressed include: quality control, procedures for selecting projects that use the Core, cost effectiveness, and increased efficiency. Training in complex techniques and methods should be described if they are functions of the proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. While research per se is not an essential part of a scientific core, quality assurance activities that evaluate its operations and are directed at problem identification and improvement of core functioning are appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing will extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a Center and is therefore an important criterion in the evaluation and funding of a Center application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

A Pilot Project Core is permitted but individual pilot projects within a Pilot Project Core do not count toward the total number of Research Projects. At least three Research Projects must be active at all times

SF424 (R&R) Cover (Pilot Project Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot Project Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Pilot Project Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot Project Core)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot Project Core)

In developing the budget for Center Core Components, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigured to maximize efficient resource utilization. The Center is intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.

Direct costs allocated to pilot projects in any year cannot exceed 25% of the Center grant’s total direct costs in that year or $200,000, whichever is smaller.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot Project Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims are required.

Research Strategy: Applicants may choose to include pilot projects in the Center, as a separate Core component. Descriptions of pilot project activities may not exceed 3 pages per pilot project. Description of the administration of the pilot projects may not exceed 5 pages. Pilot projects may be used for new, early stage or independent investigators and should represent new projects to develop and explore new activities or directions or take advantage of special opportunities. Pilot projects may be research and development pilots, feasibility studies, or other pilot work broadly defined as foundation work for further research. Pilot projects may not be used to supplement or prolong ongoing research and should not be used as bridge funds when other research support is no longer available.

The support of individual pilot project studies is typically of relatively short duration (e.g., 1-2 years), depending upon the nature of the research. Applicants may propose and request funding in the first year for specific, already conceptualized pilot projects and also for pilot projects to be added in subsequent years of the project. Applications requesting support for pilot projects must describe a process for within-Center scientific review of new pilot projects to be initiated in future years of the project and a process for evaluation of ongoing pilot projects for adequate progress. Pilot projects presented in the application will be reviewed as part of the assessment of scientific and technical merit of the application and as examples of the kinds of pilot projects the Center might initiate in the future as a result of its internal within-Center review process.

Center grantees should provide the NIDA program officer written notification of the initiation of a new pilot project. The notification should contain a brief description of, and rationale for, the planned pilot project, the amount of pilot funds to be allocated to the project, the proposed length of the project, and a statement that the project will comply with applicable NIH policies and that the necessary assurances have been submitted and obtained. The program officer should also be provided with assurance that the projects have received an appropriate within-Center review. Applicants are strongly encouraged to discuss with the program officer to ensure that the pilot project stays within the original scope.

For all pilot projects, describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials, if applicable.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing will extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a Center and is therefore an important criterion in the evaluation and funding of a Center application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

NIDA encourages up to 4 thematically integrated Research Project Components but more may be permitted if strongly justified. Justifications for more Research Project Components should be discussed with NIDA program staff as early as possible during application development.

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Each Research Project is expected to have a scientifically and administratively qualified Director with responsibility for the scientific, administrative, budgetary, and operational aspects of the project and for coordination with the Center Director and other Research Project/Core Directors. The Research Project Director should be productive, outstanding researchers and leaders of the field.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

It is expected that the Research Project Director will make a substantial commitment of time and effort to the Center, at least 1.8 person months effort to research-related activities directly supported by the Research project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Specific Aims are required.

Research Strategy: Research may focus on any area of NIDA's mission, but must bear an essential relationship to the Center’s integrating theme and efficiently use and contribute to Center resources. Each Research Project that uses Center Research Core facilities should describe how the Core resources impact the proposed project

Training Activities: While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important secondary function is the training of research and clinical personnel. Training and mentoring to enhance junior researchers' or other researchers' skills should be conducted in the context of the research, but funds may not be used for training stipends or for training not required to conduct the research. However, Center staff may participate in the development of training programs, and Center resources may be made available for use by trainees. Training activities are also expected to recruit and nurture future generations of scientists to engage in drug abuse and addiction research. The Center is strongly encouraged to provide programs to develop careers of researchers of ethnic minorities in drug addiction research and to develop programs to eliminate health disparities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. NIDA Centers are supported both for their expected crucial scientific accomplishments and for their role as vital resources to the research community. In order to maximize the impact of their work, they are expected to make their data, their methodologies and their findings available in a timely manner to other researchers and those who have a legitimate purpose for the access. In most instances, the data sharing will extend beyond that of one's own Center to the research community. This sharing can be accomplished in many ways, including posting findings on the Center's website or using archival services. Data sharing plans are expected to be provided, consistent with achieving the goals of the program. A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a Center and is therefore an important criterion in the evaluation and funding of a Center application.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is there a clear integration of the Center components -Cores and Projects- to an overarching theme that integrates and focuses the Center, as well as the presence of an essential relationship of each research project and core component to the theme?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the Center Director have the ability to lead a scientific program as documented by scientific achievements, productivity, stature in a relevant field, and planned activities? Does the Center Director have the ability to lead administrative and operational aspects of the Center, as noted by administrative skills, achievements, and planned activities and is there evidence of ability to develop or maintain a role for the Center as a national resource? Is there adequate commitment of time and effort for the research and administrative functions of the Center? As a group, are Research Project and Core investigators well suited to the projects? Is there evidence of multidisciplinary backgrounds and interests?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application clearly demonstrate, in a diagram, the feasibility of the organizational structure? Does the organizational structure have clear lines of authority that allow for efficient and cost-effective management and allocation of funds, as well as leverage of resources to enable additional or future work? Are the organizational and administrative structure and support capable of creating thematic integration that is conducive to research, synergy, and joint planning? Is there an operational programmatic structure that effectively promotes productive scientific interactions, cross fertilization, and takes maximum advantage of the applicant institution's drug abuse research capacity?

Is a process in place for long range planning and evaluation of Center activities? Is there an appropriate, fully described internal process that allows for priority setting and decision making to sustain the Center? Is there appropriate specification of criteria and processes for determining and sustaining individual participation in the Center based on productivity, research direction, and overall contribution? Are there arrangements for internal quality control of research, publications, and grant applications? Does the outside advisory structure have the capacity to provide appropriate and objective advice and evaluation? Are there adequate plans for recruitment, training, and supervision of staff?

Is there a clear integration of Center components (including components not directly supported under a P50 but which utilize core functions) to an overarching theme that integrates and focuses the Center, as well as the presence of an essential relationship of each research and core component to the theme? Are there sufficient interactions and linkages of components to each other, to show that the impact of a coordinated Center goes beyond the impact of individual research projects? Does the approach taken for Center activities make use of a depth and breadth of expertise and experience not normally present in an individual research project grant?

Do the core components as a group contribute resources that enhance cost-effectiveness and quality control in resource utilization?

Do the Center’s activities involve different scientific disciplines or subdisciplines and demonstrate substantial interaction among scientists from different disciplines or subdisciplines and different perspectives?

Will the proposed Education Activities provide high quality, appropriate research career development and are they likely to be effective in attracting and involving junior investigators and students who show potential for significant future contributions and independent research careers in the work of the Center?

Do the proposed educational and outreach activities to drug abuse research communities, organizations, general public, and/or policy makers support the ability of the Center to be a national resource?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are there plans for development and maintenance of an environment that promotes the conduct of the highest quality of research, innovation, and leadership? Does past productivity indicate likely future productivity, especially in renewal applications, where innovation needs to be demonstrated? Are there appropriate and adequate facilities for administrative, research, and shared resources, including a clearly identifiable physical location for the Center, which assures necessary functions can occur? Do the facilities indicate the Center is, or would soon be, a national scientific research resource?

Is there adequate institutional support; for example, letters of support, space and resources to be allocated from the applicant institution, substantial commitment to the Center and appreciation of its goals and role in public health, especially in the drug abuse and addiction research field?

Does the environment provide adequate high quality data analytic capacity, data base facilities, coordination, and data resources? As needed, are there provisions for shared laboratory resources, high quality laboratory space, and clinical facilities?

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. A Core does not need to be strong in all categories to be judged likely to have major impact. For example, a Core that by its nature is not innovative may be essential to promote activities in the Center.

Significance

Does the Core Component address important scientific and administrative activities of the Center? If the aims of the Core are achieved, how well will it contribute to the function of the Center? How will successful completion of the aims contribute to support of the concepts, methods, technologies, treatments, services, or preventative interventions carried out in other components of the Center? Is there adequate justification for this Core activity being conducted within a Center structure?

Investigator(s)

Are the Core Director, the collaborators, and other researchers well suited to the Core? If the Core Director is an Early Stage Investigator, New Investigator, or a researcher in the early stages of an independent career, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Innovation

Does the Core utilize novel theoretical concepts, approaches or methodologies, instrumentation, or interventions in support of the Center? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and plans for day to day management well-reasoned and appropriate to accomplish support of Center activities? Are potential problems, alternative strategies, and benchmarks for success presented? Are the arrangements and organizational structure adequately developed, well integrated, well-reasoned, and integrated with multiple other components of the Center? Is the justification for the need for Core services or resources clearly stated and are there appropriate plans for resource allocation?

If the Core activity involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. A Pilot Project Core does not need to be strong in all categories to be judged likely to have major impact. For example, a Pilot Project Core that by its nature is not innovative may be essential to promote activities in the Center.

Significance

Do the pilot research topics address an important problem or a critical barrier to progress in the field and are they consistent with the overall goals of the Center? If the aims of the project(s) are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Do the projects have the potential to develop into full scale independent projects?

Investigator(s)

Does the Director have the qualifications to lead this component? In the individual pilot projects, are the project leaders, their collaborators, and other researchers well suited to the projects? If they are Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Innovation

Do the proposed pilot projects or the process for generating new pilot projects challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses for proposed pilot projects and the process for managing the pilot project core well-reasoned and appropriate to accomplish the specific aims of the projects? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are their adequate plans to evaluate progress of ongoing pilot projects and to generate and monitor new projects? Are monitoring, oversight procedures and continuation decisions explained? Do the pilot projects chosen reflect that an appropriate process for selection of pilot projects is in place?

If the projects involve clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. A Research Project Component does not need to be strong in all categories to be judged likely to have major impact. For example, a Research Project Component that by its nature is not innovative may be essential to promote activities in the Center.

Significance

Does the Research Project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the project well integrated into the overarching theme of the Center and interactive with other research components or cores?

Investigator(s)

Are the Project Director, the collaborators, and other researchers well suited to the project and do they commit sufficient time to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Innovation

Does the project challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Drug Abuse, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Jamie Biswas, Ph.D.
Chief, Medications Research Grants Branch
Division of Pharmacotherapies and Medical
Consequences of Drug Abuse
National Institute on Drug Abuse

Telephone: 301-402-3869
FAX: 301-443-9649
Email: [email protected]

Meyer D. Glantz, Ph.D.
Assoc. Director for Science
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
Telephone: 301-443-6504
Email: [email protected]

Paul Schnur, Ph.D.
Deputy Director
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse

Telephone: 301-435-1316
FAX: 301-594-6043
Email: [email protected]

Steven Grant, Ph.D.
Chief, Clinical Neuroscience Branch
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse
Telephone: 301-443-4877
FAX: 301-443-6814
Email: [email protected]

Mark Swieter, Ph.D.
Chief, Extramural Affairs Branch
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: [email protected]

Cheryl Nathaniel
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
Telephone: 202-526-0108
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.