Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

This Funding Opportunity Announcement (FOA) hereby notifies all Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) with awards from the NIH Institutes and Centers listed in the Components of Participating Organizations and with grant funding mechanisms listed in Activity Code that funds are available for administrative supplements to awards that are studying sleep disturbances and/or chronic pain with human volunteers. The proposed supplemental activities, may include the addition of: sleep assessment to clinical studies of pain; pain assessment to clinical studies of sleep; measures of sleep and/or pain for clinical studies already incorporating sleep and/or pain measures; additional data collection time points for clinical studies already incorporating sleep and/or pain measures; or secondary data analysis of clinical studies to explore the interaction among sleep disturbances to chronic pain. The proposed supplemental activities must be within the scope of the parent application. The final goal of the supplement should be a contribution to methods or understanding needed for future larger scale studies that directly investigate the interactions between sleep disturbances and chronic pain.

Chronic sleep disturbances and chronic pain are overlapping health conditions that may impact as many as half of the adult population. Pharmacological treatment of insomnia and chronic pain (e.g., benzodiazepine and opioids), while essential to the well-being of many patients, carries significant risk for adverse events. Furthermore risks and side effects of the main classes of drugs used for treatment of these conditions appear to be amplified when these agents are used together . Hence it is of substantial public health importance to understand the interactions between disturbed sleep and chronic pain.

While there is substantial clinical evidence that chronic pain states can disrupt sleep, the impact of sleep-wake disturbances on the development of chronic pain remains less clear. Evidence supports that sleep disturbance may increase acute pain sensitivity, and that conversely, increased sleep time can reduce acute pain sensitivity. Emerging evidence indicates that sleep disturbances may also predict the development of chronic pain. A meta-analysis of nonpharmacological treatments of insomnia among chronic pain populations reported a small overall effect of reduced pain for treatment vs. control groups; however, it is important to note that only six trials were included, and most had very small sample sizes of less than 30 participants per treatment arm. Thus while a literature base is growing to support a directional association of sleep disturbance contributing to chronic pain, and the potential of sleep treatments to reduce pain, more work is needed to confirm or refute these findings, and interrogate mechanisms that underlie these interactions. In addition, it will be important to determine if some complementary treatment approaches may be able to both improve sleep and diminish chronic pain symptoms.

The goal of this administrative supplement FOA, therefore, is to supplement ongoing research that will lead to an understanding of how sleep disturbances contribute to chronic pain. This program seeks to support ongoing clinical work that will facilitate future research on how sleep disturbances may contribute to the development of chronic pain and whether interventions to improve sleep may also alleviate pain and/or reduce the functional impact of chronic pain. NCCIH has particular interest in understanding how nonpharmacological interventions may impact both sleep and pain outcomes. It is anticipated that these administrative supplements will be successful in generating information for new investigator-initiated grant submissions to the NIH for mechanistic and/or clinical studies on contributions of sleep to chronic pain including further study of nonpharmacological interventions that may impact both sleep and chronic pain.

Applications for this award must propose a comprehensive research plan that has: (1) intrinsic research importance in NCCIH priority areas (see the NCCIH Strategic Plan), (2) is within the scope of the of the parent research award, (3) will serve as a suitable vehicle for collecting pilot data on the contribution of sleep to chronic pain; and (4) can be accomplished within the remaining active funding period of the parent award. Applications that do not propose work that would help to clarify the impact of sleep disturbance on chronic pain will not be considered for funding.

Examples of the types of research this supplement could support include but are not limited to:

• Additional collection of pre- and post-intervention sleep variables to an ongoing clinical study of a non-pharmacological intervention to treat pain within a specific medical population, for example in order to examine whether enhancement of sleep precedes or is concurrent with reduction in pain measures.
• Additional collection of pre- and post-intervention pain variables in an ongoing clinical study of a non-pharmacological and/or dietary supplement intervention to treat sleep disturbances among a clinical population with relevance to chronic pain, in order to examine whether patients in the sleep treatment arm experience greater reductions in pain compared to participants in the control arm.
• Adding data collection on sleep or pain variables at new time points in observational or interventional studies assessing both sleep and pain within a chronic pain population in order to better assess temporal associations in fluctuations of sleep and pain.
• Adding use of the PROMIS tools (http://www.nihpromis.org) and/or ecological momentary assessments (EMA) of sleep or pain to other measures being used to assess these conditions in the parent grant, in order to help clarify directional associations between sleep and chronic pain.
• Secondary analyses of clinical studies including both sleep and pain measures that would help to clarify the directional relationship of sleep disturbances with chronic pain.
• Piloting the addition of new methods and measures of sleep or pain to clinical studies with standardized measures, to enhance the assessment of the impact of sleep on chronic pain. Full-scale validation studies are not within the scope of this solicitation.

At the end of the activity, supported investigators will be required to submit a brief (2-4 page) summary of the findings, relevant publications, and future plans for the collaborations. Sharing of any resource developed with these funds should also be described within the summary. The summary would be part of the annual Progress Report and the Final Report submitted for the supplement.

NICHD Specific Interests:

The National Center for Medical Rehabilitation Research (NCMRR) situated within NICHD is particularly interested in research on sleep disturbances in chronic physical disabilities or in the context of medical rehabilitation.

Before submitting an application for an administrative supplement, grantees should communicate with the Program Officer for their funded award and the NCCIH Scientific/Research contact for this announcement to discuss the planned application.

See Section VIII. Other Information for award authorities and regulations.

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.

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

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

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

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

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

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

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.

Applicants must prepare applications using current forms in accordance with the Application Guide.

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements 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.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

The Research Strategy is limited to four pages.

For this administrative supplement requests must be submitted using the electronic submission process.

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• Research Plan form: The application should include the following information in the section indicated.
• Specific Aims: Include hypotheses for proposed supplement activities.
• Research Strategy: (1) Summary or abstract of the funded parent award or project, including current progress toward achieving aims, not to exceed one page. (2) A plan for the proposed supplement activities. The plan should include a brief Significance section that provides a clear and compelling rationale for why the proposed work would result in meaningful pilot data for future clinical research on the contribution of sleep disturbances to chronic pain. It should also include an Experimental Design section detailing methods of proposed supplemental activities, including a full description of any additional measures and/or data collection time points, a detailed explanation of why such additional measures/data collection would help to ascertain the impact of sleep on chronic pain, an indication of what proportion or number of parent study participants would be able to complete supplemental measures, data management and statistical methods, including power analyses. Applicants should provide a study timeline that clearly denotes the addition of supplement activities to the activities funded by the parent award. The research plan should conclude with a Future Studies section that clearly connects proposed supplemental activities to future research questions on the contribution of sleep disorders to chronic pain.
• Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
• Sr/Key Personnel form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available, with the following additional guidance:

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
• Specific Aims: Include hypotheses for proposed supplement activities.
• Research Strategy: (1) Summary or abstract of the funded parent award or project, including current progress toward achieving aims, not to exceed one page. (2) A plan for the proposed supplement activities. The plan should include a brief Significance section that provides a clear and compelling rationale for why the proposed work would result in meaningful pilot data for future clinical research on the contribution of sleep disturbances to chronic pain. It should also include an Experimental Design section detailing methods of proposed supplemental activities, including a full description of any additional measures and/or data collection time points, a detailed explanation of why such additional measures/data collection would help to ascertain the impact of sleep on chronic pain, an indication of what proportion or number of parent study participants would be able to complete supplemental measures, data management and statistical methods, including power analyses. Applicants should provide a study timeline that clearly denotes the addition of supplement activities to the activities funded by the parent award. The research plan should conclude with a Future Studies section that clearly connects proposed supplemental activities to future research questions on the contribution of sleep disorders to chronic pain.
• If applicable, attach documents indicating that the proposed research experience was approved by the human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

For electronic application 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 using the instructions specified above.

Applicants must complete all required registrations prior to submission. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(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 (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Not Applicable

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

Administrative Review Criteria:

The Program staff of the NIH awarding component will review requests for a supplement to
determine their overall merit. The review process will be primarily based on the review criteria
listed below. These criteria are listed in order of priority:

(1) Does the proposed work help clarify the impact of sleep disturbances on chronic pain?
(2) How strongly is the research plan related to NCCIH priorities?

(3) Will the pilot data provide necessary information for future research on the contribution of
sleep disturbances to chronic pain?

(4) Is sufficient detail provided to indicate that the research team can successfully collect data on
the stated populations of interest?

(5) Can the proposed research be accomplished within remaining parent project funding?

(6) Are the proposed research methods (i.e., measures, analyses, etc.) adequately justified?

Potential to Promote Collaborations

NIH Staff will consider the potential of the proposed activities to promote collaborations and future NIH applications proposing research on the contribution of sleep disturbances to chronic pain.

Relevance to Parent Grant and Approach

NIH staff will consider the relevance of the proposed activities to the parent grant. Applicant must provide information to assess if there is adequate progress of the parent project and this information will be considered to ensure proposed project is feasible. NIH staff will consider if the proposed activities or analyses are well-reasoned and appropriate to accomplish the goals of the supplement within the remaining active funding timeframe of the parent grant and if the expertise of the proposed research team is appropriate.

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

NIH staff 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.

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

Not Applicable

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Lanay Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: lanay.mudd@nih.gov

Mary Ellen Michel, Ph.D.
National Institute of Child health and Development (NICHD)
Telephone: 301-496-5289
Email: mary.michel@nih.gov

David Thomas, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1313
Email: dthomas1@nida.nih.gov

Janet He, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: hey@ninds.nih.gov

Michael Oshinsky, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: michael.oshinsky@nih.gov

Martha Matocha, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-2775
Email: matocham@mail.nih.gov

James Witter, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-480-1284
Email: witter@mail.nih.gov

Not Applicable

Shelly M. Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

Ted Williams
National Institute of Child health and Development (NICHD)
Telephone: 301-326-6450
Email: williate@mail.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@mail.nih.gov

Tijuana Decoster, PhD
National Institute of Neurological Disorders & Stroke (NINDS)
Telephone: 301-496-9531
Email: decostert@mail.nih.gov

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sintj@mail.nih.gov

Melinda Nelson
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-5278
Email: nelsonm@mail.nih.gov

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 Part 75.