Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Pain in Aging (R01)

Activity Code

R01 Research Project Grant  

Announcement Type

Reissue of PA-09-193.

Related Notices

  • June 4, 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

PA-13-058

Companion Funding Opportunity

TPA-13-221, PA-13-059, R21 Exploratory/Developmental Grant

PA-13-060, R03 Small Research Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866, 93.273, 93.279, 93.213   

Funding Opportunity Purpose

This FOA encourages Research Project Grant (R01) applications from institutions/organizations that propose to study pain from an aging perspective, including studies of older populations, studies of age differences and age-related changes in pain processes and experiences, and studies of pain treatment and management in older adults. This FOA particularly encourages studies on 1) mechanisms and predictors of pain experience in aging, 2) development and evaluation of pain assessment tools for older adults or older model organisms, and 3) development and evaluation of pain management strategies in older adults, with particular attention to the challenges associated with treating pain in patients with multiple morbidities. Studies may address a variety of approaches and outcomes including biological (i.e., genetic, molecular, neurobiological), clinical, behavioral, psychological, and social factors.  Both animal models (especially aged animals) and human subjects are appropriate for this FOA. 

Key Dates
Posted Date

December 20, 2012

Open Date (Earliest Submission Date)

January 5, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://www.grants.gov/contactus/contactus.jsp.
Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Pain is one of the most frequently reported and costly symptoms in clinical settings, and has often been called “the fifth vital sign.” According to the Institute of Medicine’s recent report, “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research,” over 100 million Americans suffer from chronic pain conditions. This figure is greater than the number of individuals with diabetes, heart disease, stroke, and cancer combined. Annual health care costs attributable to pain are conservatively estimated at over half of a trillion dollars.

The prevalence of pain has been increasing across all adult age groups, but is consistently greatest among Americans aged 65 and older. This segment of the population also has the highest long-term consumption rate of medications for pain (1). The prevalence of age-related diseases associated with chronic pain, such as arthritis, diabetes, and cancer, is expected to rise even further due to the aging of the US population. As such, we will likely see substantially increased demand for effective pain care in older adults into the foreseeable future.

Assessment and treatment of pain may involve a broad array of pharmacologic and non-pharmacologic interventions, a variety of care providers, and multiple care settings.  With older individuals, the complexity of these factors is often compounded by aging-related issues such as age-related changes in related neural systems, multiple co-occurring diseases and conditions (multiple morbidity), multiple concurrent medications (polypharmacy), alterations in drug absorption and metabolism, impaired cognitive capacity, impaired functional capacity, and increased barriers to care. Studies looking at the effectiveness of opioids, which are the most commonly used medications for treating different types of chronic pain, as well as the risks of adverse effects stemming from the factors noted above, as well as the risks of tolerance, dependence, and addiction would be of interest. Moreover, treatment of pain in older adults frequently involves trade-offs among multiple competing risks and benefits, but there is scant evidence for weighing these factors effectively. Studies in older cohorts may be further challenged by physiologic heterogeneity, a quintessential characteristic of older adult populations. Although a variety of clinical practice guidelines for pain have been published, including those specifically for older adults (2), the evidence base underlying these guidelines would benefit from further research. In particular, understanding how differences in patient-, provider-, and system-level factors affect treatment outcomes is largely lacking.

In order to address some of these knowledge gaps and practice barriers, the National Institute on Aging (NIA) has led several initiatives aimed at identifying and supporting key research opportunities on pain and aging. In collaboration with the NIH Pain Consortium, the NIA sponsored an exploratory workshop entitled “Mechanisms and Management of Pain in the Elderly” in 2008 (see Meeting Agenda and Executive Summary). The following year, a series of program announcements focusing on pain in aging were issued (PA-09-193, PA-09-194, and PA-09-195).  In 2010, NIA, under the aegis of the NIH Pain Consortium, convened an “Expert Panel Discussion on Pharmacological Management of Chronic Pain in Older Adults” (see Meeting Agenda and Executive Summary).  A summary of the meeting, which detailed the identified research gaps and methods to address them, was published in Pain Medicine (1). In 2011, NIA issued RFA-AG-12-006, which solicited studies using existing data to evaluate the safety or effectiveness of pharmacological treatments for chronic pain in older adults. The NIA now offers this reissuance of the 2009 Program Announcement to continue its support of research on key research topics in pain from an aging perspective.

One particularly promising area of research may lie at the intersection of genetics and the neurobiology of pain. Over 130 genes have been identified that are putatively associated with pain processing, pain experience, or interactions with pain treatments. Neuroimaging studies have identified brain regions critical for processing pain information and regulating pain experiences. Collectively, these approaches may lead to enhanced strategies for diagnosis and treatment, which may benefit cognitively impaired individuals in particular, and may also advance the vision of more personalized pain management in general.

The extent to which normal age-related changes in cognitive or emotional function impact pain experiences and pain coping/management is understudied, as is the extent to which approaches to pain management impact normal psychological function in older adults. In addition, research aimed at understanding health disparities (e.g. gender, racial/ethnic, socioeconomic) in the progression and severity of pain at older ages and in trajectories of treatment, outcomes, and behavioral adaptations to painful conditions among different subpopulations of older adults is needed. 

The increasing availability of large-scale population-based survey data on painful conditions and disability among older populations in both the US and internationally also opens opportunities for comparative analyses of prevalence and severity of pain regionally and cross-nationally, and investigation of the causes of regional and national differences in pain experience and treatment.

Scope

This FOA encourages a broad range of applications examining the mechanisms and processes by which factors at all levels of analysis (from molecular to social/institutional) impact the experience, representation, processing, management, and treatment of pain in older adults. Both basic and translational research is encouraged under this FOA.   Applications at a single level of analysis are welcomed (e.g. studies of neural circuitry for pain processing in aging), as are studies examining processes across levels of analysis.  Studies focused on normal age differences and age-related changes in pain processes, as well as on age-related diseases or disorders, including pain in older adults with comorbid conditions or with Alzheimer’s disease or other age-related dementias, are strongly encouraged.  New pain assessment methods and management approaches targeting older adults are also encouraged.  Both human and animal model studies are appropriate. This FOA encompasses the range of scientific approaches, including genetic, molecular, imaging, physiological, clinical, behavioral, social, psychological, comparative effectiveness research (CER), and epidemiological (including cross-national comparative) approaches.

An association between chronic pain conditions and alcohol dependence has been suggested in numerous studies with episodes of alcohol abuse antedating chronic pain in some and alcohol dependence emerging after the onset of chronic pain in others. However, the interaction between alcohol use and pain in older people has not been investigated. While acute alcohol may be analgesic, the long-term alcohol use in chronic pain conditions in older population may worsen pain and exacerbate associated anxiety and depressive-like conditions. The effects of chronic use of alcohol on neuroimmune systems may play a crucial role in determining the pain sensitivity and treatment outcome in elderly. NIAAA is interested in receiving applications addressing neuronal and glial mechanisms related to alcohol and chronic pain in older populations.  

Additional Guidance

Because of the complexities of both aging processes and pain mechanisms, applications are encouraged to incorporate multidisciplinary approaches whenever appropriate to the study. Expertise may be integrated among multiple relevant disciplines including, but not limited to, anesthesiology, neurology, geriatrics, psychology and/or neuropsychology, neuroscience, economics, demography, epidemiology, sociology, pharmacology and/or neuropharmacology, nursing, physical medical & rehabilitation, and physical and/or occupational therapy.

Comparisons between older and younger subjects are encouraged in either animal or human studies. No individual ranges for “older” or “elderly” are specified for this FOA; rather, the demarcation between older and younger subjects should be dependent on the research hypotheses and subjects under study. Furthermore, investigators are encouraged to study a broad range of midlife and older subjects, from early to advanced old age.

Applicants can find a compilation of aging-relevant population studies at http://nihlibrary.ors.nih.gov/nia/ps/niadb.asp. Information about NIA-supported aged animal colonies and other scientific resources can be found at http://www.nia.nih.gov/research/scientific-resources.

Applicants are encouraged to use self-reported measures of pain, function, affect, or other relevant domains where appropriate, such as the Patient-Reported Outcomes Medical Information System (PROMIS), and/or objective and self-report measures of cognitive, emotional, sensory, or motor function such as the NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox).   Both PROMIS and the NIH Toolbox can also be found, along with other potentially suitable assessment tools, at www.assessmentcenter.net.

References

(1)        Reid MC, Bennett DA, Chen WG, Eldadah BA, et al. “Improving the Pharmacologic Management of Pain in Older Adults: Identifying the Research Gaps and Methods to Address Them.” Pain Medicine, 2011; 12(9):1336-1357.

(2)        American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. “Pharmacological management of persistent pain in older persons: American Geriatrics Society.” Journal of the American Geriatrics Society, 2009; 57:1331-1346.    

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project period.  The maximum period is 5 years.  

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Required Registrations

Applicant organizations 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.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

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.

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

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.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. 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 deadline 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.   

6. Other Submission Requirements and Information

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

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) 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.

Requests of $500,000 or more for direct costs in any year

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.  

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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 project that by its nature is not innovative may be essential to advance a field.

Significance

Does the 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? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited 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)? 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?   

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 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? 

Additional Review Criteria

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.

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.

Additional Review Considerations

As applicable for the project 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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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:

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Direct general inquiries, as well as questions pertaining to neurobiological, neurobehavioral, neuropsychological, or neuroepidemiological approaches, or neural mechanism-based assessment, therapeutic and clinical studies to:

Wen G. Chen, Ph.D.
National Institute on Aging (NIA)
Telephone: (301) 496-9350
Email: chenw@nia.nih.gov

Direct questions pertaining to pain management related to medical conditions common in older adults, management algorithms for older complex patients, physical function or medical outcomes, and other related geriatric issues to:

Basil Eldadah, M.D., Ph.D.
National Institute on Aging (NIA)
Phone: (301) 496-6761
Email: eldadahb@nia.nih.gov

Direct questions pertaining to racial, ethnic and socioeconomic disparities in pain; development of pain measures for population-based samples; and research addressing psychological, behavioral, or social mechanisms and processes involved in pain experience (including integrative science approaches) to:

Lisbeth Nielsen, Ph.D.
National Institute on Aging (NIA)
Phone: (301) 402-4156
Email: nielsenli@nia.nih.gov

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

Soundar Regunathan, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: (301) 443-1192
Email: soundar.regunathan@nih.gov

Partap S. Khalsa, DC, PhD, DABCO
National Center for Complementary and Alternative Medicine (NCCAM)
Phone: (301) 594-3462
Email: khalsap@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Robin Laney
National Institute on Aging (NIA)
Telephone: (301) 496-1473
Email: Robin.Laney@mail.nih.gov

Christine Kidd
National Institute on Drug Abuse (NIDA)
Telephone: (301) 435-1372
Email: ckidd@nida.nih.gov

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 443-4704
Email: jfox@mail.nih.gov

George Tucker, M.B.A.
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: (301) 594-9102
Email: gt35v@nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.