Part I Overview Information


Department of Health and Human Services

Components of Participating Organizations
National Cancer Institute (NCI) (http://www.cancer.gov)
National Heart Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute of Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute on Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institutes on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/)

Title: Recovery Act Limited Competition: Supporting New Faculty Recruitment to Enhance Research Resources through Biomedical Research Core Centers (P30)

Announcement Type

New

Request for Applications (RFA) Number: RFA-OD–09-005

Catalog of Federal Domestic Assistance Number(s)
93.701

Key Dates
Release Date: March 30, 2009
Letters of Intent Receipt Date: April 29, 2009
Application Receipt Date: May 29, 2009
Peer Review Date: July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 2009
Additional Information To Be Available Date (url Activation Date): Not Applicable
Expiration Date: May 30, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of 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 Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

This initiative, which is supported by funds provided to the NIH under the Recovery Act, is designed to provide the necessary resources for U.S. academic institutions/organizations to enhance their biomedical research efforts through the development of Biomedical Research Core Centers. For this announcement, Biomedical Core Centers are defined as a community of multidisciplinary researchers focusing on areas of biomedical research relevant to NIH, such as centers, departments, programs, and/or trans-departmental collaborations or consortia. These Core Centers are designed to provide scientific and programmatic support for promising research faculty and their areas of research. The NIH invites applications that include plans to recruit and hire investigators to conduct biomedical research in all scientific disciplines, including the field of bioethics.

These Core Center Grants are institutional awards that provide funding to hire, provide appropriate start-up packages, and develop pilot research projects for newly-independent investigators, with the goal of augmenting and expanding the institution’s community of multidisciplinary researchers focusing on areas of biomedical research relevant to NIH. Core Center Grants are institutional awards that provide support for shared resources for categorical research by faculty from different disciplines who provide a multidisciplinary approach to a joint research effort, or from the same discipline who focus on a common research problem. For this announcement, awards will be directed towards hiring investigators and providing appropriate start-up research resources (e.g., research salary, equipment, and supplies for initiating their research) that will help strengthen or expand the scientific capacity of the Biomedical Research Core Center.

Any newly- recruited research faculty receiving support under this award:

Newly-recruited research faculty receiving support under this award will be expected to develop and/or participate in research projects within the Core Center. Participation should be appropriate for a newly-independent investigator and should foster the development of preliminary data which can be used to prepare applications for future independent research project grants to further both the investigator’s research career and the scientific mission of the Core Center.

The institution will be expected to work with each newly-recruited research faculty member to develop a faculty career development plan consistent with the Core Center’s emphasis on a multidisciplinary approach to biomedical research.

See Section VIII, Other Information - Required Federal Citations, for laws and policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Core Center Grant (P30) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

This program is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5.

Contingent upon the submission of a sufficient number of scientifically meritorious applications, approximately $100 million of ARRA funds will be obligated by September 30, 2010 to support requests submitted in response to this notice or any reissuance of this notice.

The funds available and anticipated number of awards will vary among the participating NIH ICs and will depend upon scientific review. Applicants are strongly encouraged to refer to the IC Table of Contacts to gain a better understanding of the use of this program by the participating NIH ICs: (http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm).

Budgets will vary among the participating NIH ICs. Applicants should refer to the IC Table of Contacts at http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm for IC-specific allowances. Project duration of up to two years may be requested.

Because the nature and scope of the proposed project will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

NIH grants policies as described in the http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm).

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to organize and direct the proposed Core Center is invited to work with his/her institution 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.

The Institution should designate a PD/PI who is a senior official with appropriate institutional authority to carry out the project, serve as director of the Core Center, and work with Core Center investigators to develop relevant research projects, such as an Associate Dean/Director for Research, or a faculty member at the Full Professor level (or equivalent) (e.g., Department Chair/Division Chief).

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Number of Applications Per Institution/Organization: The number of applications permitted varies among participating NIH ICs. Applicants should refer to the IC Table of Contacts at http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm for IC-specific allowances. Regardless, separate components of an eligible U.S academic institution/organization may submit separate applications to any of the participating NIH ICs. (For example, the dental school may submit an application to NIDCR, while the medical school within the same academic health center may submit another application to one of the other NIH ICs, provided that a separate Core Center is being proposed.)

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through directions on the D&B web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

Special Instructions for Cover Letter

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: April 29, 2009
Application Receipt Date: May 29, 2009
Peer Review Date: July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 30, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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 and plan for the potential review workload.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to the appropriate person as listed in the IC Table of Contacts (http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm) for this program.

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, applicants are requested to send two additional copies of the application to the appropriate NIH IC, as specified in the IC Table of Contacts (http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm) for this program.

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR) and for responsiveness by the reviewing IC. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review, as indicated in the NIH Grants Policy Statement.

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 (see (http://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Research Plan and Page Limitations

Items 2-5 of the PHS398 Research Page component are limited to 12 pages and must include the following:

Describe the existing research infrastructure and environment at the applicant institution, including human resources (e.g., researchers and support personnel), equipment, physical structure, space layout, and shared resources available to be incorporated into the Core Center, and how this award would contribute to building a community of interdisciplinary researchers focusing on a common research problem.

Identify the specific research problem to be addressed, or the area(s) of research to be enhanced, by the Core Center, and the rationale for its selection.

Describe the qualifications of new investigator(s) who would be recruited into the Core Center, and how such investigator(s) would help to strengthen or expand the scientific capacity of the proposed Center.

Describe the plans/strategies for recruiting new faculty within the specified area(s) of research or for promoting non-tenured postdoctoral fellows/faculty to tenure-track faculty positions within the Core Center. Note that the NIH encourages the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and individuals from disadvantaged backgrounds. Furthermore, NIH supports the development of a diverse scientific workforce.

For the newly-recruited research faculty, describe plans for how their research ideas will be selected, developed and conducted as pilot research projects relevant to the research mission of the Core Center. Criteria for selection of research projects conducted within the Core Center must be included in the application. Note that all research conducted by investigators supported by NIH through this program must be conducted in compliance with all current Federal and NIH regulations, guidance, and policies, even if non-NIH funding is used for the project.

For the specified area(s) of research or research expertise, provide a description of existing collaborative research activities or existing relationships between the applicant institution and other components of the institution/organization. If the applicant institution is not part of an academic health center or university, describe relevant collaborative activities with other institutions. Describe how these separate components will collaborate in the research activities of the Core Center, and how they will collaborate in the recruitment and hiring of new faculty.

Describe how participation by newly-independent investigators in Core Center research projects will foster development of their academic research careers, and lead towards applications for future independent research project grants to further the mission of the Core Center.

Describe faculty development plans for the newly-hired/promoted tenure-track investigators. Provide detailed plans for assessing and monitoring the annual progress of the faculty member(s) hired and supported through this award. Describe any additional plans for ensuring the success and retention of these faculty members as productive, independent investigators that can contribute to the scientific mission of the Core Center.

Describe intra- and inter-institutional links and how the Center’s activities will assist in the development of cooperative linkages and partnerships across the academic health center, university or other collaborating institutions.

Describe institutional commitment and plans for continuity of support for new investigators at the expiration of the award. Matching funds are not required. However, commitment of an appropriate level of institutional support is expected and the highest program priority will be given to applications that confirm an institutional commitment to provide at least two additional years of support after the end of the award.

Describe the plan for evaluating the overall success of the program, including:

Letters of Commitment

The application should include letters of commitment from appropriate institutional officials describing the recruitment and appointment goals within the context of the FOA requirements and detailing the specific resources that the institution is willing to provide. Additional support letters from any partner institutions with which the applicant has established linkages or collaborations should also be included. Such support letters are not included in the Research Component page limits.

Appendix Materials

No appendix materials will be allowed for applications submitted to this FOA.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by appropriate peer review groups convened by the appropriate NIH IC and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

Overall Impact. Reviewers will provide an overall impact/priority 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 five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. 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. 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. How will the new Core Center contribute to building a community of multidisciplinary researchers focusing on a common research problem and enhance the ability of the institution/organization to conduct research in the specified area(s) of science? Will new faculty members hired under this initiative conduct research projects and receive career development support that will foster independent research careers and lead toward applications for future independent research project grants to further the mission of the Core Center?

Investigator(s). Does the PD/PI have the ability and institutional authority to provide scientific and administrative leadership and direction for the Core Center, and to work with Core Center investigators to develop relevant research projects?

Innovation. Does the application identify critical research program needs and seek creative ways to incorporate Core Center resources, new tenure-track faculty and new research projects to help address those needs?

Approach. Are the plans for recruiting and appointing new investigators within the Core Center adequate and appropriate for furthering the scientific mission of the Center? Will the research activities and resources of the proposed Core Center assist in the development and strengthening of intra- and inter-institutional relationships across the academic health center or university, or with other institutions? Is the plan for evaluation thorough and rigorous? Are the proposed scientific goals of the Core Center, as well as the plans to achieve those goals, feasible, innovative and of high scientific/technical merit? Are potential problems, alternative strategies, and benchmarks for success presented? Are the proposed plans and criteria to select relevant research projects and monitor their long term success of sufficient strength, feasibility and appropriateness, including whether there is an adequate strategy for selecting projects that leverage resources and complement the Core Center's mission and strengths?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Is the current infrastructure well described and is it conducive to conducting research projects that are relevant to the research mission of the proposed Core Center? Will the research activities within the Core Center help to foster career development for newly-independent investigators, and lead toward applications for future independent research project grants that further the mission of the Core Center? Are the institutional support, equipment and other physical resources available to the investigators adequate for the development and implementation of relevant research projects? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence that new faculty members hired under this initiative will have at least 75% protected research time during the duration of this award? Will new faculty members be given appropriate joint appointment(s) and access to facilities, resources and graduate students from other components in the institution/organization, or collaborating institutions? Are shared institutional resources being made available to investigators within the Core Center?

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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.

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.

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

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

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).

The NIH will not accept appeals of the review process outcome for applications in response to this FOA. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

The following criteria will also be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page).

Post award, a Change in Grantee Organization will not be approved.

Further, the funds provided under this program, are intended to enhance the research capability of the grantee organization/institution. Therefore, in the case of the departure of a recruited newly-hired/promoted investigator(s), transfer of funds to any consortium organization where such an individual has relocated is inconsistent with the objectives of this program. In addition, title to any equipment, supplies or other material purchased under this program remain with the grantee organization/institution.

The terms of the NoA will include a requirement that draft offer letters will be provided to the Program Officer, who will review the terms of the offers to insure that they are consistent with the requirements for new appointments as detailed in this FOA.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Applicants should refer to the IC Table of Contacts (http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm) for information regarding each IC's scientific/research contacts for this program.

2. Peer Review Contacts:

Applicants should refer to the IC Table of Contacts (http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm) for information regarding each IC's peer review contacts for this program.

3. Financial or Grants Management Contacts:

Applicants should refer to the IC Table of Contacts (http://grants.nih.gov/archive/grants/guide/contacts/RFA-OD-09-005_contacts.htm) for information regarding each IC's grants management contacts for this program.

Section VIII. Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.aphis.usda.gov/animal_welfare/publications_and_reports.shtml as applicable. Also see the Animal Welfare Act: http://www.aphis.usda.gov/animal_welfare/awa.shtml.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) and are subject to 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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NIH Funding Opportunities and Notices


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