Research (OER)
9000 Rockville Pike
Bethesda, Maryland 20892
and Human Services (HHS)
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Department
of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National
Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Human Genome Research Institute (NHGRI) (http://www.genome.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Diseases and Stroke (NINDS) (http://www.ninds.nih.gov/)
Title: Support
of Competitive Research (SCORE) Research Advancement Award (SC1)
Announcement Type
This is a conversion of PAR-06-491, which was
released on July 20, 2006.
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-08-026
Catalog of Federal Domestic Assistance Number(s)
Key Dates
Release/Posted
Date: November 16, 2007
Opening
Date: December 25, 2007 (Earliest date an application may be submitted to
Grants.gov)
NOTE:
On time submission requires that applications be successfully submitted to
Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission Dates: Standard dates for SC1
applications apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for guidance on dates.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date: Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Additional Information To Be
Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2011
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
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically
to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Objectives
In the
NIH Revitalization Act of 1993, NIH was encouraged to increase the number of
underrepresented minorities participating in
biomedical and behavioral research. In response to the Act, starting in 1996
the Minority Biomedical Research Support (MBRS) Branch of the Minority
Opportunities in Research Division (MORE) of NIGMS offered institutional grants under the Support of Competitive Research (SCORE)
program. The objective of the SCORE program is to foster the development of
faculty at minority serving institutions (MSIs) in order to
increase their research competitiveness and promote their transition to non-SCORE external sources of funding. This objective is expected to
translate into an increase in the number of
individuals from groups underrepresented in biomedical and behavioral research
professionally engaged in these areas of research, and an enhancement of an institution’s research base. SCORE SC grants are
offered to eligible MSIs. For the
purposes of this program, eligible MSIs are those with more than 50% student enrollment of individuals from
groups underrepresented in biomedical and behavioral
research.
MSIs have significantly contributed to the scientific training of students from underrepresented groups, i.e., African Americans, Hispanic Americans, Native Americans, and natives of the U.S. Pacific Islands. Faculty members at these institutions, who are involved in underrepresented student training, often engage in competitive research projects. Such investigator-initiated research contributes to basic knowledge in the biomedical and behavioral sciences, allows faculty to stay at the cutting edge of their disciplines, and improves the quality of their teaching.
Because of the mixture in the individual focus of scholarly research at MSIs, the SCORE program offers several support mechanisms for individual investigator-initiated biomedical or behavioral research projects of different scope. This support allows faculty at MSIs to conduct high-quality research and to increase their research competitiveness by progressively enhancing the pace and productivity of their projects. It is the intent of the SCORE Program that the more productive SCORE PIs will transition to non-SCORE sources of external support.
The SCORE mechanisms available to investigators according to their experience/track records are:
The SC1 mechanism is for faculty at the most advanced formative stages of their research careers, i.e., those who are engaged in the state-of-the-art biomedical/behavioral research, productive as evidenced by a steady track record of peer-reviewed publications, and planning to transition to non-SCORE sources of support. Since SC1 is a developmental award, multiple PIs, are not permitted.
SC1 PIs are encouraged to establish meaningful collaborations with R01-funded investigators in the U.S., particularly outside of the applicant’s institution, that will increase the progress and productivity of the project. These collaborators or consultants must be recognized experts in a field and must have their own research support, i.e., SC1 funds may not be used to fund a consultant’s or collaborator’s research project. Collaborators, who may be from the applicant institution or another institution in the U.S., generally provide expertise in a very specific aspect of the execution of the proposed project in which the PI has little or no experience. Collaborators from the applicant institution may be paid for the limited time, not to exceed a total of 2 person months, devoted to a specific area of the project. Consultants from domestic or foreign institutions other than the applicant institution are individuals who have committed to contributing intellectually to the scientific project development or execution but are not committing any specified measurable effort (in person months) to the project or conducting any part of the project. These consultants may be paid a reasonable fee commensurate with their limited involvement in a project. The specific role of a consultant/collaborator in a project must be described clearly in the application (see special instructions below).
SC1 awards support discrete, specified, circumscribed projects to be performed by named PIs in areas representing the investigator’s specific interests and competencies within the areas of biomedical and behavioral research limited to the NIH mission. SC1 applicants are expected to develop their research competitiveness by enhancing their research productivity. Detailed research career goals and objectives, i.e., developmental goals and objectives, as well as plans to achieve them are required in an SC1 application, and these must clearly explain how an investigator plans to move to his/her next developmental stage and transition to non-SCORE support by participating in SC1 funded research. Additionally, SC1 investigators must participate in other MORE-sponsored activities that foster their development and accelerate their transition to non-SCORE support. These activities include participation in grant-writing workshops and a biennial meeting of SCORE SC1 PIs. SC1 awards may be renewed once. Although there is no requirement of a specific amount of time that the PI must devote to the performance of an SC1 project it is expected that the amount of time requested by a PI will reflect his/her and the institution’s commitment to his/her development.
SCORE investigator-initiated research projects are limited to the NIH mission. SCORE PIs are strongly encouraged to visit the NIH website, http://www.nih.gov, to search the NIH archives for all past and currently funded NIH grants. Abstract of funded grants can be found using key words in the Computer Retrieval of Information on Scientific Projects (CRISP) available at http://www.crisp.cit.hih.gov/.
Upon receipt, SC1 grant applications are assigned to NIGMS for initial review. In the event of an award, the programmatic management of the SC1 will be transferred to NIGMS or other NIH Institute or Center (IC) based on the scientific content of the award and according to established NIH referral guidelines.
Each IC maintains a Web site with funding opportunities and areas of interest. Contact with an IC representative may help focus the research plan based on an understanding of the mission of the IC. For specific information about the mission of each NIH IC, see http://www.nih.gov/icd, which provides a brief summary of the research interests in each IC and access to individual IC home pages. Applicants are strongly advised to review the SCORE Answers to Frequently Asked Questions section in the NIGMS website, http://www.nigms.nih.gov/Minority/MBRS before they consider applying for any SCORE individual award.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the SC1 grant award
mechanism(s).
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses the modular budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
An SC1 award may be renewed once.
2.
Funds Available
Because the nature and scope
of the proposed research 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 Institutes
and Centers (ICs) provide support for this program, awards pursuant to this
funding opportunity are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications.
National Institute of General Medical Sciences intends to commit approximately:
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.
F&A costs
requested by consortium participants are not included in the direct cost
limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You may submit an application(s) if your institution/organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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. Typically the PI of a SCORE application possesses a Ph.D. or M.D./Ph.D. degree. He/she must also have a full-time regular faculty appointment at the applicant institution and be eligible to apply for a NIH R01 research grant. Postdoctoral fellows, research instructors, research assistant professors, research scientists, other research appointments or appointments contingent on an individual securing his/her salary from grants, and part-time or adjunct faculty are not eligible to apply for SCORE individual awards. Emeritus/retired investigators/professors as well as individuals with a track record of R01 or equivalent research grant awards are considered to be fully developed and may not apply for this award. Investigators who have developmental award support are ineligible to apply for SCORE individual awards, i.e., SCORE awards are not intended to duplicate other individual or institutional developmental awards; these include K awards and awards given as part of institutional centers or program projects. An applicant may not be the PI of an S06 subproject (under the previous S06 program project) or any other SCORE investigator initiated research grant at the time an SC1 award is made. Concurrent or duplicate application to any of the SCORE mechanisms (SC1, SC2, or SC3) by a single PI is not allowed. A PI may only apply for/receive one SC award at a time.
PIs who have received one cycle of R01 or R21 support may apply for an SC1 award but would receive support for only SC1 grant cycle, i.e., no renewal is allowed.
SC1 awards may not be transferred from one PI to another. If a SC1 PI moves to another SCORE eligible institution, his/her award may be transferred to the new institution provided that all transfer requirements as per NIH policy are fulfilled and the maximum number (25) of individual SCORE awards/applications and, if applicable, S06 subprojects from this institution has not been met.
All PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
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
Similar SC1 and R01 or other NIH applications may not be submitted concurrently.
New PIs, who have never received SCORE support (including S06 subprojects), may apply for an initial award of up to five years of support and are eligible for one renewal. PIs who have received previous SCORE support for any length of time may apply for a maximum of four years and are not eligible for renewal. SC1 awards may be renewed only once and renewal awards are for a maximum of four years.
Institutions receiving a new or renewal S06 award after January, 2006 may submit individual SC1, SC2 or SC3 (not S06) applications to a combined maximum of 25 total S06 subprojects and SCORE SC1, SC2 or SC3 individual investigator applications/awards. However, in this case, individual investigator-initiated SC1, SC2 or SC3 applications may only be submitted by PIs who are not already receiving S06 support (see I.B. Eligible Individuals).
Institutions that have an S06 grant in place prior to January, 2006 are not eligible to apply for any of the new SCORE individual awards until the last year of the S06 award. Note that these applications have special instructions, see section IV.2 subheading “Renewal Applications”.
Section IV. Application and Submission Information
To download a SF424
(R&R) Application Package and SF424 (R&R) Application Guide for
completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Principal Investigator (PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone
301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
SCORE investigator-initiated research projects are limited to the NIH mission. SCORE PIs are strongly encouraged to visit the NIH website, http://www.nih.gov, to search the NIH archives for all past and currently funded NIH grants and research areas. Specifically searches of abstracts of funded grants using specific key words could be done using the Computer Retrieval of Information on Scientific Projects (CRISP) at, http://crisp.cit.nih.gov/ .
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover
component)
Research & Related
Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget,
as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate
required budget component.)
Optional Components:
PHS398 Cover Letter File
SPECIAL INSTRUCTIONS
Applicants are advised to follow carefully the instructions given for electronic submission and the use of the SF424 (R&R) form at http://era.nih.gov/ElectronicReceipt/. Below are special instructions for this FOA describing the information that must be included in the required components mentioned above. Incomplete and non-compliant applications will be withdrawn and will not be reviewed.
Institutional Data - limited to one page (counted as part of the 25-page limit) and should have the following information:
a. The total student enrollment at the institution and the number and percent of underrepresented minorities (e.g. Native American, African American, Hispanic American, natives of the U.S. Pacific Islands) in the total student population;
b. Number and percent of underrepresented minority students (undergraduate and graduate) enrolled in the sciences relevant to biomedical and behavioral research;
c. Number and percent of total and underrepresented minority faculty in the sciences relevant to biomedical and behavioral research and the total number of faculty and of underrepresented minority faculty from these departments participating in funded research.
o Preliminary Studies/Progress Report - any PI who has previously received SCORE support (under an SC or an earlier S06 subproject) must include a progress report indicating the extent to which the proposed objectives were accomplished. The Progress Report, which does count toward the Research Plan page limit, must be clearly indicated in a subheading within the Preliminary Data category. PIs who have had a gap in funding must still include a report of the research accomplishments that they have achieved with previous SCORE support. This subsection is required, even though, for the purposes of electronic submission to Grants.gov, the application must be designated on the face page as “New”.
Other Research Plan Sections
Renewal Applications
As described above, a detailed progress report (refer to SF424 (R&R)) and a list of peer-reviewed publications resulting from SCORE support must be submitted by PIs who have previously received SCORE support (i.e., S06 subproject) and are submitting a first SC1 application, or by PIs submitting renewal applications. Information on the level of funding (dollars per year) during the previous grant period and on the number of technical personnel (technicians, postdoctoral research associates, and other research associates) who participated in the project (whether or not paid with SCORE funds) must be included in the progress report. The progress report section must be placed immediately after the section on background and significance as described in SF424 (R&R). Applications lacking a progress report are considered non-compliant and will not be reviewed.
S06 subproject investigators may apply for support to continue their work by the SC1 mechanism if the S06 is in its last year. Since this is a different support mechanism, the application face page should indicate that this is a NEW application (box 8); previous support and progress should be described in the text of the application. Designating the SC1 as a RENEWAL may cause the application to be rejected by Grants.gov.
Resubmission Applications
Resubmissions (previously called revised applications) of SC1 applications may be submitted. Resubmissions must include an Introduction that addresses fully the questions/issues raised by the reviewers of the previous application. In addition, the body of the application must indicate, by changes in font or other means, the revised sections, unless the changes are so extensive as to include most of the text. Do not underline or shade changes (see SF424 (R&R) instructions). A resubmission of an application previously submitted as an S06 subproject should be considered a new application.
3.
Submission Dates and Times
See Section IV.3.A. for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: December 25, 2007 (Earliest
date an application may be submitted to Grants.gov)
Application
Submission Dates: Standard dates for SC1 applications apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for guidance on dates.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. (See also Section VI.2 Award Administration Information).
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 or renewal (formerly “competing
continuation”) award if such costs: are necessary to conduct the project, and
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 or competing renewal 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 the NIH Grants
Policy Statement.
SCORE SC1 awards include some restrictions as to how the funds may be used. The following account summarizes allowable and non-allowable costs under the SCORE SC1 mechanism.
Allowable Costs
Unallowable Costs
6. Other
Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PDsPI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
PHS398 Research Plan Component Sections
Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
Applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
All applicants are expected
to include a plan for sharing research data in their application. The data
sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing research
resources plan addressing how unique research resources will be shared or
explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
“Reporting.”
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate peer review group convened by NIGMS in accordance with the
review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? What is the likelihood that the PI will transition to
non-SCORE support for a relevant biomedical or
behavioral project?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Are the PI’s developmental objectives reasonable and what
is the likelihood that they will be accomplished?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers? Does the
investigative team bring complementary and integrated expertise to the project
(if applicable)? Does the investigator’s past publication and productivity
record provide convincing evidence that the applicant is positioned to benefit
from SCORE support and achieve his/her developmental objectives in a reasonable
time frame?
Environment: Do(es) the
scientific environment(s) in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
Overall Evaluation: Summarize the major factors from the five review criteria above that contribute to or detract from scientific merit. In addition, evaluate whether the proposed project and specifically the PI’s developmental objectives and plan address the intent of the SCORE SC1 mechanism, which is to increase the number of investigators from MSIs that enhance their research competitiveness to a stage where they can successfully compete for non-SCORE support.
2.A.
Additional Review Criteria
In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Progress Report (for competing renewal applications only): Has significant progress been achieved toward each of the originally proposed research and Pi’s developmental objectives? Has the investigator’s productivity been commensurate with the support received? Has SC1 support allowed the PI to increase his/her research competitiveness and be better poised to transition to non-SCORE support?
Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Protection
of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See the “Human Subjects Sections”
of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research
Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for care and use of
vertebrate animals to be used in the project will be assessed. See the “Other
Research Plan Sections” of the PHS398 Research Plan component of the SF424
(R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.
2.C.
Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research
Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
“Reporting.”
Model Organism Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations.
3.
Anticipated Announcement and Award Dates
Earliest possible dates when awards will be made will be January for
applications reviewed at the September Council meeting, April for applications
reviewed at the January Council meeting and July for applications reviewed at
the May Council meeting.
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 NIH 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.
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 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 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.
3.
Reporting
Awardees
will be required to submit the PHS Non-Competing Grant Progress Report, Form
2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and
financial statements as required in the NIH Grants
Policy Statement.
The annual progress (refer to PHS 2590) must detail the progress accomplished towards each specific aim and provide a list of peer-reviewed publications resulting from SCORE support. Information on the level of funding (dollars per year) during the previous grant period and on the number of technical personnel (technicians, postdoctoral research associates, and other research associates) who participated in the project (whether or not paid with SCORE funds) must be included in the progress report.
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 Contact(s):
Hinda Zlotnik, Ph.D.
Minority Opportunities in Research Division
National
Institute of General Medical Sciences, NIH
45
Center Drive
Room
2AS.37, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-3900
Fax: (301)
480-2753
Email:zlotnikh@nigms.nih.gov
2. Peer Review Contact(s):
Helen R. Sunshine, PhD
Office
of Scientific Review
National
Institute of General Medical Sciences, NIH
45
Center Drive
Room
3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-2881
Fax: (301)
480-8506
Email:sunshinh@nigms.nih.gov
3.
Financial/Grants Management Contact(s):
Antoinette Holland
Division of
Extramural Activities
National
Institute of General Medical Sciences, NIH
45
Center Drive
Room
2AN.50B, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-5132
Fax: (301) 480-2554
Email:hollanda@nigms.nih.gov
Section VIII. Other Information
Required Federal Citations
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.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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.
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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS) system
(http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is
requesting that authors submit manuscripts resulting from 1) currently funded
NIH research projects or 2) previously supported NIH research projects if they
are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more
information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department
of Health and Human Services (HHS) 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 HHS
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 or Health Systems Agency review. 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. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH
Grants Policy Statement.
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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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