II. SUBMITTING YOUR APPLICATION

A. INSTRUCTIONS

This section provides instructions for assembling your grant application, the  application mailing address, and a schedule of  the PHS grant application receipt, review and  award cycles.

Number of Copies, Bindings, and Mailing Address

Submit the following materials in one package: 

Cover Letter

If the principal investigator is making a request  for assignment to a particular awarding  component or initial review group include a cover letter. These suggestions will be taken into consideration at the time of assignment, although the final determination will be made by the PHS.

The Original Application

The original application must be single-sided, with both required signatures on the Face Page. 
Do not staple or otherwise bind the original application. The pages must be assembled in the order specified in the table of contents. The Personal Data page should be placed at the end of the application; it is not to be duplicated. If  appropriate, attach the RFA label provided in  the application kit or a facsimile to the Face Page. 

Five exact, single-sided copies of the original application. 

Do not staple or otherwise bind the five copies of the original application. The copies must be made after both individuals have signed the Face Page so that their signatures are present on the copies. 

Five collated sets of Appendix material. (look at PDF).

The Appendix material, and only the Appendix material, may be stapled or bound. Items should be stapled or bound where appropriate, and each marked with the name of the principal investigator. A summary sheet, listing all of the items included in the Appendix, is helpful. 

Application Mailing Address

Mailing labels are provided at the end of the forms (MS Word or PDF).

Applications sent via the USPS EXPRESS or REGULAR MAIL should be sent to the following address:

Center for Scientific Review
National Institutes of Health
Suite 1040
6701 Rockledge Drive MSC 7710
Bethesda MD 20892-7710*

*. For courier service (non-USPS), change the zip code to 20817. The telephone number is (301) 435-0715.
*Note:  Until further notice, all applications and other deliveries to the Center for Scientific Review must come either via courier delivery or via the USPS. Applications delivered by individuals to the Center for Scientific Review will no longer be accepted. For additional information, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

There may be additional instructions for submission of responses to Requests for Applications. Applicants submitting Investigator-Initiated Interactive Research Project Grant (IRPG) applications should include all of the applications and appendix material in one package with a cover letter identifying the applications as such.

An unsolicited application will be considered on time if it is received by or mailed on or before the published receipt  date and a proof of mailing is provided. Proof of timely mailing consists of one of the following: a legibly dated U.S.  Postal Service postmark or a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks are not acceptable.

If a receipt date falls on a weekend, it will be extended to the following Monday; if the date falls on a holiday, it will be extended to the following workday.

SOLICITED APPLICATIONS MUST BE RECEIVED BY THE SPECIFIED DATES. HOWEVER, AN APPLICATION RECEIVED AFTER THE DEADLINE MAY BE ACCEPTABLE IF IT CARRIES A LEGIBLE PROOF-OF-MAILING DATE, ASSIGNED BY THE CARRIER, AND THE PROOF-OF-MAILING DATE IS NOT LATER THAN 1 WEEK PRIOR TO THE DEADLINE DATE. THESE INCLUDE REQUEST FOR APPLICATIONS (RFAS) AND PROGRAM ANNOUNCEMENTS (PAS) WITH SPECIFIED RECEIPT DATES.

The receipt date will be waived only in extenuating circumstances. To request a waiver, include an explanatory letter with the signed, completed application. No request for a waiver will be considered prior to receipt of the application, and there is no guarantee that the waiver will be granted.

Receipt, Review and Award Cycles

The PHS receipt, review, and award schedule is provided in Table 2.

Note: Several Institutes/Centers use only one or two of the receipt dates for institutional NRSA awards. Please check the program announcement, which is available at http://grants.nih.gov/training/nrsa.htm. 

For specialized grant applications, consult with the appropriate PHS awarding component prior to the preparation of an application.

Submit a complete application. Incomplete applications will be grounds for the PHS to return the application without peer review. An application will be returned if it is illegible, if the instructions were not followed, or if the material presented is insufficient to permit an adequate review. 

Unless specifically required by these instructions (e.g., vertebrate animals certification), do not send supplementary or corrective material after the receipt date unless the Scientific Review Administrator of the SRG solicits or agrees to accept this information. The application must be complete and accurate at the time of submission as there is no guarantee that the peer reviewers will consider late material.

Submissions of identical applications to different agencies within the PHS or to different Institutes within an agency are not allowed. Essentially identical applications will not be reviewed except for: 1) individuals submitting an application for an Independent Scientist Award (K02) proposing essentially identical research in an application for an individual research project; and 2) individuals submitting an individual research project identical to a subproject that is part of a program project or center grant application.

Application Assignment Information

As soon as possible after the receipt date, usually within 6 weeks, the PHS will send the principal investigator/program director and the applicant organization the application's assignment number; the name, address, and telephone number of the Scientific Review Administrator of the Scientific Review Group (SRG) to which the application has been assigned; and the assigned Institute contact and phone number. If this information is not received within that time, contact the Division of Receipt and Referral, Center for Scientific Review (CSR), National Institutes of Health, Bethesda, MD 20892-7720, (301) 435-0715. If there is a change in assignment, another notification will be sent.

All inquiries regarding the assignment, review, or recommendation on funding of applications are to be made only to PHS officials. It is inappropriate to contact consultants serving on advisory or review committees regarding these issues.

B. The Peer Review Process

Overview

Competing grant applications submitted to the PHS agencies must be submitted through the Division of Receipt and Referral, CSR, NIH unless otherwise stated. Administrative information about the application is entered into a computer system. The application is then assigned to the appropriate SRG and Institute(s). Assignment is based on the scientific content of the application using established referral guidelines.

Most applications submitted to the PHS will be reviewed through a two-tier system. The first level of review will be performed by a Scientific Review Group (SRG), often called a study section or review committee. The purpose of the SRG is to evaluate the scientific and technical merit of applications. The SRG does not make funding decisions. 

SRG members will be instructed to evaluate research applications by addressing five review criteria (see below) and assigning a single, global score for each scored application. The score will reflect the overall impact that the proposed research could have on the field based on consideration of the following NIH research evaluation criteria. RFAs and other types of grants may have different and/or additional review criteria. 

Note: Applicants must not ever contact reviewers regarding their applications since discussion of the scientific content of an application or an attempt to influence review outcome will constitute a conflict of interest in the review. Reviewers are required to notify the Scientific Review Administrator if they are contacted by an applicant. Communication by the applicant to a reviewer will result in the return of the application without peer review.

Research Project Evaluation Criteria

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 

Investigator: Is the investigator 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 (if any)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

While these review criteria are intended for use primarily with unsolicited research project applications (e.g., R01, R29, P01), to the extent reasonable, they will also form the basis of the review of solicited applications and non-research activities. However, for some activities (e.g., construction grants), use of these criteria as stated may not be feasible. 

Human Subjects/Vertebrate Animals: In conducting peer review for scientific and technical merit, SRGs will also evaluate the involvement of human/animal subjects and proposed protections from research risk relating to their participation in the proposed research plan according to the following four review criteria: (1) Risk to Subjects, (2) Adequacy of protection against risks (3) Potential benefits of the proposed research to the subjects and others and (4) Importance of the knowledge to be gained.

When human subjects are involved in the proposed clinical research, the SRG will also evaluate the proposed plans for inclusion of minorities and members of both sexes/genders, as part of the scientific assessment of Approach criterion. The evaluation will be factored into the overall score for scientific and technical merit of the application.

Dual-Level Peer Review: As part of the initial merit review, all applicants will receive a written critique based on  the comments and recommendations of the SRG. The review of most research applications will also include a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review. 

The second level of review will usually be performed by the Advisory Council or Board of the potential awarding component (Institute, Center, or other unit). Council or Board recommendations are based not only on considerations of scientific merit, as judged by the SRGs, but also on the relevance of the proposed study to an Institute's programs and priorities. The review criteria can be found on the NIH Web site, http://grants.nih.gov/grants/peer/peer.htm or obtained from GrantsInfo, (301) 435-0714, Email: GrantsInfo@nih.gov. 

C. INTERACTIONS BEFORE SUBMISSION

Additional information about the PHS peer review process and grant programs can be obtained from GrantsInfo, e-mail: GrantsInfo@nih.gov, (301) 435-0714. Information about charters and membership of SRGs, Councils, and Boards can be obtained from the appropriate agency. 

Applicants are encouraged to contact relevant Institute or Center staff for advice in preparing an application and for information regarding programmatic areas of interest. Phone numbers for contacting Institute or Center staff are listed below. 

D. INTERACTIONS AFTER SUBMISSION

If the initial assignment seems inappropriate, the principal investigator/program director may request reassignment. Such requests should be made in writing to the Division of Receipt and Referral, Center for Scientific Review, National Institutes of Health, Suite 2030, 6701 Rockledge Drive, MSC 7720, Bethesda, MD 20892-7720. Fax requests (301-480-1987) are also acceptable. Although these requests will be carefully considered, the final determination will be made by the PHS agency. 

E. INTERACTIONS AFTER REVIEW

Feedback to applicants is very important. Once the principal investigator receives the summary statement, s/he may contact the appropriate Institute program official (noted on the summary statement) for an interpretation of the reviews and the disposition of the application.

[ Table of Contents] [Section I ] [Section III ] [ Section IV ] [ Section V ] [ Section VI ]