Grant Application Form PHS 398 (Updated November 2007)

See the list of required forms (includes OSP-customized forms).

Application to the National Institutes of Health (NIH) and other Public Health Service agencies is now generally made electronically via Grants.gov. NIH has updated the PHS 398 grant application kit (11/07) for those proposals where paper submission is still required or allowed. This is the only acceptable form set until all NIH grant applications convert to electronic submission.

The PHS 398 is used for new, resubmission, renewal, and revised (supplemental) research grants, for Research Career (Type K) Awards, and for institutional training grants (T32). Forms and instructions for the latter two types of applications are found at the end of the PHS 398 instructions. Separate application kits are used for non-competing continuations (PHS 2590) and Individual National Research Service Awards (NRSA: PHS 416).

We strongly recommend that investigators familiarize themselves with the complete instructions, forms and policies contained in the PHS 398 kit.

Note that Program Announcements (PAs) and Requests for Applications (RFAs) contain important information that should be reviewed before considering application. The PAs, RFAs and any additional instructions may be obtained directly from the NIH website. Consult OSP Projects Officers with any questions. .

In October, NIH publishes a list of criteria against which proposals will be evaluated. You may wish to review these criteria before preparing your application.

Quick Links to Content

Deadlines & Start Dates

NIH deadlines and the earliest start date for funded proposals in each cycle can be found on the NIH web site: http://grants.nih.gov/grants/dates.htm.

Required Forms

Links are provided below to all required forms; these files can be opened in any version of Microsoft Word. The Face Page, Modular Budget Format and Checklist have been specifically tailored for NYU submission. Computer-generated facsimiles of all other forms/formats may be substituted but they must maintain the exact wording and format, and, in the case of forms, include all captions and spacing.

Proposal Mechanics

Deviations from font size specifications and page limitations will be grounds for PHS to reject and return the entire application without peer review. NIH now specifies the use of Ariel, Helvetica, Palatino Linotype, or Georgiatypeface and a font size of 11 points or larger. No other font types/sizes will be accepted.

  • Aside from those forms which have been preset with a smaller font, type size must meet the above specifications, and that allow no more than 15 characters per linear inch and no more than six lines per vertical inch.
  • Margins should be at least a half-inch on all four sides

Sections of the Proposal:

Face Page (form page 1)

  • Project Title: form field length is 81 characters (including spaces and punctuation).
  • Check “yes” or “no” as applicable in all cases where such boxes are provided. Do not skip any items.
  • When responding to a particular PA or RFA, enter the identifying number and title in block 2.
  • PIs who meet the "New Investigator" definition (see complete PHS 398 kit) should check "Yes" in block 3.
  • Field 3h, eRA Commons User Name, is now a required field. PIs must be registered in Commons as a PI linked to NYU; previous registration as a reviewer is not sufficient.
  • Check “yes” in block 4a (Exempt Human Subjects Research) only if the NYU Committee has previously designated the project as exempt; otherwise check “no” and indicate "pending" where the exempt number is requested.

Form Page 1 - continued

The allowability of Multiple PIs is in a pilot implementation phase and should only be included in applications responding to specific funding opportunities that clearly indicate Multiple PI as an option. For additional information on this initiative, see: http://grants.nih.gov/grants/multi_pi/index.htm.

When multiple PIs are proposed, use the Face Page (Continued) page to provide items 3a – 3h for all PIs. NIH requires one PI be designated as the “contact PI” for all communications between the PIs and the agency. The contact PI must meet all eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PI may be changed during the project period. The contact PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PIs listed on the Face Page (Continued).

Description/Project Summary; Relevance; Project/Performance Site(s); Senior/Key Personnel; Other Significant Contributors; Stem Cell Research (Form Page 2 and Form Page 2 - continued)

  • Project Summary: The first and major component of the Description is a Project Summary. It is meant to serve as a succinct and accurate description of the proposed work when separated from the application. State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project.
  • Relevance: Using no more than two or three sentences and lay language, describe the relevance of this research to public health.

NOTE: Notice of Proprietary Information. Applicants are discouraged from submitting information considered proprietary unless it is considered essential for evaluating the application. No proprietary information should appear on Form Page 2 since the project description will be entered into a public database. Any information considered to be a trade secret or commercial or financial should be identified by marking the paragraphs or lines with an asterisk (*) in the left-hand margin and listing the page numbers containing the proprietary material before the first section of the Research Plan (section a. Specific Aims).

  • Project/Performance Site(s): Include information for NYU and any other organizations where the work will be conducted. The DUNS number and Congressional District of each site must be identified.
  • Senior/Key Personnel:
    • Anyone named as key personnel must have specific effort committed to the project.
    • Starting with the PI, list all key personnel. Key personnel are defined as, and limited to, individuals who contribute in a substantive way to the scientific development or execution of the project and who have committed effort to the project. Typically, these individuals will have doctorates and be employees of the PI’s institution.
    • The eRA Commons User Name is a required field.
  • Other Significant Contributors:
    • This field identifies individuals who have committed to contribute to the scientific development or execution of the project but are not committing any specified measurable effort. Biographical sketches are required for these individuals; Other Support information is not.
    • This is also the appropriate place to list consultants who make significant contributions to the research; collaborators with no committed effort, and graduate students.
  • Stem Cells:
    • Human Embryonic Stem Cells: Previously embedded in the Description, information pertaining to projects that involve human embryonic stem cells is requested in a separate form field. A link to the Human Embryonic Stem Cell Registry is provided.

Table of Contents (form page 3)

Consecutively number pages throughout the application, and place page numbers at the bottom of each page. Do not include unnumbered pages or use suffixes, such as 5a, 5b.

Detailed Budget and Budget Justification (form pages 4 and 5)

  • Specific line items:
    • Personnel: Identify base salary and effort in person months committed to the project, whether academic, calendar and/or summer, depending on the individual appointment. Observe the legislatively imposed salary cap (currently $196,700). Include fringe benefits at NYU projected rates. Tuition remission for research assistants should be shown under "other expenses."
    • Equipment:
      • NYU defines permanent equipment as having a unit cost of $3,000 or greater and a use expectancy of at least two years. Any items of lesser value/shorter life will be treated as supplies and will be subject to indirect costs.
      • A unit can be viewed as equipment that will be combined for integrated functionality and purchased as a single acquisition. For example, the computer and the software or peripherals it requires to perform the project-based work comprise one unit. If this unit cost exceeds the $3,000 threshold, it is considered permanent equipment.
    • Other Expenses: Categorical subtotals should be expressed in round (to the nearest $1,000) numbers. Animal maintenance (unit care costs and number of care days) should be listed here.
    • Foreign Components: If relevant, provide a justification on Form Page 5. Describe furtherance of research through use of unusual experience, resources, populations, or environmental characteristics that are unavailable in the US or augment existing resources.

Biographical Sketch format page

Use the PHS sample format to prepare biographical sketches for all KEY personnel and for Other Significant Contributors, following the order of the list on Form Page 2. Limit to four (4) pages per person:

  • Positions and Honors: List chronologically, concluding with present position. Include membership on any Federal public advisory committee.
  • Selected peer-reviewed publications: or manuscripts in press (do not include those submitted or in preparation). List chronologically.
  • Research Support: List selected ongoing or completed (during the last three years) research projects (federal or nonfederal support), beginning with those most relevant to the research proposed. Briefly indicate overall goals and responsibilities of the PI.

Don't confuse "Research Support" with "Other Support." Though they sound similar, these parts of the application are very different. As part of the biosketch section of the application, "Research Support" highlights your accomplishments, and those of your colleagues, as scientists. This information will be used by the reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. In contrast, "Other Support" information is required for all applications that are selected to receive grant awards. NIH staff will request complete and up-to-date "other support" information from you after peer review. This information will be used to check that the proposed research has not already been Federally-funded.

Other Support format page

Do NOT submit this information with the application. It will, however, be requested prior to award.

Resources format page

Describe the resources available for this project. If there are multiple performance sites, then also describe resources available at each site described.

Research Plan

No Specific Form Page; use Continuation Page

The Research Plan should include sufficient information needed for evaluation of the project, independent of any other document. The format for preparing this section is provided below.

Page Limitations: The Research Plan may NOT exceed 25 pages for Items A-D. All tables, graphs, figures, diagrams, and charts must be included within the 25-page limit.

The 25-page limit will be strictly enforced. Application processing may be delayed or the application may be returned to the applicant without review.

Content of Research Plan: The PHS recommends the following format and page distribution. Organize Items A-D of the Research Plan to answer these questions:

  • What do you intend to do?
  • Why is the work important?
  • What has already been done?
  • How are you going to do the work?

A. Specific Aims: List the broad, long-term objectives and the goal of the specific research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. One page is recommended.

B. Background and Significance: Briefly sketch the background leading to the present application, critically evaluate existing knowledge, and specifically identify the gaps that the project is intended to fill. Two to three pages are recommended.

C. Preliminary Studies/Progress Report: Preliminary Studies. For new applications, use this section to provide an account of the principal investigator/program director’s preliminary studies pertinent to this application; for Competing Continuation and Supplemental Applications, a Progress Report must be provided.

Six to eight pages are recommended for the narrative portion of the Preliminary Studies/ Progress Report.

D. Research Design and Methods: Describe the research design conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project.

Although no specific number of pages is recommended for the Research Design and Methods section, be as succinct as possible. There is no requirement that all 25 pages allotted for items A-D be used.

Note on Research involving Human Subjects (Section E) and/or Research involving Animals (Section F): All projects involving either human subjects and/or vertebrate animals must be reviewed and approved by the appropriate University committee. For human subjects, contact OSP at x82121 or see NYU's human subjects website. For vertebrate animals, contact the University Animal Welfare Committee (UAWC) at x82112 or see UAWC’s website.

E. Human Subjects Research: If not applicable, so state. If applicable, this section should immediately follow the last entry in Section D.

  • There is no page limit.
  • Determination of exempt status must be made by the Institutional Review Board prior to proposal submission. If a project is deemed exempt, the applicant is not required to address the involvement of women, minorities, and children, nor are they required to submit a targeted/planned enrollment form.
  • If an exemption has or will be claimed, provide a justification which describes the population sample and any sources of research material, identifies the category of exemption, and addresses the Inclusion of Women and Minority Subjects and Children under separate headings (see below).
  • For nonexempt research, PIs must address all of the four following evaluation criteria:
    1. Risks to Subjects. Describe proposed human subjects involvement and characteristics. Identify sources of materials. Describe potential risks.
    2. Adequacy of Protection Against Risk. Describe plans for recruitment of subjects and the process of obtaining informed consent. Describe planned procedures for protecting against or minimizing potential risks and assess their likely effectiveness.
    3. Potential Benefits of the Proposed Research to the Subjects and Others. Discuss the potential benefits and why the risks are reasonable in relation to the benefits.
    4. Importance of the knowledge to be gained.
  • All applicants MUST create section headings for Inclusion of Women, Inclusion of Minorities and Inclusion of Children. Under these headings, include:
    • A description of subject selection criteria;
    • A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group or children;
    • The proposed dates of enrollment;
    • A description of proposed outreach programs for recruiting women and minorities;
    • The proposed sample composition for women and minorities using the Targeted/Planned Enrollment Format Page (new applications) or the Enrollment Report Format Page (Competing Continuation and Supplemental applications) as appropriate. You must report the annual cumulative enrollment of subjects and their distribution by sex/gender and ethnicity/race, unless otherwise notified by your program official. See detailed instructions for completing enrollment reporting forms and a list of frequently asked questions at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html;
    • For children, a description of the expertise of the investigative team for dealing with children at the ages included, the appropriateness of the facilities, and whether there are sufficient numbers to contribute to a meaningful analysis.
    • Applications that fail to address the inclusion of Women, Minorities and Children as described above will be designated as incomplete and will be returned without peer review.
  • Finally, identify any collaborating sites where research involving human subjects will take place and provide their assurance numbers.

F. Vertebrate Animals: If not applicable, so state. If applicable, this section should immediately follow Section E. Address the following five points:

  • Provide a detailed description of the proposed use of animals;
  • Justify the use of the animals, choice of species, and numbers;
  • Provide information on veterinary care;
  • Describe procedures for minimizing discomfort, distress, pain and injury;
  • Describe any method of euthanasia to be used.

N.B.: When plans for involving human subjects or animals are indefinite at the time of application, see the PHS 398 guidelines for special instructions.

G. Select Agent Research: If the activities proposed in your application involve only the use of a strain(s) of Select Agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.4(f)(5), the Select Agent requirements do not apply. Use Section G to identify the strain(s) of the Select Agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions at http://www.cdc.gov/od/sap/sap/exclusion.htm.

If the strain(s) is not currently excluded from the list of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from the list, use Section G to indicate the status of your request or your intent to apply for an exclusion and provide a brief justification for the exclusion.

If any of the activities proposed in your application involve the use of Select Agents at any time during the proposed project period, either at the applicant organization or at any other performance site, address the following three points for each site at which Select Agent research will take place. Although no specific page limitation applies to this section, be succinct. See the specific instructions in the PHS 398 instruction kit.

H. Literature Cited: Each citation must identify the title, all authors, the book or journal, volume number, page number(s), and year of publication.

I. Multiple PI Leadership Plan: For applications proposing multiple PIs, a leadership plan is required. The governance and organizational structure should be described, including communication plans and procedures for resolving conflicts. The shared administrative, technical, and scientific responsibilities for the project or program should be delineated for the PIs.

J. Consortium/Contractual Arrangements (not included in page limits)

  • Explain the programmatic, fiscal and administrative arrangements to be made between the applicant organization and the consortium organization(s).
  • Biographical sketches for all key personnel and other significant contributors.
  • Resources page for each consortium member.
  • For applications including multiple PIs, this information may be included as part of the Leadership Plan above.
  • The following information is required but does not get incorporated into the proposal:
  • Information about consortium arrangements, including a statement of work, must be supported by letters countersigned by both the collaborating PI and the collaborating institution's authorizing official.
  • Detailed budgets using PHS Form Pages 4 and 5 and a completed Checklist are required for each consortium member and/or each subcontractor.

K. Resource Sharing (not included in page limits)

  • Data Sharing. PIs requesting $500,000 or more in direct costs in any year must include a one-paragraph description of how final research data will be shared or explain why data sharing is not possible.
  • Sharing Model Organisms. All applications, regardless of the amount requested, that anticipate the development of a model organism(s) must include a description of a specific plan for sharing and distributing unique model organism research resources or explain why such sharing is restricted or not possible (http://grants1.nih.gov/grants/funding/phs398/PolAssurDef.pdf).

L. Consultants: Include letters from all individuals confirming their roles in the project and providing their rate/charge for services. DO NOT PLACE IN APPENDIX.

Checklist Form Page

  • Identify the type of application, including the PHS-assigned application number if the current application is a revision, or the grant number if it is a competing continuation or supplement.
  • Facilities and Administrative Costs (F&A or indirect costs) must be calculated for each year for which support is requested. OSP Projects Officers can assist with these calculations.
  • The Modified Total Direct Base (MTDC) on which F&A is calculated in proposals with modular budgets is the amount requested (the number of modules x $25,000) minus capital equipment, tuition remission, and the cost of each subcontract over the first $25,000 of that subcontract.

Personal Data Form Page

Complete and attach to the "original" copy of the proposal only. Do not copy.

Appendix (No Form or Format Provided)

Appendix material must be submitted on CDs in PDF format and will not be accepted on paper.  Five identical CDs containing appendix material, labeled with the PI name and application title, must be submitted in the same package with the application.  Note that not all grant mechanisms allow publications to be included.  Otherwise, only the following is permitted:

  • Up to 3 publications of the following types: manuscripts and/or abstracts accepted for publication; published manuscripts/abstracts; and relevant patents.
  • Surveys, questionnaires and other data collection instruments, clinical protocols and informed consent documents.
  • Color images of gels, micrographs, etc., provided that a photocopy is also included in the Project Description.
  • For materials that cannot be submitted on CD, applicants must contact the SRO for instructions following notification of assignment to study section.
  • For publications that are publically accessible, the URL or PMC submission identification numbers along wit the full reference should be included as appropriate in the Bibliograph and References Cited section, and/or in the Biographical Sketch.

Additional Instructions: Resubmissions, Renewals, and Revisions (supplements)

Resubmissions:

  • NIH will not consider more than two amendments to an application or any revised application.
  • The Research Plan must be preceded with an Introduction (no more than three pages) that summarizes the substantial additions, deletions and changes in the content of the application. Changes in the Research Plan must be clearly marked by appropriate bracketing, indentation, or change of typography unless the changes are so extensive as to include most of the text. This exception should be explained in the introduction. Do not underline or shade changes.

Renewals and Revisions (supplements):

  • Supplemental applications must include an Introduction describing the overall nature of the supplement and how it will influence the specific aims, research design and methodology of the current grant.
  • Provide a progress report for both Competing Continuation and Supplemental applications (see complete PHS 398 kit for detailed instructions).
  • If human subjects are involved, provide a report on the enrollment of women and men and on the race and ethnicity of research subjects using the Targeted/Planned Enrollment Format Page for Competing Continuations.
  • PHS may also request a Key Personnel Report Format Page prior to award.

Submission Procedures

  • PIs are encouraged to include a cover letter, placed on top of the original copy of the application.  Letters should be prepared according to the following format:
    • Application title.
    • Funding opportunity announcement
    • Request for assignement (referral) to a particular IC or SRG.
    • List of individuals who should not review and why.
    • Disciplines involved, if interdisciplinary.
    • Explanation for late applications.
  • PHS may also request a Key Personnel Report Format Page prior to award. Preparation for submission:
  • Secure the application and its copies with rubber bands or paper clips only. DO NOT STAPLE COPIES.
    • Include one copy of the Personal Data page with your submission package.
    • Appendix material on cd's should be bundled separately from the copies of the proposal.
    • If relevant, attach the RFA label (see complete PHS 398) to the Face Sheet of the original copy.
    • In an accompanying letter, the PI should request assignment to a particular awarding component or initial review group.
    • To ensure timely institutional review, PIs should submit completed applications to OSP at least 10 working days in advance of the PHS deadline. Although OSP uses a courier service for the delivery of proposals, we cannot guarantee overnight delivery when this is required.
  • Proposal Routing:
    • Deliver one copy of the application, along with the original of the OSP Synopsis: Application for Approval for Research or Training Proposal Submission (available from OSP), signed by PI and Department Chair, to Dean's Office. OSP cannot submit proposals without Dean's approval.
    • Deliver the original plus five agency copies to OSP, along with one additional copy for OSP. Include the original, signed synopsis form (except for FAS). FAS faculty should provide OSP with a copy of the synopsis form as it went to the Dean (with PI and Department Chair signatures).
    • The Authorizing Official at OSP reviews and signs proposal after receiving Dean’s approval, then transmits proposal with appropriate number of copies to PHS.
    • Application packages are sent to the Center for Scientific Review, National Institutes of Health, Suite 1040, 6701 Rockledge Drive MSC 7710, Bethesda, MD 20817 (courier zip code) or 20892-7710 (US mail zip code), (301)435-0715.

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