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NIH Grant Application: What Your Cover Letter Should Say

• Source: NIH Center for Scientific Review

Once you’ve finished writing and editing your NIH grant application, there’s still a vital piece left to prepare: the cover letter.

Cover letters help NIH best refer and review your application. They will be used internally by referral staff and Scientific Review Officers (SROs) but will not be shared with reviewers and other NIH staff.

Don’t miss out on the chance to support your application with additional valuable information, making sure that the right people review your application. Follow these tips from NIH for a comprehensive cover letter.

Suggest NIH assigns your application to a particular review group.

NIH’s study sections overlap, so it’s possible that more than one may have the expertise to review your grant application. You can express a preference, which NIH will try to accommodate if it’s appropriate and possible. To determine which review group is best suited for you:

• Consult NIH’s study section descriptions .
• Examine recent study section rosters . Though they can change from round to round, looking at them will help you gauge their scope.
• Consider seeking guidance from the Center for Scientific Review (CSR) SRO of the study section you have in mind, and/or from an NIH institute or center program officer.
• Comb through the NIH Reporter database of funded grants to identify study sections that reviewed successful applications in their fields.

Request NIH assigns your application to a particular NIH institute(s) or center(s).

It’s possible for one or more NIH institutes or centers to be interested in your application, and you can signal which ones you think would be most relevant. Before you submit:

• Contact one or more NIH program officer(s), who you can identify via the NIH Institute and Center staff listings on their respective websites .
• Look at the funding opportunity announcement (FOA) you will use to submit your application. Applications cannot be assigned to an institute or center that doesn’t support a particular FOA.

Describe the kinds of expertise needed to review your application.

Focus on detailing the necessary expertise, not on building a list of potential reviewers’ names, which the NIH recommends against.

Alert NIH to potential reviewers who might be in conflict with your application.

If you believe a potential reviewer couldn’t provide an impartial review, let the NIH know, even if the individual isn’t on an earlier roster. Consider:

• Potential reviewers in conflict could be people with whom you’ve had a longstanding scientific or personal disagreement.
• Researchers in your field who hold different scientific opinions or do research in an area similar to yours aren’t automatically considered biased. These individuals usually provide excellent reviews because they understand the scientific issues debated.
• Your SRO will consider the situation and make the final decision. If your SRO agrees there is a conflict, the reviewer will not be assigned to your application, and will not be in the room when it’s discussed.
• Rosters are typically posted online 30 days before your review meetings, and if you see a reviewer on it who could be biased, contact your SRO as soon as possible.
• Read through NIH conflict of interest information .

Adapted from NIH Center for Scientific Review . Original source: “Cover Letters Help Us Refer and Review Your Application."

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Five reasons to submit a cover letter with your grant application.

I recently attended a scientific meeting where I had the opportunity to talk with investigators at all stages of their scientific careers. I was surprised to learn that many didn’t know that they could submit a cover letter with their electronic grant application. Here I briefly explain some reasons to provide a cover letter, including situations that require one.

1. Suggest a particular review group for your application.

The NIH Center for Scientific Review (CSR) assigns applications to scientific review groups (SRGs), but sometimes an application could be a scientific match for more than one study section. In a cover letter, you can request assignment to a particular study section and explain why you think that study section would be the best fit. Appropriate assignment requests are honored in the majority of cases. Study section descriptions , recent study section rosters and the NIH RePORTER database of funded grants can help you identify an SRG suitable for your application.

2. Suggest a particular institute or center (IC) for funding your research.

Your research might be relevant to the mission of more than one NIH IC. You can use a cover letter to suggest that your application be assigned to a specific IC. The NIH RePORTER database is a good place to investigate the types of research supported by different ICs. Before making a request in a cover letter, you should also consult with program officers at the IC to determine whether your application would be an appropriate scientific match.

3. List the areas of expertise needed to evaluate your application.

It helps the SRG’s scientific review officer (SRO) assign appropriate reviewers to your application if you describe the scientific expertise needed to properly evaluate it. It’s important, however, that you don’t identify potential reviewers. The very fact that you recommend someone raises a concern about possible bias and usually puts that person in conflict with your application.

4. Identify potential reviewers who may be in conflict with your application.

If there is someone you feel may provide a biased evaluation of your application, let the SRO know by putting that information in a cover letter. You must explain the conflict; an example would be a longstanding scientific disagreement with an individual. Usually, there’s no conflict when someone works in a very similar area, holds a different scientific opinion or has been on the review panel for a previous application that didn’t do well. The SRO can use his/her judgment in deciding whether your explanation justifies placing that person in conflict with your application.

5. Include required information.

You need to provide a cover letter when you submit your application late or plan to send video files . Some applications, such as those for conference grants, require pre-approval for submission, so the submitted application must include a cover letter with a copy of the approval letter. For a more comprehensive list of situations that require a cover letter, visit the Create a Cover Letter webpage from NIH’s National Institute of Allergy and Infectious Diseases.

Who sees these cover letters? Only NIH staff with responsibilities relevant to application receipt, referral and review can see the cover letters; the letters are not shared with other NIH staff or reviewers.

These are some of the major, but not the only, reasons you might want to include a cover letter with your application. For more information on why and how to write a cover letter, see the Cover Letters Help Us Refer and Review Your Application webpage from CSR. Instructions for submitting a cover letter as an attachment to your application are in the NIH SF424 (R&R) Application Guide .

Note: New NIH application policies, instructions and forms are coming soon for grant applications submitted for due dates on or after May 25, 2016. One of the changes will be a new PHS assignment request form . This form provides a place to enter the information needed to process a request for a study section or funding institution assignment, as well as information about expertise needed and persons with a potential conflict. The use of this form is required for your request to be brought to the attention of the appropriate review staff. Cover letters should still be used to provide information required for application submission.

2 Replies to “Five Reasons to Submit a Cover Letter with Your Grant Application”

PDFs will accept video files. Can we insert video files in the pdf of the grant proposal?

Videos cannot be included in an application. For more details, see NOT-OD-12-141 and the video section of OER’s Format Attachments page .

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Consider including the following items when preparing a cover letter for your grant. 

Request a Specific Study Section

Be proactive in requesting assignment to a review team ( study section ) and institute (if applicable) and explain why.

Frame your request positively and explain the skills needed to review your application. When applying for an NIH grant, do not name specific people as potential reviewers. If you do, the people you requested will automatically be disqualified.

If the funding institution to which you are applying does not formally accept requests, make suggestions in your email when you submit your grant application.

Do: "This application focuses on defining the cortical mechanisms of chronic visceral pain through Transcranial Magnetic Stimulation. We would like to suggest reviewers with expertise in this technology and/or neuroplasticity despite the focus on chronic pancreatitis as the underlying cause of the pain."

Don't: "I would like to suggest Dr. X, who is an expert is neuroplasticity to be a reviewer."

List Disciplines

List the disciplines involved in your proposal to help with assignment to appropriate review teams ( study sections ).

List Approval Letters

List the  approval letters  that you have attached.

Indicate Non-Standard Time

Indicate if you are qualified to submit at a  non-standard time .

Indicate Funding Opportunity Announcement

Indicate if you are responding to a specific  Funding Opportunity Announcements  (FOA). A FOA is a document by which a federal agency or private institution makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. 

(Related terms: RFA ,  PA )

Note Special Areas

Note  special areas . Special areas refer to any involvement of human subjects, select agents, genome-wide association studies or study data, or other areas with special requirements in your research proposal. Refer to your funding institution's guidelines for areas with special requirements.

Explain Overlapping Funding

Explain your plan for dealing with a  subaward  or other funding that overlaps with the grant proposal that you are submitting.

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Revise and Resubmit an Application

Here we cover factors to consider for revising and resubmitting an application, then rules for resubmitting, and finally our advice for resubmission applications.

Before committing to a resubmission, you may want to assess your other Options if Your Application Isn't Funded as well.

Table of Contents

Considerations for resubmissions, rules for resubmitting, resubmission timing, tips for a strong resubmission application.

You probably want to jump right into your resubmission, but first check your original notice of funding opportunity (NOFO) to confirm it hasn't expired, you still meet eligibility requirements, and NIAID (or your chosen institute) still participates.

If the announcement has been reissued or updated, make sure you're aware of new deadlines, eligibility criteria, forms, and instructions, all of which may have changed since your previous application.

If you applied to a program announcement (PA), program announcement with set-aside funds (PAS), or program announcement with special receipt, referral and/or review considerations (PAR), you may resubmit to the same or a different PA, PAS, or PAR. But you'll still want to check your new NOFO for the information we just mentioned.

Should You Wait for the Summary Statement?

You may want to begin revising even before you get your summary statement since waiting may cause you to miss the next receipt date.

While you must address all the reviewers' comments from your summary statement, you can start adding new data or making other improvements to the application.

Just keep in mind that you'll still have to wait for your summary statement before you resubmit, and you may have to revise your application further based on what reviewers note.

Choose Your Path

Your resubmission can take one of two paths: revise and request the same study section or revise and request a different study section. Keep in mind you might not have a study section choice for some notices of funding opportunities, e.g., PARs.

Revising and Requesting the Same Study Section. If your reviewers were enthusiastic about your idea and found fixable problems, revising and requesting the same study section is usually the way to go. This route is the most common one and works well when the points of contention are limited.

Reviewers look at the application in the context of their critiques, so the approach is effective if you can readily answer their concerns.

Be aware that your application may still face some new reviewers who may raise different issues.

Revising and Requesting a Different Study Section. If your reviewers were not enthusiastic about your idea, reassess the study section.

Do you have a sense that no matter what you wrote your reviewers wouldn't have appreciated it? That's a clue that your application and the study section were a poor fit.

But be careful not to assume that the reviewers were the problem—first thoroughly size up the application's faults that they identified.

To gauge whether the study section may have been unsuitable, use the roster attached to your summary statement to view the committee members' names, and check out their publications. Then ask yourself these questions:

• Did the reviewers' expertise fit your topic?
• Were they knowledgeable about your methods?
• Did they understand the rationale for your research?

If the verdict is no for any of the above, the study section may not have been the best fit. Talk to colleagues and mentors to get their take and before you decide whether to request a new study section, keeping the following points in mind:

• You have no guarantee of anyone's presence at the meeting—including past reviewers—because participants rotate on and off, and NIH uses ad hoc reviewers.
• You'll still have to address reviewer critiques from the first review even though that critique came from a different study section. Your new study section sees the summary statement and expects you to make appropriate changes.

Cautionary Notes About Resubmissions

Consider the following words of caution:

• Use the most recent version of the NOFO and forms, even if it's not the one you used originally.
• Do not resubmit until you can send in the strongest possible application that effectively addresses all the reviewers' comments. We can't stress the point enough.
• If a significant amount of time passes before you can resubmit, reassess the science and consider submitting a new application instead of a resubmission, particularly if the science has evolved.

Don't launch into your resubmission until you've read our instructions and advice below.

Resubmissions have several unique rules. For example, you must address all your reviewers' points and highlight their comments in the introduction and usually in the Research Plan (unless too much has changed).

Though you may be able to start revising before you get your summary statement, you'll need the summary statement for your discussion with your program officer and to address the reviewers' feedback in the application.

When you start revising, discuss the reviewers' points one by one.

Enhance your application in any way you can—even in areas your reviewers did not question, for example, by adding new data.

When you resubmit, you're playing by new rules:

• Rule 1: You have just one opportunity to resubmit.
• Rule 2: You must apply within 37 months of the original application's receipt date.
• Rule 3: You must create a one-page introduction that addresses all your reviewers' issues that are stated in your summary statement. Reviewers will look for their comments and check that you revised accordingly.

You may also enhance the rest of your application by adding any new information and data you wish.

Here's how to proceed:

• Highlight your reviewers' comments in your introduction and the body of your application, usually in the Research Plan. But if changes are so extensive that most text would be affected, explain them in the introduction only.
• Summarizes the substantial additions, deletions, and changes to the application.
• Responds to major weaknesses raised in the summary statement.
• Note that identifying individual changes by using brackets, indents, or change of typography in the text of Specific Aims, Research Strategy, and other application attachments is no longer required, though NIH will continue to accept applications that contain the specific mark-ups.
• Include any new preliminary data you have, and strengthen the application where possible—even in areas your reviewers did not question.
• Use the forms from the most current notice of funding opportunity, and scan the notice of funding opportunity to see if anything has changed.

Even if you take all these steps, you have no guarantee of success for several reasons:

• Reviewers are not wedded to their critiques.
• New reviewers may disagree with previous comments or raise new criticisms.
• Because a summary statement is not an exhaustive critique of your proposal, it may not list all concerns reviewers had (plus issues they may have raised had the discussion continued).

That said, many people get funded after revising, and usually a resubmission can't hurt you.

Many resubmissions score better than the initial application, though of course there's no guarantee. 

Even if your resubmission scores slightly worse, that probably won't affect the funding chances of an earlier application. If you've submitted two applications, NIAID can still fund the earlier one.

eRA Commons will keep both versions of your application active. You'll see the "MAA" (Multiple Active Application) flag in the Commons. When one application is funded, NIH automatically withdraws the other.

If you are on a list for possible selective pay or end-of-year funding, resubmit—don't wait to see what will happen.

You may be able to start revising right away, but take the time to do the best job you can.

You only have one opportunity to resubmit, so make it your best shot. Do not resubmit until you can send in the strongest possible application that effectively addresses all the reviewers' comments. Get advice from your program officer and experts in your institution before proceeding and again after you prepare your resubmission.

Some people begin revising even before getting the summary statement because waiting may cause them to miss the next receipt date. Note: Summary statements for new investigator R01 applications are prioritized, and when possible, released before summary statements for other applications reviewed in the same meeting.

You could start revising before you get your summary statement if you have promising new data or other improvements you want to include.

Then after you get your summary statement, add to the revisions you've already made to address peer reviewer concerns.

We strongly recommend that even if your application scored just above the payline or is on a list for possible selective pay or end-of-year funding, don't wait to see what will happen. Start revising as soon as you can and resubmit when ready, keeping in mind the caveats noted above and in the next section below.

Read more about timing at Timelines and Due Dates .

When Not to Resubmit Quickly

Sometimes waiting has little impact on the timing of an award.

Don't rush. It's better to wait for the next receipt date than send an application prematurely. And if you need additional preliminary data or new data is imminent, wait until you have it before resubmitting.

• For Cycle 1 receipt dates (September-October Council), you often have to wait several extra months before you get an award because the Institute does not yet have a budget for the following fiscal year.
• If you wait to submit for the Cycle 3 receipt dates (May Council) instead, you could lose just a month or two before you actually get an award.

Here are some tips to help you succeed.

Capitalize on your strengths and throw out or revise the parts reviewers felt were weak. Check again that your Specific Aims line up with your hypothesis.

Respond point by point to the reviewers' comments and suggestions, stating how you dealt with all the criticisms in the summary statement. Your program officer may be able to advise you as you consider application changes.

• Summarizes the issues and criticisms and respond in as much detail as possible.
• Research Plan and elsewhere in the body of your application. Update as needed to respond. If you're cramped for space, don't drop important details in favor of making space to address reviewer comments.

Be respectful even if you disagree.

• If you disagree, explain why, and provide additional information if possible.
• Even better, change your proposal. For example, if reviewers don't like an approach, propose a different one, even if you don't agree.

Identify changes . To identify substantial scientific changes, do the following:

• Note: Identifying individual changes by using brackets, indents, or change of typography in the text of Specific Aims, Research Strategy, and other application attachments is no longer required, though NIH will continue to accept applications that contain the specific mark-ups.

Add new findings and your own improvements. You aren't limited to revising only items mentioned in the summary statement.

• In the Preliminary Studies/Progress Report, add any new findings you've gotten since the previous application.
• Don't hesitate to make other changes. Strengthen the application as much as you can.

See what worked for others. We offer two samples R01 resubmission applications that scored well.

Spot The Sample

See what worked for our two resubmission Sample Applications:

• Application from Dr. William Faubion , "Inflammatory cascades disrupt Treg function trough epigenetic mechanisms"
• Application from Drs. Li and Samulski , "Enhance AAV Liver Transduction with Capsid Immune Evasion"

Notice how they approached the reviewers in their applications and how it reflects our advice above:

• Both applications include a summary of critiques and changes made in response.
• The applicants used formatting and sectioning to highlight key points and make it easier for reviews to read the text.
• They made the corresponding changes are described in the introduction.
• Through applicants are no longer required to mark their changes, Drs. Li and Samulski used underlining to show reviewers where the text had changed, while Dr. Faubion used yellow highlighting.

If you decide against resubmitting or your resubmission application doesn’t work out, you may want to assess your other Options if Your Application Isn't Funded .

Previous Step

Have questions.

A program officer in your area of science can give you application advice, NIAID's perspective on your research, and confirmation that your proposed research fits within NIAID’s mission.

Find contacts and instructions at When to Contact an NIAID Program Officer .

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Assignment of Application

Receipt and referral.

The Division of Receipt and Referral (DRR) in the Center for Scientific Review (CSR)  serves as the central receiving point for all competing applications, whether solicited or unsolicited. Upon receipt of a competing application, DRR: checks for completeness, determines area of research, assigns applications to one or more NIH Institutes or Centers (ICs) for possible funding, assigns an identification number that looks similar to this: 1-R01-MH123456-01, and assigns the application to a review group that has the expertise to evaluate the scientific and technical merit of the application. To reach the most appropriate assignment, DRR consults with ICs’ referral staff, Scientific Review Officers (SROs) and Integrated Review Group (IRG) Chiefs, and considers applicants’ requests (see Using a Cover Letter section below). For applications assigned to an IC review branch for peer review, a general assignment is made to that IC; the staff in the review branch subsequently decides whether the application is to be reviewed by an IC standing committee or by an IC Special Emphasis Panel (SEP). Additional information about this process at CSR may be found on their submission and assignment web page  . As noted above, applications submitted to the NIH receive two assignments through the CSR DRR:

• Programmatic assignment is based on the overall mission, specific mandates and interests of the IC.
• The assigned IC is responsible for the overall administration of applications, and will potentially provide funding, depending on review and other considerations.
• Once assigned to a specific IC, your application will also be assigned to a Program Official within that IC (see Step 1 for details on the Program Official’s role ).
• The second assignment (review) is to the review cluster (Integrated Review Group [IRG]) as well as to a particular review committee (Scientific Review Group [SRG], often referred to as Study Section) that will review the application, either at  CSR   or within an IC. For example, some grant applications that are assigned to NIMH are reviewed by a NIMH Peer Review Committee or SEP instead of CSR. Review assignment is based on the specific description for each standing scientific review committee .

Identifying the Most Appropriate Review Committee for Your Grant Application

While CSR or the NIMH Review Branch retains the responsibility for making the final determination concerning assignment of grant applications to a particular review committee, it is often in your best interest to be familiar with the available choices and to express your opinion at the time of application submission (see Using a Cover Letter section below).

To help identify the most appropriate review committee, look at the description and recent rosters for each review committee. These can be found using the search feature or related links at:

• Integrated Review Groups (IRGs) conducted by CSR 
• NIMH Peer Review Committees

Applicants should also consider seeking guidance from the Scientific Review Officer, IC Program Officer (often listed within the Funding Opportunity Announcement), and check out the NIH Reporter database of funded grants in order to identify the most appropriate review committee for you grant application.

One other type of review committee is the Special Emphasis Panel (SEP). These are special committees of experts that usually meet only once for the review of a specific set of applications. These types of applications may have been submitted in response to a specific Request for Applications, or are for specific grant mechanisms that are submitted only once per year, among others types of such applications. Because SEPs are set up on an as-needed basis, applicants cannot request a specific SEP. You can look for your assigned SEP and roster 30 days before the review on this list of SEPs  . The SEP codes will have the prefixes ZRG1 for CSR review or ZMH1 for NIMH review (please note that ZMH1 SRC 99 is a holding code only, used by all review committees convened by NIMH, including those subsequently assigned to standing review committees or SEPs.)

Using a Cover Letter

Investigators may include a cover letter (a PDF attachment for electronic submissions) with their application. The information within a cover letter can help DRR in referring your application to a particular IC and help the SRO conduct the review. You can use a cover letter to suggest a particular review group, to suggest an IC you think would be interested in your research, to describe the kinds of expertise needed to review your application (you should not, however, list the names of potential reviewers), and to inform the SRO of potential reviewers who you feel might be in conflict with your application. While cover letters are encouraged, please note that CSR and IC review staff make the final assignment and conflict decisions after carefully considering your suggestions and explanations, in light of NIH policies and referral guidelines. Note that cover letters are for internal use only (i.e., referral staff and SROs). Cover letters are not provided to reviewers. You must have a cover letter for the following applications: resubmissions, applications requiring IC approval to submit (e.g., grants requesting $500,000 or more in direct costs for any year), genome-wide association studies (GWAS) or those studies that plan to access GWAS data in the NIH repository, late applications, and continuous submission (in which case you should indicate that you are a member of a NIH study section qualified to submit at a nonstandard time).

Checking on Final Assignment

Information on the final programmatic and review assignments can be found in the eRA Commons page related to the grant application several weeks after submission. If the information is not clear or there are questions about assignment, contact the peer review contact (if any) listed in the Funding Opportunity Announcement or the Division of Receipt and Referral at 301-435-0715.

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Competitive

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NIH-OD-DE-24-12495603

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You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This job is also open to USPS Commissioned Corps Officers and Call-to-Active Duty (CAD) Candidates.

• Develop annual monitoring plan for review of licenses.
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Conditions of employment.

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This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education .

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• This position is designated as a " non-emergency/teleworker " position and the selected candidate will be considered a " non-emergency/teleworker " employee. In the event of a closure, you must be available to telework or request leave.
• A one-year probationary period may be required upon selection/placement.
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• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration
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• Veterans' preference (DD-214, VA Disability Letter, etc.) : Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• Visit our sites on Career Transition Assistance Program (CTAP) / Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
• Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
• Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 09/03/2024 to receive consideration.

• To begin, click Apply to access the online application . You will need to be logged into your USAJOBS account to apply.
• Follow the prompts to select your resume and/or other supporting documents to be included with your application package . See the "Required Documents" section for any additional forms and/or supplemental materials required.
• Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim . You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
• Complete the assessment questionnaire . Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12495603
• Verify all required documentation is included in your application package , review your responses to the assessment questionnaire for accuracy, and then submit your application.

Agency contact information

HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats. Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account . At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.

The Federal hiring process is set up to be fair and transparent. Please read the following guidance.

• Criminal history inquiries
• Equal Employment Opportunity (EEO) Policy
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• New employee probationary period
• Privacy Act
• Reasonable accommodation policy
• Selective Service
• Signature and false statements
• Social security number request

Required Documents

How to apply, fair & transparent.

This job originated on www.usajobs.gov . For the full announcement and to apply, visit www.usajobs.gov/job/806510800 . Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.

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National Institutes of Health

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the largest biomedical research funding organization in the world. NIH is made up of 27 Institutes and Centers, each with a specific research agenda, often focusing on particular diseases or body systems. NIH employs approximately 18,000 employees in varied occupations, all supporting research efforts that improve health and save lives. For more information on NIH's mission and goals, and its 27 Institutes and Centers, visit the NIH website . For more information about the Office of Technology Transfer, please click here. Virtually explore the National Institutes of Health's (NIH) Bethesda campus, learn about scientific research, and get to know NIH community members who are working to help people live longer, healthier lives: https://www.nih.gov/virtual-tour/ .

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Part 1. Overview Information

National Institutes of Health ( NIH )

R21 Exploratory/Developmental Research Grant

• April 4, 2024  - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice  NOT-OD-22-198 .
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice  NOT-OD-22-189 .

See Part 2, Section III. 3. Additional Information on Eligibility.

This purpose of this notice of funding opportunity (NOFO) is to support the development of molecules that target HIV proteins or RNA for degradation or that interfere with the translation of HIV RNA into protein. This approach has the potential of eliminating HIV proteins that have been difficult to target via traditional drug discovery methodologies.

30 days prior to the application due date

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Not Applicable

It is critical that applicants follow the instructions in the Research (R) Instructions in the  How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section i. notice of funding opportunity description.

Initial efforts to inhibit HIV replication focused on the development of small molecule inhibitors that were designed to bind to the catalytic site of HIV enzymes to inhibit their function. This strategy was successful for reverse transcriptase, integrase, and protease, but these approaches do not eliminate viral expression and have led to the development of viral resistance to drugs. Also, attempts to develop small molecule therapeutics targeting other intracellular HIV proteins have not been successful.

Developing therapeutics that are not focused on small molecule inhibition of enzymatic activity would potentially expand the number of HIV targets within an infected cell.

This initiative introduces a new drug discovery paradigm for HIV: controlling virus replication by eliminating viral proteins. The most direct strategy is to eliminate one or more virus-associated proteins from the cell by targeting HIV RNA transcripts with small molecules. Small molecules could inhibit RNA splicing, block translation, or enable the degradation of RNA encoding selected viral proteins. Alternatively, viral proteins can be selectively targeted for degradation by harnessing one of several known cellular processes. These strategies may overcome the limitations of small molecule inhibitors of HIV enzymes by expanding the number of potential targets within an infected cell.

Research Objectives and Scope

This funding opportunity will support applications for projects that discover and develop novel therapeutics directed to intracellular HIV targets and eliminate viral proteins by various mechanisms including, but not limited to, protein degradation, targeting of viral RNA through inhibiting RNA processing (splicing, translation, etc.) as well as degradation. Projects may include proof-of-concept studies in HIV-infected cell lines or primary cells. Studies may extend to the optimization of existing technologies or the development of new technologies. The goal is to identify lead molecules that target HIV RNA and proteins that have the potential to advance as preclinical candidates.

Examples of the types of research responsive to this NOFO include, but are not limited to:

• The design, optimization and testing of strategies for targeting HIV proteins (or the RNA that encodes them) for degradation.
• Small molecule strategies that interfere with processes involved in the transcription or translation of HIV RNA into protein.
• Strategies that target host proteins that have been shown to be essential for HIV replication.
• Development of new methods or technologies which can be used to eliminate HIV proteins.

Applications proposing any of the following research topics will be considered non-responsive and will not be reviewed:

• Discovery of new small molecule inhibitors of HIV enzyme activity.
• Molecules that target latency reversal.
• Animal model studies using non-human primates.
• Applications proposing  Clinical Trials .

This NOFO is soliciting R21 applications that will support developmental and/or exploratory research activities for a limited project period (2 years). The companion R01 ( RFA-AI-24-057 ) will support more defined projects for longer periods (up to 5 years).  

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

The  OER Glossary  and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

NIAID intends to commit $0.8 M in FY 2025 to fund 2-3 awards.

Application budgets for NIH R21 grants are: $275,000 in direct costs over a two-year project period, with a maximum of $200,000 in direct costs in any given year.

The scope of the proposed project should determine the project period. The maximum project period is two years. 

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

Section III. Eligibility Information

1. eligible applicants eligible organizations higher education institutions public/state controlled institutions of higher education private institutions of higher education the following types of higher education institutions are always encouraged to apply for nih support as public or private institutions of higher education: hispanic-serving institutions historically black colleges and universities (hbcus) tribally controlled colleges and universities (tccus) alaska native and native hawaiian serving institutions asian american native american pacific islander serving institutions (aanapisis) nonprofits other than institutions of higher education nonprofits with 501(c)(3) irs status (other than institutions of higher education) nonprofits without 501(c)(3) irs status (other than institutions of higher education) for-profit organizations small businesses for-profit organizations (other than small businesses) local governments state governments county governments city or township governments special district governments indian/native american tribal governments (federally recognized) indian/native american tribal governments (other than federally recognized) federal governments eligible agencies of the federal government u.s. territory or possession other independent school districts public housing authorities/indian housing authorities native american tribal organizations (other than federally recognized tribal governments) faith-based or community-based organizations regional organizations non-domestic (non-u.s.) entities (foreign organizations) foreign organizations non-domestic (non-u.s.) entities (foreign organizations) are eligible to apply. non-domestic (non-u.s.) components of u.s. organizations are eligible to apply. foreign components, as defined in the nih grants policy statement , are allowed.  required registrations applicant organizations applicant organizations must complete and maintain the following registrations as described in the how to apply - application guide to be eligible to apply for or receive an award. all registrations must be completed prior to the application being submitted. registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference nih grants policy statement section 2.3.9.2 electronically submitted applications for additional information system for award management (sam) – applicants must complete and maintain an active registration, which requires renewal at least annually . the renewal process may require as much time as the initial registration. sam registration includes the assignment of a commercial and government entity (cage) code for domestic organizations which have not already been assigned a cage code. nato commercial and government entity (ncage) code – foreign organizations must obtain an ncage code (in lieu of a cage code) in order to register in sam. unique entity identifier (uei) - a uei is issued as part of the sam.gov registration process. the same uei must be used for all registrations, as well as on the grant application. era commons - once the unique organization identifier is established, organizations can register with era commons in tandem with completing their grants.gov registrations; all registrations must be in place by time of submission. era commons requires organizations to identify at least one signing official (so) and at least one program director/principal investigator (pd/pi) account in order to submit an application. grants.gov – applicants must have an active sam registration in order to complete the grants.gov registration. program directors/principal investigators (pd(s)/pi(s)) all pd(s)/pi(s) must have an era commons account.  pd(s)/pi(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in era commons. if the pd/pi is also the organizational signing official, they must have two distinct era commons accounts, one for each role. obtaining an era commons account can take up to 2 weeks. eligible individuals (program director/principal investigator) any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director(s)/principal investigator(s) (pd(s)/pi(s)) is invited to work with their organization to develop an application for support. individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for nih support. see, reminder: notice of nih's encouragement of applications supporting individuals from underrepresented ethnic and racial groups as well as individuals with disabilities , not-od-22-019 . for institutions/organizations proposing multiple pds/pis, visit the multiple program director/principal investigator policy and submission details in the senior/key person profile (expanded) component of the how to apply - application guide . 2. cost sharing.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see  NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Section IV. Application and Submission Information

1. requesting an application package.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Vishakha Sharma, PhD Telephone: 301-761-7036 Email: [email protected]  

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

Sf424(r&r) other project information, sf424(r&r) senior/key person profile, r&r or modular budget, r&r subaward budget, phs 398 cover page supplement, phs 398 research plan.

All instructions in the  How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy:

Describe the strategy to inhibit RNA splicing, block translation or enable the degradation of RNA encoding selected viral proteins or targeting selective degradation of viral proteins via known cellular processes. Provide a justification/rationale for the choice of the target and the strategy for the elimination of the HIV or host target, based on the literature and/or preliminary data if available. Describe analytical methods planned for determining the elimination of HIV proteins. If a new platform or modification of an existing platform is proposed, describe the technology and how it improves on the current platform.

Provide plans for validating HIV RNA and proteins as targets in HIV-infected cell lines or primary cells.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the  How to Apply - Application Guide .

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:  Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

Foreign organizations.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I.  contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide .

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide . Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide .

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute of Allergy and Infectious Diseases, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35 .

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] . 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. criteria.

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following:  

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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

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

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms ) or the rationale for not sharing the resources, is reasonable.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases, in accordance with NIH peer review policies and practices , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons. As part of the scientific peer review, all applications will receive a written critique. Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO. Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions: Scientific and technical merit of the proposed project as determined by scientific peer review. Availability of funds. Relevance of the proposed project to program priorities. If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the  NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures . This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships. 3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the  eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the  NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .

Section VI. Award Administration Information

1. award notices.

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in  Section IV.6. Funding Restrictions . Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the  NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see  Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200 , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities .
• HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in  NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See  2 CFR Part 200.340 Termination and  NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support . 

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the  Research Performance Progress Report (RPPR)  annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting .

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online:  https://www.era.nih.gov/need-help  (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email:  [email protected]  (preferred method of contact) Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email:  [email protected]

Gerard M. Lacourciere, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-761-7477 Email: [email protected]  

Vishakha Sharma, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-761-7036 Email: [email protected]  

Robert Kirker  National Institute of Allergy and Infectious Diseases (NIAID) Telephone: 301-451-3176  Email: [email protected]  

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

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 2 CFR Part 200.