NIAID Funding News, April 20, 2016

NIH: National Institute of Allergy and Infectious Diseases

April 20, 2016 NIAID Funding News

Feature Articles

Comparing Review of Grants and R&D Contracts

Opportunities and Resources

In The News

Advice Corner

Why Criterion Scores Don’t Add Up
Reader Questions
- Can I be named the principal investigator on multiple NIH training grants?
- I submitted an F31 and received an overall impact/priority score. How do I determine my application's percentile?

New Funding Opportunities

See the list

Comparing Review of Grants and R&D Contracts

Have you wondered how the review of grant applications compares to that of contract proposals? Read on to learn about the similarities and differences.

How does NIH handle lateness for grant applications versus contract proposals?

Grants. During a two-week window of consideration after the application due date, NIH might consider accepting a late application in certain circumstances as stated in the Late Application Submission Policy.
- The cover letter must explain the reason for late submission and it must be in relation to the person listed in the PI role on the application.
- For multiple PI applications, the reasons may apply to any or all of the PIs.
Contracts. NIH will not consider a proposal, modification, or revision received "late" by the government office designated in the solicitation unless it meets certain requirements as detailed in Federal Acquisition Regulation (FAR) 52.215-1. For example, accepting it must not unduly delay the acquisition and at least one of the following must be true:
- It is the only proposal received.
- It arrived electronically through the method authorized by the solicitation by 5 p.m. one working day before the due date and time.
- It arrived at the correct facility and was under our control before the due date and time.

Are all applications or proposals discussed?

Grants. Not necessarily. The reviewers may elect not to discuss some percentage of the applications based on preliminary scores they provide before the review meeting. The percentage of applications not discussed varies for different funding opportunities based on the number of applications received and awards to be made.
Contracts. Reviewers must discuss and score all proposals that meet any stated mandatory qualification criteria and meet material terms and obligations of the solicitation.

What happens when a reviewer has a conflict of interest?

Grants. Typically, a reviewer who has a conflict of interest with an application leaves the room during review of that application. He or she may still participate in the review of other applications.
Contracts. A potential reviewer with a conflict of interest for one proposal typically may not participate in the review of any proposals responding to the same solicitation. Conflict of interest waivers are rare due to stringent standards. With a waiver, the person with a conflict does not review that proposal but may still participate in the review of other proposals.

How does scoring differ?

Grants.
- Reviewers score applications using a scoring range of 1 to 9 for each of the NIH standard review criteria plus any funding opportunity-specific criteria. They also give each application an overall impact/priority score on a similar scale from 1 to 9. (See our article below, Why Criterion Scores Don't Add Up.)
- In some situations—e.g., grant applications reviewed at NIH's Center for Scientific Review (CSR)—the overall scores from a single study section meeting are percentiled to provide an objective ranking that can be compared across different review panels and study sections.
- Grants received in response to an NIAID-specific funding opportunity announcement are typically not reviewed at CSR and are not percentiled.
Contracts.
- Reviewers assign points based on strength or weakness relative to each technical evaluation criterion. These criteria are specific to each solicitation and have point values assigned.
- The sum of the points assigned to each criterion is the overall technical score for the proposal.

How does NIH relay results of initial peer review?

Grants. Applicants get a summary statement through IMPAC II.
Contracts.
- For proposals excluded from the competitive range or otherwise eliminated, the contracting officer notifies offerors promptly in writing. The notice states the basis for the determination and that we will not consider a proposal revision.
- For proposals in the competitive range, the contracting officer initiates discussions with the offerors. He or she notifies the offerors in writing to explain that the proposal is in the competitive range and our intent to discuss the proposal further. For more on how discussions are conducted, see FAR 15.306(d).

Who handles second-level review?

Grants. The NIH institute's advisory Council conducts second-level review.
Contracts. The contracting officer makes the source selection decision with advice from the contracting officer's representative.

Learn more

See the Peer Review portal for grants and our Peer Review of R&D Contract Technical Proposals SOP for contracts.

For comparisons of grants and contracts in areas other than review, see our February 10, 2016 article "Why You May Want to Consider a Contract."

A Funding Opportunity on Developing Countermeasures Against Select Pathogens

A new R01 funding opportunity announcement (FOA) is now part of NIAID’s Partnerships Program for Translational Research. This FOA seeks applications for milestone-driven preclinical research that will advance the development and/or production of lead therapeutics, vaccines, or medical diagnostics for select NIAID Emerging Infectious Diseases/Pathogens.

To clarify the purpose of the FOA, here are two key definitions:

Lead candidate—a candidate product or a collection of optimized products (e.g., lead candidate series) for which proof-of-concept data have been obtained
Preclinical development—all activities beyond lead candidate identification (therapeutics or vaccines) or assay/platform/prototype development (diagnostics)

Read the FOA for details on the countermeasure development activities and targeted pathogen categories it will support. A brief overview is below.

Development Activity	Targeted Pathogen Categories	Additional Information
Therapeutics Projects must focus on previously-identified, well-characterized, lead candidate (or lead candidate series) that targets one or more pathogens in either of the two categories in the next column.	Antimicrobial-Resistant Bacteria: must target at least one bacterial pathogen listed in the CDC report Antibiotic Resistance Threats in the United States, 2013	Projects must start with a single candidate therapeutic or lead candidate series. For projects initiating with a lead series, down-selection to a single lead candidate must be accomplished within the first two years of the project period.
	Emerging Viral Pathogens: must target at least one viral pathogen on the list of NIAID Emerging Infectious Diseases/Pathogens
Vaccines Projects are expected to include proof-of-concept in animal models, preclinical evaluation, and if warranted, scale-up production under Good Manufacturing Practice to provide sufficient quantities for preclinical FDA-required animal studies.	Multivalent/Universal Vaccines: examples include influenza and flaviviruses	Approaches should consider the ultimate potential of a candidate vaccine to quickly induce safe and protective responses in a diverse civilian population.
	Therapeutic Vaccines: examples include forms used for combination treatment of infections caused by Mycobacterium tuberculosis orBurkholderia pseudomallei
	Vaccines With Small Market Potential:examples include vaccines against Coccidioidesspp., Lyme borreliosis, and Zika virus
Diagnostics Projects must focus on previously identified pathogen- or host-specific targets or technologies amenable to large-scale production and validation for clinical diagnosis and point-of-care use.	Diagnostics That Facilitate Antibacterial Stewardship: must target at least three bacterial pathogens listed in the CDC report Antibiotic Resistance Threats in the United States, 2013	It is anticipated that the medical diagnostics developed through this initiative will aid healthcare providers in diagnosing individuals exposed to and/or infected with targeted NIAID Emerging Infectious Diseases/Pathogens and will be developed with the eventual and ultimate goal of obtaining FDA clearance.
	Diagnostics for Zika Virus (ZIKV): of particular interest is the development of improved serologic assays that distinguish ZIKV from other flaviviruses (especially dengue virus and yellow fever virus) in point-of-care diagnoses and/or clinical laboratory applications

NIAID will give priority to projects that address the greatest public health concerns and encourages applications that would significantly advance a candidate product toward clinical or field usefulness.

Industry Participation

If you are at an academic institution, your project must show substantive investment by at least one industry participant. This industrial participation will facilitate appropriate and validated product development activities.

Note: Applicants at industrial organizations do not need to include an academic partner.

For this FOA, we define terms as follows:

Industry: a large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, or chemical company, or a related nonprofit entity with an established track record in product development.
Substantive investment: a significant commitment of one or more resources to the project, such as:

Product development support or guidance
In kind contributions of materials and/or reagents (i.e., chemical libraries, innovative biotechnology platforms)
Providing animal or other laboratory models for evaluation
Alterations or renovations of facilities

Due Dates, Contact Information

Optional letters of intent are due September 3, 2016. The application deadline is October 3, 2016. Be sure to use FORMS-D application forms and instructions, and apply early to allow time for correcting any errors found in your application during the submission process.

If you have questions after reading the March 29, 2016 Guide announcement, direct them to Dr. Michael Schaefer, NIAID's scientific/research contact.

HIV Acquisition and Transmission: Prevention Meets Innovation

NIH seeks applications for a reissued funding opportunity announcement (FOA) supporting the Prevention Innovation Program III. The Prevention Innovation Program (PIP) encourages research and development efforts to establish and maintain a sustainable pipeline for HIV acquisition and transmission prevention.

PIP’s purpose is to support novel, high-risk, and underexplored strategies in the field of nonvaccine Biomedical Prevention (nBP). For the purposes of this FOA, nBP strategies include: topical microbicides and topical or systemic pre-exposure prophylaxis (PrEP), and Multipurpose Prevention Technologies (MPT).

Research areas of interest include:

Discovery and development of microbicides, PrEP, and MPT products or strategies for use singly or in combination against HIV and sexually transmitted infections linked to HIV acquisition
Development of new and emerging technologies, approaches, and processes that contribute to the creation of more efficient methods for assessing microbicide, PrEP, and MPT product safety, efficacy, acceptability, and adherence
Development of novel age appropriate formulation strategies suitable for use in infants, children, and adolescents to deliver sustained-release prevention products

Additionally, since part of this FOA’s focus is on building and maintaining a sustainable pipeline of prevention strategies and delivery systems, NIAID encourages applications proposing products or drug delivery systems that provide for longer intervals of protection (60 to 365 days) if sufficiently justified and practical.

Read the FOA for additional responsive areas of interest, as well as research areas that will be considered nonresponsive and therefore will not be reviewed.

Application Budget

Application budgets are limited to $400,000 each year in annual direct costs. Applicants will submit a four-year R01 grant application and are required to identify a single “Go/No-Go” decision criterion to be achieved by the second year progress report, in order to continue receiving funding for years three and four.

Failure to achieve the “Go/No-Go” decision criterion will result in negotiation of a reduced budget for year three of the grant, followed by award closeout.

Application Submission

Submit your application by August 3, 2016. Be sure to use FORMS-D application forms and instructions and apply early to allow time to correct any errors found in your application during the submission process.

For complete details, read the March 29, 2016 Guide announcement. Send questions to Dr. Jim Turpin, the scientific/research contact for the FOA.

An Opportunity to Manufacture HIV Vaccine Platforms

NIAID is seeking contract proposals for the manufacture of promising HIV vaccine candidates, supported by existing preclinical animal data or early clinical data, to further advance candidates in Phase I/II/III trials.

Primary areas of interest include recombinant HIV protein, poxvirus as vaccine vectors, DNA vaccines, and other platforms; for a complete list, see the solicitation. Offerors are not limited to these areas when submitting proposals.

Proposals will be evaluated on their potential to quickly and efficiently advance the vaccine platforms through the following staged approach:

Stage I: Refine and implement a product development plan
Stage II: Manufacture, formulate, and release the product for Phase I/II/III clinical trials
Stage III: Implement stability program and applicable pre-licensure activities

Award Details

NIAID expects to award two or three cost-reimbursement, completion-type contracts beginning on or about September 1, 2017. The initial period of performance is one to two years, with options for additional terms granted at the government’s discretion, for a possible total term of seven years.

These awards will not support clinical trials.

Application Information

Offerors must submit a separate proposal for each vaccine platform. The deadline to apply is June 29, 2016, at 3 p.m. Eastern time.

For complete details, read the March 11, 2016 solicitation. Questions? Contact Robert J. Corno, the solicitation’s primary point of contact.

Look Out for Reissued Program Announcements

As we last told you in “The Changeover to FORMS-D Is Imminent,” NIH is in the process of reissuing a significant number of funding opportunity announcements (FOAs), a process that will continue over the next two months.

For FOAs with multiple receipt dates, NIH will reissue the FOA with an added FORMS-D compatibility shortly after the last due date before May 25, 2016. The FORMS-C compatible version of the FOA will be taken down sometime thereafter, specifically at the updated expiration date listed in the FOA.

The following FOAs have already been reissued with FORMS-D compatibility:

Research Project Grants (R)
- PA-16-160, NIH Research Project Grant (Parent R01)
- PA-16-161, NIH Exploratory/Developmental Research Grant Program (Parent R21)
- PA-16-162, NIH Small Research Grant Program (Parent R03)

PA-16-200, Academic Research Enhancement Award (Parent R15)

Career Development Awards (K)
- PA-16-190, Mentored Research Scientist Development Award (Parent K01)
- PA-16-191, Mentored Clinical Scientist Research Career Development Award (Parent K08)
- PA-16-198, Mentored Patient-Oriented Research Career Development Award (Parent K23)
- PA-16-206, Midcareer Investigator Award in Patient-Oriented Research (Parent K24)
- PA-16-194, Mentored Quantitative Research Development Award (Parent K25)
- PA-16-193, NIH Pathway to Independence Award (Parent K99/R00)
Training Grants (T)
- PA-16-152, Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32)
- PA-16-151, Ruth L. Kirschstein National Research Service Award (NRSA) Short-Term Institutional Research Training Grant (Parent T35)

Again, as you’ll see on our NIAID Funding Opportunities List, the FORMS-C compatible versions of most of these FOAs are still available. You can also find the FORMS-C version linked under “Announcement Type” within each of the reissued, FORMS-D compatible FOAs.

Remember that during this transition you are choosing the FORMS set appropriate to the FOA’s due date, not your application’s submission date. For due dates on or after May 25, 2016, you will use FORMS-D application packages and guides. For due dates before May 25, you will use FORMS-C.

Keep in mind, the FOAs are configured to allow FORMS-C submissions for 14 days after the close date to accommodate late, continuous submission, and system issue policies. Still, this represents a shorter window for continuous submission than is typical. Such applications that are non-AIDS and were submitted on or before April 18, 2016, will go to October 2016 Council for second-level review. Non-AIDS continuous submission applications submitted after April 18 should use FORMS-D and will go to January 2017 Council.

Similarly, the deadline for continuous submission applications for the May 7, 2016 AIDS due date is May 23, 2016. (Since May 7 is a Saturday, the deadline is actually May 9, 2016.) Again, this is a shorter extension for continuous submission than is normal. These applications will go to October 2016 Council. After May 24, AIDS-related applications with continuous submission should use FORMS-D and will receive second-level review at the January 2017 Council. (See When must I stop using the old FORMS-C application forms if I am eligible to submit under the continuous submission policy?)

If you are applying for a due date on or after May 25, 2016, be sure to use one of the newly reissued, FORMS-D compatible FOAs. In some cases, you may need to wait a month or more until the reissued FOA is posted to complete your application.

Public Access Compliance for Shared Resources

If your award’s only contribution to a publication is a shared resource, you don’t need to list the publication in section C.1 of a Research Performance Progress Report (RPPR) or in the progress report publication list of a renewal application. Remember, awardees are responsible for public access compliance of all publications listed in those two sections.

This relieves you of the responsibility to track and report most publications that arise from the resources you share. Instead you can:

List or summarize these publications in section B.2 of your RPPR. Section B.2 requests a description of accomplishments and other achievements. Publications listed or summarized in this section will not count against the section’s two-page limit.
List or summarize these publications in the appropriate sharing plan (e.g., Data Sharing Plan, Genomic Data Sharing Plan, Model Organism Sharing Plan, Resource Sharing Plan) of a renewal application.

You are using these sections to highlight how shared resources led to noteworthy impacts. If you choose to provide a list, it doesn’t need to be comprehensive.

Conversely, if your resource sharing leads to any personnel from your grant being listed as an author on a resultant publication, you are responsible for tracking and reporting that publication. But short of authorship, you have considerable discretion in deciding whether your contribution justifies publication reporting and claiming public access policy responsibilities.

For complete details, read the March 24, 2016 Guide notice.

News Briefs

Career Development Mentors Need eRA Commons Usernames.

Beginning with applications submitted for the June 12, 2016 due date, individual mentored career development applications require that an eRA Commons username be included for the primary mentor identified in the application. See the March 28, 2016 Guide notice for full details.

Administrative Supplements for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

Several NIH institutes, including NIAID, seek to expand Myalgic Encephalomyelitis/Chronic Fatigue Syndrome research within the scope of ongoing grants through administrative supplements—adding assays, bioinformatics, and modeling approaches, or human cohorts to parent awards' studies. For NIAID, your requested award budget cannot exceed $150,000 in direct costs for up to 12 months. Find additional guidance in the April 7, 2016 Guide notice.

Sign Up for Grants Management Workshop in Johannesburg, South Africa.

The next Upcoming NIH Grants Policy and Management Training Workshop will take place in Johannesburg, South Africa, May 25 to 27, 2016. Principal investigators, grant administrators, business officials, and budget coordinators are encouraged to attend. Be sure to review theAgenda and then Register to attend.

Zika Virus R21 FOA Will Transition to FORMS-D on May 25, 2016.

Applicants interested in Rapid Assessment of Zika Virus (ZIKV) Complications (R21), take note: on May 25, 2016, NIH will close that funding opportunity announcement's FORMS-C application package and post a FORMS-D version. If you begin an application using FORMS-C before May 25, you will have until June 24 to complete it. Your choice of form set will not impact your Council round assignment.

See the April 7, 2016 Guidenotice to learn more.

Why Criterion Scores Don’t Add Up

The May 2016 review cycle marks the seventh anniversary of criterion scores in the peer review process, and yet there is still some confusion about how these scores are used.

To arrive at your overall impact/priority score, reviewers first consider the core review criteria: significance, innovation, investigator, approach, environment, and any additional funding opportunity-specific requirements. They then assign an overall impact/priority score. This deliberate approach anchors assessments and encourages consistent use of the scoring range.

Thus, while criterion scores and overall impact/priority scores are both numerical values, there is no mathematical formula linking the two.

NIAID funds the research it deems most likely to exert a sustained, powerful influence on its field. The overall impact/priority score reflects the review criteria as is appropriate for each opportunity and application.

Therefore an application does not need to be exceptionally strong in all of the review criteria to get an exceptional overall impact/priority score. For example, reviewers may give an application an outstanding overall impact/priority score due to its high significance and feasibility, even though it has only a good innovation score. Alternatively, a critical flaw in the study design may cast doubt on the likelihood that you can execute a proposal with strong significance and innovation, resulting in a marginal overall impact/priority score.

In the case of multiproject applications (e.g., P01s and U19s), strong synergy among projects often leads to an overall impact/priority score for the entire proposal that is greater than the scoring average of the individual components.

Criterion scores are provided for all applications. However, only applications that are discussed receive overall impact/priority scores. The criterion scores reflect the views of the assigned reviewers, while your overall impact/priority score reflects the scores of all the panel members who voted. Therefore, it’s important to read the resume and summary of the discussion in the summary statement as well as the comments from individual reviewers.

Scores and reviewer comments can help investigators earn better overall impact/priority scores upon resubmission. By understanding which criteria scored poorly, investigators can better target areas for improvement.

To learn more about the mechanics of the peer review process, see How Reviewers Score Applications.