NIAID Funding News October 7, 2015

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles.

Stay Mindful of Federal Law and NIH Policy on Select Agents

NIAID-funded researchers often deal with biological agents or toxins that have the potential to pose a threat to public health and safety. Before you apply for NIAID funding, you should first know whether your proposed research includes a select agent and how to proceed if it does.

Should you propose to use a select agent in your research, and the project is funded, you will be responsible for adhering to the Federal Select Agent Program (FSAP).

Step 1: Check the Regulations

Begin by checking the Select Agents and Toxins List for your proposed research materials. You might also want to check Select Agents and Toxins Exclusions for specific, attenuated strains of the toxins or viruses with which you will work, and the HHS select agents and toxins regulations (42 CFR Part 73), which has a list of agents and also explains toxin quantities and regulated molecular sequences.

The lists are updated regularly, so you should double check before each application. For example, if you are applying for a renewal, the list may have changed since you received your original award.

When your research proposal includes a select agent not on the exclusions list, you need to register with CDC. Complete Registration for Possession, Use, and Transfer of Select Agents and Toxinsand submit your completed forms to either FSAP or CDC. You will not be able to use NIH funds for select agent research until your registration is complete. Compliance Assistance is a great resource for help preparing your lab for research using select agents.

Step 2: Complete Your Application

If your research includes a select agent, you will need to describe in your Research Strategy how and where you will use the agent. You will also need to complete the Select Agent Research attachment to the PHS 398 Research Plan form and describe biocontainment resources (e.g., facilities and controls) at each performance site in the Facilities and Other Resources section of the Research and Related Other Project Information form. You must include the registration status of all entities where select agents will be used. If you are using a regulated select agent, the best way to demonstrate that your facilities are certified is to provide their FSAP registration numbers as part of your site descriptions. If the performance site is a foreign institution, provide the name of the country where select agent research will be performed.

Reviewers will look to see that your plan demonstrates a thoughtful and practical approach to handling select agents and ensures lab safety. They will evaluate select agents as Biohazards, an Additional Review Criteria that can influence the overall impact/priority score of the project, and as an Additional Review Consideration, which is an administrative issue that does not affect the scoring of the project. To read what the Center for Scientific Review instructs reviewers, see Guidance on Review of Biohazards Including Select Agents.

If you receive a fundable score in peer review, NIAID will present your application to our Advisory Council to solicit recommendations and address any concerns.

For contracts and solicitations, offerors are responsible for following the terms listed in Select Agent Language for Solicitations and Contracts. The language includes specific guidelines for progress reports, subcontracts, and oversight for highly pathogenic agents. Offerors must also complete successful registration with and obtain certification from CDC in accordance with FSAP.

Step 3: Selected for Funding

Your program officer should be aware that your proposed research includes work with select agents not on the exclusions list.

The program officer will make sure that you follow the Select Agent Terms of Award for NIAID Grants. Keep in mind, you cannot use funds for research involving select agents until your final Registration for Possession, Use, and Transfer of Select Agents and Toxins certificate from CDC is secured. Your grants management specialist may request a copy of the registration.

If a foreign institution is the grantee, there is a separate registration process, including a laboratory review for biosafety by NIAID site visit representatives, which is a topic we will explore in more detail in a future issue. Such visits are not required for work with select agents in a foreign laboratory where a U.S. institution is the grantee. All funded institutions are responsible for their foreign subcomponents' and subcontractors' compliance with the NIAID select agent policy.

All U.S. institutions that work with select agents, regardless of funding source, must have a CDC audit as part of the process required for work with select agents in the laboratory (regular inspections occur at least once every three years).

Step 4: Research

Once you have completed NIAID’s administrative requirements for select agent or toxin research, you can start your research project. Remember, you are responsible for following U.S. Regulations 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73.

You should also be aware that, under the USA Patriot Act, people defined as "restricted" cannot work with pathogens or toxins that are potential bioterrorism agents. Read the Foreign Workers on NIH Awards SOP for the Patriot Act definition of restricted persons. The FBI oversees individual laboratory clearance for work with select agents. See Personnel Suitability Assessment FAQs for more information.

Related Resources

  • Biodefense and Select Agents portal
  • Select Agent Awards SOP
  • NIAID Select Agent Policy for Foreign Institutions Questions and Answers
  • Lock icon: This link will not work for public visitors. Special Issues Requiring Council Review SOP

  • Apply for Grand Challenges Funding

    If you're working on NIAID-related topics, check out two Grand Challenges programs from the Bill and Melinda Gates Foundation.

    Grand Challenges Explorations

    Applicants at any experience level and from any organization can submit a proposal until November 11, 2015, for one of these global health and development topics:

    Initial grants will be $100,000 each, and projects showing promise may get up to another $1 million.

    New Interventions for Global Health: Vaccine Manufacturing

    Through this challenge, the Gates Foundation hopes to lower production cost for expensive vaccines that target diseases of great global burden. Your application must focus on at least one of the following vaccine types:

    • Human papillomavirus
    • Inactivated poliovirus
    • Measles-rubella
    • Pentavalent
    • Pneumococcal
    • Rotavirus

    Send a letter of intent by November 5, 2015, to propose a manufacturing platform that can produce vaccines at a final finished goods production cost of less than or equal to 15 cents per dose.

    Read more about this grant opportunity at New Interventions for Global Health: Vaccine Manufacturing.

    Header: Other News.

    Funding Restricted for Certain Human Pluripotent Cell Research

    Effective immediately—and until it issues a subsequent policy notice—NIH will not fund any competing grant applications or contract proposals for research in which human pluripotent cells are introduced into nonhuman vertebrate animal pregastrulation stage embryos.

    At present, for research involving such studies, NIH

    • Will not fund any competing grant applications or contract proposals.
    • Will not consider requests for administrative supplements or revisions to any grants or modifications to R&D contracts.
    • Will hold peer reviewed competing applications for funding decisions.
    • Will not review competing applications or contract proposals pending submission or peer review.
    • Will address ongoing NIH awards with awardees on a case-by-case basis.

    Applicants have an option to withdraw their application and submit again at the next available due date.

    In the meantime, NIH will evaluate ethical issues in the field of regenerative medicine through the use of human pluripotent cells.

    For additional background information and policy implementation details, read the September 23, 2015 Guide notice.

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    Know the Importance of Civil Rights Protections in NIH-Supported Activities

    To provide a nondiscriminatory research and research-related environment, grantee institutions, PIs, and others who administer NIH-funded activities must identify and eliminate any barriers to participation.

    Federal civil rights laws prohibit discrimination on the basis of 1) race, color, national origin, disability, and age in all programs and activities that receive federal financial assistance, and 2) sex in educational programs or activities conducted by colleges and universities. These protections apply in all NIH-supported settings, including research, educational programs, conferences, and other activities.

    Before NIH makes a grant award, grantees must file an Assurance of Compliance with the HHS Office for Civil Rights. By filing this form, the applicant organization agrees to comply with the following civil rights statutes:

    Additionally, a proposed civil rights rule, Nondiscrimination in Health Programs and Activities, is undergoing HHS review and is open for public comment. The proposed rule seeks to clarify the definition of “health program or activity,” as well as understand the rule’s potential impact on grantees conducting health research. Send feedback by November 9, 2015.

    For more details, read the September 8, 2015 Guide notice. If you have questions, contact Lisa Evans in the Office of Extramural Research.

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    News Briefs

    AORs: Verify Your Institution's Grant Info Before October 12. NIH will soon populate RePORT with information from FY 2015 grants. To help ensure the data's accuracy, every institution's authorized organizational representative (AOR) or signing official should review and submit corrections for his or her institution's awards. Find instructions in the September 21, 2015 Guide notice.

    Check Out Opportunity for NIH-NSF Infectious Diseases Program. Investigators interested in the ecology and evolution of infectious diseases should explore a joint NIH-NSF funding opportunity announcement. The FOA seeks applications that propose a multidisciplinary approach to studying how infectious disease agents reach humans and other hosts. For complete details, see theSeptember 14, 2015 Guide announcement, and go to the National Science Foundation Ecology and Evolution of Infectious Diseases Program Solicitation.

    ASSIST Now an Option for Small Business Grant Applications. Small businesses can now use ASSIST when applying for funding under the R41, R42, R43, R44, U43, U44, UT1, UT2, UB1, and SB1 activity codes. ASSIST will be a submission option for all NIH competing grant applications by the end of 2015, as seen on the Target Timeline for Single-Project ASSIST Support.

    For K22, Not Affiliated? Not a Problem. If you want to apply for an NIAID Career Transition Award (K22) but are not affiliated with an organization, you may still apply. Be sure to read and follow Special Instructions for Submitting K22 Applications From Unaffiliated Applicants Using the SF 424 (R&R).

    Precision Medicine Working Group Issues Recommendations. The Precision Medicine Initiative Working Group, tasked with developing a plan for creating and managing a cohort of one million or more Americans, completed The Precision Medicine Initiative Cohort Program—Building a Research Foundation for 21st Century Medicine. Based on the report's recommendations, NIH will pursue a longitudinal, long-term effort to identify the molecular, environmental, and behavioral factors that contribute to diverse diseases, facilitate the development and testing of novel therapies and prevention approaches, and pioneer mobile health (mHealth) technologies, e.g., smart phone apps, to correlate activity, physiologic measures, and environmental exposures with health outcomes.

    Register Now for November Webinars From CSR. The NIH Center for Scientific Review (CSR) will host two Webinars, one aimed at university research administrators and one on research project grants (R01s), to give participants useful insights into the application submission and peer review process. The Webinars will take place from 2 to 4 p.m. EST on November 5 and 6, 2015, respectively. See CSR Webinars for full details.

    Header: Advice Corner.

    Important Reminder: Abide by Biosketch Rules

    With numerous application deadlines coming up, we want to give you this important reminder: Be sure to use the new biosketch format announced in the December 5, 2014 Guide notice. If you haven't already, become familiar with how the new biosketch differs from the old.

    One of the changes is that you now have five pages (versus four pages previously). Don't exceed the five-page limit since doing so will result in an error during the eRA Commons validations process. That means your application won't move forward until you make corrections.

    For more information on the new biosketch format, go to NIH's Biosketches Frequently Asked Questions, including What application submission validations will eRA systems enforce for biosketches? and What does it mean to be compliant with the new biosketch policy?

    Header: Reader Questions.

    Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

    “For a PI whose salary is greater than the annual cap, how should we compute 75 percent effort?”—V. Ben Supan, Johns Hopkins University

    The PI can list his or her "actual" salary and 75 percent of that or 75 percent of the allowable salary cap. Regardless, we won’t pay more than 75 percent (if that’s the effort) of the allowable salary cap. If the application is funded, we would adjust the salary before issuing the Notice of Award.

    See the December 30, 2014 Guide notice to learn more.

    “Will I lose my new investigator status if I apply for and receive an R21 grant?”—anonymous reader

    No, you would not lose your new investigator status for a future R01 application if you received an exploratory/developmental (R21) grant.

    Remember, we don’t typically advise new investigators to apply for an R21 first. Smaller awards like the R21 are not designed to help you establish a research career. While they do help some investigators, our statistical analyses indicate they don’t tend to create a path to independent research.

    See our New Investigator Guide to NIH Funding, which discusses award types and their advantages or disadvantages, including Why You Should Consider an R01.

    If you decide that an R21 is most appropriate for your research idea, speak with a scientific/research contact listed in Contacts and Special Interests to get advice specific to your situation.

    Header: New Funding Opportunities.

    See other announcements at NIAID Funding Opportunities List.

Content last reviewed on October 8, 2015