NIAID Funding News November 4, 2015

Feature Articles

• Genomic Data Sharing and You

Opportunities and Resources

• Funding for Research on Diseases Caused by Eukaryotic Pathogens
• NIH Program Could Be a Big Deal for Small Business Awardees

In The News

• Timeline for NIH Transition to New Application Forms
• Take Note of New Training Tables, New System to Compile Them
• Comment on Proposed Changes to Human Subjects Protections
• News Briefs
  • Watch Webinar to Learn About Clinical Center Collaboration
  • Researching the Nexus of Environment and Child Health
  • NIH Highlights Expected Changes in FY 2016 Grants Policy Statement
  • Check Out Webinar on NIH Extramural Loan Repayment Program

Advice Corner

• Be On Time With Closeout Reports
• Reader Questions
  • Do any of NIAID's R01 sample applications use the new biosketch?
  • Is there a way to see a list of grants that were awarded through a particular funding opportunity announcement?

New Funding Opportunities

• See the list

Genomic Data Sharing and You

Make sure you're comfortable with the ins and outs of NIH's Genomic Data Sharing (GDS) policy, which went into effect on January 25, 2015. NIH announced the final GDS policy in an August 27, 2014 Guide notice.

Qualifying Research

The policy applies to all NIH-funded grants or contracts at any funding level if they generate large-scale human or nonhuman genomic data.

"Large-scale" is a key qualifier; not every project that generates genomic data falls within the scope of the GDS policy. As examples, large-scale data include the following:

• Genome-wide association studies (GWAS)
• Single nucleotide polymorphism (SNP) arrays
• Genome sequence, transcriptomic, epigenomic, and gene expression data

For more examples of qualifying research, read the policy and see the supplemental information linked below.

What to Do

When you propose research that will generate large-scale genomic data, your application or proposal must include a plan to address genomic data sharing. See the links below for more on the plan.

If you were funded before the policy kicked in on January 25, 2015, NIH encourages you to comply with the GDS policy as follows:

• Provide an updated genomic data sharing plan in your next progress report.
• If your studies involve human participants, transition to informed consent for broad sharing and future research purposes. This would be particularly helpful for new or additional specimen collections.

The supplemental information also includes a few examples of research that wouldn’t fall under this policy, such as using genomic data as a control in assay development.

More Guidance

These highlights from NIH's Genomic Data Sharing website should get you started:

• Supplemental Information. Get examples of genomic research projects that are subject to the policy and the timeline for submitting and sharing data.
• Researchers. Learn how to register your studies once you're funded, access data, and more.
  • Guidance for Investigators Developing Genomic Data Sharing Plans. Follow a list of elements in a standard genomic data sharing plan, then see example plans.
  • Guidance for Institutions Submitting Applications and Contract Proposals Under the GDS Policy. Find details on investigator and institution responsibilities, including informed consent, data submission, and data access.

Funding for Research on Diseases Caused by Eukaryotic Pathogens

Do you have an idea or disease model that could lead to new or novel interventions against eukaryotic pathogens (e.g., parasites and fungi) for which current therapies are inadequate or becoming ineffectual due to resistance? Then consider a new funding opportunity announcement (FOA) for early-stage, preclinical investigations of promising therapeutic approaches for these diseases.

Scientific Scope

Applicants should propose innovative research. For example, you could use a synthetic disease model to identify and validate a novel therapeutic target or identify a novel therapeutic. Find a list of suggested approaches in the Research Objectives and Scope section of the October 21, 2015 Guide announcement.

The FOA also identifies approaches that are considered nonresponsive and will not be reviewed. For example, you cannot propose to develop antibacterial or antiviral agents, nor can you propose to develop vaccine or immunostimulatory agents. Be sure to review the full list before beginning your application.

Note that this FOA will not fund clinical trials and clinical trial planning activities. You may, however, discuss clinical development strategies in your application.

Phased Innovation Awards

This FOA uses the phased innovation award (R21/R33) activity code. You will start with a two-year R21 award for milestone-driven proof-of-concept studies, then further develop your project under an R33 award for up to three additional years. The R21 budget is limited to $275,000 in direct costs over the two-year project period, with a maximum of $200,000 in direct costs allowed in any single year. The R33 award phase is limited to $300,000 in annual direct costs.

NIAID intends to commit $4.5 million in FY 2017 to fund 20 to 25 R21 awards. We expect about half of the funded R21 awards to successfully transition to the R33 award.

Find additional information about the R21/R33 activity code in Questions and Answers for RFA-AI-15-054, Discovery/Development of Novel Therapeutics for Eukaryotic Pathogens (R21/R33). Refer to the FOA for complete application instructions and details about the transition process.

Optional letters of intent are due by January 10, 2016. The application deadline is February 10, 2016.

NIH Program Could Be a Big Deal for Small Business Awardees

We have good news for small businesses that want to strategically position their technology in the marketplace. NIH's Niche Assessment Program is back and open to all active Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase I—including Fast-Track—awardees (by grant or contract).

How the Program Works

An NIH contractor, Foresight Science and Technology, will perform market analysis appropriate for each SBIR/STTR technology and develop an in-depth report that addresses a number of items, including: identifying your competitive advantages, identifying your market size and potential market share, and making recommendations on a market entry strategy.

Foresight will also identify and qualify companies or funding agencies that might serve as potential commercialization partners for your business.

The results of this program can help small businesses develop their commercialization plans for their Phase II application.

For more information, see the October 16, 2015 Guide notice.

Sign Up, Get Questions Answered

Act now: there are only 177 spots available and enrollment is on a first come, first serve basis. If you'd like to participate, complete theNIH SBIR/STTR Setup Form.

Direct general questions about the Niche Assessment Program to Robert Vinson, Jr., program manager.

Timeline for NIH Transition to New Application Forms

In October, NIH announced the coming transition from FORMS-C to FORMS-D. The switch to a new form set will incorporate several policy changes, including implementation of the overhauled rigor and transparency policy.

To carry out the transition, NIH will release updated application guides (available at SF 424 (R&R) Application and Electronic Submission Information), post the new form set, and update or reissue most funding opportunity announcements (FOAs).

Below, we review the general timeline for the forms changes. In future issues, we will explain each policy change in greater detail as its respective implementation date approaches.

Timeline

As first explained in the October 13, 2015 Guide notice, the transition will take place over two phases. Some changes (e.g., the availability of xTRACT) are already in effect. All changes will be in effect by May 25, 2016.

The due date of the FOA to which you apply will determine what application guide and form set you should use. Following the correct instructions and form set will help you account for the changing policy areas with ease.

Phase I

The first phase is designed to incorporate changes to the following four policy areas:

Applications due on or after January 25, 2016, but before May 25, 2016, must take these policies into account.

To do so, you need to follow updated general and small business application guides, which NIH will publish by November 25, 2015. The updated application guides will instruct you on how to properly address the policies listed above.

Wait to use an updated application guide, otherwise you risk noncompliance in the policy areas above. This could have a negative effect on your score or delay your award.

Remember, for applications due before January 25, 2016, none of the changes will yet be in effect. Applicants should reference the SF 424 (R&R) Application Guides and Supplemental Instructions posted on November 25, 2014.

For applications with due dates on or after January 25, 2016, but before May 25, 2016, you will continue to use FORMS-C. The FORMS-C template can accommodate the changes described above, so you must rely on the application guides to ensure you comply with current NIH policy.

For contracts, individual requests for proposals (RFPs) will reflect the above policy changes as applicable in their instructions.

Phase II

The second phase includes the actual switch from FORMS-C to FORMS-D and incorporates the following policy changes in addition to those listed above:

For applications due on or after May 25, 2016, you will use FORMS-D. All FOAs will be reissued or updated by March 25, 2016, to allow the use of FORMS-D.

Additionally, new application guides will be posted to reflect FORMS-D by March 25, 2016. By following the updated application guides, accounting for the changing policy areas in your application should be straightforward.

Again for contracts, individual RFPs will reflect the above policy changes in their instructions as applicable.

The Big Takeaway

Over the next eight months, you must be deliberate in choosing the correct application guide and the correct form set when applying for an NIH grant. Updated application guides and form sets will be posted at least 60 days before a corresponding due date.

Based on the due date of the FOA to which you apply, you will use either FORMS-C or FORMS-D and need to choose the appropriate application guide to ensure you are optimally addressing the policy areas listed above.

For example, if you are applying to a FOA with a June 1, 2016 due date, you need to wait for NIH to post an updated or reissued FOA with links to FORMS-D before starting the application. When writing your application, be careful to select the application guide appropriate to FORMS-D.

Another example: Applications for the May 7, 2016 AIDS due date must use FORMS-C and the FORMS-C application guide, even though FORMS-D and the FORMS-D application guide will be posted by the end of March. The availability of a newer form set does not matter; your application's due date is the key.

Finally, for continuous submission applications, you need to choose an application guide and form set based on the due date of the FOA to which you are applying, not your personal date of submission. Appropriate application guides and form sets will remain available until all relevant continuous submission deadlines have passed.

Post-Award Forms and Instructions

NIH is also updating the forms you will use for progress reports and other post-award actions in light of the policy changes listed above.

See the October 13, 2015 Guide notice for a list of planned changes to forms and their targeted effective dates. The first major change will be new training data tables in use for the Research Performance Progress Report (RPPR), scheduled for implementation by December 1, 2015. Read Take Note of New Training Tables, New System to Compile Them, below, to learn more.

All major changes should be complete by March 25, 2016. NIH and NIAID will issue additional Guide notices and reminders as each major change is implemented.

Resources

• High-Level List of FORMS-D Preaward Form Changes
• Do I Have the Right Form Version for My Application?
• Form Update 2016—Frequently Asked Questions

Take Note of New Training Tables, New System to Compile Them

New data tables—and a new electronic system for compiling them—are now available for institutional training grant applications and Research Performance Progress Reports (RPPRs).

NIH revised the data tables to reduce the number of tables from 12 to 8, minimize the reporting of individual-level information, and extend the tracking of trainee outcomes from 10 to 15 years.

Investigators should use the new Data Tables as follows:

• For RPPRs due December 1, 2015, and after
• For grant application due dates of May 25, 2016, and after

Also for those dates, you can create data tables using a new electronic system: the Extramural Trainee Reporting And Career Tracking (xTRACT), which is a new module in the eRA Commons.

xTRACT launched last month and is now in a pilot phase as an option for creating data tables. Your other option is to continue using fillable tables in MS Word.

Note that while xTRACT will be available as an option, it will not be required in FY 2016. For full details, read the October 13, 2015Guide notice.

Comment on Proposed Changes to Human Subjects Protections

Now is your chance to provide feedback on revisions to the Federal Policy for the Protection of Human Research Subjects, popularly referred to as the Common Rule.

Proposed changes would 1) decrease administrative burdens, delays, and ambiguity for investigators, institutions, and institutional review boards (IRBs); and 2) strengthen, modernize, and make regulations more effective in protecting research subjects.

These proposed protections seek to:

• Increase human subjects' ability and opportunity to make informed decisions
• Reduce potential harms and increase justice by improving human subject protections in areas such as information disclosure risk and coverage of clinical trials and IRBs
• Facilitate current and evolving types of research that offer promising approaches to treating and preventing medical and societal problems

For more details, including information on how to submit a comment, see the Federal Register's September 8, 2015 Proposed Rule. The deadline to respond is 5 p.m. on December 7, 2015. Also see HHS’s NPRM for Revisions to the Common Rule to learn more.

News Briefs

Watch Webinar to Learn About Clinical Center Collaboration. Investigators interested in Opportunities for Collaborative Research at the NIH Clinical Center should plan to join an informational Webinar next Monday, November 9, from 10 to 11:30 a.m. EST. Read the October 21, 2015 Guide notice for full details.

Researching the Nexus of Environment and Child Health. In an October 20, 2015 Guide notice, NIH announced its plans for a new program in FY 2016: Environmental Influences on Child Health Outcomes (ECHO). Through ECHO, NIH will support synergistic, longitudinal studies of extant maternal and pediatric cohorts that represent a broad range of environmental exposures. The studies will collect standardized data, such as demographics, normative development, patient/person reported outcomes, environmental exposures, and genetic influences.

NIH Highlights Expected Changes in FY 2016 Grants Policy Statement. Read a Summary of Upcoming Significant Changes to the NIH Grants Policy Statement to learn how several general, administrative, and regulatory requirements will be changed or clarified in the FY 2016 NIH GPS. Most of the changes implement previously announced provisions.

Check Out Webinar on NIH Extramural Loan Repayment Program. Go to NIH Loan Repayment Program Application Technical Assistance Webinar for Monday’s presentation. It's worth a look to get an overview of LRP, details about eligibility, and information on completing the application. If you're submitting one for this cycle, remember the deadline is November 16, just over a week from now.

Be On Time With Closeout Reports

A short but important reminder: When your grant ends, you must submit closeout reports on time. You could face potential adverse enforcement actions, to include cost disallowances from NIH or NIAID, if you do not submit your closeout reports through eRA Commons within 120 days after the project's end date.

Closeout reports affected by this deadline are the Final Federal Financial Report (FFR), Final Invention Statement and Certification, and Final Progress Report (FPR).

To read more about the grant closeout process, the requirements, and how to respond, see NIH's Closeout page and our June 17, 2015 NIAID Funding News article "Avoid Adverse Consequences: Send Grant Closeout Reports on Time."

If you have questions, contact your grants management specialist.

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.

“Do any of NIAID's R01 sample applications use the new biosketch?”—anonymous reader

No, however NIH does provide a good sample to follow after the instructions within this Biographical Sketch document.

We regularly update our Sample Applications and Summary Statements and hope to post an R01 sample application that uses the new biosketch as soon as possible.

“Is there a way to see a list of grants that were awarded through a particular funding opportunity announcement?”—anonymous reader

Yes. Go to NIH RePORTER and enter the funding opportunity announcement's number (e.g., PAR-13-150) in the box marked FOA. It's the bottom right field in the "Project Details" section. Then click "Submit Query" to see a list of awarded projects.

• RFA-AG-16-020, Impact of Aging on Currently Employed Animal Models of Disease and Chronic Conditions: Demonstration Projects
• PA-16-019, Innovation Corps (I-Corps) at NIH Program for NIH and CDC Phase I Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grantees (Admin Supp)
• RFA-AI-15-056, International Centers of Excellence for Malaria Research
• RFP-NIAID-NIHOA2015025, NIAID Technical and Administrative Management Services

See other announcements at NIAID Funding Opportunities List.