January 16, 2008

News Articles

• NIAID's FY 2008 Budget -- Not As It Appears to Be
• Get the Latest Revised Forms and Instructions
• Peer Reviewers Get More Flexibility in Submitting Grant Applications
• Submit on CD: Appendices for Paper Applications
• Authenticate Your Cultured Cell Lines
• E-Application Correction Window: Two Days
• Certify That You've Registered With ClinicalTrials.gov
• Welcome Five New Council Members
• Congratulations to Presidential Award Winner Susan M. Kaech

Opportunities and Resources

• Coming Soon: Initiative on Centers for Immunity and Biodefense
• Wanted: Intramural Tenure-Track Investigator
• Introducing the NIAID Good Clinical Practices Learning Center
• Just the Facts for NIAID
• Resource for New Investigators

Advice Corner

• Reader Questions
  • Adjusting Person Months for Other Support
  • PI Changing Institutions
  • Preaward Costs and Noncompeting Grants

New Funding Opportunities

• See the list.

	News Articles

NIAID's FY 2008 Budget -- Not As It Appears to Be

The wait is over. NIH and other federal government agencies received their FY 2008 appropriations on December 26 when the President signed H.R. 2764 into law. NIH received $29.2 billion, an increase of just over 1 percent from FY 2007.

Though NIAID's budget of $4.561 billion seems a pretty good jump from FY 2007's $4.368 billion, it includes a $295 million pass-through for the Global Fund to Fight HIV/AIDS, Tuberculosis, and Malaria. Excluding the pass-through, NIAID's research budget decreases $3.0 million compared to last fiscal year. See the following calculation:

• FY 2008: $4.561 billion minus $295 million pass-through equals $4.266 billion.
  
• FY 2007: $4.368 billion minus $99 million pass-through equals $4.269 billion.
  
• The dollar difference between $4.266 billion and $4.269 billion is -$3.0 million.
  

Now that we have an appropriation, our budget office is developing our financial management plan. As soon as it's ready, we'll add information to Paylines and Budget. Visit often for updates or Subscribe to Email Alerts.

Get the Latest Revised Forms and Instructions

NIH has issued revised forms and instructions (11/2007) for the following. As always, be sure to use the latest versions. The announcements appeared in the January 4, 2008, NIH Guide.

• PHS 398 paper grant application, Guide notice:
  • For grant types, other than fellowships, that have not moved to electronic submission. Find transition dates on NIH's Transition Plan.
  • Must be used for May 25, 2008, and subsequent due dates.
• PHS 2590 noncompeting progress report, Guide notice:
  • All progress reports received on or after March 1, 2008, must use the new instructions and forms.
• PHS 2271 Statement of Appointment, Guide notice:
  • Must be used for all trainee appointments made on or after May 1, 2008.
• PHS 3734 Official Statement Relinquishing Interest and Rights in a PHS Research Grant and HHS 568 Final Invention Statement and Certification, Guide notice:
  • Use immediately.
    

Peer Reviewers Get More Flexibility in Submitting Grant Applications

NIH is giving some appointed members of chartered study sections more wiggle room when it comes to submitting their own grant applications.

A new policy allows some reviewers to submit -- as soon as they're ready -- R01, R21, and R34 applications that would normally be submitted for Standard Due Dates. Continuous submission does not apply to other activity codes, applications submitted for special dates (e.g., RFAs, some PARs), or applicants requesting a study section.

If you're eligible for continuous submission, we strongly encourage you to include a cover letter with the study section you serve on and your period of service. This helps ensure that NIH identifies you correctly, rather than as someone submitting late.

For details, read the January 4, 2008, Guide notice and the Companion Notice on late submissions.

Submit on CD: Appendices for Paper Applications

Investigators submitting a paper PHS 398 application for the May 25, 2008 and subsequent due dates must provide appendix material on CD only. You should also include five identical CDs in the same package with the application.

For materials (e.g., medical devices, prototypes) that cannot be submitted on CD, contact the scientific review officer.

Find additional information in the January 4, 2008, Guide notice.

Authenticate Your Cultured Cell Lines

If your research involves cultured cell lines, be sure to describe how you will authenticate them in your application.

NIH gives highest consideration to investigators who include a careful method of authentication, and it encourages peer reviewers to consider this issue when they evaluate grant applications.

See the November 28, 2007, Guide notice for more information.

E-Application Correction Window: Two Days

You now have just two business days, rather than five, to revise your electronic application after the deadline if it still has errors or warnings.

The former five-day correction window is no longer needed because many applicants are familiar with the electronic process and system response times have improved. See statistics in the November 30, 2007, Guide notice.

Because you might need to revise before time runs out, you should submit your application as early as possible. After the deadline, you may revise only to address errors and warnings. NIH does not allow other changes.

NIH may eliminate the correction window entirely after all application types go electronic.

For advice, read If You Want to Correct After Passing Commons Validation in the NIH Grant Cycle: Application to Renewal.

Note that the correction window is not the same as the viewing window to check your application image. Both windows are two days, but they are not cumulative and depending on your timing, they might not overlap.

Certify That You've Registered With ClinicalTrials.gov

Be prepared to certify in your competing application or noncompeting progress report that you've registered an applicable clinicial trial with ClinicalTrials.gov.

This new regulation is part of Public Law 110-85 , which we wrote about in our December 5 article, "New Law Affects ClinicalTrials.gov."

You'll need to start complying this year as follows:

• Competing applications -- submitted to the NIH on or after January 25, 2008
• Noncompeting progress reports -- for grants with budget start dates of April 1, 2008 or later

For more information, including what to put in your application or progress report, see the December 21, 2007, Guide notice.

Welcome Five New Council Members

We'd like to welcome the new members of our main advisory body, the National Advisory Allergy and Infectious Diseases Council.

Acquired Immunodeficiency Syndrome (DAIDS) Subcommittee

• Carol A. Carter, Ph.D., professor of molecular genetics and microbiology and adjunct professor of physiology and biophysics at the State University of New York at Stony Brook.
• Louis J. Picker, M.D., associate director of the Vaccine and Gene Therapy Institute and professor of pathology, molecular microbiology, and immunology at Oregon Health and Science University. He is also director of the Pathobiology and Immunology Division of the Oregon National Primate Research Center.
• Christel H. Uittenbogaart, M.D., professor of pediatrics and microbiology, immunology, and molecular genetics at the University of California, Los Angeles.

Microbiology and Infectious Diseases (DMID) Subcommittee

• Ann Arvin, M.D., Lucile Salter Packard Professor of Pediatrics and professor of microbiology and immunology at Stanford University School of Medicine. She also serves as vice provost and dean of research at Stanford University.
• Regina Rabinovich, M.D., M.P.H., director of infectious diseases, Global Health Program at the Bill and Melinda Gates Foundation.

For bios and pictures, go to Biographical Sketches of NIAID Council Members on our Council page.

Congratulations to Presidential Award Winner Susan M. Kaech

Our kudos to Susan M. Kaech, Ph.D., winner of the coveted Presidential Early Career Award for Scientists and Engineers (PECASE), the U.S. government’s highest honor for new investigators in science and technology.

Funded with both an R01 and an R21 from NIAID, Dr. Kaech was recognized for characterizing the development of memory T cells in long-term immune protection.

Dr. Kaech’s work explores how memory T cells emerge during infection and vaccination and is trying to identify the signals and genetic pathways that control the formation of this important cell type. 

Working at Yale University, the assistant professor of immunobiology studies the differentiation of naïve CD8 T cells into effector cells and then into long-lived memory cells during acute viral and bacterial infections, such as lymphocytic choriomeningitis virus and Listeria monocytogenes in mice. 

A central question in the development of memory T cells is: what causes a small minority of effector cells to survive and become long-lived memory cells while the majority die? Read more about Dr. Kaech’s Research Interests. Her long-term aim is to improve the design of vaccines and immunotherapies to fight infectious diseases and cancer. This work may also uncover why some immunizations fail to induce long-term T-cell immunity.

In a ceremony at the White House on November 1, eleven NIH grantees and one intramural scientist representing nine institutes received the PECASE. This year, 58 researchers funded by 11 federal agencies were honored with the award, which President Clinton inaugurated in 1996.

Read more in the November 1 press release. To see the list of NIH winners, scroll down the PECASE main page.

	Opportunities and Resources

Coming Soon: Initiative on Centers for Immunity and Biodefense

You should soon see an RFA for Cooperative Centers for Translational Research on Human Immunity and Biodefense. The program's goal is to establish infrastructure and research support for studies focused on the human immune response to NIAID Category A, B, and C pathogens and emerging and re-emerging infectious diseases.

If you're interested in applying and want to be notified when the funding opportunity announcement comes out, Subscribe to Email Alerts. The FOA is due out later this month and will have a June 2008 receipt date.

For more information, contact Helen Quill, Division of Allergy, Immunology, and Transplantation, at 301-496-7551 or hquill@niaid.nih.gov.

Wanted: Intramural Tenure-Track Investigator

In case you missed our December 15 Email Alert, here's a career opportunity you might be interested in.

NIAID's Division of Intramural Research (DIR) is seeking an outstanding tenure-track investigator to develop a clinical research program to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Act quickly if you want to be considered. You have until Thursday, January 31 to submit your curriculum vitae, bibliography, and an outline of your proposed research program.

For further information, contact Karyl Barron, DIR deputy director, at 301-402-2208 or kbarron@nih.gov.

Introducing the NIAID Good Clinical Practices Learning Center

Want to learn more about human subjects research? The NIAID Good Clinical Practices (GCP) Learning Center offers free computer-based GCP courses that cover (1) the scientific and ethical standards of human subjects research at NIH and HHS and (2) international clinical trials policies, guidelines, and regulations.

The four courses are the following:

• History of Human Subjects Research, Ethics, and Regulations
• Regulatory Framework for Conducting Human Subjects Research
• Planning Human Subjects Research
• Conducting Human Subjects Research

Principal investigators can login using their eRA Commons username and password, and NIAID staff can login with their NIH username and password. If you don't have either of those accounts, you can register for an NIH External Account.

Just the Facts for NIAID

Interested in NIAID's budget and funding history? Want to know more about our extramural grants, contracts, and research training programs? Check out our FY 2006 Fact Book, now on the Overview page of the NIAID Web site.

For a hard copy of the Fact Book, contact Tony Jenkins, Office of Strategic Planning and Financial Management, at 301-496-6752 or jenkinsan@niaid.nih.gov.

Resource for New Investigators

Check out presentations from NIAID's New Investigator Workshop held in October. Go to New Investigator Workshop on the NIAID Web site.

	Advice Corner

Reader Questions

Angela Caruso, Division of Geriatrics, School of Medicine, Johns Hopkins University, asks:

"If I need to adjust person months for my other support, would I do so to my pending application or to an active grant?"

Generally, you would adjust person months to your pending application, though you can adjust effort for your active projects.

If you go the second route, note the following about approvals for changes to effort:

• For an active grant not funded by NIH -- your institutional business official must submit documentation (i.e., a letter or email) indicating that the funding organization has approved the change.
• For an active grant funded by NIAID -- the grants management specialist for your pending application must obtain written approval from the program officer of the active grant.
• For an active grant funded by another NIH institute -- the grants management specialist for your pending application must obtain written approval (email) from the other institute's grants management specialist, who must get approval from the program officer.

A reader asks:

"What happens to an award if the PI changes institutions?"

When a PI moves to another institution, the original grantee institution can either release the award to the new institution or keep the award and nominate a new PI.

For more information, see Some Actions Require Our Approval in the NIH Grant Cycle: Application to Renewal.

To change the PI, see the Change of Prinicipal Investigator SOP.

A program officer in NIAID's Division of AIDS asks:

"Can grantees charge preaward costs to noncompeting grants?"

Yes. Grantees may incur preaward costs before the beginning date of a noncompeting grant. However, there is risk involved since incurring preaward costs does not obligate NIAID to issue an award notice or increase the amount of the approved or committed budget.

For more information, read Terms and Conditions of NIH Grant Awards in the NIH Grants Policy Statement.

	New Funding Opportunities

• RFA-AI-08-002, Regional Centers of Excellence  for Biodefense and Emerging Infectious Diseases Research
• RFA-AI-07-040, BARDA/NIAID Medical Countermeasures to Mitigate and/or Treat Ionizing Radiation-Induced Pulmonary Injury: Project Bioshield
• RFA-AI-07-037, BARDA/NIAID Medical Countermeasures to Mitigate and/or Treat Ionizing Radiation-Induced Cutaneous Injury: Project BioShield
• PA-08-044, Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources
• PA-08-043, Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources

See these and older announcements on our NIAID Funding Opportunities List.