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News Articles

Clipart: Tight budget.

Expect Nearly Flat Budgets Next Fiscal Year

Both the president and Congress plan to rein in federal spending next fiscal year, making the "doubling the NIH budget" era feel like a fading memory.

At May Council, Dr. Fauci presented the president's FY 2006 budget request. NIAID will fare better than most NIH institutes with a 1.3 percent budget increase, to $4.46 billion. Rising less than inflation, this budget level would mean hard choices for the Institute and its funded investigators. Congress has already started tweaking the request, but we do not expect major changes.

For NIH as a whole, growth is even more meager, rising only 0.5 percent over FY 2005 levels. In other parts of HHS, budgets are either flat or lower -- the president would fund all of HHS at less than its FY 2005 budget.

A few bright spots stand out. Our AIDS budget is slated to rise in support of HIV vaccine research. This move follows the June 2004 G-8 Summit's endorsement of a Global HIV Vaccine Enterprise to accelerate vaccine development. And funding for the NIH Roadmap is going up, boosting the budget for the NIH Office of the Director 7.6 percent.

In mid-June, the House subcommittee that covers NIH finished its markup, adopting the president's budget for NIH with two exceptions: it took away $100 million for the Global AIDS Fund and added $97 million for biodefense research, yielding a net loss of $3 million.

You can find a table of the House markup for NIH on page 7 of the Labor, Health and Human Services, Education, and Related Agencies Appropriations -- FY 2006. Read more about the budget process at Planning and Budget Cycle.

Clipart: Reimbursement.

NIH Streamlines Reviewer Reimbursement

Starting this fall, NIH plans to pay peer reviewers for travel expenses using a flat rate -- the same per diem and honorarium for all. This move will make your life as a reviewer easier since you will no longer have to track expenses or hold on to receipts. Based on an NSF model, the new approach should help NIH improve its service to you.

Though NIH is still determining the rate, you should expect to be well reimbursed. The NIH travel vendor will pay airline and some other travel costs. If you have additional expenses, you will file for an exception.

Until the new system is in place, please continue to send in those familiar vouchers and receipts.

Clipart: Clinical.

New Guidances for Human Subjects Research

Last month the Office for Human Research Protections (OHRP) issued two new human subjects guidances: one for filing incident reports and another for applications that plan to study children.

When do you need to file an incident report? File one if you have unanticipated problems that pose risks to subjects or others, you are not in compliance with either human subjects regulations or IRB requirements, or you face a suspension or termination of IRB approval.

Read the full Guidance on Reporting Incidents to OHRP for details on whether to report an incident, what information to include, timelines, and other important items.

Unlike the guidance for filing incident reports, regulations for studying children apply only to research supported or conducted by HHS. Special Protections for Children as Research Subjects details how and when you must submit a protocol to OHRP and other important information.

Clipart: Training.

New Carryover Policy for Training Grants, Application Deadline Reminder

From now on, T32 and T35 grantees with a new or renewal institutional training award will no longer be able to automatically carry over funds from one year to the next. In light of the near flat budgets we anticipate next fiscal year, NIAID made the change to make sure precious training funds aren't languishing unused in the bank.

If you already have a training award, you will still have automatic carry over authority until the end of its current project period, e.g., a four-year award, but your next grant will not. The new policy affects grants funded after FY 2004 only.

Keep in mind that if your unobligated balances get too big, your grants management specialist and program officer may reduce your award.

From the tickler file: September 10 is the only NIAID receipt date for T32 and T35 applications. It's our one exception to the NIH Standard Due Dates for Competing Applications table.

Clipart: Mail.

Attention T Grantees, Trainees, Fellows: Send Forms Here

If you are a T32 or T35 grantee or trainee, or an F32 fellow, please send your NRSA forms for activation, appointment, termination, and payback to:

Cindy McDermott
Grants Management Program
DEA, NIAID
6700B Rockledge Drive
Room 2119
Bethesda, MD 20892-7614 (Use this ZIP code for the U.S. Postal Service, including express mail.)
Bethesda, MD 20817 (Use this ZIP code for commercial carriers such as FedEx and UPS.)

Clipart: Online.

Close Out Your Grant Online

Taking another step toward electronic grants administration, NIH just announced that you can now send us all your closeout documents online through the eRA Commons: final financial, progress, and invention reports. For details, read the June 17, 2005, Guide notice.

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Congratulations New NIAID Chiefs and Directors

At May Council, Dr. Fauci announced three staff changes in addition to Dr. Chuck Hackett's promotion, which we covered in Chuck Hackett Is New Deputy Director, DAIT.

Taking on two positions for NIAID, Michael G. Kurilla, M.D., has become associate director for biodefense product development in our Office of the Director and director of the Office of Biodefense Research Affairs in DMID. Dr. Kurilla was associate director of the Infectious Diseases Therapeutic Development Group at Wyeth, where he supervised antibacterial research and HIV drug development. He joined DMID's Respiratory Diseases Branch in 2003 as a medical officer. In his new role, he will coordinate development of biodefense products for NIAID.

DMID's Respiratory Diseases Branch has a new chief, Linda C. Lambert, Ph.D. Dr. Lambert came to DMID in 1999 as the influenza program officer, managing NIAID's extramural influenza research program. In 2003, she moved up in the division, becoming acting chief of a newly created section that oversees extramural research on influenza, SARS, and related respiratory viruses. With her new opportunity, Dr. Lambert will apply her knowledge and expertise to all respiratory diseases.

Also in DMID, B. Fenton "Lee" Hall, M.D., Ph.D., is the new chief of the Parasitology and International Programs Branch. Dr. Hall trained in infectious diseases in NIAID's Laboratories of Clinical Investigation and Parasitic Diseases and at Yale University. In 1991, he returned to the Institute as a medical officer and host immunity program officer in DMID's Parasitology and International Programs Branch. He initiated a program on parasite vaccine development and was chief of the Malaria Vaccine Development Section.

Opportunities and Resources

Clipart: Targeted research.

Help Develop Assays for Influenza Therapeutics

NIAID just announced a new $10 million Project BioShield initiative to develop assays for influenza therapeutics. You probably remember that last year the Project BioShield Act authorized HHS to develop countermeasures for biological, chemical, radiological, or nuclear agents that could threaten public health. NIAID was charged to oversee the program and is awarding its grants, contracts, and cooperative agreements.

Under the new initiative, we will fund investigators to develop assays for screening and developing influenza therapeutics but not to produce or screen candidate therapeutics. Grantees can receive up to $1.5 million in total costs for as long as 18 months.

For this initiative, you must first get our approval to submit an application. You can request this approval through August 18, 2005. If we approve it, you'll submit your application by September 1, 2005. For more instructions, read the June 17, 2005, Guide notice.

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Find a Date . . . On Our Calendars

Do you know where to find a handy page with schedules for review meetings, application receipt dates, grants, Council meetings, scientific meetings, and more?

Go to the NIAID R01 Application to Award Timeline. If your link of interest is missing, drop us a line from our Feedback Form, so we can add your faves to the Find It! A-Z list.

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Check Out Our Concepts from May Council

You may want to flip through our new May 2005 Council Concepts: Potential Opportunities to learn where NIAID may be putting some of its future dollars. Concepts give you a preview of Institute priorities that represent science planning at its earliest stages. To learn some interesting ways to benefit from this information, go to Concepts May Turn Into Initiatives and Application Approach: What Are Your Choices?

Advice Corner

Clipart: R34.

Are R34s for Resubmitted Applications?

Yes. Beginning with the September 1, 2005, receipt date, you must submit a Clinical Trial Planning Grant (R34) application for an investigator-initiated clinical trial, whether the application is new or amended. We will treat all R34 applications as new because NIAID, not the Center for Scientific Review, will peer review them.

As always, if you submitted an application that was not funded, use the feedback from the review to strengthen it. For more guidance on resubmitting, see the reader question in this issue, Resubmitting After Responding to a PA.

Find help and information on the R34 process on our Investigator-Initiated Clinical Trial Planning and Implementation Grants questions and answers.

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Reader Question on Grantees Subcontracting Resources

Manzoor Kahn, professor, Creighton University Medical Center, wrote:

"I am interested in developing knockout strains of mice to continue our research, which is funded through an Academic Research Enhancement Award (R15). A biotech company can do this for us on a contract basis. Is there a funding mechanism that will pay to generate the knockout strains, so I can then request funding for the actual project by applying for an R01 or R15?"

Apply for either an R01 or R15, and place the cost of knock-out mice production as a subcontract from your institution to the institution that will produce the mice. Include the details of the mice studies in your application. The initial peer review committee will evaluate all aspects of your project, including the mice research.

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Reader Question on Resubmitting After Responding to a PA

Ann Terka, project coordinator, Institute of Bioinformatics, University of Georgia, wrote:

"How do I know if I can resubmit an application that responded to a PA, and where can I find information on reapplying?"

To figure out whether you can resubmit an application that responded to a program announcement, go to the NIH Funding Opportunities Relevant to NIAID table and look for your PA on the list. If it's not there, it's no longer open. If it is, you can find the expiration date by clicking on the title to access the Guide notice. You can resubmit until that time unless NIAID decides to extend the PA.

To find out more about applying and reapplying, go to the following pages:

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