This Program Announcement expires on April 1, 2005, unless reissued.

INNOVATION GRANTS FOR AIDS RESEARCH

Release Date:  January 16, 2002

PA NUMBER:  PA-02-046

National Institute of Allergy and Infectious Diseases
 (http://www.niaid.nih.gov)
National Institute of Biomedical Imaging and Bioengineering
 (http://www.nibib.nih.gov)
National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research
 (http://www.nidr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov/)
National Institute of Mental Health
 (http://www.nimh.nih.gov)

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS 
THAT $250,000 PER YEAR IN ALL YEARS.  MODULAR BUDGET INSTRUCTIONS ARE 
PROVIDED IN SECTION C OF THE PHS 398 (REV. 5/01) AVAILABLE AT 
https://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

National Institute of Allergy and Infectious Diseases (NIAID), National 
Institute of Biomedical Imaging and Bioengineering (NIBIB), National 
Institute of Child Health and Human Development (NICHD), National Institute 
of Dental and Craniofacial Research (NIDCR), and the National Institute of 
Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of 
Mental Health (NIMH), encourage the submission of applications to bring new, 
scientifically challenging and untested ideas into AIDS research.   There are 
a number of critical questions in AIDS research that remain under explored, 
and new approaches are needed to make progress in these areas. 

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This Program Announcement 
(PA), Innovation Grants in AIDS Research, is related to HIV infection and 
sexually transmitted diseases. Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of state and local governments, and eligible 
agencies of the Federal government. Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as 
principal investigators.  

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research project 
grant (R21) award mechanism. Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant. 
Applicants may request up to two years of support and up to $150,000 per 
annum in direct costs.  Exceptions can be made if specific costly reagents or 
animals are needed to perform these studies, with compelling justification.  
Applicants should contact program staff for approval before applying.  
Program staff may be able to advise prospective applicants concerning 
alternative NIH-sponsored resources that may be available to them. Contact 
program staff listed under INQUIRIES for further information.

This award is non-renewable.  However, it is hoped that grantees funded 
through this exploratory phase program will elect to seek continuing support 
for their projects through the R01 or P01 grant mechanisms.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/01). Additional 
information on Modular Grants can be found at 
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

Significant progress has been made in our understanding of HIV and HIV 
disease. Yet in all aspects of AIDS research there remain difficult unsolved 
questions.  Research projects that take a fresh approach in tackling these 
questions are needed.  Specifically applications are sought that propose to 
test novel and significant hypotheses for which there is scant precedent or 
limited preliminary data and which, if confirmed, would have a substantial 
impact on current thinking and understanding of HIV/AIDS, or projects that 
develop innovative techniques or methodologies with in vivo relevance that 
will provide new insights into HIV pathobiology. 

In brief, the sponsoring NIH institutes are seeking applications in the 
following areas for this PA:

Therapeutics discovery - objectives may include, but are not limited to, new 
approaches for therapies targeted at:

o viral and cellular processes involved in the transmission, local 
propagation, and spread of HIV
o novel approaches to maternal infant transmission
o viral or cellular processes involved in the maintenance of viral reservoirs 
o host and viral factors involved in HIV infection of the nervous system
o rebuilding strong and effective anti-HIV responses
o novel targets or drug candidates for the most medically significant HIV-
associated infections (such as tuberculosis, pneumocystis pneumonia, 
hepatitis C, Human papilloma virus) 
o mitigating the side effects (such as metabolic complications) of 
antiretroviral therapies, including effects in pregnant women and children.  

Microbicide discovery - objectives may include, but are not limited to, new 
approaches for microbicides addressing: 

o viral and cellular processes involved in the transmission, local 
propagation, and spread of HIV
o processes for cervicovaginal and rectal transmission of HIV 
o improved methods of formulation and delivery 
o preclinical systems to test microbicide safety and efficacy

Pathogenesis research - objectives may include, but are not limited to, new:

o hypotheses on the mechanisms of transmission, establishment, spread, 
resistance to, and maintenance of HIV infection 
o hypotheses and approaches to study mechanisms of neuropathogenesis of HIV
o mechanisms of maternal infant, oral, cervicovaginal and rectal transmission 
of HIV 
o concepts in the viral or immune-mediated pathogenesis of HIV
o approaches to animal and xenoinfection models
o mechanisms of interactions between HIV and other infectious agents that 
exacerbate or mitigate transmission or disease
o rapid, simple, and accurate imaging techniques and  methodologies for 
assessing the immune status and disease state of individuals, including infants.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of 
clinical research, updated racial and ethnic categories in compliance with 
the new OMB standards, clarification of language governing NIH-defined Phase 
III clinical trials consistent with the new PHS Form 398, and updated roles 
and responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
https://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

SPECIAL REQUIREMENTS 

Clinical trials will not be supported under this announcement.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at:  
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 
5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html must be 
used in applying for these grants and will be accepted at the 
standard application deadlines https://grants.nih.gov/grants/dates.htm) 
as indicated in the application kit.  This version of the PHS 398 is 
available in an interactive, searchable format.  For further assistance 
contact GrantsInfo, Telephone 301/710-0267, Email:  GrantsInfo@nih.gov.

Application Instructions

The following instructions are to be used in conjunction with the 
information accompanying application form PHS 398 (rev. 5/2001), they refer 
only to selected items in the application form.  All PHS 398 requirements 
should be followed, with the exception of those items affected by the 
following instructions.  Applications not conforming to the requested format 
will be returned to the applicant without review.

o Specific Instructions for Modular Grant Applications
 
The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff.   
The research grant application form PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.    

o Research Plan

Items a - d of the Research Plan (Specific Aims, Background and 
Significance, Preliminary Studies, and Research Design and Methods) may not 
exceed a total of 10 pages.  Please note that a Progress Report is not needed, 
competing continuation applications will be not accepted for an R03.

o Appendix

Appendix material may only include color and/or glossy pictures 
with descriptions. 

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

All grant applications submitted to CSR must come via United States Postal 
Service or a recognized delivery/courier service.  Individuals may not 
personally deliver packages to Rockledge.  For further information please see 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

Applications must be received by or mailed before the receipt dates described 
at https://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the same 
as one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established NIH referral 
guidelines. Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures. As part of the initial merit review, all 
applications will be discussed, receive a written critique, assigned a 
priority score, and receive a second level review by the appropriate national 
advisory council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals. Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application. Particular 
emphasis will be given to the significance of the question being addressed.
 
(1) Significance: Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) Approach: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation: Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(4) Investigator: Is the investigator appropriately trained and well suited 
to carry out this work? Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment: Does the scientific environment in which the work will be 
done contribute to the probability of success? Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o the reasonableness of the proposed budget and duration in relation to the 
proposed research, and

o the adequacy of the proposed protection for human subjects, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. The following will be considered in making funding decisions: 

o scientific merit (as determined by peer review)
o availability of funds, and
o programmatic priorities

INQUIRIES

Inquiries are encouraged. The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Carl W. Dieffenbach, Ph.D. 
National Institute of Allergy and Infectious Diseases 
Room Number 4133 MSC-7626
6700-B Rockledge Drive
Bethesda, MD  20892-7626 
Telephone:  (301) 496-0637 
FAX:  (301) 402-3211 
Email:  cdd@nih.gov

Joan Harmon, Ph.D.
National Institute of Biomedical Imaging and Bioengineering
31 Center Drive, Room 1B37, MSC 2077
Bethesda, MD  20892-2077
Telephone:  301-451-6772
Fax:  301-480-4515
Email:  harmonj@nibib.nih.gov

Robert Nugent, Ph.D.
National Institute of Child Health and Human Development
Room 4B11C MSC-7510
6100 Executive Blvd. 
Bethesda, MD  20892-7510
Telephone:  (301) 435-6871
FAX:  (301)496-8678
Email:  nugentr@mail.nih.gov
  
Dennis Mangan, Ph.D. 
National Institute of Dental and Craniofacial Research 
Room 4AN-32F MSC-6402
45 Center Drive 
Bethesda, MD  20892-6402  
Telephone:  (301) 594-2421 
FAX:  (301) 480-8318 
Email:  Dennis.Mangan@nih.gov

Frank A. Hamilton, M.D., MPH
National Institute of Diabetes and Digestive and Kidney Diseases
Democracy 2, Room 669 MSC-5450
6707 Democracy Blvd. 
Bethesda, Maryland  20892-5450
Telephone:  (301) 594-8877
FAX:  (301) 480-8300
Email:  fh14e@nih.gov

Dianne M. Rausch, Ph.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 6212, MSC 9619
Bethesda, MD  20892-9619
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  dr89b@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Lori Zimand
National Institute of Allergy and Infectious Diseases
Room 2253, MSC-7614
6700B Rockledge Drive
Bethesda, MD  20892-7614
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
Email:  lz36k@nih.gov

Annette Hanopole 
National Institute of Biomedical Imaging and Bioengineering
31 Center Drive, Room 1B37, MSC 2077
Bethesda, MD  20892-2077
Telephone:  301-451-6768
Fax:  301-480-4515
Email:  hanopolea@nibib.nih.gov

Christopher Myers
National Institute of Child Health and Human Development
6100 Executive Blvd. MSC-7510 
Bethesda, MD  20892-7510
Telephone:  (301) 435-6996 
Email:  cm143g@nih.gov

William Powell
National Institute of Dental and Craniofacial Research 
Room 4AN-44 MSC-6402
45 Center Drive 
Bethesda, MD  20892-6402  
Telephone:  (301) 594-4800
FAX:  (301) 480-8301
Email:  wp43y@nih.gov

Donita Marconi
National Institute of Diabetes and Digestive and Kidney Diseases 
6707 Democracy Blvd. Democracy Plaza 2
Room 710 MSC-5456
Bethesda, Maryland  20892-5456
Telephone:  (301) 594-8860
Fax:  (301) 480-3504
Email:  marconid@extra.niddk.nih.gov

Diana S. Trunnell
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalogue of Federal Domestic Assistance in 
the following citations: No. 93.855, Immunology, Allergy, and Transplantation 
Research, No. 93.856, Microbiology and Infectious Diseases Research, No. 
93.286 Biomedical Imaging research, 93.287 Bio-engineering research, 
No.98.865 Child Health and Human Development, No. 93.121, Oral Diseases and 
Disorders Research, No. 93.848 for Diseases of the Digestive Tract and 
Kidney, and 92.242 for mental health aspects of HIV disease. Awards are made 
under authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and administered under NIH grants policies 
and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program 
is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products. In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, and portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children. This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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