WOMEN’S HIV PATHOGENESIS PROGRAM

Release Date:  April 5, 2000

RFA:  HD-00-006

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  June 1, 2000
Application Receipt Date:       July 12, 2000

PURPOSE

The National Institute of Child Health and Human Development (NICHD) invites 
program project (P01) grant applications to conduct focused research on the 
pathogenesis of HIV-1 infection in women.  A Women’s HIV Pathogenesis Program 
will be established to address gender-specific research on HIV pathogenesis 
and women.  The purpose of this Program is to increase our understanding of 
the causal relationships between HIV-1 pathogenesis and factors unique to 
women, such as their reproductive physiology.  Studies conducted within the 
Program projects will focus on identification of gender-specific biological 
factors that could impact on HIV-1 transmission, disease acquisition and 
manifestations in women.  Applications in response to this solicitation 
should be multidisciplinary in scope.  Within the research program as a 
whole, NICHD plans to address these pathogenesis research questions in a 
variety of female populations, including minority women, substance abusers, 
perimenopausal women, and lesbian women.  Indeed, since the vast majority of 
the women infected in the United States are black or Hispanic, these studies 
will be directed primarily at answering questions in minority populations. 
The results of the studies supported through this initiative are anticipated 
to have practical implications for improving the care of HIV-infected women.  

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 RFA is related to 
several priority areas.  Potential applicants may obtain "Healthy People 
2010" at http://www.health.gov/healthypeople.
                                             
ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic 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.  Foreign institutions are not eligible to apply, but 
units collaborating with applicants may be located at foreign sites.  
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

Potential applicants are encouraged to contact the program staff listed under 
INQUIRIES prior to submission. 

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) program project 
grant (P01) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed projects will be solely that of the applicant.  The 
total project period for an application submitted in response to this RFA may 
not exceed five years.  This RFA is a one-time solicitation.  Future 
unsolicited competing continuation applications will compete with all 
investigator-initiated 
applications and be reviewed according to the customary peer review 
procedures.  The P01 supports broadly based multidisciplinary research 
programs that have a well-defined central research focus or objective.  An 
important feature is that the interrelationships among the individual 
projects will result in a greater contribution to the overall program goals 
than if each project were pursued independently.  The program project grant 
requires a minimum of three 
interrelated individual research projects that contribute to the overall 
program objective.  The application may request support for certain common 
core resources.  Complete guidelines for the NICHD Program Project Grant are 
available at:  http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.   These 
guidelines must be followed in preparing applications in response to this 
RFA.

FUNDS AVAILABLE

The NICHD intends to commit approximately $3.5 million Total Costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2001 to fund three to 
four new grants in response to this RFA.  An applicant may request a project 
period of up to five years and a budget for direct costs of up to $750,000 in 
the first year, excluding F & A costs on consortium arrangements.  Annual 
budgets for Years 02 to 05 should not exceed the first year budget plus a 
three percent yearly increase.  Equipment requests are discouraged and must 
be well justified. 

Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of awards also will vary.  Although the financial 
plans of the NICHD provide support for this program, awards pursuant to this 
RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. 

RESEARCH OBJECTIVES

Background

In the U.S. and worldwide, HIV-1 infection in women is increasing in 
incidence. Worldwide, 90 percent of new HIV-1 infections are now transmitted 
through heterosexual intercourse.  In the U.S., women of color are 
disproportionately affected.  Of women recently diagnosed with AIDS, 81 
percent are black or Hispanic.  Data are continuing to emerge that suggest or 
demonstrate that some aspects of HIV-1 disease in women, including routes of 
transmission, differ markedly from those in men.  The gender-specific 
features of HIV-1 infection in women, such as later diagnosis of infection, 
cervical disease, and disease progression with lower viral loads, among 
others, require special attention.

To date, two major efforts have addressed the questions relevant to women 
with regard to HIV infection and disease.  In 1993, to carry out 
epidemiology-based investigations on the impact of HIV infection in women, 
the NIH established the Women’s Interagency HIV Study (WIHS).  A similar 
effort was coordinated by the U.S. Centers for Disease Control and Prevention 
(CDC) as the HIV Epidemiology Research Study (HERS).  A related program 
announcement (PA-97-105) offered investigators an opportunity to collaborate 
with WIHS investigators in conducting studies of HIV pathogenesis within the 
WIHS cohort. 

The purpose of this RFA is to complement the current epidemiological studies 
and other research in the area of HIV-1 and women.  There are many 
pathogenesis questions that require additional resources beyond that possible 
under existing mechanisms.  Additionally, there are presently no clinical 
trials systems that integrate research on the social and behavioral issues 
that could influence the outcome of pathogenesis studies.

In 1996, pilot studies were undertaken for laboratory-intensive 
investigations nested within the epidemiology cohorts.  Several institutes 
[NICHD, the National Institute of Dental and Craniofacial Research (NIDCR), 
and the National Institute of Allergy and Infectious Diseases (NIAID)] funded 
these studies through a variety of mechanisms.  The pilot studies focused on 
HIV pathogenesis in women, including factors affecting HIV-1 shedding in the 
genital tract, oral cavity, and other compartments, and the effect of the 
menstrual cycle on virologic and immunologic parameters in HIV-infected 
women.  Additionally, some aspects of gender-specific research relevant to 
this RFA were discussed at a satellite workshop during the Retrovirus 
meetings held in 2000, sponsored by the NIH Office of AIDS Research, NIAID, 
and NICHD. The summary of this workshop is available at 
http://www.nichd.nih.gov/rfa/hd-00-006/hd-00-006.htm.  

The program projects to be established through this RFA are intended to 
create a more formal infrastructure for the next generation of investigator-
driven pathogenesis studies in HIV-infected women.  The program project 
mechanism was selected because it is ideal for combining multiple clinical 
and basic component projects with a central theme, focus or objective, and 
for fostering interactions and collaborations between basic and clinical 
scientists.  Furthermore, the nucleus of multidisciplinary scientists in each 
program project will provide a fertile environment for cross-training basic 
and clinical scientists.

Research Scope

The Program is intended to establish and foster ongoing productive 
relationships between clinical and laboratory investigators in the area of 
women"s HIV pathogenesis.  Research in the area of the pathophysiology of HIV 
in women has been limited. The effect of the reproductive health of women on 
disease presentation, diagnosis, and acquisition is largely unknown. The 
relationship of immune decline in women and conditions such as female genital 
tract and reproductive organ infections needs to be determined.  There is 
limited information on the effect of therapy or prevention on gender-specific 
aspects of HIV infection and disease manifestation. Conditions such as 
esophageal candidiasis and bacterial pneumonia that occur more frequently in 
women than in men may have a differential impact on immune function and 
decline.  The interaction of unique gender-specific social and behavioral 
attributes, including maternal stress factors, on disease manifestation, 
progression, diagnosis, and pathophysiology is also unknown. Knowledge about 
gender-specific variation in biological markers for diagnosis, patient 
monitoring, and understanding pathophysiology is limited.  The causal 
relationships between HIV pathogenesis and factors unique to women need to be 
addressed. 

The Program is not intended to be a cohort study, however, study subjects may 
be recruited from existing cohorts.  The goals of the program projects will 
be to:  (1) recruit women (nationally and, where necessary, internationally) 
from all racial and ethnic groups, ages, HIV exposure groups, and lifestyles, 
(2) establish productive working relationships between clinical and 
laboratory investigators, and (3) where appropriate, be capable of making 
comparisons, both prospectively and retrospectively, with male control 
groups. 

Similarly, these program projects are not intended to address HIV treatment 
as a primary end-point. However, there may be occasions where randomization 
of patients will be necessary to address a pathogenesis question in order to 
understand an association more fully in terms of what is the cause and what 
is the effect.

Examples of research topics that might be addressed in the application 
include, but are not limited to:

1.  Effects of endogenous and exogenous hormones on HIV-related immunologic 
and virologic factors in the plasma and female genital tract, as well as 
other aspects of the biology of HIV infection in women.  Research may 
include, for example: 

o  Study of the combined effects of exogenous hormones [hormone replacement 
therapy (HRT), contraceptives] and antiretroviral therapy.

o  Generation of normative data regarding differences in the total number of 
lymphocytes, lymphocyte turnover/distribution, and impact of hormonal cycles 
on both viral and cellular dynamics.

o  Comparative studies between different age groups of HIV-infected women to 
assess the effect of natural hormonal changes on virologic and immunologic 
parameters of infection.

2.  Interrelationships among the factors determining HIV detection in the 
genital tract micro-environment, including antiretroviral therapy, cytokines, 
bacterial flora and co-infections, hormones, epithelial integrity, and local 
antibody production.  Research may include, for example:

o  Determination of the origin and impact of viral dynamics in the blood and 
at the tissue level.

o  Studies designed to elucidate the fundamental underlying mechanisms of 
estrogen, progesterone, and other hormones on HIV replication in the genital 
tract.

3.  Effects of spermicides/microbicides on HIV detection in the genital 
tract, with some emphasis on studying effects on local milieu.  These studies 
may be designed to complement larger Prevention Trials Network studies.  
Research may include, for example:

o  Study of the effect of treatment and/or prophylaxis on the 
microenvironment and on the virologic and immunologic parameters associated 
with HIV.

4.  The factors and mechanisms determining the manifestations of HIV in the 
oral cavity and reproductive tract and other body compartments, and its 
ability to persist at latent reservoir sites despite potent antiretroviral 
therapy.  Research may include, for example:

o  Study of the relationship between cell-free and cell-associated virus in 
various reservoirs and the possible variation of this relationship over time.  
Attention should be directed to examination of the factors that influence 
this relationship.

o  Development and evaluation of new sampling and/or quantitative 
technologies for measurement of HIV in potential reservoirs.

o  Study of the interrelationships between and among antiretroviral therapy, 
development of resistance, sequence diversity and local drug levels, and 
their impact on genital HIV.  Studies might also focus on examination of 
these same factors and their impact on HIV in other protected sites.

The topics listed above are only examples, are not in priority order, and are 
not intended to be all-inclusive.  Investigators are encouraged to explore 
and develop new, innovative projects and research cores that are consistent 
with the overall objectives of this RFA. 
 
In addition to the primary focus on pathogenesis, the program projects will 
provide opportunities to implement studies of behavioral variables that could 
affect the measured primary outcomes.  Such studies might include methods to 
improve recruitment and retention of participants, and examination of the 
impact of participation in the proposed projects upon individuals’ behavior 
change.

Applicants are encouraged to work with existing epidemiology and clinical 
trial networks that have access to women, nationally and internationally, to 
complement ongoing research within the scientific agendas of those networks.  
Where appropriate, applications may propose research questions that would be 
answered by the program projects in collaboration with other pre-existing 
research groups.
	
SPECIAL REQUIREMENTS

Applications submitted in response to this RFA should be prepared in 
accordance with the instructions presented in the NICHD Program Project (P01) 
Guidelines, available at http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.

Required Application Components

The proposed program projects should include a minimum of three interrelated 
research projects and supporting core resources, including (1) a Clinical 
Core, consisting of infectious disease specialists, 
obstetrician/gynecologists, endocrinologists, epidemiologists, behavioral and 
social scientists, and/or other clinical researchers capable of recruiting, 
retaining, and studying HIV-infected women in complex protocols that address 
critical HIV pathogenesis research questions, (2) a Laboratory Core, composed 
of virologists, immunologists, pharmacologists, geneticists, pathologists, 
and/or other laboratory scientists with experience in basic science and the 
complex methodologies necessary to address questions of HIV pathogenesis, and 
(3) an Administrative Core composed of statisticians, programmers, and 
technical specialists, responsible for assisting in protocol implementation, 
monitoring, training, data management and analysis, and operational 
activities such as protocol development. 

Each application must include all components, however, one or more of the 
components may be located at collaborating institutions (see below).  The 
disciplines to be included in the cores, as mentioned above, are examples of 
the types of expertise needed, proposed cores need not include 
representatives of all disciplines listed.

For the purposes of this RFA, each core must be utilized by at least two 
component projects at all times during the period of award.  This is an 
exception to the NICHD P01 Guidelines stating that each core should be 
utilized by three or more component projects. 

Collaborative Arrangements

Two or more institutions that can demonstrate a credible plan for 
collaborative research may apply as a consortium.  Evidence of prior 
collaboration and/or a plan for proposed collaborations between the clinical 
and laboratory investigators should be cited.  A multi-institutional network 
application must be submitted by one applicant organization that will receive 
any resultant award.  The application must provide details of agreements 
regarding sub-contracting arrangement, coordination, and support of 
activities at and among participating institutions, and  must demonstrate the 
potential effectiveness of such a sub-network for the ongoing work of the 
program project.

Research groups that have already established strong clinical/laboratory 
connections focusing on women-specific issues are encouraged to apply.  It is 
also possible that these program projects would forge linkages to the various 
adult clinical trial networks and/or might conduct investigations of their 
own to facilitate or inform clinical trials.  Applicants who have developed 
international relationships to augment existing national programs are 
encouraged to apply as one unit, combining a U.S. and a foreign component.  
Although the primary thrust of research carried out by the program projects 
will be domestic, some of the research questions of interest may benefit from 
an international component.  However, the Principal Investigator of such a 
collaborative application must be based in the U.S. and the major focus of 
the application should be on scientific issues of general applicability, 
including women in the United States.

Minimum Requirements for Applicants

Applicants must have access to infectious disease specialists, obstetrical 
and gynecologic off protocol care, such as colposcopy, childcare, and case 
management workers capable of addressing the complex needs of the affected 
population.  All applicants are expected to propose specific research 
projects that maximize the advantages of the applicant"s site, i.e., their 
patient population, previous research experience, and existing clinical and 
laboratory investigator networks.

Clinical Core Requirements

The clinical core should be multidisciplinary in scope, including both 
biomedical and, where appropriate, behavioral scientists, and demonstrate the 
ability to recruit and retain women for complex pathogenesis-based studies, 
that may or may not integrate a behavioral component.  Individual units may 
develop special emphasis pilot projects related to their area of expertise or 
the nature of their patient population, e.g., substance abusers, women who 
have sex with women, older infected women.  Clinical cores are expected to 
propose a Clinical Director, in one of the subspecialties (infectious 
disease, obstetrician/gynecologists, endocrinologists, epidemiologists, 
behavioral and social scientists) who has a primary role in providing care to 
HIV-infected women, who has access to the women referred to, and who has a 
strong interest in defining, developing, and implementing laboratory-based, 
focused pathogenesis studies in HIV-infected women.  Investigators who have 
access to cohorts of HIV-infected women through multiple funded networks, 
including, but not limited to, AIDS Clinical Trials Groups, Women"s 
Interagency HIV Study, Community Program for Clinical Research on AIDS, HIV 
Epidemiology Research Study, Women"s and Infant"s Transmission Study, 
Prevention Trials Network, and other NIH- and Public Health Service-sponsored 
cohorts are encouraged to apply.

Laboratory Core Requirements

The laboratory core should include a multidisciplinary team of basic science 
investigators with a documented ability to develop and address HIV 
pathogenesis.  Laboratory cores are also expected to propose a Laboratory 
Director who has expertise in laboratory analysis procedures including tests 
specific to women, who has had access to samples from women, and who has an 
interest in defining laboratory-based pathogenesis studies in HIV-infected 
women.  In-house expertise is required in handling non-routine specimens, 
such as processing and analyzing genital tract specimens, breast milk, tears, 
or saliva.  Applicants must demonstrate the ability for the laboratory core 
to maintain a close cooperative relationship with clinical investigators, 
particularly with regard to obtaining, processing, and shipping of clinical 
specimens.  Applicants must document plans to utilize novel assays they may 
develop in the context of the project’s gender-specific research agenda, 
efficiently and accurately report results, and perform quality assurance on 
the procedures employed in the laboratory.  While it is anticipated that the 
laboratory cores of the program projects will include virologists, 
immunologists, pharmacologists, geneticists, pathologists, and/or other 
laboratory scientists, it is not expected that each core will have expertise 
in all of these areas.

Annual Meetings

The Program Director for the overall grant and the principal investigator for 
each component project should plan to attend an annual NIH-sponsored two-day 
meeting in Bethesda, MD.  These meetings will be attended by investigators 
supported through this RFA and will provide an opportunity for investigators 
to communicate, discuss the progress of their research, 
exchange ideas and information, share resources, and foster collaborations 
that are relevant to the research goals of the NIH women’s pathogenesis 
initiative.  This requirement is designed to establish an interactive network 
of investigators who are interested in multidisciplinary approaches to 
enhancing our understanding of the pathogenesis of HIV infection in women.

Applications should include a request for funds to support attendance of the 
Program Director and project principal investigators at the annual meetings, 
as well as a statement of agreement to participate in these meetings and to 
cooperate with investigators at other program project sites.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided 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 research involving human subjects should read the 
“NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research,” published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 
18, 1994, and available at: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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/or 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,” published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and available at:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policies.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of this RFA.  
Although the letter of intent is not required, is not binding, and is not a 
factor in the peer review of the application, the information it contains is 
helpful in planning for the review of applications.  It allows NICHD staff to 
estimate the potential review workload and to avoid conflict of interest in 
the review process.

The letter of intent is to be sent to Dr. Patricia Reichelderfer at the 
address listed under INQUIRIES by June 1, 2000.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev.4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at:  
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone (301) 435-0714, E-mail:  grantsinfo@nih.gov. 

Application Instructions

Applicants for P01 grants must follow special application guidelines in the 
NICHD PROGRAM PROJECT (P01) GUIDELINES (June 1998) that is available from 
NICHD program staff listed under INQUIRIES, below, and on the Internet at: 
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.  These guidelines contain 
important information on the suggested format of applications and on review 
criteria.  

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display 
the number of this RFA, HD-99-006. 
A sample modified RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note that 
this is in pdf format.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number 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 three 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)

At the time of submission, two additional copies of the application and all 
five sets of any appendices should be sent to:

L.R. Stanford, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 5E03, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)
Telephone: (301) 496-1485

Applications must be received by July 12, 2000.  If an application is 
received after that date, it will be returned to the applicant without 
review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

NIH policy permits a component research project of a multi-project grant 
application to be concurrently submitted as a traditional individual research 
project (R01) application.  If, following review, both the multi-project 
application and the R01 application are found to be in the fundable range, 
the investigator must relinquish the R01 and will not have the option to 
withdraw from the multi-project grant.  This policy is intended to preserve 
the scientific integrity of a multi-project grant, which may be seriously 
compromised if a strong component project(s) is removed from the program.  
Investigators wishing to participate in a multi-project grant must be aware 
of this policy before making a commitment to the Program Director and 
applicant institution.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness by the NICHD.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NICHD in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will receive a written 
critique and may undergo a process in which only those applications deemed to 
have the highest scientific merit will be discussed, assigned a priority 
score, and receive a second level review by the National Advisory Child 
Health and Human Development Council.

Applicants will not be reviewed by a site visit.

REVIEW CRITERIA

For program projects, peer review of scientific and technical merit focuses 
on three areas:  (1) review of the individual component projects, 2) review 
of the individual cores, and (3) review of the program as an integrated 
effort and the overall merit of the program.

The review criteria to be used to evaluate applications submitted in response 
to this RFA are presented in APPENDIX II, GUIDELINES FOR REVIEWERS COMMENTS, 
of the NICHD PROGRAM PROJECT (P01) GUIDELINES (June 1998), available at: 
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.

SCHEDULE

Letter of Intent Receipt Date:  June 1, 2000
Application Receipt Date:  July 12, 2000
Peer Review Date:  September/October 2000
Advisory Council Review:  January 2001      
Earliest Anticipated Award Date:  February 12, 2001         

AWARD CRITERIA

Criteria that will be used to make award decisions include scientific and 
technical merit as determined by peer review, programmatic priorities and 
relevance, program balance, and the availability of funds.  

INQUIRIES

Applicants are strongly encouraged to contact program staff early in 
application development with any questions regarding the responsiveness of 
their planned application to the goals of this RFA.  Inquiries concerning 
this RFA are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.  

Frequently asked questions and additional resources for applicants will be 
made available at http://www.nichd.nih.gov/rfa/hd-00-006/hd-00-006.htm.

Direct inquiries regarding programmatic issues to:

Patricia Reichelderfer, Ph.D.
Contraception and Reproductive Health Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8B13G, MSC 7510
Bethesda MD 20892-7510
Telephone:  301-496-1661
Fax:  301-480-1972
E-mail:  pr20f@nih.gov

Direct inquiries regarding fiscal matters to:

Michael J. Loewe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17J, MSC 7510
Bethesda MD 20892-7510 
Telephone:  301-435-7008 
Fax:  301-402-0915 
E-mail:  ml70m@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.864.  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 inter-governmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The Public Health Service strongly encourages all grant 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 case, any 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.



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