NUTRITION AND THE DEVELOPMENT, TREATMENT, AND PREVENTION OF HIV DISEASE IN 
WOMEN, INFANTS, AND CHILDREN 

RELEASE DATE:  August 11, 2003

PA NUMBER: PA-03-163

March 2, 2006 (NOT-OD-06-046)   Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: July 15, 2006 unless reissued.

National Institute of Child Health and Human Development (NICHD)       
 (http://www.nichd.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.865

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Child Health and Human Development (NICHD) invites 
new and experienced basic scientists, epidemiologists, and clinical 
investigators to submit research grant applications to further understanding 
of the relationship between nutrition and HIV.  Applications are encouraged 
that address preclinical or clinical, biomedical and/or behavioral research 
that concentrates on studies of:  (1) nutritional factors and HIV 
transmission; (2) nutritional requirements for optimal growth, development,  
and maintenance of health; (3) impact of HIV infection on breastfeeding; (4) 
interactions between antiretroviral therapies, diet, nutrition and health; 
(5) nutritional assessment methodologies; and (6) specific functional 
biomarkers of outcome related to the nutrition/HIV relationship.  

This announcement is intended to stimulate and strengthen a multidisciplinary 
approach to a complex, under-researched area and to form a basis for future 
research.  

RESEARCH OBJECTIVES

Background

The interaction of HIV infection and AIDS with nutritional status has been a 
distinguishing characteristic of the disease course since the earliest days 
of the epidemic.  In many areas of the developing world, particularly sub-
Saharan Africa where HIV infection is endemic, concomitant malnutrition both 
in terms of macronutrient malnutrition, i.e., marasmus and kwashiorkor, and 
the "hidden hunger" of micronutrient deficiencies is also prevalent. 

In the early days before the infectious agent was identified, AIDS was 
referred to as "slim disease" to reflect the characteristic wasting syndrome 
associated with the natural history of HIV/AIDS and related diseases.  In 
reference to the nutrition and HIV relationship, most of the research 
attention has been focused on the impact of the disease on metabolism and, in 
particular, the AIDS wasting syndrome.  Little attention has been paid to the 
potential role of nutrition in relation to the infectivity of the virus 
(nutrition-viral interaction), transmission of the virus (nutrition-host 
interaction), HIV pathogenesis and disease progression, resistance to 
opportunistic infections, or the efficacy of available interventions.  
Further, much of the evidence that does exist with regard to either the 
metabolic consequences of HIV infection or the potential role of diet or 
specific nutrients in the course of HIV infection is limited to data 
collected from adult patients.  Although some data exist about the 
deleterious effect of HIV infection on the growth of infected children, 
little data exist about the role of nutrition in either mother-to-child 
transmission, subsequent sequelae of the disease or response to treatment in 
infants or children.

In assessing the diet/disease relationship, four general approaches are 
available:  measurement of dietary intake, anthropometric assessment, 
assessment of biochemical indices of nutrient status, or direct nutritional 
intervention.  The use of one of these approaches to the exclusion of the 
others to explore the nutrition and HIV relationship is problematic for the 
following reasons:

1. It is difficult to make any inferences about biochemical indices without 
knowing an individual's dietary intake. 

2. Given the metabolic consequences of HIV disease and its treatment, e.g., 
the effect of antiretroviral (ARV) therapy on body composition, reliance on 
anthropometry in the absence of information about diet and/or nutritional 
biochemistry will result in potential invalid conclusions about HIV and 
nutrition per se.

3. Aberrant circulating levels of a particular nutrient may be due to 
inadequate intake or an inherent biochemical problem associated either 
directly with HIV infection or in response to HIV-related opportunistic 
infections (OI).

4. Without knowing the pre-supplementation status of an individual, it is 
difficult to distinguish between the elimination of dietary deficiency and  
the correction of an inherent nutritional anomaly associated with either HIV 
infection or concomitant OI.

5. It is necessary to use the appropriate biochemical or physiological 
biomarker to distinguish between these latter two contingencies, to avoid 
drawing invalid or inaccurate conclusions concerning the role of essential 
nutrients in HIV infection.

Research Scope  

This PA encourages research using appropriate combinations of available 
nutritional assessment methodologies to address any of the issues listed 
below.  The following are examples of topics that might be proposed for study 
in response to this announcement.  However, these are only examples and are 
not meant to be limiting. 

o Nutritional/dietary factors affecting maternal to child transmission of HIV 
infection;

o Nutrient requirements of HIV-infected infants and children for optimal 
growth, development, and maintenance of health;

o Impact of HIV infection on breastfeeding, to include changes in maternal 
nutritional requirements before and during lactation, changes in milk 
composition consequent to HIV infection, impact of suboptimal nutritional 
status on lactation in HIV-infected women, differences between children 
infected in utero or perinatally and those infected during breastfeeding in 
terms of health outcomes;

o Potential interactions among ARV therapies, diet, nutrition and health 
including:  (a) Potential impact of nutritional status on efficacy of 
interventions including ARV in women and children; and (b) potential impact 
of ARV on nutritional status of HIV-infected women, infants, and children;
  
o Impact of sub-optimal nutritional status on health of HIV-infected women of 
reproductive age;

o Potential interactions among nutritional status, "traditional medicine,"  
and/or ARV;

o Surveillance of at-risk populations:  Part of the difficulty in extracting 
the role that nutrition might play in the course of HIV infection is that 
once the infection is established, it has its own metabolic consequences. 
Therefore, pre-infection data are needed in high-risk populations as well as 
comparative data by age and sex for demographically similar, uninfected 
children.  Such data sets should include an appreciation of current dietary 
intake patterns utilizing available food composition data for indigenous 
foods.

Applications that include proposals for the development of nutritional 
assessment methodologies and specific functional biomarkers of outcome 
related to the nutrition/HIV relationship are encouraged, as are proposals 
that employ methods that could be effectively deployed in field settings in 
resource-poor environments.

MECHANISM OF SUPPORT

This PA will use the NIH Research Project Grant (R01) and Small Grant (R03) 
award mechanisms.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.

For information on the new NIH Small Grant Research Program (PA-03-108) see
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html. 

The R01 should be used for full-scale research projects.  The R03 mechanism 
is appropriate for small research projects that can be carried out in a short 
period of time with limited resources (total annual direct costs of up to 
$50,000 per year for up to two years).  Examples of such projects include 
pilot or feasibility studies; secondary analysis of existing data; small, 
self-contained research projects; development of research methodology; or 
development of new research technology. 

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_I_1.htm.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the following 
characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments 
o Eligible agencies of the Federal government  
o Domestic or foreign  
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with his/her institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:  

Jack Moye, Jr., MD
Pediatric, Adolescent and Maternal AIDS Branch
6100 Executive Boulevard, Room 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-7350
FAX:  (301) 496-8678
Email:  [email protected] 

o Direct your questions about financial or grants management matters to:  

Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  [email protected] 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email:  [email protected]. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
Contact the IC program staff at least six weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types.  Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.  

SENDING AN APPLICATION TO THE NIH:  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)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
dates described at 
http://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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate R01 applications for 
scientific and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board.

REVIEW CRITERIA

The following criteria will be applied to both R01 and R03 applications.  
However, the NIH R03 small grant is a mechanism for supporting discrete, 
well-defined projects that realistically can be expected to be completed in 
two years and that require limited levels of funding.  Because the research 
plan is restricted to 10 pages, a small grant application will not have the 
same level of detail or extensive discussion found in an R01 application.  
Accordingly, reviewers should evaluate the conceptual framework and general 
approach to the problem, placing less emphasis on methodological details and 
certain indicators traditionally used in evaluating the scientific merit of 
R01 applications including supportive preliminary data.  Appropriate 
justification for the proposed work can be provided through literature 
citations, data from other sources, or from investigator-generated data.  
Preliminary data are not required, particularly in applications proposing 
pilot or feasibility studies.  
 
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:

o Significance
o Approach
o Innovation
o Investigator
o Environment 

The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.

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?

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?

INNOVATION:  Does the project employ novel concepts, approaches or methods?  
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

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)?

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?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed.  (See criteria included in the 
section on Federal Citations, below.)

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data. 

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

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

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 "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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at 
http://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 
http://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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 
http://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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 
PA is related to one or more of the priority areas.  Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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, 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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