DIET COMPOSITION AND ENERGY BALANCE

RELEASE DATE:  December 10, 2003

PA NUMBER:  PA-04-033

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. Accordingly, this funding opportunity 
expires on the date indicated below. Replacement R01 (PA-06-173) and R21 (PA-06-174) 
funding opportunity announcements have been issued for the submission date 
of June 1, 2006 and submission dates thereafter. 

See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and 
AIDS-related R03 and R21 Applications.
EXPIRATION DATE: March 2, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://nccam.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) 
 (http://www.ninds.nih.gov/)
Office of Dietary Supplements (ODS)
 (http://dietary-supplements.info.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  
93.847, 93.848, 93.853, 93.399, 93.866, 93.273, 93.213, 93.837, and 93.865

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Supplementary Instructions
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 goal of this program announcement is to invite research applications 
investigating the role of diet composition in energy balance, including 
studies in both animals and humans.  Both short and longer-term studies would 
be encouraged, ranging from basic studies investigating the impact of micro-or 
macronutrient composition on appetite, metabolism, and energy expenditure 
through clinical studies evaluating the efficacy of diets differing in micro- 
or macronutrient composition, absorption, dietary variety, or energy density 
for weight loss or weight maintenance.

RESEARCH OBJECTIVES

Overweight and obesity have increased dramatically in prevalence in the US.  
More than 60 percent of the US population is overweight (BMI ?25) and 31 
percent meet criteria for obesity (BMI ?30. Obesity is particularly prevalent 
among some minority populations, such as African American, Hispanic, and 
Native American women.  Overweight prevalence is also increasing in children, 
with more than 15 percent of children and adolescents considered overweight 
and an additional 15 percent at risk for overweight. Obesity is associated 
with numerous serious and chronic diseases, including type 2 diabetes, 
cardiovascular disease, sleep apnea, and certain forms of cancer. The causes 
of obesity are complex, and involve both genetic and environmental components.  
Environmental changes over the past two decades have increased sedentary 
behaviors, decreased physical activity, and increased consumption of more 
energy dense foods and larger portion sizes.  Although an imbalance in energy 
consumption and expenditure are required to promote inappropriate weight gain, 
the relative contributions of each to the burgeoning obesity epidemic remain 
in dispute.     

An important gap in knowledge concerns the role of diet composition in energy 
balance.  Diets low in carbohydrates have been purported to enhance weight 
loss, while those high in carbohydrates (particularly simple sugars and 
refined grain products) have been cited by some as contributing to weight 
gain.  Some shorter-term studies (up to six months in duration) have reported 
greater weight loss in those who consumed a low-carbohydrate diet compared 
with a diet higher in carbohydrate; however, the contribution of reduced 
caloric consumption to weight loss with such diets has not been adequately 
studied. Even when carbohydrate level is similar, factors such as glycemic 
index, nutrient density, fiber content, and dietary variety, have also been 
proposed to affect energy intake, with potential relevance for enhancing 
attempts to promote weight loss and prevent inappropriate weight gain.  In 
addition to carbohydrates, further research is needed to elucidate the role 
of other macronutrients in energy balance (including fats, proteins and 
ethanol).  Some fatty acids (such as conjugated linoleic acid) have been 
alleged to promote weight loss and/or improve body composition, although 
studies in humans have been inconsistent.  Micronutrients such as calcium 
have been proposed to play a role in energy balance, either through decreased 
fat absorption or via other mechanisms, although research in this area is 
still formative. In addition, the relative impact of calcium from dairy 
products versus other food or supplement sources also remains in question. 

The mechanisms by which diet composition affects energy balance are not well 
understood, but may include alternations in appetite, nutrient absorption, 
neuroendocrine and gastrointestinal factors, energy partitioning, physical 
activity and other components of energy expenditure.  Furthermore, the short- 
and long-term impact of diet composition on factors such as body composition, 
risk factors for cardiovascular disease, cancer, renal function, psychosocial 
function, and other health parameters is also not well characterized.  

Although there have been numerous animal studies assessing the impact of diet 
composition on appetite and body weight, these studies have been limited by 
availability and use of well-defined and standardized diets.  Lack of methods 
in laboratory practice that would permit the assessment of dietary 
composition and the lack of data comparing commercial preparations from 
various suppliers may contribute significant variability to studies designed 
to assess the impact of diet on energy balance. In addition to long-term 
studies of weight gain in response to standardized diets, short-terms studies 
with well-characterized diets varying in macro- and micronutrient composition 
would help to define the effect of diet composition on endocrine and neuronal 
axes involved in regulation of both food intake and energy partitioning. 

This program announcement invites research applications investigating the 
role of diet composition in energy balance, including studies in both animals 
and humans.  Collaborations between basic and clinical researchers, which 
explore mechanisms underlying differences in response to diet composition, 
are particularly encouraged. Examples of the type of research topics and 
approaches that would be solicited under this program announcement include 
(but are not limited to): 

1) Studies addressing the impact of diets varying in levels of protein, 
carbohydrate, fat, phytochemicals, or ethanol on appetite, food selection and 
intake, and energy expenditure.

2) Studies examining the role of diets differing in glycemic index, dietary 
variety, food volume, or nutrient density on appetite, caloric intake, 
nutrient absorption, weight, metabolomic profiles, and body composition both 
short- and long-term.

3) Investigation of the impact of diet composition on neuroendocrine, 
gastrointestinal, and other factors that may impact energy balance.

4) Research assessing the impact of diets differing in macronutrient 
composition on psychological/behavioral function (including mood and eating-
related cognitions and behaviors), bone, renal function, cardiovascular 
disease, and cancer risk.

5) The impact of food components such as conjugated linoleic acid (either 
from food or supplement sources) or calcium (either from dairy or non-dairy 
sources, including dietary supplements) on energy balance, body composition, 
and disease risk.

6) Studies assessing genomic and epigenomic factors underlying individual or 
population differences in response to diet composition that relate to chronic 
disease prevention. 

7) Brain imaging studies in humans and non-human primates to assess positron 
emission tomography, functional magnetic resonance, or cerebral blood flow 
imaging responses to specific dietary constituents.

8) Studies to develop methods to assess dietary composition.

9) Studies measuring the effects of sleep deprivation, either by experimental 
manipulation or due to a disease process on macronutrient consumption (e.g., 
does sleep deprivation lead to changes in cravings for carbohydrate and fat? 
Does sleep deprivation lead to change in body weight?)

10) Studies assessing dietary composition effects on the magnitude and time 
course of neurobehavioral and physiological responses to sleep loss, and the 
interaction of these effects with BMI, gender, age, and ethnicity

11) Studies assessing life-stage, racial/ethnic, and gender-related factors 
underlying response to diet composition, including studies in children, 
adolescents, and adults of various ages.

12) Validation of medium or long-term effects of different dietary 
macronutrient composition on energy intake in community-dwelling individuals 
using doubly labeled water

MECHANISM(S) OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  As an applicant, you 
will be solely responsible for planning, directing, and executing the 
proposed project.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 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 budget format.  Otherwise, follow the instructions 
for non-modular budget research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.  

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) 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 institutions/organizations
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 their 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 to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Susan Z. Yanovski, M.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 665
Bethesda, MD  20892-5450
Phone:  (301) 594-8882
Fax:  (301) 480-8300
Email: sy29f@nih.gov

John A. Milner, Ph.D. 
Nutritional Science Research Group 
Division of Cancer Prevention 
National Cancer Institute 
6130 Executive Blvd., Suite 3164 
Rockville, MD 20892 
Phone: (301) 496-0118 
Fax (301) 480-3925 
Email: jm524n@nih.gov

Marguerite Klein
National Center for Complementary and Alternative Medicine 
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475 
Phone:  (301) 402-5860
Fax:  (301) 480-3621
Email:  kleinm@mail.nih.gov

Catherine (Cay) Loria, Ph.D., M.S., M.A.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8150
Bethesda, MD 20892-7934  
Phone:  (301) 435-0702    
Fax:  (301) 480-1667
Email: loriac@nih.gov

Chhanda Dutta, Ph.D.
Geriatrics and Clinical Gerontology Program 
National Institute on Aging 
Gateway Building, Suite 3C-307
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Phone: (301) 435-3048
Fax: (301) 402-1784
Email: duttac@nia.nih.gov 

R. Thomas Gentry, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd.,  Suite 302  
Bethesda, MD, 20892-7003 
Phone: (301) 443-6009   
Fax:  (301) 480-2358
Email: tgentry@niaaa.nih.gov

Gilman D. Grave, M.D.  
Endocrinology, Nutrition and Growth Branch  
Center for Research for Mothers and Children  
National Institute of Child Health and Human Development  
6100 Executive Blvd., Suite 4B-11  
Bethesda, MD 20892-7510  
Phone: (301) 496-5593  
Fax: (301) 480-9791  
Email: gg37v@nih.gov
 
Merrill M. Mitler, Ph.D.
Systems and Cognitive Neuroscience
National Institute of Neurological Disorders and Stroke 
6001 Executive Blvd., Room 2116 
Bethesda, MD  20892  
Phone: (301) 496-9964
Fax:  (301) 402-2060   
Email: mitlerm@ninds.nih.gov  

Paul Coates, Ph.D.
Office of Dietary Supplements
6100 Executive Blvd., 3 B01, 
Bethesda, MD  20892-7517
Phone: (301) 435-2920
Fax: (301) 480-1845
Email: CoatesP@od.nih.gov 

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

Sharon Bourque
Grants Management Specialist  
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 719
Bethesda, MD  20892-5456
Phone:  (301) 594-8846
FAX:  (301) 480-3504
Email: sb114m@nih.gov   

Debra  Dunne
Grants Management Specialist  
National Cancer Institute
6120 Executive Blvd., Room 243
Bethesda MD 20892
Phone: (301) 496-3154
FAX: (301) 496-8601
Email: dunne@mail.nih.gov 

Marc Milton Pitts, M.B.A.  
Senior Grants Management Specialist  
National Center for Complementary and Alternative Medicine   
6707 Democracy Blvd., Suite 401 
Bethesda, MD  20892-5475 
Phone:  (301)594-9095   
Fax:  (301) 480-1552  
Email: pittsm@mail.nih.gov 

Kieran Kelley         
Senior Grants Management Specialist
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7170
Bethesda, Maryland 20892-7926 
Phone: (301)-435-0154
FAX: (301)-480-3310
Email: kelleyk@nhlbi.nih.gov

John Bladen
Grants Management Specialist  
National Institute on Aging
7201 Wisconsin Avenue, Room 2N212
Bethesda, MD  20892-9205
Phone:  (301)402-1472
Fax:  (301)402-3672
Email: jbladen@mail.nih.gov

Judy S. Fox 
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd, Willco Bldg, 504  
Bethesda, MD 20892-7003  
Phone: (301) 443-4704  
FAX:  (301) 443-3891
Email: jsimons@niaaa.nih.gov  

Lisa Moeller
Grants Management Specialist  
National Institute of Child Health and Human Development  
6100 Executive Blvd., Room 8A17F  
Bethesda, MD 20892-7510  
Phone:  (301) 496-1305  
FAX:  (301) 480-4783  
Email: lm236j@nih.gov 

Kimberly D. Campbell 
Grants Management Specialist 
National Institute of Neurological Disorders and Stroke 
6001 Executive Blvd., Suite 3249  
Bethesda, Maryland 20892-9537
Phone:  (301) 496-7809 
Fax:  (301) 402-0219 
Email: KC274K@nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html n 
an interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 435-0714, Email: GrantsInfo@nih.gov.

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

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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.

INSTRUCTIONS FOR R21 APPLICATIONS:  This program announcement allows the 
submission of R21 (Exploratory/Developmental Research Grant) applications.  
R21 applications must adhere to the page and budgetary limitations described 
in the trans-NIH R21 program announcement (PA-03-107) available at: 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. 

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:
   
1) Contact the IC program staff at least 6 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 unfunded version 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 8 weeks.

PEER REVIEW PROCESS

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

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

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 written critique
o 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 evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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). 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 
 
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).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. 
 
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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants 
and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing . Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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 are 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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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 
RFA 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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