RELEASE DATE:  February 2, 2004

PA NUMBER:  PA-04-053

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 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. The 
non-AIDS portion of this funding opportunity expires on the date indicated below. 
Replacement R21 (PA-06-400) funding opportunity announcements 
have been issued for the submission date of June 1, 2006 and submission dates 
for AIDS and non-AIDS applications thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH) 
National Cancer Institute (NCI) 
National Institute of Nursing Research (NINR) 
National Institute of Dental and Craniofacial Research (NIDCR) 
National Center for Complementary and Alternative Medicine (NCCAM) 

93.361 (NINR); 93.121 (NIDCR); 93.213 (NCCAM)


o Purpose of the 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


The National Cancer Institute’s Office of Cancer Complementary and 
Alternative Medicine (OCCAM), the National Center for Complementary and 
Alternative Medicine (NCCAM), the National Institute of Nursing Research 
(NINR), and the National Institute of Dental and Craniofacial Research 
(NIDCR)invite research grant applications from interested investigators to 
conduct innovative developmental pilot research investigating complementary 
approaches in cancer. The intent of this initiative is to encourage and 
support the development of basic and clinical complementary cancer research 
and to provide the basis for more extended research projects by establishing 
the methodological feasibility, strengthening the scientific rationale for 
these projects, and collecting preliminary data. This announcement is also 
intended to stimulate and facilitate the entry of promising investigators 
into research in these topics through a program of exploratory investigator-
initiated R21 grants.

The exploratory/developmental (R21) grant mechanism is used for pilot 
projects or feasibility studies to support the exploration of feasibility, as 
well as the development, of projects investigating complementary approaches 
in cancer and for the generation of preliminary data.  The R21 mechanism is 
specifically intended to support innovative ideas where preliminary data are 
sparse or do not exist.  The R21 supported projects are intended to serve as 
a foundation for planning and developing future research projects (R01s).  
The objective of this Program Announcement (PA) is to encourage applications 
from individuals who are interested in testing novel or conceptually creative 
ideas that may produce innovative advances in the understanding and use of 
complementary approaches in cancer.

The widespread use of a variety of nutritional, psychological and natural 
medical approaches has been well documented.  Recent surveys demonstrate that 
between 9 and 91 percent of U.S. cancer patients use these kinds of therapies 
at some time after their diagnosis. Despite the broad use of complementary 
approaches in the treatment for cancer, there is a lack of data available to 
indicate whether these practices are efficacious and safe.  Various NIH 
advisory groups have cited the need for increased research on these 
approaches for the treatment of cancer and have encouraged the NIH to support 
the evaluation of such therapies.

There is a paucity of funded R01 research grants in these topics in cancer 
research.  Therefore, to increase the number and quality of investigator-
initiated R01 research grants on complementary approaches in cancer, the 
NCI's Office of Cancer Complementary and Alternative Medicine took the lead 
in developing this PA for Developmental Projects in Complementary Approaches 
to Cancer Care. 

The intent of this initiative is to encourage and support the development of 
basic, and clinical (prevention, therapeutic, and palliative) cancer research 
in complementary approaches.  Another goal of this initiative is to 
facilitate communication and collaboration between practitioners in 
complementary approaches and the conventional cancer research communities.  

For the purpose of this PA, applicants may consider complementary approaches 
as they relate to the prevention, diagnosis, and treatment of cancer, cancer-
related symptoms, and side effects of conventional treatment.  In addition, 
applicants may consider research that focuses on the potential interactions 
of complementary approaches with conventional cancer therapies.  
Complementary approaches that are considered responsive to this announcement 
include (but are not limited to) those involving nutritional approaches, 
natural products, mind-body approaches, energy therapies, herbal medicines, 
and interventions based upon those within traditional medical systems such as 
Traditional Chinese Medicine or Ayurvedic medicine.

Topics of program interest include but are not limited to: 

Approaches related to management of cancer-related symptoms and side effects 
of conventional treatment.

Design and pilot testing of interventions for comparative studies of 
complementary modalities as interventions for end of life and palliative care 
(e.g., relaxation therapy, music therapy).  

Development of methodologies to improve assessment of the impact of 
complementary approaches to treatment; e.g., instrument development, 
biobehavioral markers, acceptance of longitudinal designs or prevention. 

Feasibility studies of behavioral interventions that incorporate principles 
of cultural competency, in particular within populations that utilize 
culture-specific traditional methods of treating cancer.
Applications that are relevant to understudied populations (i.e., the use of 
complementary approaches in children or older adults.  Descriptive studies of 
the prevalence of CAM use in understudied populations including the impact of 
such use on the primary modality of treatment are also appropriate.

Nutritional approaches in the prevention and treatment of cancer, as well as 
to prevent disease recurrence.

Preclinical studies of candidate complementary approaches with appropriate 
models to demonstrate efficacy and toxicity, and improvement over current 
clinically approved cancer treatment and disease management.

Preclinical studies to advance understanding of mechanism of actions a well 
as drug-drug interactions.

Isolation and pharmacological studies of active ingredients from herbal or 
other traditional medicine preparations, including a defined reconstitution 
of more than one pure ingredient, such as drug-drug interaction. 

Applications that seek to clarify markers of exposure to bioactive food 
components and their biological response in specific targets are also 
Applicants are encouraged to review the most recent NCI Plan and Budget 
Proposal for additional information about topics that are of program 
relevance to the NCI.  These documents are available through, by email at, or by 
telephone at 1-800-4-cancer and are published each year.  The document for 
fiscal year 2004: “The Nation’s Investment in Cancer Research:  A Plan and 
Budget Proposal for Fiscal Year 2004” is NIH Publication No. 03-4373.

Applicants are also encouraged to review the topics that have been processed 
through the NCI’s Best Case Series program.  For additional information, see or contact Dr. Wendy Smith listed under INQUIRIES.

The National Institute of Nursing Research (NINR) also encourages 
applications that are consistent with its strategic plan and research themes 
for the future. In keeping with its research themes, projects that may lead 
to improved strategies for managing the effects of illness to improve quality 
of life, reducing health disparities, and enhancing the end-of-life 
experience for patients and their families are particularly welcome. For 
further information on NINR’s strategic plan, the applicant may refer to

The National Institute of Dental and Craniofacial Research (NIDCR) highlights 
in its strategic plan ( and in its 
Plan to Eliminate Health Disparities 
( oral and pharyngeal 
cancers as one of the diseases of interest.  The NIDCR encourages 
applications that explore complimentary approaches for the prevention of 
primary and recurrent lesions from these cancers.  Also of interest are 
studies on complimentary approaches that improve the quality of life for 
individuals receiving treatment for oral and pharyngeal cancers.  The NIDCR 
will not support the conduct of pilot clinical trials under this PA.  

The interests of the National Center for Complementary and Alternative 
Medicine include the safety, efficacy, and mechanisms of action of the CAM 
modalities described above as applied to the prevention and treatment of 
cancer, as well as treatment for cancer symptoms and side effects of 
conventional therapies. NCCAM’s interest in studying complex natural products 
focuses on the polypharmacy of these products.  Therefore, NCCAM will not 
accept applications to isolate the active constituents of complex natural 
products for the express purpose of developing these constituents as discrete 
drugs.  NCCAM does however support research characterizing single 
constituents extracted from complex natural products for the purposes of 
identifying and/or standardizing whole products, comparing the activities of 
single constituents and complex products, or identifying mechanisms of action 
for the whole product.  

In addition, it is highly recommended that applicants contact program staff 
listed at the end of this announcement with questions about specific issues 
in cancer research or in complementary approaches.  Applicants should also 
review the document “Strategies for Success:  How to Write a Grant in Cancer 
Complementary and Alternative Medicine” available through the NCI’s Office of 
Cancer Complementary and Alternative Medicine (OCCAM) (see program contacts 
under INQUIRIES and

It is the sole responsibility of the applicant to obtain all necessary 
clearances from the Food and Drug Administration (FDA) as required.  It is 
expected that applicants will have contacted the FDA about necessity of an 
Investigation New Drug (IND) request well before submission of the current 
application.  In addition, applicants are strongly encouraged to consult 
their local Institutional Review Boards (IRBs) concerning IND status and the 
IRB approval process.


This PA will use the NIH Exploratory/Developmental (R21) award mechanism.  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project. The earliest anticipated award date is 
September 2004.

The applicant may request a project period of up to two years with a combined 
budget for direct costs of up $275,000 for the two year period.  For example, 
the applicant may request $100,000 in the first year and $175,000 in the 
second year.  The request should be tailored to the needs of the project.  
Normally, no more than $200,000 may be requested in any single year.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format (see   
Specifically, if you are submitting an application with direct costs in each 
year of $275,000 or less, use the modular budget format.  This program does 
not require cost sharing as defined in the current NIH Grants Policy 
Statement at    


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 


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


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 inquiries regarding specific questions related to this announcement, 
questions about scientific/research issues and/or methodological issues in 
investigating complementary approaches in cancer research to:
Wendy B. Smith, M.A., Ph.D.
Research Development and Support Program
Office of Cancer Complementary and Alternative Medicine
National Cancer Institute
6116 Executive Blvd, Room 609
Bethesda, MD  20892-7302
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 435-7980
FAX:  (301) 480-0075
OCCAM website:

Direct inquiries regarding specific scientific research issues in cancer to:
Preclinical studies of candidate CAM with appropriate models to demonstrate 
efficacy and toxicity, and improvement over current clinically approved 
cancer treatment and disease management. Preclinical studies of mechanism of 
actions, drug-drug interactions:

Yali Hallock, PhD  
Developmental Therapeutics Program  
Division of Cancer Treatment and Diagnosis  
National Cancer Institute  
6130 Executive Boulevard, EPN Room 8058
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8783  
FAX: (301) 402-5200

Clinical studies of CAM to improve the therapeutic index of conventional 
systemic or surgical therapies for cancer by either improving efficacy or 
decreasing toxicity of conventional therapy: 

Dr. Roy Wu
Clinical Grants and Contracts Branch
Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 7009, MSC 7432
Bethesda, Maryland 20892-7432
Rockville, MD 20852 (for express/courier service) 
Telephone: 301-496-8866 
FAX: 301-480-4663 
Symptom management during active treatment and/or at the end of life:

Ann O'Mara, PhD, MPH, RN
Program Director
Community Clinical Oncology Program
National Cancer Institute
6130 Executive Boulevard, EPN Room 2011
Bethesda, MD 20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-8541 
FAX: 301-496-8667 

Survivorship research:

Diana Jeffery, Ph.D., Program Director
Office of Cancer Survivorship
National Cancer Institute
Division of Cancer Control & Population Sciences
6130 Executive Boulevard. EPN Room 4088
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-4540
FAX: 301-594-5070

Nutritional approaches in the prevention and treatment of cancer, as well as 
to prevent disease recurrence:

William F. Anderson, MD
Medical Officer
GI and Other Research Group
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 2144
Bethesda, MD 20892-7317
Rockville, MD 20852 (for express/courier service)
Telephone:  301-594-7672
FAX: 301.435.6344

Biomarkers for assessing nutritional status and targets of action of 
bioactive food components:

Cindy D. Davis, Ph.D.  
Program Director
Nutritional Science Research Group 
Division of Cancer Prevention 
National Cancer Institute 
National Institutes of Health 
6130 Executive Boulevard, EPN Room 3169 
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service) 
Telephone: 301-594-9692 
FAX: 301-480-3925 

For issues concerning relevance to NINR contact:

Martha L. Hare, Ph.D., R.N
NIH/National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza, Room 710
Bethesda, MD 20892-4870 
Bethesda, MD 20817 (for express/courier service)
Telephone: 301-451-3874
FAX: 301-480-8260

For issues concerning CAM and oral and pharyngeal cancers contact:

Maria Teresa Canto, DDS, MPH Program Director, Population Sciences 
Clinical, Epidemiology and Behavioral Branch  
Division of Population and Health Promotion Sciences NIDCR  
45 Center Drive MSC 6402  
Natcher Bldg, Room 4AS43B  
Bethesda, MD  20892-6402  
Telephone: 301-594-5497  
FAX: 301-480-8322  

For questions concerning relevance to NCCAM contact:

Barbara Sorkin, Ph.D., Program Officer, Oncological Sciences
NIH/National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Room 401
Bethesda, MD 20892-5475
Telephone: 301-496-8004
FAX: 301-480-3621

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

Ms. Eileen Natoli
Grants Administration Branch
National Cancer Institute
6116 Executive Boulevard, EPS Room 243
Bethesda, Maryland 20892
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8791
FAX:  (301) 496-8601


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 The Duns number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

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  Application 
deadlines are also indicated in the PHS 398 application kit.

initiated R21 applications 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 includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at

For the NIH Exploratory/Developmental Grant (R21), applicants may request 
direct costs in $25,000 modules, up to a total direct cost of $275,000 for 
the combined two year award period.      

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  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.


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 
( 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


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 the 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 

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 

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?  Does the applicant describe how the results of this 
exploratory/developmental research will lead to the development of an R01 

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.

the study will involve natural products usually prepared as complex mixtures, 
applicants should follow guidance provided at

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).

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).

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.  


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


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


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.

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:  

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 
a complete copy of the updated Guidelines are available at
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 

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
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 

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

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.

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 
( 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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at 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 

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

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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