CULTURAL COMPETENCE AND HEALTH DISPARITIES ACADEMIC AWARD
  
RELEASE DATE:  December 12, 2003
 
RFA Number:  RFA-HL-04-012

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung, and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.837, 93.838, 93.839
 
LETTER OF INTENT RECEIPT DATE: January 23, 2004; September 19, 2004; 
September 19, 2005.

APPLICATION RECEIPT DATE: February 23, 2004; October 19, 2004; October 19, 2005.
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The overall objective of this program is to enhance the ability of 
physicians and other health care professionals, to address disparities 
in the occurrence, management, and outcomes of cardiovascular, 
pulmonary, hematological, and sleep disorders among various population 
groups in the U.S. in a culturally sensitive manner. This academic 
award provides support to medical institutions in the U.S. to develop 
core curricula and other educational materials that will increase the 
overall knowledge and skills of medical students, house staff, and 
other professionals, including practicing physicians on the ethnic, 
cultural, religious, socioeconomic, linguistic and other factors that 
contribute to health disparities, and on culturally competent 
approaches to mitigating these disparities.

RESEARCH OBJECTIVES

Racial, ethnic, cultural and linguistic differences that exist in the 
U.S. population present a unique challenge for the practice of 
medicine.  Despite major improvements in the overall national health in 
the U.S., major disparities continue to exist in the health status, 
incidence of illness, and access to health care among different 
population groups. This is particularly true for minority populations, 
such as African Americans, Latino/Hispanic Americans, Native Americans, 
Alaska Natives and Pacific Islanders, who face a disproportionate 
burden of disease compared to the non-minority U.S. population.  
Hypertension, cardiovascular diseases, stroke, sickle cell disease, 
sleep disorders and asthma are several diseases within the mission of 
the NHLBI that disproportionately affect minorities.  

Among the factors that are believed to be associated with health 
disparities are national origin, ethnicity, cultural, linguistic and 
family backgrounds, individual experiences, age and gender, financial 
status, geographic location, educational level, and occupation. 
Physician’s lack of knowledge and experience with these factors may 
further exacerbate their effects. Lack of diversity in the workforce 
may also contribute to health care industry’s inability to meet the 
needs of diverse patient populations, thereby affecting the quality of 
care and contributing to health disparities.

For the purpose of this RFA, cultural competence is defined as the 
health care provider’s ability to deliver culturally appropriate and 
specifically tailored care to patients with diverse values, beliefs, 
and behaviors.  Very few programs are currently available to train 
health care providers on the health implications of cultural diversity 
and how they shape a person’s approach to health and illness.  
Especially lacking are didactic courses and training programs that 
enhance physician knowledge of the manifold factors that influence the 
health needs and attitudes of people from diverse backgrounds, and of 
ways to apply this knowledge in patient care.  

This Cultural Competence and Health Disparities Academic Award 
initiative seeks to fill this gap by promoting the development and use 
of relevant curricula in medical schools, as well as the training of 
physicians already in the health care pipeline.  This program is 
designed to provide resources to domestic medical institutions, to 
develop mechanisms that offer students and physicians, knowledge, 
sensitivity and experience in understanding and managing cultural 
barriers to health care, and to enable institutions to develop “best 
practices” in the delivery of optimal health care to multiethnic 
populations with heart, lung, blood or sleep disorders. It is hoped 
that this program will impact public health by identifying factors that 
increase risk to specific diseases and help physicians deliver the best 
possible health care.

The Program

This program will be implemented in two phases: Curriculum Development, 
and Implementation.

1) Curriculum Development Phase: This phase will include: (i) the 
identification of elements or components of core curricula for medical 
schools on cultural sensitivity and health disparities, and (ii) the 
development, testing and utilization of relevant materials and 
resources in appropriate settings.  The course(s), materials and 
resources will especially: a) focus on the factors (e.g., cultural, 
religious and geographic backgrounds; beliefs; values; traditions; 
attitudes; and practices) that affect health, and disease occurrence; 
b) examine how these factors may influence medical help seeking 
behavior, compliance, adherence, and response to treatment; and c) 
identify strategies for delivering culturally sensitive information and 
interventions to the health care professionals. It is desirable that in 
addition to medical students, house staff, and other professionals, 
including practicing physicians are incorporated into the program.

Each applicant will describe: a) plans for the development of curricula 
and other materials, including procedures to evaluate the process and 
progress of curriculum development, plans for enlisting the support of 
professional and other organizations involved in medical education in 
these efforts; and b) plans and milestones for institutionalizing the 
curricular changes. These efforts may eventually culminate in the 
development of a single curriculum, or, if deemed necessary and 
justified, more than one curriculum. The curricula and any educational 
materials designed must be suitable for implementation at other sites. 
The curricula may be developed in the context of a single or several-
multiple ethnic/cultural group(s) and disease category(ies), or some 
combinations of these to provide one broadly applicable. The curricula 
may be adaptable into existing courses, or as stand-alone customized 
course(s). It is expected that this phase will be completed in 24–30 
months.

2) Implementation and Training Phase: The curriculum development should 
be followed by an implementation phase that includes evaluation of 
products in appropriate settings (e.g., classrooms, professional 
meetings, focus groups, etc) and dissemination of educational 
materials, to the medical education community. This will include 
medical schools, and organizations coordinating residency programs, 
post-graduate courses, and continuing medical education, etc. It is 
expected that appropriate outlets will be used to encourage their 
integration into medical school curricula as well as training programs 
for physicians in practice, to help enhance their cultural competence 
and ability to deal with health disparities in the U.S. Each applicant 
should detail plans for conducting and testing the effectiveness of the 
proposed curriculum, including benchmarks against which success of the 
program can be measured. 

In addition, to aid in the selection of the “coordinating center” each 
applicant must indicate how the investigators will coordinate their 
efforts with those of other participants in this program, expected to 
number 10-12. The coordination efforts should include, among others, 
organization of group meetings and conference calls to develop common 
ideas and plans for completing the two phases of the program as 
detailed above, and for generating interim and final progress reports.  
The NHLBI will designate one of the awardees as the “Coordinating 
Center” and will provide additional funds earmarked for carrying out 
the coordinating responsibilities. 

The NHLBI will work closely with the Coordinating Center as well as the 
individual awardees, as necessary, to help meet the goals of the 
program, namely, the development and dissemination of curricula and 
other educational resources designed to enhance the cultural competence 
of health-care providers and reduce health disparities in the nation.

MECHANISM OF SUPPORT

This RFA will use the NIH K07 Academic Career Award mechanism. As an 
applicant, you will solely be responsible for planning, directing, and 
executing the proposed project.  See the SUPPLEMENTARY INSTRUCTIONS 
section for additional information. An unsuccessful application to this 
RFA for one receipt date may be submitted as an amended application at 
a later receipt date. The anticipated award date for the first receipt 
date is September 30, 2004; for the second is July 1, 2005; and for the 
third is July 1, 2006. 

FUNDS AVAILABLE
 
The NHLBI intends to commit approximately $24 million over a seven-year 
period in response to this RFA. Ten to 12 applications will be funded 
per announcement (a total of 30 to 36 applications in response to three 
announcements). An applicant must request a project period of 5 years 
and a budget for direct costs (DC) up to $120,000 per year. Because the 
nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size of each award will also 
vary. Although the financial plans of the NHLBI provide support for 
this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications. 

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 a universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply

An eligible institution (e.g., university) may submit only a single 
application in response to this RFA.  Multiple applications from 
different divisions, faculties, centers, schools, etc. at the same 
university will be returned without further consideration by the NIH.
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   
 
Individuals with the skills, knowledge, and resources necessary to 
carry out the proposed academic program are 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 especially encouraged to apply.
   
The candidate must be an established, independent and qualified 
professional of a health care institution or medical faculty in an 
accredited school of medicine or osteopathy in the U.S., its 
territories, or its possessions; must be in a position to devote at 
least 30 but not more than 50 percent effort to the program for a five-
year period; a faculty member interested in medical education programs 
related to the mission of the NHLBI; have the potential to develop and 
implement a high quality educational curriculum; have the support of 
the educational leadership at the institution and demonstrate knowledge 
and commitment in cultural aspects of medical education for medical 
students, physicians, physicians in training, patients, nurses, and the 
public. 

SPECIAL REQUIREMENTS 
 
The educational materials for curricular improvements resulting from 
this program must be amenable to adaptation at other sites.  All 
applications must also include plans to evaluate the outcomes of this 
educational and research initiatives.  The responsibilities of the 
Principal Investigator and key personnel must be clearly stated at the 
beginning of the research plan and placed in the context of other 
institutional and research commitments.  Since the Cultural Competence 
and Health Disparities Academic Award primarily provides support for 
the salary of the Principal Investigator, applications that are 
contingent on receiving support from other agencies and institutions 
must identify these resources in relationship to the proposed program 
plan.

Allowable Cost:

The salary for the Principal Investigator must be in conformance with 
the institutional salary rates for the effort devoted to the Academic 
Award, subject to the maximum legislated salary rate in effect at the 
time of award. The institution may supplement the NIH salary up to a 
level consistent with the institution's salary scale. However, 
institutional supplementation of salary must not require extra duties 
or responsibilities that would interfere with the purpose of the 
Academic Award.  

Support & Development: 

Funds may be requested for technical support up to a maximum of $25,000 
DC per year for the following: a) personnel other than the PI, if 
required, (e.g., technical and support staff and consultants, 
educational and evaluation specialists) for development, 
implementation, and evaluation of the program; b) consumable supplies 
essential to the proposed program are allowable, but equipment costs 
are not allowable; c) funds for travel for the Principal Investigator 
to meet in Bethesda, Maryland with other investigators and NHLBI staff 
to exchange ideas, develop collaborative projects, and provide needed 
technical support ($2,000 should be allocated for this purpose for two 
trips per year).

The institution selected as coordinating center will receive an 
additional $25,000 DC for personnel support and $20,000 DC for 
administrative expenses to cover conference calls, arranging meetings, 
organization of committees, preparation of program status reports, 
overall evaluation of the program, and plans for dissemination of 
educational materials generated by this program. In the final year of 
the program $40,000 will be provided to the coordinating center for 
organizing a conference for wide dissemination of the group’s 
curricular development and training.  These funds should not be 
requested in the budget. 

Awards will be provided for the reimbursement of facilities and 
administrative (F&A) costs at a rate of eight percent of total direct 
costs.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to 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:

Héctor Ortega, M.D., Sc.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute 
6701 Rockledge Drive, Room 1008, MSC795
Bethesda, MD  20892
Telephone:(301) 435-0202
FAX:(301) 480-3557
Email:ortegah@mail.nih.gov

Susan Czajkowski, Ph.D.  
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute 
6701 Rockledge Drive, Room 
Bethesda, MD  20892
Telephone: (301) 435-0406
FAX:(301) 480-1773
Email: czajkows@mail.nih.gov 

Beth Schucker, M.S.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute 
6701 Rockledge Drive, Room 
Bethesda, MD  20892
Telephone: (301) 435-0535
FAX:(301) 480-1335
Email: schuckeb@mail.nih.gov

Ellen Werner, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute 
6701 Rockledge Drive, Room 
Bethesda, MD  20892
Telephone: (301) 435-0061
FAX:(301): (301) 480-0867
Email: wernerem@mail.noh.gov 

o Direct your questions about peer review issues to:

Anne P. Clark, Ph.D.
Chief Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute 
6701 Rockledge Drive, Room 7178, MSC 7924
Bethesda, MD  20892-7924
Bethesda, MD  20817 (for express/courier service)
Telephone: (301) 435-0270 
FAX: (301) 480-0730
Email:clarka@nhlbi.nih.gov

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

Mr. Howard Moore
Division of Extramural Affairs
National Heart, Lung, and Blood Institute 
6701 Rockledge Drive, Room 7156
Bethesda, MD  20892
Telephone: (301) 435-0171
Email:piker@nhlbi.nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed application
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows NHLBI staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document to Dr. Anne Clark at the address listed under the 
WHERE TO SEND INQUIRES.

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 in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

SUPLEMENTARY INSTRUCTIONS

Applicants should follow these modified instructions from the PHS 398 
Section IV (Research Career Award) in preparing an application.  In the 
Section for “Budget” (Table of Contents (TC) Section I,4) the applicant 
should include a categorical budget as described in the special 
requirements section of this RFA. Applicants do not need to provide 
“sponsor/mentor” related information (e.g. letters of support, other 
support for the Mentor) (TC Section I,6) or “Career Goals and 
Objectives & Development Activities” information (TC Section II,3.B & 
3.C).  Additionally, because development and implementation of 
educational materials do not require specific hypothesis to be tested, 
a hypothesis is not required (TC Section II, 6.A). However, in the 
section for “Research Plan” a clear description of specific aims and 
objectives is required following the “Curriculum development and 
Implementation” sections described in this RFA. 

Coordinating Center: At the end of the Research Plan, each application 
must provide a “coordinating plan” as described under RESEARCH 
OBJECTIVES, The Program.  Applicants are allowed up to three additional 
pages for the description of their coordinating plan.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to Dr. Anne Clark at 
the address listed under WHERE TO SEND INQUIRES.

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

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.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.  
 
PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NHLBI. Incomplete and/or nonresponsive 
applications will not be reviewed. 

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NHLBI in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NHLBI National Advisory Council. 
 
REVIEW CRITERIA

The following review criteria will be applied:

Candidate

o  Evidence of excellence in research and academic activities;

o  Experience in teaching, curriculum development, leadership,  
administrative skills, and/or planning and conduct of research; 

o  Ability and commitment to work cooperatively with other awardees to 
develop innovative cultural competence curricula, materials, and 
programs available;

Research Plan 

o  Quality and feasibility of the curricular development plan including 
identification of strategies for delivering culturally sensitive 
information and interventions;

o  Potential of the program for making an impact on culturally 
competent approaches to mitigating disparities;

o  Quality of the evaluation plan of the proposed training and 
educational program(s);
  
o  Plans for institutionalizing the curricular program; and
 
Environment

o  Commitment of the institution to strengthening research and 
education activities in a cultural sensitive manner in heart, lung, 
blood, and sleep disorders;

o  Commitment of the institution to the proposed level of effort 
related to this award; 

o  Merit of the institution plan to strengthen educational and training 
activities beyond the current status of activities and capacities; 

o  Scope and nature of collaboration among participating schools and 
departments; and

o  Adequacy of the research facilities and training opportunities for 
this award.

Plans for Coordination

o  Adequacy of the proposed activities appropriate for facilitating 
coordination, and prior experience in performing coordination 
functions.

Reviewers will comment on the proposed coordination plans but this will 
not influence the final 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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below).

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

Letter of Intent Receipt Date: January 23, 2004; September 19, 2004; 
September 19, 2005.
Application Receipt Date: February 23, 2004; October 19, 2004; 
October 19, 2005.
Peer Review Date: June, 2004; February 2005; February 2006.
Council Review: September, 2004; June 2005; June 2006.
Earliest Anticipated Start Date: September 30, 2004; July 1, 2005; 
July 1, 2006.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic 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 

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.

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 RFA 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.healthypeople.gov/.

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.


Return to Volume Index

Return to NIH Guide Main Index


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)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.