CDC PUBLIC HEALTH RESEARCH: HEALTH PROTECTION RESEARCH INITIATIVE
INVESTIGATOR INITIATED RESEARCH (R01)

RELEASE DATE:  April 22, 2004
 
RFA Number:  RFA-CD-04-002 

EXPIRATION DATE:  June 23, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:  
Centers for Disease Control and Prevention (CDC) 
 (http://www.cdc.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:  
Office of the Director (OD), Office of Science Policy and Technology 
Transfer, Office of Public Health Research, (OPHR)
 (http://www.cdc.gov/od/ads)

Note:  The policies, guidelines, terms, and conditions stated in this 
announcement may differ from those used by the NIH. 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.062

LETTER OF INTENT RECEIPT DATE:  May 24, 2004
APPLICATION RECEIPT DATE:  June 22, 2004  

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 Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The Centers for Disease Control and Prevention (CDC), Office of Public 
Health Research (OPHR) announces the availability of fiscal year (FY) 
2004 public health research funds to support innovative public health 
research that addresses priority health protection issues.  Health 
protection should be interpreted to include activities that 1) promote 
health and/or prevent disease, injury, or disability or 2) protect 
people from health threats including infectious, environmental, and 
terrorist threats.  This RFA focuses specifically on health promotion 
in the workplace.

RESEARCH OBJECTIVES

Background

The large discrepancies between what Americans spend on health and the 
outcomes they experience may stem from how the nations’ health 
knowledge and resources are deployed within the health system and other 
sectors of society.  Most resources are deployed when people seek care 
for specific diseases and health conditions; health protection, health 
promotion, and prevention activities account for less than 3% of the 
nation’s investment for health services. A major obstacle to 
prioritizing health promotion is the fact that there is insufficient 
evidence to support specific programs, practices, and policies that 
affect health decisions made by people and those responsible for health 
policies and programs in the public health, health care delivery, and 
educational systems, as well as their counterparts in businesses and 
other private sector enterprises, governments, and governmental 
agencies.  Development of this evidence is hampered by the lack of 
support for public health research investigations that encompass the 
relevant disciplines across all academic environments.  CDC has 
initiated this RFA to support investigator-initiated research as one 
key component of its public health research agenda to address this gap 
in health promotion. 

CDC has aligned its priorities and investments with those of the 
Department of Health and Human Services to achieve 2 overarching health 
protection goals: 

1) Health promotion/Disease, injury and disability prevention: All 
people will achieve their optimal lifespan with the best possible 
quality of health in every life stage.  The strategies to accomplish 
this goal include developing the knowledge and tools that integrate 
perspectives from multiple scientific disciplines to focus on health 
evolving in “life stages” over a lifetime (infants, children, 
adolescents, young adults, middle-age adults, and older adults, and in 
all situations (at work, in communities, in school, at home). Integral 
to the successful accomplishment of this goal is the elimination of 
health disparities that afflict many people in our society. 

2) Preparedness: People in all communities will be protected from 
infectious, environmental, and terrorist threats. The strategies to 
accomplish this goal include developing the knowledge and tools that 
integrate perspectives from multiple scientific disciplines to focus on 
exposure prevention, rapid detection and diagnosis, investigation, 
containment, and recovery from health threats. 

CDC’s health protection research initiative is designed to support 
achievement of these goals, and will help develop and disseminate the 
knowledge and tools that can be used by individuals, public health 
professionals, health care providers, educators, policy makers, 
businesses, private sector organizations, and others to protect and 
measurably improve the health of Americans and reduce health 
disparities at all life stages and in all settings.

CDC’s intent is to ensure that a diverse pool of highly trained and 
creative scientists are supported and encouraged to accomplish the 
nation’s public health research agenda.  The objective of this RFA is 
to support innovative investigations that address CDC’s health 
promotion research priorities.  The proposed research should add 
substantially to the body of knowledge necessary to have a significant 
impact on the health status of Americans in one or more life stages.  

Objectives and Focus Areas

Applicants should focus their investigations, which will ultimately 
make a substantive contribution to CDC’s overarching goals (above) and 
a significant impact on people’s health status.  Specifically, the 
research outcomes should ultimately translate into extended lifespan or 
improved quality of health at any or all of the life-stages as defined 
in the background portion of this section, and/or should substantively 
contribute to people’s protection from non-occupational infectious, 
environmental, or terrorist threats.  Public health research should 
help close the gap between fundamental scientific knowledge and the 
information and motivators needed by individuals, families, 
communities, or the sectors that serve them to effectively use new 
knowledge and tools for making or supporting health decisions. In 
addition, the knowledge gained should be useful to public health 
practitioners, policy-makers, or even to the self-help or self-
management of diseases, risk factors, or risk conditions by 
individuals, communities, and populations. 

This first RFA for the health protection research initiative will give 
priority to research that identifies innovative cost-effective health 
promotion policies, programs, and activities in the workplace or 
affecting the workplace.  Although important to worker health, this RFA 
is not intended to cover research on occupational safety and health 
programs, policies, and activities.  If resources allow, future RFAs 
will expand the scope of this initiative to address health protection 
research relevant to other populations and sectors. 

The knowledge base needed for successful implementation of health 
promotion programs in the workplace needs to be greatly expanded.  This 
RFA will support investigations with a high probability of identifying 
cost-effective interventions that improve the health of the American 
workforce and the determinants of their successful implementation.  A 
desired outcome would be the identification of critical success factors 
that could be used to motivate adaptation and implementation of 
evidence-based interventions to promote workers’ health across the 
business sector.  These might be “best processes” to complement “best 
practices” derived from clinical or other efficacy studies.  A 
successful approach to health promotion in the workplace must be 
economically sustainable to achieve widespread impact, and 
investigations that address this issue are needed. 

There are many strategies that could be used to address this RFA, but 
this first RFA will give priority to those applications that emphasize 
the design and evaluation of interventions and identification of 
determinants affecting the successful implementation of evidence-based 
cost-effective health promotion interventions in the workplace or that 
have impact on the workplace.  Hence, the application should address at 
least one of the following issues: 

1.   Identification of cost-effective interventions that improve the 
health of employees as measured by: 
a.   mortality, morbidity, and disability, 
b.   quality of life (e.g., satisfaction with daily functioning, 
energy level, attentiveness),
c.   productivity (e.g., increase in on-the-job-productivity, 
decrease of absenteeism), 
d.   employer and/or employee health-related costs.

2.   Identification of the determinants of successful implementation 
and dissemination of evidence-based health promotion, 
interventions among individual employees, or groups of employees, 
or employers.

3.   Identification of the determinants of successful translation of 
evidence-based health promotion interventions to special employee 
populations to reduce health disparities.

4.   Evaluation of the impact of employee health policy alternatives 
on the health of individuals or groups of employees and their 
families.

5.   Determinants of the economic drivers of health and health 
decisions for employers and employees. 

6.   Identification and evaluation of public health informatics and 
communication strategies and tools to improve health decisions, 
health alerting, health literacy, or health assessment among 
employees and employers.

7.   Identification of strategies to improve the workforce’s 
protection from urgent non-occupational infectious, 
environmental, or terrorist threats. 

Because effective health promotion/prevention interventions often 
require a trans-disciplinary and trans-sector approach, projects that 
include close and ongoing collaborations with business leaders and 
affected employees and their representatives in the design, conduct, 
interpretation, communication, dissemination, and implementation of the 
research are encouraged. Likewise, linkages with experts from the 
public health and healthcare delivery system sectors may be critical to 
the success of many projects.  

MECHANISM OF SUPPORT

This RFA will use the RO1 award mechanism.  The applicant is 
responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Awards are not 
renewable.

This RFA uses the modular budgeting as well as the non-modular 
budgeting formats, as described on the website: 
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 NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm .  

FUNDS AVAILABLE 
 
The CDC intends to commit up to $14,000,000 in FY 2004 funds for 20 to 
40 new grants in response to this RFA.  The award provides up to three 
consecutive 12-month budget periods within a project period of up to 3 
years with a budget for direct costs of up to $300,000 per year. Direct 
costs include salary support (plus fringe benefits), technical 
assistance, equipment, supplies, consulting fees, domestic travel, 
publications, and other costs.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary.  
Although the financial plans of CDC 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 is a(n):     

o   Public or private academic institution
o   Eligible agency of the federal government
o   Unit of state, county, local, or tribal government
o   Healthcare organization 
o   Research institution 

The institution must be located in the United States or its territories 
and have, or be affiliated with, a well-established research or public 
health program, with qualified faculty in public health, basic, or 
other research to serve as mentors.  The institution must be able to 
demonstrate a commitment to adequately supporting the investigator to 
ensure successful accomplishment of the research. 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

The Principal Investigator must have a research or a health-
professional doctorate or its equivalent.  Principal investigators must 
be established in their field with expertise appropriate to the purpose 
of this RFA and have specific authority and responsibility to carry out 
the proposed project.  Examples of appropriate career appointments 
could include faculty positions at academic institutions or similar 
research positions at other eligible institutions. Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for CDC programs.    

SPECIAL REQUIREMENTS

The following are applicant requirements:

1)   Applicant should demonstrate effective and well defined 
working relationships within the performing organization and 
with outside entities which will ensure implementation of the 
proposed activities. 
2)   Principal Investigators are encouraged to submit only one 
proposal in response to this program announcement.  With few 
exceptions, only one application per Principal Investigator 
will be funded under this announcement.
   
WHERE TO SEND INQUIRIES

CDC encourages inquiries concerning this RFA and welcomes 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:

Tanja Popovic, M.D., Ph.D., F.A.A.M.
Acting Associate Director for Science
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone:  (404) 639-7240
Email: TPopovic@cdc.gov

o Direct your questions about peer review issues to:

Catherine Spruill
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone:  (404) 639-7240
Email: CSpruill@cdc.gov

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

Sylvia Dawson
Procurements and Grants Office
Centers for Disease Control and Prevention
Koger Office Park, Colgate Building, Mail-Stop E-14
2920 Brandywine Road, 
Atlanta, Georgia, 30341-5539 
Telephone:  (770) 488-2771
Email: SDawson@cdc.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 research
o   Name, address, telephone number, and e-mail address 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 OPHR 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.  The letter of intent should be sent to:

Heidi Steele
Office of Public Health Research
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone:  (770) 488-8612
Email: HSteele@cdc.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 document 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.
 
Instructions provided with this RFA supercede instructions provided in 
PHS 398.  

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

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 

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
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier services)
 
At the time of submission, two additional copies of the application and 
the appendix material must be sent to:

Heidi Steele
Office of Public Health Research
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone:  (770) 488-8612
Email: HSteele@cdc.gov

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.
 
Upon receipt, applications will be reviewed for completeness by Center 
for Scientific Review, NIH, and for responsiveness by the Office of 
Public Health Research, CDC. Incomplete applications and applications 
that are not responsive to the eligibility criteria will not be 
reviewed.  Applicants will be notified that their applications did not 
meet submission requirements.

PEER REVIEW PROCESS  

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 CDC in accordance with the review criteria 
stated below.  CDC uses a peer review process modeled after that of the 
NIH, including a streamlined review process, essentially as spelled out 
in the website located at: http://www.csr.nih.gov/REVIEW/streamln.htm 

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

Applications in the upper half will receive a secondary review by the 
secondary review committee.

REVIEW CRITERIA

The goal of this award is to fund research that identifies innovative 
cost-effective health promotion policies, programs, and activities in 
the workplace or affecting the workplace.  Although important to worker 
health, this RFA is not intended to cover research on occupational 
safety and health programs, policies, and activities.  If resources 
allow, future RFAs will expand the scope of this initiative to address 
health protection research relevant to other populations and sectors. 

FIRST LEVEL OF REVIEW: 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 health promotion 
issue?  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?  What is the 
potential impact on the individuals, health care providers, educators, 
policy makers, businesses, private sector organizations, and others 
engaged in protecting health and promoting healthy environments? Does 
this study address any other CDC priorities such as reducing racial and 
ethnic health disparities?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of 
the project?  Are the measures of effectiveness well defined, 
objective, quantitative and relevant to the intended outcome?  Are the 
measures of effectiveness related to the performance goals stated in 
the “Purpose” section of this announcement?  Does the applicant 
acknowledge potential problem areas and consider alternative tactics?  
Do the proposed methods include the participation and involvement of 
the affected population? Does the proposed project include a trans-
disciplinary and trans-sector approach?

INNOVATION: Innovation as applied to health promotion includes entirely 
new ideas for intervention activities, new approaches to replication or 
applicability research (e.g., adapting previously used intervention or 
policy ideas to include new areas of consideration, such as the impact 
of obesity on absenteeism), new approaches to achieve dissemination or 
implementation of programs or policies previously shown to be 
effective, and new approaches to identify factors that contribute to 
the success or failure of implementation or to sustaining 
interventions. 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)?  Has the investigator demonstrated experience in an area 
relevant to health protection research?  Has the investigator 
experience with teams that include various scientific disciplines and 
skill in contributing to the confluence of their research findings? 

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, at 
least one of the following strategies must be employed.  The extent to 
which one or more of the strategies are employed in the proposed 
research will be considered in the determination of scientific merit 
and priority score:

1.   Cost-effective interventions that improve the health of employees 
as measured by: 
a.   mortality, morbidity, and disability, 
b.   quality of life (e.g.,  satisfaction with daily 
functioning, energy level, attentiveness)
c.   productivity (e.g., increase in on-the-job-productivity, 
decrease of absenteeism), 
d.   employer and/or employee health-related costs.
2.   Identification of the determinants of successful implementation 
and dissemination of evidence-based interventions among 
individual employees, or groups of employees, or employers.
3.   Identification of the determinants of successful translation of 
evidence-based interventions to special employee populations to 
reduce health disparities.
4.   Evaluation of the impact of employee health policy alternatives 
on the health of individuals or groups of employees and their 
families.
5.   Determinants of the economic drivers of health and health 
decisions for employers and employees.
6.   Identification and evaluation of public health informatics and 
communication strategies and tools to improve health decisions, 
health alerting, health literacy, or health assessment among 
employees and employers.
7.   Identification of strategies to improve the workforce’s 
protection from urgent infectious, environmental, or terrorist 
threats. 

SECONDARY REVIEW LEVEL: Applications will receive a programmatic review 
that will consider the following 1) the potential impact of the 
research outcome on workplace or workforce conditions 2) severity of 
the problem, and 3) likelihood of rapid application of research results 
to known issues in health protection strategies.

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.  This will not 
be scored; however, an application can be disapproved if the research 
risks are sufficiently serious and protection against risks is so 
inadequate as to make the entire application unacceptable.  (See 
criteria included in the section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES IN RESEARCH: The adequacy of plans to 
address the CDC policy requirements regarding the inclusion of women, 
racial and ethnic groups (and subgroups), as appropriate for the 
scientific goals of the research.  Review criteria include: (1)  The 
proposed plan for the inclusion of both sexes and racial and ethnic 
minority populations for appropriate representation; (2) The proposed 
justification when representation is limited or absent; (3) A statement 
as to whether the design of the study is adequate to measure 
differences when warranted; and (4) A statement as to whether the plans 
for recruitment and outreach for study participants include the process 
of establishing partnerships with community(ies) and recognition of 
mutual benefits. 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: CDC expects researchers who are supported by CDC 
funding to make their data available for analysis by other public 
health researchers and include a data sharing plan in their 
application.  CDC requires that mechanisms for, and costs of, data 
sharing be included in contracts, cooperative agreements, and 
applications for grants. CDC reviewers must check whether applications 
for CDC funds include mechanisms for, and costs of, sharing data.  The 
costs of sharing or archiving data may be included in the amount of 
funds requested in applications for first-time or continuation funds. 
Applicants for CDC funds who incorporate data release into their study 
designs can (1) readily and economically set up procedures for 
protecting the identities of research subjects and (2) produce useful 
data with appropriate documentation. Awardees who fail to release data 
in a timely fashion will be subject to procedures normally used to 
address lack of performance (e.g., reduction in funding, restriction of 
funds, or grant termination). Researchers who contend that the data 
they collect or produce are not appropriate for release must justify 
that contention in their applications for CDC funds. 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. CDC’s policy is available at: 
http://www.cdc.gov/od/ads/pol-385.htm 
 
BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT SCHEDULE

Letter of Intent Receipt Date: May 24, 2004
Application Receipt Date: June 22, 2004
Earliest Anticipated Award Date: September 30, 2004 

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 (as determined by the secondary review).
 
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 CDC to ensure that individuals of both sexes and the various 
racial and ethnic groups will be included in all CDC-supported studies 
involving human subjects, whenever feasible and appropriate.  
Furthermore, it is CDC policy to identify significant gaps in knowledge 
about health problems that affect women and racial and ethnic minority 
populations and to encourage studies which address these problems. 
Policy available in the Federal Register volume 60 number 179, 
September 15, 1995, page 47948-51.

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. Guidance is 
available 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). 
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 CDC GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for CDC funding must be self-contained within specified page 
limitations.  Unless otherwise specified in a CDC 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 Section 301 of the Public Health Service Act as 
amended (42 USC section 241).  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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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