CDC PUBLIC HEALTH RESEARCH: HEALTH PROTECTION RESEARCH INITIATIVE
MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (KO1)

RELEASE DATE:  April 22, 2004

RFA Number:  RFA-CD-04-001

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 NUMBERS:  93.063

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 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 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 FY 2004 public 
health research funds to support the development of a qualified and 
experienced cadre of independent public health researchers to addresses 
priority health protection issues.  Health protection should be 
interpreted to include activities that 1) promote health/or prevent 
disease, injury, or disability or 2) protect people from health threats 
including infectious, environmental, and terrorist threats. 

RESEARCH OBJECTIVES

Background

The large discrepancies between what Americans spend on health and the 
outcomes they experience may stem from how the nation’s 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 
appropriately trained, qualified, and supported public health research 
investigators in relevant disciplines across all academic environments. 
CDC has initiated this focus on career development of qualified 
investigators 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 strategy to accomplish this 
goal includes 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, and at 
play).  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 measurably 
improve the health of Americans and reduce health disparities at all 
life stages and in all settings at home, in school, at work and at 
play. 

CDC’s intent is to ensure that a diverse pool of highly trained and 
creative scientists will be available in adequate numbers to carry out 
the nation’s public health research agenda.  The objective of this RFA 
is to develop a qualified, experienced, and sustainable cadre of 
independent public health researchers to address CDC’s health promotion 
research priorities.  This award will support career development 
experiences that lead to independence and substantially expand the 
knowledge and capabilities of current research scientists.  Hence, the 
award is specifically designed to support postdoctoral professionals 
with research experience at the time of application.  The 
characteristics of ideal candidates vary.  Some individuals may propose 
to refocus their current research career trajectory to address health 
protection priorities.  Others may transition from a completely 
different field of investigation or may be returning to their research 
career after a hiatus.  Other applicants may be research faculty from 
underrepresented groups or faculty at minority serving institutions who 
want to enhance their research skills and knowledge through a period of 
supervised training at a research center. The proposed career 
development experience should add substantially to the existing 
research capabilities of the applicant or result in new research 
capabilities.  The candidate must provide a plan for achieving 
independent research support in the specified field by the end of the 
award period. 

Objectives and Focus Areas

Applicants should focus their projects to achieve substantive 
contributions to CDC’s overarching goals (above) and a measurable 
impact on people’s health status.  Specifically, the research outcomes 
should 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. 

Although CDC’s public health research priorities involve a broad range 
of activities, applicants are encouraged to seek career development 
strategies that include close collaboration with members of the study 
population and colleagues from non-academic sectors including public 
health agencies, healthcare organizations, schools, or businesses.  
Such research systematically engages the collaborators in formulating, 
conducting, interpreting, communicating, and disseminating the research 
aimed at improving health quality, increasing lifespan, encouraging 
healthy lifestyles, and protecting communities from a variety of health 
threats.  Translating research findings into effective solutions people 
or organizations can utilize will require investigators to address one 
or more of the following focus areas:

   1. Identification of new social, environmental, genomic, and 
developmental determinants of health amenable to intervention.
   2. Identification of cost-effective interventions that improve the 
health of individuals, families, or communities.
   3. Identification of the determinants of successful implementation 
and dissemination of evidence-based interventions among individuals, 
families, communities, or the sectors serving them.
   4. Identification of the determinants of successful translation of 
evidence-based interventions to special populations to reduce health 
disparities.
   5. Applications of genetic information to improve health.
   6. Evaluation of the impact of policy alternatives on the health of 
individuals, families, or communities.
   7. Determinants of the economic drivers of health and health 
decisions for individuals, families, communities, or the sectors 
serving them.
   8. Identification and evaluation of public health informatics and 
communication strategies and tools to improve health decisions, 
health alerting, health literacy, or health assessment.
   10. Identification of strategies to improve the prevention and early 
detection of public health threats.

MECHANISM OF SUPPORT

This RFA will use the K01 award mechanism.  The applicant and her/his 
mentor on behalf of the applicant's institution, are responsible for 
planning, directing, and executing the proposed project.  This RFA is a 
one-time solicitation.  Awards are not renewable.

This RFA uses the non-modular budget format.  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 $10,000,000 in FY 2004 funds for 
approximately 20 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.  An applicant may request 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 training 
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.  

At least 75 percent of the recipient's full-time professional effort 
must be devoted to the goals of this award.  The remainder may be 
devoted to teaching, practice, or other research pursuits consistent 
with the objectives of the award. Both the didactic and the research 
phases of an award period must be designed to develop the necessary 
knowledge and research skills in scientific areas relevant to the 
career goals of the candidate.  

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) 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 and its 
territories and have, or be affiliated with, a well-established 
research and public health career development program, with qualified 
faculty in public health, and/or clinical, or basic research to serve 
as mentors.  The institution must be able to demonstrate a commitment 
to the development of the candidate as a productive, independent 
researcher.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS  

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

Because of the focus on progression to independence as a researcher, a 
candidate for the K01 should propose a period of career development 
consistent with his or her previous research experience.  It is open to 
candidates having faculty appointments, or similar appointments at 
eligible institutions and holding a Ph.D., M.D., D.V.M., D.O., or 
equivalent professional degree, who wish to develop research 
capabilities in research areas relevant to the nation’s public health 
research agenda.  All programs must be tailored to meet the individual 
needs of the candidate ensuring that he/she will gain the skills and 
knowledge necessary to carry out high-quality, public health research.  
The candidate and the mentor are jointly responsible for the 
preparation of the plan for this program. The sponsoring institution 
may form an advisory committee to assist with the development of a 
program of study or to monitor the candidate’s progress through the 
career development program.

Applications may be submitted, on behalf of candidates, by domestic, 
non-Federal organizations, public or private, such as medical, dental, 
or nursing schools or other institutions of higher education. 
Minorities, women, and individuals with disabilities are encouraged to 
apply.  Candidates must be U.S. citizens or non-citizen nationals, or 
must have been lawfully admitted for permanent residence by the time of 
award.  Individuals admitted for permanent residence must be able to 
produce documentation of their immigration status such as an Alien 
Registration Receipt Card (I-551) or some other verification of legal 
admission as a permanent resident.  Non-citizen nationals, although not 
U.S. citizens, owe permanent allegiance to the U.S.  They are usually 
born in lands that are not states but are under U.S. sovereignty, 
jurisdiction, or administration.  Individuals on temporary or student 
visas are not eligible for this award.

SPECIAL REQUIREMENTS

Mentor at Same or Collaborating Research Center

Each candidate must also identify and complete arrangements with a 
mentor (at the same institution or at a collaborating research center) 
who is recognized as an accomplished investigator in the proposed 
research area and who will provide guidance for the candidate's 
development and research plan. Arrangements with mentors at 
institutions at a distance from the applicant institution will be 
considered, but approaches for ensuring close and active involvement of 
a distant mentor must be clearly outlined in the application. Plans for 
intensive training of the candidate should be developed with the 
mentor.  The establishment of a viable mentoring plan is essential to 
the success of the candidate. 

The commitment of the mentor and the mentor's department chair to 
training must be documented in the application.  A mentoring plan that 
describes the candidate’s interaction with the mentor and his/her 
staff, how it will enhance the candidate’s research capabilities and 
teaching skills, and steps to assist the candidate advance his or her 
career goals must be delineated in the application.  The mentor must 
provide an annual evaluation of the candidate’s career development.  
This evaluation is to be included as part of the annual progress report 
if an award is made.

Allowable Costs:

1. Salary:  The CDC will provide salary and fringe benefits for the 
career award recipient.  The total salary requested is based on a full-
time, 12-month staff appointment.  It must be consistent both with the 
established salary structure at the institution and with salaries 
actually provided by the institution from its own funds to other staff 
members of equivalent qualifications, rank, and responsibilities in the 
department concerned.  If full-time, 12-month salaries are not 
currently paid to comparable staff members, the salary proposed must be 
appropriately related to the existing salary structure. Additional 
information on the cost principles for educations institutions is 
available on the website:  
http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html

The institution may supplement the CDC salary contribution up to a 
level that is consistent with the institution's salary scale; however, 
supplementation may not be from Federal funds unless specifically 
authorized by the Federal program from which such funds are derived.  
Because the salary amount provided by this award is based on the full-
time institutional salary, no other PHS funds may be used for salary 
supplementation.  Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with the 
purpose of the K01.  

2. Research Development Support: All expenses must be directly related 
to the proposed research career development program. The facilities and 
administrative cost rate applied is limited to 8 percent of the direct 
cost, excluding tuition and related fees and equipment expenses, or to 
the facilities and administrative cost rate, whichever results in the 
lesser amount. Ancillary Personnel Support: Salary for secretarial and 
administrative assistance, etc., is not allowed.

3. Evaluation:  In carrying out its stewardship of human resource 
related programs, the CDC may begin requesting information essential to 
an assessment of the effectiveness of this program.  Accordingly, 
recipients are hereby notified that they may be contacted after the 
completion of this award for periodic updates on various aspects of 
their employment history, publications, support from research grants or 
contracts, honors and awards, professional activities, and other 
information helpful in evaluating the impact of the program.

4. Other Income: The career award recipient may not retain fees 
resulting from clinical practice, professional consultation, or other 
comparable activities required by the research and research-related 
activities of this award.  CDC assigns fees to the grantee institution 
for disposition by any of the following methods:

The funds may be expended by the grantee institution in accordance with 
the CDC policy on supplementation of career award salaries and to 
provide fringe benefits in proportion to such supplementation. Such 
salary supplementation and fringe benefit payments must be within the 
established policies of the grantee institution.

o   The funds may be used for health-related research purposes.

o   The funds may be paid to miscellaneous receipts of the U.S. 
Treasury. Checks should be made payable to the Department of 
Health and Human Services, CDC, and forwarded to the Director, 
Office of Financial Management, CDC, Atlanta, Georgia, 30333.  
Checks must identify the relevant award account and reason for 
the payment.

o   Awardees may retain royalties and fees for activities such as 
scholarly writing, service on advisory groups, or honoraria from 
other institutions for lectures or seminars, provided these 
activities remain incidental and provided that the retention of 
such pay is consistent with the policies and practices of the 
grantee institution.

o   Funds budgeted in a CDC supported research or research training 
grant for the salaries or fringe benefits of individuals, but 
freed as a result of a career award, may not be re-budgeted.  The 
awarding component will give consideration to approval for the 
use of released funds only under unusual circumstances.  Any 
proposed retention of funds released as a result of a career 
award must receive prior written approval of the CDC.

5. Special Leave: Leave to another institution, including a foreign 
laboratory, may be permitted if the proposed experience is directly 
related to the purpose of the award.  Only local, institutional 
approval is required if such leave does not exceed 3 months.  For 
longer periods, prior written approval of the CDC is required.  To 
obtain prior approval, the award recipient must submit a letter to the 
CDC describing the plan, countersigned by his or her department head 
and the appropriate institutional official.  A copy of a letter or 
other evidence from the institution where the leave is to be taken must 
be submitted to assure that satisfactory arrangements have been made.  
Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave 
requires the prior written approval of the CDC and will be granted only 
in unusual situations.  Support from other sources is permissible 
during the period of leave.  Such leave does not reduce the total 
number of months of program support for which an individual is 
eligible.  

Under unusual and pressing circumstances, an award recipient may submit 
a written request to the awarding component requesting a reduction in 
professional effort below 75 percent.  Such requests will be considered 
on a case-by-case basis during the award period.  In no case, will it 
be permissible to work at a rate of less than 50 percent effort.  The 
nature of the circumstances requiring reduced effort might include 
medical conditions, disability, or pressing personal or family 
situations such as child or elder care. Permission to reduce the level 
of effort will not be approved to accommodate other sources of funding, 
job opportunities, clinical practice, or clinical training. In each 
situation, the grantee institution must submit documentation supporting 
the need for reduced effort along with assurance of a continuing 
commitment to the scientific development of the award recipient.  

Further, the award recipient must submit assurance of his or her 
intention to return to full-time professional effort (at least 75 
percent) as soon as possible.  During the period of reduced effort, the 
salary and other costs supported by the award will be reduced 
accordingly. 

6. Termination or Change of Institution:  When a grantee institution 
plans to terminate an award, the CDC must be notified in writing at the 
earliest possible time so that appropriate instructions can be given 
for termination. The Associate Director for Science (ADS) of the CDC 
may discontinue an award upon determination that the purpose or terms 
of the award are not being fulfilled.  In the event an award is 
terminated, the CDC shall notify the grantee institution and career 
award recipient in writing of this determination, the reasons, the 
effective date, and the right to appeal the decision. 

Awardees planning a change of institution, must submit a written 
request for transfer to CDC in advance of the change, countersigned by 
the appropriate institutional business official, describing the reasons 
for the change and including the new sponsor's name and bios ketch.  
The award recipient must establish in this request that the specific 
aims of the research program to be conducted at the new institution are 
within the scope of the original peer reviewed research program.  
Additionally, the new sponsor must have the appropriate research 
expertise to supervise the program and sufficient research support to 
ensure continuation of the research program to the end of the award.  
CDC staff will review this request and may require a review by an 
initial review group and/or the appropriate National Advisory Council 
or Board. Upon approval of this request, a new career award application 
must be submitted by the new institution far enough in advance of the 
requested effective date to permit review.  The period of support 
requested in the new application must be no more than the time 
remaining within the existing award period.  

7. Change of Mentor: When a mentor at the grantee institution is to be 
replaced, the institution must submit a letter from the proposed mentor 
documenting the need for substitution, the new mentor's qualifications 
for supervising the program, and the level of support for the 
candidate's career development.  The letter must also document that the 
specific aims of the research program will remain within the scope of 
the original peer reviewed research program. CDC staff will evaluate 
the request, and will notify the grantee institution of the evaluation 
results.  

8. A final progress report, invention statement, and Financial Status 
Report are required upon either termination of an award or 
relinquishment of an award in a change of institution situation.

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:

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.
 
The application must address the following issues:

Candidate

o   Describe the candidate's commitment to a career in public health 
research and his/her potential to make future contributions to 
public health.
o   Establish the candidate's potential to develop into an 
independent investigator, describe the long-term career 
objectives, and explain how this award will contribute to these 
goals.
o   Affirm a commitment of at least 75 percent effort to research 
career development activities.
o   Include as part of the application three sealed letters of 
recommendation addressing the candidate's potential for a 
research career.

Career Development Plan

o   The career development and training experience must focus on 
health protection research.  Describe the career development plan 
incorporating consideration of the candidate's goals and prior 
experience.  A systematic plan should be presented for obtaining 
the necessary basic science/clinical background and research 
experience to launch an independent research career.  The career 
development plan must be specifically tailored to the needs of 
the candidate and the ultimate goal of achieving independence as 
a researcher.

Research Plan

o   The research project for his award must specifically be in the 
area of health protection research.  The research plan must be 
described as outlined in form PHS 398 including sections on the 
Specific Aims, Background and Significance, Preliminary Studies, 
Research Design and Methods.  The K01 candidate should consult 
with the proposed mentor(s) regarding the development of this 
section.

Training in the Responsible Conduct of Research

o   Candidates for K01 awards must describe plans to receive 
instruction in the responsible conduct of research.  These plans 
must detail the proposed subject matter, format, frequency, and 
duration of instruction.  No award will be made if an application 
lacks this component.

Mentor's Statement

o   The application must include a statement from the mentor 
including information on the mentor's experience in public health 
research and previous experience as a research supervisor.  The 
application must also include information to describe the 
mentor's research support related to the candidate's research 
plan and the nature of the supervision that will occur during the 
proposed award period.  Because this program is intended to 
provide a means to promote more extensive interaction among 
researchers, in some cases more than one mentor will be 
appropriate.  The co-mentor(s) must provide similar information.  
If more than one mentor is proposed, the respective areas of 
expertise and responsibility should be described.

Environment and Institutional Commitment

o   The sponsoring institution must document a strong, well-
established public health research program including a high-
quality research environment with faculty that have had 
productive collaborations.  The sponsoring institution also must 
provide a statement to document the level of commitment to the 
candidate's development into a productive, independent 
investigator during the period of the award.  This must include 
an indication of support for the candidate's proposed level of 
effort (at least 75 percent), commitment to the necessary release 
time, as well as the availability of support and supervision 
during the award period.  
 
Budget requests must be provided according to the instructions in form 
PHS 398, and the limitations referenced above.

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 in accordance with the review criteria stated below.  CDC 
uses a peer review process modeled after that of the NIH, including a 
streamline 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 mentored research scientist award aims to increase the number of 
independent researchers that have the capacity to conduct innovative 
public health research that addresses priority health protection 
issues.  The following criteria will be considered in the evaluation of 
the proposed mentored research scientist development award program:

o Candidate -- The candidate's overall qualification as demonstrated by 
academic record and research performance, potential for a career as an 
independent researcher, commitment toward pursuit of a research career. 

o Candidate's Career Development Plan -- The quality of the research 
career development plan, based on the candidate's past research 
experience, training, and career goals, as demonstrated by such things 
as relevance of the proposed didactic training, and structure of 
interaction with the mentor.  The likelihood that the plan will 
contribute substantially to the achievement of scientific independence 
and the quality of the proposed training in responsible conduct of 
research will be considered. 

o Research Project -- Scientific and technical merit or the research 
question, design, and methodology.  Reviewers recognize that applicants 
will have variable amounts of previous research experience. Those with 
limited research experience are less likely to be able to prepare a 
research plan with the breadth and depth of that submitted by a more 
experienced investigator.  Nevertheless, all applications must include 
a fundamentally sound research plan but reviewers will consider the 
applicant’s prior experience in judging the level of detail provided. 
Appropriateness of the research project as a vehicle for developing the 
candidate's research skills.

o Mentor(s)/ Co-Mentor (s) -- The mentor's accomplishments in the 
scientific research area(s) proposed, plans for mentoring the 
candidate, experience and record in training investigators, and 
commitment for the duration of the project.  A curriculum vitae with 
relevant publications and a list of current and pending research 
support must be included for all mentors.  Mentors should also include 
a list of current and past research trainees (not more than the last 10 
years) with information on their current positions.

o Environment -- The applicant institution's ability to provide 
adequate facilities, resources, and opportunities necessary for the 
candidate's training, and the institutional commitment to the 
candidate.  If the mentor(s)' institution is different from the 
applicant, the quality and extent of interaction of the faculty and 
assurance that the candidate is an integral part of the institution’s 
research program.  The quality of the research and research training 
programs at the mentor's institution will be considered.

o Institutional commitment -- The institution's commitment to the 
development of the candidate.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

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

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).

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.  

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 secondary review 
committee.
 
REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45 CFR Part 46) 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 CDC 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)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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