TRANSITION TO INDEPENDENT POSITIONS (TIP)

RELEASE DATE:  March 18, 2002

RFA:  ES-02-006

National Institute of Environmental Health Sciences (NIEHS) 
 (http://www.niehs.nih.gov)

LETTER OF INTENT RECEIPT DATE:  June 10, 2002

APPLICATION RECEIPT DATE:  July 10, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS RFA

Human health and human disease result from three interactive elements: (1) 
environmental exposures, (2) individual susceptibility, and (3) time.  The 
mission of the National Institute of Environmental Health Sciences (NIEHS) is 
to reduce the burden of human illness and dysfunction from environmental 
exposures by understanding each of these elements and how they interrelate.  
The NIEHS achieves its mission through multi-disciplinary biomedical research 
programs, prevention and intervention efforts, and communication strategies 
that encompass training, education, technology transfer, and community 
outreach.

An important element of the NIEHS mission is to develop the next generation of 
exceptionally talented young scientists who are committed to understanding the 
impact of environmental exposures on human health.  The NIEHS TIP Program is a 
Research Scholar Development Award (K22) program targeted to talented 
postdoctoral scientists.  It provides a unique mechanism for attracting and 
supporting the transition to independent faculty positions of exceptionally 
talented new investigators who can impact our understanding of the problems 
and mechanisms associated with exposure to environmental agents in order to 
better protect the public health.

RESEARCH OBJECTIVES

Background

The Congress of the United States enacted the National Research Service Act 
(NRSA) Program in 1974 to help ensure that highly trained scientists would be 
available in adequate numbers and in appropriate research areas to carry out 
the Nation"s biomedical and behavioral research agenda.  Under this 
congressional authority, the NIEHS awards the NRSA individual postdoctoral 
fellowship (F32) and Intramural Research Training Award (IRTA) to the most 
promising applicants to support full-time research training related to the 
mission of the NIEHS.  The goal of these and other postdoctoral training 
programs is to develop the next generation of exceptionally talented young 
scientists who are committed to understanding the impact of environmental 
exposures on human health.  The NIEHS has determined that there is a need for 
a mechanism to assist exceptionally talented investigators in making the 
career transition from postdoctoral training to independent academic research 
positions.  To meet this need, the NIEHS has initiated the TIP Program to 
facilitate the transition of the most talented postdoctoral investigators into 
career positions relevant to the research priorities of the NIEHS.

Goals and Scope

The NIEHS TIP Program is designed for exceptionally talented new environmental 
health scientists in basic, clinical or population-based (epidemiology) 
research who have demonstrated outstanding scientific abilities during their 
training.  The objective of the program is to provide a commitment of support 
for the most promising new investigators early in their career while they 
establish their independent research program in a research-intensive 
environment relevant to environmental health sciences.  The TIP investigators 
are expected to design and pursue their research projects independently in 
their areas of interest.  It is anticipated that the successful applicant will 
use the award to establish an independent research program and obtain 
preliminary data that will be the basis for a future research application.  
Specifically, the TIP investigator is expected to use the preliminary data in 
the environmental health sciences as a basis for an investigator initiated 
research grant (R01) or equivalent to the National Institutes of Health (NIH) 
in an area of a science directly relevant to the mission of the NIEHS within 
the first 24 months after initiation of the award.

The NIEHS has identified priority areas of research that can significantly 
contribute to our understanding of the impact of environmental exposure on 
human health.  Research proposals that address one of these areas will receive 
a priority for funding.  The current areas of special emphasis are:

o Molecular Epidemiology (this is an emerging area of science of particular 
importance to NIEHS)

o Basic Molecular Mechanisms of Environmental Insult

o Genetic Susceptibility and Predispostion (Environmental Genome Project)

o Human Health Effects of Complex Mixtures

o Reproductive Health

o Neurodegenerative/Neurobehavioral Diseases or Disorders

o Translational Research

o Impact of Environmental Exposures on Special Populations (Women, Children 
and Minorities)

o Diet and Nutrition 

o Immune System Modulation

Additional information about these research topics is available on the NIEHS 
website at:  http://www.niehs.nih.gov/dert/programs/special/special.htm.
This site is updated each year.

MECHANISM OF SUPPORT

This RFA will use the NIH Research Scholar Development Award (K22) mechanism.  
As an applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  Future 
unsolicited, competing-continuation applications based on this project will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  The anticipated award date 
is September 2004.

FUNDS AVAILABLE

The NIEHS intends to commit approximately $500,000 in FY04 to fund four to 
five new awards in response to this RFA.  An applicant may request a project 
period of up to three years and a budget for direct costs of up to $100,000 
per year.  Although the financial plans of the NIEHS 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.  
Scholar Development grants (K22) are not renewable but may be extended at no 
additional costs at the discretion of the sponsoring institution where the TIP 
award has been made.  At this time, it is not known if this RFA will be 
reissued.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

To be eligible to apply for a TIP Award the following criteria will apply:

1. The applicant must be either:

A. A current or former NIEHS Individual National Research Service Fellow 
(NRSA, F32), or

B. A current or former NIH Individual NRSA (F32) Fellow who is training in an 
area specific to the mission of the NIEHS, but whose support is from another 
Institute, Center or Division (IC) of the NIH and whose proposed research 
project directly addresses the effect of an environmental exposure on human 
illness or dysfunction, or

C. A current NIEHS Intramural Research Training Awardee (IRTA), equivalent 
staff fellow, or intramural clinical fellow who has competed successfully in 
the NIEHS Intramural eligibility process.  NIEHS clinical fellows with the 
M.D., M.D.- Ph.D., D.O., D.D.S., Pharm.D - MS, Pharm.D - Ph.D., RN - Ph.D. or 
comparable clinical or combined clinical/research degrees are eligible to 
apply.  In most cases, clinical fellow applicants will have finished their 
clinical training and may have had some research experience in either a 
laboratory or clinical setting prior to an appointment in the NIEHS Intramural 
Program. Clinical candidates should possess aptitudes for independent research 
in clinically relevant, patient-oriented or population- based research (e.g., 
epidemiology, behavior, or disease prevention) areas.  The Intramural contact 
person for this program is Dr. Steven Akiyama, 919-541-3467 or 
akiyama@niehs.nih.gov.

Individuals with a research or health professional doctoral level degree or 
equivalent with at least 18 months but not more than six years (72 months) of 
postdoctoral research training at the time of application, and with 
demonstrated outstanding abilities in basic, clinical or population-based 
(e.g., epidemiologic) research, are eligible to apply.  This includes 
individuals with postdoctoral research experience in any environment (e.g., 
academic, industry, and government).  Individuals who have had more than six 
years (72 months) of postdoctoral research experience are NOT eligible to 
apply.  However, years of clinical training will not count against the six 
years of relevant research experience.  Individuals who have held research or 
other professorship or equivalent positions in academe or elsewhere or have 
been a Principal Investigator on either PHS research grants (e.g., R29, R01, 
P01, or its subprojects) or non-PHS peer-reviewed research grants are NOT 
eligible to apply for this award.

The NIEHS will return applications not considered relevant either to the 
mission or to the research priorities of the NIEHS as part of the initial 
review described in the section, REVIEW CRITERIA of this Request for 
Applications.  This decision is final.  Fellows are STRONGLY ENCOURAGED to 
contact the program administrator listed under WHERE TO SEND INQUIRIES to 
determine the priority and relevance of his/her research topic to the NIEHS 
prior to submitting an application.  Applicants should identify an NIEHS area 
of special emphasis that is relevant to his/her research interests.  This 
information is available on the NIEHS web site at 
http://www.niehs.nih.gov/dert/programs/special/special.htm.

Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH programs.  
Candidates must be U.S. citizens or non-citizen nationals, or must have been 
lawfully admitted for permanent residence and possess an Alien Registration 
Card (I-151 or I-152) or some other verification of legal admission as a 
permanent U.S. resident, at the time of submission.  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, 
jurisdictions, or administration.  Individuals on temporary or student visas 
are NOT eligible to apply.  The TIP K22 is a domestic U.S. award and may not 
be awarded to non-U.S. grantee institutions.  

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:

Carol Shreffler, Ph.D.
Scientific Program Administrator
Organs and Systems Toxicology Branch (EC-23)
Office of Program Development
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive  
Research Triangle Park, NC  27709 
Telephone:  (919) 541-1445
FAX:  (919) 541-5064 
Email:  shreffl1@niehs.nih.gov

o Direct your questions about peer review to:

Linda Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30) 
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences 
P.O. Box 12233, 111 T.W. Alexander Drive
Research Triangle Park, NC  27709 
Telephone:  (919) 541-1307 
FAX:  (919) 541-2503 
Email:  bass@niehs.nih.gov

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

Ms. Carolyn Mason
Grants Management Officer
Grants Management Branch (EC-22)
Office of Program Operations
Division of Extramural Research and Training 
National Institute of Environmental Health Sciences 
P.O. Box 12233, 111 T.W. Alexander Drive  
Research Triangle Park, NC  27709 
Telephone:  (919) 541-1373 
FAX:  (919) 541-2860  
Email:  mason6@niehs.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 project
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 NIEHS staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent to by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Linda Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30) 
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences 
P.O. Box 12233, 111 T.W. Alexander Drive
79 T.W. Alexander Drive, 3rd Floor (for express/courier service)
Research Triangle Park, NC  27709 
Telephone:  (919) 541-1307 
FAX:  (919) 541-2503 
Email:  bass@niehs.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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.

SUPPLEMENTAL INSTRUCTIONS

Only one grant application may be submitted by a Principal Investigator for 
the specified receipt date.  The applicant institution information requested 
on the face page should be that for the institution from which the application 
is being submitted, i.e., the institution where the trainee is located at the 
time of submission.  The Description, Performance Sites, and Key Personnel 
should appear as page two.

The Detailed Budget for the Initial Budget Period (Form Page 4) and Budget for 
Entire Proposed Period of Support (Form Page 5) are NOT required for the 
initial application and should be omitted.  A detailed budget is subsequently 
required only for the activation of the award at the academic institution of 
employment.  See specific instructions below for allowable costs

The maximum amount awarded to each grantee on this RFA will be $300,000 direct 
costs for a three-year project period.  The amount awarded for any given year 
(budget period) will not exceed $100,000 direct costs.  

The maximum salary allowed from this award is $50,000 per year.  

A two section narrative presentation (two-page maximum) should be inserted in 
the application just prior to the research plan titled "Future Goals and 
Objectives" and "Biography", respectively.  In the Future Goals and Objectives 
section (one-half page maximum), the applicant should briefly describe his/her 
career track vision and describe the types of positions to be pursued.  In the 
Biography section (one and one-half page maximum), the applicant should 
describe their scientific development from graduate school through 
postdoctoral experience(s).  For each training experience, the applicant 
should describe his/her role in the laboratory/project and cite relevant 
publications that resulted from the experience.  The applicant should also 
include in this section a short narrative on how the proposed research project 
will lead to a successful R01 application.

The Research Plan itself (Specific Aims, Background and Significance, 
Preliminary Studies, Research Design and Methods sections) is not to exceed 15 
pages.  Tables and figures but not the Literature Cited section are included 
in the 15-page limitation.  Applications that exceed the page limitations 
stated in this RFA announcement or the PHS 398 requirements for font size 
(height or letters), type density (characters per inch), and margins (see PHS 
398 directions) will be returned to the investigator.

The Research Plan is expected to follow the typical NIH grant application 
organization and structure, and should include, but is not limited to the 
following:

o a one-page description (or less) of the long term research goals and how 
his/her research program would impact on an environmental health problem, and

o a specific testable hypothesis, and

o a set of specific aims to address the hypothesis, and

o methods to obtain data to satisfy the specific aims.

If the application is a revision of a previously considered application, there 
should be a clear indication of changes marked as indicated in the 
instructions for the PHS 398 application.  It is expected that a TIP award 
would provide an investigator the opportunity to obtain the scientific data 
needed for a subsequent investigator-initiated research grant (R01) or 
equivalent to the NIH within the mission of the NIEHS.

The applicant MUST send three letters of recommendation to Dr. Linda Bass at 
the address provided above.  The letters must address the applicant"s 
potential to become an important contributor to basic or clinical biomedical 
or behavioral research or population-based (e.g., epidemiological) research 
relevant to the mission of NIEHS.  One of the letters of recommendation MUST 
be from the current postdoctoral mentor and one MUST be from the applicant"s 
pre-doctoral program, preferably the mentor.  Applications submitted without 
concomitantly submission of reference letters to Dr. Bass will be considered 
incomplete and will not be accepted.  Late receipt of letters of 
recommendation (e.g. letters not submitted concomitantly with the application) 
will not be allowed.  

Note: The letter from the current postdoctoral mentor should address the 
following points.

1. The applicant"s role and intellectual contribution to the research 
activities of the laboratory.

2. The current postdoctoral mentor"s role in the development of the proposed 
project.

3. The applicant"s potential for independent research.

Color/glossy photos may be submitted as an appendix, however, the appendix may 
not be used to circumvent the page limitation.  Letters of recommendation are 
not considered appendices, and do not count towards the 15-page limit.

The applicant must provide one to three publications from his/her Ph.D. work 
and one publication from his/her postdoctoral work.

A PHS 398 form biographical sketch of the postdoctoral mentor should be 
included in the application.

SPECIFIC INSTRUCTIONS FOR ALLOWABLE COSTS

The detailed budget for the TIP award will be $100,000 direct cost per year 
for three years.  The total direct costs for this award are $300,000 over a 
period of three years.  Facilities and Administration (F&A) costs will be 
reimbursed at eight percent of modified total direct costs or at the actual 
facilities and administration (indirect) cost rate, whichever is less.

The awardee and sponsoring institution will have considerable latitude in 
deciding how these funds will be expended, with the exception of salary 
(described below).  This is to allow sufficient flexibility and benefit to the 
awardee"s research and academic career.

Salary:  The awardee may request up to $50,000 per year (plus fringe benefits) 
from this award for salary.  The award does not require that salary support be 
derived from the award, use of the entire direct costs for research related 
expenses is allowed. The total salary requested must be 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 to other staff members of equivalent qualifications, rank, and 
responsibilities in the department.

Research-Related Expenses:  The entire direct costs of this award, or the 
balance remaining after subtracting the amount devoted to salary, may be used 
for supplies, equipment, technical personnel, travel and other 
research related expenses.

Applicants must budget travel costs associated with a professional meeting 
(one per year) in their applications.

Equipment is limited to $100,000 direct costs for the three-year project 
period.   
  
Ancillary Personnel Support:  Salary for secretarial or administrative 
assistance is not allowed.

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 available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.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 must be 
sent to:

Linda Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30)
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P. O. Box 12233
111 T.W. Alexander Drive 
79 T. W. Alexander Drive, 3rd Floor (for express/courier service)
Research Triangle Park, NC  27709

APPLICATION PROCESSING

Applications must be received by 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.

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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIEHS.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.  

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 NIEHS in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o Receive a written critique
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 second level review by the National Advisory Environmental Health 
Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. In the 
written comments, reviewers will be asked to discuss the following aspects of 
your application.

Candidate

o the applicant"s potential to become an important contributor to basic, 
clinical or population-based (e.g., epidemiological) research or behavioral 
science within the mission of NIEHS,

o the qualifications and research experience of the Principal Investigator and 
staff, particularly, but not exclusively, in the area of the proposed 
research.

Research Plan

o the originality, innovation and scientific or medical significance of the 
project as to new concepts and ideas,

o the appropriateness and adequacy of the experimental approach and 
methodology proposed to carry out the research, the appropriateness of the 
work proposed to the experience level of the principal investigator, the 
acknowledgment of potential problem areas and consideration of alternative 
tactics,

o the adequacy of plans to include both genders, minorities, and their 
subgroups as appropriate for the scientific goals of any clinical research 
activities.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o the adequacy of the proposed protection for humans, animals, or the 
environment to the extent they may be adversely affected by the activities 
proposed in the application.

Budget

Although a budget is not required, the appropriateness of the scope of work 
for the funds that are available through this grant will be considered.  The 
applicant should assume that general laboratory equipment items such as 
spectrophotometer, centrifuges, etc., will be available at the institution. 
However, highly sophisticated or limited use equipment required for the 
studies should be identified and funds for the use of such equipment should be 
considered by the applicant in developing the research plan.  For example, 
magnetic resonance imaging equipment and fluorescence cell sorters are 
available for a fee at many institutions, and the cost for their use should be 
considered by the applicant.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  June 10, 2002
Application Receipt Date:  July 10, 2002
Peer-Review Date:  October-November, 2002
Council Date:  February 2003
Earliest Award Date:  To be determined

AWARD CRITERIA

The anticipated date of notification of a Letter to Commit Funds is March-
April, 2003.  The following will be considered in making funding decisions:
(a) potential of the applicant to make a significant contribution to the NIEHS 
mission, (b) quality of the proposed projects scientific merit as determined 
by peer review, (c) availability of funds, and (d) program balance among 
research areas of the announcement.

AWARD PROCESS AND INITIATION

At the time a decision is made to make an award, the applicant will be 
provided a Letter to Commit Funds that states intent to commit funds, which 
will be signed by the NIEHS Grants Management Officer. This letter states the 
conditional intent of the NIEHS to make a grant award and may be used by the 
candidate when entering into negotiations for a position with a suitable 
institution to document potential grant support for the candidate"s research 
project.  The date of this letter will determine the expiration date of the 
NIEHS offer to commit funds to a grant award.  Please note that this is 
different from the usual NIH process since this commitment is not made 
initially to a specific institution.

After a TIP investigator has identified a permanent position, preferably 
tenure-track or equivalent, at a research intensive domestic institution 
(sponsoring grantee institution), the sponsoring institution will request that 
an award be issued by submitting the appropriately prepared form PHS 398 
(competing grant application) that includes a detailed budget.  The 
application must also include letters from the institutional official signing 
the application describing the position and confirming that the TIP 
investigator has been offered and has accepted a permanent, preferably tenure-
track or equivalent, position.  In addition, a statement from the Department 
Chair or equivalent official must be included which describes the resources 
that will be available for the TIP investigator.  Finally, if the research 
involves animals/human subjects, the certification that the protocols were 
approved by the appropriate institutional committee of the designated grantee 
institution must be provided.  These and other relevant materials are to be 
submitted to the NIEHS Grants Management Office at the address listed on the 
Letter of Commitment.

These materials will be used by NIEHS staff to carefully assess the 
appropriateness and soundness of the proposed arrangement.  The institution 
will be examined for its ability to make a significant commitment of 
resources, time and other factors conducive to the research project and career 
establishment of the TIP investigator.  In addition, the TIP investigator must 
be appointed to a permanent position in a research-intensive environment 
relevant to environmental health sciences.  It is the intent of the NIEHS that 
the applicant relocate to another, different research intensive institution, 
and not remain at the current postdoctoral institution.  Arrangements in which 
a candidate moves from a postdoctoral position to that of an assistant 
professor at the same institution are specifically discouraged, and if 
proposed by the TIP investigator, must document an especially strong, 
compelling case for such a position"s eligibility for consideration.

Please note that an award can ONLY be made after the TIP investigator has 
accepted a position at a sponsoring institution, this acceptance of a position 
must be confirmed by the institutional official.  Finally, it is important to 
note that no funds can be obligated or used until the award has been made to a 
grantee sponsoring institution.

NIEHS recognizes that each TIP investigator will have unique circumstances 
that will affect the timing for the initiation of the award.  Thus, the NIEHS 
will allow the TIP investigator up to 18 months between the date of the Letter 
to Commit Funds notifying the applicant of funding availability for an 
application and the start of a permanent position at a research-intensive 
institution.  The grantee institution application submitted on behalf of the 
TIP applicant to activate the award must be received no later than 5:00 p.m. 
(EST) of the last business day of the first week in August of the year in 
which the 18-month period concludes.  Please note that this timing is 
determined by the Federal fiscal year, not subject to change, and funds 
identified in the NIEHS Letter to Commit Funds will not be available after the 
close of the final NIEHS fiscal year for the 18-month period specified 
therein.

REQUIRED FEDERAL CITATIONS

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 involving human subjects 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 read the AMENDMENT "NIH 
Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research – Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001, http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html, a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min//guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.  

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

HUMAN EMBRYONIC STEM CELLS (hESC)

Criteria for Federal funding of research on hESCs can be found at 
http://grants.nih.gov/grants/stem_cells.htm 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 
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 applications 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.

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 the directly access an Internet site.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This RFA is related to one or more of 
the priority areas.  Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.113 and 93.115, and is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.  Awards 
are made under authorization of Sections 301 and 405 of the Public Health 
Service Act, as amended  (42 USC 241 and 284) and administered under NIH 
grants policies described at http://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92.  

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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