TRANSITION TO INDEPENDENT POSITIONS (TIP)

RELEASE DATE:  March 4, 2004  

RFA Number:  RFA-ES-04-002

Expiration Date:  July 14, 2004

Department of Health and Human Services (DHHS)

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

COMPONENTS OF PARTICIPATING ORGANIZATION: 
National Institute of Environmental Health Sciences (NIEHS)
 (http://www.niehs.nih.gov)
Office of Dietary Supplements (ODS)
 (http://ods.od.nih.gov/)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.113 and 93.115

LETTER OF INTENT RECEIPT DATE:  June 13, 2004
APPLICATION RECEIPT DATE:  July 13, 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 Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Allowable Costs
o Peer Review Process
o Review Criteria
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 Ruth L. Kirschstein 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 non-mentored 
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 Obesity and the Environment

o The Translation of Basic Biology to Clinical Studies and Environmental 
Medicine: The Connection of Environmental Exposures and Clinical Outcome

o Epigenetics: Role in Environmentally induced Diseases/Dysfunction

o Single Nucleotide Polymorphisms and Disease Susceptibility

o Environmental Health and the Biology of Aging

o Comparative Toxicogenetics

o Systems Biology Approaches to the Study of the Mechanism of Mixture 
Toxicology

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.

The Office of Dietary Supplements is willing to support applications that 
address the role of dietary supplements in health promotion and disease 
prevention.  Priority areas for research funding are contained in the 2004-
2009 Strategic Plan for the Office of Dietary Supplements 
http://ods.od.nih.gov/pubs/SP10B.Web.pdf

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 July, 2005.

This RFA uses just-in-time concepts.  A detailed budget will be required at 
the time of activation of the award.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at: 
http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_part2.htm#matching_or_cost_sharing

FUNDS AVAILABLE

The NIEHS intends to commit approximately $500,000 in FY05 to fund 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.

ELIGIBLE INSTITUTIONS

It is anticipated that applications will originate from the fellow’s current 
postdoctoral institution and the awards will be made at the institution where 
the postdoctoral applicant accepts a suitable position.  Institutions 
eligible to receive awards include public or private domestic institutions, 
such as universities, colleges, hospitals, and laboratories.  Please see the 
Award Process and Initiation section below for details.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

o The applicant must be either:

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

2. 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

3. 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. William T. Schrader, 
919-541-3433, or schrader@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.  In exceptional circumstances, waivers 
to the six-year limitation may be requested in writing, and these will be 
considered on a case-by-case basis.  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, 
R21, P01, or its subprojects) or non-PHS peer-reviewed research grants 
intended for faculty members are NOT eligible to apply for this award.

A candidate for a K22 may not simultaneously submit or have pending an 
application for any other PHS award that duplicates any provision of this 
award.  K22 recipients may not concurrently hold or be awarded any other 
career development award.  K22 recipients are expected to apply for 
independent research grant support during the period of the 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
Cellular, Organ and Systems Toxicology Branch (EC-23)
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

Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, MSC 7517
Suite 3B01
Bethesda, MD  20892-7517
Telephone:  (301) 435-3608
Fax:  (301) 480-1845
Email: piccianm@od.nih.gov

o Direct your questions about peer review to:

Janice B. Allen, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30) 
Division of Extramural Research and Training
National Institute of Environmental Health Sciences 
P.O. Box 12233
Research Triangle Park, NC  27709 
Telephone:  (919) 541-7556 
FAX:  (919) 541-2503 
Email: Allen9@niehs.nih.gov

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

Ms. Susan Ricci
Grants Management Branch (EC-22)
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) 316-4666
FAX:  (919) 541-2860 
Email: ricci@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:

Janice B. Allen, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30) 
Division of Extramural Research and Training
National Institute of Environmental Health Sciences 
P.O. Box 12233
79 T.W. Alexander Drive, Bldg 4401 Room 3170B (Courier or Express)
Research Triangle Park, NC  27709 
Telephone:  (919) 541-7556
FAX:  (919) 541-2503 
Email: allen9@niehs.nih.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

SUPPLEMENTARY 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 his/her 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 reference bibliography, 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.

Although the research proposal is expected to be independently designed and 
independently carried out by the candidate, input by the sponsor and other 
senior faculty into the review and editing of the application is encouraged 
as a part of the career development experience.

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 include three letters of recommendation that 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 without letters of recommendation 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.  Letters should be mailed directly to Dr. Janice Allen, Scientific 
Review Administrator, at the address given in the WHERE TO SEND INQUIRIES 
section of this RFA. 

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/labels.pdf

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Janice B. Allen, Ph.D.
Scientific Review Administrator
Scientific Review Branch (EC-30)
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
79 T.W. Alexander Drive, Bldg. 4401 Room 3170B (Courier or express service)
Research Triangle Park, NC  27709

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 acknowledgment of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.  

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  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 nonresponsive applications 
will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NIEHS in accordance with the review criteria stated below.  

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 evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
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, 
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.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROECTION 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.

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 13, 2004
Application Receipt Date:  July 13, 2004
Peer-Review Date:  October-November, 2004
Council Review:  February, 2005
Earliest Anticipated Start Date:  July, 2005

AWARD CRITERIA

The anticipated date of notification of a Letter to Commit Funds is March-
April, 2005.  The following will be considered in making funding decisions:

o Potential of the applicant to make a significant contribution to the NIEHS 
mission.
o Quality of the proposed project’s scientific merit as determined by peer 
review.
o Availability of funds.
o 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.

The submitted 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 will 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

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on 
Humane Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), 
as mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), 
and the USDA Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects 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 should 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 subject 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://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 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR).  Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution.  The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
Entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under 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.  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 Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and 
established within the Office of the Director, National Institutes of Health 
(NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law 
103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act "to 
establish standards with respect to dietary supplements." This law authorized 
the establishment of the ODS.

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.


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