NHLBI CAREER TRANSITION AWARD (K22)

RELEASE DATE:  August 26, 2002

PA NUMBER: PAR-02-154 (Reissued as PAR-07-317)
                      (Expiration Date extended, see NOT-HL-06-119)
                      (Expiration Date extended, see NOT-HL-05-120)

EXPIRATION DATE:  June 2, 2006 for New Applications
                  January 22, 2007 for Revised Applications (see NOT-HL-06-119)

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

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The overall goals of the National Heart, Lung, and Blood Institute (NHLBI) 
Career Transition Award (K22) program are to enable outstanding individuals to 
obtain a research training experience in the NHLBI Division of Intramural 
Research and to facilitate their successful transition to an extramural 
environment as independent researchers.  The award will provide up to three 
years of support for research training in an NHLBI intramural laboratory 
followed by two years of support for an independent research project in an 
extramural institution.  It is anticipated that awardees will subsequently 
obtain research project grants such as the R01 to support the continuation of 
their work.

RESEARCH OBJECTIVES

The NHLBI intramural research environment has provided a unique opportunity 
for the training of new scientists who have subsequently entered the 
extramural biomedical research community and have become leaders in their 
fields of investigation.  The goal of the NHLBI K22 program is to provide 
highly qualified new investigators with an opportunity to receive mentored 
research experience in the NHLBI Division of Intramural Research and then to 
provide them with bridge funding to facilitate the transition of their 
research programs to extramural institutions.

To achieve these objectives, the NHLBI Career Transition Award will support 
two phases of research:  an intramural phase and an extramural phase, for a 
total of four to five years of combined support.  Transition from the 
intramural phase of support to the extramural phase is not automatic.  
Approval of the transition will be based on the success of the awardees" 
research program as determined by an NHLBI progress review, which will take 
place no later than the end of the second year of the Intramural Support 
Phase, and the evaluation of a research plan to be carried out at the 
extramural institution.  The extramural institution must demonstrate a 
commitment to the candidate by providing protected research time and space 
needed to perform the proposed research.  Matching funds from the extramural 
institution for equipment and supplies (and if necessary, salary) are 
encouraged.  Awardees approved to proceed with the second phase of support 
will receive notification of approval in writing from the NHLBI.  An 
application from the extramural institution on behalf of the candidate will be 
required for the NHLBI to process the second phase of the K22.

NHLBI DIVISION OF INTRAMURAL RESEARCH

The NHLBI provides leadership for a national program in diseases of the heart, 
blood vessels, blood, and lungs, and in the use of blood and the management of 
blood resources.  It plans, conducts, fosters, and supports an integrated and 
coordinated program of research, investigations, clinical trials, and 
demonstration and education projects relating to the causes, prevention, 
methods of diagnosis, and treatment (including emergency medical treatment) of 
cardiovascular and cardiopulmonary diseases.

The Division of Intramural Research conducts clinical research on the normal 
and pathophysiologic functioning of the cardiac, pulmonary, blood, and 
endocrine systems and basic research on normal and abnormal cellular behavior 
at the molecular level.  The research activities of the laboratories and 
branches range from structural organic chemistry to cardiology.  Major areas 
of interest include:

Mechanisms of gene regulation, viral-mediated gene transfer and gene therapy, 
the molecular basis of lipoprotein dysfunctions and the atherogenic process, 
the molecular basis of diseases of the alveolar structures of the lung and the 
design of new therapeutic modalities, the cellular and molecular events 
underlying ischemic heart disease and myocardial hypertrophy, biochemical 
events associated with aging and certain pathologic processes, molecular, 
structural, and developmental aspects of muscle and nonmuscle contractile 
systems, cell and organelle movement, molecular and cellular processes for the 
conversion of metabolic energy into useful work, mechanisms of cardiac 
development,  the molecular basis of transmembrane signaling, the 
pathophysiology of renal function at the cellular and molecular levels, the 
biochemistry of trace nutrients, enzyme kinetics, metabolic regulation, and 
protein chemistry, the cellular and molecular basis of toxicities induced by 
drugs and other foreign compounds, molecular immunology and cytokines, 
hematopoietic stem cell biology and bone marrow transplantation, 
pathophysiology of vascular diseases with emphasis on molecular genetic 
interventions, cardiac imaging through ultrasound and magnetic resonance 
imaging, as well as some aspects of cardiovascular devices, computational 
biophysics, and mass and optical spectroscopy.  Animal medicine and surgery 
support is provided to both clinical and basic science by full-time NHLBI 
staff.

MECHANISM OF SUPPORT 

Awards in response to this PA will use the K22 mechanism.  Planning, 
direction, and execution of the candidate"s individual research and training 
program will be the responsibility of the candidate and his/her mentor.  The 
total period of support is four or five years (two or three years intramural, 
plus two years extramural).  Awards are not renewable. Total direct costs for 
the intramural phase are based on the candidate"s experience, not to exceed 
$150,000 per year, including salary, those for the extramural phase cannot 
exceed $150,000 including fringe benefits per year in direct costs or $300,000 
for the two-year period.  (For information about specific allowable costs, 
please see ALLOWABLE COSTS).  The NHLBI anticipates making five awards per 
year.

ALLOWABLE COSTS

Intramural Support Phase:

Support during the intramural phase will include a fellowship stipend, be 
based on the candidate"s years of postdoctoral experience, commensurate with 
the NHLBI intramural salary structure.  Research expenses including personnel, 
consultants, equipment, supplies, and travel will be negotiated with the 
laboratory chief and will depend on the nature and scope of the research 
approved by peer review. Allowable costs will follow those specified for the 
Extramural Support Phase which follows.

Extramural Support Phase:

1. Salary:  The NIH NHLBI will provide salary for the award recipient of up to 
$75,000 per year plus commensurate fringe benefits for a minimum of 75 percent 
effort.  Although a greater effort may be proposed, the maximum allowable 
salary is $75,000.  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 from its own funds to other staff members of equivalent 
qualifications, rank, and responsibilities in the department concerned.  The 
institution may supplement the NIH 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.  Institutional supplementation of 
salary must not require extra duties or responsibilities that would interfere 
with the purpose of the K22.  If the grant is subject to streamlined non-
competing application procedures (SNAP), institutions may rebudget funds 
within the total costs awarded to cover salaries consistent with the 
institution"s salary scale provided they do not exceed the current legislated 
maximum salary.

2.  Research Support:  The NHLBI will provide up to $75,000 per year for (a) 
research expenses, such as supplies, equipment, and technical personnel, (b) 
travel to research meetings or training, and (c) statistical services, 
including personnel and computer time.  Total direct costs, including salary, 
fringe benefits and research support, may not exceed $150,000 per year.

3.  Ancillary Personnel Support:  Salary for secretarial and administrative 
assistance, etc., is not allowed.

4.  Facilities and Administrative Costs (F&A):  F&A costs will be reimbursed 
at eight percent of modified total direct costs.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any eligible individual with the skills and knowledge necessary to enter into 
the mentored training experience is invited to work with the Division of 
Intramural Research at NHLBI to develop an application for support. 
Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH programs.

The candidate must have a research or a health-professional doctorate or its 
equivalent, and must have postdoctoral research experience, during which the 
potential for highly productive basic or clinical research was demonstrated.  
During the intramural phase of the award, the candidate will spend full time 
on research. During the subsequent two-year extramural phase, the candidate 
must spend a minimum of 75 percent of full-time professional effort conducting 
research and research career development activities.

The required research experience may have been completed in an intramural NIH 
laboratory or at an extramural institution.  To obtain support for the 
extramural phase, candidates must have a formal tenure- track (or equivalent) 
offer in an extramural institution.

Minorities, women, and persons with disabilities are encouraged to apply. 
Candidates must be U.S. citizens or noncitizen nationals, or must have been 
lawfully admitted for permanent residence and possess an Alien Registration 
Receipt Card (I-151 or I-551) or some other verification of legal admission as 
a permanent resident.  Individuals on temporary or student visas are not 
eligible.

Former principal investigators on NIH research project (R01), FIRST Awards 
R29), SBIR/STTR awards, sub-projects of program project (P01) or center grants 
P50), K08 awards, or the equivalent, are not eligible.  Former principal 
investigators of an NIH Small Grant (R03) or Exploratory/ Development Grants 
R21) remain eligible.  A candidate for the NHLBI Career Transition Award may 
not concurrently apply for any other PHS award that duplicates the provisions 
of this award nor have another application pending award.

SPECIAL REQUIREMENTS

Acceptance into the NHLBI Career Transition Award Program does not convey any 
commitment or intent of the NHLBI to consider the awardee for a tenure track 
position within the NHLBI.  The NHLBI Career Transition Award is specifically 
intended to help develop scientists who will pursue their careers in the 
extramural biomedical research community.  However, the NHLBI K22 awardees are 
not explicitly precluded from applying for available tenure track positions at 
the NIH.  If an awardee obtains an NIH position, the NHLBI Career Transition 
Award will be terminated.

Once a K22 award is made, the awardee is expected to remain with the NHLBI 
Intramural Program for at least 18 months.  Exceptions may be reviewed on a 
case-by-case basis.

APPLICATION PROCEDURES:  Individuals interested in applying for the NHLBI K22 
Award must first identify a mentor within the Division of Intramural Research. 
The mentor should be in a position to offer a training experience that will 
enhance the candidate"s ability to conduct independent research.  The NHLBI 
Office of Education can assist in identifying potential mentors within the 
Division of Intramural Research.  Candidates wishing to take advantage of this 
assistance should contact the Office of Education at 
direducation@nhlbi.nih.gov and submit a curriculum vitae and a brief 
pre-application description of his/her past training, research experience and 
research interests as well as future research plans.  

Senior DIR staff will review this application for an intramural training 
position and attempt to identify appropriate mentors in the applicant"s area 
of interest who are willing to provide research training and provide this 
information to the applicant.  The Office of Education may then arrange for 
the applicant to visit the NIH campus and meet with these investigators so 
that a prospective mentor can be selected.  Once a mentor is identified, the 
candidate and mentor must work together to complete the application.  The 
application must include information regarding the candidate"s long-term 
career plan, a research training plan, including descriptions of proposed 
formal course work, a research plan, and the mentor"s statement of support.  
The application should specifically address how training to be received in the 
Division of Intramural Research will enhance the candidate"s ability to 
achieve their career goals of becoming an independent investigator.  

The application must address the following issues:

Candidate

o The candidate"s commitment to a career in biomedical or behavioral research.

o The candidate"s potential to develop into a successful independent 
investigator.

o The candidate"s immediate and long-term career objectives, explaining how 
the research training under the award will contribute to their attainment.

o Letters of recommendation.  Three sealed letters of recommendation 
addressing the candidate"s potential for a research career must be included as 
part of the application.

o Candidates 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, as well as the amount and 
nature of senior staff participation.  No award will be made if an application 
lacks this component.

Research Plan

o Describe the research plan and the use of a basic or clinical approach to a 
biomedical or behavioral problem.  The candidate must describe the research 
plan as outlined in form PHS 398 including sections on the Specific Aims, 
Background and Significance, Progress Report/Preliminary Studies, Research 
Design and Methods.

Mentor"s Training Plan (Intramural Phase)

o The mentor must describe the elements of research training planned for the 
candidate, including any formal course-work, and specify how the candidate"s 
scientific independence and professional development will be promoted.

Budget

The applicant should work with the potential NHLBI mentor to devise a budget 
for the Intramural Phase. Budget information for TOTAL DIRECT COSTS and cost 
justifications should be developed in accordance with the Budget Information 
instructions in form PHS 398.  For candidates who receive approval for 
transition to the Extramural Phase a budget will be submitted at that time as 
part of the form PHS 2590 (noncompeting application) as discussed below in 
EXTRAMURAL SUPPORT PHASE.

WHERE TO SEND INQUIRIES

E-mail and telephone inquiries concerning this PA are encouraged, especially 
during the planning phase of the application.  The opportunity to clarify any 
issues or address questions from potential applicants is welcome.

o Direct your questions about intramural programmatic issues to:

Dr. Herbert M. Geller
Director, Office of Education 
Division of Intramural Research
National Heart, Lung, and Blood Institute
10 Center Drive, Room 8C104, MSC 1754
Bethesda, MD  20892-1754
Telephone:  (301) 451-9440
FAX: (301) 594-8133
Email:  direducation@nhlbi.nih.gov  

o Direct your questions about extramural programmatic issues to:

Beth Schucker, M.A.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9206, MSC 7940
Bethesda, MD  20892- 7940
Telephone:  (301) 435-0535
FAX:  (301) 480-1454
Email:  schuckeb@nih.gov 

o Direct your questions about peer review issues and mail two copies of the 
completed application and any appendix material to:

Anne Clark, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD  20892-7924
Telephone:  (301) 435-0270
FAX:  (301) 480-0730
Email:  clarka@nhlbi.nih.gov 

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

Dawn Walker
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7148, MSC 7926
Bethesda, MD  20892-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email: walkerde@nhlbi.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  (See additional instructions for 
preparing individual research career award applications on page IV-1) 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. 

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines for Career 
Development Awards which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

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:

o To identify the application as a response to this PA, on page 1 of the 
application, on item 2 check "YES", enter the number of this PA and "NHLBI 
Career Transition Award" as the title.

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 as well as 
five collated sets of Appendix material must be sent to Dr. Anne P. Clark at 
the address listed in the WHERE TO SEND INQUIRIES section.

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not 
accept any application in response to this PA 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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened by NHLBI in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique 
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score 
o Receive a second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA

The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.

Intramural Support Phase

(1) CANDIDATE:

o Commitment to an independent research career.

o Potential to develop as an outstanding scientist who will make significant 
contributions to the field.

o All candidates for this award must have had previous research experience.  
Quality and breadth of prior scientific training and experience including, 
where appropriate, the record of previous research support and publications.

(2)  RESEARCH PLAN:

o A sound research plan that is appropriate for the research training 
objectives of the candidate must be provided.

o Appropriateness of the research plan as a vehicle for enhancing research 
skills necessary to fulfill the objectives of the career development plan,

o Scientific and technical merit of the research question, design, and 
methodology, judged in the context of the candidate"s proposed career 
objectives,

(3) CAREER DEVELOPMENT PLAN:

o Appropriateness of the proposed training experience to the candidate"s 
career development, considering the candidate"s goals and prior experience.

o Adequacy of plans to obtain instruction in the responsible conduct of 
research.

(4)  MENTOR:

o Research qualifications and previous experience as a research supervisor. 

o Adequacy of the nature and extent of supervision that will occur during the 
proposed award period.

o Appropriateness of the mentor"s research interests and qualifications to the 
career development needs of the candidate.

o Adequacy of the proposed mentoring plan.

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

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  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 included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research (see Allowable Costs).

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

SELECTION PROCEDURES

Intramural Support Phase

Following peer review, applications will be considered by a NHLBI Selection 
Committee (NSC) consisting of Senior Scientists from the NHLBI Intramural 
Program convened by the Division of Extramural Affairs, NHLBI.  Based on 
priority score ranking and programmatic needs, this committee will determine 
the final candidates to be selected.

ACTIVATING THE EXTRAMURAL SUPPORT PHASE

The candidate must receive approval in writing from the NHLBI and must be 
accepted by an extramural institution in order to activate the extramural 
support phase.  The extramural institution will submit an application on 
behalf of the candidate for the extramural phase of support, using form PHS 
2590, the noncompeting application.  The application submitted by the awardee 
and the extramural institution for activation of the extramural phase of the 
program will be evaluated by NHLBI extramural staff for completeness and 
responsiveness to the program.

EVALUATION

Intramural Support Phase

Each awardee will be evaluated for progress on an annual basis by the mentor, 
Laboratory Chief, and Scientific Director.

Extramural (Transition) Support Phase

The awardee will be required to submit a form PHS 2590 non-competing 
continuation application for the final years of extramural support.  The 
application should provide a description of the research and career progress 
of the awardee, including: 1) publications in press or submitted, 2) current 
investigator-initiated research grant support, and 3) all applications 
submitted for investigator-initiated research grant support.  After the 
completion of this award, periodic updates on various aspects of 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 may be solicited from awardees.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the 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 applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA 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 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 PA 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. 93.837, 93.838, and 93.839, 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)(or 
other authorizations) 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 Parts 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.


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