QUICK-TRIALS FOR NOVEL CANCER THERAPIES 

RELEASE DATE:  October 7, 2002

PA NUMBER:  PAR-03-005 (see replacement PAR-04-155) 

EXPIRATION DATE: August 10, 2004, unless reissued. 

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

APPLICATION RECEIPT DATES: December 9, 2002, April 9, 2003, August 11, 2003, 
December 9, 2003, April 9, 2004, August 9, 2004

This Program Announcement (PA) replaces PA-00-047, which was published in the 
NIH Guide on January 27, 2000.

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

Continuing progress in basic cancer research and drug development has led to 
discoveries of new agents or approaches for molecular targeting in novel 
cancer therapies. These new agents or approaches suppress tumor growth 
through multiple mechanisms such as cell cycle control, activation of tumor 
suppressor genes, essential signal pathway blockage, tumor vaccines, tumor 
microenvironment modification, etc. Rapid translation of these exciting 
discoveries into clinical practice requires timely support to accommodate the 
special needs of novel cancer therapy development. This PA is intended to 
continue providing investigators with rapid access to support for pilot, 
Phase I, and Phase II cancer clinical trials as well as patient monitoring 
and laboratory studies. The focus of this QUICK-TRIAL PA is on translational 
research in new agent development to ensure the timely exploitation of new 
cancer therapeutic approaches including the development of new cancer 
prevention agents. This PA is aimed at providing a new approach in the grant 
application process by offering a rapid turnaround from application 
submission to funding. Features of this initiative include a modular grant 
application and award process, inclusion of the clinical protocol within the 
grant application, and accelerated peer review with the goal of issuing new 
awards within six months of application receipt. Inclusion of the complete 
clinical protocol within the PHS 398 grant application is intended to 
simplify the application process by eliminating the need to duplicate 
protocol details in the Research Plan section and to insure proper peer 
review of the application. In addition, QUICK-TRIAL applications do not 
require extensive preliminary data in the grant application and support 
exploratory translational and clinical research studies involving cancer 
prevention, chemotherapy and rapid development and application of novel 
clinical cancer therapies including image guided therapeutic procedures. 
Investigators may apply for a maximum of two years of funding support using 
the exploratory or developmental (R21) grant mechanism for up to $250,000 
direct costs per year.

RESEARCH OBJECTIVES

Advances in the understanding of molecular cancer genetics, basic cancer 
biology, and the development of powerful technologies such as microarray, 
proteomics and bioinformatics have led to the identification of many new 
molecular targets and pathways in cancer cells. These discoveries have 
created new frontiers for novel molecular cancer prevention and treatment 
leading to the development of molecular medicine in cancer therapy. In 
addition, these novel targets and pathways have presented excellent 
translational research opportunities for revolutionizing cancer drug 
development and bringing more effective molecular cancer therapies and cancer 
prevention strategies into clinical practice.

Novel approaches or agents for inhibiting tumor growth either directly or by 
impacting the tumor microenvironment are ready to be tested in the clinic 
with new tools and laboratory analyses that allow investigators to ascertain 
how specific targets are affected by therapy. These agents include new 
classes of cytotoxic agents, agents or approaches that act via 
immune-stimulatory effects, agents that stimulate apoptosis, inhibit 
angiogenesis and metastasis or alter tumor cell signaling pathways, and 
agents targeted specifically to novel cancer cell targets. New clinical 
therapeutic trials may employ drugs/agents, biologics, radiation, heat, or 
surgery used as single agents/modalities or in combination for the treatment 
of early and advanced disease. In addition, clinical trials of therapies for 
cancer treatment, including but not limited to herbal therapies, dietary 
supplements, bioactive food components, or unconventional pharmacological and 
biological interventions (e.g. antineoplastons, Coley's toxin, enzyme 
therapies, etc.) will be considered. Another relevant area of investigation 
is the use of anatomical and molecular image guidance for targeted treatment 
with ablative techniques or delivery of chemotherapeutic agents.
At present, there are few funding mechanisms targeted to stimulate the 
translation of promising and potentially relevant advances in new prevention 
or therapeutic agent development from the laboratory into the clinical 
setting. Quite frequently the initial stages of clinical investigation are 
the most difficult to accomplish. They are resource intensive, and to be done 
well they require laboratory, pharmacology, and other resource support, as 
well as substantial personnel effort, none of which is supported by 
traditional health benefit programs. Nonetheless, these early studies tend to 
fare poorly in competition for conventional grant support precisely because 
they are preliminary and cannot serve as the definitive tests of new 
approaches. Even when funding is received, the review and award cycle may 
introduce a year or more of delay. Except where there is an industrial 
sponsor with a particular commitment to development of an agent, it may take 
a long time for a promising approach to get through the initial phase of 
demonstrating feasibility and interest, or it may never be tested in more 
than one or two diseases. 

This PA will continue to support scientific, technological, clinical and 
logistical needs in novel cancer therapy development. In addition, this PA 
will complement the Rapid Access to Intervention Development (RAID) program 
by providing an initiative with accelerated peer review and funding to 
support the clinical and laboratory costs of early clinical testing to ensure 
the timely development of new therapeutic approaches.

MECHANISM OF SUPPORT 

This PA will use the National Institutes of Health (NIH) 
exploratory/developmental grant (R21) award mechanism. The 
exploratory/developmental (R21) grant mechanism is utilized for pilot 
projects or feasibility studies to support creative, novel, high risk/high 
payoff research that may produce innovative advances in science.  
Applications submitted in response to this PA will be limited to $250,000 
direct costs per year (includes third party facilities and administrative 
costs).  These grants are non-renewable, and continuation of projects 
developed under this program will be through the traditional unsolicited 
investigator-initiated research grant program. As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project. All PHS and NIH grant policies will apply to applications received 
and awards made in response to this program announcement.  The total project 
period for applications submitted in response to this PA may not exceed 2 
years. 

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (See http://grants.nih.gov/grants/funding/modular/modular.htm).   

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community based organizations

An application may include one or more institutions (e.g., individual 
institutions, consortia, cancer centers) with established clinical, 
laboratory, and statistical resources.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

Direct your questions about scientific/research issues to:

Drs. Roy Wu, Heng Xie, Steven Krosnick
Clinical Grants & Contracts Branch 
Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Executive Plaza North, Rm. 7009
6130 Executive Boulevard
Bethesda, MD 20892-7432
Phone: 301-496-8866
Fax: 301-480-4663
E-mails: wur@ctep.nci.nih.gov, xieh@ctep.nci.nih.gov, 
krosnicks@ctep.nci.nih.gov

Dr. Keyvan Farahani
Biomedical Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Executive Plaza North, Suite 6000
6130 Executive Boulevard
Phone: 301-496-9531
Fax: 301-480-3507
E-mails: farahank@mail.nih.gov

Dr. Wendy B. Smith
Research Development and Support Program
Office of Cancer Complementary and Alternative Medicine
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Suite 102
Bethesda, MD 20892-7302
Phone: 301-435-7980
Fax: 301-480-0075
E-mail: smithwe@mail.nih.gov

Dr. John A. Milner
Nutritional Science Research Group 
Division of Cancer Prevention 
National Cancer Institute 
6130 Executive Boulevard
Executive Plaza North, Suite 3164
Rockville, MD 20892 
Phone: 301-496-0118 
Fax 301-480-3925 
E-mail: milnerj@mail.nih.gov

Dr. William F. Anderson
Gastrointestinal and Other Cancers
Division of Cancer Prevention 
National Cancer Institute 
6130 Executive Boulevard, Rm. 2141
Bethesda, MD 20892-7317
Phone: 301-594-7672
Fax: 301-435-6344
E-mail: wanderso@mail.nih.gov

Dr. Ron Lieberman
Prostate and Urologic Cancer Research Group
Division of Cancer Prevention
National Cancer Institute 
Executive Plaza North, Rm. 2102
Bethesda, MD 20892-7317
Phone: 301-594-0456 
Fax: 301-435-1564
E-mail: r139r@nih.gov

Direct your questions about financial or grants management matters to:

Ms. Jill Rogers
Grants Management Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Phone:  (301) 496-8699 or (301) 496-7800
FAX:  (301) 496-8601
Email: rogerj@gab.nci.nih.gov

SUBMITTING AN APPLICATION

Applicants are strongly encouraged to contact program staff, listed under 
WHERE TO SEND INQUIRIES, with any questions regarding their proposed project. 
Applications must be prepared using the PHS 398 research grant application 
instructions and forms (Revised 5/2001, Updated: 6/28/2002).  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) 710-0267, Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted by the receipt dates listed at the beginning of 
this program announcement. Amended applications are due on the same receipt 
dates. 

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

SPECIAL REQUIREMENTS

1.  Although preliminary data are not required for an R21 application, they 
may be included.

2.  RESOURCES: A description of both the clinical and laboratory facilities 
and resources should be included in the grant application. This includes 
detailed information on plans for data management, quality control of patient 
and laboratory data, and computer resources and plans for handling both 
laboratory and clinical data. If Cancer Center cores will be used for these 
tasks, letters of support from the appropriate individual with authority to 
commit the needed resources should be included in the application. Provide 
information on resources provided by the drug sponsor if not in your 
institution.

3.  RESEARCH PLAN: Applications in response to this PA should be concise and 
substantially shorter than regular grant applications.  ITEMS a-d MAY NOT 
EXCEED 15 PAGES IN TOTAL.

Item a - Specific Aims - In one page or less, list in priority order, the 
broad, long-range objectives.  Describe concisely and realistically the 
hypothesis to be tested and what the specific research described in this 
application is intended to accomplish.

Item b - Background and Significance - In two pages or less, use this section 
to describe (a) how the proposed research will contribute to meeting the 
goals and objectives of the PA; and, (b) explain the rationale for the 
selection of the general methods and approaches proposed to accomplish your 
specific aims.  Describe the significance of the planned studies and consider 
how the pilot study, if encouraging, could transition into an eventual 
definitive test of the therapeutic approach.  Describe the innovative aspects 
of the studies including novel concepts, approaches, or methodologies.  Do 
not include background material provided in the clinical protocol document 
but you may refer to the appropriate sections/pages of the protocol.

Items c-d - Progress Report/Preliminary Studies, Research Design and Methods 
- In twelve pages or less, complete as instructed in the PHS 398 booklet.  TO 
THE EXTENT THAT MATERIAL INCLUDED IN THE CLINICAL PROTOCOL IS ADEQUATE FOR 
REVIEW, IT NEED NOT BE REPEATED IN THIS SECTION.  (The clinical protocol must 
be included in the Human Subjects section even if support is only requested 
for laboratory studies.) The investigator may use this section to address the 
following:

- Preliminary studies pertinent to the application;
- Rationale and hypothesis for the clinical trial and laboratory studies;
- General methods that will be utilized (clinical, laboratory, or both, as 
appropriate); reason(s) for selecting these approaches; provide specific 
details for those techniques which are unique or where a significant 
departure from a generally accepted technique is important for reviewers to 
know;
- Outcome measures that will be used to assess the success or failure of each 
set of experiments (include statistical analyses for laboratory and clinical 
studies); clinical endpoints should be discussed with particular emphasis on 
those aspects that may be especially complicated in clinical trials (e.g., 
lack of conventionally measurable disease; patients whose only 
evidence of disease is biochemical);
- A statistical section should be included discussing the choice of the 
clinical trial design and laboratory analyses with power calculations. The 
statistician involved with the study should be identified and a letter of 
support included if no effort is requested on the grant application.  Plans 
for data management and verification of research data should also be 
included;
- Potential pitfalls in the experimental design and alternative studies that 
will be done if the proposed experiments fail. 

4.  HUMAN SUBJECTS: IN ADDITION TO THE INFORMATION REQUESTED IN THE PHS 398 
FORM, INCLUDE THE COMPLETE CLINICAL PROTOCOL IN THIS SECTION. Informed 
consent form(s) must be included. NIH will treat as confidential any 
scientific, preclinical, clinical, or formulation data and information that 
the sponsor deems to be proprietary and confidential.  

5.  IN ADDITION, applicants must insure that the first page of the human 
subjects section includes the following information:

1a)  If NCI-provided agent(s) to be used:  CTEP-assigned LOI # and date of 
CTEP LOI response letter confirming potential availability__________

1b) If agent(s) will be provided by a company, a letter is provided 
confirming plans to provide agents and date available__________

1c)  If this protocol is an initial IND-filing study:  date IND submitted to 
FDA__________

1d)  None of the above (1a, 1b, or 1c) applies__________

NCI/CTEP or drug company correspondence should be included in the Appendix, 
as applicable.

6.  APPENDIX: Include a maximum of 10 publications, manuscripts (accepted for 
publication), abstracts, patents, or other printed material relevant to this 
project.  Include letters from appropriate drug sponsor.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five 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)

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 Center for 
Scientific Review 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 to the National Cancer 
Institute. An appropriate scientific review group convened by CSR 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 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 Those that receive a priority score will undergo a second level review by 
the National Cancer  Advisory Board or other appropriate board or 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 in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, 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)

DATA SHARING:  If appropriate, the adequacy of the proposed plan to share 
data.

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

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:  

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

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).  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH 
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials" 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html for 
additional information. Information concerning the "Essential Elements of Data 
and Safety Monitoring Plan for Clinical Trials Funded by the NCI" is available: 
http://www.cancer.gov/clinical_trials/

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: 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.  A 
continuing education program in the protection of human participants in 
research in now available online at: http://cme.nci.nih.gov/

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.  Guidance 
for investigators and institutional review boards regarding research involving 
human embryonic stem cells, germ cells, and stem cell-derived test articles 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.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. 93.395, 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 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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