ENHANCING HIV VACCINE EFFICACY IN HIGH-RISK DRUG USERS

RELEASE DATE:  January 6, 2003

RFA NUMBER:  DA-03-002 

National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

LETTER OF INTENT RECEIPT DATE:  March 14, 2003

APPLICATION RECEIPT DATE:  April 14, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

NIDA invites domestic and international research applications related to the 
determination of HIV vaccine efficacy in high-risk drug-using populations. In 
drug-using populations, full efficacy of HIV vaccine candidates, currently in 
development, will be achieved through vaccine trials evaluating the candidate 
vaccine in combination with intervention(s) for substance abuse and related 
comorbidities. The current initiative seeks to support clinical research to 
develop strategies for implementing promising HIV vaccine candidates in 
cohorts of individuals at high risk for HIV infection and who abuse drugs or 
who are at high risk to abuse drugs. 

Most exposure to HIV is through high-risk behaviors and, in a substantial 
proportion of cases, individuals who are at high risk for HIV infection will 
likely remain at high risk for decades. A successful preventive or 
therapeutic vaccine for HIV/AIDS will, therefore, have to induce long-lasting 
immune responses or be given as boosts on a regular basis. Further, few 
studies have assessed the impact of behavioral interventions and/or treatment 
interventions for substance abuse on HIV incidence. Deployment of a vaccine 
that has shown efficacy in clinical trials - in the absence of the concurrent 
intervention for high-risk activity - could result in a vaccine whose 
effectiveness proves lower than its efficacy. Thus, behavioral and/or 
treatment interventions for substance abuse need to be identified and tested 
in populations at high-risk for HIV infection and targeted for phase III 
vaccine trials.

The purpose of this RFA is to determine the validity of novel approaches to 
address the prevention of HIV and related blood-borne and sexually 
transmitted infections; as well as, to establish and study cohorts of high-
risk drug users in the context of the developing HIV vaccine. Well-designed, 
targeted counseling and other interventions, such as chemotherapy for drug 
abuse, are needed to be adaptable and responsive to changing patterns of drug 
use and increasing risk behaviors of individuals exposed to first generation 
HIV vaccines. It is important to assess the effectiveness, sustainability, 
and durability of HIV prevention interventions and treatment interventions 
for substance users/abusers in concert with cohort HIV vaccinations studies. 
The data generated from such studies would provide efficacious mass 
vaccination paradigms for high-risk drug users.      

RESEARCH OBJECTIVES

Background

AIDS was first recognized as a growing epidemic among injection drug users 
(IDUs) and their sexual partners in the early 1980s.  While considerable 
scientific progress has been made since then in understanding, preventing, 
and treating the intertwined epidemics of drug abuse and HIV/AIDS, much 
remains unknown or poorly understood today. Emerging drugs of abuse, such as 
the club drugs ecstasy, GHB, ketamine, and methamphetamine, as well as more 
potent supplies of heroin, cocaine, and marijuana, are rapidly changing the 
profiles of populations at risk.  In the United States, since the epidemic 
began, injection drug use has directly or indirectly accounted for 
approximately 36 percent of AIDS cases. Fifty-seven percent of all AIDS cases 
among women have been attributed to injection drug use or sex with partners 
who inject drugs. Racial and ethnic minority populations of both genders have 
been deeply affected by drug abuse, HIV/AIDS, and other infectious diseases 
in recent years, with new HIV infections continuing at an alarming rate in 
the U.S. and in other nations.

Well-designed, targeted counseling and other interventions, such as 
chemotherapy for drug abuse, are needed to be adaptable and responsive to 
changing patterns of drug use and increasing risk behaviors of individuals 
exposed to first generation HIV vaccines. To date, over 60 phase I/II trials 
of 30 candidate vaccines for HIV/AIDS have been conducted worldwide. Most 
initial approaches focused on the HIV envelope protein, produced in insect, 
bacteria, yeast or mammalian cells, which was logical given that envelope is 
the primary target for neutralizing antibodies in HIV-infected persons. At 
least 13 different gp120 and gp160 envelope candidates have been evaluated in 
phase I/II trials, predominantly through a NIAID-supported AIDS Vaccine 
Evaluation Group.  Overall, they have been safe and immunogenic in diverse 
populations that have excluded substance abusers. In these studies 
neutralizing antibodies have been induced in nearly 100 percent of the 
recipients, but rarely induced CD8+ cytotoxic T lymphocytes (CTL) even when 
formulated in novel adjuvants that effectively induced CTL in mice. Mammalian 
derived envelope preparations have been better inducers of neutralizing 
antibody than candidates produced in yeast and bacteria. The antibodies 
induced by these early envelope preparations were relatively specific for 
clade B isolates and rarely neutralized primary isolates of HIV.

As low levels of neutralizing antibody titers in some circumstances may 
provide protection from viral infection, bivalent preparations of gp120, 
based on one lab (B) and one primary isolate (B or E) of HIV, have been 
developed and are now being tested in phase III trials in Thailand in a 
cohort of intravenous drug users.  
 
In an effort to induce both CTL and antibody responses, attention has also 
turned to evaluating a combination vaccine approach in which two types of 
vaccines are used. Most commonly referred to as "prime-boost", this has 
involved an immunization (priming) with a recombinant viral vector followed 
by or combined with boosting doses of recombinant protein. Three recombinant 
attenuated vaccinia vectors and five recombinant canarypox vectors have been 
evaluated in phase I trials, alone, and in combination with a recombinant 
protein envelope boost. To date, all recombinant viral vectors have been 
shown to be safe and immunogenic and have been shown to prime the immune 
response to an envelope boost, thereby necessitating fewer doses of 
recombinant protein to reach maximum antibodies titers. However, the 
antibodies elicited in prime-boost protocols so far have a limited breadth of 
reactivity.

Full efficacy of these HIV vaccine candidates will be achieved through 
vaccine trials evaluating the candidate vaccine in combination with an 
intervention for substance abuse and high-risk sexual behavior among 
substance abusers. The current initiative seeks to support clinical research 
to develop strategies for implementing promising HIV vaccine candidates in 
cohorts of individuals at high risk for HIV infection and who abuse drugs. 
Areas of interest include but are not limited to:

o Behavioral interventions that can be coupled to vaccine schedules that 
enhance vaccine efficacy and promote HIV prevention and/or STD prevention and 
treatment among distinct drug using population subgroups (e.g., IDUs, crack 
abusers, club drug abusers)

o Drug treatment interventions that can be coupled to vaccine schedules that 
enhance vaccine efficacy and promote HIV prevention and/or STD prevention and 
treatment among distinct drug using population subgroups (e.g., IDUs, crack 
abusers, club drug abusers and polydrug abusers)

o Assess the acceptability (i.e., identify factors that facilitate and 
hinder) of implementing vaccine trial schedules among distinct drug- using 
population subgroups (e.g., IDUs, crack abusers, club drug abusers and 
polydrug abusers)

o Develop, implement, and evaluate community-based programs targeted to high-
risk individuals that promote HIV vaccine acceptance

o Longitudinal evaluation of substance users/abusers for surrogate 
immunological and/or genetic markers of HIV vaccine efficacy and 
modifications of immune responses due to drug abuse

o Use of surrogate vaccines, such as hepatitis B vaccine, in high-risk 
substance users/abusers to study medical management issues including 
adherence, clinical setting and services related to substance abuse and its 
comorbidities, vaccination efficacy parameters, patient follow-up to 
vaccination schedule
 
o Mathematical modeling of HIV vaccination in substance using/abusing 
populations

o Develop and evaluate research methods strategies to efficiently estimate 
the combined and individual effects of the behavioral interventions and 
vaccine components on both behavioral outcomes and incidence rates of 
infection

o Therapeutic HIV vaccination paradigms for substance abusers combining 
vaccination with antiretroviral therapy
 
o Barriers to implementing HIV vaccination strategies for IDU populations and 
other disenfranchised individuals

o Implementing vaccine protocols in high-risk adolescents

o Ethical issues related to HIV vaccines and substance abusers

o Investigations of comorbidities, e.g. hepatitis infection, psychiatric 
illness, in substance abusers that would influence the effectiveness of an 
HIV vaccine 

o Neurological aspects of HIV/AIDS, addiction and vaccination

o Clearly defined basic research vaccination studies to understand the basic 
mechanisms where drug addiction processes may influence the immune response 
to the vaccine candidate. Drugs of interest include, but are not limited to, 
opiates, cannabinoids, cocaine and metamphetamine.
 
MECHANISMS OF SUPPORT

This RFA will use National Institutes of Health (NIH) investigator-initiated 
research project (R01), and the NIDA exploratory/developmental (R21) award 
mechanisms. NIDA's R21 grant is limited to 3 years with maximum direct cost 
amount per year of $100,000. The R21 mechanism is intended to encourage 
exploratory research projects with sound methodology and strong rationales in 
underdeveloped research areas of HIV prevention interventions for drug users, 
such as the areas covered in this RFA.  Applicants are also advised to 
contact NIDA program staff listed under INQUIRIES for additional information. 

As an applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  Future 
unsolicited, competing-continuation applications based on this project will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures. The anticipated award date 
is September 2003.

This RFA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

FUNDS AVAILABLE

NIDA intends to commit approximately $2,000,000 in FY 2003 to fund six to ten 
new awards in response to this RFA.  Because the nature and scope of the 
research proposed may vary, it is anticipated that the number of awards and 
the size of each award will also vary.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary. Although 
the financial plans of NIDA 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. 

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
 
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 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:

Thomas F. Kresina, Ph.D.
Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA)
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5200, MSC 9593
Bethesda, MD 20892-9593
Telephone:  (301) 402-1913
Email:  tk13v@nih.gov

o Direct your questions about peer review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland  20892-9547
Telephone: (301) 443-2755
Email: tlevitin@mail.nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, Maryland  20892-9541
Telephone:  (301) 443-6710
E-mail:  gfleming@mail.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 research
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 NIDA staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Director 
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Rockville, Maryland 20852 (for express/courier service)
Telephone: (301) 443-2755
Fax:  (301) 443-0538

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center For Scientific Review
National Institutes Of Health/DHHS
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:

Director 
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Rockville, Maryland 20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

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

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIDA in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on Drug 
Abuse.

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:

o 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.

o 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)

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  March 14,2003
Application Receipt Date:  April 14, 2003
Peer Review Date:  June/July 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phases 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.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing services.  Persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
Drug Abuse recognizes the importance of research involving the administration 
of drugs to human subjects and has developed guidelines relevant to such 
research.   Potential applicants are encouraged to obtain and review these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at www.nida.nih.gov  under the Funding, or may be obtained 
by calling (301) 443-2755.

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 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.279, 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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