HEPATITIS C DIAGNOSIS, TREATMENT AND INTERACTION WITH HIV/AIDS

RELEASE DATE:  January 23, 2002

RFA:  RFA-DA-02-008

PARTICIPATING INSTITUTES AND CENTERS (ICs):

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

LETTER OF INTENT RECEIPT DATE:  March 18, 2002
APPLICATION RECEIPT DATE:       April 16, 2002

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE

The NIDA plans to support a new National Drug Abuse Research Initiative for 
accelerating research on the diagnosis and treatment of Hepatitis C in drug 
abusing populations, especially those at risk for or infected with HIV/AIDS, 
including such areas as the development of (1) innovative minimally invasive 
methods for early diagnosis, (2) improved minimally invasive techniques to 
predict clinical course, (3) studies elucidating factors that influence 
clinical course, e.g. patterns of abuse of alcohol and other drugs, 
nutrition, stress, re-infection, (4) studies of the interaction of hepatitis 
C with co-morbid conditions, e.g. hepatitis B, HIV/AIDS, (5) treatment 
regimens for hepatitis C and its co-morbid conditions that are effective and  
deliverable in drug abusing populations both within and outside of drug abuse 
treatment, (6) studies that address hepatitis C diagnosis and treatment in 
special populations of drug abusers, e.g., minorities, women versus men, 
pregnant women, women with childcare responsibilities, (7) interventions that 
promote the prevention of medical consequences of hepatitis C, (8) models of 
delivery of diagnostic and treatment services that address issues of access, 
cost,  organization and management and effectiveness, and (9) interventions 
for the  prevention of transmission by infected drug abusers. These research 
efforts should involve interdisciplinary collaborations including such areas 
as basic virological and biological science, immunology, behavioral science, 
prevention science, epidemiology and clinical trials.  It is the intent for 
this RFA to support research that can demonstrate reciprocal interactions 
between basic and applied research components to facilitate creative and 
innovative research along the continuum of disciplines. However, the primary 
intent of this RFA is to support studies that relate directly to the 
development and testing of protocols for hepatitis C diagnosis and treatment 
in drug abusing populations, so as to provide data essential to the 
formulation of clinical guidelines in these areas. 

RESEARCH OBJECTIVES

Background

Previous research has identified the high prevalence of hepatitis C in drug 
abusing populations and has related that prevalence to injection drug use. 
However, a previous NIH sponsored Consensus Conference on Hepatitis C 
recommended that treatment for hepatitis C not be initiated in drug abusing 
populations prior to the achievement of a full year of sobriety. This 
recommendation, in the absence of significant data and in the absence of 
treatment alternatives currently available, expressed concerns that the level 
of adherence to treatment among injection drug users would not reach the 
level that would allow treatment to be effective and, that the resulting 
abbreviated and/or intermittent treatment would promote the development and 
transmission of resistant viral strains and exhaust the limited resources 
available to provide treatment to those infected with hepatitis C. Thus, 
despite a demonstrated high level of early infection with hepatitis C and the 
known potential of hepatitis C to result in chronic progressive liver disease 
leading from fibrosis to cirrhosis and liver failure, research on the 
diagnosis and development and implementation of effective treatment of 
hepatitis C in drug abusing populations remains an underdeveloped area. The 
objective of this RFA is to proceed as rapidly as possible towards the 
developed of data-based clinical guidelines for the diagnosis and treatment 
of hepatitis C in drug abusing populations and thus minimize the influence of 
institutionalized pessimism with respect to the possibility of effective, 
deliverable treatment for drug abusers.

Research Goals and Scope

The NIDA recognizes the need to encourage the development of new, innovative 
interventions in the diagnosis and treatment of the medical consequences of 
drug abuse, including hepatitis C and co-morbid conditions, with a particular 
emphasis on HIV/AIDS. The overall goal for this RFA is to stimulate the 
development and testing of diagnostic and treatment interventions, including 
the possibility of early diagnosis and treatment, that can ultimately be 
demonstrated to be effective in drug abusing populations, and, hence to 
prevent the development of the medical consequences of hepatitis C and its 
co-morbid conditions, especially HIV/AIDS. Intrinsic to this effort is the 
need to elucidate the underlying mechanisms that determine the effectiveness 
of these interventions, including factors ranging from the basic biology and 
virology to those related to adherence and the organization and delivery of 
health services. The results of these studies should promote the development 
of diagnostic and treatment interventions that target critical mechanisms in 
the cycle of transmission, development of infection and progression of 
hepatitis C in drug abusers at risk for or infected with HIV. Additionally, 
it is recognized that even the most effective diagnostic and treatment 
interventions have not benefited all who have been exposed to those 
interventions.  Thus, current challenges in diagnostic and treatment research 
include the need to better characterize subgroups or individuals who are 
refractory to existing interventions and develop new paradigms for targeting 
these resistant populations.  

It is the intent of this RFA to support interdisciplinary collaborations 
along a continuum of research, ranging from basic science that can inform or 
guide the development of novel hepatitis C diagnostic and treatment 
interventions, through clinical trials and the development of guidelines for 
clinicians in the area of the diagnosis and treatment of hepatitis C in drug 
abusing populations at risk for or infected with HIV. Preliminary diagnostic 
and treatment development, efficacy testing, and effectiveness trials of 
promising new diagnostic methods and treatment interventions are encouraged.  
Studies at the following levels of analysis are appropriate and applicants 
should incorporate more than one level of analysis in the interdisciplinary 
proposal: (a) Basic research studies, with potential application to the 
development of innovative diagnostic methods and comprehensive treatment 
interventions;(b) Research on the development, refinement and pilot testing 
of new diagnostic methods and treatment interventions, including studies 
aimed at translating discoveries from basic virological, immunological, 
behavioral, cognitive, social or health services research into novel or 
improved diagnostic methods or treatment interventions; (c) Efficacy testing 
of diagnostic methods or treatment interventions that show promise; including 
research on the hypothesized mechanisms through which these interventions 
produce their effects; (d) Effectiveness and cost-effectiveness trials of 
diagnostic methods and treatment interventions.

Applications are encouraged to include the study of racial, ethnic minority 
group membership, sexual orientation, and effects of gender and culture 
whenever possible and appropriate.

The following provide examples of scientific themes in the area of diagnosis 
and treatment of hepatitis C in drug abusing populations that might benefit 
from interdisciplinary collaborations within the context of this RFA.  
However, the list is not intended to be all-inclusive, and many other 
significant topics of scientific inquiry may be appropriate:

o Studies of the effects of drug and alcohol abuse patterns, including drug 
abuse history, continued drug abuse, and relapse to drug abuse in, for 
example, dropouts from drug abuse treatment, on (1) the onset and progression 
of hepatitis C, including basic studies of effects of drugs of abuse on the 
viral replication and/or the development of unique viral isolates, (2) immune 
processes related to disease transmission and course, and (3) response to 
treatment regimens. Studies examining the possible effects of repeated or re-
infection among drug abusers in treatment for hepatitis C may be included.
 
o Studies of the effects/side effects of treatment of hepatitis C, e.g., the 
development and treatment of depression during the course of treatment with 
interferon, and development of ways of dealing with such side effects so as 
to minimize dropouts from treatment or other forms of non-adherence.
 
o Development of minimally invasive ways of predicting the course of 
hepatitis C and monitoring the effectiveness of treatment intervention, e.g., 
ways of ascertaining levels of fibrosis of the liver that do not involve the 
need for liver biopsy.
 
o Development and testing of minimally invasive diagnostic methods that allow 
the very early identification of infection so as to facilitate tests of early 
treatment intervention, since at least one study suggests that such early 
treatment may lead to higher rates of treatment success.

o Effects of metabolic, endocrine and gastrointestinal factors, including 
macro and micro nutrient deficiency in the course and treatment of hepatitis C. 

o Elucidation of the basic mechanisms at the cellular and sub-cellular, e.g., 
mitochondrial, levels of the pathogenesis of hepatitis C infection in drug 
abusing populations, emphasizing the influences of factors unique or 
predominant in drug abusers and including mechanisms effecting  response to 
treatment.

o Studies of the influence of alcohol as a cofactor in processes related to 
the acquisition and treatment of hepatitis C in drug abusing populations.

o Studies of the drug-abuse-related factors and mechanisms that influence the 
pathogenesis of hepatitis C disease.  Examples include studies of (1) effects 
of host and viral genetics on resistance, course of hepatitis C infection and 
response to treatment and (2) proteomic issues related to the aforementioned. 

o Research elucidating factors important in addressing diagnostic and 
treatment issues for hepatitis C and its co-morbid conditions among special 
populations, e.g., minorities, gender differences, pregnant women. For 
example, questions of why African Americans seem to do worse than Caucasians 
in results of treatment for hepatitis C may be explored.

o Examination of co-factors that increase the risk of acquisition of 
hepatitis C in non-injection drug users, e.g., some data indicates a 
prevalence of up to 20-35%. 

o Examination of the influence of co-infection with other forms of hepatitis, 
e.g., hepatitis B, hepatitis G, and other infectious diseases, e.g., HIV, on 
the disease course and treatment of hepatitis C. 

o Study of drug interactions among medications used to treat hepatitis C and 
those  used to treat (1) drug abuse, e.g., methadone, buprenorphine/naloxone, 
(2) co-morbid mental disorders, e.g., antidepressants, and (3) co-morbid 
infectious diseases, e.g., HIV, hepatitis B, tuberculosis. 

o Development of methods to maximize adherence to treatment in drug abusing 
populations both in and out of drug abuse treatment and study of the effects 
of degrees of non-adherence on the effectiveness of treatment.

o Research on the most effective ways of organizing, delivering, (e.g., 
linkage to primary care and/or drug abuse treatment, other outpatient models 
for care delivery), and financing health service systems to maximize ability 
to deliver effective treatment for hepatitis C and it co-morbid conditions to 
drug abusing populations, including special populations as minorities, women 
versus men, pregnant women, injection versus non-injection drug users.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
(R01), small grant (R03) 
(http://grants.nih.gov/grants/guide/pa-files/PAR-00-059.html), 
and exploratory/developmental grant (R21) 
(http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) award 
mechanisms.  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant. The RFA is a one-time 
solicitation.  Future unsolicited competing continuation applications will 
compete with all investigator-initiated applications and be reviewed 
according to the customary peer review procedures.  The anticipated award 
date is September 30, 2002.

The exploratory/developmental (R21) grants are limited to 3 years and small 
grants (R03) are limited to 2 years.  Both are non-renewable and limited in 
direct cost amount per year (R03, $50,000; R21, $100,000).  The R03 mechanism 
is intended for newer, less experienced investigators, for investigators at 
institutions without well-developed research traditions and resources, or for 
experienced investigators wishing to change research directions or test new 
methods or techniques.  The R21 mechanism is intended to encourage 
exploratory research projects with sound methodology and strong rationales in 
underdeveloped research areas of drug abuse, such as the areas covered in 
this RFA.  Investigators may also choose to include methods development as 
one component within any of the other mechanisms.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely 
that of the applicant.  

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 million in FY 2002. Because the 
nature and scope of the research proposed may vary, it is anticipated that 
the size of each award will also vary. It is anticipated that approximately 
3-6 awards will be made under this announcement. 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.

ELIGIBILITY 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

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:

Sander Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 443-1801
FAX:  (301) 594-6566
Email:  SG73F@NIH.GOV
 
o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tl25u@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
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@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 IC 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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tl25u@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.

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
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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tl25u@nih.gov

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 the (IC) 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 this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
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?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

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

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

(5) ENVIRONMENT:  Does the scientific environment in which the 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?

(6) RELEVANCE:  The relevance of the proposed work to the purpose of the RFA.

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 (including 
data safety monitoring plans), 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 18, 2002
Application Receipt Date:         April 16, 2002
Peer Review Date:                 June/July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002

AWARD CRITIERIA 

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 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 biomedical and behavioral research 
projects involving human subjects, unless a clear and compelling rationale 
and justification are 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 is 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:  
It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

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 RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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 http://www.nida.nih.gov under the Funding, or may be 
obtained by calling (301) 443-2755.

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.

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.  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 and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-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.

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.