ALCOHOL ABUSE AND HIV/AIDS IN RESOURCE-POOR SOCIETIES 

RELEASE DATE:  January 6, 2004

PA NUMBER:  PA-04-048

March 2, 2006 (NOT-OD-06-046)   Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: November 30, 2006, unless reissued.

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
 (http://www.niaaa.nih.gov/)  

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.273

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks 
applications for cross-national and international multidisciplinary research 
on the intersection of alcohol consumption and the HIV epidemic.  
Investigators representing a broad array of academic disciplines and engaged 
in cross-cutting fields of science are encouraged to consider designing 
studies that utilize rigorous methodologies from epidemiological, biomedical, 
and behavioral research traditions.  Special emphasis areas include:  the 
prevention and treatment of HIV and other blood-borne infections in sexually 
active populations of alcohol users; the clinical course and consequences of 
HIV and related health conditions as these are affected by alcohol use; 
adherence to HIV/AIDS therapy and medication regimes as these are affected by 
alcohol use; the causes and consequences of differences in HIV-associated 
risks, morbidity, and mortality between men and women, adults and 
adolescents, and majority and minority populations who consume alcohol at 
various levels; the effectiveness of alcohol treatment as a means of lowering 
the risk that currently infected individuals will spread the HIV virus to 
others; and the design, development, and evaluation of prevention 
interventions to reduce the impact of alcohol use and sex-related risk 
behaviors on the primary and secondary transmission of HIV and other 
infectious diseases.

Researchers are encouraged to utilize integrative, multi-method approaches in 
their study designs.  Examples of newer technologies that may be employed 
include, but are not limited to, automated techniques for monitoring 
medications adherence, computer assisted survey administration, geospatial 
coding of alcohol-related events, econometric methods of assessing cost-
effectiveness and burden of illness, and creative use of existing data 
resources to improve medical informatics.  Other applications may focus on 
low cost, low technology, but clinically effective methods for improving the 
delivery of prevention or medical care, thereby enhancing the availability of 
these services to low income patients and the exportability of these services 
these improvements to resource-poor societies.

Established researchers are urged to recruit new, domestic and foreign 
researchers to work on their projects, to provide training and mentoring to 
help achieve their project's specific aims, and to nurture the career 
development and independence of new researchers.

RESEARCH OBJECTIVES

Background

Epidemiological studies on the dynamics of alcohol abuse and HIV demonstrate 
a continual need to reach new and emerging risk groups in diverse geographic 
settings with effective prevention interventions.  Data from the WHO indicate 
that while alcohol consumption is declining in most of the developed 
countries, it is rising in many resource-poor countries and the countries of 
Central and Eastern Europe.  Males do most of the drinking in these 
countries, and evidence available regarding patterns of drinking suggests 
that heavy drinking is prevalent in these countries.  The contribution of 
alcohol to the global burden of disease is significant and growing in some 
regions, to the point that in parts of Central and Eastern Europe, alcohol 
use is contributing to an unprecedented decline in male life expectancy.  
These same parts of the world have seen significant increases in rates of HIV 
infection over recent years, and there is growing evidence that escalating 
rates of alcohol abuse and HIV infection are closely related. For example, 
while the epidemic in sub-Saharan Africa, home of two-thirds (23.3 million) 
of the 33.6 million people in the world living with HIV/AIDS in 1999, has 
been driven largely by heterosexual transmission, there, as elsewhere, 
alcohol use is becoming increasingly important as rates of alcohol use 
continue to rise.

It is well known that alcohol use increases the risk of exposure to HIV 
through its association with high risk sexual and substance abuse behaviors.  
However, there is also growing evidence that alcohol consumption may play an 
important role in susceptibility to infection and the progression of HIV 
disease.  This latter includes the occurrence and course of comorbid 
conditions such as HCV and TB. Research also suggests that alcohol use has 
important influences on adherence to medications and provider advice, 
provider and patient attitudes towards treatment, and survival.

Challenges for cross-national and international HIV research efforts lie in: 
the diversity of risk groups and communities of alcohol users; the rapidly 
changing alcohol, alcohol-and sex-related risk profiles of susceptible 
populations: the variability in global alcohol use patterns: the complex 
interactions among behavioral, ethnic/racial, sociocultural, environmental, 
and biomedical factors that influence the initiation and progression of 
alcohol abuse and the spread of HIV and other infections; the challenge of 
delivering effective medical services in resource-poor contexts,; and the 
differences among resource-abundant and resource-poor countries as to their 
understanding of the interrelationship of alcohol abuse and HIV, their public 
health knowledge and experience, and their capacities to respond with 
durable, effective measures to contain the epidemic.

Areas of Research Focus

This initiative will support cross-national and international research that 
includes but is not limited to the following interrelated areas:

1) Adaptation, replication, and evaluation of community-based prevention 
interventions to reduce risk behaviors and avert incident HIV and other 
infections in high-risk populations.  This includes studies of the 
effectiveness of such interventions and their adaptability and diffusion to 
societies and cultures different from those in which they were originally 
developed. 

2) Comparative effectiveness and sustainability of prevention and treatment 
interventions among alcohol-abusing populations in diverse international 
settings, including studies of environmental factors affecting availability,  
access and adherence to multiple types of behavioral and therapeutic 
interventions, the development of improved, accessible clinical management 
approaches, and research on models for facilitating cooperation among 
research and service professionals in international settings. Studies 
examining community-level interventions which address related social and 
health policy issues (e.g., alcohol outlet density, alcohol taxation 
policies, prevention and treatment service distribution, etc.) are of 
particular interest.

3) Comparative studies of the single and combined components of various 
prevention/ intervention strategies and services among alcohol-using men and 
women and their sexual partners in diverse international settings, including 
studies of their differential impacts on the incidence, prevalence, and 
transmission of HIV and other blood-borne infections, their cost-
effectiveness, and the nature and extent of their linkages to other social, 
health, and medical services.

4) Studies which identify and evaluate outcome measures and data collection 
systems appropriate to the evaluation of research-based HIV prevention 
interventions for reducing alcohol-related HIV exposure implemented in 
international settings.

5) Research on the integration of alcohol treatment services with other 
medical services provided to AIDS patients.   This includes studies of access 
to alcoholism treatment services, outcomes and cost effectiveness of 
integrated treatment, organizational configurations that best facilitate the 
delivery of combined services, and cross training of both addiction and other 
medical care specialists to increase competence in delivering combined care.

6) Studies of the translation of research findings into improved clinical 
practice for HIV patients.  Especially relevant are studies of the 
international diffusion and cross-cultural adaptation of improved treatment 
practices.

7) Development of innovative, comprehensive interventions to improve access 
to and delivery of HIV vaccines, antiretroviral and other therapeutic agents, 
routine screening services for sexually transmitted diseases (STDs), and HIV 
testing and counseling services to alcohol-using populations.

8) Bioethical considerations in research methodologies, and in the design and 
implementation of culturally appropriate, available, and affordable 
prevention interventions for alcohol use and HIV risk, including counseling 
and testing services, medical care, and alcohol treatment services to men and 
women with alcohol abuse/dependence, their sexual partners, and their 
children infected with HIV and other infectious diseases.

9) Risk-factor epidemiology of HIV and co-occurring blood-borne infections in 
alcohol-using men and women, in their sexual partners, and in their children.  

10) Behavioral dynamics and alcohol use-related processes associated with the 
acquisition and transmission of HIV and other infections, including 
individual, social, environmental, cultural, economic, gender-based, and 
other factors which influence alcohol-related risk behaviors.

11) Socioeconomic and demographic characteristics, sexual and alcohol-using 
behaviors, health care utilization and treatment seeking, HIV virologic and 
immunologic status, and the health and medical consequences of HIV and other 
blood-borne infections in alcohol-using populations.

12) Virologic, immunologic, genetic, and alcohol use factors and the 
mechanisms by which they may influence susceptibility, recovery and 
persistence, and progression of HIV and other diseases in alcohol-using men 
and women, in their sexual partners, and in their children. 

13) Research on the characteristics of community-based organizations and 
coalitions most likely to be successful in implementing effective science-
based interventions for reducing alcohol-related HIV exposure in at-risk 
communities.

MECHANISM(S) OF SUPPORT 

This PA will use the National Institutes of Health (NIH) Research Project 
Grant (R01), Exploratory/Developmental Grant (R21), and Small Grant (R03) 
award mechanisms. Responsibility for the planning, direction, and execution 
of the proposed project will be solely that of the applicant. Applications 
for R01s may request support for up to 5 years. Facilities and Administrative 
(F&A) costs will be awarded based on the negotiated rate at the time of the 
award. More detailed information on the R21 mechanism can be found at 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. More detailed 
information on the R03 mechanism can be found at 
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html. 
Exploratory/Developmental Grants and Small Grants cannot be renewed: however, 
a no-cost extension of up to one year may be granted prior to expiration of 
the project period. Investigators are encouraged to seek continued support 
after completing an Exploratory/Developmental Grant project or a Small Grant 
project through a Research Project Grant (R01). 

This PA uses just-in-time concepts.  It also uses the modular budgeting 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 budget format.  Otherwise follow the instructions 
for non-modular budget research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.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 institutions/organizations
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 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:

o Direct your questions about scientific/research issues to:

Mike Hilton, Ph.D.
Division of Epidemiology and Prevention
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 302
6000 Executive Boulevard MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 402-9402
FAX: (301) 443-480-2358
Email: [email protected]

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

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 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: [email protected].

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  All applications 
for this PA are considered "AIDS and AIDS-Related" applications and are 
therefore subject to the receipt dates of May 1, September 1, and January 2.  
Application deadlines are also indicated in the PHS 398 application kit.  

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your         
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member       
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

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 mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not 
accept any application in response to this PA that is essentially the same as 
one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.   Appropriate scientific review groups 
convened 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 Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The 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, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 
forward.

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?

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?

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

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)?

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?  

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score.
 
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:  

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

REQUIRED FEDERAL CITATIONS 

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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing 
Investigators should seek guidance from their institutions, on issues related 
to institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers will 
consider the data sharing plan but will not factor the plan into the 
determination of the scientific merit or the priority score.

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 "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.

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.

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

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

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm 

The 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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