ALCOHOL ABUSE AND HIV/AIDS IN RESOURCE-POOR SOCIETIES
RELEASE DATE: January 14, 2003
RFA: AA-03-009
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
LETTER OF INTENT RECEIPT DATE: March 25, 2003
APPLICATION RECEIPT DATE: April 25, 2003
THIS 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 OF THIS RFA
The National Institute on Alcohol Abuse and Alcoholism seeks
applications for international, cross-disciplinary research on
HIV/AIDS, other blood-borne infections [i.e., hepatitis B virus (HBV),
and hepatitis C virus (HCV)], tuberculosis (TB), and comorbid
conditions and consequences in alcohol abusing and dependent
individuals, their sexual partners, and their children. This RFA is
intended to build on lessons learned in developed countries in response
to the interrelated epidemics of alcohol and HIV/AIDS and other
infectious diseases. It seeks to foster cross-national and
international research collaborations that, through both independent
research and the recruitment, training, and mentoring of new, multi-
disciplinary researchers, lead to the development, adaptation,
replication, and evaluation of effective interventions and approaches
to slow or reverse the spread of HIV and other infections in vulnerable
heavy drinking populations.
Epidemiologic 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 largely driven 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; 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.
This RFA will support 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 hypotheses-driven 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 in diverse
communities of alcohol users, their sexual partners, and their
children; 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; and the design, development, and evaluation of
behavioral and biomedical prevention measures to reduce the impact of
alcohol use and sex-related risk behaviors on the primary and secondary
transmission of HIV and other infectious diseases. Community-level
interventions which address related social and health policy issues
(e.g., alcohol outlet density, alcohol taxation policies, prevention
and treatment service distribution) are also of interest.
Researchers are encouraged to utilize integrative, multi-method
approaches in their study designs. Examples of newer technologies which
may be employed include but are not limited to geospatial coding of
alcohol-related events and alcohol prevention and treatment resources
and medical informatics systems with the capacity to integrate multiple
clinical databases.
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 with
potential to enrich the multiple disciplines involved in preventing HIV
and other infections in high-risk alcohol-using populations.
RESEARCH OBJECTIVES
BACKGROUND
Alcohol consumption and its consequences together with HIV/AIDS are
major public health burdens in many parts of the world. Chronic abusive
alcohol use can lead to life threatening organ system damage. Light to
moderate consumption can induce behavioral and organ system changes
which may influence HIV transmission, pathogenesis, and disease
progression. There is an overlap between persons at risk for alcohol-
related problems and individuals at risk for HIV infection. Regardless
of the level consumed, alcohol is likely to influence the health status
of persons infected with HIV and those whose behaviors place them at
risk for acquiring the virus.
In addition to being a risk factor in the contraction and progression
of HIV disease, alcohol misuse affects adherence to complex HIV
medication regimens and to physician advice. Recent evidence has
indicated interactive effects of alcohol use and HIV infection on brain
functioning and cognitive processes. Whether alcohol consumption
increases susceptibility to opportunistic infections in HIV+ patients
and whether alcohol-induced immunosuppression affects pathogenesis and
disease progression are important questions. However, carrying out
research on the effects of alcohol consumption and drinking behaviors
on HIV-related health outcomes is challenging. While clinical findings
have associated increased levels of chronic alcohol consumption with
diminished immune function, as evidenced by reduced levels of CD4 and
CD8 activity, many questions about the relationship between alcohol
consumption, increased susceptibility to HIV infection, and accelerated
progression to AIDS remain unanswered. Strain variations of HIV,
individual differences in susceptibility, long incubation time
following seroconversion, and varying patterns of adherence to HIV
medications are only some of the challenges in studying disease
progression. Comorbid mental and somatic illnesses and environmental
stress are additional confounding factors, each of which may vary in
its impact across cultures and subcultures.
Cumulative research on alcohol and HIV/AIDS has shown that reductions
in alcohol consumption are associated with declining incidence in HIV
and other blood-borne infections in at-risk populations. Despite the
significant advances that have been made, however, HIV and other
infectious diseases continue to spread among alcohol-using populations
in the U.S. and worldwide. The cumulative evidence from research on
prevention and treatment programs for alcohol use disorders shows that
no single approach is sufficient to avert new HIV and other infections
in all alcohol users and their sexual partners. Research gaps remain
in a number of key areas, including but not limited to: our
understanding of the epidemiology of risks for HIV/AIDS in alcohol-
using populations and others at risk; the clinical course and
consequences of HIV and co-occurring infections associated with
continual risky alcohol use and sexual practices; the individual (e.g.,
age, gender, race/ethnicity) and environmental (e.g., social, economic,
cultural) factors that influence attitudes, beliefs, and behaviors
related to alcohol use and risky sex; and the impact of alcohol abuse,
HIV/AIDS, and related infectious diseases on diverse community
populations throughout the world. It is therefore of continuing
importance to conduct cross-national and international research which
seeks to clarify the role of alcohol in HIV transmission and disease
progression, and to develop and test comprehensive, cost-effective
preventive interventions which both reduce the risk of alcohol-related
HIV transmission and improve the treatment of HIV infected alcohol
abusing and/or alcohol dependent individuals.
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 OF SUPPORT
This RFA will use NIH (NIH) Exploratory/Developmental Grant (R21) award
mechanism. 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 29,
2003.
This RFA uses just-in-time concepts. It also uses the modular
budgeting format. (see
https://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.
FUNDS AVAILABLE
The NIAAA intends to commit approximately $2 million in FY 2003 to fund
8 to 16 new and/or competitive continuation grants in response to this
RFA. An applicant may request a project period of up to 3 years and a
budget for direct costs of up to $250,000 per year. 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 the NIAAA 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:
Michael Hilton, Ph.D.
Office of Collaborative Research
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: mhilton@niaaa.nih.gov
o Direct your questions about peer review issues to:
Eugene Hayunga, Ph.D.
Chief, Scientific Review Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 409
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-4375
FAX: (301) 443-6077
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 Boulevard, MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-2434
FAX: 301- 443-0788
Email: jfox@willco.niaaa.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
- Descriptive title of the proposed research
- Name, address, and telephone number of the Principal Investigator
- Names of other key personnel
- Participating institutions
- 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 NIAAA 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:
RFA-AA-03-009
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
Willco Bldg, Suite 409
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-4375
FAX: (301) 443-6077
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 https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
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
https://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
https://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:
https://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:
RFA-AA-03-009
Extramural Project Review Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Room 409, MSC 7003
Bethesda, MD 20892-7003
Rockville, MD 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 the NIAAA.
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 NIAAA 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 NIAAA National Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of your application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning your application's overall score, weighting them
as appropriate for each application. Your application does not need to
be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
you may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the
aims of your application are achieved, how do they advance scientific
knowledge? What will be the effect of these studies on the concepts or
methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Do you acknowledge potential problem areas and
consider alternative tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to your
experience level as the principal investigator and to that of other
researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
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 DATA SHARING: The adequacy of the proposed plan to share data.
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 25, 2003
Application Receipt Date: April 25, 2003
Peer Review Date: June-July 2003
Council Review: September 17, 2003
Earliest Anticipated Start Date: September 29, 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 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:
https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://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
https://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
https://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
https://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. 93.273 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
https://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.