RELEASE DATE:  July 20, 2004

PA NUMBER:  PAR-04-129 (See Modification PAR-07-001)

EXPIRATION DATE:  September 18, 2006 (Expired September 18, 2006 per NOT-OD-06-104)

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)



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


The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports
research programs to advance understanding of the biological and 
behavioral processes involved in the development, expression, and 
consequences of alcoholism and other alcohol-related problems.  The 
Institute also supports prevention, treatment, and health services 
research on alcohol abuse and alcoholism.  A part of the NIAAA mission 
is the dissemination of new knowledge acquired from alcohol research to 
diverse audiences including scientists; educators; clinicians and other 
health and social service providers; patients and their families; 
professionals within the criminal justice system; and the general 
public. This Program Announcement (PA) identifies health education 
activities that NIAAA will consider for award through Education Project 
Grants (R25).


Broad ranges of educational approaches are included within the context 
of this PA.  The major areas of activity include:

With respect to K-12 programs specifically, the following criteria 
should be considered:

A.)K-12 Science Education and Undergraduate/Graduate Education- 
Educational activities directed toward enhancing the knowledge of 
primary/secondary school educators and/or students and/or 
undergraduate/graduate students on the science of alcohol and/or 
alcohol-related problems.  Activities and projects under this objective 
should attempt to meet criteria as detailed below:

1. Applicants are highly recommended to include K-12 teachers and 
related educators as consultants or as members of the development team.

2. For K-12 programs, materials developed should be easily integrated 
into an existing school’s curriculum, using between two and five class 
periods for implementation, depending upon the type of scheduling that 
exists within the school system (thus, block scheduling and related 
scheduling models should use no more than two class periods; regular 
scheduling may use up to five)

3. For K-12 programs, materials should align with National Science 
Education Content and Teaching Standards (NSES) at least, and if 
possible, with AAAS’ Benchmarks for Science Literacy 2061.

4. For K-12 programs, materials should be readily adaptable to specific 
state standards in the initial state(s) that the material is to be 
proposed for use or pilot/field testing.  Incorporated state standards, 
such as McRel, should be used as a guideline for future potential 
national implementation  

5. Multimedia components are encouraged, especially those that use 
innovative, cutting-edge technology.  However, use of multimedia must 
not be at the expense of science content and educational methodology.  
In addition, submissions must also be flexible for underprivileged 
classrooms (in the case of K-12 programs) and/or school districts that 
may not have availability of certain multimedia devices or adequate 
student to computer ratios. 

6. For K-12 programs, lessons, though targeted towards a certain age-
level, should be adaptable to diverse student bodies, to promote 
greater usability.  Specifically, teachers are faced with inclusion 
classrooms that are made up of gifted students, English as a Second 
Language (ESL/ESOL) students and students with a wide variety of mental 
and physical disabilities among others.  Submissions should have 
activities that while promoting inquiry, also differentiate to various 
degrees (i.e. open-ended, guided and structured inquiry model) as a 

7. Evaluation components to assess student learning, teacher usability 
and ease of implementation, as well as measured changes with respect to 
related state and/or national standardized exam scores, must be 
included.  Evaluations need to provide a fair, balanced comparison 
(control groups must be provided with adequate references and resources 
on content) that allows for an accurate assessment of improvement.  
Grantees should be willing to work with administrators and policy 
makers, and through doing so, develop an evaluation piece that is 
conducted throughout the developmental process, targeting not only 
academic improvement, but more importantly how the product is being 
used (feasibility, time spent using it in class, adoptability to other 
courses/grades, etc).  Finally, survey questions should be provided and 
collected from both teachers (especially) and students to be used for 
further modifications and updated editions of the curricula itself, 
especially if applicants are seeking continuation awards.

The remaining criteria should be pertinent to both K-12 and 
undergraduate/graduate academic environments:

Materials should include a background section (does not need to be 
substantial in length) for teachers that accounts for the technical 
content included and provides assistance with preparation and 
implementation of the activities.  Teacher materials need to be 
developed to the degree that teachers require only minimal preparation 
to learn about and implement the lesson(s).  This may vary to a degree 
with respect to undergraduate/graduate school programs.  In addition, 
teacher training sessions/workshops should be developed as part of the 
grant submission.

Material should have a targeted grade/age level.  Pilot and field 
testing should be done in various socioeconomic rural, urban and 
suburban school settings to determine student and teacher feasibility 
and interest, and must include and account for feedback from both.  In 
addition, these materials should be inquiry-based and constructivist in 
nature. The 5E’s Instructional Model (Engage, Explore, Explain, 
Elaborate and Evaluate) is encouraged for design purposes in K-12 
educational programs.

It is anticipated that one of the results of these projects will be 
publications submitted to appropriate science education research 
journals.  In addition, it is desirable that products that are 
developed under this mechanism be shared with NIAAA for use on both the 
NIAAA and NIAAA Cool Spot (adolescent) websites, as well as for use in 
various science teacher workshops, trainings, conferences and 

Project members should work with teachers and/or professors on 
integration of programs, but also on actual instruction in the 
classroom.  Thus, focus group testing should involve the PI or other 
qualified member of the team providing actual instruction of developed 
module(s) to K-12 classrooms and college environments, in various 

B.) Health Professions Education- This area of activity includes 
projects designed to support and study the dissemination of new 
knowledge acquired through alcohol research to a wide array of health 
professionals—both individuals currently practicing their professions 
and those in training for health professions. A broad definition of 
health professions is adopted, including but not necessarily limited 
to: social workers, occupational therapists, nurses, physicians, 
psychologists, counselors, and others involved in areas of physical, 
mental and/or behavioral health services where target groups experience 
alcohol use disorders. Appropriate activities may include, but are not 
limited to, the development of courses, program, curricula, and related 
materials designed to educate scientists, educators, service providers, 
and others about scientific advances in our knowledge of alcoholism, 
alcohol abuse, and alcohol-related problems (for example health-related 
complications with individuals who have diabetes and consume alcohol). 
Activities and projects under this objective should attempt to meet the 
criteria as detailed below: 1) Applicants are strongly encouraged to 
include members of the target health professions audience as 
consultants or in the planning process; 2) Educational intervention 
innovations and materials should be transferable, adoptable, and 
adaptable by educators in health profession training settings other 
than those where they have been initially pilot tested; 3) Educational 
innovations should address relevance and relatedness to current and/or 
emerging standards for education in the target profession;            
4) Evaluation components must address outcomes and be conducted using 
appropriate types of research designs, instrumentation, procedures, 
sampling strategies, and plans for analyses; and 5) Products developed 
under this mechanism may be shared with NIAAA for use and dissemination 
through its websites, workshops, trainings, conferences, and 

C.) Public Health Education- Educational activities directed to 
patients, their families, and the general public, which impart 
knowledge gained through research on alcohol-related health issues, 
including those related to screening, treatment, and prevention. The 
development of materials designed to increase the health of the general 
public and their knowledge of scientific advances. In particular, 
programs targeted toward 18-24 year olds are encouraged, given that 
this is known to be a high-risk drinking period. The translation of 
scientific knowledge into practice is important to make our research 
findings have more significant meaning.


This Program Announcement (PA) uses the National Institutes of Health 
(NIH) Education Project Grant (R25) mechanism.  As an applicant you 
will be solely responsible for planning, directing and executing the 
proposed project.  The total project period for an application 
submitted in response to this PA is generally two years, though if 
strong, an exception could be made (if justification is provided) to 
allow for funding not to exceed five years.  Competing renewal 
applications may be submitted for additional years beyond the initial 
project period.

The maximum award will be $250,000 in direct costs per year.  Indirect 
costs will be paid at 8% of direct costs, less appropriate exclusions.  
It is anticipated that two to three R25 awards will be available 
annually.  Given the diverse nature of activities supported under this 
PA, the size of awards will vary.

This level of support is dependent on the receipt of a sufficient 
number of applications of high scientific merit.  Although this program 
is provided for in the financial plans of the NIAAA, awards pursuant to 
this PA are contingent upon the availability of funds for this purpose.

Facilities and Administrative (F&A) costs will be awarded based on the 
negotiated rate at the time of the award.  These awards are not 
renewable; however, a no-cost extension of up to one year may be 
granted to the grantee institution prior to expiration of the project 
period.  Investigators are encouraged to seek continued support for 
their research projects through a research project grant (R01).


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 Faith-based and community-based organizations
o Foreign institutions are not eligible to apply

Small Business organizations are eligible to apply for alcohol science 
education projects through the Small Business Innovative Research 
(SBIR) or Small Business Technology Transfer (STTR) programs.  
Information on the SBIR and STTR programs is available at and from the NIAAA 
program official listed under INQUIRIES.


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.


Allowable costs must be consistent with NIH policy and be reasonable, 
allowable, and well-documented and justified for the research education 
program.  Grant funds may not be used to supplant funds otherwise 
available at the applicant institution.

Personnel Costs - individuals participating in the design and 
implementation of the alcohol education project may request salary and 
fringe benefits appropriate for the percent of time devoted to the 
program.  Normally, all personnel costs (including administrative and 
clerical costs) associated with directing, coordinating, and 
administering the program are not expected to exceed 25% of the total 
direct cost.  Salaries requested may not exceed the levels commensurate 
with the institution's policy for similar positions and may not exceed 
the congressionally mandated cap.  

Limited administrative and clerical salary costs associated distinctly 
with the program that are not normally provided by the applicant 
organization may be direct charges to the grant only when specifically 
identified and justified.  Consultation costs, equipment, supplies, 
necessary travel, and other program-related expenses must be justified 
as specifically required by the program proposed and not duplicate 
items generally available for educational programs at the host 

Participant Support - participants in the alcohol education project may 
receive subsistence allowance, which includes partial costs of meals 
and lodging (unless furnished as part of the fee for registration).  

Individuals supported by NIH training and career development mechanisms 
(K, T or F Grants) may not receive stipend or salary support from the 
Alcohol Education Project Grant.  However, if funds are not available 
from other sources, limited support to defray participation costs 
(e.g., travel, meals, lodging) may be provided.

Partial costs for off-site rental space will be considered if it is 
short-term and shown to be necessary for the implementation and 
execution of the educational program (seminar, workshop, etc.).  
Matching funds from applicant institutions or other organizations for 
such off-site costs are strongly encouraged.

Facilities and Administrative (F&A) Costs, formerly known as "indirect 
costs," may be allowed for the applicant organization and any approved 
subcontract based on 8% of total direct costs exclusive of tuition and 
fees and expenditures for equipment.

Normally, funds will not be provided for fringe benefits or health 
insurance for participants involved in this education program.

Note that all costs associated with consortium/contractual 
arrangements, both direct and F&A costs are considered direct costs and 
are included in the $250,000 direct costs ceiling limitation for this 


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

Inquiries concerning Education Project Grants focused on K-12 Science 
Education and Undergraduate/Graduate Education should be directed to:

Jason Lazarow, M.Ed.
Science Education Coordinator
Health Sciences Education Branch
Office of Research Translation and Communications
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
(note new physical address)
5635 Fishers Lane
Room 3101, MSC 9304 
Bethesda, MD 20892-9304
(For FedEx/UPS, use Rockville, 20852-1705)
Telephone: (301) 435-8043
Fax: (301) 480-1726
Inquiries concerning Education Project Grants focused on Health 
Professions Education:

Isabel Ellis, MSW
Public Health Analyst
Health Sciences Education Branch 
Office of Research Translation and Communications (ORTC) 
National Institute on Alcohol Abuse & Alcoholism
National Institutes of Health
(note new physical address)
5635 Fishers Lane
Room 3111, MSC 9304
Bethesda, Maryland  20892-9304
(For FedEx/UPS, use Rockville, 20852-1705)
Telephone: (301) 443.8771
FAX: (301) 480.2358

Inquiries concerning Education Project Grants focused on Public Health 
Education should be directed to:

Margaret M. Murray, MSW
Chief, Health Sciences Education Branch
Office of Research Translation and Communications
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
(note new physical address)
5635 Fishers Lane
Room 3105,MSC 9304
Bethesda, MD 20892-9304
(For FedEx/UPS, use Rockville, 20852-1705)
Telephone: (301) 443-2594
Fax: (301) 480-1726

Inquiries regarding fiscal matters should be directed to:

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
(note new physical address)
5635 Fishers Lane
MSC 9304
Bethesda, MD 20892-9304
(For FedEx/UPS, use Rockville, 20852-1705)
Telephone: (301) 443-4704
Fax: (301) 443-3891


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 D&B number can be obtained by calling (866) 
705-5711 or through the web site at 
The D&B number should be entered on line 11 of the face page of the PHS 
398 form. The PHS 398 is available at in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

The PA title and number must be typed on line 2 of the face page of the 
application form and the YES box must be marked.  


Applications that do not conform to the specific instructions detailed 
below will be returned without review.

1.  Application face page:  item number two on this page must include 
the program announcement number and the title, Alcohol Education 
Project Grant (R25).

2.  Description, Performance Sites, and Key Personnel (Form Page 2):  
under Performance Sites include "Consortium/Contractual Arrangements," 
with a description of plans for collaborating with other institutions 
for purposes of exchange and sharing of resources, including faculty, 
equipment, and facilities. If multiple sites are to be used, the 
applicant institution must be one of those sites and for other sites a 
strong justification must be included.

3.  Resources (Resources Format Page):  describe the educational 
environment; include a description of the facilities, laboratories, 
participating departments, computer services, and any other resources 
to be used in the conduct of the proposed education program.  Use 
continuation pages, as necessary.

4.  Education Plan: 

a) Program Direction - describe arrangements for the organization and 
administration of the program, as well as evidence of institutional and 
community commitment and support for the proposed program.  

b) Program Faculty/Staff - describe the characteristics and 
responsibilities of the faculty; provide evidence that the applicant 
and/or supporting personnel (including consultants) are actively 
engaged in research or other scholarly activities related to alcohol 
abuse and alcoholism.  NIAAA recommends a multidisciplinary advisory 
group that would include addiction specialists, prevention researchers 
and experts in an appropriate related educational field.  The primary 
responsibility of this advisory group is the recruitment and selection 
of curriculum specialists, teachers, school administrators, and 
students as appropriate.    

c) Program Participants - provide detail about the proposed 
participants; include a description of plans for recruiting individuals 
from underrepresented racial/ethnic groups, women and persons with 
disabilities.  Competing continuation applications must include a 
detailed account of experiences in recruiting and retaining individuals 
from underrepresented groups during the previous award period.

d) Education Evaluation Plan – education evaluation plans are 
encouraged in determining the success of the program in achieving its 
goals and objectives.  Pilot testing and field testing is highly 
recommended as part of the evaluation plan, including pre- and post-
tests, and surveys.  Please note that applications that do not have an 
adequate education evaluation plan will be considered non-responsive to 
this program announcement. 

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at  Application deadlines are also 
indicated in the PHS 398 application kit.  

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)


Applications must be mailed on or before the receipt dates described at 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 

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.


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 ( 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 
o Receive a written critique
o Receive a second level review by the National Institute on Alcohol 
Abuse and Alcoholism Advisory Council.


The goals of NIH-supported Alcohol Education projects are to enhance 
the exposure and understanding of K-12 students and their teachers (or 
appropriate intended audiences), as well as the general public to basic 
research and its outcomes and implications. One of the major intents of 
NIAAA’s educational programs is to increase the number of individuals 
who will pursue biomedical careers generally, and alcohol research 
careers specifically.  To this end, NIAAA also encourages the 
recruitment of underrepresented minorities and underserved populations. 

In the written comments, reviewers will be asked to evaluate the 
application in order to judge the likelihood that the proposed project 
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 Evaluation
o Personnel
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?

o Briefly summarize the background leading to the development of this 
plan. Explain why the particular strategy was chosen.  Include 
information on the process and rationale for selecting the scientific 
area, the educational approach, and the target population, and indicate 
how this project will address an unmet need.  

o Describe the advantages and limitations of the model selected, and 
its potential for widespread dissemination and adaptability for use by 

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?

o Identify the long-range goals for the project and describe the 
specific objectives for the proposed project period. 
o Include preliminary studies relevant to your application conducted by 
the principal investigator and/or other key personnel.  In addition, 
provide other relevant information that will establish the experience 
and competence of both the program leadership staff and partnership 
organizations to effectively carry out the proposed project. 
o A description of the educational approach, the scientific content, 
and the nature and extent of existing educational and scientific 
partnerships and collaborative interactions. 
o A description of any dissemination activities to date, or a 
description of the stage of development of the current model with 
respect to future dissemination plans. 

o Describe in detail the activities proposed and how they will 
contribute to achieving the stated goals of the program.  
o Give quantitative data on the numbers of teachers, students, and/or 
members of the general public projected to be involved and the quantity 
and types of educational materials to be produced and/or disseminated. 
o Explain the relevance and potential of this project for dissemination 
to a broad population, including efforts aimed at underrepresented 
groups in science, both women and minorities. 
o Explain clearly the nature and extent of educational and scientific 
partnerships and collaborations to be developed (or, for those already 
established, any plans for expansion or modification), and the roles of 
key participants in the planning and conduct of the project.  
o Provide documentation of the interest and commitment of members and 
participants to this project. 
o Discuss how the proposed educational programs or research project
is both appropriate and adequate to achieve the educational goals 
o Describe the administrative plan to organize and manage the overall 
project, and provide a timetable for the various tasks and activities 
for the entire project period requested.

EVALUATION:  All applications must include a detailed Evaluation Plan 
for assessing the success of the proposed educational program.  The 
Evaluation Plan should be an integral component of the early planning 
stages and must continue through the life of the project.  The use of 
external evaluators is required unless a valid justification can be 
made for an internal evaluation team. 

o Provide a detailed plan for evaluating the effectiveness of the 
program in achieving its objectives. 

o Document that the evaluation team is appropriate and qualified for 
your proposed project.

o Describe the development and implementation of the plan for formative 
and summative evaluations of project activities.  Include strategies 
for revisions to evaluative instruments and educational processes 
and/or materials. 

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 

o Discuss how the curriculum, educational, research and/or 
collaborative plans include original and unique approaches for 
addressing the needs put forth in the goals and objectives.

o Present your plan to include related learning tools, such as 
teamwork, writing and mathematics skills, inquiry-based thinking and 
problem solving under the umbrella of your main science education 
topic.  If appropriate discuss your plans to challenge existing science 
education paradigms or to develop new approaches for improving science 

PERSONNEL: 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)?

o Present a discussion as to how the program leadership has 
demonstrated a record of achievements and that their qualifications are 
appropriate to achieving the proposed goals and implementing the stated 

o Discuss how the K-12 partners will provide input in the proposed 
program with respect to educational content, sophistication level of 
the students and relevance to state and national testing standards.  As 
appropriate letters of participation and support from collaborators, 
school officials and teachers must be included as Appendix materials.

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?  

o Discuss how the inquiry-based scientific and educational environment 
described in your proposal will foster student interest and 
participation, increase the awareness of the scientific process and 
ultimately generate a high level of confidence in the students for 
health science related careers.

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:

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).

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).

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.  


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


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


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.

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. 

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 

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

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

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.

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).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
( 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

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 

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at 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 

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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