DEVELOPMENTAL PSYCHOPHARMACOLOGY

RELEASE DATE:  April 21, 2003

PA NUMBER:  PA-03-113

EXPIRATION DATE:  March 2006, unless reissued.

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  No. 93.242, 93.279, 93.865

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  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This Program Announcement replaces PA-00-114.

The National Institute of Mental Health (NIMH), the National Institute of Child 
Health and Human Development (NICHD), and the National Institute on Drug Abuse 
(NIDA) request research grant applications to study the possible clinically 
significant effects that various psychotropic medications may have on the brain 
when administered during the developing phase that spans from birth to early 
adulthood.  The purpose of this program announcement is to spur new clinical and 
basic research on the possible impact of psychotropic pharmacotherapy on the 
developing brain.  The main goal is to generate data that are relevant to the 
clinical use of psychotherapeutic medications in children and adolescents with 
respect to safety and/or efficacy within dose ranges, schedules, and routes of 
administration that are usually employed therapeutically.  The ultimate purpose 
is to increase our knowledge of the safety and effectiveness of 
psychopharmacological treatments administered to children and adolescents.

RESEARCH OBJECTIVES

Background

Psychotropic medications are prescribed with increased frequency to children and 
adolescents, often for extended periods of time.  Millions of prescriptions of 
stimulants, antidepressants, and other psychotropic medications are written 
every year for patients under 18 years of age.  These pharmacological compounds 
act on and through neurotransmitter systems that undergo major developmental 
changes in humans during the first two decades of life.  Interactions between 
drugs and the developing brain are important considerations in assessing the 
efficacy and safety of these agents in children and adolescents.  As 
psychopharmacological treatments become more accepted in clinical practice, 
there is increasing concern over the possibility that long-term exposure of 
developing children to psychoactive agents might result in subtle but 
significant long-lasting adverse effects.  Thus, experimental data are needed 
to clarify the nature, extent, and impact of these interactions.  In addition, 
identification of brain regions and physiological mechanisms responsible for 
both the therapeutic and negative effects of drugs will be useful for the 
development of more selective psychotherapeutic mechanisms with fewer side 
effects.  For ethical, methodological, and practical reasons, it is often 
difficult or impossible to conduct this type of experiment in humans.  In 
these cases, research in animals is appropriate.

Currently, very limited experimental data indicate that exposure of animals to 
psychotropic medications such as serotonergic or antidopaminergic agents in 
early life can result in specific biochemical and molecular changes in the adult 
CNS.  In some cases, these changes can persist upon drug discontinuation and 
into adulthood.  Interpretation of results of these experiments is limited by 
the compounds, doses, administration regimens and routes employed, and the lack 
of studies of chronic neurochemical or behavioral drug effects.  These and other 
methodological limitations of previous studies have severely restricted 
generalizations of the results of small numbers of animal studies to humans.

Research Objectives

The ultimate goal of this research is to determine the short and long-term 
consequences of chronic or acute psychotherapeutic drug administration.  As 
such, relevant studies in developing animals will examine behavioral, 
neurochemical, physiological, and molecular effects of early drug administration 
in both young and adult animals.  Studies should focus on specific behaviors 
and their relationship to biochemical endpoints within defined brain regions.  
Research approaches to address these questions could include, but are not 
limited to the following:

a) Develop models of psychotherapeutic medication delivery in normal developing 
animals - Studies are needed to examine the long-term effects of chronic and 
acute administration of therapeutic doses of psychotherapeutic medications 
prescribed in children.  Examples of relevant medications include, but are not 
limited to antidepressants, mood stabilizers, and stimulants (as used in the 
treatment of ADHD).  Examples of relevant research include:

o  Examine effects of routes of administration that emulate as closely as 
possible human dosing regimens and plasma drug concentrations across a range of 
therapeutic doses.  Comparisons should assess species, sex, and age differences 
in the kinetics and metabolism of drugs over the range of therapeutic doses.
o  Examine effects of age and duration of psychotherapeutic drug administration 
in animals within and across identified brain regions.
o  Determine specificity of chronic psychotherapeutic drug effects to 
developmental periods.

Endpoint measures for these studies might include, but are not limited to, 
neurotransmitters (levels, metabolism, synthesis, release), expression and 
activity of receptors, transporters, and other signaling molecules, gene 
regulation, neuroendocrine measures in brain, electrophysiological activity, 
plasticity, and brain development and growth including neuroanatomical and 
neurochemical markers of brain development, tropic factor expression and action, 
circadian rhythms, and hormonal effects on these processes.

b) Develop and apply behavioral models in animals to assess long-term effects of 
psychotherapeutic drug administration during development on cognitive and 
emotional measures.  Examples of relevant research include:

o  Develop objective and reliable measures to mirror specific clinical 
behavioral attributes associated with psychiatric disorders occurring in 
children and that serve as specific markers of psychotherapeutic drug efficacy.
o  Develop behavioral measures that are applicable over the lifespan including 
juvenile, adolescent, and aged animals.
o  Identify specific behavioral measures in young animals that are predictive of 
adult behavioral responses including, for example, cognitive ability, drug 
response, attention, and response to environmental challenges.
o  Develop and apply behavioral measures to genetic models employing regionally 
and temporally selective manipulations of gene expression in brain to study 
anatomical, neurochemical, and signaling pathways mediating drug-induced 
behavioral changes.
o  Examine the effects of chronic drug administration in developing animals on 
adult behavioral responses to pharmacological or environmental challenges (i.e., 
stressors) or reinforcing stimuli.

The behavioral models should be amenable to studies of the neural pathways, 
transmitters, and signaling molecules responsible for therapeutic and negative 
effects of drugs.

Examples of some relevant behavioral measures for examining long-term effects of 
therapeutic doses of psychotherapeutic medications might include, but are not 
limited to, cognition, learning and memory, attention, impulsivity, exercise, 
play, anxiety, fear, response to novelty, and social behavior.  Studies of the 
behavioral effects of stimulant medications used to treat ADHD, for example, 
might identify mechanisms responsible for drug effects on attention, eating, or 
sleep.

c) Apply pharmacological and behavioral animal models to assess drug mechanisms 
and brain sites responsible for therapeutic and adverse drug effects in 
developing animals.  Relevant questions include but are not limited to the 
following:

o  Examine long-term effects of chronic psychotherapeutic medication 
administration in developing animals (i.e., antidepressants, stimulants, mood 
stabilizers, and antipsychotics agents) on brain and behavior.  Identify 
developmental stages that may be uniquely sensitive to drug effects.
o  Identify brain regions responsible for the therapeutic and negative effects 
of therapeutic doses of psychotherapeutic medications on behavior.
o  Determine neurochemicals responsible for the beneficial and adverse effects 
of psychotherapeutic medications in developing animals.  Identify cellular 
mechanisms. 
o  Develop strategies for identifying novel psychotherapeutic medications with 
fewer adverse effects.
o  Examine the combined consequences of early environmental experience and 
psychotherapeutic drug administration on brain and behavioral measures in adult 
animals.

Integrative studies in both non-human primates and preliminary studies in other 
species are encouraged.  Brain imaging and gene targeting approaches to identify 
molecules and brain regions responsible for behavioral effects of drugs are also 
appropriate.

d) Develop and expand clinical studies to examine possible effects of 
psychotherapeutic administration on the development of children as assessed by 
behavioral and brain measures obtained during childhood and/or in adults.  
Examples of relevant research include:

o  Study the possible impact of psychopharmacological treatment on 
developmentally relevant clinical parameters, such as, physical growth, sexual 
maturation, and cognitive development.
o  Study possible toxicities of psychotropic medications, which are specific or 
more common in certain phases of development as compared with adulthood.
o  Utilize non-invasive imaging techniques to study the effects on the brain of 
psychotropic medication in children.
o  Employ brain imaging techniques to assess the effects of childhood drug 
administration on brain development and adult brain function.
o  Identify brain regions responsible for the therapeutic and negative effects 
of therapeutic doses of psychotherapeutic medications.
o  Develop valid biochemical, imaging, or pharmacogenetic biomarkers or 
objective behavioral outcome measures for assessing clinical efficacy and 
safety of psychotherapeutic medications.

e) Study the possible effects of development on the pharmacokinetics, 
metabolism, disposition, and pharmacodynamics of psychotropic medications 
commonly used in children and adolescents.  Examine gender and ethnic 
differences in these measures.  Examples of possible relevant research:

o  Study the pharmacokinetics, pharmacodynamics, and/or pharmacokinetic/ 
pharmacodynamic correlations of medications commonly used in the treatment of 
children with mental disorders.
o  Study developmentally mediated changes in the ability to metabolize 
psychotropic medications in children.
o  Study the bioavailability of liquid formulations of psychotropic medications 
used in young children.
o  Study the effects of drug-drug interactions when combined therapies of 
psychotropic medications are used.
o  Study the effect of development on the bio-distribution of psychoactive 
agents.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH Research Project Grant (R01), NIH 
Exploratory/Developmental Research Grant Award (R21), and NIH Small Research 
Grant Program (R03) award mechanisms.  As an applicant, you will be solely 
responsible for planning, directing, and executing the proposed project.

The Small Grant (R03) provides two years of funding with a maximum of $50,000 
direct costs for each year.  Information on the requirements for the NIH small 
grant program may be obtained at: 
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html. 

The Exploratory/Developmental Grant (R21) provides up to two years of funding 
with a maximum of $275,000 direct costs over the entire budget period.  It is 
intended for development and pilot testing of novel models, sensitive 
neurochemical measurements, interventions and other aspects of intervention 
development.  Information on the requirements for the NIH 
Exploratory/Developmental Grant may be obtained at: 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. 

The total project period for an R01 application submitted in response to this 
PA may not exceed five years.

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

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  Questions regarding scientific/research issues about basic or clinical 
neuroscience research including sites and mechanisms of drug action may be directed 
to:

Lois Winsky, Ph.D.
Division of Neuroscience and Basic Behavioral Research
National Institute of Mental Health
6001 Executive Boulevard, Room, 7184, MSC 9641
Bethesda, MD  20892-9641
Telephone:  (301) 443-5288
FAX:  (301) 402-4740
Email:  lois@helix.nih.gov

o  Questions regarding scientific/research issues about research focused on 
clinical outcomes may be directed to:

Benedetto Vitiello, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7147, MSC 9633
Bethesda, MD  20892-9633
Telephone:  (301) 443-4283
FAX:  (301) 443-4045
Email:  bvitiell@nih.gov

o  Questions regarding psychotropic medication interactions with child growth may 
be directed to:

George P. Giacoia, M.D.
Center for Research in Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11B
Bethesda, MD  20982-5288
Telephone:  (301) 496-5589
FAX:  (301) 480-9791
Email:  gg65m@NIH.GOV

o  Questions regarding applications relevant to drug abuse may be directed to:

Nancy S. Pilotte, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 435-1317
FAX:  (301) 594-6043
Email:  npilotte@mail.nih.gov

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

Carol J. Robinson
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
FAX:  (301) 443-6885
Email:  crobinso@mail.nih.gov

Mary E. Daley
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03D, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1305
FAX:  (301) 402-0915
Email:  md74u@nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, MSC 9541
Bethesda, MD 20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gfleming@nida.nih.gov

SUBMITTING AN APPLICATION

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

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.  Application deadlines are 
also indicated in the PHS 398 application kit.

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

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 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.  An appropriate scientific review group 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  Receive a written critique
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 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 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, 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).

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 CONSIDERATIONS

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

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.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a project 
that is supported in whole or in part with Federal funds and (2) cited publicly 
and officially by a Federal agency in support of an action that has the force 
and effect of law (i.e., a regulation) may be accessed through FOIA.  It is 
important for applicants to understand the basic scope of this amendment.  NIH 
has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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

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.health.gov/healthypeople.

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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