PRELIMINARY INVESTIGATIONS LEADING TO OPTIMAL TRIALS IN NEUROLOGY 

RELEASE DATE:  September 17, 2003

PA NUMBER: PAR-03-174 (January 11, 2007 - This funding opportunity has been 
replaced by PAR-07-294, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.)

(Guidelines for enrollments of subject, see NOT-NS-05-010)

EXPIRATION DATE:  November 2, 2006  (Extended per NOT-NS-06-009)

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:  

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

COMPONENTS OF PARTICIPATING ORGANIZATIONS:

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.853

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 Special Requirements 
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 PAR replaces PAR-01-119.

The NINDS is committed to identifying effective treatments for neurological 
disorders by supporting well-executed clinical trials. Before a definitive 
clinical trial can be designed, preliminary clinical studies are often 
required.  The NINDS announces its interest in supporting studies required to 
obtain necessary information to establish clearly the clinical basis for 
proceeding to a definitive trial.  The purpose of the PRELIMINARY 
INVESTIGATIONS LEADING TO OPTIMAL TRIALS IN NEUROLOGY grant (for brevity 
referred to as NINDS Preliminary Clinical Trials grant) is to obtain 
preliminary data and conduct studies to support the rationale for a subsequent 
definitive clinical trial of an intervention to treat or prevent neurological 
disease. 
  
RESEARCH OBJECTIVES

The objective of the NINDS Preliminary Clinical Trials Grant is to enhance the 
quality of clinical research to evaluate interventions for the treatment or 
prevention of neurological disease.  To meet this objective, the proposed 
study must address questions that, when answered, will optimize the design of 
the eventual definitive clinical trial rather than simply address the clinical 
question with lower power.  The research proposal should directly address how 
the preliminary study will advance the design of a subsequent definitive 
clinical trial for efficacy.  

Examples of relevant clinical research for this mechanism include, but are not 
limited to, the following:

o Studies to optimize the intervention strategy (e.g., dose, duration, 
frequency of dosing).  For example, studies designed to investigate dose-
concentration, dose-response, or concentration-response relationships may 
contribute to optimal dosage selection for definitive trials.  

o Studies to assess the appropriate delivery system or parameter settings of 
an electronic device or surgical technique.

o Studies to assess the safety and tolerability at various doses or 
concentrations of a specific intervention.

o Studies designed to evaluate whether an intervention produces sufficient 
evidence of short-term activity (e.g., biomarker activity) in humans as to 
justify an efficacy trial.  

o Studies designed to select the best of two or more potential interventions 
or dosing regimens to evaluate in a subsequent definitive trial, based on 
tolerability or evidence of biological activity.

o Studies to identify inclusion and exclusion criteria to be applied in the 
phase III clinical trial.  

Note that in each of the above examples, the study is designed to provide 
specific data that will be necessary to design the subsequent definitive 
efficacy trial.  In many cases, a control group is not necessary to achieve 
these objectives.  

Some aspects of feasibility and study mechanics may also be addressed as 
secondary aims in a preliminary clinical trial, but are not in themselves 
sufficiently important to merit a grant award under this mechanism.  Examples 
of these types of secondary objectives include the following:

o Determining the optimal outcome evaluation measure, its variability, and the 
optimal timing of outcome evaluations in the context of the intervention.

o Collecting information about potential surrogate outcome measures, 
questionnaires or rating scales.

o Developing and refining data collection procedures.

o Developing and refining standardized methods of assessing outcome. 

o Evaluating whether clinicians can correctly administer the study 
intervention.

o Determining the best methods for identifying and recruiting study subjects. 

The NINDS Preliminary Clinical Trial mechanism is NOT intended to support the 
conduct of clinical trials whose primary aim is to evaluate treatment efficacy 
or studies designed to obtain a preliminary estimate of the magnitude of 
intervention effect.  Treatment efficacy should be evaluated in a properly 
designed definitive clinical trial in which the sample size is based on the 
smallest clinically meaningful difference.  Thus, an application for funding 
through the NINDS Preliminary Clinical Trial mechanism should not propose a 
miniature version of the definitive trial.  
 
MECHANISM OF SUPPORT 

This PA will use the NIH R01 award 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 may not exceed 3 years.

This PA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format.  Otherwise, follow the instructions 
for non-modular budget research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. 

ELIGIBLE INSTITUTIONS 

You may submit an application if your institution has any of the following 
characteristics: 
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research.  If so, 
a letter of agreement from either the GCRC Program Director or Principal 
Investigator should be included with the application.

As described in the section on Federal Citations (below), provisions for 
monitoring patient safety are required in all clinical trials.  The proposed 
budget should include any anticipated costs related to data and safety 
monitoring. Acceptable data and safety monitoring related expenses may 
include, but are not limited to, the following: salary support for an 
independent medical safety monitor, costs of preparing and transmitting 
adverse event or data monitoring reports to the medical safety monitor or to 
the Data and Safety Monitoring Board, costs related to holding conference 
calls or traveling to Data and Safety Monitoring Board meetings.

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 three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

John R. Marler, M.D.
Associate Director for Clinical Trials
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2216
Bethesda, MD 20892-9520
Telephone:  (301) 496-9135
Fax:  (301) 480-1080
Email:  jm137f@nih.gov

Scott Janis, Ph.D.
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2210
Bethesda, MD 20892-9520
Telephone:  (301) 594-0211
Fax:  (301) 480-1080
Email: sj151t@nih.gov

o Direct your questions about peer review issues to: 

Alan Willard, Ph.D.
Chief, Scientific Review Branch
NSC/NINDS/NIH
6001 Executive Boulevard, room 3208
Bethesda, MD 20892-9529
Telephone:  (301) 496-9223
Fax:  (301) 402-0182
E-mail:  aw135y@nih.gov

Katherine Woodbury Harris, Ph.D.
SRA, Scientific Review Branch
NSC/NINDS/NIH
6001 Executive Boulevard, room 3208
Bethesda, MD 20892-9529
Telephone:  (301) 496-5980
Fax:  (301) 402-0182
E-mail:  kw47o@nih.gov

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

Gladys Melendez-Bohler
Senior Grants Management Specialist
NIH/NINDS/GMB/Suite 3290
6001 Executive Blvd.
Rockville, MD 20892
Telephone: (301) 496-3929
Fax:  (301) 402-0219
Email:  bohlerg@ninds.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements.  The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/.  The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form.  The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Investigators planning to submit a proposal in response to this PA are 
encouraged to contact NINDS program staff early in the planning process to 
discuss their ideas. Discussion with NINDS program staff does not guarantee 
funding nor does it supersede NINDS or NIH review.

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

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

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

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

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

SENDING AN APPLICATION TO THE NIH: The title, NINDS PRELIMINARY 
INVESTIGATIONS LEADING TO OPTIMAL TRIALS IN NEUROLOGY, and the number of this 
announcement must be typed on line 2 of the face page of the application form 
and the YES box must be checked.

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, mail two additional copies of the application to:

Alan Willard, Ph.D.
Chief, Scientific Review Branch
NSC/NINDS/NIH
6001 Executive Boulevard, room 3208
Bethesda, MD 20892-9529
Telephone:  (301) 496-9223
Fax:  (301) 402-0182
E-mail:  aw135y@nih.gov

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

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

PEER REVIEW PROCESS 

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened by NINDS in accordance with the peer review criteria stated below 
will evaluate applications for scientific and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NINDS 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 the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority score.  
For example, an investigator may propose to carry out important work that by 
its nature is not innovative, but is essential to move a field forward.

(1) SIGNIFICANCE:  Does this study address an important problem?  Has the 
applicant addressed both the significance of the eventual definitive clinical 
trial AND the significance of this study in providing knowledge needed to 
proceed to the definitive clinical trial?  Is there a sufficient body of high 
quality preclinical or clinical research that supports the rationale for the 
proposed study?  What is the state of equipoise in the medical and patient 
communities with respect to the proposed intervention?  What is the potential 
impact of the proposed intervention on health care and quality of life?  If 
the aims of the study are achieved, how will these results contribute to the 
design and implementation of the definitive clinical trial?  

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics? 

For the proposed preliminary study, reviewers will evaluate whether the 
approach is adequate in each of the following areas: 

o Plans for the sequence of clinical studies, including the proposed 
preliminary study, that will produce a definitive clinical trial; 

o The scientific soundness of the proposed methodology, such as translation of 
the clinical question into statistical hypotheses, selection of outcome 
measure(s), inclusion and exclusion criteria, plans for identifying, 
screening, and enrolling subjects, plans for randomization and masking, if 
appropriate, implementation of intervention (including determination of 
treatment dose), and plans for follow-up of patients;

o The soundness of plans for analysis of the primary and secondary questions, 
including the adequacy of the target sample size for achieving the goals of 
the study;

o The completeness and quality of the protocol and standardized procedures 
that will be used for this study;  

o The ethical aspects of the study, including risks and benefits to patients, 
the adequacy of subject education and consent procedures, and safety 
protections;

o The adequacy of plans for safety monitoring of the study;

o The adequacy of data management and quality control procedures.
  
Although plans for data management and analyses will be evaluated by 
reviewers, sophisticated data management procedures are not required for a 
preliminary study. However, data management procedures may be tested in the 
study. Likewise, detailed description of specific methods to be used for data 
analyses is not required; it is assumed that in most cases, preliminary 
studies will provide mostly descriptive statistics.  Reviewers will evaluate 
plans for demographic subgroup analyses, if applicable. 

(3) INNOVATION:  Are the aims of the study original?  While the proposed study 
design, methods, and interventions may not necessarily be innovative, the 
underlying aims should represent an advancement in the field. 

(4) INVESTIGATOR:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)? The 
reviewers should consider training and expertise in the clinical problem and 
the proposed intervention, and training and expertise in clinical trials.  If 
a multicenter study is proposed, the reviewers should also evaluate the 
investigator's ability to organize and manage the research group.

(5) ENVIRONMENT:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support? Have appropriate agreements with participating industry sponsors, if 
any, been established?

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 

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

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

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

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

REQUIRED FEDERAL CITATIONS 

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

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

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

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase 3 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 3 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://stemcells.nih.gov/index.asp 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, in the project 
description and elsewhere in the application as appropriate, 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.healthypeople.gov/.

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

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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