PHASE III CLINICAL TRIALS IN ORAL INFECTIOUS DISEASES 

RELEASE DATE:  November 20, 2003
 
PA NUMBER:  PAR-04-025

EXPIRATION DATE:  November 1, 2006 unless reissued. 

Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.121 (Oral Diseases and 
Disorders)

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

PURPOSE OF THIS PA  

The National Institute of Dental and Craniofacial Research (NIDCR) encourages 
submission of investigator-initiated grant applications for Phase III 
clinical trials to assess the efficacy and safety of preventive or 
therapeutic interventions for oral infectious diseases.  Such interventions 
should have high potential for translation into clinical practice and for 
improving the oral health status of all Americans. NIDCR’s prior support for 
basic and clinical research has shown that dental caries, periodontal 
diseases, and many other oral diseases involve infectious processes that 
result from the interplay of infectious agents, environmental influences 
(e.g., diet), genetic factors, and host response. This initiative seeks to 
accelerate the translation of such findings into well-documented, cost-
effective interventions of proven efficacy for preventing and treating oral 
infectious diseases. Clinical trials focusing on the periodontal diseases and 
dental caries are particularly encouraged given the uniquely prominent role 
that these disorders have in the delivery and cost of oral health care as 
well as their widespread prevalence in the population. However, clinical 
trials involving other oral conditions with an infectious cause – bacterial, 
viral, or fungal – will also be considered responsive to this PA. 
Applications that address novel interventions, higher risk population groups 
with oral health care disparities, research gaps, and common pathologic 
mechanisms are particularly encouraged. 

RESEARCH OBJECTIVES

To ensure that the scientific advances of the post-genomic era “enter the 
mouth,” the NIDCR must enhance the translation of basic science findings into 
clinical trials. Clinically relevant evidence must be obtained from 
definitive clinical trials in order to define optimally effective clinical 
practices.  Such practices require extending current paradigms of preventive, 
surgical, and reparative dental care to paradigms that emphasize 
prevention/earlier detection/and novel interventions based on a more thorough 
biologic understanding of oral health and disease.  Therefore, the NIDCR 
recognizes the need to encourage and support high quality definitive clinical 
trials that address significant clinical problems.  These clinical trials 
need to be appropriately designed and of sufficient power to have an impact 
on the public health and future clinical practice. Thus, the specific goal of 
this program announcement is to encourage investigators to design and submit 
high quality Phase III randomized clinical trials to improve the prevention 
and treatment of infectious oral diseases. 

Oral infectious diseases are endemic in the population and are the most 
prevalent chronic infections in humans. Periodontal diseases and dental 
caries are the most common infectious oral conditions. Both are the result of 
infections caused by bacteria in the dental plaque biofilm. Periodontal 
diseases range from mild forms such as gingivitis to severe forms of 
periodontitis that result in destruction of periodontal support and tooth 
loss. Approximately half of the U.S. adult population aged 35 to 44 have 
gingivitis and about one-fourth have severe periodontitis.  Although 
pathogenic bacteria in dental plaque are the primary etiologic agents for 
periodontal disease, diabetes and tobacco use increase risk for this 
infectious disease. Accumulating evidence also indicates a potential link 
between maternal periodontal disease and the incidence of preterm birth and 
/or low-birth weight babies and between periodontal disease and both 
cardiovascular disease and pulmonary disease.
   
Even though many more children and adolescents remain caries free today than 
previously, dental caries is still the most common chronic infectious disease 
of childhood in the United States. Early childhood caries (ECC) affects the 
primary dentition and is seen in about 18% of children aged 2 to 4. Children 
whose parents or caregivers have less than a high school education or who are 
Mexican American, American Indian, or Alaska Native appear to be at a highest 
risk for developing ECC. Maternal oral infections and their transmission to 
infants and young children are known to play an important role in ECC. The 
majority (51.6%) of children aged 5 to 9 years have at least one carious 
lesion or dental restoration in the primary of permanent dentition. This 
prevalence increases to 77.9% at 17 years of age and to 84.7% in adults 18 or 
older. Furthermore, 49.7% of people 75 years or older have root caries. 
Medically compromised patients receiving radiation and chemotherapy are 
particularly vulnerable to dental caries. Treatment for the periodontal 
diseases and dental caries accounted for much of the estimated $60 billion 
Americans spent for dental services in 2001.

In addition to encouraging Phase III clinical trials to prevent or treat 
caries and periodontal disease, this program announcement also applies to 
clinical trials that focus on other oral diseases or conditions (e.g., 
salivary diseases, oral mucosal lesions) associated with bacterial, viral, or 
fungal infections. For example, the human papilloma virus (HPV) is found in a 
variety of oral lesions and candidiasis, a fungal infection caused by Candida 
albicans, often causes oral symptoms of burning and soreness as well as 
sensitivity to acidic and spicy foods.  In most cases, candidiasis can be 
controlled with local or systemic antifungal medications, but control of this 
fungal infection can be difficult in patients with compromised immune 
systems.

SCOPE

The purpose of this PA is to encourage Phase III clinical trials that address 
the efficacy and safety of biologically-based preventive or therapeutic 
interventions for oral infectious diseases. These studies should be 
sufficiently powered to provide definitive results with clinically meaningful 
outcomes. Examples of studies that would be responsive to this program 
announcement are listed below. These are only illustrative examples and 
applicants are encouraged to propose other topics that are consistent with 
the goals of this program announcement.

o   Clinical trials involving, chemotherapeutic, pharmacologic, passive 
immunotherapy, or other interventions to prevent and/or treat the periodontal 
diseases and various types of dental caries (e.g., ECC, root caries), 
particularly in population subgroups with known risk factors and who are at 
risk for disparities in oral health care; 

o   Clinical trials focusing on the prevention or treatment of oral 
manifestations or complications of infections caused by herpes viruses, human 
papilloma virus, Human Immunodeficient Virus (HIV), enteroviruses or other 
human viruses;

o   Clinical trials testing new therapeutics or management strategies for oral 
candidiasis and other fungal infections;

o   Clinical trials testing interventions for noma and other disfiguring or 
debilitating oral infections;

o   Clinical trials on interventions for managing and treating mucosal 
infections in patients with AIDS or immune dysfunction secondary to cancer 
therapy. 

MECHANISM(S) OF SUPPORT 

This PA will use the NIH U01 award mechanism. As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.

This PA uses just-in-time concepts.  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.    

The NIH (U01) is a cooperative agreement award mechanism. In the cooperative 
agreement mechanism, the Principal Investigator retains the primary 
responsibility and dominant role for planning, directing, and executing the 
proposed project, with NIH staff being substantially involved as a partner 
with the Principal Investigator, as described under the section "Cooperative 
Agreement Terms and Conditions of Award" The total project period for an 
application submitted in response to this PA may not exceed five years.  The 
award may be competitively renewed for a second period, up to five years, 
based on peer review of a renewal application and the availability of funds.  
The NIDCR does not envision more than one renewal period.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign institutions/organizations

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

This PA solicits fully developed Phase III clinical trials. This PA will be 
of special interest to investigators who already have data and other 
preliminary requisites specified by NIDCR for all Phase III clinical trials. 
For a complete description of the NIDCR’s clinical trial program and specific 
requirements for Phase III clinical trials to be supported by NIDCR see 
“Information for Investigators” at http://www.nidcr.nih.gov under the heading 
“Clinical Trials.” 

To obtain preliminary data to support the development of a Phase III clinical 
trial you may wish to consider submitting an application in response to PAR-
03-043/NIDCR Clinical Pilot Data Grant 
(http://grants.nih.gov/grants/guide/pa-files/par-03-043.html). If you have 
preliminary data but wish to refine the trial’s protocol and procedures 
before applying under this PA, it may be appropriate to submit an application 
in response to PAR-03-042/NIDCR Clinical Trial Planning Grant 
(http://grants.nih.gov/grants/guide/pa-files/par-03-042.html).  

The Phase III clinical trial application should consist of a minimum of two 
grant applications: one from the Study Chair and one from the Data 
Coordinating Center.  Applications for participating clinical sites may be 
submitted as separate grant applications or as subcontracts to the Study 
Chair or Data Coordinating Center applications.  Given the complexity of 
Phase III clinical trials, NIDCR encourages the use of a Data Coordinating 
Center as an integral part of the clinical trial organization.  As part of 
the Study Chairs’ application, NIDCR requires the submission of a detailed 
Manual of Operations (MOP, see 
http://www.nidr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp for a 
model MOP), plans for establishing a Data and Safety Monitoring Board (DSMB), 
plans for regular meetings of the clinical trial steering committee, and 
documentation of the ability to enroll the specified number of patients. All 
applications with direct costs $500,000 or more in any year of the proposed 
research, must have a data sharing plan.

Prior to submitting an application in response to this PA or for a Clinical 
Trial Planning Grant or a Clinical Pilot Data Grant, investigators are 
requested to submit a brief description of the proposed Phase III clinical 
trial for programmatic review by NIDCR.  This review is designed to provide 
assistance and program advice to prospective applicants for clinical trials.  
This brief description should not exceed 2 pages in length.  See 
http://www.nidr.nih.gov/clinicalTrials/proposalProcedure.asp for details on 
topics to be covered plus review criteria to be used by NIDCR in conducting 
the programmatic review.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD 

Under the cooperative agreement, there will be substantial NIDCR scientific 
and/or programmatic involvement with the awardee. The NIDCR’s purpose is to 
assist, support, and/or stimulate the recipient's activity by facilitating 
performance of the effort as a partner.  The NIDCR will not assume direction, 
prime responsibility, nor a dominant role in the activity.  For details of the 
responsibilities, relationships and governance of the study to be funded as 
U01s (cooperative agreements) please refer to 
http://www.nidcr.nih.gov/clinicalTrials/terms_conditions.asp.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and the NIDCR’s clinical trial 
program 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:

Dr. Richard Mowery
Clinical, Epidemiology and Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
Building 45, Room 4As43F, MSC 6401
Bethesda, MD 20892-6401
Telephone:  (301) 594-4848
FAX:  (301) 480-8322
Email: rm33a@nih.gov

Or 

Dr. Bruce Pihlstrom
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
Building 45, Room 4As43H, MSC 6401
Bethesda, MD 20892-6401
Telephone:  (301) 594-4830
FAX:  (301) 480-8322
Email:  pihlstrb@mail.nih.gov

o Direct your questions about peer review issues to: 

Dr. George Hausch 
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD  20892-6402
Telephone: (301) 594-2904
FAX: (301480-8303
Email: George.Hausch@nih.gov

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

Mary Daley
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: 301-594-4800
FAX 301-594-3562
Email: daleym@mail.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.

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

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

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 $500,000 or more in direct costs for any year 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 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)

In order to facilitate the review of applications assigned to the NIDCR, the 
applicant must, at the same time, mail or deliver two copies of the 
application and all copies of the appendix material to:

Dr. George Hausch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44F – MSC 6402
Bethesda, MD 20892-6402

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

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

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines. Appropriate scientific review groups 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory Dental and 
Craniofacial Research 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 evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.

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

SIGNIFICANCE: Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced? What 
will be the effect of these studies on the concepts or methods that drive 
this field?

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

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

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support? 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, specific 
review criteria for Phase III clinical trials to be used by the Special 
Review Panel have been developed for the Administrative Center/Chair 
application, Coordinating Center application, Clinical Center applications, 
and Laboratory/Testing Center application. These criteria can be found at 
http://www.nidr.nih.gov/clinicalTrials/reviewCriteria.asp 

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

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

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

ADDITIONAL REVIEW CONSIDERATIONS 

Sharing Research Data 

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

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

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS 

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

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

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

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

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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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