Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institute of Health (NIH), (

Components of Participating Organizations
National Heart, Lung and Blood Institute (NHLBI), (
National Institute of Allergy and Infectious Diseases (NIAID), (
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (
National Eye Institute (NEI), (
National Institute of Diabetes and Digestive and Kidney (NIDDK), (
National Institute of Neurological Diseases and Stroke (NINDS), (
National Institute of Nursing Research (NINR), (
Office of Rare Diseases (ORD), (
Office of Research on Women’s Health (ORWH), (

Title: Sarcoidosis: Research into the Cause of Multi-organ Disease and Clinical Strategies for Therapy (R01)

Announcement Type

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using For more information and an initial timeline, see NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( Specific funding opportunity announcements will also clearly indicate if submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site ( for the most current information when preparing a grant application.

Program Announcement (PA) Number: PA-06-123

Catalog of Federal Domestic Assistance Number(s)
93.838, 93.856, 93.846, 93.867, 93.849, 93.853, 93.361

Key Dates
Release Date: January 20, 2006
Application Submission Dates: Standard dates apply, please see
Peer Review Date(s):
Council Review Date(s):
Earliest Anticipated Start Date:
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII.
Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The purpose of the PA is to stimulate research on the etiology and management of sarcoidosis, an immune mediated granulomatous inflammatory disorder. Studies supported by this PA would include investigations to find the etiology(ies) and related host factors that might enhance susceptibility to sarcoidosis, especially development of symptomatic multi-organ disease that has a propensity to involve critical organs (such as lungs, heart, eyes, central/peripheral nervous system, liver, kidneys and other abdominal viscera) that create serious illness. Study of the still problematic management and the biological, behavioral, or psychosocial burden on individuals, families, and community is encouraged. Moreover, there is interest for approaches to risk reduction, psychological coping, and management of complications and side effects of treatment.


Although sarcoidosis was described originally through its skin manifestations in 1869, involvement of multiple organs and organ systems was soon recognized. In representative U.S. patient series (Lung 2002; 180:281-299), disease symptoms involving the lungs were found in over 90% of patients, and about 30-50% of patients had illness detected in 2 or 3 other organ sites. Critical organ involvement occurs for eyes, heart and nervous system in approximately 15%, 10%, and 5% of patients, respectively. The prevalence of sarcoidosis in the U.S. population is estimated at 200,000 cases; the incidence in Afro-Americans is about 30/100,000 people and in Caucasians about 10/100,000 people. Sarcoidosis typically occurs during the third decade, but also occurs in older adults. The disease is found worldwide. There are health disparities observed among ethnic groups with sarcoidosis related to gender and age at diagnosis.

Although the clinical description and natural history of sarcoidosis are well recorded, many very basic things remain unknown about this problematic illness. An autoimmune or infectious cause has long been suspected, but definite isolation or identification of a microbe or antigen has been difficult to establish with certainly. Sarcoidosis is an immune-mediated disorder. Studies in sarcoidosis show oligoclonal expansion of T cell populations that are skewed towards the Th1-type phenotype. These T cells bear specific T cell receptor rearrangements consistent with Major Histocompatibility gene complex (MHC)-restricted antigen-driven host responses. However, the antigenic peptides associated with these MHC-restricted processes are unknown.

The presentation and clinical course of sarcoidosis are variable. A form of acute illness that may resolve quickly is termed L fgren’s syndrome; this features respiratory symptoms and painful lower leg skin areas (erythema nodosum). Initial symptoms of sarcoidosis may present in the lungs, but these may subside or can persist without much incapacity and remain stable. A more progressive or chronic form involving several organ systems can occur, and affects about 25% of those with sarcoidosis. For some patients, this form can be relentless and results in significant complications, including blindness, meningitis, arthritis, renal disease, systemic morbidity, dermatitis and even death. Multiple approaches, relevant to this announcement, have been used in the study of sarcoidosis including the following highlights which also emphasize gaps in our knowledge of disease pathogenesis.


The NIH support for clinical and basic research on sarcoidosis dates to the 1970’s when some of the seminal findings about the disordered human immune response and development of granulomatous inflammation were made at the Clinical Center of the intramural NIH campus in Bethesda. Such findings were investigated by other research groups, also. The NHLBI has supported a broad research program in sarcoidosis. The Institute supported A Case Control Etiologic Study of Sarcoidosis (ACCESS), a multicenter study of over 700 individuals with sarcoidosis, which represents the largest sarcoidosis cohort that has been studied (American Journal Respiratory Critical Care Medicine 2001; 164: 1885-1889).

A number of observations have begun to emerge from this study, which investigated the possible, but complex role of infectious agents, genetic components, and environmental or work related exposures in the etiology of sarcoidosis. Of critical importance was to actually define how organ involvement is determined and what evidence is needed. An initial attempt was made to screen sarcoidosis patients for a special variety of microorganisms, known as cell wall deficient forms of mycobacteria, in their peripheral blood cells. Other results support a role for genetic factors as contributing to the risk of developing sarcoidosis; several environmental exposures and particular occupational histories appear to be more prevalent among subjects with sarcoidosis.

NHLBI is currently supporting a multi-center study to conduct a genetic linkage study to identify sarcoidosis-associated genes and to investigate how genes and environmental risk factors interact to cause sarcoidosis. A major goal of this study is the identification of individuals who are at increased risk for developing sarcoidosis.

Several other NHLBI-supported projects investigate the basic mechanisms that regulate granuloma formation. The NHLBI intramural research program in the Clinical Center at NIH has supported a clinical study to evaluate pentoxifylline in treating patients with sarcoidosis.

In August 2002, the NHBLI convened a sarcoidosis working group to review the science and identify important new research directions and priorities in sarcoidosis. Investigators with expertise in infectious disease, gastroenterology, genetics, pulmonary medicine, and immunology, as well as patients and patient advocacy groups, were invited to this meeting. Among the recommendations ( American Journal Respiratory and Critical Care Medicine 2004;70: 567-571) for future research were suggestions to: develop a tissue bank to collect lung biopsy and other affected tissue plus associated clinical data from patients with sarcoidosis; identify genetic factors involved in sarcoidosis; study the immunopathogenesis and role of infection in sarcoidosis in relevant animal models and in human tissue; identify targets for potentially novel treatment that later could lead to clinical trials; improve management of patients with sarcoidosis, including attention to educating primary care physicians, nurses, mental health providers, as well as communications with patients and their families; develop better markers for assessing disease activity and predicting prognosis; and develop clinical trials to study potentially promising new therapies for sarcoidosis.


Of importance is that all NIH Sarcoidosis programs translate the results of the research into usable information for the public and health care professionals. Obviously sarcoidosis remains a troublesome, unsolved disease, variously affecting people. Many unanswered questions remain. Collaborations and interactions between the scientific community, NIH, patients, and patient advocacy groups have provided a new perspective and given urgency to addressing research questions in sarcoidosis. Positive interactions among all groups should continue if progress towards better understanding and ultimately a cure for this disease can become a reality. NIH is committed to continued support of sarcoidosis research and hopes this PA will stimulate interest within the scientific community, patient groups, and the public to advance this important area of research.

Examples of research topics include but are not limited to:

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R01 award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

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.

2. Cost Sharing

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: part2.htm#matching or cost sharing.

The most current Grants Policy Statement can be found at:

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

See Section VI.2 Administrative and National Policy Requirements for additional information.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Application Submission Dates:
Peer Review Date:
Council Review Date:
Earliest Anticipated Start Date:

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH 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 eight (8) weeks.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 at includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

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.

3. Include a cover letter with the application that identifies 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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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 the priority score. Applicants with questions about the data sharing plan should contact the program official listed on this grant announcement.

Sharing Research Resources

NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement and Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer-review procedures ( will evaluate applications for scientific and technical merit.

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

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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. Note that an 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 or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Herbert Y. Reynolds, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 10018
National Institutes of Health, DHHS
6701 Rockledge Drive, MSC 7952
Bethesda, MD 20892-7952
Telephone: ( 301) 435-0218
Fax: (301) 480-3557

Richard T. Sawyer, Ph.D.
Program Officer
Division of Allergy, Immunology and Transplantation
National Institutes of Allergy and Infectious Disease
National Institutes of Health, DHHS
6610 Rockledge Drive, Room 3103
Bethesda, MD 20892-6601
Telephone: (301) 402-8179
Fax: (301) 402-0528

Elizabeth Gretz, Ph.D.
Rheumatic Disease Branch
Immunology and Inflammation Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health, DHHS
One Democracy Plaza, Suite 800
6701 Democracy Boulevard, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301) 594-5032
Fax: (301) 480-4543

Grace L. Shen, Ph.D.
Director, Ocular Immunology Program
Division of Extramural Research
National Eye Institute
National Institutes of Health, DHHS
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
(Courier Services Use: Rockville, MD 20852)
Telephone: (301) 451-2020
Fax: (301) 402-0528

Jose Serrano, M.D., Ph.D.
Liver & Biliary Programs
Liver Disease Research Branch
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health, DHHS
Two Democracy Plaza, Room 657, MSC 5450
Bethesda, MD 20892-5450
Telephone: (301) 594-8871
Fax: (301) 480-8300

Michael Nunn, Ph.D.
Program Director
National Institute of Neurological Diseases and Stroke
National Institutes of Health, DHHS
6001 Executive Boulevard, Room 2115
Bethesda, MD 20892-9521
Telephone: (301) 496-1431
Fax: (301) 402-2060
Email: nunnm@ninds,

Karen Huss, DNSc, RN
Program Director
Research Training Contact, Office of Extramural Programs
Division of Extramural Activities
National Institutes of Nursing Research
National Institutes of Health, DHHS
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-5970
Fax: (301) 480-8260

Stephen Groft, Pharm.D.
Office of Rare Diseases
National Institutes of Health, DHHS
Room 3B01, MSC 7518
6100 Executive Boulevard
Bethesda, MD 20892-7518
Telephone: (301) 402-4336
Fax: (301) 480-9655

Lisa Begg, Dr.P.H., R.N.
Director of Research Programs
Office of Research on Women's Health
Office of the NIH Director
National Institutes of Health, DHHS
Telephone: (301) 496-7853
Fax: (301) 402-1798

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

Robert Pike
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, Blood Institute
National Institutes of Health, DHHS
Two Rockledge Centre, Room 7152
Bethesda, MD 20892 -7926
Telephone: (301) 435-0166
Fax: (301) 480-3310

Ann White Devine
Supervisor, Grants Management Branch
National Institutes of Allergy and Infectious Diseases
National Institutes of Health, DHHS
6700B Rockledge Drive, Room 2114
Bethesda, MD 20892-7614
Telephone: (301) 402-5601
Fax: (301) 480-3780

Melinda Nelson
Chief, Grants Management Officer
National Institutes of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health, DHHS
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-3535
Phone: (301) 480-5450

William W. Darby
Chief, Grants Management Branch
National Eye Institute
National Institutes of Health, DHHS
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: (301) 496-9997

Sharon T. Bourque
Senior Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health, DHHS
Two Democracy Boulevard, Room 719
Bethesda, MD 20892, MSC 5456
Telephone: (301) 594-8846
Fax: (301) 480-3504

Brian Albertini
Office of Grants and Contracts Management
National Institutes of Nursing Research
National Institutes of Health, DHHS
One Democracy Plaza
6701 Democracy Boulevard, Room 710
Bethesda, MD 20892-4870 (courier use 20817)
Telephone: (301) 594-6869
FAX: (301) 402-4502

Mary Demory
Office of Rare Diseases
Office of the Director
National Institutes of Health, DHHS
6100 Executive Boulevard, Room 3A07G
Bethesda, MD 20892
Telephone: (301) 402-4338

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( as applicable.

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 (

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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

Sharing Research Data:
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 (

Investigators should seek guidance from their institutions, on issues related to institutional policies and 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.

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 access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (; a complete copy of the updated Guidelines is available at 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: (1) 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 (2) 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (

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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for federal funding ( 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system ( at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from (1) currently funded NIH research projects or (2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at and view the Policy or other Resources and Tools including the Authors' Manual (

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).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at

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

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

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:

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