Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Human Genome Research Institute (NHGRI), (http://www.genome.gov)
National Heart, Lung and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

Title: Molecular Screening Assay Development for SCD

Announcement Type
New

Request For Applications (RFA) Number: RFA-HG-05-001

Catalog of Federal Domestic Assistance Number(s)
93.172, 93.839

Key Dates
Release Date: December 27, 2004
Letter of Intent Receipt Date: March 25, 2005
Application Receipt Date(s): April 26 , 2005
Peer Review Date: June/July, 2005
Council Review Date: September, 2005
Earliest Anticipated Start Date: September 21, 2005
Expiration Date: April 27, 2005

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
        A. Cooperative Agreement Terms and Conditions of Award
          1. Principal Investigator Rights and Responsibilities
          2. NIH Responsibilities
          3. Collaborative Responsibilities
          4. Arbitration Process
      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

Background

Sickle cell disease was the first disease whose genetic etiology was defined. That occurred more than half-a-century ago, and since then many excellent researchers have given the disorder much attention. This has produced major gains in both understanding the biology of the disorder, such as the pathophysiological importance of polymerization, and in developing better therapies, such as hydroxyurea. Despite such advances, sickle cell disease continues to be a significant cause of mortality, morbidity, and health disparities, both in the United States and globally. The completion of the sequence of the human genome in April 2003 opened up the possibility of applying genomic and other high throughput proteomic technologies to the study of this disease.

The National Institutes of Health hosted a conference, "New Directions for Sickle Cell Therapy in the Genome Era," in Bethesda, MD, in November 2003 to consider how the new tools and techniques of genomics might be applied both to understand more fully the biology of sickle cell disease and to develop more effective therapeutic and preventive strategies for the disease. The purpose of the conference was to discuss how to move the field of sickle research dramatically forward, and yet be mindful of the social and cultural history of this disease. Over 120 individuals from the United States and abroad, including from the Caribbean and west and east Africa, attended this conference. The conference report can be viewed at: http://www.genome.gov/11509561.

Following the conference, staff from eight NIH institutes and centers formed the Trans-NIH Sickle Cell Disease Therapies Working Group. The Working Group developed a number of initiatives for consideration for implementation over the course of the next several years. This initiative is in response to one of the recommendations. The National Heart, Lung and Blood Institute recently published a RFA, “Sickle Cell Disease Clinical Research Network “ that is also related to this initiative. Information about this RFA can be found at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-05-006.html. A LISTSERV, SCDR-L, has also been established to keep the community apprised of these initiatives as they are developed as well as other fundingopportunities. To join SCDR-L, send an e-mail to listserv@list.nih.gov. Type as the body of the message: Subscribe SCDR-L Your Name (Example: subscribe SCDR-L Jane Doe).

Research Objectives

The goal of this RFA is to support the development of scientifically and technologically robust screening assays that can be automated and used for the identification of compounds that can be utilized in both basic research and therapeutics development programs in sickle cell disease. The proposed assay protocols must employ reagents and readouts that can be used in the high throughput molecular screen (HTS) environments. Funding will be provided to enable investigators to develop and transform promising assay protocols for sickle cell disease by demonstrating the responsiveness and robustness required for use in HTS.

HTS is the automated, simultaneous testing of thousands of distinct chemical compounds in models of biological mechanisms or disease. Active compounds identified through HTS can provide powerful research tools to elucidate biological processes and to do chemical genetics, or can form the basis of therapeutics development programs. The immense potential of HTS to affect the understanding of biology and disease is largely untapped because access to automated screening facilities and large compound libraries is limited in the academic community. The NIH Molecular Libraries Roadmap Initiative will provide unprecedented access to these resources and allow the broad application of HTS in NIH-supported research.

In the fall of 2004, an intramural facility (the NIH Chemical Genomics Center or NCGC) will be established and it is anticipated that a number of extramural screening centers will be established thereafter , along with a coordinating center. The proposed network will provide access to high throughput screening of a public collection of chemically diverse small molecules (assembled by NIH in a complementary effort) in a variety of assays to identify molecules that will be useful as biological probes. It is anticipated that some probes may advance beyond the realm of research tools and serve as starting points for target validation. The chemical structures of compounds in the small molecule repository and the screening data generated by the centers will be available via a public cheminformatics database (PubChem, being developed by the National Center for Biotechnology Information).

Many of the in vitro models of biological mechanisms and disease currently used to study the effects of specific compounds or genetic perturbations can be adapted to high throughput formats. There are a number of characteristics that make an assay suitable for high throughput approaches. The assay must be robust, reproducible and have a readout that is amenable to automated analysis. In addition, it must be possible to miniaturize the assay to a 96-well or higher density format. A broad range of models share these features, including biochemical assays, cellular models and simple model organisms such as yeast or C. elegans. This RFA will support the development of innovative assays for use in both basic research and therapeutics development programs for sickle cell disease, with an emphasis on novelty of approach to biology or disease. Appropriate assays might include but are not limited to:

Proposals should include assay development plans that are sufficient to demonstrate reproducibility in a low-to-moderate throughput setting, i.e., tens or hundreds of compounds, and must be feasible for adaptation to an automated, high-throughput screening approach. For example, it must be possible to reduce the assay to a 96-well or higher density format, and the assay should have a readout compatible with current HTS instrumentation.

Demonstration of feasibility for HTS must include:

The applicant must provide a clear plan for evaluating the significance of the active compounds obtained in a high throughput screen using the assay. This plan should be feasible for the evaluation of a few hundred active compounds that may be identified in a primary HTS effort. The plan should include counter-screens and secondary screens to rule out artifacts and prioritize active compounds for further testing. Limited chemistry optimization will be available on a competitive basis in the Molecular Libraries Screening Centers.

The overall goals for the use of the proposed assay in an HTS effort should be well defined and clearly presented. This discussion should include the expected future use of the compounds in a follow-up research program, either in the context of biological research or therapeutics development.

This RFA is intended to allow development and adaptation of screening assays for consideration for use at the NIH Molecular Libraries Screening Centers. These centers will work collaboratively with selected grantees to adapt assays for HTS, and will apply the assays in screening a large, diverse compound collection. Although assays developed under this RFA will be eligible for consideration by the NIH screening centers, funding under this RFA does not carry a commitment by NIH to accept the assay for screening at a center. An independent review panel will be established to select the most promising assays for testing in the HTS centers. Grantees will be free to use the assays developed under this RFA for screening elsewhere. Adherence to the criteria described in the Research Objectives will be considered in accepting applications for review. Applications that do not meet these criteria will not be reviewed.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This is a two year grant. The maximum amount of an award will be $100,000 total cost for the first year of the award and $200,000 for the second year of the award. Therefore, the budgets may have to be adjusted during final budget negotiations.

This funding opportunity uses just-in-time concepts. It also uses the modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).

2. Funds Available

The participating ICs, National Human Genome Research Institute and National Institute of Heart, Lung and Blood, intend to commit approximately 300,000 dollars (total cost) in FY 2005 to fund three new grants in response to this RFA. An applicant may request a project period of up to two years and a budget for direct costs up to approximately $75,000 (direct cost) for the first year of the award and a budget of approximately $100,000 or 125,000 (direct cost) for the second year of the award. The anticipated start date is September 21, 2005 and the period of performance is from September 21, 2005 to September 20, 2007.ok,jp

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

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. Since the focus is on sickle cell disease and assay development appropriate for HTS, it is critical that the research team have comprehensive knowledge in these areas.

2. Cost Sharing or Matching

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria
Only one application per institution will be accepted.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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 http://www.dnb.com/us/. 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.

Molecular Screening Assay Development for SCD. RFA HG-05-001.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 25 , 2005.
Application Receipt Date(s): April 26 , 2005.
Peer Review Date: June/July, 2005.
Council Review Date: September, 2005.
Earliest Anticipated Start Date: September 21, 2005.

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent should be sent to:

Bettie J. Graham, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 496-7531
Email: bettie_graham@nih.gov

3.B. Sending an Application to the NIH

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

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Rudy Pozzatti, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5 635 Fishers Lane
Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 402-0838
Email: rudy_pozzatti@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHGRI. Incomplete and non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

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 http://grants.nih.gov/grants/policy/data_sharing. 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.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). 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, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHGRI. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHGRI in accordance with the review criteria stated below.

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

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.

1. 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?

2. 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?

3. 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?

4. 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)?

5. 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.

Feasibility for HTS : Although high throughput screening is outside the immediate scope of this announcement, is it feasible to adapt the proposed assay to a high throughput format? Is it likely that the assay will produce reliable results in a high throughput screen?

Future Plans: Is there an adequate plan for evaluating the activities of the compounds identified in a high throughput screen, e.g., in secondary screens? Are there important and well-defined goals for the use of active compounds identified using the proposed assay, either for use as research tools or for therapeutics development?

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.

2.C. Sharing Research Data

1. Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may 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. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2. Data Sharing Plan: 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. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The initial reviewers will be asked to assess the adequacy of the sharing plans. Things that they will consider are: are the plans reasonable, when will the resource be available, how will the resource be made available and to whom, plans for transferring the assay to the HTS centers and how the PI plans to work with the Center to make the assay compatible with the protocols of the HTS center, and the language in the material transfer agreement.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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.

3. Anticipated Announcement and Award Dates
Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

Applicant institutions will be notified if an award will be made through the receipt of the Notice of Grant Award. If the institution is e-mailed enabled, the Notice of Grant Award will be e-mailed to the institution. If the institution is not e-mailed enabled, the Notice of Grant Award will be mailed.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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:

Bettie J. Graham, Ph.D. or Brad Ozenberger, Ph.D.
Division: Division of Extramural Research
Institute or Center: National Human Genome Research Institute
Street Address: 5635 Fishers Lane
Building Number, Room Number: Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 496-7531
Email: bettie_graham@nih.gov or bozenberger@mail.nih.gov

Greg Evans, Ph.D.
Blood Diseases Program
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., MSC 7950
Room 10152
Bethesda, MD 20892-7950
Phone: 301-435-0055
E-mail: evansg@nih.gov

2. Peer Review Contacts:

Rudy Pozzatti, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5 635 Fishers Lane
Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 402-0838
Email: rudy_pozzatti@nih.gov

3. Financial or Grants Management Contacts:

Ms. Cheryl Chick
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Tw inbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 402-0733
Email: cheryl_chick@nih.gov

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 (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) 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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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).

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.

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: http://www.lrp.nih.gov/.


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