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 Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Title: NIAID Clinical Trial Planning (R34) Grants

Announcement Type
New

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

Program Announcement (PA) Number: PAR-05-112

Catalog of Federal Domestic Assistance Number(s)
93.856, 93.855

Key Dates
Release Date: May 19, 2005
Letters of Intent Receipt Date(s): 30 days before planned application submission date
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details, beginning with September 1, 2005 for AIDS applications and October 1, 2005 for all other applications
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (Url Activation Date): June 1, 2005
Expiration Date for R34 Non-AIDS Applications: March 2, 2006
Expiration Date for R34 AIDS and AIDS-Related Applications: May 2, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

NIAID will support clinical trials planning (R34) grants for complete planning and design of, and documentation for, investigator-initiated Phase I, II, III, and IV clinical trials. A clinical trial is the prospective testing of the effect and value of a preventive, diagnostic, or therapeutic intervention(s) against a control in human subjects. The R34 planning grant is designed to: (1) permit early peer review of the rationale for the proposed clinical trial; (2) permit assessment of the design/protocol of the proposed trial in an early form; (3) provide support for the development of a complete study protocol and associated documents including a manual of operations and (4) support the development of other essential elements of a clinical trial. The receipt of an R34 grant is a prerequisite for submission of a clinical trial implementation application.

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

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. 

One application may be submitted by an NIAID approved applicant.

The PHS 398 application instructions are 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.

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

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

As announced in Notice NOT-AI-05-021 (http://grants.nih.gov/grants/guide/notice-files/NOT-AI-05-021.html), NIAID will support investigator-initiated clinical trials through a two part grant process: (1) clinical trial planning (R34) grant followed by (2) clinical trial implementation cooperative agreement. This program announcement, NIAID CLINICAL TRIAL PLANNING (R34) GRANTS (PAR-05-112) addresses the R34 grant; a companion PAR, NIAID CLINICAL TRIAL IMPLEMENTATION (U01) COOPERATIVE AGREEMENT, (PAR-05-113) addresses the clinical trial implementation cooperative agreement.

Overview of the NIAID policy for investigator-initiated clinical trials

Part 1. Clinical Trial Planning (R34) Grant. NIAID will support clinical trials planning (R34) grants for complete planning and design of, and documentation for, investigator-initiated Phase I, II, III, and IV clinical trials. A clinical trial is the prospective testing of the effect and value of a preventive, diagnostic, or therapeutic intervention(s) in human subjects. The R34 grant will provide up to one year of support. Pre-approval from NIAID is required for submission of an R34 application. R34 applications will be peer reviewed by NIAID study sections. For R34 awardees who, based on the results of the planning effort, propose to implement the trial, the product of the R34 will be a cooperative agreement grant application for clinical trial implementation (details are presented in PAR-05-113). As a result of the planning effort, investigators may opt not to apply for an implementation grant; if that is the result, the principal investigator must so inform NIAID.

Part 2. Clinical Trial Implementation (U01) Cooperative Agreement Grant. NIAID will accept, peer review, and consider for funding applications for implementation of investigator-initiated clinical trials from R34 awardees only . Each clinical trial implementation application will use the PHS 398 grant application and include the study protocol, Investigator's Brochure when appropriate or other equivalent document(s) that contains relevant non-clinical and pre-clinical data on study products, a manual of operations, and meet all NIH, FDA, and OHRP policy requirements. In order not to delay the initiation of clinical trials, the peer review and award of the clinical trial implementation grant will be made within four months of application receipt. The material in the implementation grant application must be sufficient to allow the applicant to initiate study staff training followed by study subject recruitment upon award of an implementation cooperative agreement and final NIAID approval.

The R34 Grant The R34 grant will provide support for the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and Investigator's Brochure (or equivalent) and all essential elements of the study required in a manual of operations/procedures for the clinical trial. The Clinical Trial Planning Grant is not designed for the collection of preliminary data (clinical or pre-clinical) or the conduct of pilot studies to support the rationale for a clinical trial. It is expected that receipt of an R34 grant will lead to the timely submission of an application for support of the full-scale trial, incorporating the elements developed under the planning grant. Prospective applicants should note that funding of a Clinical Trial Planning Grant does not guarantee or imply funding for a subsequent application.

Background

Most clinical trials supported by NIAID are conducted by research networks awarded as cooperative agreements under NIAID Requests for Applications (RFAs) and contracts under NIAID Requests for Proposals (RFPs). Information about NIAID supported clinical trials can be found at: http://www.niaid.nih.gov/clintrials/. The networks are composed of coordinating centers, statistical units, data centers, central laboratories, data safety and monitoring boards, clinical centers, and other specialized resources. Additionally, the networks are provided with assistance from NIAID staff. This combination of collaborating organizations and specialists ensures that all elements of the planning and design of clinical trials can be addressed and fully documented before a decision is made to implement a trial.

NIAID has determined that any investigator-initiated clinical trial it supports should be developed with the same rigor in planning, design, and documentation. Further, NIAID will base the decision to support the implementation of the trial(s) on the products of this planning, design, and documentation effort.

NIAID recognizes that investigators considering submitting an investigator-initiated research grant application for clinical trial(s) or including clinical trial(s) will generally not have the resources to complete this rigorous planning, design, and documentation process without support from NIAID.

Some prior and ongoing investigator-initiated trials have been and are well-designed, well conducted research efforts. However, in some cases, the actual conduct of clinical trials has been delayed, deferred, or cancelled because the research plans in grant applications presented only general information about proposed trials. Conversion of these research plans to trial implementation has often proven to be lengthy, costly, and sometimes impossible.

NIAID issued two NIH Guide notices concerning the monitoring of clinical trials (Notice AI-00-003 on February 25, 2000 and Notice AI-02-032 on July 8, 2002 ). Standard NIAID Terms and Conditions of Award for clinical studies and trials were promulgated. Awardees were and are required to comply with these Clinical Terms of Award. These terms require that all clinical trials and studies supported by NIAID be monitored commensurate with the degree of potential risk to study subjects and complexity of the study. The details can be found at the following locations: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf and http://www.niaid.nih.gov/ncn/pdf/clintermguidance.pdf. The implementation of the clinical terms of award at the time of grant award has had both positive and negative consequences. It has helped put structure and regulatory (GCP-Good Clinical Practice, GLP-Good Laboratory Practice, and GMP-Good Manufacturing Practice) compliance into the clinical trial effort and ensure adequate inclusion of and protection for study subjects. But, for the investigators, it has often meant additional time and effort that had not been planned for and was not reflected in the grant research plan and budget. For NIAID, it has meant that additional funds had to be added to grants to permit completion of a planned trial. For NIAID, it has meant the expenditure of large amount of staff effort. For both the investigator and the NIAID, it has often resulted in substantial delays in the start of the clinical trial. And all too often it has led to disputes between investigators and NIAID during the clinical trial development process. NIAID believes that these problems will be ameliorated by a two part grant process that separates clinical trials planning and design from clinical trials implementation. The R34 grants will give the Investigators the time and funds necessary to complete detailed planning and design that will meet all regulatory requirements.

Scope

The R34 planning grant process is designed to:

Activities supported by the R34 include, but are not limited to, the following examples:

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 NIH Clinical Trial Planning Grant (R34) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The Clinical Trial Planning Grant is for new projects only; competing continuation applications will not be accepted. A Clinical Trial Planning Grant will support planning for one clinical trial only.

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). 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.

2. Funds Available

You may request a project period of up to one year. Direct cost limits are:

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 must obtain written approval (either by letter or e-mail) from NIAID before submission of an R34 grant application. Contact the appropriate program officer in the NIAID Division of AIDS, Division of Allergy, Immunology, and Transplantation, or Division of Microbiology and Infectious Diseases to initiate the approval process (see http://www.niaid.nih.gov/ncn/staff/default.htm for staff contacts). If approved, you may submit (an) application(s) if your organization has any of the following characteristics:

Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research.

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 or Matching

Not Required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

You must receive written approval (letter or e-mail) from NIAID before submission of an R34 grant application. See “Section 1.A. Eligible Institutions” above.

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.

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

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 IV.6 Other Submission Requirements.

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

Letters of Intent Receipt Date(s): 30 days before planned application submission date
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details, beginning with September 1, 2005 for AIDS applications and October 1, 2005 for all other applications
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details

3.A.1. Letter of Intent

NIAID 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 is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Marc Lesnick, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3264, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 594-6636
FAX: (301) 480-2408
Email: mlesnick@niaid.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 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

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

Marc Lesnick, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases Room 3264, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 594-6636
FAX: (301) 480-2408
Email: mlesnick@niaid.nih.gov

3.C. Application Processing

Applications must be submitted 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 CSR.

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

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Minimum Application Requirements for an R34 Grant are the following:

Pre-application approval by NIAID is required for submission of a clinical trial planning grant (R34) application:

1) Contact NIAID program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for your application. In order that NIAID can make an informed decision concerning acceptance of a planning grant application, please be prepared to describe the scientific basis for, and clinical significance of, the proposed clinical trial; analysis of the need and potential impact on healthcare; comparison with competitive therapies and degree of similarity with other clinical trials; and relevance of the proposed clinical trial to outcomes desired by the target patient population.

2) Obtain agreement from NIAID that the NIAID will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the NIAID staff member who agreed to accept assignment of the application.

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 http://grants.nih.gov/grants/funding/phs398/phs398.html 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 http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

Not applicable to clinical trial planning grants; however, must be addressed in any subsequent clinical trial implementation application (See PAR-05-113).

Sharing Research Resources

Not applicable to clinical trial planning grants; however, must be addressed in any subsequent clinical trial implementation application (See PAR-05-113).

Section V. Application Review Information

1. Criteria
Not applicable

2. Review and Selection Process

Appropriate scientific review groups convened by the National Institute of Allergy and Infectious Diseases 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:

The following will be considered in making funding decisions:

The NIH R34 is designed to support planning activities in preparation for a full-scale clinical trial. These activities are primarily logistical, conceptual, and/or technical in nature. They do not involve the collection of data typical of research-related activities supported by the traditional NIH research project grant. As such, the evaluation of R34 applications will focus on the justification of or need for the proposed trial along with the appropriateness of the proposed planning activities and qualifications and completeness of the proposed team.

Criterion A. Justification of the Need for the Future Clinical Trial

(1) Rationale/Significance Are the study objective(s) and hypothesis(es) adequately defined?

Are the significance and need to perform a future clinical trial adequately justified? Would the results of the proposed trial be likely to affect health care policy or practice?

(2) Approach

Are the conceptual framework, design, methods, and analyses, as currently developed, appropriate for the aim of the future clinical trial?

The reviewers will consider the appropriateness of the intervention(s), selection of endpoints, study population (inclusion/exclusion criteria), randomization schemes, data management, statistical analysis, recruitment and retention plans, and capacity to generalize results.

(3) Investigators Is the investigator appropriately trained and suited to carry out the proposed trial?

Is the work proposed appropriate to the experience level of the Principal Investigator and the research team? Is there clear evidence of leadership? Is there evidence documenting the investigators' ability to organize and manage complex projects?

(4) Environment

Does the scientific environment in which the proposed clinical trial will be carried out contribute to the probability of success? Will the proposed clinical trial take advantage of the unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

Criterion B. Assessment of the Proposed Planning Period Activities

(1) Rationale/Significance

Will the activities planned enhance the development of the future clinical trial? Will the proposed planning period address major barriers to the future clinical trial?

(2) Approach

Evaluate the adequacy of the activities proposed for the planning period. Will these activities contribute to the likelihood of timely and successful trial implementation? Can these activities be accomplished in the proposed time period? These activities may include, but are not limited to: (a) developing/finalizing the study protocol, investigator's brochure, and manual of operations; (b) finalizing plans for addressing gender/minority inclusion and human subjects protection requirements; (c) establishing collaborative arrangements; (d) developing tools needed for data collection and data management; (e) developing/finalizing safety and monitoring plans; and (f) developing plans for requisite staff training.

(3) Investigators

Is the investigator appropriately trained and suited to carry out the proposed planning activities? Is the work proposed appropriate to the experience level of the Principal Investigator and the research team? Is there clear evidence of leadership? Is there evidence documenting the investigators' ability to plan, organize, and manage complex projects?

(4) Environment/Organization

Does the scientific environment in which the planning activities will take place contribute to the probability of success? Are there adequate plans for the development of an effective organizational structure for carrying out the proposed trial? Are there adequate plans for the development of an essential committee structure, e.g., Steering, Executive, Planning, Data and Safety Committees? Does the application appropriately address issues such as the flow of information to and from the Coordinating Center, to the enrolling centers, and to the appropriate committees?

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).

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.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

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/grants/policy/nihgps_2003/NIHGPS_part4.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. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award 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 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.

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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Clinical trial planning (R34) planning grants have a maximum duration of one year. To meet reporting requirements, awardees must submit either a Clinical trials implementation application or a final grant report.

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:

Karen Reese, MS, CCRA
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4125, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 496-7124
Fax: (301) 402-1506
E-mail: kreese@niaid.nih.gov

Josiah Wedgwood, MD, Ph.D
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3019, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-7105
FAX: (301) 480-1450
Email: JWedgwood@niaid.nih.gov

Irene B. Glowinski, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 6071, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 496-1884
Fax: (301) 451-1318
E-mail: Iglowinski@niaid.nih.gov

Dr. Holli Hamilton
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 6045, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 402-8412
FAX: (301) 480-0728
Email: hhamilton@mail.nih.gov

2. Peer Review Contacts:

Marc Lesnick, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3264, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 594-6636
FAX: (301) 480-2408
Email: mlesnick@niaid.nih.gov

3. Financial or Grants Management Contacts:

Laura Eisenman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2120, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5541
Fax: (301) 480-3780
Email: leisenman@mail.nih.gov

Section VIII. Other Information

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). 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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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.

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.

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 (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).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, 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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