Guidelines for
INVESTIGATOR INITIATED MULTI-SITE CLINICAL TRIALS

National Heart, Lung, and Blood Institute
National Institutes of Health

Revised: October 2007

A. PURPOSE OF THIS DOCUMENT

This document outlines National Heart, Lung, and Blood Institute (NHLBI) policy and procedures for Investigator-Initiated, multi-site, randomized, controlled clinical trials and provides guidelines for the preparation and submission of these applications. It lists the requirements placed on the receipt, review, and funding of these applications and presents guidelines for the submission of such trials. With the change to electronic submission NHLBI has changed these guidelines to facilitate the submission of clustered applications through Funding Opportunity Announcement (FOA) Program Announcement (PA) Number: PAR-07-373 entitled "Investigator Initiated Multi-Site Clinical Trials (R01) . This is NOT a solicitation for such applications.

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B. INSTITUTE ACCEPTANCE OF APPLICATIONS

Applications for support of Investigator-Initiated Clinical Trials must be submitted to NIH electronically through Grants.gov using the SF424 Research forms (see Section C).

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must contact NHLBI staff well in advance of submitting the application as they are developing plans for the study. Applicants must obtain agreement from the NHLBI that it will accept the application for review. NHLBI will assess programmatic priority based on the consideration of anticipated program needs and balance as well as costs and budgetary constraints. Applicants must include the PHS398 Cover Letter component with the SF424 application to identify the staff member(s) of the NHLBI who agreed to accept assignment of the application. This policy applies to all new applications, competing renewal (formerly “competing continuation”) applications, resubmission (formerly “revised/amended”) applications, and revision (formerly “competing supplemental”) applications. See NOT-OD-02-004, October 16, 2001.

Additional information on the policy may be found at: http://www.nhlbi.nih.gov/funding/policies/500kweb.htm.

Note that this policy requires applicants requesting $500,000 or more in direct costs to request permission to submit an application no later than six weeks prior to the grant application deadline. Applications with direct costs for any year (excluding consortium F&A costs) greater than the cap for Program Project Grants are considered only annually on or after November 15. Discussion with relevant staff should occur well in advance of these deadlines.

All applications for multi-center clinical trials involving a randomized clinical or behavioral intervention and assigned to the NHLBI, undergo primary technical review by the Clinical Trials Review Committee (a standing review committee) or, more rarely, a similar ad hoc Special Emphasis Panel (SEP) managed by the NHLBI's Division of Extramural Research Activities. Most applications for single-center studies and multi-center studies without a randomized intervention undergo primary technical review by the appropriate study sections in the Center for Scientific Review (CSR). As with any other grant application, the application will be assigned to the appropriate NHLBI Division and Program for scientific administration and management.

All new clinical trial applications must be received on one of the following receipt dates:

February 5th
June 5th
October 5th

Renewal, revised, and resubmitted applications must be received on one of the following receipt dates:

March 5th
July 5th
November 5th

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C. APPLICATION FORMAT

All applications must be prepared in response to the Funding Opportunity Announcement (FOA) Program Announcement (PA) Number: PAR-07-373 entitled “Investigator Initiated Multi-Site Clinical Trials (R01)” (http://grants.nih.gov/grants/guide/pa-files/PAR-07-373.html). Applications submitted in response to this FOA must be submitted electronically through Grants.gov (http://www.grants.gov ) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget orResearch & Related Budget: Use only one , as appropriate. (See Section IV.6., “ Special Instructions ,” regarding appropriate required budget component. Research & Related Budget is required for foreign applications.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Multi-site clinical trials must include two or more enrollment sites, may have a separate Data Coordinating Center, and may have core facilities.  A separate Data Coordinating Center application is required for Phase III clinical trials with direct costs of $500,000 or more in any year (see below).The structure and function of separate centers and cores must be carefully and completely described and justified. Budget justifications and facility statements must be submitted for each center. The choice of mechanism for support of multiple centers, consortia or single awards to multiple centers, will be made during the consultation with Institute staff.

The information provided in the application should be organized in a manner that will facilitate peer review. The body of the application must present an overview of the state of the science, current status and relevance of the trial, a discussion of the specific protocol, and the approach to data collection and analysis.

Data collection forms, informed consent forms, letters of support, and other complementary materials that provide further details of the protocol and data analysis methods may be included in well organized appendices. Note, NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

All applications must provide detailed scientific and operational plans as well as funding needs. If the trial is designed for more than a five year period, complete, justified budgets for the future years also must be included in the budget justification. The review of the application will evaluate the entire project.

Investigators are encouraged to refer to the NHLBI’s clinical research guide at http://www.nhlbi.nih.gov/crg/index.php for additional guidance and resources on clinical research.

Budget

Investigators must submit a total overall budget and a complete, justified, individual budget for each year of support requested. If the trial is designed for more than a five year period, complete, justified budgets for the future years also must be included in the budget justification. Separate itemized budgets must be prepared for each subcontract and/or for each collaborating center or core, if multiple centers or cores are proposed. All costs requested and all changes in budgets after the first year should be clearly identified and justified. If part of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to commit the institution.Further information concerning budget preparation may be obtained from the Director, Office of Grants Management, DERA, NHLBI.

Special Instructions for Applications for Phase III Clinical Trials Requesting $500,000 (direct costs) or More in Any Year

All requests to accept applications for Phase III clinical trials with direct costs greater than $500,000 in any year must include plans to submit at least two applications, one of which is for the support of a Data Coordinating Center (DCC). The principal investigator for the DCC cannot be involved in (and cannot be a principal investigator on) any other award associated with the trial.

Multiple applications submitted as part of a Phase III clinical trial with direct costs over $500,000 in any year will be considered as a cluster for the purposes of peer review and funding. Until Grants.gov develops a Federal-wide procedure, the following instructions must be followed:

Each application in the cluster must be prepared in response to the Funding Opportunity Announcement (FOA) Program Announcement (PA) Number: PAR-07-373 entitled “Investigator Initiated Multi-Site Clinical Trials (R01)” (http://grants.nih.gov/grants/guide/pa-files/PAR-07-373.html). Each application must be submitted electronically through Grants.gov (http://www.grants.gov ) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

Title

The title of each application must use the Title field to denote clustering using a common base title plus a tag denoting the linkage. The tag identifier should be placed at the end of the title. Commonly used tags for Phase III multi site clinical trials include “ Clinical Coordinating Center “ (or “CCC”), “ Data Coordinating Center” (or “DCC”), “Economics and QOL Core”, “Imaging Core”, etc. The Clinical Coordinating Center or the Data Coordinating Center may be designated as the lead application if applicable, but designating a lead application is not required. If either is considered the lead application, it should be indicated at the end of the tag, and in the abstract.. The system truncates any title that exceeds the maximum character limit, so titles need to be succinct (i.e. no more than 80 characters).

Example: “Perioperative Cardiac Event Trial (PROTECT) – CCC – Lead Application” (59 characters)

Trials with very long titles (i.e. more than 80 characters with tag) should use only an acronym plus the appropriate tag, and the full title should be spelled out in the abstract).

Example: “HF-ACTION – DCC ” (acronym for “The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial – Data Coordinating Center”).

Cover Letter

For applications submitted as part of a Phase III clinical trial with direct costs over $500,000 in any year, a cover letter is required. The cover letter must include an identical list of all the collaborative applications including for each the name of the PI; the unique Title (including the Tag), and the Applicant Institution.

Other Attachments

List of Clustered Applications : For applications submitted as part of a Phase II or Phase III clinical trial with direct costs over $500,000 in any year (excluding consortium F&A costs), a list of the collaborative applications must be included in Item 11. Other Attachments in the Other Project Information Component as well as in the cover letter. Each application must include an identical list of all the collaborative applications including for each the name of the PI, the unique Title+Tag, and the Applicant Institution. In the body of the text, begin the section with a heading indicating “Grouped Applications”. When saving the file, name it “Clustered Applications” as well to ensure the application is bookmarked appropriately.

The following sections must be included in the grant application:

o Specific Aims

The specific aims of the trial must be clearly and concisely presented. These should include a clear specification of the primary and major secondary endpoints to be measured, with a clear differentiation of the importance of various endpoints.

o Significance

The significance of the proposed clinical trial must be clearly stated. It is particularly important that there be a discussion of how the trial will test the hypothesis proposed. The application should make clear the need for the study with emphasis on how the results will advance our knowledge of theory and practice in this area. A discussion of the costs and benefits of the study should be included for evaluation of the trial's significance.

o Preliminary Studies

The studies that led to the proposed clinical trial should be presented. Data from pilot studies which show the need for and the feasibility of the trial should also be presented. Additional supporting data from other research should be included so that the approach chosen is clearly justified. Conceptualization and planning must have progressed to a stage sufficient to allow for an overall assessment of the likelihood of the success of the trial.

o Experimental Design and Methods

1. Detailed Clinical Protocol

List the inclusion and exclusion criteria and describe the procedure to be utilized for assignment of patients to experimental conditions. Discuss in detail the study design for the intervention(s) to be used, including the rationale for the particular design chosen and procedures to assure compliance with, and standardized implementation of the proposed protocol. Discuss potential biases in the research protocol proposed and how they will be addressed. Clinical (including behavioral), laboratory, and physiological tests and protocols should be described briefly here and in more detail in an appendix. Methods of randomization must be described and endpoints clearly defined. Assumptions and steps used to arrive at the proposed sample size must be described. Details of the sample size calculations should be presented in an appendix.

2. Patient Availability and Recruitment

Discuss the availability of patients for the proposed study. Discuss the characteristics of this population and why it is an appropriate group to answer the question posed. Outline the approaches to be utilized for the recruitment, retention and follow up of the required number of patients. Discuss plans for maintaining the cooperation of the study population as well as plans for addressing any anticipated changes in the composition of the study population over the course of the trial. Data should be presented supporting recruitment and retention estimates. The ability of clinical centers to recruit and retain the proposed number of subjects, including women and minority subjects, must be addressed.

3. Data Management, Quality Control, and Data Analysis

Describe the approach to data management. Include methods for monitoring the quality and consistency of the intervention(s) and data collection. Include prototypes of data collection forms in an appendix. Describe the methods of data analysis, linking the analyses to the hypotheses to be tested, and include methods of data preparation and presentation, and analytic methods. Primary and secondary endpoints should be clearly defined, justified and related to the power calculations.

If a separate application for a DCC is included, details of the data management, quality control and data analysis plans should be included in this application.

o Human Subjects

As of October 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html), NIH implemented a policy requiring education on the protection of human research participants for all key personnel submitting applications for grants or proposals for contracts or receiving new or non-competing awards for projects involving human research participants.

Assurances of the protection of human participants and the biohazard safety of employees (if applicable) must be provided both for the overall study and for individual field centers. The applicant must discuss any issues which might lead to concern for the welfare of participants. All forms to be used to obtain informed consent AT EACH CENTER must be included in an appendix. At a minimum, the human subjects sections of data coordinating center applications must address data security measures and confidentiality.

Applicants should refer to Part II of the SF424 Application Guide “Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan”.

Women, Children and Minority Subjects and Minority Institution Participation

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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Policy Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", published in the NIH Guide for Grants on October 9, 2001 (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. Other relevant documents may found at: http://grants.nih.gov/grants/funding/women_min/women_min.htm .

The Human Subjects section of the application should include the following: The literature and/or data sets must be reviewed to indicate to the extent possible (a) the distribution, by gender and minority status, of the US population with the disease or health problem under investigation and (b) whether the impact of the intervention may be expected to vary according to gender or minority status. Specific goals for women and minority recruitment and plans for achieving those goals must be explicitly stated. Approximate percentages of women and each minority group expected in the study sample and the basis for these estimates must be provided. Generally, representation of women and minorities will not be considered adequate unless they occur in the study population in the same proportions as in the U.S. population having the disease entity being studied. Outreach and/or sampling plans to ensure adequate gender and minority representation must be presented. Past track records in recruitment of women and minorities should be presented. Efforts to enlist minority institutions in the study must be documented.

Applicants should refer to Part II of the SF424 Application Guide “Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan”.

Inclusion of Children

It is the policy of NIH that children (i.e. individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

The Human Subjects section of the application should include the following: The literature and/or data sets must be reviewed to indicate to the extent possible (a) the distribution, by appropriate age groupings, of the US population with the disease or health problem under investigation and (b) whether the impact of the intervention may be expected to vary according to age. Specific goals for the recruitment of children and plans for achieving these goals must be explicitly stated. Approximate percentages of children, in appropriate age or Initiated Clinical Trials Guidelines categories, expected in the study sample and the basis for these estimates must be provided. Generally, representation of children will not be considered adequate unless they occur in the study population in the same proportions as in the U.S. population having the disease entity being studied Outreach and/or sampling plans to ensure adequate representation of children must be presented. Past track records in recruitment of children should be presented.

Applicants should refer to Part II of the SF424 Application Guide “Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan”.

Reporting Format

In addition to the written plans for the inclusion of women, minorities, and children in the proposed clinical study, the composition MUST be provided using the "Targeted/Planned Enrollment Format Page" and/or "Enrollment Format Page" as applicable, from the “Human Subject Sections” of the PHS398 Research Plan component of the SF424 (R&R)) .

Study Organization and Administration

Describe the organization of the study and how the trial will be managed. Include a description of the role of any internal or external advisory committees, including the data and safety monitoring committee, the responsibility and authority of the director of the data coordinating center, and policies and methods concerning blinding of study results. Discuss the coordination of any centers or cores proposed. Include a complete description of any sub-contracts for personnel or facilities. Documentation of commitment, co-signed by a business official and the principal investigator at the participating center, must be included with the application. A timetable for completion of the various stages of the trial should also be included.

Investigators

The overall clinical trial must be directed by an investigator with experience in the conduct of clinical trials and expertise in the content area of the trial. Such experience must be carefully documented. Biographical sketches for all key investigators must be provided. Most clinical trial designs will require a multidisciplinary team.

Each center or core proposed must have a director designated. The experience of each director must be carefully documented. In addition, the authority of each center or core director within the study must be specified.

Facilities

Clinical, data management, and laboratory facilities and required equipment should be described in detail for all participating institutions.

Budget

Investigators must submit a total overall budget and a complete, justified, individual budget for each year of support requested. If the trial is designed for more than a five year period, complete, justified budgets for the future years also must be included in the budget justification. Separate itemized budgets must be prepared for each subcontract and/or for each collaborating center or core, if multiple centers or cores are proposed. All costs requested and all changes in budgets after the first year should be clearly identified and justified. If part of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to commit the institution.Further information concerning budget preparation may be obtained from the Director, Office of Grants Management, DERA, NHLBI.

For applications under consideration for funding, NHLBI 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

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D. DATA AND SAFETY MONITORING

As of the October 2000 receipt date (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) applicants must supply a general description of the Data and Safety Monitoring Plan for all clinical trials as part of the research application. A SEPARATE section of the application should include a general description of the plan, and describe the entity that will be responsible for monitoring, and the policy and procedures for adverse event reporting. All monitoring plans must include a description of how Adverse Events will be reported to the Institutional Review Board (IRB), the NIH, the Office of Biotechnology Activities (if required), and the Food and Drug Administration in accordance with IND or IDE regulations.

NIH requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to participants (http://grants.nih.gov/grants/guide/notice-files/not98-084.html). The purpose of this board is to provide independent advice concerning scientific issues pertaining to subject safety and data quality. In monitoring the safety of the trial, the board also may recommend termination in the event of early significance of findings or the determination of unacceptable adverse effects or futility. The data and safety monitoring board is normally appointed in consultation with the NHLBI and consists of individuals who are not associated with the institutions participating in the trial. Potential members of this board should NOT be named in the application.

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E. INSTITUTE STAFF INVOLVEMENT

Before making an award for an Investigator-Initiated Clinical Trial, NHLBI will routinely consider the desirability of substantial continued staff involvement in a supportive mode. If such Involvement is deemed appropriate by the Institute, the award mechanism will be a cooperative agreement (U01). Regardless of the mechanism of support, the NHLBI staff will closely monitor progress during the award. This monitoring will include submission of the IRB approved protocol to the NHLBI Program Official, adequate serious adverse event management and reporting, regular communications with the principal investigator and staff, as well as attendance at the steering committee, data and safety monitoring board, and related meetings. The Terms and Conditions for an award for a clinical trial will include recruitment milestones expected to be met by the study as a whole at specific time periods, accrual goals for women and minorities (as appropriate), any requirements regarding minimum effort of specific key personnel, and any other identified requirements for completion of the approved research. As with any award, continuation, even during the period recommended for support, is conditional upon satisfactory progress. If, at any time, recruitment falls significantly below the projected milestones for recruitment, the NHLBI will consider ending support and negotiating a phase-out of the award. The NHLBI retains, as an option, periodic external peer review of progress.

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F. REPORTING REQUIREMENTS

Recruitment progress (including recruitment of women, children and specific minority groups), indices of quality control, and related operational features must be reported at regular intervals to the NHLBI program office. Annual and final reports are required as in any grant.

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G. NHLBI REVIEW OF APPLICATIONS

In the initial peer review by NHLBI, multi-center applications are reviewed by the Clinical Trials Review Committee (a standing review committee) or, more rarely, a similar ad hoc Special Emphasis Panel managed by the NHLBI’s Division of Extramural Research Activities. The usual review is based on the application without contacting the investigators. In rare cases, applicants may be contacted by telephone. This initial peer review is concerned with scientific, technical, and management issues (see below).

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the NHLBI National Advisory Council.

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

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

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.

• Significance
• Approach
• Innovation
• Investigator
• Environment

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? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

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 or methodologies, tools, or technologies for this area?

Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

For the initial review of any DATA COORDINATING CENTERS OR CORE FACILITIES the same criteria will be used.

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H. SUBMISSION OF APPLICATION

Receipt dates for all Investigator-Initiated Clinical Trial grant applications are as follows:

Receipt Date              Receipt Date                                  Review by                        Review by                  Earliest
New Applications       Renewal, Resubmission,               Clinical Trials                  NHLBI National        Award
                                     Revision Applications                  Review Committee         Advisory Council         Date
February 5                   March 5                                           June/July                              October                      December 1
June 5                          July 5                                                October/November             February                    April 1
October 5                    November 5                                     February/March                   May                            July 1

Failure to meet these deadlines may result in delay of a round in review of the application.

The National Institutes of Health's Division of Research Grants has the responsibility for assigning applications to the appropriate Institute. An assignment to NHLBI will be based on the goals of the proposed program.

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I. CONTACTS FOR FURTHER INFORMATION

Director, Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 9136
Bethesda, Maryland 20892-7950
(301-435-0080)

Director, Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 8128
Bethesda, Maryland 20892-7940
(301-435-0466)

Director, Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 10138
Bethesda, Maryland 20892-7952
(301-435-0233)

Director, Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 10122
Bethesda, Maryland 20892-7938
(301-435-0422)

Scientific Review Administrator
Clinical Trials Review Committee
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 7194
Bethesda, Maryland 20892-7924
(301-435-0288) Director, Office of Grants Management
National Heart, Lung, and Blood Institute
Rockledge 2 Building, Room 7154
Bethesda, Maryland 20892-7926
(301-435-0166)

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