Grants for Research Projects

AGENCY:

National Institutes of Health, Department of Health and Human Services.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The National Institutes of Health (NIH) proposes to amend the existing regulations governing grants for research projects by revising the definition of Principal Investigator to mean one or more individuals designated by the grantee in the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the project, rather than limiting the role of principal investigator to one single individual, and the conditions for multiple or concurrent awards permitting the Secretary to evaluate, approve and make one or more awards pursuant to one or more applications.

DATES:

Comments must be received on or before August 24, 2007 in order to assure that NIH will be able to consider the comments in preparing the final rule.

ADDRESSES:

Persons and organizations interested in submitting comments, identified by RIN 0925-AA42, may do so by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• E-mail: jm40z@nih.gov. Include RIN number 0925-AA42 in the subject line of the message.
• Fax: 301-402-0169.
• Mail: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20892.
• Hand Delivery/Courier: 6011 Executive Boulevard, Suite 601, Rockville, MD 20892.

FOR FURTHER INFORMATION CONTACT:

Jerry Moore at the address above, or telephone 301-496-4607 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

On September 30, 2003, NIH Director Elias A. Zerhouni announced a series of far-reaching strategic initiatives known collectively as the NIH Roadmap for Medical Research (NIH Roadmap). The NIH Roadmap is an innovative approach designed to transform the nation's medical research capabilities and accelerate fundamental research discovery and translation of that knowledge into effective prevention strategies and new treatments. One of the NIH Roadmap initiatives encourages interdisciplinary research and team science and includes a recommendation to modify grant and research contract applications to allow proposing of more than one Principal Investigator when appropriate. This is congruent with the January 4, 2005, directive issued by the President's Office of Science and Technology Policy (OSTP) to all Federal research agency heads instructing the heads to accommodate the recognition of two or more Principal Investigators on research projects (grants and contacts). While this new OSTP policy does not prohibit the use of a single Principal Investigator when that is most appropriate for a particular research project, it simply permits the designation of more than one Principal Investigator when that more accurately reflects the management needs of a research project.

For the purpose of implementing the NIH Roadmap initiatives, the NIH plans to modify research grant and contract applications to request information on more than one Principal Investigator, consistent with the new OSTP policy establishing the appropriateness of multiple Principal Investigators. Accordingly, we propose to revise the definition of the term Principal Investigator set forth in § 52.2 of the Grants for Research Projects regulations codified at 42 CFR Part 52, and the conditions for multiple or concurrent awards permitting the Secretary to evaluate, approve and make one or more awards pursuant to one or more applications.

Specifically, in this Notice of Proposed Rulemaking (NPRM) we propose to amend the existing regulations governing grants for research projects by revising the definition of Principal Investigator so that it does not limit the role of Principal Investigator to one single individual.

As announced in NIH notice number NOT-OD-07-017 ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html ), these individual(s) must be judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant in order to be considered Principal Investigator(s). While this rule would permit the applicant organization to designate multiple individuals as Principal Investigators who share the authority and responsibility for leading and directing the project, intellectually and logistically, each Principal Investigator is responsible and accountable to the applicant organization (or, as appropriate, to a collaborating organization), for the proper conduct of the project or program, including the submission of all required reports. In other words, the presence of more than one identified Principal Investigator on an application or award diminishes neither the responsibility nor the accountability of any individual Principal Investigator.

Additionally, we propose to amend § 52.6 by revising paragraph (d) permitting the Secretary to evaluate, approve and make one or more awards pursuant to one or more applications.

Under current regulations, the Secretary is permitted to evaluate, approve and make more than one award pursuant to two or more applications. In some cases, however, it may be desirable to disaggregate a single application to make more than one award. For example, in the case of an application for support of a project that involves more than one Principal Investigator affiliated with more than one institution, it may be desirable to administer the project with more than one award. In addition, applications that involve subprojects may be disaggregated into separate awards to improve scientific management. The revised regulatory language clarifies options and provides an opportunity to contemplate more than one award that may involve more than one institution in response to a single application. In some of these cases separate records will be associated in the NIH data system so that the components can be managed as a single project to promote close collaboration with their counterparts. Actual awards also will be associated through special terms of award to clearly note collaborations and any special requirements resulting from such collaborations, In other cases, it may be appropriate to consider multiple applications from more than one institutions that are managed as a single unit with multiple awards to the different institutions to facilitate collaboration. This change will foster interdisciplinary and collaborative research and will improve management flexibility even when components of such collaborative research programs are administered by different NIH awarding components.

The purpose of this NPRM is to invite public comment on the proposed regulation. The following is provided as public information.

Executive Order 12866

Executive Order 12866 requires that all regulatory actions reflect consideration of the costs and benefits they generate, and that they meet certain standards, such as avoiding the imposition of unnecessary burdens on the affected public. If a regulatory action is deemed to fall within the scope of the definition of the term “significant regulatory action” contained in § 3(f) of the Order, prepublication review by the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) is necessary. This proposed rule was reviewed under Executive Order 12866 by OIRA and was deemed significant.

Executive Order 12866 also requires each agency to write all rules in plain language. In addition to your substantive comments on this proposed rule, we invite comments on how to make this proposed rule easier to understand. For example:

• Have we organized the material to suit your needs?
• Are the requirements in the rule clearly stated?
• Does the rule contain technical language or jargon that is not clear?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
• Could we improve clarity by adding illustrative examples, tables, lists, or diagrams?
• What else could we do to make the rule easier to understand.?

Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980 (5 U.S.C. chapter 6) requires that regulatory proposals be analyzed to determine whether they create a significant impact on a substantial number of small entities. The Director, NIH, certifies that any final rule resulting from this proposed rule will not have any such impact.

Executive Order 13132

Executive Order 13132, Federalism, requires that federal agencies consult with State and local government officials in the development of regulatory policies with federalism implications. The Director, NIH, reviewed the proposed rule as required under the Executive Order and determined that it does not have any federalism implications. The Director, NIH, certifies that the proposed rule will not have an effect on the States, or on the distribution of power and responsibilities among the various levels of government.

Paperwork Reduction Act

This proposed rule does not contain any information collection requirements which are subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance numbered programs affected by the proposed regulations are:

93.113—Biological Response to Environmental Health Hazards

93.114—Applied Toxicological Research and Testing

93.115—Biometry and Risk Estimation-Health Risks from Environmental Exposures

93.118—Acquired Immunodeficiency Syndrome (AIDS) Activity

93.121—Oral Diseases and Disorders Research

93.135—Centers for Research and Demonstration for Health Promotion and Disease Prevention

93.136—Injury Prevention and Control Research and State and Community Based Programs

93.172—Human Genome Research

93.173—Research Related to Deafness and Communication Disorders

93.184—Disabilities Prevention

93.213—Research and Training in Complementary and Alternative Medicine

93.242—Mental Health Research Grants

93.262—Occupational Safety and Health Program

93.271—Alcohol Research Career Development Awards for Scientists and Clinicians

93.273—Alcohol Research Programs

93.279—Drug Abuse and Addiction Research Programs

93.281—Mental Health Research Career/Scientist Development Awards

93.283—Centers for Disease Control and Prevention-Investigations and Technical Assistance

93.361—Nursing Research

93.389—National Center for Research Sources

93.390—Academic Research Enhancement Award

93.393—Cancer Cause and Prevention Research

93.394—Cancer Detection and Diagnosis Research

93.395—Cancer Treatment Research

93.396—Cancer Biology Research

93.821—Biophysics and Physiological Sciences Research

93.837—Heart and Vascular Diseases Research

93.838—Lung Diseases Research

93.839—Blood Diseases and Resources Research

93.846—Arthritis, Musculoskeletal and Skin Diseases Research

93.847—Diabetes, Endocrinology and Metabolism Research

93.848—Digestive Diseases and Nutrition Research

93.849—Kidney Diseases, Urology and Hematology Research

93.853—Clinical Research Related to Neurological Disorders

93.855—Allergy, Immunology and Transplantation Research

93.856—Microbiology and Infectious Diseases Research

93.859—Biomedical Research and Research Training

93.865—Research for Mothers and Children

93.866—Aging Research

93.867—Vision Research

93.879—Medical Library Assistance

93.929—Center for Medical Rehabilitation Research

93.934—Fogarty International Center Research Collaboration Award

93.939—Blood Diseases and Resources Research

93.941—HIV Demonstration, Research, Public and Professional Education Projects

93.942—Research, Treatment and Education Programs on Lyme Disease in the United States

93.943—Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected Population Groups

93.947—Tuberculosis Demonstration, Research, Public and Professional Education

List of Subjects in 42 CFR Part 52

• Grant programs—Health; Medical research; Occupational safety and health

Editorial Note:

This document was received by the Office of the Federal Register on June 20, 2007.

For reasons presented in the preamble, it is proposed to amend part 52 of title 42 of the Code of Federal Regulations as set forth below.

PART 52—GRANTS FOR RESEARCH PROJECTS

1. The authority citation for part 52 continues to read as follows:

Authority: 42 U.S.C. 216.

1A. We propose to amend § 52.2 by revising the definition of the term “Principal investigator” to read as follows: