[Federal Register Volume 72, Number 121 (Monday, June 25, 2007)]
[Proposed Rules]
[Pages 34655-34657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 52

RIN 0925-AA42


Grants for Research Projects

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

ACTION: Notice of proposed rulemaking.

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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: [email protected]. 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 Sec.  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

[[Page 34656]]

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 Sec.  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 Sec.  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

[[Page 34657]]

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.

    Dated: May 11, 2006.
Elias A. Zerhouni,
 Director, National Institutes of Health.
    Approved: October 12, 2006.
Michael O. Leavitt,
Secretary.

    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 Sec.  52.2 by revising the definition of 
the term ``Principal investigator'' to read as follows:


Sec.  52.2  Definitions.

* * * * *
    Principal investigator means the individual(s) judged by the 
applicant organization to have the appropriate level of authority and 
responsibility to direct the project or program supported by the grant 
and who is or are responsible for the scientific and technical 
direction of the project.
* * * * *
    2. We propose to amend Sec.  52.6 by revising paragraph (d) to read 
as follows:


Sec.  52.6  Grant awards.

* * * * *
    (d) Multiple or concurrent awards. Whenever a research project 
involves a number of different but related problems, activities or 
disciplines which require evaluation by different groups, or whenever 
support for a project could be more effectively administered by 
separate handling of separate aspects of the project, the Secretary may 
evaluate, approve and make one or more awards pursuant to one or more 
applications.
* * * * *
 [FR Doc. E7-12223 Filed 6-22-07; 8:45 am]
BILLING CODE 4140-01-P