[Federal Register Volume 74, Number 216 (Tuesday, November 10, 2009)]
[Rules and Regulations]
[Pages 57918-57921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27025]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 52

[Docket No. NIH-2007-0929]
RIN 0925-AA42


Grants for Research Projects

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

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health is amending the current 
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 pursuant to one or more applications.

DATES: This final rule is effective December 10, 2009.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
Office of Management Assessment, National Institutes of Health, 6011 
Executive Boulevard, Room 601, MSC 7669, Rockville, MD 20852-7669, or 
telephone 301-496-4607.

SUPPLEMENTARY INFORMATION: On September 30, 2003, the NIH Director 
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 for the proposing of more than one Principal 
Investigator when appropriate. This is congruent with the January 4, 
2005, directive issued by the 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 contracts). This OSTP policy does not 
prohibit the use of a single Principal

[[Page 57919]]

Investigator when that is most appropriate for a particular research 
project; it simply permits the designation of one or 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, now 
known as the Common Fund, the NIH plans to modify research grant and 
contract applications to request information on more than one Principal 
Investigator, consistent with the OSTP policy establishing the 
appropriateness of multiple Principal Investigators. Accordingly, we 
are revising the definition of the term Principal Investigator set 
forth in section 52.2 of the Grants for Research Projects regulations, 
codified at 42 CFR part 52, so that it does not limit the role of 
Principal Investigator to one single individual, and the conditions for 
multiple or concurrent awards set forth in section 52.6, paragraph (d) 
of the Grants for Research Projects regulations, codified at 42 CFR 
part 52, to permit the Secretary to evaluate, approve, and make one or 
more awards pursuant to one or more applications.
    As announced in NIH notice number OD-07-017 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html), these individuals 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 
Investigators. While this rule permits 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, 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 institution that are managed 
as a single unit, with multiple awards to the different institutions to 
facilitate collaboration.
    We believe 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.
    On June 25, 2007, we published a Notice of Proposed Rulemaking in 
the Federal Register (72 FR 34655-34657) in which we announced our 
intention to amend the current regulations governing NIH grants for 
research projects, as previously discussed, and solicited public 
comment. We provided for a 60-day comment period. We received comments 
from 11 separate individuals and institutions concerning various 
aspects of the NPRM. Most comments supported NIH's proposed actions. 
However, several comments raised concerns about the actions. In order 
to make it easier to identify comments and NIH's responses to the 
comments, the word ``Comment'' appears in parentheses before the 
description of the comment, and the word ``Response'' appears in 
parentheses before NIH's response.
    (Comment) Three commenters indicated that having multiple PIs on a 
research grant would result in many disputes, some of which would need 
to be resolved by NIH. They suggested that one person will always have 
the vision that guides the study and that having additional PIs could 
lead to confusion and diffuse authority and could result in a team that 
is less productive. They indicated that NIH should not permit more than 
a single PI.
    (Response) The NIH believes there are many projects that already 
involve collaboration at the leadership level. Also, there are many 
projects that cannot be accomplished without a partnership between 
individuals with different disciplinary or experimental backgrounds. 
Offering the option of having more than one PI will enable all members 
of the leadership team to be recognized for their respective 
contributions. It is not clear to us that there will be more disputes 
in a partnership setting than there would be in a more hierarchical 
setting. However, each multiple PI application must include a 
leadership plan that establishes an approach for dispute resolution. 
This approach has been used successfully for many years in the 
administration of program project and center grants, which involve more 
than one research component. Furthermore, NIH will not require all 
projects to include more than one PI. The NIH is offering this 
management approach as an option to more effectively credit partnering 
collaborators.
    (Comment) One commenter stated that allowing multiple PIs will 
permit more senior investigators to take money away from junior 
collaborators.
    (Response) The issue of inequities between junior and senior 
collaborators is an issue that all institutions need to consider. The 
NIH believes that in cases of a true partnership, recognizing the names 
of both junior and senior collaborating PIs will offer an opportunity 
to reduce any power differential that might exist with respect to the 
project or within the grantee organization. It is not clear how making 
this option available would allow more senior investigators to take 
money away from junior collaborators.
    (Comment) One commenter supported the proposed revision of the 
definition of the term ``Principal Investigator'' in section 52.2. 
However, the same commenter was concerned that institutions should be 
consulted if NIH decides to make more than one award in response to a 
singe application (section 52.6).
    (Response) We agree with the second comment that NIH should consult 
with institutions when it decides to make more than one award in 
response to a single application (section 52.6). Over the years NIH has 
occasionally disaggregated complex multiple project awards into 
separate, single project awards when the individual projects have 
appeared to be more meritorious than the combined, multicomponent 
approach. In all such cases, NIH

[[Page 57920]]

consulted the grantee institution(s) before such awards were made. We 
agree with the proposal and have modified the language set forth in 
section 52.6 to read as follows: ``* * * [T]he Secretary may evaluate, 
approve, and make one or more awards pursuant to one or more 
applications. When making more than one award in response to a single 
application, the Secretary shall consult with the applicant 
organization(s), as appropriate.''
    (Comment) One commenter was concerned that the rationale for 
disaggregating single applications into several awards was not fully 
articulated. The commenter believed that it could have utility in the 
case of a project that involved collaborating PIs at different 
institutions, which could be supported through multiple, linked awards, 
but in the view of the commenter, this was not sufficiently explained 
in the final rule.
    (Response) The commenter provided an important point. As previously 
indicated, NIH has experience in disaggregating complex awards into one 
or more discrete projects when the individual projects are more 
meritorious than the combined, complex project. In the case of 
collaborative applications for a single project that involves more than 
one institution, it may be ideal from a management perspective to make 
more than one award that is linked to fund the remote parts of the 
project. The alternative and more commonly employed approach is to make 
a single award to one of the institutions and to manage the parts of 
the project that occur at a separate institution through a sub-award. 
The NIH has used both approaches. Presently, NIH is not in a position 
to consider large numbers of collaborative applications that involve 
multiple institutions or to manage a large number of linked awards. 
Nonetheless, the change in the final rule will permit such management 
approaches in the future.
    (Comment) One commenter supported the proposal to allow multiple 
PIs and multiple awards in response to a single application.
    (Comment) One commenter supported the proposed redefinition of the 
term Principal Investigator and the language which permits the 
evaluation approval and issuance of more awards pursuant to one or more 
grant applications.
    (Comment) One commenter supported the proposed rule, indicating 
that it will encourage collaboration and will facilitate the 
management, oversight, and stewardship of Federal funds.
    (Comment) One commenter supported the proposed revision of the 
definition of ``Principal Investigator,'' indicating that it will 
preserve the role, authority and responsibility of all collaborating 
PIs.
    (Comment) One commenter fully supported expanding the position of 
Principal Investigator as proposed, indicating that it will better 
reflect the intellectual leadership of many NIH grants.
    (Comment) One commenter indicated that the designation of multiple 
Principal Investigators is an excellent idea, noting that it will be 
beneficial for young investigators who frequently get ``second 
billing'' on a proposal because of the feeling that a senior colleague 
is more likely to be funded.
    (Comment) One commenter stated that having the ability to make more 
than one award to recognize collaborating institutions will improve the 
business process for collaborating institutions, although this was not 
specifically mentioned in the NPRM.
    We provide the following as public information.

Regulatory Flexibility Act

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

Executive Order 12866

    Executive Order 12866, ``Regulatory Planning and Review,'' 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 
section 3(f) of Executive Order 12866, prepublication review by the 
Office of Management and Budget (OMB)'s Office if Information and 
Regulatory Affairs (OIRA) is necessary. This final 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. With this in mind, we have made every effort to make 
this rule easy to understand.

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, 
has reviewed this final rule and as required has determined that it 
does not have any Federalism implications. The Director, NIH, certifies 
that the final rule will not have an effect on the States, or on the 
distribution of power and responsibilities among the various levels of 
government.

Unfunded Mandates Act of 1995

    This final rule will not result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$12,000,000 or more [adjusted for inflation] in any one year and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the Unfunded Mandates Act of 1995.

Paperwork Reduction Act

    This final rule contains information collection requirements that 
were approved under OMB 0925-0001 in April 2006.

The Catalogue of Federal Domestic Assistance

    The Catalogue of Federal Domestic Assistance numbered programs that 
are affected by the final rule include the following:

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 Resources

[[Page 57921]]

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
93.701--Trans-NIH Recovery Act Research Grant
93.702--NCRR Recovery Act Construction Support
93.821--Biophysics and Physiological Sciences Research
93.827--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: July 21, 2009.
Raynard S. Kington,
Director, National Institutes of Health.
    Approved: September 22, 2009.
Kathleen Sebelius,
Secretary.

0
For reasons presented in the preamble, we amend Part 52 of Title 42 of 
the Code of Federal Regulations as set forth below.

PART 52--GRANTS FOR RESEARCH PROJECTS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 216.


0
2. We 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.
* * * * *

0
3. We 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. When making more than one award in response to a single 
application, the Secretary shall consult with the applicant 
organization(s), as appropriate.
* * * * *

[FR Doc. E9-27025 Filed 11-9-09; 8:45 am]
BILLING CODE 4140-01-P