Federal Register, Volume 74 Issue 216 (Tuesday, November 10, 2009)

[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]

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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.

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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