Grants for Research Projects, 57918-57921 [E9-27025]
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Federal Register / Vol. 74, No. 216 / Tuesday, November 10, 2009 / Rules and Regulations
ALTERNATIVE TESTING METHODS FOR CONTAMINANTS LISTED AT 40 CFR 143.4(b)
Contaminant
Methodology
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Sulfate ..............
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Ion Chromatography .........................................
Gravimetric with ignition of residue ...................
Gravimetric with drying of residue ....................
Turbidimetric method ........................................
Automated methylthymol blue method .............
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1 Standard Methods for the Examination of
Water and Wastewater, 21st edition (2005).
Available from American Public Health
Association, 800 I Street, NW, Washington,
DC 20001–3710.
2 EPA Method 200.5, Revision 4.2.
‘‘Determination of Trace Elements in
Drinking Water by Axially Viewed
Inductively Coupled Plasma-Atomic
Emission Spectrometry.’’ 2003. EPA/600/R–
06/115. (Available at https://www.epa.gov/
nerlcwww/ordmeth.htm.)
3 Standard Methods Online are available at
https://www.standardmethods.org. The year
in which each method was approved by the
Standard Methods Committee is designated
by the last two digits in the method number.
The methods listed are the only online
versions that may be used.
4 Available from ASTM International, 100
Barr Harbor Drive, West Conshohocken, PA
19428–2959 or https://astm.org. The methods
listed are the only alternative versions that
may be used.
*
*
*
*
*
6 Standard
Methods for the Examination of
Water and Wastewater, 20th edition (1998).
Available from American Public Health
Association, 800 I Street, NW., Washington,
DC 20001–3710.
*
*
*
*
*
srobinson on DSKHWCL6B1PROD with RULES
10 Mitchell
Method M5271, Revision 1.1.
‘‘Determination of Turbidity by Laser
Nephelometry,’’ March 5, 2009. Available at
https://www.nemi.gov or from Leck Mitchell,
Ph.D., PE, 656 Independence Valley Dr.,
Grand Junction, CO 81507.
11 Mitchell Method M5331, Revision 1.1.
‘‘Determination of Turbidity by LED
Nephelometry,’’ March 5, 2009. Available at
https://www.nemi.gov or from Leck Mitchell,
Ph.D., PE, 656 Independence Valley Dr.,
Grand Junction, CO 81507.
12 Orion Method AQ4500, Revision 1.0.
‘‘Determination of Turbidity by LED
Nephelometry,’’ May 8, 2009. Available at
https://www.nemi.gov or from Thermo
Scientific, 166 Cummings Center, Beverly,
MA 01915, https://www.thermo.com.
13 Modified ColitagTM Method, ‘‘Modified
ColitagTM Test Method for the Simultaneous
Detection of E. coli and other Total Coliforms
in Water (ATP D05–0035),’’ August 28, 2009.
Available at https://www.nemi.gov or from
CPI, International, 580 Skylane Boulevard,
Santa Rosa, CA 95403.
14 EPA Method 557. ‘‘Determination of
Haloacetic Acids, Bromate, and Dalapon in
Drinking Water by Ion Chromatography
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ASTM 4
EPA Method
*
*
*
Electrospray Ionization Tandem Mass
Spectrometry (IC–ESI–MS/MS),’’ August
2009. EPA 815–B–09–012. Available at
https://epa.gov/safewater/methods/analytical
methods_ogwdw.html.
15 AMI Turbiwell, ‘‘Continuous
Measurement of Turbidity Using a SWAN
AMI Turbiwell Turbidimeter,’’ August 2009.
Available at https://www.nemi.gov or from
Markus Bernasconi, SWAN Analytische
Instrumente AG, Studbachstrasse 13, CH–
8340 Hinwil, Switzerland.
16 EPA Method 334.0. ‘‘Determination of
Residual Chlorine in Drinking Water Using
an On-line Chlorine Analyzer,’’ August 2009.
EPA 815–B–09–013. Available at https://epa.
gov/safewater/methods/analyticalmethods_
ogwdw.html.
17 ChloroSense. ‘‘Measurement of Free and
Total Chlorine in Drinking Water by Palintest
ChloroSense,’’ September 2009. Available at
https://www.nemi.gov or from Palintest Ltd,
21 Kenton Lands Road, PO Box 18395,
Erlanger, KY 41018.
18 EPA Method 302.0. ‘‘Determination of
Bromate in Drinking Waters using TwoDimensional Ion Chromatography with
Suppressed Conductivity Detection,’’
September 2009. EPA 815–B–09–014.
Available at https://epa.gov/safewater/
methods/analyticalmethods_ogwdw.html.
19 EPA 415.3, Revision 1.2. ‘‘Determination
of Total Organic Carbon and Specific UV
Absorbance at 254 nm in Source Water and
Drinking Water,’’ August 2009. EPA/600/R–
09/122. Available at https://www.epa.gov/
nerlcwww/ordmeth.htm.
[FR Doc. E9–27044 Filed 11–9–09; 8:45 am]
BILLING CODE 6560–50–P
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
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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 (https://grants.nih.gov/
grants/guide/notice-files/NOT-OD-07017.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
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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 60day 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
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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
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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
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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
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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 EstimationHealth 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
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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
PART 52—GRANTS FOR RESEARCH
PROJECTS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 216.
2. We amend § 52.2 by revising the
definition of the term ‘‘Principal
investigator’’ to read as follows:
■
§ 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.
*
*
*
*
*
■ 3. We amend § 52.6 by revising
paragraph (d) to read as follows:
§ 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
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
List of Subjects in 42 CFR Part 52
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Grant programs—Health, Medical
research, Occupational safety and
health.
44 CFR Part 65
Dated: July 21, 2009.
Raynard S. Kington,
Director, National Institutes of Health.
Approved: September 22, 2009.
Kathleen Sebelius,
Secretary.
Changes in Flood Elevation
Determinations
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Interim rule.
For reasons presented in the
preamble, we amend Part 52 of Title 42
of the Code of Federal Regulations as set
forth below.
SUMMARY: This interim rule lists
communities where modification of the
Base (1% annual-chance) Flood
Elevations (BFEs) is appropriate because
■
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[Docket ID FEMA–2008–0020; Internal
Agency Docket No. FEMA–B–1063]
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of new scientific or technical data. New
flood insurance premium rates will be
calculated from the modified BFEs for
new buildings and their contents.
DATES: These modified BFEs are
currently in effect on the dates listed in
the table below and revise the Flood
Insurance Rate Maps (FIRMs) in effect
prior to this determination for the listed
communities.
From the date of the second
publication of these changes in a
newspaper of local circulation, any
person has ninety (90) days in which to
request through the community that the
FEMA Assistant Administrator for
Mitigation reconsider the changes. The
modified BFEs may be changed during
the 90-day period.
ADDRESSES: The modified BFEs for each
community are available for inspection
at the office of the Chief Executive
Officer of each community. The
respective addresses are listed in the
table below.
FOR FURTHER INFORMATION CONTACT:
Kevin C. Long, Engineering
Management Branch, Mitigation
Directorate, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646–2820.
SUPPLEMENTARY INFORMATION: The
modified BFEs are not listed for each
community in this interim rule.
However, the address of the Chief
Executive Officer of the community
where the modified BFE determinations
are available for inspection is provided.
Any request for reconsideration must
be based on knowledge of changed
conditions or new scientific or technical
data.
The modifications are made pursuant
to section 201 of the Flood Disaster
Protection Act of 1973, 42 U.S.C. 4105,
and are in accordance with the National
Flood Insurance Act of 1968, 42 U.S.C.
4001 et seq., and with 44 CFR part 65.
For rating purposes, the currently
effective community number is shown
and must be used for all new policies
and renewals.
The modified BFEs are the basis for
the floodplain management measures
that the community is required to either
adopt or to show evidence of being
already in effect in order to qualify or
to remain qualified for participation in
the National Flood Insurance Program
(NFIP).
These modified BFEs, together with
the floodplain management criteria
required by 44 CFR 60.3, are the
minimum that are required. They
should not be construed to mean that
the community must change any
existing ordinances that are more
stringent in their floodplain
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]]>Agencies
[Federal Register Volume 74, Number 216 (Tuesday, November 10, 2009)]
[Rules and Regulations]
[Pages 57918-57921]
From the Federal Register Online via the Government Printing 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
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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 (https://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
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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
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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.
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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
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1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 216.
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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.
* * * * *
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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
