COMPLETING THE PREAWARD PROCESS
Following the peer review process, applications that an IC may
fund are reviewed for a number of other considerations. These
include, as applicable, alignment with NIH's funding principles
(see below), review of the project budget, assessment
of the applicant's
management systems, and determination of applicant compliance
with eligibility and public policy requirements. Based on the
outcome of these reviews, the IC will determine whether an award
can be made, if special conditions are required, and the appropriate
level of funding.
Although these reviews and determinations are initially made prior
to the issuance of a new award, grantees must continue to comply
with eligibility and public policy requirements and maintain adequate
management systems throughout the period of support. The preaward
process for noncompeting continuation applications is a streamlined
version of this process, including an assessment of progress (see
"Administrative
Requirements
Noncompeting Continuation Awards").
Funding Principles
NIH awards grants on the basis of reasonable and allowable costs
consistent with the principles of sound cost management and in
consideration of IC priorities (e.g., program relevance), constraints
on the growth of average grant costs, and available funds.
NIH has also adopted the following core funding principles specifically
for research project grants:
- NIH will award noncompeting research project grants at committed
levels.
- Determination of commitments for future years must take into
consideration stability of support for investigators, optimum
portfolio balance, and opportunities to address emerging problems.
Eligibility
NIH awards may be made only to eligible applicants. Continued
funding is dependent on the grantee's maintaining eligibility.
In general, domestic or foreign, public or private, non-profit
or for-profit organizations are eligible to receive NIH grants.
However, on the basis of statutory, regulatory, or published policy
limitations, under certain programs or types of awards, NIH may
limit eligibility to, or exclude from eligibility, classes or
types of entities. Examples would be limitations on the participation
of foreign entities, and programs under which only small businesses
are eligible applicants. The determination of eligibility includes
verification of the applicant's status. The applicant may be required
to provide proof of its status through documentation or by signing
a certification (e.g., a small business applying under the SBIR
or STTR programs).
In addition to reviewing applicants' organizational eligibility,
NIH may consider other eligibility factors relating to the applicant's
ability to responsibly handle and account for Federal funds and
to carry out the project. These factors include the applicant's
intended role in the project, where the project will be performed,
the role of the PI in the project, and his/her employment and
citizenship status. Although some of these same considerations
are reviewed as part of the peer review, at this stage in the
process NIH's concern is making an award to a legal entity that
will be accountable both for the performance of the approved project
or activity and the appropriate expenditure of funds. NIH will
not make an award to an applicant that does not have a substantive
role in the project and would simply serve as a conduit for another
entity.
The IC GMO will also verify whether the applicant, proposed PI,
or other key personnel are debarred or
suspended from participation
in Federal assistance programs, and whether the applicant is
delinquent
on the repayment of any Federal debt (see "Public
Policy
Requirements and Objectives
Ethical and Safe
Conduct in Science and Organizational Operations" for certification
requirements).
Although PIs and other personnel under research projects are not
required to be U.S. citizens, NIH will not intercede on behalf
of non-citizens whose stay in the United States may be limited
by their visa status. As a result, NIH requires the applicant
to determine and indicate, in its application, that such individuals'
visas will allow them to remain in this country long enough for
them to be productive on the project. If a grant is awarded on
the basis of this information and the individual's visa does not
allow for such a stay, NIH may terminate the grant (see "Administrative
Requirements Changes in
Project and Budget" and "Administrative
Requirements Enforcement Actions
Suspension,
Termination, and Withholding of Support").
The eligibility requirements for trainees and fellows are addressed
in "National Research Service
Awards" in Part III.
NIH continues its oversight of eligibility considerations, from
both a legal and programmatic perspective, in the postaward phase
by monitoring changes in grantee and project status and taking
actions necessary to protect the Federal Government's interests.
Cost Analysis and Assessment
of Management Systems
The GMO will ensure that a cost analysis is performed on any application
that includes a detailed budget. Cost analysis involves obtaining
cost breakdowns, validating cost data, evaluating specific elements
of cost, and examining data to determine the necessity for, and
the reasonableness and allowability of, the costs included in
the application budget. The extent of cost analysis will depend
on the type of funding instrument, the complexity of the project,
prior experience with the applicant, and other factors. Detailed
information on the applicable cost principles and on allowable
and unallowable costs under NIH grants is provided in
"Cost
Considerations"
in this Part.
In addition to considering the specific information provided in
the application, the GMO determines the adequacy of the applicant's
financial and business management systems that will support the
expenditure of and accountability for NIH funds. When an applicant
has had no prior Federal grants or cost-reimbursement contracts,
the GMO may review the applicant's financial management and other
management systems before award, or within a reasonable time after
award, to determine their adequacy and acceptability. For an applicant
with prior NIH or other Federal cost-reimbursement awards, the
GMO may review recent audit reports and other available information
to determine whether the applicant's management systems meet the
standards established in 45 CFR Part 74 or 92, as appropriate.
The GMO will advise the applicant if additional information is
required. On the basis of the review results, the GMO will determine
the need for any corrective action and may impose special conditions
on the award.
OVERVIEW OF TERMS AND CONDITIONS
Parts II and III of this policy statement are the terms and conditions
of NIH grants and cooperative agreements and will be incorporated
by reference in all NIH awards as specified in "Introduction
Background
and Supersession". These terms and conditions are not intended
to be all-inclusive. In addition to the requirements included
in this policy statement, NIH grants are subject to the requirements
of:
- The authorizing program legislation;
- Program regulations, including those at 42 CFR Part 52;
- Other statutory requirements, such as those included in appropriations
acts; and
- HHS requirements in 45 CFR Part 74 or 92, as appropriate for
the type of recipient organization and the type of activity (e.g.,
research).
Notice of these latter requirements will generally be provided
in the Notice of Grant Award (NGA), but such notice is not required
in order for the award to be subject to the requirements of pertinent
statutes and regulations. An individual award may also contain
award-specific terms and conditions. For example, the GMO may
include terms or conditions necessary to address concerns about
an applicant's management systems.
Program and administrative policies and the terms and conditions
of individual awards are intended to supplement, rather than substitute
for, governing statutory and regulatory requirements. Thus, the
requirements of this policy statement apply in addition to governing
statutory and regulatory requirements, and award-specific terms
apply in addition to the requirements of this policy statement.
This policy statement is intended to be compliant with governing
statutes and the requirements of 45 CFR Parts 74 and 92, as modified
by previously approved waivers and deviations. However, if there
is a perceived conflict between or among these three categories
of requirements; i.e., statutory and regulatory requirements,
this policy statement, and award-specific terms and conditions,
or if the grantee has other questions concerning award terms and
conditions, the grantee should request written clarification from
the IC GMO. This may be done at any time; however, if the inclusion
of the term or condition would cause the grantee not to accept
the award or to be unable to comply, the question should be raised
before funds are requested from the HHS payment system. By drawing
funds from the HHS payment system, the grantee agrees to the terms
and conditions of the award as interpreted and applied by the
awarding office.
PUBLIC POLICY REQUIREMENTS AND OBJECTIVES
The following subsections deal with public policy requirements
and objectives applicable to NIH awards. The term "public
policy" indicates that the requirement is based on social,
economic, or other objectives or considerations that may be attached
to the expenditure of Federal funds by grantees and contractors,
in general, or may relate to the expenditure of Federal funds
for research or other specified activities, in particular. In
addition to cross-cutting requirements that apply to Federal agencies
and their grant programs, NIH grantees are subject to requirements
contained in NIH's annual appropriations acts that apply to the
use of NIH grant funds. Some of those requirements are included
here since they have been included in the appropriations acts
for several years without change, but those requirements may be
changed or other requirements may be added in the future.
NIH intends to uphold high ethical, health, and safety standards
in both the conduct of the research it funds and the expenditure
of public funds by its grantees. The public policy requirements
specified below set many of those standards. The signature of
the authorized official on the application indicates that the
organization is in compliance with, or intends to comply with,
these requirements. Applicants and grantees should take particular
note of requirements for assurances or certifications, the absence
or inadequacy of which may delay an award or make an applicant
ineligible for award. In general, assurances are required on a
one-time basis, with updating or changes as necessary, and certifications
are required annually and are accomplished by the authorized institutional
official's signature on the application (see discussion of individual
requirements below).
The grantee is responsible for establishing and maintaining the
necessary processes to monitor its compliance and that of its
employees and contractors with these requirements, taking appropriate
action to meet the stated objectives, and informing NIH of any
problems or concerns.
If a grant is awarded on the basis of false or misrepresented
information, or if a grantee does not comply with these public
policy requirements, NIH may take any necessary and appropriate
action, including using any of the remedies described in "Administrative
Requirements
Enforcement Actions"
or other available legal
remedies.
The HHS Inspector
General (IG) maintains a post office box and
a toll-free hotline for receiving information from individuals
concerning fraud, waste, or abuse under HHS grants and cooperative
agreements. This information is kept confidential, and callers
are not required to give their names. The address and
telephone
number are included in Part IV.
Table 2 is provided to assist the
grantee in determining the applicability
of particular public policy requirements and objectives to its
own activities as well as in determining whether to include a
requirement in a consortium agreement
or a contract for routine
purchased goods or services under the grant (see
"Glossary"
for definitions). The table distinguishes between these types
of transactions under a grant and indicates whether a given public
policy requirement would normally apply. However, even if the
table indicates a requirement is "Not Applicable," that
public policy requirement could potentially be applicable in a
specific situation; e.g., if a contract under a grant involves
research activity. Therefore, this table should be used as general
guidance only. The grantee should consult the terms and conditions
of its award and contact the awarding office GMO if there is any
question concerning the applicability of a particular public policy
requirement or objective.
The listing in Table 2 provides summary information on each requirement
and indicates where, in this policy statement, it is covered in
more detail. However, the governing statute, regulations, or other
cited policies or documents should be consulted for complete information.
TABLE 2
Public Policy
Requirements and Objectives
|
Requirement
or
Objective
|
Grantee
|
Consortium
Participant
| Contractor under Grant (Rou
tine Goods/Services)*
|
GPS Section for
Additional Information
|
Acknowledgment of Federal Funding
| X
| X
| N/A
| Part II-Availability of Information
Part III-National Research Service Awards
|
Age Discrimination Act of 1975
| X
N/A to foreign and
international organizations
| X
N/A to foreign and international organizations)
| X
N/A to foreign and international
organizations
| Part II-Civil Rights
Part III-National Research Service Awards; Awards to Foreign Institutions, International Organizations and Domestic Grants with Substantial Foreign Components (hereafter, in this Table, Awards to Foreign Institutions)
|
Animal Welfare
| X
| X
| X
| Part II-Animal Welfare
Part III-National Research Service Awards; Awards to Foreign
Institutions
|
Ban on Human
Embryo Research and Cloning
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals as Research Subjects, Patients or Recipients of Services (hereafter, in this Table, Requirements Affecting the Rights and Welfare of Individuals)
|
Civil Rights Act of 1964 (Title VI)
| X
N/A to foreign and
international organizations
| X
N/A to foreign and international organizations
| X
N/A to foreign and international
organizations
| Part II-Civil Rights
Part III-National Research Service Awards; Awards to Foreign Institutions
|
Confidentiality of
Patient Records
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals
|
Conflict of Interest
| X
(42 CFR Part 50 N/A to SBIR/STTR Phase I)
| X
| N/A
| Part II-Ethical and Safe Conduct in Science and Organizational Operations
|
Controlled Substances
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals
|
Debarment and
Suspension
| X
(N/A to certain foreign organizations)
| X
(N/A to certain foreign organizations)
| If contract equals or exceeds $100,000; N/A to certain foreign organizations
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
Part III-Awards to Foreign
Institutions
|
Drug-Free Workplace
| X
| N/A
| N/A
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
Part III-Awards to Foreign
Institutions
|
Education
Amendments of 1972
(Title IX)
| X
(N/A to foreign and international organizations
| X
(N/A to foreign and international organizations)
| X
(N/A to foreign and international organizations)
| Part II-Civil Rights
Part III-National Research Service Awards; Awards to Foreign
Institutions
|
Elimination of
Architectural Barriers to the Handicapped
| X
| N/A
| X
| Part III-Construction Grants
|
Flood Insurance
| X
| N/A
| NA
| Part III-Construction Grants
|
The Freedom of
Information Act
| Applies to covered material in NIH's possession
| Applies to covered material in NIH's possession
| Applies to covered material in NIH's possession
| Part II-Availability of Information
|
Health and Safety Guidelines
| X
| X
| Applies as required by Federal, State or local regulations
| Part II-Ethical and Safe Conduct in Science and Organizational Operations
|
Historic
Properties/Archeological Sites
| X
| N/A
| X
| Part III-Construction Grants
|
Human Subjects
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals
Part III-National Research Service Awards; Awards to Foreign
Institutions
|
Inclusion of Children as Subjects in Clinical Research
| X
| X
| N/A
| Part II-Requirements for
Inclusiveness in Research Design
Part III-National Research Service Awards; Awards to Foreign
Institutions
|
Inclusion of Women/Minorities as Subjects in Clinical Research
| X
| X
| N/A
| Part II-Requirements for
Inclusiveness in Research Design
Part III-National Research Service Awards; Awards to Foreign
Institutions
|
Intergovernmental Review under EO 12372
| X
| N/A
| N/A
| Part III-Construction Grants
|
Investigational New Drug Applications
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals
|
Labor Standards
under Federally
Assisted Construction
| X
| N/A
| X
| Part III-Construction Grants
|
Limitation on Use of Funds for Promotion or Legalization of Controlled Substances
| X
| X
| X
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
|
Lobbying |
Certification required if total costs expected to exceed $100,000
| Certification
required if greater than $100,000 only
| Certification
required on
contracts greater than $100,000 only
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
|
Metric System
| X
| X
| X
| Part II-Other Public Policy
Requirements and Objectives
Part III-Construction Grants
|
Military
Recruiting/ROTC
Program Access to Institutions of Higher Education
| X
| X
| X
| Part II-Other Public Policy Requirements and Objectives
|
Misconduct in Science
| X
| X
| N/A
| Part II-Ethical and Safe Conduct in Science and Organizational Operations
Part III-Awards to Foreign Institutions
|
National
Environmental Policy Act of 1969
| X
| N/A
| N/A
| Part III-Construction Grants
|
Nondelinquency on Federal Debt
| X
| Applies to
individuals as participants
| N/A
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
Part III-Awards to Foreign
Institutions
|
The Privacy Act
| Applies to
covered
material in
NIH's
possession
| Applies to
covered
material in NIH's possession
| Applies to covered material in NIH's possession
| Part II-Availability of Information
|
Pro-Children Act of 1994
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals
|
Program Fraud and Civil Remedies and False Claims Acts
| X
| X
| N/A
| Part I-Application and Review
Processes-Legal Implication of
Application
|
Protection of
Research Subjects' Identity
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals
|
Public Disclosure
| X
| N/A
| N/A
| Part III-Construction Grants
|
Recombinant DNA and Institutional
Biosafety Committees
| X
| X
| X
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
Part III-National Research Service Awards
|
Rehabilitation Act of 1973 (section 504)
| X
(N/A to foreign and
international organizations)
| X
(N/A to foreign and international organizations)
| X
(N/A to foreign and international
organizations)
| Part II-Civil Rights
Part III-National Research Service Awards; Awards to Foreign
Institutions
|
Relocation Assistance and Real Property
Acquisition
| X
| N/A
| N/A
| Part III-Construction Grants
|
Research on
Transplantation of Fetal Tissue
| X
| X
| X
| Part II-Requirements Affecting the Rights and Welfare of Individuals
|
Restriction on
Distribution of Sterile Needles
| X
| X
| X
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
|
Seat Belt Use
| X
| N/A
| N/A
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
|
Smoke-Free
Workplace
| X
| N/A
| N/A
| Part II-Ethical and Safe Conduct in Science and Organizational
Operations
|
Year 2000
Compliance
| X
| X
| X
| Part II-Other Public Policy
Requirements and Objectives
|
*A designation of N/A in this table indicates that a particular requirement does not apply to an otherwise eligible grantee, consortium participant or contractor or may not apply because the type of activity covered is one not normally performed by such an entity.
|
|