Clinical Trial?
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.
ODS intends to commit $500,000 in FY 2021 and $500,000
in FY 2022 to fund up to four awards per fiscal year.
Award Budget
Application budgets are limited to no more than 25% of the
Council-approved direct costs for the current budget year of the project or
$100,000 (direct costs), whichever is less, and must reflect the actual needs
of the proposed validation study. The requested budget may include the cost
of validation methods training, consultants and fees, if any, paid to a
recognized training organization.
The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives, as long as the
research objectives are within the original scope of the peer reviewed and
approved project, or the cost increases are for unanticipated expenses within
the original scope of the project. Any cost increases need to result from
making modifications to the project that would increase or preserve the overall
impact of the project consistent with its originally approved objectives and
purposes.
Award Project Period
The project and budget periods must be within the
currently approved project period for the existing parent award. Supplements
may be requested for up to one year. The validation studies proposed for this
supplement must be accomplished within the competitive segment of the parent
award. Therefore, applicants must have at least 18 months of active support
remaining on the parent grant as of the application due date.
NIH grants policies as
described in the NIH Grants
Policy Statement will apply
to the applications submitted and awards made from this FOA.
Section III. Eligibility
Information
1. Eligible Applicants
Eligible Organizations
All organizations administering an eligible parent award may
apply for a supplement under this announcement.
Higher Education Institutions
-
Public/State Controlled Institutions of Higher Education
-
Private Institutions of Higher Education
The following types of
Higher Education Institutions are always encouraged to apply for NIH support as
Public or Private Institutions of Higher Education:
-
Hispanic-serving Institutions
-
Historically Black Colleges and Universities (HBCUs)
-
Tribally Controlled Colleges and Universities (TCCUs)
-
Alaska Native and Native Hawaiian Serving Institutions
-
Asian American Native American Pacific Islander Serving
Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
-
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of
Higher Education)
-
Nonprofits without 501(c)(3) IRS Status (Other than Institutions
of Higher Education)
For-Profit Organizations
-
Small Businesses
-
For-Profit Organizations (Other than Small Businesses)
Governments
-
State Governments
-
County Governments
-
City or Township Governments
-
Special District Governments
-
Indian/Native American Tribal Governments (Federally Recognized)
-
Indian/Native American Tribal Governments (Other than Federally
Recognized)
-
U.S. Territory or Possession
Other
-
Independent School Districts
-
Public Housing Authorities/Indian Housing Authorities
-
Native American Tribal Organizations (other than Federally
recognized tribal governments)
-
Faith-based or Community-based Organizations
-
Regional Organizations
This announcement is for supplements to existing projects.
To be eligible, the parent award must be active and the research proposed in
the supplement must be accomplished within the competitive segment. The
proposed supplement must be to provide for an increase in costs due to
unforeseen circumstances. All additional costs must be within the scope of the
peer reviewed and approved project.
IMPORTANT: The research proposed by the NIH grantee in the supplement
application must be within the original scope of the NIH-supported grant
project. Validation studies must be conducted in a laboratory that is a participating
component of the active parent award. Validation studies may not be
sub-contracted to a commercial laboratory that was not a participant in the
parent award.
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not
eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement,
are not allowed.
Required Registrations
Applicant
Organizations
Applicant organizations must complete and maintain the following
registrations as described in the SF 424 (R&R) Application Guide to be eligible
to apply for or receive an award. Since administrative supplements are made
against active grants and cooperative agreements, many of these registrations
may already be in place. All registrations must be completed prior to the
application being submitted. Registration can take 6 weeks or more, so applicants
should begin the registration process as soon as possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.
-
Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that applicants
be issued a DUNS number. After obtaining a DUNS number, applicants can begin
both SAM and eRA Commons registrations. The same DUNS number must be used for
all registrations, as well as on the grant application.
-
System for Award Management (SAM)
Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.
- o
NATO
Commercial and Government Entity (NCAGE) Code Foreign organizations must
obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
-
eRA Commons - Applicants
must have an active DUNS number to register in eRA Commons. Organizations can
register with the eRA Commons as they are working through their SAM or
Grants.gov registration, but all registrations must be in place by time of
submission. eRA Commons requires organizations to identify at least one Signing
Official (SO) and at least one Program Director/Principal Investigator (PD/PI)
account in order to submit an application.
-
Grants.gov Applicants
must have an active DUNS number and SAM registration in order to complete the Grants.gov
registration. Grants.gov registration is only required if you plan to submit
using the 'Electronic Application Submission through Grants.gov' option.
Program
Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons.If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.
Eligible Individuals (Program Director/Principal
Investigator)
Individual(s) must hold an active grant or cooperative
agreement, and the research proposed in the supplement must be accomplished
within the competitive segment of the active award. Individuals are encouraged to
work with their organizations to develop applications for support.
For supplements to parent awards that include multiple PDs/PIs, the supplement
may be requested by any or all of the PDs/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the parent award. Do
not use this administrative supplement application to add, delete, or change
the PDs/PIs listed on the parent award. Visit the Multiple Program
Director/Principal Investigator Policy in the SF424 (R&R) Application Guide
for more information.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH
Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one
application, provided that each is sufficiently distinct from any other
administrative supplement currently under consideration by the awarding NIH Institute
or Center.
Only applications with at least 18 months remaining on the
active parent award at the time of the submission due date will be accepted.
Section IV. Application and
Submission Information
1. Requesting an
Application Package
Applicants must prepare applications using current forms in
accordance with the Application Guide.
The application forms package specific to this opportunity
must be accessed through ASSIST, Grants.gov Workspace or an institutional
system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are
available in Part 1 of this
FOA. See your administrative office for instructions if you plan to use an
institutional system-to-system solution.
2. Content and Form of Application Submission
All forms must be completed for the supplemental activities only
and must not reflect funding or activities for the previously awarded parent
award.
It is critical that applicants follow the instructions for
their submission option (SF424 (R&R)
Application Guide, as appropriate) except
where instructed in this funding opportunity announcement to do otherwise.
Conformance to documented requirements is required and strictly enforced.
Applications that are out of compliance with these instructions may be delayed
or not accepted for review.
Page Limitations
All page limitations applicable to the parent award as
described in the Application Guide and the Table of
Page Limits for the activity code of the parent award must be followed,
with the following exceptions or additional requirements:
Application Submission
Administrative supplement requests must be submitted through
Grants.gov using electronic submission processes.
Instructions for Electronic
Application Submission through Grants.gov
Use the Apply button(s) in Part I of this
announcement to access the application forms package posted at Grants.gov. If
presented with more than one form package, use the Competition ID and
Competition Titles provided to determine the most appropriate application forms
package for your situation.
Prepare applications using the SF424 (R&R) forms
associated with the chosen package. Please note that some forms marked optional
in the application package are required for submission of applications for this
announcement. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate required and
optional forms, with the following additional guidance:
- SF424 R&R
Cover form: Select Revision in the Type of Application field.
- Research
Plan form (e.g., PHS 398 Research Plan form, PHS 398 Career Development Award
Supplemental form): At a minimum, the Research Strategy section should be
completed and must include a summary or abstract of the funded parent award or
project. The Research Strategy is expected to provide descriptions of the
instrumentation and materials proposed for validation studies. Applicants are also
expected to provide details on how they will assure the identity and purity of
reference materials and calibrants, whether commercially purchased or produced
in-house. Other sections should also be included if they are being changed by
the proposed supplement activities.
- Project/Performance
Site Location(s) form: Include the primary site where the proposed supplement
activities will be performed. If a portion of the proposed supplement
activities will be performed at any other site(s), identify the locations in
the fields provided.
- Sr/Key
Personnel (Expanded) form: List the PD/PI as the first person (regardless of
their role on the supplement activities). List any other Senior/Key Personnel
who are being added through this supplement, or for whom additional funds are
being requested through this supplement; include a biographical sketch for
each.
- Budget
forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds
requested for the additional supplement activities.
- R&R
Other Project Information form:
o Abstract
for the Administrative Supplement application.
o If
applicable, attach PDF documents in the Other Attachments field indicating
that the proposed research experience was approved by the Institutional Animal
Care and Use Committee (IACUC) or human subjects Institutional Review Board
(IRB) at the grantee institution. Name the documents IACUC Documentation.pdf
and/or IRB Documentation.pdf . Adherence to the NIH policy for including women
and minorities in clinical studies must also be ensured, if additional human
subjects involvement is planned for the supplement.
Product
Integrity Information (Uploaded via the Other Attachments Section for
electronic submissions): To ensure reproducibility of the research, dietary
supplements must be rigorously identified, characterized, and documented. The
following information is required for product integrity evaluation (see NCCIH's
Natural Product Integrity Policy for additional information).
o Establish
the identity, composition, and purity of the test article(s) (dietary
supplement that is being investigated and appropriate controls). Manufacturer
provided lot- or batch-specific certificates of analysis (CoAs), with
quantitative analytical results, may be acceptable; product specification sheets
and safety data sheets are NOT adequate.
Characterize
the test article composition, including ingredient content and quantity, and
report results of the laboratory analysis to confirm information on the
certificate of analysis, if applicable.
For complex
test article(s) derived from living organisms, the complete
taxonomic/scientific name along with the common name and source of the
plant/animal material/extract/phytochemical.
For all
test articles, provide documentation demonstrating both chemical and isomeric
purity (when appropriate), including the methodology used in purity
determination.
State the
constituent(s), if any, to which the test article is standardized.
Assure
test article(s) is/are free of impurities (accidental or deliberate), e.g., pesticides,
drugs, microbes, or metals.
Identify
the manufacturer or distributor (if any) by name and address and contact
information along with product brand name, if applicable.
o Establish
stability and reproducibility of the test article preparation.
Provide
documentation that demonstrates stability of test article(s) for at least the
duration of the study and explain how the test article(s) will be monitored for
stability throughout the project period.
Provide
documentation that demonstrates reproducibility of test article(s)
characteristics, especially if more than one batch is used in the study.
o
If the test article is administered via a vehicle other than a
tablet/capsule, provide information on the source and composition of the
vehicle (e.g. diet) and assure that the test article(s) remain stable and bioavailable
(e.g., probiotic added to porridge, a botanical added to animal diet)
throughout the study.
o For
placebo, verify that it matches the test article on sensory characteristics,
that the sensory characteristics are stable, and that it contains no bioactive
materials.
3. Unique Entity Identifier
and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement
for obtaining a unique entity identifier and for completing and maintaining
active registrations in System for Award Management (SAM), NATO Commercial and
Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
4. Submission Dates and
Times
Part I. Overview Information
contains information about Key Dates and Times. Applicants are encouraged to
submit electronic applications before the due date to ensure they have time to
make any application corrections that might be necessary for successful
submission. When a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.
Applicants
are responsible for viewing their electronic application before the due date in
the eRA Commons to ensure accurate and successful submission.
For electronic application submission, information on the
submission process and a definition of on-time submission are provided in the SF424(R&R)
Application Guide.
For paper-based application
submission, information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS 398
Application Guide.
5. Intergovernmental Review
(E.O. 12372)
This initiative is not subject to intergovernmental
review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
7. Other Submission Requirements
and Information
Applications must be submitted using the instructions
specified above.
Applicants must complete all required registrations prior
to submission. Section III.
Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission
process, visit How to
Apply Application Guide. If you encounter a system issue beyond your
control that threatens your ability to complete the submission process on-time,
you must follow the Dealing
with System Issues guidance. For assistance with application
submission contact the Application Submission Contacts in Section VII.
Important
reminders:
For applications submitted electronically on the SF424
(R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID
in the Credential field of the Senior/Key Person Profile form of the SF
424(R&R) Application Package. Failure to register in the Commons and to
include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the (SAM). Additional
information may be found in the Application Guide.
Post Submission Materials
Not Applicable
Section V. Application Review Information
Administrative Supplements do not receive peer review. Instead,
the administrative criteria described below will be considered in the administrative
evaluation process.
The staff of the NIH awarding component will evaluate
requests for a supplement to determine its overall merit. The following general
criteria will be used:
Budget and
Period of Support
NIH staff will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.
Overall Impact
NIH staff will consider the ability of the proposed
supplement activities to increase or preserve the parent award’s overall impact
within the original scope of award:
-
Will the administrative supplement help stimulate dietary
supplement research where it is lacking or lagging, or help distinguish between
benefits and risks where data are in conflict, and/or focus on the use of
dietary supplements in improving or maintaining health and reducing the risk of
chronic disease?
-
Will the administrative supplement increase or preserve the likelihood
for the project to exert a sustained, powerful influence on the research
field(s) involved?
-
Will the administrative supplement increase or preserve the
likelihood for the program to exert a sustained, powerful influence on the
research field(s) involved?
-
Will the administrative supplement increase or preserve the potential
benefit of the instrument requested for the overall research community and its
potential impact on NIH-funded research?
In addition, each of the following criteria will be evaluated
as applicable for the proposed supplement.
Protections for Human Subjects:
For research that involves human
subjects but does not involve one of the categories of research that are exempt
under 45 CFR Part 46, NIH staff will evaluate the justification for involvement
of human subjects and the proposed protections from research risk relating to
their participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human
subjects and meets the criteria for one or more of the categories of research
that are exempt under 45 CFR Part 46, NIH staff will evaluate: 1) the
justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities,
and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined
clinical research, the committee will evaluate the proposed plans for the
inclusion (or exclusion) of individuals on the basis of sex/gender, race, and
ethnicity, as well as the inclusion (or exclusion) of individuals of all ages
(including children and older adults) to determine if it is justified in terms
of the scientific goals and research strategy proposed.
Vertebrate Animals
NIH staff will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following five points: (1) description of
proposed procedures involving animals, including species, strains, ages, sex,
and total number to be used; (2) justifications for the use of animals versus
alternative models and for the appropriateness of the species proposed; (3)
interventions to minimize discomfort, distress, pain and injury; and (4)
justification for euthanasia method if NOT consistent with the AVMA Guidelines
for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they
would any other application proposing the use of vertebrate animals. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.
Biohazards
NIH staff will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.
2. Review and Selection
Process
Administrative supplement requests will undergo an
administrative evaluation by NIH staff, but not a full peer review. Applications
submitted for this funding opportunity will be assigned to the awarding
component for the parent award and will be administratively evaluated using the
criteria shown above.
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award
Administration Information
1. Award Notices
A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications.
This may be as an NoA for the supplemental activities only; alternatively, it
may be as either a revision to the current year NoA or included as part of a
future year NoA. The NoA signed by the grants management officer is the
authorizing document and will be sent via email to the grantee’s business
official.
Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website. When calculating the award for additional funds, NIH will 1) prorate
funding if the requested budget period is adjusted at the time of award, and 2)
use the institution’s current F&A rate; i.e., the rate in effect when the
new funding is provided.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants
Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
Specific Types of Grants, Grantees, and Activities. More information is
provided at Award
Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS
must administer their programs in compliance with federal civil rights laws that
prohibit discrimination on the basis of race, color, national origin,
disability, age and, in some circumstances, religion, conscience, and sex.
This includes ensuring programs are accessible to persons with limited English
proficiency. The HHS Office for Civil Rights provides guidance on complying
with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html
and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in
scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment requirements,
and other considerations. Thus, criteria in research protocols that target or
exclude certain populations are warranted where nondiscriminatory
justifications establish that such criteria are appropriate with respect to the
health or safety of the subjects, the scientific study design, or the purpose
of the research. For additional guidance regarding how the provisions apply to
NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA.
-
Recipients of FFA must ensure that their programs are accessible
to persons with limited English proficiency. HHS provides guidance to
recipients of FFA on meeting their legal obligation to take reasonable steps to
provide meaningful access to their programs by persons with limited English
proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html
and https://www.lep.gov. For further guidance on providing
culturally and linguistically appropriate services, recipients should review
the National Standards for Culturally and Linguistically Appropriate Services
in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
-
Recipients of FFA also have specific legal obligations for serving
qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
-
HHS funded health and education programs must be administered in
an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html;
https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
For information about NIH's commitment to supporting a safe and respectful work
environment, who to contact with questions or concerns, and what NIH's
expectations are for institutions and the individuals supported on NIH-funded
awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
-
Recipients of FFA must also administer their programs in
compliance with applicable federal religious nondiscrimination laws and
applicable federal conscience protection and associated anti-discrimination
laws. Collectively, these laws prohibit exclusion, adverse treatment,
coercion, or other discrimination against persons or entities on the basis of
their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html
and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more
information about obligations and prohibitions under federal civil rights laws
at https://www.hhs.gov/ocr/about-us/contact-us/index.html
or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory
provisions contained in Section 872 of the Duncan Hunter National Defense
Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be
subject to the Federal Awardee Performance and Integrity Information System (FAPIIS)
requirements. FAPIIS requires Federal award making officials to review and
consider information about an applicant in the designated integrity and
performance system (currently FAPIIS) prior to making an award. An applicant,
at its option, may review information in the designated integrity and
performance systems accessible through FAPIIS and comment on any information
about itself that a Federal agency previously entered and is currently in FAPIIS.
The Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants.
This provision will apply to all NIH grants and cooperative agreements except
fellowships.
Cooperative Agreement Terms and Conditions of Award
Any supplements to Cooperative Agreements will be subject to
the same Cooperative Agreement terms and conditions as the parent award.
3. Reporting
Reporting requirements will be specified in the terms and
conditions of award as applicable to the supplemental activities. In most non-competing
continuation applications, the progress report and budget for the supplement
must be included with, but clearly delineated from, the progress report and budget
for the parent award. The progress report must include information about the
activities supported by the supplement even if support for future years is not
requested. Continuation of support for the supplement activities in the
remaining years of the competitive segment of the grant will depend upon
satisfactory review by the NIH awarding component of progress for both the parent
award and the supplement project, the research proposed for the next budget
period, and the appropriateness of the proposed budget for the proposed effort.
This information is submitted with the Research Performance
Progress Report (RPPR) and financial statements as required in the NIH Grants
Policy Statement.
The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov
on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.
In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of information
reported in the System for Award Management (SAM) about civil, criminal,
and administrative proceedings in connection with the award or performance of a
Federal award that reached final disposition within the most recent five-year
period. The recipient must also make semiannual disclosures regarding
such proceedings. Proceedings information will be made publicly available
in the designated integrity and performance system (currently FAPIIS). This is
a statutory requirement under section 872 of Public Law 110-417, as amended (41
U.S.C. 2313). As required by section 3010 of Public Law 111-212, all
information posted in the designated integrity and performance system on or
after April 15, 2011, except past performance reviews required for Federal procurement
contracts, will be publicly available. Full reporting requirements and
procedures are found in Appendix XII to 45 CFR Part 75 Award Term and
Conditions for Recipient Integrity and Performance Matters.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions
regarding ASSIST, eRA Commons, application errors and warnings, documenting
system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions,
application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred
method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding
Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Scientific/Research Contact(s)
Adam J. Kuszak, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-496-1795
Email: kuszakaj@mail.nih.gov
D. Craig Hopp, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-5825
Email: hoppdc@mail.nih.gov
Nancy J. Emenaker, Ph.D., R.D.
National Cancer Institute (NCI)
Telephone: 240-276-7125
Email: emenaker@mail.nih.gov
Karl Krueger, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7026
Email: kruegerk@mail.nih.gov)
Padma Maruvada, Ph.D.
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
Telephone: 301-594-8884
Email: maruvadp@mail.nih.gov
Thaddeus Schug, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-9469
Email: schugt2@niehs.nih.gov
Peer Review Contact(s)
Not Applicable
Financial/Grants Management Contact(s)
Shelley Carow
National Center for Complementary and Integrative Health
NCCIH)
Telephone: 301-594-3788
Email: scarow@mail.nih.gov
Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov
Kevin Reeves
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
Telephone: 301-594-8861
reeveskm@niddk.nih.gov)
Aaron Nicholas
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7823
Email: nicholaa@niehds.nih.gov
Section VIII. Other Information
Recently issued trans-NIH policy
notices may affect your application submission. A full list of policy
notices published by NIH is provided in the NIH
Guide for Grants and Contracts. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.