Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-Award and Post-Award Requirements, 39439-39441 [2023-12854]
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Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Notices
entities implement the requirement for
limited review of research by an IRB to
meet the conditions of four exemptions
found at 45 CFR 46.104(d) of the 2018
Requirements (the Common Rule). The
draft guidance discusses the concept of
limited IRB review, which appears in
these exemptions, and provides
information about how limited review
may be conducted. When finalized, this
will provide OHRP’s first formal
guidance on this topic. This draft
guidance was developed after taking
into consideration input received from
HHS and other Common Rule
departments and agencies.
II. Equity and Justice Considerations
OHRP is particularly interested in
public comments on any impact this
guidance may have on considerations
for equity and justice in human research
protections.
III. Electronic Access
Persons with access may obtain the
draft guidance documents on OHRP’s
website at https://www.hhs.gov/ohrp/
regulations-and-policy/requests-forcomments/.
Julie A. Kaneshiro,
Acting Director, Office for Human Research
Protections.
[FR Doc. 2023–12924 Filed 6–15–23; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health,
HHS.
Notice.
The National Institutes of
Health (NIH) announces publication and
serves as Notice for the extramural
community on recent policy changes
made for the Small Business Innovation
Research Program (SBIR) and the Small
Business Technology Transfer Program
(STTR). This Notice implements
additional disclosure requirements and
post-award reporting requirements for
small business concerns (SBCs) for
covered relationships. In addition, this
serves as notification of NIH’s due
diligence program to assess security
risks and denial of award when foreign
relationships or commitments with
countries of concern pose a significant
risk as provided in the SBIR and STTR
Extension Act of 2022 at https://
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Stephanie Fertig, Health and Human
Services (HHS) Small Business Program
Lead, Small business Education and
Entrepreneurial Development (SEED).
Email: SEEDinfo@nih.gov. Phone
number (301) 827–8595. Centers for
Disease Control and Prevention (CDC)
Contact: Terrance Perry, CDC Office of
Grants Services, Office of Financial
Resources. Email: OGSPolicy@cdc.gov.
Phone number (770) 488–8424). Food
and Drug Administration (FDA) Contact:
Kimberly Pendleton, FDA Office of
Finance, Budget, Acquisitions, and
Planning. Email: Kimberly.Pendleton@
fda.hhs.gov. Phone number (240) 402–
7610.
Background
Implementation of the NIH SBIR and
STTR Foreign Disclosure Pre-Award
and Post-Award Requirements
ACTION:
The policy changes are now
available for viewing.
ADDRESSES: Please visit our website to
view the policy changes at https://
grants.nih.gov/policy/PolicyNotices.
php.
DATES:
SUPPLEMENTARY INFORMATION:
National Institutes of Health
AGENCY:
www.congress.gov/117/plaws/publ183/
PLAW-117publ183.pdf under these
programs. This policy serves as an
update to section 18. Grants to For Profit
Organizations of the NIH Grants Policy
Statement (GPS) at https://
grants.nih.gov/grants/policy/nihgps/
HTML5/section_18/18_grants_to_forprofit_organizations.htm and will be
incorporated in the FY24 publication. In
addition, the NIH Application Guide
will be updated to reflect instructions
for submission of required
documentation.
The SBIR and STTR Extension Act of
2022 (the Act) Public Law 117–183, 136
stat. 2180 https://www.congress.gov/
117/plaws/publ183/PLAW117publ183.pdf, signed into law by
President Biden on September 30, 2022,
reauthorized the SBIR program, the
STTR program, and related pilot
programs through September 30, 2025.
The Act includes major changes to the
SBIR and STTR programs, including:
• increased minimum performance
standards (refer to NOT–OD–23–092,
https://grants.nih.gov/grants/guide/
notice-files/NOT-OD-23-092.html),
• disclosure requirements regarding
ties to foreign countries,
• a requirement for federal agencies
that manage SBIR and STTR programs
to establish a due diligence program to
assess security risks posed by
applicants,
• denial of award and recovery
authority provisions when ties to
foreign countries of concern pose a
significant risk.
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39439
Foreign countries of concern are
defined in the Act as the People’s
Republic of China, the Democratic
People’s Republic of North Korea, the
Russian Federation, the Islamic
Republic of Iran, or any other country
determined to be a country of concern
by the U.S. Secretary of State. An up-todate list of countries determined to be
countries of concern by the Secretary of
State will be maintained and accessible
on SBIR.gov on SBA’s Required
Disclosures of Foreign Affiliations or
Relations web page at https://
www.sbir.gov/foreign_disclosures.
In response to the passing of the Act,
the U.S. Small Business Administration
(SBA) has issued a form, Required
Disclosures of Foreign Affiliations or
Relationships to Foreign Countries
(referred to as the ‘‘disclosure form’’
hereafter) that will be administered by
federal agencies to identify and assess
the risk of covered foreign relationships
for SBC applicants applying for SBIR
and STTR funding. Publication of the
final form is forthcoming.
Applicability
This policy applies to all competing
applications for funding under the NIH,
CDC, and FDA SBIR and STTR
programs submitted for due dates on or
after September 5, 2023.
Policy
Each SBC applying for the SBIR and
STTR programs under the NIH, CDC,
and FDA is required to disclose all
funded and unfunded relationships
with foreign countries, using the
disclosure form, for all owners and
covered individuals. A ‘‘covered
individual’’ is defined as all senior key
personnel identified by the SBC in the
application (i.e., individuals who
contribute to the scientific development
or execution of a project in a
substantive, measurable way).
Applicants must include the following
information on the disclosure form:
• the identity of all owners and
covered individuals of the SBC who are
a party to any malign foreign talent
recruitment program;
• the existence of any parent
company, joint venture, or subsidiary of
the SBC that is based in or receives
funding from, any foreign country of
concern;
• any current or pending contractual
or financial obligation or other
agreement specific to a business
arrangement, or joint venture-like
arrangement with an enterprise owned
by a foreign state or any foreign entity;
• whether the SBC is wholly owned
in a foreign country;
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39440
Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
• any venture capital or institutional
investment and if the investing entity
has a general partner or any other
individual holding a leadership who has
a foreign affiliation with any foreign
country of concern;
• any technology licensing or
intellectual property sales or transfers to
a foreign country of concern during the
5-year period preceding submission of
the proposal;
• any foreign business entity, offshore
entity, or entity outside the United
States related to the SBC;
• any owners, officers, or covered
individuals that have a foreign
affiliation with a research institution
located in a foreign country of concern;
• information technology and
information safeguarding plans.
Upon request, applicants will submit
the completed disclosure form via the
Just-In-Time (JIT) process described in
the NIH GPS section 2.5.1 Just-in-Time
Procedures at https://grants.nih.gov/
grants/policy/nihgps/HTML5/section_2/
2.5.1_just-in-time_procedures.htm. The
disclosure form and any additional
agency-specific information must be
submitted electronically using the Justin-Time feature in the eRA Commons.
Applicants must continue to comply
with NIH Other Support disclosure
requirements as provided in Section
2.5.1 at https://grants.nih.gov/grants/
policy/nihgps/HTML5/section_2/2.5.1_
just-in-time_procedures.htm. SBC
applicants applying to CDC and FDA
will follow each agency’s policies for
submitting additional documents during
the pre-award process. Applicants may
be required to provide similar
information on the disclosure form that
is also submitted as a part of the other
support reporting for senior/key
personnel identified in the application.
Applicants that do not submit the
completed disclosure form during the
JIT process will not be considered for
funding.
SBIR/STTR Notices of funding
opportunities and terms and conditions
of award will be updated to reflect the
policy above.
Due Diligence Program To Assess
Security Risks
NIH, CDC, and FDA have
implemented a due diligence program
designed to assess security risks posed
by applicants. The due diligence
program will assess the cybersecurity
practices, patent analysis, employee
analysis, and foreign ownership of a
SBC seeking an award, including the
financial ties and obligations of the SBC
and employees of the SBC to a foreign
country, foreign person, or foreign
entity. After reviewing the application,
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including JIT elements and the
disclosure form, NIH, CDC, and FDA
may request the SBC provide copies of
any contractual or financial obligation
or other agreement specific to a business
arrangement, or joint venture-like
arrangement with an enterprise owned
by a foreign state or any foreign entity
in effect during the 5-year period
(calendar year) preceding submission of
the proposal. NIH, CDC, and FDA may
decline to move forward with an award
based on security risks determined
during the assessment. NIH, CDC, and
FDA will not issue an award prior to
completing the assessment process.
Denial of Awards
Applicants and recipients are
encouraged to consider whether their
entity’s relationships with foreign
countries of concern will pose a security
risk. Prior to issuing an award, NIH,
CDC, and FDA will determine whether
the SBC submitting the application:
• has an owner or covered individual
that is party to a malign foreign talent
recruitment program;
• has a business entity, parent
company, or subsidiary located in the
People’s Republic of China or another
foreign country of concern; or
• has an owner or covered individual
that has a foreign affiliation with a
research institution located in the
People’s Republic of China or another
foreign country of concern.
A finding of foreign involvement with
countries of concern will not necessarily
disqualify an applicant. NIH, CDC, and
FDA will provide SBC applicants the
opportunity to address any identified
security risks prior to award. Final
award determinations will be based on
whether the applicant’s involvement
falls within any of the following risk
criteria, per the Act:
• interfere with the capacity for
activities supported by NIH, CDC, or
FDA to be carried out;
• create duplication with activities
supported by NIH, CDC, or FDA;
• present concerns about conflicts of
interest;
• were not appropriately disclosed to
NIH, CDC, or FDA;
• violate Federal law or terms and
conditions of NIH, CDC, or FDA; or
• pose a risk to national security.
NIH, CDC, and FDA will not issue an
award under the SBIR/STTR program if
the covered relationship with a foreign
country of concern identified in this
guidance is determined to fall under any
of the criteria provided above, and the
risk cannot be resolved.
Post-Award Reporting Requirements
Recipients are responsible for
monitoring their relationships with
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foreign countries of concern post-award,
for any changes that may impact
previous disclosures. SBCs receiving an
award under the SBIR/STTR program
are required to submit an updated
disclosure form to report any of the
following changes to NIH, CDC, and
FDA throughout the duration of the
award:
• any change to a disclosure on the
disclosure form;
• any material misstatement that
poses a risk to national security; and
• any change of ownership, change to
entity structure, or other substantial
change in circumstances of the SBC that
NIH, CDC, and FDA determine poses a
risk to national security.
Updated disclosure forms are required
within 30 days of any change in
ownership, entity structure, covered
individual, or other substantive changes
in circumstance, as described above. In
addition, regular updates are required at
the time of all SBIR/STTR annual,
interim, and final Research Performance
Progress Reports (RPPRs). Recipients
will be required to upload these
updated disclosures using the
Additional Materials (AM) tool in eRA
Commons. System enhancements to
facilitate these uploads are underway,
with an anticipated deployment in
calendar year 2024. The RPPR
Instruction Guide will be updated to
reflect this process.
If the recipient reports a covered
foreign relationship that meets any of
the risk criteria prohibiting funding
described in this guidance, NIH, CDC,
and FDA may withhold funding until
the covered relationship has been
dissolved. The recipient will be
required to submit documentation
verifying the relationship has been
terminated. If the risk cannot be
resolved, NIH, CDC, and FDA may deem
it necessary to terminate the award for
material failure to comply with the
federal statutes, regulations, or terms
and conditions of the federal award.
Refer to Section 8.5.2 Remedies for
Noncompliance or Enforcement
Actions: Suspension, Termination, and
Withholding of Support (https://
grants.nih.gov/grants/policy/nihgps/
HTML5/section_8/8.5.2_remedies_for_
noncompliance_or_enforcement_
actions-_suspension__termination__
and_withholding_of_
support.htm?Highlight=termination for
more information. Recipients are
encouraged to monitor their covered
foreign relationships post-award and
avoid entering into relationships, both
funded and unfunded, that may pose a
security risk and jeopardize their ability
to retain their award.
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Federal Register / Vol. 88, No. 116 / Friday, June 16, 2023 / Notices
Agency Recovery Authority and
Repayment of Funds
An SBC will be required to repay all
amounts received from NIH, CDC, and
FDA under the award if either of the
following determinations are made
upon assessment of a change to their
disclosure:
• the SBC makes a material
misstatement that NIH, CDC, and FDA
determine poses a risk to national
security; or
• there is a change in ownership,
change in entity structure, or other
substantial change in circumstances of
the SBC that NIH, CDC, and FDA
determine poses a risk to national
security.
The repayment requirements and
procedures provided in Section 8.5.4
Recovery of Funds at https://
grants.nih.gov/grants/policy/nihgps/
HTML5/section_8/8.5.4_recovery_of_
funds.htm of the NIH GPS apply and
may also be subject to additional
noncompliance and enforcement actions
as described in Section 8.5.2 of the GPS.
Recipients are required to follow the
repayment procedures provided in the
Guidance for Repayment of Grant Funds
to the NIH at https://grants.nih.gov/
policy/compliance.htm.
Dated: June 6, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National
Institutes of Health.
[FR Doc. 2023–12854 Filed 6–15–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Therapeutic
Immune Regulation.
Date: July 13–14, 2023.
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Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, 1 Bethesda
Metro Center, Bethesda, MD 20814.
Contact Person: Yue Wu, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 803C, Bethesda, MD 20892,
(301) 867–5309, wuy25@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Behavioral Neuroscience.
Date: July 13–14, 2023.
Time: 8:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn, Washington DC/
Georgetown, 2201 M Street NW, Washington,
DC 20037.
Contact Person: Simone Chebabo Weiner,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1011K,
Bethesda, MD 20892, (301) 435–1042,
weinersc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Cancer Immunology and
Immunotherapy.
Date: July 13–14, 2023.
Time: 9:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ola Mae Zack Howard,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4192,
MSC 7806, Bethesda, MD 20892, 301–451–
4467, howardz@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Cell Biology, Developmental
Biology, and Bioengineering.
Date: July 13–14, 2023.
Time: 9:30 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Alexander Gubin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4196,
MSC 7812, Bethesda, MD 20892, 301–435–
2902, gubina@csr.nih.gov.
Name of Committee: Infectious Diseases
and Immunology B Integrated Review Group;
HIV Immunopathogenesis and Vaccine
Development Study Section.
Date: July 13–14, 2023.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
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39441
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Health Services and Systems.
Date: July 13, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Wenjuan Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3154,
Bethesda, MD 20892, (301) 480–8667,
wangw22@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Bioengineering, Surgery,
Anesthesiology, and Trauma.
Date: July 13, 2023.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Donald Scott Wright,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
MSC 7854, Bethesda, MD 20892, (301) 435–
8363, wrightds@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Pathogenic Eukaryotes.
Date: July 13, 2023.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bakary Drammeh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 805–P,
Bethesda, MD 20892, (301) 435–0000,
drammehbs@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Aging.
Date: July 13, 2023.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Thomas Y Cho, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 710B,
Bethesda, MD 20892, (301) 402–4179,
thomas.cho@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Skeletal Muscle and Exercise
Physiology/Musculoskeletal Rehabilitation
Sciences.
Date: July 13, 2023.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Notices]
[Pages 39439-39441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12854]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-
Award and Post-Award Requirements
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) announces publication
and serves as Notice for the extramural community on recent policy
changes made for the Small Business Innovation Research Program (SBIR)
and the Small Business Technology Transfer Program (STTR). This Notice
implements additional disclosure requirements and post-award reporting
requirements for small business concerns (SBCs) for covered
relationships. In addition, this serves as notification of NIH's due
diligence program to assess security risks and denial of award when
foreign relationships or commitments with countries of concern pose a
significant risk as provided in the SBIR and STTR Extension Act of 2022
at https://www.congress.gov/117/plaws/publ183/PLAW-117publ183.pdf under
these programs. This policy serves as an update to section 18. Grants
to For Profit Organizations of the NIH Grants Policy Statement (GPS) at
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_18/18_grants_to_for-profit_organizations.htm and will be incorporated in
the FY24 publication. In addition, the NIH Application Guide will be
updated to reflect instructions for submission of required
documentation.
DATES: The policy changes are now available for viewing.
ADDRESSES: Please visit our website to view the policy changes at
https://grants.nih.gov/policy/PolicyNotices.php.
FOR FURTHER INFORMATION CONTACT: Stephanie Fertig, Health and Human
Services (HHS) Small Business Program Lead, Small business Education
and Entrepreneurial Development (SEED). Email: [email protected]. Phone
number (301) 827-8595. Centers for Disease Control and Prevention (CDC)
Contact: Terrance Perry, CDC Office of Grants Services, Office of
Financial Resources. Email: [email protected]. Phone number (770) 488-
8424). Food and Drug Administration (FDA) Contact: Kimberly Pendleton,
FDA Office of Finance, Budget, Acquisitions, and Planning. Email:
[email protected]. Phone number (240) 402-7610.
SUPPLEMENTARY INFORMATION:
Background
The SBIR and STTR Extension Act of 2022 (the Act) Public Law 117-
183, 136 stat. 2180 https://www.congress.gov/117/plaws/publ183/PLAW-117publ183.pdf, signed into law by President Biden on September 30,
2022, reauthorized the SBIR program, the STTR program, and related
pilot programs through September 30, 2025.
The Act includes major changes to the SBIR and STTR programs,
including:
increased minimum performance standards (refer to NOT-OD-
23-092, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-092.html),
disclosure requirements regarding ties to foreign
countries,
a requirement for federal agencies that manage SBIR and
STTR programs to establish a due diligence program to assess security
risks posed by applicants,
denial of award and recovery authority provisions when
ties to foreign countries of concern pose a significant risk.
Foreign countries of concern are defined in the Act as the People's
Republic of China, the Democratic People's Republic of North Korea, the
Russian Federation, the Islamic Republic of Iran, or any other country
determined to be a country of concern by the U.S. Secretary of State.
An up-to-date list of countries determined to be countries of concern
by the Secretary of State will be maintained and accessible on SBIR.gov
on SBA's Required Disclosures of Foreign Affiliations or Relations web
page at https://www.sbir.gov/foreign_disclosures.
In response to the passing of the Act, the U.S. Small Business
Administration (SBA) has issued a form, Required Disclosures of Foreign
Affiliations or Relationships to Foreign Countries (referred to as the
``disclosure form'' hereafter) that will be administered by federal
agencies to identify and assess the risk of covered foreign
relationships for SBC applicants applying for SBIR and STTR funding.
Publication of the final form is forthcoming.
Applicability
This policy applies to all competing applications for funding under
the NIH, CDC, and FDA SBIR and STTR programs submitted for due dates on
or after September 5, 2023.
Policy
Each SBC applying for the SBIR and STTR programs under the NIH,
CDC, and FDA is required to disclose all funded and unfunded
relationships with foreign countries, using the disclosure form, for
all owners and covered individuals. A ``covered individual'' is defined
as all senior key personnel identified by the SBC in the application
(i.e., individuals who contribute to the scientific development or
execution of a project in a substantive, measurable way). Applicants
must include the following information on the disclosure form:
the identity of all owners and covered individuals of the
SBC who are a party to any malign foreign talent recruitment program;
the existence of any parent company, joint venture, or
subsidiary of the SBC that is based in or receives funding from, any
foreign country of concern;
any current or pending contractual or financial obligation
or other agreement specific to a business arrangement, or joint
venture-like arrangement with an enterprise owned by a foreign state or
any foreign entity;
whether the SBC is wholly owned in a foreign country;
[[Page 39440]]
any venture capital or institutional investment and if the
investing entity has a general partner or any other individual holding
a leadership who has a foreign affiliation with any foreign country of
concern;
any technology licensing or intellectual property sales or
transfers to a foreign country of concern during the 5-year period
preceding submission of the proposal;
any foreign business entity, offshore entity, or entity
outside the United States related to the SBC;
any owners, officers, or covered individuals that have a
foreign affiliation with a research institution located in a foreign
country of concern;
information technology and information safeguarding plans.
Upon request, applicants will submit the completed disclosure form
via the Just-In-Time (JIT) process described in the NIH GPS section
2.5.1 Just-in-Time Procedures at https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm. The
disclosure form and any additional agency-specific information must be
submitted electronically using the Just-in-Time feature in the eRA
Commons. Applicants must continue to comply with NIH Other Support
disclosure requirements as provided in Section 2.5.1 at https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm. SBC applicants applying to CDC and FDA will follow
each agency's policies for submitting additional documents during the
pre-award process. Applicants may be required to provide similar
information on the disclosure form that is also submitted as a part of
the other support reporting for senior/key personnel identified in the
application. Applicants that do not submit the completed disclosure
form during the JIT process will not be considered for funding.
SBIR/STTR Notices of funding opportunities and terms and conditions
of award will be updated to reflect the policy above.
Due Diligence Program To Assess Security Risks
NIH, CDC, and FDA have implemented a due diligence program designed
to assess security risks posed by applicants. The due diligence program
will assess the cybersecurity practices, patent analysis, employee
analysis, and foreign ownership of a SBC seeking an award, including
the financial ties and obligations of the SBC and employees of the SBC
to a foreign country, foreign person, or foreign entity. After
reviewing the application, including JIT elements and the disclosure
form, NIH, CDC, and FDA may request the SBC provide copies of any
contractual or financial obligation or other agreement specific to a
business arrangement, or joint venture-like arrangement with an
enterprise owned by a foreign state or any foreign entity in effect
during the 5-year period (calendar year) preceding submission of the
proposal. NIH, CDC, and FDA may decline to move forward with an award
based on security risks determined during the assessment. NIH, CDC, and
FDA will not issue an award prior to completing the assessment process.
Denial of Awards
Applicants and recipients are encouraged to consider whether their
entity's relationships with foreign countries of concern will pose a
security risk. Prior to issuing an award, NIH, CDC, and FDA will
determine whether the SBC submitting the application:
has an owner or covered individual that is party to a
malign foreign talent recruitment program;
has a business entity, parent company, or subsidiary
located in the People's Republic of China or another foreign country of
concern; or
has an owner or covered individual that has a foreign
affiliation with a research institution located in the People's
Republic of China or another foreign country of concern.
A finding of foreign involvement with countries of concern will not
necessarily disqualify an applicant. NIH, CDC, and FDA will provide SBC
applicants the opportunity to address any identified security risks
prior to award. Final award determinations will be based on whether the
applicant's involvement falls within any of the following risk
criteria, per the Act:
interfere with the capacity for activities supported by
NIH, CDC, or FDA to be carried out;
create duplication with activities supported by NIH, CDC,
or FDA;
present concerns about conflicts of interest;
were not appropriately disclosed to NIH, CDC, or FDA;
violate Federal law or terms and conditions of NIH, CDC,
or FDA; or
pose a risk to national security.
NIH, CDC, and FDA will not issue an award under the SBIR/STTR
program if the covered relationship with a foreign country of concern
identified in this guidance is determined to fall under any of the
criteria provided above, and the risk cannot be resolved.
Post-Award Reporting Requirements
Recipients are responsible for monitoring their relationships with
foreign countries of concern post-award, for any changes that may
impact previous disclosures. SBCs receiving an award under the SBIR/
STTR program are required to submit an updated disclosure form to
report any of the following changes to NIH, CDC, and FDA throughout the
duration of the award:
any change to a disclosure on the disclosure form;
any material misstatement that poses a risk to national
security; and
any change of ownership, change to entity structure, or
other substantial change in circumstances of the SBC that NIH, CDC, and
FDA determine poses a risk to national security.
Updated disclosure forms are required within 30 days of any change
in ownership, entity structure, covered individual, or other
substantive changes in circumstance, as described above. In addition,
regular updates are required at the time of all SBIR/STTR annual,
interim, and final Research Performance Progress Reports (RPPRs).
Recipients will be required to upload these updated disclosures using
the Additional Materials (AM) tool in eRA Commons. System enhancements
to facilitate these uploads are underway, with an anticipated
deployment in calendar year 2024. The RPPR Instruction Guide will be
updated to reflect this process.
If the recipient reports a covered foreign relationship that meets
any of the risk criteria prohibiting funding described in this
guidance, NIH, CDC, and FDA may withhold funding until the covered
relationship has been dissolved. The recipient will be required to
submit documentation verifying the relationship has been terminated. If
the risk cannot be resolved, NIH, CDC, and FDA may deem it necessary to
terminate the award for material failure to comply with the federal
statutes, regulations, or terms and conditions of the federal award.
Refer to Section 8.5.2 Remedies for Noncompliance or Enforcement
Actions: Suspension, Termination, and Withholding of Support (https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.5.2_remedies_for_noncompliance_or_enforcement_actions-_suspension__termination__and_withholding_of_support.htm?Highlight=termination for more information. Recipients are encouraged to monitor their
covered foreign relationships post-award and avoid entering into
relationships, both funded and unfunded, that may pose a security risk
and jeopardize their ability to retain their award.
[[Page 39441]]
Agency Recovery Authority and Repayment of Funds
An SBC will be required to repay all amounts received from NIH,
CDC, and FDA under the award if either of the following determinations
are made upon assessment of a change to their disclosure:
the SBC makes a material misstatement that NIH, CDC, and
FDA determine poses a risk to national security; or
there is a change in ownership, change in entity
structure, or other substantial change in circumstances of the SBC that
NIH, CDC, and FDA determine poses a risk to national security.
The repayment requirements and procedures provided in Section 8.5.4
Recovery of Funds at https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.5.4_recovery_of_funds.htm of the NIH GPS apply and may also
be subject to additional noncompliance and enforcement actions as
described in Section 8.5.2 of the GPS. Recipients are required to
follow the repayment procedures provided in the Guidance for Repayment
of Grant Funds to the NIH at https://grants.nih.gov/policy/compliance.htm.
Dated: June 6, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-12854 Filed 6-15-23; 8:45 am]
BILLING CODE 4140-01-P
