National Center for Advancing Translational Science; Notice of Charter Renewal, 13739 [2022-05029]
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Federal Register / Vol. 87, No. 47 / Thursday, March 10, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist the office in processing
your requests. The guidance may also be
obtained by mail by calling CDER at at
1–800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Sarah Venti, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, drugtrackandtrace@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Verification Systems Under
the Drug Supply Chain Security Act for
Certain Prescription Drugs.’’ The
DSCSA (Title II of Pub. L. 113–54) was
signed into law on November 27, 2013.
Section 202 of the DSCSA added section
582 to the FD&C Act (21 U.S.C. 360eee–
1), which established the requirement
that trading partners have systems in
place to enable them to comply with
certain verification obligations. This
revised draft guidance provides
recommendations for robust verification
systems for the determination,
quarantine, and investigation of suspect
products, as well as the quarantine,
notification, and disposition of
illegitimate products. This revised draft
guidance also addresses: The manner in
which FDA recommends that trading
partners submit cleared product
notifications (i.e., notifications that a
suspect product is not an illegitimate
product); the statutory requirements for
responding to requests for verification;
and the statutory requirements for
processing saleable returns.
In the Federal Register of October 25,
2018 (83 FR 53880), FDA announced the
availability of a draft guidance entitled
‘‘Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs’’ dated October 24,
2018. FDA received several comments
on the draft guidance, which have been
taken into consideration. In response to
comments received from stakeholders,
this draft guidance revises the October
2018 draft guidance to: (1) Provide
FDA’s interpretation of what
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‘‘possession or control’’ means as used
throughout the DSCSA; (2) explain that
the guidance uses the term verification
in referring to both the broad set of
requirements set forth in paragraphs
(b)(4), (c)(4), (d)(4), and (e)(4) of section
582 of the FD&C Act in addition to
using the term with the meaning
defined in section 581(28) of the FD&C
Act, where appropriate to the context;
(3) recognize that, in cases where the
DSCSA directs trading partners to
coordinate with one another during
investigations and dispositions of
products, certain types of trading
partners are typically better suited to
handle specific aspects of those
statutory requirements; (4) clarify that
FDA will make requests for verification
if a trading partner is in possession or
control of a product that the Agency has
determined to be suspect product; (5)
clarify FDA’s understanding of what
‘‘electronic quarantine’’ means; (6)
clarify when samples of illegitimate
product should be retained; (7) clarify
FDA’s expectations related to the
requirements for responding to requests
for verification from authorized trading
partners; (8) inform trading partners of
the information that should be
communicated among trading partners
when determining whether a suspect
product is illegitimate; and (9) inform
trading partners of the information that
should be included when responding to
requests for verification from FDA and
other trading partners (where
applicable), and verifying saleable
returned product. In addition, editorial
changes were made to improve clarity.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Verification
Systems Under the Drug Supply Chain
Security Act for Certain Prescription
Drugs.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance includes
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act (PRA) of
1995 (44 U.S.C. 3501–3520) (PRA). FDA
intends to solicit public comment and
obtain OMB approval for any
information collections recommended
in this guidance that are new or that
would represent substantive or material
modifications to those previously
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approved collections of information
found in FDA regulations or guidance.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: March 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05018 Filed 3–9–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Science; Notice of
Charter Renewal
In accordance with Title 42 of the
U.S. Code of Federal Regulations,
Section 217a, notice is hereby given that
the Charter for the National Center for
Advancing Translational Sciences
Advisory Council was renewed for an
additional two-year period on February
7, 2022.
It is determined that the National
Center for Advancing Translational
Sciences Advisory Council is in the
public interest in connection with the
performance of duties imposed on the
National Institutes of Health by law, and
that these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Claire
Harris, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Stop Code 4875), Telephone (301)
496–2123, or harriscl@mail.nih.gov.
Dated: March 4, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–05029 Filed 3–9–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Notices]
[Page 13739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05029]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Advancing Translational Science; Notice of
Charter Renewal
In accordance with Title 42 of the U.S. Code of Federal
Regulations, Section 217a, notice is hereby given that the Charter for
the National Center for Advancing Translational Sciences Advisory
Council was renewed for an additional two-year period on February 7,
2022.
It is determined that the National Center for Advancing
Translational Sciences Advisory Council is in the public interest in
connection with the performance of duties imposed on the National
Institutes of Health by law, and that these duties can best be
performed through the advice and counsel of this group.
Inquiries may be directed to Claire Harris, Director, Office of
Federal Advisory Committee Policy, Office of the Director, National
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda,
Maryland 20892 (Mail Stop Code 4875), Telephone (301) 496-2123, or
[email protected].
Dated: March 4, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-05029 Filed 3-9-22; 8:45 am]
BILLING CODE 4140-01-P
