Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability, 53880-53882 [2018-23306]
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Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–23291 Filed 10–24–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—RFA–CE19–
001; Correction
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—RFA–
CE19–001; October 30–November 2,
2018, 8:30 a.m.–5:00 p.m., EDT which
was published in the Federal Register
on August 23, 2018 Volume 83, Number
164, pages 42655–42656.
The date should read as follows:
October 29, 2018, 3:00 p.m.–5:00 p.m.,
EDT, October 30–November 2, 2018,
8:00 a.m.–5:00 p.m., EDT.
FOR FURTHER INFORMATION CONTACT:
Mikel L. Walters, M.A., Ph.D., Scientific
Review Official, NCIPC, CDC, 4770
Buford Highway NE, Mailstop F–63,
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mwalters@cdc.gov.
The Chief Operating Officer, Centers
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announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–23297 Filed 10–24–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
daltland on DSKBBV9HB2PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
18:10 Oct 24, 2018
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that REVCOVI
(elapegademase-lvlr) Injection,
manufactured by Leadiant Bioscience
Inc., meets the criteria for a priority
review voucher. REVCOVI
(elapegademase-lvlr) Injection is
indicated for the treatment of Adenosine
Deaminase-Severe Combined
Immunodeficiency (ADA–SCID) in
pediatric and adult patients.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about REVCOVI
(elapegademase-lvlr) Injection, go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23308 Filed 10–24–18; 8:45 am]
Notice.
VerDate Sep<11>2014
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that REVCOVI
(elapegademase-lvlr) Injection,
manufactured by Leadiant Bioscience
Inc., meets the criteria for a priority
review voucher.
SUMMARY:
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3462]
Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs.’’ The draft guidance
addresses the verification systems that
manufacturers, repackagers, wholesale
distributors, and dispensers must have
in place to comply with the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the Drug Supply
Chain Security Act (DSCSA).
Specifically, this draft guidance covers
the statutory verification system
requirements that include quarantine
and investigation of a product
determined to be suspect and
quarantine and disposition of a product
determined to be illegitimate. The draft
guidance also addresses the statutory
requirement for notification to the
Agency of a product that has been
cleared by a manufacturer, repackager,
wholesale distributor, or dispenser after
a suspect product investigation because
it is determined that the product is not
an illegitimate product.
DATES: Submit either electronic or
written comments on the draft guidance
by December 24, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–3462 for ‘‘Verification Systems
Under the Drug Supply Chain Security
Act for Certain Prescription Drugs; Draft
Guidance for Industry; Availability.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
VerDate Sep<11>2014
18:10 Oct 24, 2018
Jkt 247001
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft 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 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.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
53881
The draft guidance provides
recommendations for robust verification
systems for the determination,
quarantine, and investigation of suspect
products as well as quarantine and
disposition of illegitimate products. As
explained in the draft guidance,
verification systems may include
existing standard operating procedures
or other processes or procedures
provided that the verification systems
ensure that the trading partner meets its
obligations under section 582 of the
FD&C Act. This 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). Finally,
the draft guidance also addresses the
statutory requirements for verification,
including verification of saleable
returns, at the package level for product
identifiers on packages and homogenous
cases intended to be introduced in a
transaction into commerce. While
DSCSA also requires trading partners to
notify the Agency of illegitimate
products or products with high risk of
illegitimacy, this requirement was
previously discussed in a separate
guidance document, and is therefore not
addressed in this draft guidance.
This 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 Agency’s current thinking
on verification systems for certain
human, finished, prescription drugs
under section 582 of the FD&C Act. 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. This draft guidance is not
subject to Executive Order 12866.
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). In
accordance with the PRA, prior to
publication of any final guidance
document, 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 material
modifications to those previously
approved collections of information
found in FDA regulations or guidance.
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Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: October 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23306 Filed 10–24–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2306]
Testicular Toxicity: Evaluation During
Drug Development; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Testicular Toxicity: Evaluation During
Drug Development.’’ The guidance
addresses nonclinical findings that may
raise concerns of a drug-related adverse
effect on the testes, clinical monitoring
of adverse testicular effects early in
clinical development, and the design
and conduct of a safety clinical trial
assessing drug-related testicular
toxicity. The guidance is intended to
assist sponsors developing drugs and
therapeutic biologics regulated within
the Center for Drug Evaluation and
Research to identify nonclinical signals
of testicular toxicity and to evaluate the
potential for such toxicity in humans.
This guidance finalizes the draft
guidance of the same name issued on
July 17, 2015.
DATES: The announcement of the
guidance is published in the Federal
Register on October 25, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
18:10 Oct 24, 2018
Jkt 247001
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–2306 for ‘‘Testicular Toxicity:
Evaluation During Drug Development.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this 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 that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Jennifer Mercier, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5390,
Silver Spring, MD 20993–0002, 301–
796–0957.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Testicular Toxicity: Evaluation During
Drug Development.’’ This guidance is
intended to help sponsors identify
nonclinical signals that raise concern
regarding the potential for human
testicular toxicity and to evaluate those
signals appropriately in human studies.
The guidance describes the standard
battery of nonclinical studies that are
used to assess the effects of
E:\FR\FM\25OCN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53880-53882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3462]
Verification Systems Under the Drug Supply Chain Security Act for
Certain Prescription Drugs; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Verification Systems Under the Drug Supply Chain Security Act for
Certain Prescription Drugs.'' The draft guidance addresses the
verification systems that manufacturers, repackagers, wholesale
distributors, and dispensers must have in place to comply with the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug
Supply Chain Security Act (DSCSA). Specifically, this draft guidance
covers the statutory verification system requirements that include
quarantine and investigation of a product determined to be suspect and
quarantine and disposition of a product determined to be illegitimate.
The draft guidance also addresses the statutory requirement for
notification to the Agency of a product that has been cleared by a
manufacturer, repackager, wholesale distributor, or dispenser after a
suspect product investigation because it is determined that the product
is not an illegitimate product.
DATES: Submit either electronic or written comments on the draft
guidance by December 24, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or
[[Page 53881]]
anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-D-3462 for ``Verification Systems Under the Drug Supply Chain
Security Act for Certain Prescription Drugs; Draft Guidance for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft 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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a 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.
The draft guidance provides recommendations for robust verification
systems for the determination, quarantine, and investigation of suspect
products as well as quarantine and disposition of illegitimate
products. As explained in the draft guidance, verification systems may
include existing standard operating procedures or other processes or
procedures provided that the verification systems ensure that the
trading partner meets its obligations under section 582 of the FD&C
Act. This 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). Finally, the draft guidance also addresses the statutory
requirements for verification, including verification of saleable
returns, at the package level for product identifiers on packages and
homogenous cases intended to be introduced in a transaction into
commerce. While DSCSA also requires trading partners to notify the
Agency of illegitimate products or products with high risk of
illegitimacy, this requirement was previously discussed in a separate
guidance document, and is therefore not addressed in this draft
guidance.
This 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 Agency's current thinking on verification
systems for certain human, finished, prescription drugs under section
582 of the FD&C Act. 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. This draft guidance is not subject to Executive Order
12866.
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). In accordance with the PRA, prior to publication of any final
guidance document, 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 material modifications to those
previously approved collections of information found in FDA regulations
or guidance.
[[Page 53882]]
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: October 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23306 Filed 10-24-18; 8:45 am]
BILLING CODE 4164-01-P
