Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability, 40159-40160 [2017-17919]
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Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices
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[FR Doc. 2017–17935 Filed 8–23–17; 8:45 am]
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Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
on the draft guidance by October 23,
2017.
Food and Drug Administration
ADDRESSES:
[Docket No. FDA–2017–D–1956]
Electronic Submissions
Identifying Trading Partners Under the
Drug Supply Chain Security Act; Draft
Guidance for Industry; Availability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announcing the availability of a draft
guidance for industry entitled
‘‘Identifying Trading Partners Under the
Drug Supply Chain Security Act’’ (draft
trading partner guidance). FDA is
issuing this guidance to assist industry
and State and local governments in
understanding how to categorize the
entities in the drug supply chain in
accordance with the Drug Supply Chain
Security Act (DSCSA). This guidance
explains how to determine when certain
statutory requirements will apply to
entities that may be considered trading
partners in the drug supply chain. FDA
is also soliciting public input specific to
the activities of ‘‘private-label
distributors’’ of drug products and
whether those activities fall within the
definitions under DSCSA of the various
trading partners.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
You may submit comments
as follows:
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
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
E:\FR\FM\24AUN1.SGM
24AUN1
rmajette on DSKBCKNHB2PROD with NOTICES
40160
Federal Register / Vol. 82, No. 163 / Thursday, August 24, 2017 / Notices
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–
2017–D–1956 for ‘‘Identifying Trading
Partners Under the Drug Supply Chain
Security Act; 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/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.
VerDate Sep<11>2014
15:29 Aug 23, 2017
Jkt 241001
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 to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), 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:
Melissa Mannion, 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
‘‘Identifying Trading Partners Under the
Drug Supply Chain Security Act.’’ The
DSCSA (Title II of Pub. L. 113–54)
establishes new requirements to develop
and enhance drug distribution security
by 2023. It does this, in part, by defining
different types of entities in the drug
supply chain as trading partners (i.e.,
manufacturers, repackagers, wholesale
distributors, third-party logistics
providers, and dispensers). Among
other things, the DSCSA requires that
trading partners of manufacturers,
wholesale distributors, dispensers, and
repackagers must meet the applicable
requirements for being ‘‘authorized
trading partners.’’ In addition, the
DSCSA outlines requirements for
specific trading partners, including drug
product tracing and licensure
requirements. FDA has received
questions about which types of entities
are included in each of the trading
partner definitions and this guidance is
intended to help clarify and explain the
relevant statutory provisions. The
guidance covers who is considered to be
a manufacturer, a repackager, a
wholesale drug distributor, a third-party
logistics provider, and a dispenser for
purposes of certain DSCSA
requirements.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
II. Additional Issues for Consideration:
Specific Request for Comments and
Information
In addition to comments on the draft
guidance generally, FDA is requesting
comments specifically related to the
activities of private-label distributors
(PLDs), and whether those activities fall
within the definitions under DSCSA of
the various trading partners. FDA
considers a PLD to be an entity that
owns and distributes a manufactured
product under its own label or trade
name. Because there are many different
business models for PLDs, resulting in
situations where a PLD could be
considered a manufacturer, wholesale
distributor, or dispenser, we are asking
for comments on how the different
business models might impact a PLD’s
status as an authorized trading partner
under the DSCSA.
This draft guidance is being issued
consistent with FDA’s good guidance
practices (see 21 CFR 10.115). The draft
guidance, when finalized, will represent
the current thinking of FDA on
‘‘Identifying Trading Partners under the
Drug Supply Chain Security 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.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
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: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17919 Filed 8–21–17; 11:15 am]
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AGENCY:
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[Federal Register Volume 82, Number 163 (Thursday, August 24, 2017)]
[Notices]
[Pages 40159-40160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17919]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-1956]
Identifying Trading Partners Under the Drug Supply Chain Security
Act; 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
``Identifying Trading Partners Under the Drug Supply Chain Security
Act'' (draft trading partner guidance). FDA is issuing this guidance to
assist industry and State and local governments in understanding how to
categorize the entities in the drug supply chain in accordance with the
Drug Supply Chain Security Act (DSCSA). This guidance explains how to
determine when certain statutory requirements will apply to entities
that may be considered trading partners in the drug supply chain. FDA
is also soliciting public input specific to the activities of
``private-label distributors'' of drug products and whether those
activities fall within the definitions under DSCSA of the various
trading partners.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 23, 2017.
ADDRESSES: You may submit comments 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 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
[[Page 40160]]
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-2017-D-1956 for ``Identifying Trading Partners Under the Drug
Supply Chain Security Act; 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.
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 to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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: Melissa Mannion, 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 ``Identifying Trading Partners Under the Drug Supply Chain
Security Act.'' The DSCSA (Title II of Pub. L. 113-54) establishes new
requirements to develop and enhance drug distribution security by 2023.
It does this, in part, by defining different types of entities in the
drug supply chain as trading partners (i.e., manufacturers,
repackagers, wholesale distributors, third-party logistics providers,
and dispensers). Among other things, the DSCSA requires that trading
partners of manufacturers, wholesale distributors, dispensers, and
repackagers must meet the applicable requirements for being
``authorized trading partners.'' In addition, the DSCSA outlines
requirements for specific trading partners, including drug product
tracing and licensure requirements. FDA has received questions about
which types of entities are included in each of the trading partner
definitions and this guidance is intended to help clarify and explain
the relevant statutory provisions. The guidance covers who is
considered to be a manufacturer, a repackager, a wholesale drug
distributor, a third-party logistics provider, and a dispenser for
purposes of certain DSCSA requirements.
II. Additional Issues for Consideration: Specific Request for Comments
and Information
In addition to comments on the draft guidance generally, FDA is
requesting comments specifically related to the activities of private-
label distributors (PLDs), and whether those activities fall within the
definitions under DSCSA of the various trading partners. FDA considers
a PLD to be an entity that owns and distributes a manufactured product
under its own label or trade name. Because there are many different
business models for PLDs, resulting in situations where a PLD could be
considered a manufacturer, wholesale distributor, or dispenser, we are
asking for comments on how the different business models might impact a
PLD's status as an authorized trading partner under the DSCSA.
This draft guidance is being issued consistent with FDA's good
guidance practices (see 21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Identifying
Trading Partners under the Drug Supply Chain Security 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.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17919 Filed 8-21-17; 11:15 am]
BILLING CODE 4164-01-P