Standardization of Data and Documentation Practices for Product Tracing; Draft Guidance for Industry; Availability, 9004-9006 [2018-04180]
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9004
Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
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–
2004–N–0258 for ‘‘Food Labeling:
Serving Sizes of Foods That Can
Reasonably Be Consumed at One Eating
Occasion; Dual-Column Labeling;
Updating, Modifying, and Establishing
Certain Reference Amounts Customarily
Consumed; Serving Size for Breath
Mints; and Technical Amendments—
Small Entity Compliance Guide.’’
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.’’ We
will review this copy, including the
claimed confidential information, in our
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
VerDate Sep<11>2014
18:10 Mar 01, 2018
Jkt 244001
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 SECG to the Office of
Nutrition and Food Labeling, Center for
Food Safety and Applied Nutrition
(HFS–800), Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT:
Jillonne Kevala, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1450.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 27,
2016 (81 FR 34000), we issued a final
rule pertaining to serving sizes for food.
The final rule amends the definition of
a single-serving container; requires
dual-column labeling for certain
containers; updates, modifies, and
establishes certain Reference Amounts
Customarily Consumed (RACCs);
amends the serving size for breath
mints; and makes certain technical
amendments to various aspects of
preexisting serving size regulations. The
final rule, which is codified at §§ 101.9
and 101.12 (21 CFR 101.9 and 101.12),
became effective July 26, 2016, and has
a compliance date of July 26, 2018, for
manufacturers with $10 million or more
in annual food sales, and July 26, 2019,
for manufacturers with less than $10
million in annual food sales. On
October 2, 2017, FDA published a
proposed rule to extend the compliance
dates by approximately 1.5 years—to
January 1, 2020, for manufacturers with
$10 million or more in annual food sales
and to January 1, 2021, for
manufacturers with less than $10
million in annual food sales—and
explained that, pending completion of
the rulemaking with respect to the
compliance dates, we intend to exercise
enforcement discretion with respect to
the compliance dates announced in the
final rule (82 FR 45753). A final
determination regarding the compliance
dates is pending.
We examined the economic
implications of the final rule as required
by the Regulatory Flexibility Act (5
U.S.C. 601–612) and determined that
the final rules on nutrition labeling,
taken as a whole, will have a significant
economic impact on a substantial
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number of small entities. In compliance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Pub. L. 104–121, as amended by Pub.
L. 110–28), we are making available the
SECG to explain the actions that a small
entity must take to comply with the
rule.
We are issuing the SECG consistent
with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The
SECG represents the current thinking of
FDA on this topic. 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 guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information
found in FDA regulations. The
collections of information in §§ 101.9
and 101.12 have been approved under
OMB control number 0910–0381.
III. Electronic Access
Persons with access to the internet
may obtain the SECG at either https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04284 Filed 3–1–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–0688]
Standardization of Data and
Documentation Practices for Product
Tracing; 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
‘‘Standardization of Data and
Documentation Practices for Product
Tracing.’’ The draft guidance elaborates
on the standards for the interoperable
exchange of transaction information,
transaction history, and transaction
statements (product tracing information)
SUMMARY:
E:\FR\FM\02MRN1.SGM
02MRN1
Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
provided under the drug supply chain
security provisions of the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
This guidance is intended to assist
trading partners in standardizing the
data contained in the product tracing
information that trading partners must
provide, capture, and maintain under
the FD&C Act. In addition, this guidance
includes recommendations for
documentation practices that a trading
partner can use to meet its product
tracing obligations, including in
situations where a trading partner is
permitted by law to provide other
trading partners with product tracing
information that omits certain elements
that would otherwise be required.
DATES: Submit either electronic or
written comments on the draft guidance
by May 1, 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:
daltland on DSKBBV9HB2PROD with NOTICES
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
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
VerDate Sep<11>2014
18:10 Mar 01, 2018
Jkt 244001
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–0688 for ‘‘Standardization of
Data and Documentation Practices for
Product Tracing; 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
9005
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 that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Connie Jung, 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
On November 27, 2013, the Drug
Supply Chain Security Act (Title II of
Pub. L. 113–54) was signed into law.
Section 202 of the Drug Supply Chain
Security Act (DSCSA), which added
new sections 581 and 582 to the FD&C
Act (21 U.S.C. 360eee and 360eee–1), set
forth new definitions and requirements
related to product tracing. The DSCSA
outlines critical steps to build an
electronic, interoperable system by
November 27, 2023, that will identify
and trace certain prescription drugs as
they are distributed within the United
States.
Under section 582(b)(1), (c)(1), (d)(1),
and (e)(1) of the FD&C Act, certain
trading partners in the pharmaceutical
distribution supply chain
(manufacturers, wholesale distributors,
dispensers, and repackagers) are
required to capture, maintain, and
provide the subsequent purchaser of
certain prescription drug products with
product tracing information. These
requirements took effect on January 1,
2015, for manufacturers, wholesale
distributors, and repackagers, and on
July 1, 2015, for dispensers.
As required by section 582(a)(2)(A) of
the FD&C Act, FDA established initial
standards in 2014 to facilitate the
interoperable exchange of transaction
information, transaction history, and
transaction statements between trading
partners (79 FR 70878, November 28,
2014). Those standards help trading
partners comply with the requirements
of section 582(b)(1), (c)(1), (d)(1), and
(e)(1) of the FD&C Act to provide the
subsequent trading partners with
product tracing information, in paper or
electronic format, through the extension
and/or use of current systems and
processes.
E:\FR\FM\02MRN1.SGM
02MRN1
9006
Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
This draft guidance elaborates on the
initial standards that FDA established in
2014. It is intended to assist trading
partners in standardizing the data that
are contained in the product tracing
information they must provide to
subsequent purchasers. It is also
intended to help trading partners
understand the data elements that
should be included in the product
tracing information, particularly in
situations where they are permitted by
law to provide other trading partners
with product tracing information that
omits certain elements that would
otherwise be required. In addition, the
draft guidance recommends
documentation practices that trading
partners can use to satisfy the
requirements of section 582(b)(1), (c)(1),
(d)(1), and (e)(1) of the FD&C Act.
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 current thinking of FDA
about standardization of data and
documentation practices for the
exchange of product tracing
information. 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 guidance is not
subject to Executive Order 12866.
daltland on DSKBBV9HB2PROD with NOTICES
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 of 1995
(PRA) (44 U.S.C. 3501–3520). 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 modifications to those
previously approved collections of
information found in FDA regulations or
guidances.
III. Electronic Access
Persons with access to the internet
may obtain the document 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: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04180 Filed 3–1–18; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:10 Mar 01, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1255]
E18 Genomic Sampling and
Management of Genomic Data;
International Council for
Harmonisation; 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
guidance for industry entitled ‘‘E18
Genomic Sampling and Management of
Genomic Data.’’ The guidance was
prepared under the auspices of the
International Council for Harmonisation
(ICH), formerly the International
Conference on Harmonisation. This
guidance focuses on the general
principles of collecting, processing,
transporting, storing, and disposing of
genomic samples or data in clinical
studies. The guidance is intended to
provide harmonized principles of
genomic sampling and of management
of genomic data in clinical studies to
foster interactions amongst
stakeholders, including drug
developers, investigators, and
regulators; and to encourage genomic
research within clinical studies.
DATES: The announcement of the
guidance is published in the Federal
Register on March 2, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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–
2016–D–1255 for ‘‘E18 Genomic
Sampling and Management of Genomic
Data; International Council for
Harmonisation; Guidance for Industry.’’
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
E:\FR\FM\02MRN1.SGM
02MRN1
]]>Agencies
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9004-9006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-0688]
Standardization of Data and Documentation Practices for Product
Tracing; 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
``Standardization of Data and Documentation Practices for Product
Tracing.'' The draft guidance elaborates on the standards for the
interoperable exchange of transaction information, transaction history,
and transaction statements (product tracing information)
[[Page 9005]]
provided under the drug supply chain security provisions of the Federal
Food, Drug, and Cosmetic Act (FD&C Act). This guidance is intended to
assist trading partners in standardizing the data contained in the
product tracing information that trading partners must provide,
capture, and maintain under the FD&C Act. In addition, this guidance
includes recommendations for documentation practices that a trading
partner can use to meet its product tracing obligations, including in
situations where a trading partner is permitted by law to provide other
trading partners with product tracing information that omits certain
elements that would otherwise be required.
DATES: Submit either electronic or written comments on the draft
guidance by May 1, 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 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-0688 for ``Standardization of Data and Documentation
Practices for Product Tracing; 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. 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: Connie Jung, 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
On November 27, 2013, the Drug Supply Chain Security Act (Title II
of Pub. L. 113-54) was signed into law. Section 202 of the Drug Supply
Chain Security Act (DSCSA), which added new sections 581 and 582 to the
FD&C Act (21 U.S.C. 360eee and 360eee-1), set forth new definitions and
requirements related to product tracing. The DSCSA outlines critical
steps to build an electronic, interoperable system by November 27,
2023, that will identify and trace certain prescription drugs as they
are distributed within the United States.
Under section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C
Act, certain trading partners in the pharmaceutical distribution supply
chain (manufacturers, wholesale distributors, dispensers, and
repackagers) are required to capture, maintain, and provide the
subsequent purchaser of certain prescription drug products with product
tracing information. These requirements took effect on January 1, 2015,
for manufacturers, wholesale distributors, and repackagers, and on July
1, 2015, for dispensers.
As required by section 582(a)(2)(A) of the FD&C Act, FDA
established initial standards in 2014 to facilitate the interoperable
exchange of transaction information, transaction history, and
transaction statements between trading partners (79 FR 70878, November
28, 2014). Those standards help trading partners comply with the
requirements of section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the
FD&C Act to provide the subsequent trading partners with product
tracing information, in paper or electronic format, through the
extension and/or use of current systems and processes.
[[Page 9006]]
This draft guidance elaborates on the initial standards that FDA
established in 2014. It is intended to assist trading partners in
standardizing the data that are contained in the product tracing
information they must provide to subsequent purchasers. It is also
intended to help trading partners understand the data elements that
should be included in the product tracing information, particularly in
situations where they are permitted by law to provide other trading
partners with product tracing information that omits certain elements
that would otherwise be required. In addition, the draft guidance
recommends documentation practices that trading partners can use to
satisfy the requirements of section 582(b)(1), (c)(1), (d)(1), and
(e)(1) of the FD&C Act.
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 current thinking of FDA about
standardization of data and documentation practices for the exchange of
product tracing information. 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 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 of 1995 (PRA) (44 U.S.C. 3501-3520).
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 modifications to those previously approved
collections of information found in FDA regulations or guidances.
III. Electronic Access
Persons with access to the internet may obtain the document 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: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04180 Filed 3-1-18; 8:45 am]
BILLING CODE 4164-01-P
