Identification of Medicinal Products-Implementation and Use; Guidance for Industry; Availability, 19150-19152 [2023-06587]
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
of the statutory provision, which is
March 29, 2023. Although this policy is
being implemented immediately
without prior comment, FDA will
consider all comments received and
revise the guidance document as
appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidance represents the current thinking
of FDA on ‘‘Cybersecurity in Medical
Devices: Refuse to Accept Policy for
Cyber Devices and Related Systems
Under Section 524B 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.
the FD&C Act’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number GUI00007021 and complete
title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
814, subpart H ............................................................................
860, subpart D ............................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
Premarket notification ................................................................
Premarket approval ....................................................................
Humanitarian Device Exemption ...............................................
De Novo classification process ..................................................
Q-submissions ...........................................................................
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
award of the priority review voucher.
FDA has determined that DAYBUE
(trofinetide), approved March 10, 2023,
and manufactured by Acadia
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
[FR Doc. 2023–06646 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Cybersecurity in
Medical Devices: Premarket Submission
Considerations for Cyber Devices and
Related Systems Under Section 524B of
VerDate Sep<11>2014
17:22 Mar 29, 2023
Jkt 259001
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
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 DAYBUE
(trofinetide), manufactured by Acadia
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. DAYBUE
(trofinetide) solution is for the treatment
of Rett Syndrome in adults and
pediatric patients 2 years of age and
older.
SUPPLEMENTARY INFORMATION:
PO 00000
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0910–0120
0910–0231
0910–0332
0910–0844
0910–0756
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 DAYBUE
(trofinetide), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06593 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–0266]
Identification of Medicinal Products—
Implementation and Use; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\30MRN1.SGM
Notice of availability.
30MRN1
Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Identification of Medicinal Products—
Implementation and Use.’’ This
guidance explains FDA’s position and
progress on aligning the Agency’s
standards to Identification of Medicinal
Products (IDMP) standards, which the
Agency supports, to identify and
describe marketed medicinal products
with the exception of investigational
medicinal products, with the goal of
harmonizing the standards for the
international exchange of medicinal
product data. The guidance is intended
to assist sponsors, applicants, and
registrants who are involved in the
regulatory submission of medicinal
product data.
DATES: The announcement of the
guidance is published in the Federal
Register on March 30, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
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.
VerDate Sep<11>2014
17:22 Mar 29, 2023
Jkt 259001
• 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–
2023–D–0266 for ‘‘Identification of
Medicinal Products—Implementation
and Use.’’ 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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
PO 00000
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19151
Submit written requests for single
copies of the 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, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: TaJen Chen, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1196, Silver Spring,
MD 20993–0002, 301–796–7921, Tajen.chen@fda.hhs.gov; or Diane
Maloney, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Identification of Medicinal Products—
Implementation and Use.’’ We are
issuing this guidance consistent with
our good guidance practices (GGP)
regulation (§ 10.115 (21 CFR 10.115)).
We are implementing this guidance
without prior public comment because
we have determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). We made
this determination because the
harmonization of global IDMP
implementation is a process whereby
regulatory recommendations across
different countries or regions become
aligned over time using international
guidance documents, consensus
standards, policies, and procedures.
This guidance presents a least
burdensome policy to advance
international harmonization by using
the most efficient means to achieve
regulatory goals. Although this guidance
document is immediately in effect, it
remains subject to comment in
accordance with FDA’s GGP regulation.
The guidance supports the
development and implementation of the
International Organization for
Standardization (ISO) IDMP standards
for substances, terminologies, and other
E:\FR\FM\30MRN1.SGM
30MRN1
19152
Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
information for use throughout the
global medicinal product development
lifecycle. In 2013, FDA established an
internal committee to determine the
conformance of FDA standards to the
ISO IDMP standards. Over several years,
the committee analyzed the structure,
format, and content of the Unique
Ingredient Identifier, Structured Product
Labeling Pharmaceutical Dosage Form
Terminology, Unified Code for Units of
Measure, and National Drug Code to
assess their conformance to ISO 11238,
ISO 11239, ISO 11240, and ISO 11615,
respectively. FDA’s internal committee
determined that the Agency’s standards
conform to the ISO IDMP standards for
regional use. Topics covered in this
guidance include:
• Introduction and scope
• Introduction to the five ISO IDMP
standards: ISO 11238 (substance), ISO
11239 (dose form), ISO 11240 (units
of measure), ISO 11615 (medicinal
product identification), and ISO
11616 (pharmaceutical product
identification)
• Benefits of IDMP implementation and
use, including drug safety and
pharmacovigilance, medicinal
product traceability for global supply
chain integrity, and regulatory
registration and exchange of
medicinal product information
• FDA’s approach to the IDMP
standards
• Phased approach to the global
implementation
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Patent Term Restoration; Due Diligence
Petitions; Filing, Format, and Content of
Petitions—21 CFR Part 60
[FR Doc. 2023–06587 Filed 3–29–23; 8:45 am]
The guidance represents the current
thinking of FDA on ‘‘Identification of
Medicinal Products—Implementation
and Use.’’ 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.
ADDRESSES:
OMB Control Number 0910–0233—
Extension
This information collection supports
Agency regulations. FDA’s patent
extension activities are conducted under
the authority of section 505(j) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(j)) and the
Generic Animal Drug and Patent Term
Restoration Act of 1988 (Pub. L. 100–
670) (21 U.S.C. 301, et seq.). The
regulations are codified in 21 CFR part
60, Patent Term Restoration. New
human drug, animal drug, human
biological, medical device, food
additive, or color additive products
regulated by FDA must undergo FDA
safety, or safety and effectiveness review
before marketing is permitted. If the
product is covered by a patent, part of
the patent’s term may be consumed
during this review, which diminishes
the value of the patent.
In enacting section 505(j) of the FD&C
Act and the Generic Animal Drug and
Patent Term Restoration Act of 1988,
Congress sought to encourage
development of new, safer, and more
effective medical and food additive
products. It did so by authorizing the
U.S. Patent and Trademark Office
(USPTO) to extend the patent term by a
portion of the time during which FDA’s
safety and effectiveness review
prevented marketing of the product. The
length of the patent term extension is
generally limited to a maximum of 5
years and is calculated by USPTO based
on a statutory formula. When a patent
holder submits an application for patent
term extension to USPTO, USPTO
requests information from FDA,
including the length of the regulatory
review period for the patented product.
If USPTO concludes that the product is
eligible for patent term extension, FDA
publishes a notice that describes the
length of the regulatory review period
and the dates used to calculate that
period. Interested parties may request,
under § 60.24 (21 CFR 60.24), revision
of the length of the regulatory review
period, or may petition under § 60.30
(21 CFR 60.30) to reduce the regulatory
review period by any time where
marketing approval was not pursued
with ‘‘due diligence.’’
In 21 CFR 60.36(a) due diligence is
defined as ‘‘that degree of attention,
continuous directed effort, and
timeliness as may reasonably be
expected from, and are ordinarily
exercised by, a person during a
regulatory review period.’’ As provided
in § 60.30(c), a due diligence petition
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1393]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Patent Term
Restoration; Due Diligence Petitions;
Filing, Format, and Content of
Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by May 1,
2023.
DATES:
FDA tentatively concludes that this
guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0233. The title of this
information collection is ‘‘Patent Term
Restoration; Due Diligence Petitions;
Filing, Format, and Content of
Petitions.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
III. Electronic Access
FOR FURTHER INFORMATION CONTACT:
II. Paperwork Reduction Act of 1995
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4164–01–P
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
VerDate Sep<11>2014
17:22 Mar 29, 2023
Jkt 259001
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
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]]>Agencies
[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Notices]
[Pages 19150-19152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06587]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0266]
Identification of Medicinal Products--Implementation and Use;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
[[Page 19151]]
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Identification of Medicinal Products--Implementation and Use.'' This
guidance explains FDA's position and progress on aligning the Agency's
standards to Identification of Medicinal Products (IDMP) standards,
which the Agency supports, to identify and describe marketed medicinal
products with the exception of investigational medicinal products, with
the goal of harmonizing the standards for the international exchange of
medicinal product data. The guidance is intended to assist sponsors,
applicants, and registrants who are involved in the regulatory
submission of medicinal product data.
DATES: The announcement of the guidance is published in the Federal
Register on March 30, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2023-D-0266 for ``Identification of Medicinal Products--
Implementation and Use.'' 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, 240-
402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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 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, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Ta-Jen Chen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1196, Silver Spring, MD 20993-0002, 301-
796-7921, [email protected]; or Diane Maloney, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Identification of Medicinal Products--Implementation and
Use.'' We are issuing this guidance consistent with our good guidance
practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)). We are
implementing this guidance without prior public comment because we have
determined that prior public participation is not feasible or
appropriate (Sec. 10.115(g)(2)). We made this determination because
the harmonization of global IDMP implementation is a process whereby
regulatory recommendations across different countries or regions become
aligned over time using international guidance documents, consensus
standards, policies, and procedures. This guidance presents a least
burdensome policy to advance international harmonization by using the
most efficient means to achieve regulatory goals. Although this
guidance document is immediately in effect, it remains subject to
comment in accordance with FDA's GGP regulation.
The guidance supports the development and implementation of the
International Organization for Standardization (ISO) IDMP standards for
substances, terminologies, and other
[[Page 19152]]
information for use throughout the global medicinal product development
lifecycle. In 2013, FDA established an internal committee to determine
the conformance of FDA standards to the ISO IDMP standards. Over
several years, the committee analyzed the structure, format, and
content of the Unique Ingredient Identifier, Structured Product
Labeling Pharmaceutical Dosage Form Terminology, Unified Code for Units
of Measure, and National Drug Code to assess their conformance to ISO
11238, ISO 11239, ISO 11240, and ISO 11615, respectively. FDA's
internal committee determined that the Agency's standards conform to
the ISO IDMP standards for regional use. Topics covered in this
guidance include:
Introduction and scope
Introduction to the five ISO IDMP standards: ISO 11238
(substance), ISO 11239 (dose form), ISO 11240 (units of measure), ISO
11615 (medicinal product identification), and ISO 11616 (pharmaceutical
product identification)
Benefits of IDMP implementation and use, including drug safety
and pharmacovigilance, medicinal product traceability for global supply
chain integrity, and regulatory registration and exchange of medicinal
product information
FDA's approach to the IDMP standards
Phased approach to the global implementation
The guidance represents the current thinking of FDA on
``Identification of Medicinal Products--Implementation and Use.'' 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
FDA tentatively concludes that this guidance contains no collection
of information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06587 Filed 3-29-23; 8:45 am]
BILLING CODE 4164-01-P
