[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]
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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.
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[[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