Notice2023-09173
Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Elements and Terminologies; Establishment of a Public Docket; Request for Comments
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Published
May 1, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies for the electronic submission of PQ/CMC data. Building on the Agency's previous Federal Register notices published on July 11, 2017, and March 18, 2022, requesting comments on PQ/CMC data elements and controlled terminology, the Agency is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data. In addition, the progress toward the establishment of standardized pharmaceutical data elements and terminologies will require further interactions between the Agency and interested parties and various stakeholders, including industry. Accordingly, FDA is planning to request comment on additional PQ/CMC data elements and terminologies over time. FDA is establishing an open docket to facilitate efficient receipt of comments and public posting of updated draft documents on PQ/CMC data elements and terminologies.
Full Text
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<title>Federal Register, Volume 88 Issue 83 (Monday, May 1, 2023)</title>
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[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26567-26569]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09173]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1443]
Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls
Data Elements and Terminologies; Establishment of a Public Docket;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and
Controls (PQ/CMC) Data Elements and Terminologies for the electronic
submission of PQ/CMC data. Building on the Agency's previous Federal
Register notices published on July 11, 2017, and March 18, 2022,
requesting comments on PQ/CMC data elements and controlled terminology,
the Agency is continuing to seek comment on the accuracy, suitability,
and appropriateness of revised and/or new data elements and
terminologies for submission of PQ/CMC data. In addition, the progress
toward the establishment of standardized pharmaceutical data elements
and terminologies will require further interactions between the Agency
and interested parties and various stakeholders, including industry.
Accordingly, FDA is planning to request comment on additional PQ/CMC
data elements and terminologies over time. FDA is establishing an open
docket to facilitate efficient receipt of comments and public posting
of updated draft documents on PQ/CMC data elements and terminologies.
DATES: Comments may be submitted to this docket at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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,
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-N-1443 for ``Draft Pharmaceutical Quality/Chemistry
Manufacturing and Controls Data Elements and Terminologies; Request for
Comments.'' Received comments filed in a timely manner will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Scott Gordon, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#6d2a0409080203432a021f0902032d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="74331d10111b1a5a331b06101b1a341210155a1c1c075a131b02">[email protected]</span></a>, 240-402-8560; Diane Maloney, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Norman
Gregory, Center for Veterinary Medicine, Food and Drug Administration,
7500 Standish Pl., HFV-143, Rockville, MD 20855,
<a href="/cdn-cgi/l/email-protection#0b456479666a65254c796e6c6479724b6d6f6a25636378256c647d"><span class="__cf_email__" data-cfemail="b9f7d6cbd4d8d797fecbdcded6cbc0f9dfddd897d1d1ca97ded6cf">[email protected]</span></a>, 240-402-0684.
SUPPLEMENTARY INFORMATION:
I. Background
PQ/CMC is a term used to describe manufacturing and testing data of
pharmaceutical products. PQ/CMC encompasses topics such as drug
stability, quality specification, batch formula, and batch analysis,
which are important aspects of drug development and manufacturing. PQ/
CMC plays an integral part in the regulatory review process and life-
cycle management of pharmaceutical products. The development of a
structured format for PQ/CMC data will enable consistency in the
content and format of PQ/CMC data submitted, thus providing a
harmonized language for submission content, allowing reviewers to query
the data, and, in general, contributing to a more efficient and
effective regulatory decision-making process by creating a standardized
data dictionary.
The impetus for this standardization effort was the provisions from
the 2012 Food and Drug Administration Safety and Innovation Act (Pub.
L. 112-144), which authorized the Agency to require certain submissions
to be submitted in a specified electronic format. PQ/CMC
standardization supports FDA's regulatory needs in receiving structured
and standardized pharmaceutical quality data and includes two
objectives: (1) to standardize the pharmaceutical quality data that is
currently received by FDA in electronic common technical document
(eCTD) Module 3 (and relevant sections of Module 2) from the sponsoring
organizations, and (2) to use these structured elements and develop a
Health Level 7 Fast Health Interoperability Resources data exchange
solution.
On July 11, 2017, FDA published a Federal Register notice
requesting comment on a draft PQ/CMC Data Elements and Controlled
Terminology document (82 FR 32003). That document proposed structured
data standards for a set of eCTD Module 3 content. Based on a range of
public feedback, FDA published a Federal Register notice on March 18,
2022 (87 FR 15435), requesting comment on a significantly revised and
expanded set of data elements and terminologies, including additional
subject areas of Module 3. The information released for public comment
is not intended to be comprehensive in covering all eCTD product
quality information, only those concepts that were considered amenable
to structuring and would bring value to the quality review process.
This information should not be viewed as guidance, technical
specification, or an implementation guide, as it is meant solely for
comment.
Through this notice, the Agency is continuing to seek comment on
the accuracy, suitability, and appropriateness of revised and/or new
data elements and terminologies for submission of PQ/CMC data. The
Agency intends to issue guidance on the standardization of PQ/CMC data
elements and terminologies for electronic submissions.
II. Establishment of a Docket
FDA is establishing an open docket on matters related to PQ/CMC
Data Elements and Controlled Terminologies. Coinciding with publication
of this notice, a document will be available at FDA's PQ/CMC web page
designated as ``Chapters,'' each of which will cover information
relevant to selected parts of eCTD Module 3 and/or Module 2.3. The
first Chapter, Chapter 1, is provided solely for context as it is a
reiteration of content previously released for
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comment. FDA is not seeking comment on the content of Chapter 1.
Chapter 2 in this document is the first new Chapter, which provides
draft designs of data elements and terminologies, in some cases new and
in other cases updated from Chapter 1, associated with PQ/CMC subject
areas and concepts and scoped to some of what is currently submitted in
Module 3 of the eCTD submission. Since the data elements and
terminologies in Chapter 2 are new and/or updated, review of Chapter 1,
solely as a reference, is highly recommended.
After publication of this notice with Chapter 2 of the PQ/CMC Data
Elements and Terminologies document, subsequent Chapters will be posted
on FDA's PQ/CMC web page (<a href="https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc">https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc</a>). Public comments, specifying to which Chapter the
comments are submitted, can be made to the open docket. Comments may be
submitted to this docket at any time, but comments should be submitted
on new Chapters within 60 days of being posted on FDA's PQ/CMC web page
to ensure that the Agency considers your comment before it begins work
on the final version of the Chapter. FDA will aim to provide a new
Chapter of the PQ/CMC Data Elements and Terminologies periodically. FDA
is targeting posting updates to this content to FDA's PQ/CMC web page
by the end of the calendar months of March, June, September, and
December of each year. This update may consist of a note that there is
no new content for review in this period or, alternatively, that there
is new content to be reviewed for comment, along with a link to the
relevant documentation, background, and instructions on submitting
comments.
III. Electronic Access
Persons with access to the internet may obtain the draft data
elements and terminologies at either <a href="https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc">https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09173 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P
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