[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26567-26569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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,

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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 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-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 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.

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, 
[email protected], 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, 
[email protected], 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 (https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc). 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 https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc or https://www.regulations.gov.

    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