Notice2022-05790
Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 18, 2022
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 Exchange for the electronic submission of PQ/CMC data. This document provides draft design of Health Level 7 (HL7) Fast Health Interoperability Resources (FHIR) profiles that contain the data elements and terminologies associated with PQ/CMC subject areas and scoped to some of what is currently submitted in Module 3 of the electronic Common Technical Document (eCTD) submission. It 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. The Agency is seeking comment on the mapping of the PQ/CMC data elements to the various FHIR Resources. This document should not be viewed as guidance, technical specification, or an implementation guide, as it is meant solely for comment. The FHIR mapping presented in this document is bound to the HL7 FHIR R5 draft release. As such, it is likely that some parts of the mapping presented in this document may change based on comments during the HL7 balloting and reconciliation process. However, since HL7 balloting has variable and extensive timelines, the Agency determined that it would be prudent to provide an early opportunity for comment that will inform final development of the exchange standard.
Full Text
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<title>Federal Register, Volume 87 Issue 53 (Friday, March 18, 2022)</title>
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[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15435-15436]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0297]
Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls
Data Exchange; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; 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 Exchange for the electronic submission of PQ/CMC
data. This document provides draft design of Health Level 7 (HL7) Fast
Health Interoperability Resources (FHIR) profiles that contain the data
elements and terminologies associated with PQ/CMC subject areas and
scoped to some of what is currently submitted in Module 3 of the
electronic Common Technical Document (eCTD) submission. It 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. The
Agency is seeking comment on the mapping of the PQ/CMC data elements to
the various FHIR Resources. This document should not be viewed as
guidance, technical specification, or an implementation guide, as it is
meant solely for comment. The FHIR mapping presented in this document
is bound to the HL7 FHIR R5 draft release. As such, it is likely that
some parts of the mapping presented in this document may change based
on comments during the HL7 balloting and reconciliation process.
However, since HL7 balloting has variable and extensive timelines, the
Agency determined that it would be prudent to provide an early
opportunity for comment that will inform final development of the
exchange standard.
DATES: Submit either electronic or written comments by May 17, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 17, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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, 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-2022-N-0297 for ``Draft Pharmaceutical Quality/Chemistry
Manufacturing and Controls (PQ/CMC) Data Exchange for the electronic
submission of PQ/CMC data; Request for Comments.'' Received comments,
those filed in a timely manner (see ADDRESSES), 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
[[Page 15436]]
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: Bryan Spells, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#1557676c747b3b466570797966557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="baf8c8c3dbd494e9cadfd6d6c9fadcdedb94d2d2c994ddd5cc">[email protected]</span></a>, 240-402-6511; Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; 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#1c52736e717d72325b6e797b736e655c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="7c32130e111d12523b0e191b130e053c1a181d5214140f521b130a">[email protected]</span></a>, 240-402-0684; or Michael Kerrigan, Center
for Veterinary Medicine, Food and Drug Administration, 7500 Standish
Pl. (HFV-143), Rockville, MD 20855, 240-402-0644,
<a href="/cdn-cgi/l/email-protection#81cce8e2e9e0e4edafcae4f3f3e8e6e0efc1e7e5e0afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="df92b6bcb7bebab3f194baadadb6b8beb19fb9bbbef1b7b7acf1b8b0a9">[email protected]</span></a>.
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. 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 data in pharmaceutical quality and includes two
objectives: (1) To standardize the pharmaceutical quality data that is
currently received by FDA in eCTD Module 3 from the sponsoring
organizations, and (2) to use these structured elements and develop a
FHIR data exchange solution.
Through this notice, the Agency is seeking comment on the mapping
of the PQ/CMC data elements to the various FHIR Resources. After
receiving comments, the Agency intends to issue guidance on the
standardization of PQ/CMC data elements and terminologies for
electronic submissions.
II. 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-resources-data-standards">https://www.fda.gov/industry/fda-resources-data-standards</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05790 Filed 3-17-22; 8:45 am]
BILLING CODE 4164-01-P
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