[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15435-15436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05790]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 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

[[Page 15436]]

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: 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,  
[email protected], 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, 
[email protected], 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, 
[email protected].

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 https://www.fda.gov/industry/fda-resources-data-standards or https://www.regulations.gov.

    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