[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Pages 42506-42507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18080]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2608]


Standardized Data for Pharmaceutical Quality/Chemistry 
Manufacturing and Control; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the following public meeting entitled ``Standardized Data 
for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/
CMC).'' This public meeting is intended to provide members of the 
pharmaceutical industry and other interested stakeholders an 
opportunity to discuss with FDA, and provide input on, topics and 
issues related to standardized data for electronic submission of PQ/CMC 
data, as detailed in the 2017 Federal Register notice (FRN), ``Draft 
Standardization of Pharmaceutical Quality/Chemistry Manufacturing and 
Control Data Elements and Terminologies.'' FDA will use the information 
from the public meeting to improve the usability of the proposed data 
standards.

DATES: The public meeting will be held on October 19, 2018, from 9 a.m. 
to 4 p.m. Submit either electronic or written comments on this public 
meeting by November 16, 2018.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the 
public meeting participants (non-FDA employees) is through Building 1, 
where routine security check procedures will be performed. For parking 
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 November 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 16, 2018. 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. Docket comments 
previously submitted to the FRN (Docket No. FDA-2017-N-2166, https://www.federalregister.gov/a/2017-14456) noted in the SUMMARY section, 
should not be resubmitted, as these are already under consideration.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-2018-N-2608 for ``Standardized Data for Pharmaceutical Quality/
Chemistry Manufacturing and Control; Public Meeting.'' 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.
    <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 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

[[Page 42507]]

``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.gpo.gov/fdsys/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.

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#5a1828233b3474092a3f3636291a3c3e3b74323229743d352c"><span class="__cf_email__" data-cfemail="c684b4bfa7a8e895b6a3aaaab586a0a2a7e8aeaeb5e8a1a9b0">[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#a0eecfd2cdc1ce8ee7d2c5c7cfd2d9e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="246a4b5649454a0a635641434b565d644240450a4c4c570a434b52">[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#430e2a202b22262f6d082631312a24222d032527226d2b2b306d242c35"><span class="__cf_email__" data-cfemail="f1bc98929990949ddfba9483839896909fb1979590df999982df969e87">[email protected]</span></a>. Alternatively, send questions to the PQ-
CMC mailbox: <a href="/cdn-cgi/l/email-protection#dc8c8df19f919f9cbab8bdf2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="e8b8b9c5aba5aba88e8c89c680809bc68f879e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    PQ/CMC is a term used to describe manufacturing and quality control 
information submitted to FDA in support of submissions. PQ/CMC plays an 
integral part in the regulatory review process and life cycle 
management of pharmaceutical products. This information is primarily 
submitted in Module 3 of the Electronic Common Technical Document. The 
standardization of PQ/CMC data elements and terminologies will 
facilitate the Agency's transition to a streamlined electronic review 
environment.
    FDA intends to identify and standardize data elements and 
terminologies for information commonly used and submitted in support of 
drug product applications. The impetus for this standardization effort 
was the provisions from the Food and Drug Administration Safety and 
Innovation Act (21 U.S.C. 301 note) (Pub. L. 112-144), which authorized 
the Agency to require certain submissions to be submitted in a 
specified electronic format. 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 consistent look and feel for every 
application, and, in general, contributing to a more efficient and 
effective regulatory decision-making process by creating standardized 
data dictionaries.
    As part of this effort, in 2017, FDA released a FRN presenting a 
``Draft Standardization of Pharmaceutical Quality/Chemistry 
Manufacturing and Control Data Elements and Terminologies'' for public 
comment (https://www.federalregister.gov/a/2017-14456). FDA has 
subsequently utilized the comments received to revise and improve the 
data elements, terminologies, and definitions for PQ/CMC 
standardization. FDA intends to continue public engagement regarding 
PQ/CMC data standards development by holding the public meeting 
announced in this notice. After the public meeting, the Agency intends 
to issue a draft guidance on the standardization of PQ/CMC data 
elements and terminologies for electronic submissions.

II. Purpose of the Public Meeting

    The purpose of the October 19, 2018, public meeting is to provide 
members of the pharmaceutical industry and other interested 
stakeholders an opportunity to discuss with FDA, and provide input on, 
topics and issues related to standardized data for electronic 
submission of PQ/CMC data, as detailed in the FRN, ``Draft 
Standardization of Pharmaceutical Quality/Chemistry Manufacturing and 
Control Data Elements and Terminologies,'' released in 2017 for public 
comment (https://www.federalregister.gov/a/2017-14456). FDA will use 
the information from the public meeting to improve the usability of the 
proposed data standards. The public meeting will focus on the current 
state of PQ/CMC standardization and its future development, to which 
the output and comments from this meeting will contribute. Topics of 
discussion may include:
    <bullet> Ongoing development of PQ/CMC data elements and 
terminologies, including revisions informed by public response to the 
``Draft Standardization'' FRN, developing the technical specifications 
for PQ/CMC data submissions, and upcoming development and testing of 
PQ/CMC data exchange mechanisms.
    <bullet> Ongoing efforts to maximize harmonization of PQ/CMC 
standardization with other national and international data 
standardization activities sharing the same domain space as PQ/CMC 
(e.g., International Organization for Standardization Identification of 
Medicinal Products (ISO IDMP) standards development, the European 
Medicines Agency's Substance, Product, Organisation and Referential 
(SPOR) Master Data initiative).
    <bullet> An understanding of industry business practices regarding 
submission of PQ/CMC data which will help to inform development of PQ/
CMC standardization.
    FDA will consider all comments made at this meeting or received 
through the docket (see ADDRESSES).

III. Participating in the Public Meeting

    Registration: To register to attend ``Standardized Data for 
Pharmaceutical Quality/Chemistry Manufacturing and Control; Public 
Meeting'' please register at: https://www.eventbrite.com/e/standardized-data-for-pqcmc-public-meeting-registration-47224509780 by 
September 21, 2018. Please provide complete contact information for 
each attendee, including name, title, affiliation, address, email, and 
telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by September 21, 2018, midnight Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted.
    If you need special accommodations due to a disability, please 
contact Bryan Spells, 240-402-6511, email <a href="/cdn-cgi/l/email-protection#7f3d0d061e11512c0f1a13130c3f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="70320209111e5e2300151c1c03301614115e1818035e171f06">[email protected]</span></a> at 
least 7 days before the meeting.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES).

    Dated: August 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18080 Filed 8-21-18; 8:45 am]
 BILLING CODE 4164-01-P


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