[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 32003-32004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2166]


Draft Standardization of Pharmaceutical Quality/Chemistry 
Manufacturing and Control Data Elements and Terminologies; 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 standardized Pharmaceutical Quality/Chemistry 
Manufacturing and Control (PQ/CMC) data elements and terminologies for 
the electronic submission of PQ/CMC data. The establishment of 
standardized pharmaceutical quality data elements and terminologies 
will provide opportunities for FDA and industry to transform PQ/CMC 
submission data into a readily useable electronic format. As a result, 
these established data elements and terminologies will improve the 
efficiency and quality of the drug review process. The Agency is 
seeking comment on the accuracy, suitability, and appropriateness of 
these data elements and terminologies for submission of PQ/CMC data. 
FDA is considering implementing PQ/CMC requirements as a Health Level 7 
(HL7) Structured Product Labeling (SPL) document. The proposed data 
elements and terminologies can be obtained on https://www.regulations.gov in Docket No. FDA-2017-N-2166.

DATES: Submit either electronic or written comments by September 11, 
2017. Late, untimely filed comments

[[Page 32004]]

will not be considered. Electronic comments must be submitted on or 
before September 11, 2017. The https://www.regulations.gov electronic 
filing system will accept comments until midnight Eastern Time at the 
end of September 11, 2017. 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.

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, 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-2017-N-2166 for ``Draft Standardization of Pharmaceutical Quality/
Chemistry Manufacturing and Control Data Elements and Terminologies; 
Request for Comments.'' Received comments, those filed in a timely 
manner (see DATES), 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.
     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.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: Norman Schmuff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 2526, Silver Spring, MD 20993-0002, 301-
796-1454; 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, 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. Alternatively, send 
questions to the PQ-CMC mailbox: [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, 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 standardization of PQ/CMC data elements 
and terminologies will facilitate the Agency's transition to an 
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 2012 Food and Drug Administration Safety 
and Innovation Act (FDASIA) (Pub. L. 112-144), which authorized the 
Agency to require certain submissions to be 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 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.
    After receiving comments, the Agency will consider future actions 
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 proposed data 
elements and terminologies at https://www.regulations.gov.

    Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysys.
[FR Doc. 2017-14456 Filed 7-10-17; 8:45 am]
 BILLING CODE 4164-01-P