[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Pages 28664-28665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13195]



Food and Drug Administration

[Docket No. FDA-2017-N-2697]

Submission of Proposed Recommendations for Industry on Developing 
Continuous Manufacturing of Solid Dosage Drug Products in 
Pharmaceutical Manufacturing; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.


SUMMARY: In connection with promoting the use of innovative 
technologies, the Food and Drug Administration (FDA or Agency) is 
establishing a public docket to invite discussion of issues related to 
the adoption of continuous manufacturing by the pharmaceutical 

DATES: Submit electronic or written comments by September 21, 2017.

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 September 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 21, 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.

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-2697 for ``Submission of Proposed Recommendations for 
Industry on Developing Continuous Manufacturing of Solid Dosage Drug 
Products in Pharmaceutical Manufacturing; Establishment of a Public 
Docket.'' 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.
     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 
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.

[[Page 28665]]

    Submit written requests for single copies of the Engineering 
Research Center for Structured Organic Particulate Systems (C-SOPS) 
document to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the C-SOPS document.

FOR FURTHER INFORMATION CONTACT: Sau (Larry) Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2128, Silver Spring, MD 20993-0002, 301-
796-2905, [email protected].


I. Background

    During a May 7, 2015, workshop on the Future of Pharmaceutical 
Manufacturing, FDA agreed that interested parties could submit for 
Agency consideration draft guidance or other materials discussing the 
science, technology, and best practices related to continuous 
manufacturing. On June 13, 2016, C-SOPS submitted to FDA an industry-
coordinated best practices document on continuous manufacturing. FDA is 
interested in public comments about the science, technology, and 
practices discussed in the C-SOPS document and is opening this docket 
for that purpose. In addition, FDA is seeking comments on other 
recommendations regarding continuous manufacturing that have already 
been published, including ``Regulatory and Quality Considerations for 
Continuous Manufacturing: May 20-21, 2014, Continuous Manufacturing 
Symposium.'' FDA invites comment on control strategy, facility, and 
process validation considerations for continuous manufacturing of solid 
oral dosage forms. This request is not limited to comments on the 
proposal described in the C-SOPS submission.

II. Electronic Access

    Persons with access to the Internet may obtain the C-SOPS document 
at https://www.regulations.gov.

    Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13195 Filed 6-22-17; 8:45 am]