[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28664-28665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13195]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
industry.
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
``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.
[[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].
SUPPLEMENTARY INFORMATION:
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]
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