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Notice

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

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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 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.Start Printed 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.

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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, Sau.Lee@fda.hhs.gov.

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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.

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Dated: June 15, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

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[FR Doc. 2017-13195 Filed 6-22-17; 8:45 am]

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