The Food and Drug Administration (FDA) is establishing a public docket to invite discussion of issues related to the adoption of continuous manufacturing by the pharmaceutical industry.
Electronic comments must be submitted on or before September 21, 2017. Regulations.gov 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 must be submitted via Regulations.gov. Comments submitted electronically, including attachments, will be posted to the docket unchanged and made public. Therefore it is important comments do not include any confidential information that an organization or a third party may not wish to be posted, such as medical information, Social Security numbers, or confidential business information, such as a manufacturing process.
To submit written/paper submissions, mail, hand deliver, or courier to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at Regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
To submit a comment with confidential information, submit comments only as a written/paper submission. Confidential submissions require two copies in total. One copy will include the information claimed 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 and will be available for public viewing and posted at Regulations.gov. Submit both copies to the Dockets Management Staff. To remain anonymous, provide this information on the cover sheet and not in the body of comments and 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 see FDA's posting of comments to public dockets.
For access to the docket to read background documents or the electronic and written/paper comments received, go to 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.
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]