Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period

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Choosing an item from suggestions will bring you directly to the content. FDA is reopening the comment period on the request for information and comments published on March 3, 2026 (91 FR 10397). Either electronic or written comments must be submitted by July 13, 2026. Table of Contents Enhanced Content - Table of Contents This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect. This PDF is FR Doc. 2026-11690 as it appeared on Public Inspection on 06/10/2026 at 8:45 am. It was viewed 79 times while on Public Inspection. If you are using public inspection listings for legal research, you should verify the contents of the documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice of publication to the public and judicial notice to the courts under 44 U.S.C. 1503 & 1507. Learn more here. Published Document: 2026-11690 (91 FR 35483) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format. AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information and comments; reopening of the comment period. SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments that appeared in the Federal Register of March 3, 2026. In the notice, FDA requested comments on the Agency's series of guidances for industry on scale-up and postapproval changes for specific dosage forms. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the request for information and comments published on March 3, 2026 (91 FR 10397). Either electronic or written comments must be submitted by July 13, 2026. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 13, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received 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 ( printed page 35484) 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”). 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-2026-N-0809 for “Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments.” 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, 240-402-7500. 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 onhttps://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.govinfo.gov/content/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, 240-402-7500. FOR FURTHER INFORMATION CONTACT: Ashley Boam, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993-0002, 301-796-6341, cder-quality-policy@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of March 3, 2026, FDA (91 FR 10397), published a request for information and comments with a 90-day comment period to request information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes for specific dosage forms. FDA received requests to extend the comment period to allow sufficient time to develop and submit meaningful comments. FDA has considered the requests and is reopening the comment period for an additional 30 days, until July 13, 2026. The Agency believes that this extension allows adequate time for interested persons to submit comments. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.