[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)] [Notices] [Pages 52138-52139] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-26412] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-0410] Guidance for Industry on SUPAC-MR, Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes for Chemistry, Manufacturing, and Controls; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- Summary: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.'' The purpose of this guidance document is to provide insight and recommendations to pharmaceutical sponsors of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and abbreviated antibiotic applications (AADA's) who intend to change the components or composition, the manufacturing (process or equipment), the scale-up/scale-down of manufacture, and/or the site of manufacture of a modified release solid oral formulation during the postapproval period. This guidance document represents the agency's current thinking on scale-up and postapproval changes (SUPAC) for modified release solid oral dosage forms regulated by the Center for Drug Evaluation and Research (CDER). DATES: Written comments may be submitted at any time. ADDRESSES: Submit written requests for single copies of ``SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation'' to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your requests. Submit written comments on the guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Mehul U. Mehta, Center for Drug Evaluation and Research (HFD-860), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-0501. SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a guidance for industry entitled ``SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation.'' The purpose of this guidance document is to provide insight and recommendations to pharmaceutical sponsors of NDA's, ANDA's, and AADA's who intend to change: (1) The components or composition; (2) the manufacturing (process or equipment); (3) the scale-up/scale-down of manufacture; and/or (4) the site of manufacture of a modified release solid oral formulation during the postapproval period. The guidance document defines the following: (1) Levels of change; (2) recommended chemistry, manufacturing, and controls (CMC) tests to support each level of change; (3) recommended in vitro dissolution release tests and/or in vivo bioequivalence tests to support each level of change; and (4) documentation to support the change. For postapproval changes for modified release dosage forms that affect components and composition, manufacturing process or equipment changes, scale-up, and site change, this guidance supersedes the recommendations in section 4.G of the Office of Generic Drugs Policy and Procedure Guide 22-90 (FDA, September 11, 1990). For all other dosage forms and changes, this guidance does not affect the recommendations in Guide 22-90. This guidance document represents the agency's current thinking on SUPAC for modified release solid oral dosage forms regulated by CDER. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. Interested persons may, at any time, submit written comments on the guidance document to the Dockets Management Branch (address above). Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the guidance [[Page 52139]] document and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. An electronic version of this guidance is also available on the Internet at http://www.fda.gov/cder/guidance/index.htm. Dated: September 29, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-26412 Filed 10-3-97; 8:45 am] BILLING CODE 4160-01-F