[Federal Register Volume 64, Number 38 (Friday, February 26, 1999)]
[Notices]
[Page 9516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4767]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Food and Drug Administration
 [Docket No. 95D-0349]


 Guidance for Industry on SUPAC-IR/MR: Immediate Release and 
Modified Release Solid Oral Dosage Forms, Manufacturing Equipment 
Addendum; Availability

  AGENCY:  Food and Drug Administration, HHS.

  ACTION:  Notice.

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  SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``SUPAC-IR/MR: 
Immediate Release and Modified Release Solid Oral Dosage Forms, 
Manufacturing Equipment Addendum.'' This guidance is intended to 
provide insight and recommendations to pharmaceutical sponsors of new 
drug applications and abbreviated new drug applications who wish to 
change equipment during the postapproval period.

  DATES:  Written comments may be submitted at any time.

  ADDRESSES:  Copies of this guidance for industry are available on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit 
written requests for single copies of ``SUPAC-IR/MR: Immediate Release 
and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment 
Addendum'' to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your requests. Submit written 
comments on the guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

  FOR FURTHER INFORMATION CONTACT: John L. Smith, Center for Drug 
Evaluation and Research (HFD-590), Food and Drug Administration, 9201 
Corporate Blvd., Rockville, MD 20850, 301-827-2175.

  SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
guidance for industry entitled ``SUPAC-IR/MR: Immediate Release and 
Modified Release Solid Oral Dosage Forms, Manufacturing Equipment 
Addendum.'' This guidance is intended to provide recommendations to 
pharmaceutical manufacturers using CDER's Guidance for Industry on 
``Immediate Release Solid Oral Dosage Forms, Scale-Up and Post-Approval 
Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution 
Testing, and In Vivo Bioequivalence Documentation'' (SUPAC-IR), which 
published in November 1995 and CDER's Guidance for Industry ``SUPAC-MR: 
Modified Release Solid Oral Dosage Forms Scale-Up and Post-Approval 
Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution 
Testing and In Vivo Bioequivalence Documentation,'' which published in 
September 1997.
     This guidance is a revision of and supersedes the guidance 
entitled ``SUPAC-IR: Immediate Release Solid Oral Dosage Forms, 
Manufacturing Equipment Addendum,'' which published in October 1997. 
The guidance includes information on equipment used to manufacture 
modified release solid oral dosage form products as well as immediate 
release solid oral dosage form products and may be used to determine 
what documentation should be submitted to FDA regarding equipment 
changes made in accordance with the recommendations in the SUPAC-IR 
guidance and SUPAC-MR guidance.
     This guidance represents the agency's current thinking on scale-up 
and postapproval equipment changes for immediate release and 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 requirement of the applicable statute, regulations, or 
both.
     Interested persons may, at any time, submit written comments on 
the guidance 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. The guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 19, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-4767 Filed 2-25-99; 8:45 am]
BILLING CODE 4160-01-F