[Federal Register Volume 63, Number 81 (Tuesday, April 28, 1998)]
[Notices]
[Pages 23291-23292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Draft Guidance for Industry on SUPAC-IR/MR: Immediate Release and 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availability of a draft guidance for industry entitled ``SUPAC-IR/MR: 
Immediate Release and Modified Release Solid Oral Dosage Forms, 
Manufacturing Equipment Addendum.'' This draft guidance is intended to 
provide insight and recommendations to pharmaceutical sponsors of new 
drug applications (NDA's) and abbreviated new drug applications 
(ANDA's) who wish to change equipment during the postapproval period.

DATES: Written comments may be submitted on the draft guidance document 
by June 29, 1998. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm.'' Written requests for 
single copies of the draft guidance for industry should be submitted to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.

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 
draft guidance for industry entitled ``SUPAC-IR/MR: Immediate Release 
and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment 
Addendum.'' This draft guidance is intended to provide recommendations 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 draft guidance is a revision of the guidance entitled ``SUPAC-
IR: Immediate Release Solid Oral Dosage Forms, Manufacturing Equipment 
Addendum'' that published in October 1997, and the draft guidance is 
intended to supersede the previously published guidance. The draft 
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 sections V and VI.A of 
the SUPAC-IR guidance

[[Page 23292]]

and in sections VI and VII of the SUPAC-MR guidance.
    This draft 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 submit written comments on the draft 
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 draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: April 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-11197 Filed 4-27-98; 8:45 am]
BILLING CODE 4160-01-F