[Federal Register Volume 62, Number 203 (Tuesday, October 21, 1997)]
[Notices]
[Pages 54640-54641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27738]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a Level 1 guidance for industry entitled ``SUPAC-IR: 
Immediate Release Solid Oral Dosage Forms--Manufacturing Equipment 
Addendum.'' This guidance is intended 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 wish to change equipment during 
the postapproval period. This guidance document represents the agency's 
current thinking on scale-up and postapproval equipment changes (SUPAC) 
for immediate release 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 the guidance to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, 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 
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:  John L. Smith, Office of Generic 
Drugs, Center for Drug Evaluation and Research (HFD-623), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5848.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``SUPAC-IR: Immediate 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 was issued in November 
1995. The manufacturing equipment addendum may be used in conjunction 
with the SUPAC-IR guidance in determining 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 54641]]

    This guidance for industry represents the agency's current thinking 
on scale-up and post approval equipment changes for immediate 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 to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments and requests are to be identified with the docket 
number found in brackets in the heading of this document. The guidance 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday.
    Persons with access to the Internet may obtain copies of ``SUPAC-
IR: Immediate Release Solid Oral Dosage Forms--Manufacturing Equipment 
Addendum'' by using the World Wide Web (WWW) and going to ``http://
www.fda.gov/cder/guidance/index.htm''.

    Dated: October 14, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-27738 Filed 10-20-97; 8:45 am]
BILLING CODE 4160-01-F