[Federal Register Volume 64, Number 166 (Friday, August 27, 1999)]
[Notices]
[Page 46917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2635]


Draft Guidance for Industry on ANDA's: Blend Uniformity Analysis; 
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availability of a draft guidance for industry entitled ``ANDA's: Blend 
Uniformity Analysis.'' This draft guidance is intended to provide 
recommendations to holders of abbreviated new drug applications 
(ANDA's) on establishing in-process acceptance criteria related to 
blend uniformity analysis (BUA) for the manufacture of some drug 
products.

DATES: Written comments may be submitted on the draft guidance by 
October 26, 1999. 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ADDRESSES: Copies of this draft guidance are available on the Internet 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single copies of the draft guidance for industry should be submitted to 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. Send one self-addressed adhesive label to assist the office 
in processing your requests. Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Devinder S. Gill, Office of Generic 
Drugs (HFD-623), Center for Drug Evaluation and Research, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5848.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``ANDA's: Blend Uniformity 
Analysis.'' This draft guidance is intended to provide recommendations 
on when BUA should be performed. The recommendations, when applicable, 
apply to original ANDA's and supplemental ANDA's for formulation and 
process changes.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It represents 
the agency's current thinking on BUA for ANDA's. 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 statutes, 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: August 20, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-22317 Filed 8-26-99; 8:45 am]
BILLING CODE 4160-01-F