[Federal Register Volume 67, Number 96 (Friday, May 17, 2002)]
[Notices]
[Pages 35120-35121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2635]


ANDAs: Blend Uniformity Analysis; Withdrawal of Draft Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
withdrawal of a draft guidance that was issued on August 27, 1999.

FOR FURTHER INFORMATION CONTACT: Devinder S. Gill, Center for Drug 
Evaluation and Research (HFD-623), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5848.

SUPPLEMENTARY INFORMATION:  In a notice published in the Federal 
Register of August 27, 1999 (64 FR 46917), FDA announced the 
availability of a draft guidance for industry entitled ``ANDAs: Blend 
Uniformity Analysis.'' The draft guidance was intended to provide 
recommendations to sponsors of abbreviated new drug applications 
(ANDAs) on what information should be provided in an ANDA to support 
the demonstration and bioequivalence batches and to establish in-
process acceptance criteria related to blend uniformity analysis (BUA) 
for the manufacture of some drug products. Written comments on the 
draft guidance were to be submitted by October 26, 1999.
    After careful consideration of the comments received, FDA has 
decided to withdraw the draft guidance. The information and comments 
from the public raised scientific issues relating to the scope of the 
guidance and methodology for blend uniformity analysis in general, 
including the: (1) Adequacy of current blend sampling

[[Page 35121]]

techniques and (2) appropriateness of various test methods for 
assessing blend uniformity. The agency has decided that further 
research on BUA is needed. FDA is participating in research on BUA 
through the Product Quality Research Institute (PQRI). Based on the 
results of the research and recommendations submitted by PQRI, FDA will 
determine whether a new guidance on BUA will be issued.
    An applicant or manufacturer must still comply with any applicable 
regulations regardless of the status of this guidance. For example, an 
application must include specifications and analytical methods to 
ensure the identity, strength, quality, purity, and bioavailability of 
the drug product (21 CFR 314.50(d)(1)(ii)(a)), and a manufacturer must 
monitor and validate the performance of processes that could be 
responsible for variability, including adequacy of mixing to ensure 
uniformity and homogeneity (21 CFR 211.110(a)(3)). An evaluation of 
uniformity of a blend may be necessary to fulfill such requirements.

    Dated: May 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-12359 Filed 5-16-02; 8:45 am]
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