[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Notices]
[Pages 60683-60684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0168]


Publication of Guidances for Industry Describing Product-Specific 
Bioequivalence Recommendations

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of draft and revised draft product-specific bioequivalence 
(BE) recommendations. The recommendations provide product-specific 
guidance on the design of BE studies to support abbreviated new drug 
applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 
30388), FDA announced the availability of a draft guidance for 
industry, ``Bioequivalence Recommendations for Specific Products,'' 
explaining the process that would be used to make product-specific BE 
recommendations available to the public on FDA's Web

[[Page 60684]]

site. The BE recommendations identified in this document were developed 
using the process described in that guidance.

DATES:  Submit written or electronic comments on the draft product-
specific BE recommendations by January 23, 2008. General comments on 
agency guidance documents are welcome at any time.

ADDRESSES:  Submit written requests for single copies of the individual 
BE guidances to the Division of Drug Information (HFD-240), 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 draft product-specific BE recommendations to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0495.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 31, 2007 (72 FR 30388), FDA 
announced the availability of a draft guidance for industry, 
``Bioequivalence Recommendations for Specific Products,'' that 
explained the ``process'' that would be used to make product-specific 
BE recommendations available to the public on FDA's Web site at http://www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm. As described in 
that draft guidance, FDA adopted this process as a means to develop and 
disseminate product-specific BE recommendations and provide a 
meaningful opportunity for the public to consider and comment on those 
recommendations.
    In that same issue of the Federal Register (72 FR 30386), FDA also 
announced that 200 product-specific BE recommendations were being made 
available on FDA's Web site at http://www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm. However, a number of the recommendations 
listed in that notice were not posted on the Web site. In addition, 
some of the recommendations posted on the Web site were omitted from 
the Federal Register notice. Finally, four recommendations announced in 
the May 31, 2007, notice and posted on the Web site were incorrect and 
have now been corrected. This document clarifies the notice of May 31, 
2007 (72 FR 30386), as follows:

A. Recommendations Listed in the May 31, 2007, Federal Register Notice 
That Were Not Posted on the Web Site

    (1) Ganciclovir
    (2) Ibuprofen; Pseudoephedrine HCl
    (3) Felbamate (multiple dosage forms)
    (4) Leflunomide
    These drugs are now available on the Web site.

B. Recommendations Posted on the Web Site That Were Not Listed in the 
May 31, 2007, Federal Register Notice

    (1) Fosinopril Sodium
    (2) Hydrochlorothiazide and Irbesartan
    (3) Levonorgestrel
    (4) Lidocaine
    (5) Loratadine
    (6) Phenytoin Sodium (multiple RLDs)
    (7) Phenytoin
    (8) Terazosin HCl

C. Recommendations Listed in the May 31, 2007, Federal Register Notice 
and Posted on the Web Site That Were Incorrect

    (1) Mycophenolate mofetil tablet 50723, corrected the analytes to 
measure
    (2) Mycophenolate mofetil capsule 50722, corrected the analytes to 
measure
    (3) Erlotinib HCl tablet, deleted the IND requirement
    (4) Hydrochlorothiazide and losartan potassium tablets, added 
waiver strength 12.5 mg/100mg
    The recommendations listed in sections I.A, B, and C of this 
document are available for comment by (see DATES).

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on any of the specific 
BE recommendations posted on FDA's Web site. Two copies of mailed 
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, notices, and 
received comments are available for public examination in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain these BE 
recommendations at either http://www.fda.gov/cder/guidance/index.htm or 
http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: October 19, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21062 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S