[Federal Register Volume 66, Number 46 (Thursday, March 8, 2001)]
[Notices]
[Page 13935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2636]


Guidance for Industry on Levothyroxine Sodium; Questions and 
Answers; 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 guidance for industry entitled ``Levothyroxine 
Sodium: Questions and Answers.'' The guidance is intended to answer 
questions concerning applications for orally administered levothyroxine 
sodium drug products.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of this 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 to the Dockets Management Branch (HFA 305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug 
Evaluation and Research (HFD 7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301 594 2041.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Levothyroxine Sodium: Questions and Answers.'' In the 
Federal Register of August 18, 1999 (64 FR 44935), FDA announced the 
availability of a draft version of this guidance. The August 18, 1999, 
document gave interested persons 60 days to submit comments. FDA has 
revised the guidance in response to comments. Among the revisions being 
made is that FDA has extended the deadline for levothyroxine sodium 
drug products to have approved applications from August 14, 2000, to 
August 14, 2001. This extension was announced in the Federal Register 
on April 26, 2000 (65 FR 24488).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
The guidance represents the agency's current thinking on issues 
concerning applications, including applications under section 505(b)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)), for 
levothyroxine sodium. 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 and regulations.

II. Comments

    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 are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm.

    Dated: March 1, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-5609 Filed 3-7-01; 8:45 am]
BILLING CODE 4160-01-F