[Federal Register Volume 64, Number 159 (Wednesday, August 18, 1999)]
[Notices]
[Page 44935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2636]


Draft Guidance for Industry on Levothyroxine Sodium; Availability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availability of a draft guidance for industry entitled ``Levothyroxine 
Sodium.'' The draft guidance is intended to answer questions concerning 
applications for orally administered levothyroxine sodium drug 
products.

DATES: Written comments on the draft guidance may be submitted by 
October 18, 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ADDRESSES: Copies of this draft guidance are available on the Internet 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''. Submit written 
requests for single copies of the draft guidance for industry to the 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 Submit written comments on the draft 
guidance to the Dockets Management Branch (HFD-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Levothyroxine Sodium.'' In the 
Federal Register of August 14, 1997 (62 FR 43535), FDA announced that 
orally administered levothyroxine sodium drug products are new drugs. 
The notice stated that manufacturers who wish to continue to market 
these products must submit applications as required by section 505 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) and 
21 CFR part 314. The notice stated that FDA is prepared to accept new 
drug applications for these products, including applications under 
section 505(b)(2) of the act. A number of questions have arisen with 
respect to applications for levothyroxine sodium. This draft guidance 
is intended to answer questions about submitting applications for 
orally administered levothyroxine sodium drug products.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents the agency's current thinking on issues concerning 
applications, including applications under section 505(b)(2) of the 
act, 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 statute, 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 9, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-21353 Filed 8-17-99; 8:45 am]
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