[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] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 99D-2636] Draft Guidance for Industry on Levothyroxine Sodium; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Levothyroxine Sodium.'' The draft guidance is intended to answer questions concerning applications for orally administered levothyroxine sodium drug products.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Written comments on the draft guidance may be submitted by October 18, 1999.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Copies of this draft guidance are available on the Internet at ``www.fda.gov/cder/guidance/index.htm''. Submit written requests for single copies of the draft guidance for industry to the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD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 Submit written comments on the draft guidance to the Dockets Management Branch (HFD-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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FDA is announcing the availability of a draft guidance for industry entitled ``Levothyroxine Sodium.''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 This draft guidance is intended to answer questions about submitting applications for orally administered levothyroxine sodium drug products.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] BILLING CODE 4160-01-F