[Federal Register Volume 65, Number 115 (Wednesday, June 14, 2000)]
[Notices]
[Page 37396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1307]


Draft Guidance for Industry on Development of Parathyroid Hormone 
for the Prevention and Treatment of Osteoporosis; 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availability of a draft guidance for industry entitled ``Development of 
Parathyroid Hormone for the Prevention and Treatment of Osteoporosis.'' 
Parathyroid hormone (PTH) is being studied for use in the prevention 
and treatment of osteoporosis. In response to preclinical studies 
submitted to FDA in which osteosarcomas developed in rats and mice 
following administration of PTH and related peptides, the agency is 
developing guidance for the development of PTH as a drug for 
osteoporosis. This guidance is intended to improve the benefit to risk 
ratio of treatment with PTH and related peptides.

DATES: Submit written comments on the draft guidance by August 14, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 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 Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Eric Colman, Center for Drug 
Evaluation and Research (HFD-510), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-6371.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Development of Parathyroid 
Hormone for the Prevention and Treatment of Osteoporosis.'' This draft 
guidance is being issued in response to information submitted to the 
agency regarding the development of osteosarcomas in two strains of 
rats and one strain of mice following treatment with PTH and related 
peptides from weaning to 18 months. Given the uncertain clinical 
relevance of the findings in rodents, and in an effort to improve the 
benefit to risk ratio of PTH when used in studies of the prevention 
and/or treatment of osteoporosis, the draft guidance recommends that 
special consideration be given to the design and conduct of clinical 
trials evaluating the safety and effectiveness of PTH. These special 
considerations relate to inclusion and exclusion criteria, patient 
followup, and patient informed consent.
    This 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 the development of 
parathyroid hormone in the prevention and treatment of osteoporosis. 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, 
regulations, or both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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 are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 6, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-14986 Filed 6-13-00; 8:45 am]
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