[Federal Register Volume 62, Number 69 (Thursday, April 10, 1997)]
[Notices]
[Pages 17627-17628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9239]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Opportunity for a Clinical Trial-
Cooperative Research and Development Agreement (CT-CRADA) for Phase II
Clinical Trial on the Use of Minocycline to Treat Osteoporosis
AGENCY: National Institutes of Health, PHS, DHHS.
ACTION: Notice.
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SUMMARY: The National Institute of Aging (NIA) is seeking a
Collaborator to participate in a CT-CRADA to run a Phase II clinical
trial on the use of minocycline to treat osteoporosis, and to assist in
the development of analogues to minocycline.
The term of the CT-CRADA will be up to five (5) years.
DATES: Interested parties should notify this office in writing of their
intent to file a formal proposal no later than June 9, 1997. Formal
proposals must be submitted to this office no later than July 9, 1997.
ADDRESSES: Inquiries and proposals regarding this opportunity should be
addressed to Bruce D. Goldstein, J.D.; Office of Technology
Development, National Cancer Institute; Executive Plaza South, Suite
450; 6120 Executive Blvd., MSC 7182, Bethesda, Maryland, 20892
(Telephone No. 301-496-0477; FAX No. 301-402-2117).
SUPPLEMENTARY INFORMATION: A CRADA is the anticipated joint agreement
to be entered into by NIA pursuant to the Federal Technology Transfer
Act of 1986, as amended by the National Technology Transfer Act (Pub.
L. 104-113 (Mar. 7, 1996)) and by Executive Order 12591 of April 10,
1987. NIA has recently published a discovery by its staff that
minocycline, an antibiotic related to tetracycline, increases bone
mineral density, improves bone strength and formation, and slows bone
resorption in old laboratory animals with surgically-induced menopause.
Bone, 19:637-644 (Dec. 1996). Accordingly, NIA has begun to organize
Phase II clinical trials.
Under the present proposal, the specific goals of the CT-CRADA will
be the development of the following technology:
Development of one or more protocols for the clinical
trial of minocycline in the treatment of osteoporosis;
Execution of clinical trials;
Joint publication of research results; and
[[Page 17628]]
Development of improved derivatives of minocycline.
Party Contributions
The role of NIA includes the following:
(1) Develop and file, in consultation with Collaborator, any and
all regulatory applications for the use of minocycline in the treatment
of osteoporosis;
(2) Provide staff, expertise, and materials for the development and
execution of protocols, and for the development and testing of
promising minocycline analogues;
(3) Together with the Collaborator, evaluate the results of joint
research, and to ensure progress toward meeting the CT-CRADA goals; and
(4) Provide work space and equipment for testing of any prototype
pharmaceutical compositions developed.
The role of the successful Collaborator will include the following:
(1) Provide staff, expertise, and materials for the development and
production of pharmaceutical compositions;
(2) Purchase or manufacture an adequate supply of minocycline;
(3) Together with NIA, evaluate the results of joint research, and
to ensure progress toward meeting the CT-CRADA goals;
(4) Provide funding in support of the clinical trials; and
(5) Provide resource to develop and market any promising analogues
to minocycline.
Selection Criteria
Proposals submitted for consideration should fully address each of
the following qualifications:
(1) Expertise
The successful Collaborator should have the following expertise:
A. Demonstrated expertise in developing and producing high quality
pharmaceutical compositions;
B. Demonstrated ability to secure national and/or international
marketing and distribution of pharmaceutical compositions;
C. Demonstrated expertise in overseeing all aspects of product
development;
D. Demonstrated intellectual ability to guide development of
product line which addresses the requirements of NIA.
(2) Reputation
The successful Collaborator should be recognized in the
pharmaceutical industry for each of the following:
A. Producing quality pharmaceutical products;
B. Indications of high levels of satisfaction by industry experts
with the Collaborator's products; and
C. Strong commitment to the research and development of new
pharmaceuticals.
(3) Physical Resources
The successful Collaborator should be able to demonstrate it will
have the following material resources as of the commencement of
research under the CT-CRADA:
A. An established headquarters with offices, space, and equipment;
B. Adequate means for communication with the Collaborator during
business hours, such as by telephone, mail, e-mail, the Internet, and
other evolving technologies; and
C. Sufficient financial resources to support, at a minimum, the
current activities of the CT-CRADA to meet the needs of NIA.
Dated: March 26, 1997.
Thomas D. Mays,
Director, Office Technology Development, National Cancer Institute,
NIH.
[FR Doc. 97-9239 Filed 4-9-97; 8:45 am]
BILLING CODE 4140-01-M
