[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:
    <bullet> Development of one or more protocols for the clinical 
trial of minocycline in the treatment of osteoporosis;
    <bullet> Execution of clinical trials;
    <bullet> Joint publication of research results; and

[[Page 17628]]

    <bullet> 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