[Federal Register Volume 62, Number 219 (Thursday, November 13, 1997)]
[Notices]
[Pages 60901-60903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Exchange of Letters Between the Food and Drug Administration and 
the Australian Therapeutic Goods Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
an exchange of letters (EOL) between FDA and the Australian Therapeutic 
Goods Administration. The purpose of the EOL is to facilitate the 
exchange of documents and information concerning a drug or biological 
preparation that is considered for orphan status.

DATES: The agreement became effective August 12, 1997.


[[Page 60902]]


FOR FURTHER INFORMATION CONTACT: Marlene E. Haffner, Office of Orphan 
Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3666.

SUPPLEMENTARY INFORMATION: It is FDA's policy that EOL's be used in 
lieu of a formal agreement when the actions contemplated require only a 
limited resource expenditure and do not rise to the significance of a 
formal agreement. For example, an exchange of letters could formalize 
an understanding that each agency will provide the other with documents 
that are available upon request to any member of the public. Each 
letter should set out only the actions to be carried out by the agency 
signing the letter and not mutual considerations. FDA uses the same 
clearance for EOL's as it does for memoranda of understanding (MOU's). 
Therefore, MOU's in accordance with 21 CFR 20.108 (c), which states 
that all written agreements and MOU's between FDA and others shall be 
published in the Federal Register, the agency is publishing notice of 
this EOL.

    Dated: November 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
    The EOL's are set forth as follows:

Exchange of Letters Between the Food and Drug Administration and the 
Australian Therapeutic Goods Administration

225-97-8003

August 12, 1997
    Mr. Terry Slater
    National Manager
    Therapeutic Goods Administration
    Commonwealth Department of Health and Family Services
    P.O. Box 100
    Woden ACT 2606
    AUSTRALIA
    Dear Mr. Slater:
    The U.S. Food and Drug Administration is pleased to cooperate 
with your government in facilitating the exchange of documents and 
information concerning a drug or biological preparation that your 
government is considering for orphan product status. We hope that 
this cooperation will facilitate and expedite access to needed 
therapy for Australian patients with rare diseases.
    Upon request from the Australian Therapeutic Goods 
Administration (TGA), and to the extent permitted by U.S. law and 
FDA regulations, and as appropriate, with the permission of the U.S. 
sponsor, the FDA Office of Orphan Products Development (OPD) intends 
to provide to the TGA a copy of the U.S. designation request and 
review performed by the OPD on a particular product, whether such 
orphan designation request has or has not been granted.
    Upon request from the TGA, and under the same terms and 
conditions noted in the preceding paragraph, the Center for Drug 
Evaluation and Research (CDER) or the Center for Biologic Evaluation 
and Research (CBER) intends to provide summary information 
concerning evaluation and approval of a particular product. OPD 
expects to be receptive to requests for assistance in seeking 
permission of the sponsor to permit TGA to utilize the necessary 
information. We understand that the reports and information FDA 
provides will form the basis for a similar orphan product evaluation 
for Australia.
    Information provided by FDA pursuant to this arrangement will be 
provided in confidence to the TGA. The information will be provided 
in accordance with FDA law and regulations, including privacy and 
confidentiality requirements, and only with assurances of TGA's 
authority and commitment to protect the information from public 
disclosure in Australia. Copies of designation or evaluation reports 
will be provided to the TGA in conformance with the requirements of 
Part 20 of Title 21, U.S. Code of Federal Regulations, and with the 
written consent (where appropriate) of the U.S. sponsor of the 
designation request or product approval application.
    For the purpose of coordination, we propose that the respective 
liaison officials be:
For the FDA:
Director, Office of Orphan Products Development
Food and Drug Administration/HF-35
5600 Fishers Lane Room 8-73
Rockville, Maryland 20857
U.S.A.
Telephone: 301-827-3666
FAX: 301-443-4915
For the Australian TGA:
Director, Drug Safety and Evaluation Branch
Therapeutic Goods Administration
P.O. Box 100
Woden, ACT 2606
Australia
Telephone: 61 2 6232 8100
FAX: 61 2 6232 8140
    To help ensure that this information exchange program works well 
and meets our mutual needs and requirements, we feel that it is 
important that, at appropriate intervals, and by mutual concurrence, 
a discussion or meeting take place between representatives of our 
two agencies to assess the activities and the provisions outlined in 
this letter.
    We anticipate that these arrangements will provide a sound basis 
on which further cooperative arrangements between us on products for 
patients with rare diseases will develop.
Sincerely,
Marlene E. Haffner, M.D., M.P.H.
Rear Admiral, United States Public Health Service
Director, Office of Orphan Products Development
Marlene E. Haffner, MD, MPH
Rear Admiral, United States Public Health Service
Director, Office of Orphan Products Development
5600 Fishers Lane, HF-35
Room 8-73
Rockville, MD 20857 USA
Dear Dr. Haffner:
    The purpose of this letter is to formalise our agreement 
regarding provision of information on orphan drugs by the U.S. Food 
and Drug Administration (FDA) U.S.A. to the Therapeutic Goods 
Administration (TGA), Department of Health and Family Services, 
Australia.
    The TGA formally requests that the U.S. FDA provide orphan drug 
designation reports and orphan drug evaluation reports to the TGA.
    In the spirit of co-operation, and on behalf of the TGA, I agree 
as follows:
    1. Following receipt by the TGA of an application requesting 
orphan drug designation of a drug in Australia, the TGA will request 
from the Office of Orphan Drugs Development a copy of an orphan drug 
designation report for the drug.
This request will apply in cases where the drug has been granted 
orphan drug designation in the U.S. or where the drug has been 
refused orphan drug designation in the U.S.
    2. Following receipt by the TGA of an application to register a 
product for which orphan designation has been granted for the drug 
in Australia, the TGA will request from the U.S. FDA a copy of the 
Center for Drug Evaluation and Research (CDER) evaluation reports or 
the Center for Biologics Evaluation and Research (CBER) evaluation 
report.
This request will apply in cases where a drug has been granted 
orphan drug designation in the U.S. and where an application to 
register a product containing that drug in the U.S. has been 
approved, refused, or is pending.
    3. It is intended that where possible, the reports provided 
under this arrangement will form the basis of the evaluation of 
similar application sin Australia. Therefore, the reports must be 
sufficiently complete to enable appropriate evaluation of the 
product.
    4. Information will be provided in accordance with agency 
regulations (including confidentiality requirements).
    5. Copies of designation reports of evaluation reports will be 
provided to the TGA only after the written consent of the U.S. 
sponsor of the designation request or product registration 
application has been obtained, except as otherwise provided in FDA's 
regulations disclosure (21 CFR 20.89).
    6. Liaison officers for the purpose of coordinating these 
provisions are as follows:
For the FDA:
    Director, Office of Orphan Products Development
    Food and Drug Administration/HF-35
    5600 Fishers Lane, Room 8-73
    Rockville, Maryland 20857
    U.S.A.
    Telephone: 301-827-3666
    FAX: 301-443-4915
For the TGA:
    Director, Drug Safety and Evaluation Branch
    Therapeutic Goods Administration
    P.O. Box 100
    Woden, ACT 2606

[[Page 60903]]

    Australia
    Telephone: 61 2 6232 8100
    FAX: 61 2 6232 8140
I am confident the implementation of these provisions will provide a 
sound basis on which to develop further cooperative arrangements 
between us on orphan drug products and to work toward a reciprocal 
arrangement in the future.
I look forward to your official confirmation these arrangements can 
be agreed.
Yours sincerely
Terry Slater
National Manager
Therapeutic Goods Administration
12 August 1997
[FR Doc. 97-29906 Filed 11-12-97; 8:45 am]
BILLING CODE 4160-01-F