[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Notices]
[Pages 45827-45828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0307]


Draft Guidance for Industry; Exports and Imports Under the FDA 
Export Reform and Enhancement Act of 1996; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
November 24, 1998, the comment period for the draft guidance document 
that appeared in the Federal Register of June 12, 1998 (63 FR 32219). 
The draft guidance document addressed issues concerning the exportation 
of human drugs, animal drugs, biologics, food additives, and devices 
under the FDA Export Reform and Enhancement Act, as well as the 
importation of components, parts, accessories, or other articles for 
incorporation or further processing into articles intended for export. 
This action is being taken in response to a request from the Health 
Industry Manufacturers Association.

DATES: Written comments by November 24, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 12, 1998 (63 
FR 32219), FDA published a draft guidance document entitled ``FDA Draft 
Guidance for Industry on: Exports and Imports Under the FDA Export 
Reform and Enhancement Act of 1996.''
    Enacted and later amended in 1996, the FDA Export Reform and 
Enhancement Act (Pub. L. 104-134, as amended by Pub. L. 104-180) 
significantly changed the export requirements for human drugs, animal 
drugs, biologics, devices, and, to a limited extent, food additives. 
For example, before the law was enacted, most exports of unapproved new 
drug products could only be made to 21 countries identified in section 
802 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
382), and these exports were subject to various restrictions. The FDA 
Export Reform and Enhancement Act amended section 802 of the act to 
allow, among other things, the export of unapproved new drugs to any 
country in the world if the drug complies with the laws of the 
importing country and has valid marketing authorization from any of the 
following countries: Australia, Canada, Israel, Japan, New Zealand, 
Switzerland, South Africa, and the countries in the European Union (EU) 
and the European Economic Area (EEA). (Currently, the EU countries are 
Austria, Belgium, Denmark, Germany, Greece, Finland, France, Ireland, 
Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the 
United Kingdom. The EEA countries are the EU countries, Iceland, 
Liechtenstein, and Norway. The list of countries will expand 
automatically if any country accedes to the EU or becomes a member of 
the EEA.)
    The draft guidance document provides information on the statutory 
requirements for exporting human drugs, animal drugs, biologics, and 
medical devices; general requirements for products exported under 
section 801 of the act (21 U.S.C. 381); labeling requirements for drugs 
and biologics exported under section 801(e) of the act; requirements 
for exports of unapproved drugs, biologics, and devices under section 
802(b) of the act; requirements for exports of unapproved drugs and 
devices for investigational use; requirements for exports of unapproved 
drugs and devices in anticipation of foreign approval; requirements for 
exports of drugs and devices for diagnosing, preventing, or treating a 
tropical disease or a disease ``not of significant prevalence in the 
United States;'' export notifications to FDA; and ``import for 
export.''
    The draft guidance document represents the agency's current 
thinking on exports and imports-for-export under sections 801 and 802 
of the act. 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.
    On June 23, 1998, the Health Industry Manufacturers Association 
(HIMA) requested a 90-day extension of the comment period. HIMA 
explained that ``the complexity of the issues with the additional 
complication of summer vacation schedules prevents us from providing 
substantive comments within the time provided.'' The agency considered 
HIMA's request and, through this notice, is extending the comment 
period by 90 days until November 24, 1998.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance document. 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. A copy of the draft 
guidance document and received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday. The draft

[[Page 45828]]

guidance document may also be seen on FDA's web site at 
``www.FDA.gov''.

    Dated: August 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23026 Filed 8-24-98; 3:45 pm]
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