[Federal Register Volume 72, Number 156 (Tuesday, August 14, 2007)]
[Notices]
[Page 45436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-0307] (Formerly Docket No. 98D-0307)


Guidance for Industry on Exports Under the Food and Drug 
Administration Export Reform and Enhancement Act of 1996; 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 guidance for industry entitled ``FDA Guidance for 
Industry: Exports Under the FDA Export Reform and Enhancement Act of 
1996.'' The guidance document addresses issues pertaining to the 
exportation of human drugs, animal drugs, biologics, devices, food, 
food additives, color additives and dietary supplements under the FDA 
Export Reform and Enhancement Act.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of International Programs (HFG-1), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Include a self-
addressed adhesive label to assist that office in processing your 
request. Submit written comments to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Barbara Ward-Groves, Office of 
International Programs, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-4480 or 404-253-1221.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 12, 1998 (63 FR 32219), FDA 
published a draft guidance document entitled ``FDA Guidance for 
Industry on: Exports and Imports Under the FDA Export Reform and 
Enhancement Act of 1996.'' FDA wrote the draft guidance to help 
interested parties understand and comply with the FDA Export Reform and 
Enhancement Act. Enacted and later amended in 1996, the FDA Export 
Reform and Enhancement Act (Public Law 104-134, as amended by Public 
Law 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, Bulgaria, Cyprus, the Czech 
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, 
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, 
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the 
United Kingdom. Currently, 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 guidance document provides information on the statutory and 
regulatory requirements for exporting FDA-regulated products, including 
general requirements for products exported under section 801 of the 
act, labeling requirements for drugs and biologics exported under 
section 801(e) of the act, export requirements for unapproved drugs, 
biologics, and devices under section 802(b) of the act, exports of 
unapproved drugs and devices for investigational use, exports of 
unapproved drugs and devices in anticipation of foreign approval, 
exports of drugs and devices for diagnosing, preventing, or treating a 
tropical disease or disease ``not of significant prevalence in the 
United States,'' and export notifications to FDA. The guidance document 
announced in this notice finalizes the draft guidance issued June 12, 
1998.
    The guidance document is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115) and represents FDA's 
current thinking on exports under sections 801(e) 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 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The guidance and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    An electronic version of the guidance is available on the Internet 
at http://www.fda.gov or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 7, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15840 Filed 8-13-07; 8:45 am]
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