[Federal Register: August 14, 2007 (Volume 72, Number 156)]
[Notices]
[Page 45436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14au07-65]
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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published a draft guidance document entitled ``FDA Guidance for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 FDA wrote the draft guidance to help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]
BILLING CODE 4160-01-S