[Federal Register Volume 64, Number 116 (Thursday, June 17, 1999)]
[Proposed Rules]
[Pages 32442-32443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15395]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 64, No. 116 / Thursday, June 17, 1999 / 
Proposed Rules  

[[Page 32442]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 98N-0583]
RIN 0910-AB16


Exports: Notification and Recordkeeping Requirements; Extension 
of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to July 
16, 1999, the comment period for the proposed rule that appeared in the 
Federal Register of April 2, 1999 (64 FR 15944). The proposed rule 
would establish the notification and recordkeeping requirements for 
persons exporting human drugs, biologics, devices, animal drugs, food, 
and cosmetics that may not be marketed or sold in the United States. 
FDA is taking this action in response to numerous issues raised by the 
proposed rule thus far.

DATES: Written comments by July 16, 1999.

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: 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 
unapproved human drugs, biologics, devices, and animal drugs. For 
example, before the law was enacted, most exports of unapproved new 
drug products could only be made to the 21 countries then 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 numerous restrictions. 
The FDA Export Reform and Enhancement Act amended section 802 of the 
act to allow, among other things, the export of unapproved new human 
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) and certain other requirements are 
met (see section 802(b)(1)(A) of the act). 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. This provision of section 802 of the act also applies to the 
export of certain devices that cannot be sold or marketed in the United 
States.
    The FDA Export Reform and Enhancement Act also modified the export 
authority in section 801 of the act (21 U.S.C. 381). Before enactment 
of the FDA Export Reform and Enhancement Act, section 801(e)(1) of the 
act applied to the exportation of certain foods, drugs, devices, and 
cosmetics. Products exported under section 801(e) of the act are not 
considered adulterated or misbranded if the product intended for 
export: (1) Meets the foreign purchaser's specifications; (2) is not in 
conflict with the laws of the country to which it is being exported; 
(3) is labeled on the outside of the shipping package that the product 
is intended for export; and (4) is not sold or offered for sale in 
domestic commerce (see section 801(e)(1) of the act). Additional 
requirements apply to certain devices (see section 801(e)(2) of the 
act). The FDA Export Reform and Enhancement Act extended these four 
basic requirements to all exports under sections 801 and 802 of the 
act, and to exports of partially processed biologics under section 
351(h) of the Public Health Service Act (the PHS Act) (42 U.S.C. 
262(h)) (see section 801(e) and (f) of the act); section 802(f)(3) of 
the act; and section 351(h) of the PHS Act, and made section 801(e) of 
the act the principal export authority for the exportation of 
unapproved animal drugs other than animal drugs banned in the United 
States. It also imposed additional labeling requirements on certain 
exports of approved drugs (see section 801(f) of the act).
    The FDA Export Reform and Enhancement Act also established 
recordkeeping and notification requirements. Products exported under 
section 802 of the act are subject to certain requirements under 
section 802(f) and (g) of the act. Section 802(f) of the act prohibits 
a drug or device from being exported under section 802 of the act if 
it: (1) Does not conform with current good manufacturing practices; (2) 
is adulterated under certain provisions in section 501 of the act (21 
U.S.C. 351); (3) does not comply with section 801(e)(1) of the act; (4) 
is the subject of a determination by FDA or the U.S. Department of 
Agriculture (with respect to veterinary biologics) that the probability 
of reimportation of the exported drug or device would present an 
imminent hazard to the public health and safety of the United States; 
(5) would present an imminent hazard to the public health of the 
foreign country; (6) fails to comply with labeling requirements in the 
country receiving the exported drug or device; or (7) is not promoted 
in accordance with labeling requirements.
    Section 802(g) of the act requires an exporter of a drug or device 
under section 802(b)(1)(A) of the act to provide a ``simple 
notification'' to the agency ``identifying the drug or device when the 
exporter first begins to export such drug or device'' to any of the 25 
countries identified in section 802(b)(1)(A) of the act. For exports to 
other, nonlisted countries, section 802(g) of the act requires the 
exporter to provide a simple notification ``identifying the drug or 
device and the country to which such drug or device is being 
exported.'' This section also requires persons export under any 
provision of section 802 of the act to ``maintain records of all drugs 
or

[[Page 32443]]

devices exported and the countries to which they were exported.''
    In the Federal Register of April 2, 1999 (64 FR 15944), FDA 
published a proposed rule that would establish the notification and 
recordkeeping requirements for persons exporting human drugs, 
biologics, devices, animal drugs, food, and cosmetics that may not be 
marketed or sold in the United States. Because reactions to the 
proposed rule thus far have raised numerous issues, the agency wants to 
ensure that interested persons have an adequate opportunity to examine 
the rule and to submit comments. Therefore, FDA is extending the 
comment period until July 16, 1999.
    Interested persons may, on or before July 16, 1999, submit to the 
Dockets Management Branch (address above) written comments on the 
proposed rule. 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 proposed rule and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday. 
The proposed rule may also be obtained through FDA's web site at 
``www.FDA.gov''.

    Dated: June 10, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15395 Filed 6-15-99; 10:04 am]
BILLING CODE 4160-01-F