[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
