Exports: Notification and Recordkeeping Requirements; Extension of Comment Period

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