Draft Guidance for Industry; Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0307]

Draft Guidance for Industry; Exports and Imports Under the FDA

Export Reform and Enhancement Act of 1996; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to

November 24, 1998, the comment period for the draft guidance document

that appeared in the Federal Register of June 12, 1998 (63 FR 32219).

The draft guidance document addressed issues concerning the exportation

of human drugs, animal drugs, biologics, food additives, and devices

under the FDA Export Reform and Enhancement Act, as well as the

importation of components, parts, accessories, or other articles for

incorporation or further processing into articles intended for export.

This action is being taken in response to a request from the Health

Industry Manufacturers Association.

DATES: Written comments by November 24, 1998.

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: In the Federal Register of June 12, 1998 (63

FR 32219), FDA published a draft guidance document entitled ``FDA Draft

Guidance for Industry on: Exports and Imports Under the FDA Export

Reform and Enhancement Act of 1996.''

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 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, 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.)

The draft guidance document provides information on the statutory

requirements for exporting human drugs, animal drugs, biologics, and

medical devices; general requirements for products exported under

section 801 of the act (21 U.S.C. 381); labeling requirements for drugs

and biologics exported under section 801(e) of the act; requirements

for exports of unapproved drugs, biologics, and devices under section

802(b) of the act; requirements for exports of unapproved drugs and

devices for investigational use; requirements for exports of unapproved

drugs and devices in anticipation of foreign approval; requirements for

exports of drugs and devices for diagnosing, preventing, or treating a

tropical disease or a disease ``not of significant prevalence in the

United States;'' export notifications to FDA; and ``import for

export.''

The draft guidance document represents the agency's current

thinking on exports and imports-for-export under sections 801 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 statute, regulations, or both.

On June 23, 1998, the Health Industry Manufacturers Association

(HIMA) requested a 90-day extension of the comment period. HIMA

explained that ``the complexity of the issues with the additional

complication of summer vacation schedules prevents us from providing

substantive comments within the time provided.'' The agency considered

HIMA's request and, through this notice, is extending the comment

period by 90 days until November 24, 1998.

Interested persons may submit to the Dockets Management Branch

(address above) written comments on the draft guidance document. 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 draft

guidance document and received comments may be seen in the office above

between 9 a.m. and 4 p.m., Monday through Friday. The draft

[[Page 45828]]

guidance document may also be seen on FDA's web site at

``www.FDA.gov''.

Dated: August 21, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-23026 Filed 8-24-98; 3:45 pm]

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