[Federal Register Volume 62, Number 2 (Friday, January 3, 1997)]
[Notices]
[Pages 414-415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-35]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96S-0285]


Establishment of a Public Docket for Documents and Other 
Information Pertaining to Exports and Import-for-Export of Certain FDA-
Regulated Products Under the FDA Export Reform and Enhancement Act of 
1996

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket for documents and other information 
pertaining to the export and the import-for-export of certain FDA-
regulated products (such as drugs, biologics, and devices) under the 
FDA Export Reform and Enhancement Act of 1996. This action will ensure 
that this information is equally available to all interested persons on 
a timely basis.

ADDRESSES: The public docket is available under the docket number found 
in brackets in the heading of this notice and is located in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The public docket may be 
reviewed between 9 a.m. and 4 p.m., Monday through Friday.

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: On April 26, 1996, the President signed the 
FDA Export Reform and Enhancement Act of 1996 (Pub. L. 104-134) into 
law. This law significantly alters the statutory requirements for the 
export of unapproved drugs (including biologics and animal drugs) and 
devices. The law also permits the importation of components of drugs 
and devices and food additives, color additives, and dietary 
supplements into the United States if those components are incorporated 
into articles (``import-for-export'') that are exported in accordance 
with the Federal Food, Drug, and Cosmetic Act, as amended.
    On August 6, 1996, the President signed Pub. L. 104-180, which 
included, in section 603, minor technical amendments. The public may 
obtain a document that sets forth the current statutory provisions 
(combining the pre-existing law with the amendments made in April and 
August 1996) on FDA's home page on the Internet (www.FDA.gov).
    FDA employees, in the usual discharge of their responsibilities and 
in response to inquiries and requests from companies, firms, and trade 
associations, often provide information on FDA's export and import 
activities. The information provided often addresses historical and 
current information on statutory or regulatory requirements and on 
current FDA export and import policies and programs.
    To help make information regarding FDA's interpretation and 
implementation of the FDA Export Reform and Enhancement Act of 1996 
available to all interested persons, FDA has developed a mechanism for 
providing public access to relevant documents and other information 
created by FDA employees. Specifically, FDA has created a public docket 
where documents, such as letters on the export of unapproved drugs for 
investigational use and sent by FDA to various companies and trade 
associations and guidance to field personnel concerning procedures for 
articles imported for manufacturing and subsequent export, will be 
maintained. The documents placed in the public docket are not intended 
to create or confer any rights for or on any person and do not operate 
to bind or otherwise obligate or commit FDA or the public to the views 
expressed. Instead, the documents represent either the agency's current 
thinking on a particular issue at the time the document was created or 
at best the best advice of that employee at that time on the issue. 
(See 21 CFR 10.85(k)).

[[Page 415]]

    To ensure that the information in the public docket is kept 
current, FDA will remove information in the docket that is more than 3 
years old. FDA will review the public docket annually to determine its 
usage; if FDA determines that it is not being used, FDA will 
discontinue its use.
    The public docket is available for public review in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-35 Filed 1-2-96; 8:45 am]
BILLING CODE 4160-01-F