[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]
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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.
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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