110 STAT. 1321-313
PUBLIC LAW 104-134—APR. 26, 1996
FDA Export
Reform and
Enhancement
Act of 1996.
21 USC 301 note.
Records.
Reports.
purchase program, including the program authorized under section
32 of the Act of August 24, 1935 (7 U.S.C. 612c) except that
the Department of Agriculture or other Federal agency may utilize
lot inspection to establish a reasonable degree of certainty that
fish or fish products purchased under a Federal commodity purchase
program, including the program authorized under section 32 of
the Act of August 24, 1935 (7 U.S.C. 612c), meet Federal product
specifications.
7 USC 1941 note. SEC. 2002.
Notwithstanding any other provision of law, the Secretary of
Agriculture is hereby authorized to make or guarantee an operating
loan under Subtitle B or an emergency loan under Subtitle C
of the Consolidated Farm and Rural Development Act (7 U.S.C.
1922 et. seq.), as in effect prior to April 4, 1996, to a loan applicant
who was less than 90 days delinquent on April 4, 1996, if the
loan applicant had submitted an application for the loan prior
to April 5, 1996.
CHAPTER lA
FOOD AND DRUG EXPORT REFORM
SEC. 2101. SHORT TITLE; REFERENCE.
(a) SHORT TITLE.—T his chapter may be cited as the "FDA
Export Reform and Enhancement Act of 1996".
(b) REFERENCE. — Wherever in this chapter (other than in section 2104) an amendment or repeal is expressed in terms of an
amendment to, or repeal of, a section or other provision, the ref-
erence shall be considered to be made to a section or other provision
of the Federal Food, Drug, and Cosmetic Act. (21 U.S.C. 321 et
seq.)
SEC. 2102. EXPORT OF DRUGS AND DEVICES.
(a) IMPORTS FOR EXPORT. —Section 801 (21 U.S.C. 381) is
amended—
(1) in subsection (d), by adding at the end thereof the
following:
"(3) No component of a drug, no component part or accessory
of a device which is ready or suitable for use for health-related
purposes, and no food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from
importation into the United States under subsection (a) if—
"(A) the importer of such article of a drug or device or
importer of the food additive, color additive, or dietary supplement submits a statement to the Secretary, at the time of
initial importation, that such article of a drug or device, food
additive, color additive, or dietary supplement is intended to
be incorporated by the initial owner or consignee into a drug,
biological product, device, food, food additive, color additive,
or dietary supplement that will be exported by such owner
or consignee from the United States in accordance with section
801(e) or 802 or section 351(h) of the Public Health Service
Act;
"(B) the initial owner or consignee responsible for such
imported article maintains records that identify the use of
such imported article and upon request of the Secretary submits
a report that provides an accounting of the exportation or
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