H. R. 3448—82
and investigations. The memorandum of understanding shall con-
tain provisions regarding reimbursement. Such provisions may, at
the sole discretion of the head of the other department or agency,
require reimbursement, in whole or in part, from the Secretary
for the examinations or investigations performed under this section
by the officers or employees of the other department or agency.
‘‘(B) A memorandum of understanding under subparagraph (A)
between the Secretary and another Federal department or agency
is effective only in the case of examinations or inspections at facili-
ties or other locations that are jointly regulated by the Secretary
and such department or agency.
‘‘(C) For any fiscal year in which the Secretary and the head
of another Federal department or agency carries out one or more
examinations or inspections under a memorandum of understanding
under subparagraph (A), the Secretary and the head of such depart-
ment or agency shall with respect to their respective departments
or agencies submit to the committees of jurisdiction (authorizing
and appropriating) in the House of Representatives and the Senate
a report that provides, for such year—
‘‘(i) the number of officers or employees that carried out
one or more programs, projects, or activities under such memo-
randum;
‘‘(ii) the number of additional articles that were inspected
or examined as a result of such memorandum; and
‘‘(iii) the number of additional examinations or investiga-
tions that were carried out pursuant to such memorandum.’’.
SEC. 315. RULE OF CONSTRUCTION.
Nothing in this title, or an amendment made by this title,
shall be construed to alter the jurisdiction between the Secretaries
of Agriculture and of Health and Human Services, under applicable
statutes and regulations.
Subtitle B—Protection of Drug Supply
SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS;
SHIPPING INFORMATION; DRUG AND DEVICE LISTING.
(a) ANNUAL REGISTRATION; LISTING.—Section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended—
(1) in subsection (i)(1)—
(A) by striking ‘‘Any establishment’’ and inserting ‘‘On
or before December 31 of each year, any establishment’’;
and
(B) by striking ‘‘shall register’’ and all that follows
and inserting the following: ‘‘shall, through electronic
means in accordance with the criteria of the Secretary,
register with the Secretary the name and place of business
of the establishment, the name of the United States agent
for the establishment, the name of each importer of such
drug or device in the United States that is known to
the establishment, and the name of each person who
imports or offers for import such drug or device to the
United States for purposes of importation.’’; and
(2) in subsection (j)(1), in the first sentence, by striking
‘‘or (d)’’ and inserting ‘‘(d), or (i)’’.
H. R. 3448—83
(b) IMPORTATION; STATEMENT REGARDING REGISTRATION
OF
MANUFACTURER.—
(1) IN GENERAL.—Section 801 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 308(a) of this Act,
is amended by adding at the end the following subsection:
‘‘(o) If an article that is a drug or device is being imported
or offered for import into the United States, and the importer,
owner, or consignee of such article does not, at the time of offering
the article for import, submit to the Secretary a statement that
identifies the registration under section 510(i) of each establishment
that with respect to such article is required under such section
to register with the Secretary, the article may be refused admission.
If the article is refused admission for failure to submit such a
statement, the article shall be held at the port of entry for the
article, and may not be delivered to the importer, owner, or con-
signee of the article, until such a statement is submitted to the
Secretary. Subsection (b) does not authorize the delivery of the
article pursuant to the execution of a bond while the article is
so held. The article shall be removed to a secure facility, as appro-
priate. During the period of time that such article is so held,
the article shall not be transferred by any person from the port
of entry into the United States for the article, or from the secure
facility to which the article has been removed, as the case may
be.’’.
(2) PROHIBITED
ACT.—Section 301 of the Federal Food,
Drug, and Cosmetic Act, as amended by section 307(b) of this
Act, is amended by adding at the end the following:
‘‘(ff) The importing or offering for import into the United States
of a drug or device with respect to which there is a failure to
comply with a request of the Secretary to submit to the Secretary
a statement under section 801(o).’’.
(c) EFFECTIVE DATE.—The amendments made by this section
take effect upon the expiration of the 180-day period beginning
on the date of the enactment of this Act.
SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING
IMPORT COMPONENTS INTENDED FOR USE IN EXPORT
PRODUCTS.
(a) IN GENERAL.—Section 801(d)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as
follows:
‘‘(3)(A) Subject to subparagraph (B), no component of a drug,
no component part or accessory of a device, or other article of
device requiring further processing, which is ready or suitable for
use for health-related purposes, and no article of a 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 each of the following conditions is met:
‘‘(i) The importer of such article of a drug or device or
importer of such article of a food additive, color additive, or
dietary supplement submits to the Secretary, at the time of
initial importation, a statement in accordance with the fol-
lowing:
‘‘(I) Such statement provides that such article is
intended to be further processed by the initial owner or
consignee, or incorporated by the initial owner or consignee,
into a drug, biological product, device, food, food additive,
H. R. 3448—84
color additive, or dietary supplement that will be exported
by the initial owner or consignee from the United States
in accordance with subsection (e) or section 802, or with
section 351(h) of the Public Health Service Act.
‘‘(II) The statement identifies the manufacturer of such
article and each processor, packer, distributor, or other
entity that had possession of the article in the chain of
possession of the article from the manufacturer to such
importer of the article.
‘‘(III) The statement is accompanied by such certificates
of analysis as are necessary to identify such article, unless
the article is a device or is an article described in paragraph
(4).
‘‘(ii) At the time of initial importation and before the
delivery of such article to the importer or the initial owner
or consignee, such owner or consignee executes a good and
sufficient bond providing for the payment of such liquidated
damages in the event of default as may be required pursuant
to regulations of the Secretary of the Treasury.
‘‘(iii) Such article is used and exported by the initial owner
or consignee in accordance with the intent described under
clause (i)(I), except for any portions of the article that are
destroyed.
‘‘(iv) The initial owner or consignee maintains records on
the use or destruction of such article or portions thereof, as
the case may be, and submits to the Secretary any such records
requested by the Secretary.
‘‘(v) Upon request of the Secretary, the initial owner or
consignee submits a report that provides an accounting of the
exportation or destruction of such article or portions thereof,
and the manner in which such owner or consignee complied
with the requirements of this subparagraph.
‘‘(B) Notwithstanding subparagraph (A), the Secretary may
refuse admission to an article that otherwise would be imported
into the United States under such subparagraph if the Secretary
determines that there is credible evidence or information indicating
that such article is not intended to be further processed by the
initial owner or consignee, or 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 the initial owner or consignee from the United States in accord-
ance with subsection (e) or section 802, or with section 351(h)
of the Public Health Service Act.
‘‘(C) This section may not be construed as affecting the responsi-
bility of the Secretary to ensure that articles imported into the
United States under authority of subparagraph (A) meet each of
the conditions established in such subparagraph for importation.’’.
(b) PROHIBITED ACT.—Section 301(w) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331(w)) is amended to read as follows:
‘‘(w) The making of a knowingly false statement in any state-
ment, certificate of analysis, record, or report required or requested
under section 801(d)(3); the failure to submit a certificate of analysis
as required under such section; the failure to maintain records
or to submit records or reports as required by such section; the
release into interstate commerce of any article or portion thereof
imported into the United States under such section or any finished
product made from such article or portion, except for export in
H. R. 3448—85
accordance with section 801(e) or 802, or with section 351(h) of
the Public Health Service Act; or the failure to so export or to
destroy such an article or portions thereof, or such a finished
product.’’.
(c) EFFECTIVE DATE.—The amendments made by this section
take effect upon the expiration of the 90-day period beginning
on the date of the enactment of this Act.
Subtitle C—General Provisions Relating to
Upgrade of Agricultural Security
SEC. 331. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION
SERVICE ACTIVITIES.
(a) IN GENERAL.—The Secretary of Agriculture (referred to
in this section as the ‘‘Secretary’’) may utilize existing authorities
to give high priority to enhancing and expanding the capacity
of the Animal and Plant Health Inspection Service to conduct
activities to—
(1) increase the inspection capacity of the Service at inter-
national points of origin;
(2) improve surveillance at ports of entry and customs;
(3) enhance methods of protecting against the introduction
of plant and animal disease organisms by terrorists;
(4) develop new and improve existing strategies and tech-
nologies for dealing with intentional outbreaks of plant and
animal disease arising from acts of terrorism or from uninten-
tional introduction, including—
(A) establishing cooperative agreements among Veteri-
nary Services of the Animal and Plant Health Inspection
Service, State animal health commissions and regulatory
agencies for livestock and poultry health, and private vet-
erinary practitioners to enhance the preparedness and
ability of Veterinary Services and the commissions and
agencies to respond to outbreaks of such animal diseases;
and
(B) strengthening planning and coordination with State
and local agencies, including—
(i) State animal health commissions and regulatory
agencies for livestock and poultry health; and
(ii) State agriculture departments; and
(5) otherwise improve the capacity of the Service to protect
against the threat of bioterrorism.
(b) AUTOMATED RECORDKEEPING SYSTEM.—The Administrator
of the Animal and Plant Health Inspection Service may implement
a central automated recordkeeping system to provide for the reliable
tracking of the status of animal and plant shipments, including
those shipments on hold at ports of entry and customs. The Sec-
retary shall ensure that such a system shall be fully accessible
to or fully integrated with the Food Safety Inspection Service.
(c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated to carry out this section, $30,000,000 for fiscal
year 2002, and such sums as may be necessary for each subsequent
fiscal year.