(3) in subsection (g)(1), by striking ‘‘or a vehi-
cle, a device’’ and inserting ‘‘, a vehicle, a device, or
banked human tissue’’ and by inserting after each
other occurrence of ‘‘device’’ the following: ‘‘or
banked human tissue’’.
(f) INVESTIGATIONS.—Section 702 (21 U.S.C. 372)
is amended—
(1) in subsection (b), by inserting ‘‘, banked
human tissue’’ after ‘‘drug’’, and
(2) in subsection (d), by inserting ‘‘or banked
human tissues’’ after ‘‘drugs’’.
(g) RECORDS OF INTERSTATE SHIPMENT.—Section
703 (21 U.S.C. 373) is amended—
(1) by inserting ‘‘or banked human tissues’’
after ‘‘drugs’’ each place it occurs, and
(2) by inserting ‘‘or banked human tissue’’
after ‘‘drug’’ each place it occurs.
(h) INSPECTIONS.—Section 704 (21 U.S.C. 374) is
amended—
(1) in subsection (a)(1)(A), by inserting ‘‘,
banked human tissues’’ after ‘‘drugs’’ each place it
occurs,
(2) in subsection (a)(1)(B), by inserting ‘‘,
banked human tissues’’ after ‘‘prescription drugs’’
each place it occurs, and
(3) in subsection (b), by inserting ‘‘, banked
human tissue’’ after ‘‘drug’’.
(i) PUBLICITY.—Section 705(b) (21 U.S.C. 375(b))
is amended by inserting ‘‘, banked human tissues’’ after
‘‘drugs’’.
(j) INTERSTATE COMMERCE PRESUMPTION.—Sec-
tion 709 (21 U.S.C. 379a) is amended by inserting ‘‘or
banked human tissue’’ after ‘‘device’’.
(k) IMPORTS AND EXPORTS.—Section 801 (21 U.S.C
381) is amended—
(1) in the first sentence of subsection (a), by in-
serting ‘‘, banked human tissues’’ and ‘‘drugs’’,
(2) in subsection (a)(3), by inserting ‘‘or 545’’
after ‘‘505’’, and
(3) in subsections (b) and (e)(1), by inserting
‘‘, banked human tissue’’ after ‘‘drug’’.
SEC. 6. FUNDING.
(a) IMPOSITION.—Each human tissue bank—
(1) which has a permit issued under section
545(d) shall pay a fee for such permit, and
(2) which is registered under section 545(e)
shall pay a fee for such registration.
The fees imposed under this subsection are imposed to
cover the costs of the Secretary in the implementation of
sections 545 and 546.
(b) FEE AMOUNT.—The Secretary shall determine
the amount of the fees imposed by subsection (a) on the
basis of the gross revenue of the human tissue bank pay-
ing the fee which relates to the procurement, processing,
storage, and distribution of human tissue.
(c) CREDITING AND AVAILABILITY OF FEES.—
(1) IN GENERAL.—Fees collected for a fiscal
year pursuant to subsection (a) shall be credited to
the appropriation account for salaries and expenses
of the Secretary and shall be available in accordance
with appropriation Acts until expended without fiscal
year limitation.
(2) COLLECTIONS.—The fees imposed under
subsection (a)—
(A) shall be collected in each fiscal year in
an amount equal to the amount specified in ap-
propriation Acts for such fiscal year, and
(B) shall only be collected and available to
defray the costs of implementing sections 545
and 546.
(d) EFFECTIVE DATE.—The fee authorized by sub-
section (a)(1) shall take effect 4 years after the date of
the enactment of the Human Tissue for Transplantation
Act of 1993 and the fee authorized by subsection (a)(2)
shall take effect one year after the date of the enactment.
SEC. 7. HUMAN HEART VALVES.
(a) ENFORCEMENT.—The Secretary of Health and
Human Services may not enforce the Secretary’s regula-
tion, promulgated on May 13, 1987, and published at page
18162 of 52 Federal Register, insofar as such regulation
applies to human heart valves.
(b) PREMARKET APPROVAL DETERMINATION.—The
determination of the Secretary issued June 26, 1991 (56
FR 29177), acting through the Food and Drug Adminis-
tration, that human heart valves are replacement heart
valves subject to premarket approval under section 515
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360e) shall have no legal force and effect.