retary and the remainder of such fee shall
be available upon completion of a com-
prehensive, substantive review of the supple-
ment or submission.
‘‘(v) 
INTEREST
ON
ESCROW.—The
amount of interest which may accrue on
fees in the escrow account established under
paragraph (1) shall be paid into the Gen-
eral Fund of the Treasury.
‘‘(B) LIMIT
ON
AVAILABILITY.—Not more
than 5 percent of the projected fee receipts in
any fiscal year may be used for activities de-
scribed in subparagraphs (L) and (N) of section
741(3), except that up to 15 percent of the pro-
jected fee receipts in any fiscal year may be used
for such activities after the Commissioner of the
Food and Drug Administration issues a public
notice that the Food and Drug Administration
has met the applicable goals referenced in section
2(3) of the Medical Device User Fee Act of 1994.
If subsequent to such public notice the Food and
Drug Administration is not meeting such
goals—
‘‘(i) the Commissioner shall issue a
public notice of the Food and Drug Admin-
istration’s actual performance level, and
‘‘(ii) not more than 5 percent of pro-
jected fee receipts may be used for such ac-
tivities until the Commissioner issues a sub-
sequent notice that the Food and Drug Ad-
ministration is again meeting such goals.
‘‘(3) COLLECTIONS AND APPROPRIATION ACTS.—
The fees authorized by this section—
‘‘(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 increases in the costs of the resources allo-
cated for the process for the review of device ap-
plications and related activities (including in-
creases in such costs for an additional number of
full-time equivalent employees in the Department
of Health and Human Services to be engaged in
such process) over such costs for fiscal year 1994
multiplied by the adjustment factor.
‘‘(4) AUTHORIZATION
OF
APPROPRIATIONS.—
There are authorized to be appropriated for fees under
this section—
‘‘(A) $23,000,000 for fiscal year 1995,
‘‘(B) $21,300,000 for fiscal year 1996,
‘‘(C) $23,000,000 for fiscal year 1997,
‘‘(D) $24,000,000 for fiscal year 1998, and
‘‘(E) $24,000,000 for fiscal year 1999,
as adjusted to reflect the percentage adjustment of fees
authorized under subsection (c)(1).
‘‘(h) COLLECTION OF UNPAID FEES.—In any case
where the Secretary does not receive payment of a fee for
a pending application assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim
of the United States Government subject to subchapter II
of chapter 37 of title 31, United States Code.
‘‘(i) POSITIONS.—Any employee whose salary is paid
for by fees authorized under this section shall not be in-
cluded in calculating any limit on full-time equivalent posi-
tions or the grade levels for such positions.’’.
SEC. 4. ANNUAL REPORTS.
(a) FIRST REPORT.—Within 90 days after the end of
each fiscal year during which fees are collected under part
3 of subchapter C of chapter VII of the Federal Food, Drug,
and Cosmetic Act, the Secretary of Health and Human
Services shall submit a report stating the Food and Drug
Administration’s progress in achieving the goals identified
in section 2(3) of this Act during such fiscal year and the
Food and Drug Administration’s future plans for meeting
such goals. There shall be included in such report—
(1) a specific statement from the Secretary con-
cerning the Food and Drug Administration’s actions
to reduce the backlog in the review of device applica-
tions and meeting statutory review times applicable
to submissions for devices, and
(2) the following data from the Center for De-
vices and Radiological Health and the Center for Bio-
logics Evaluation and Research:
(A) The number of device submissions found
not fileable.
(B) Total elapsed time for review of device
submissions.
(C) Total time for review of device submis-
sions as calculated by such Center.
(D) The number of negative decisions for
device submissions.
(E) The number of non-approveable letters
for device submissions.
(F) The number of deficiency letters for de-
vice submissions.
(G) The total number of device applications
by type of application.
(H) The number of device applications
withdrawn by the sponsor.
(I) The number of major amendments to de-
vice applications and the number of device ap-
plications subject to post-market requirements es-
tablished as a condition of approval of a device
application.
(J) The number of devices with post-ap-
proval problems which resulted in one or more of
the following actions: Withdrawal of approval or
temporary suspension of an approved applica-
tion under section 515 of the Federal Food,
Drug, and Cosmetic Act, mandatory product re-
call under section 518 of such Act, seizure under
section 304 of such Act, or criminal prosecution
under section 303 of such Act.
(K) Information for subparagraphs (A)
through (J) for fiscal year 1994.
(b) SECOND REPORT.—Within 120 days after the end
of each fiscal year during which such fees are collected, the
Secretary of Health and Human Services shall submit a
report on the implementation of the authority for such fees
during such fiscal year and on the use of the Food and Drug
Administration made of the fees collected during such fiscal
year.
(c) ESCROW ACCOUNT REPORT.—The Secretary of
Health and Human Services shall report to the Congress
annually—
(1) the closing monthly balance of the escrow ac-
count established under section 742(g)(2) of the Fed-
eral Food, Drug, and Cosmetic Act,
(2) the monthly receipt of fees insuch account re-
ported for each fee established under section 742(b) of
such Act, and
(3) the monthly accrual of interest in such ac-
count
(d) COMMITTEES.—The reports described in sub-
sections (a), (b), and (c) shall be submitted to the Committee
on Energy and Commerce of the House of Representatives
and the Committee on Labor and Human Resources of the
Senate.
SEC. 5. REGULATIONS.
(a) GENERAL RULE.—This Act and the amendment
made by section 3 shall not be in effect after June 30, 1995,
unless the Secretary of Health and Human Services,
through the Commissioner of Food and Drugs, approves—
(1) regulations described in subsection (b), and
(2) regulations which identify devices in class II
of the device classes in section 513 of the Federal
Food, Drug, and Cosmetic Act that are appropriate
for exemption from the requirement of section 510(k)
of such Act and which exempts such devices from such
requirement following their reclassification into class
I.
(b) REGULATIONS.—
(1) PROPOSED.—Not later than November 30,
1994, the Secretary shall issue proposed regulations
that—
(A) identify all devices in class I of the de-
vice classes in section 513 of the Federal Food,
Drug, and Cosmetic Act which are exempt from
the requirement of section 510(k) of such Act,
and
(B) identify the criteria for selecting devices
for such exemption.
The Secretary shall provide an opportunity to com-
ment on such proposed regulations for 60 days after
publication.
(2) FINAL.—Not later than February 28, 1995,
the Secretary shall issue final regulations which grant
an exemption to the devices identified in the proposed
regulations which clearly meet the criteria for exemp-
tion from the requirement of such section 510(k) of
the Federal Food, Drug, and Cosmetic Act.
(3) OTHER REGULATIONS.— Not later than June
30, 1995, the Secretary shall issue final regulations
for the remainder of the devices from the list pub-
lished in the proposed regulations which exempts such
devices from such requirement or which continues the
applicability of such requirement.
(c) FEES.—An applicant under a device substantial
equivalence submission under section 510(k) of the Federal
Food, Drug, and Cosmetic Act which the Secretary proposed
to exempt from the requirement of such section under sub-
section (b)(1) shall not be required to pay a fee for such
submission unless the Secretary issues a final regulation re-
quiring such submission. An applicant under a substantial
equivalence submission under such section 510(k) which the
Secretary exempts from the requirement of such section
under subsection (a) shall not be required to pay a fee for
such submission.
SEC. 6. SUNSET.
This Act and the amendment made by section 3 shall
not be in effect after September 30, 1999.
HR 4864 RH——2