skip navigation
[1] See References in Text note below.
[2] So in original. The period probably should be a comma.
§ 379j. Authority to assess and use device fees
(a)
Types of fees
(1)
In general
Beginning on October 26, 2002, the Secretary shall assess and collect fees in accordance with this section.
(2)
Premarket application, premarket report, supplement, and submission fee
(A)
In general
Except as provided in subparagraph (B) and subsections (d) and (e) of this section, each person who submits any of the following, on or after October 1, 2002, shall be subject to a fee established under subsection (c)(1) of this section for the fiscal year involved in accordance with the following:
(iv)
For a 180-day supplement, a fee equal to 21.5 percent of the fee that applies under clause (i).
(B)
Exceptions
(i)
Humanitarian device exemption
An application under section
360j
(m) of this title is not subject to any fee under subparagraph (A).
(ii)
Further manufacturing use
No fee shall be required under subparagraph (A) for the submission of a premarket application under section
262 of title
42 for a product licensed for further manufacturing use only.
(iii)
State or Federal Government sponsors
No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, or premarket notification submission submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
(iv)
Premarket notifications by third parties
No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section
360m of this title.
(v)
Pediatric conditions of use
(I)
In general
No fee shall be required under subparagraph (A) for a premarket application, premarket report, or premarket notification submission if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
(II)
Subsequent proposal of adult conditions of use
In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.
(C)
Payment
The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and October 26, 2002, shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section
360e
(c)(3) [1] of this title shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003.
(D)
Refunds
(i)
Application refused for filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.
(ii)
Application withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.
(iii)
Application withdrawn before first action
After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement. The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.
(b)
Fee revenue amounts
Except as provided in subsections (c), (d), (e), (g), and (h) of this section, the fees under subsection (a) of this section shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; and $29,785,000 in fiscal year 2005. If legislation is enacted after October 26, 2002, requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications.
(c)
Annual fee setting
(1)
In general
The Secretary shall, 60 days before the start of each fiscal year after September 30, 2002, publish in the Federal Register fees under subsection (a) of this section. The fees established for fiscal year 2006 shall be based on a premarket application fee of $259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.
(2)
Limit
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.
(3)
Supplement
(A)
In general
For fiscal years 2006 and 2007, the Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of fiscal year 2008.
(B)
Notice to Congress
Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.
(d)
Small businesses; fee waiver and fee reduction regarding premarket approval fees
(1)
In general
The Secretary shall grant a waiver of the fee required under subsection (a) of this section for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term “small business” means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vi) of subsection (a)(2)(A) of this section may be paid at a reduced rate in accordance with paragraph (2)(C).
(2)
Rules relating to premarket approval fees
(A)
Definition
For purposes of this paragraph, the term “small business” means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms.
(B)
Evidence of qualification
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate. The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, partners, and parent firms, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, partners, and parent firms, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.
(C)
Reduced fees
Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) of this section may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement.
(D)
Request for fee waiver or reduction
An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a) of this section. The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.
(e)
Small businesses; fee reduction regarding premarket notification submissions
(1)
In general
For fiscal year 2004 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(vii) of this section may be paid at a reduced rate in accordance with paragraph (2)(C).
(2)
Rules relating to premarket notification submissions
(A)
Definition
For purposes of this subsection, the term “small business” means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms.
(B)
Evidence of qualification
An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate. The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, partners, and parent firms, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, partners, and parent firms, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.
(C)
Reduced fees
(i)
In general
For fiscal year 2004 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 80 percent of the fee that applies under subsection (a)(2)(A)(vii) of this section, as adjusted under clause (ii) and as established under subsection (c)(1) of this section.
(ii)
Adjustment per fee revenue amount
For fiscal year 2004 and each subsequent fiscal year, the Secretary, in setting the revenue amount under subsection (c)(1) of this section for premarket notification submissions, shall determine the revenue amount that would apply if all such submissions for the fiscal year involved paid a fee equal to 1.42 percent of the amount that applies under subsection (a)(2)(A)(i) of this section for premarket applications, and shall adjust the fee under subsection (a)(2)(A)(vii) of this section for premarket notification submissions such that the reduced fees collected under clause (i) of this subparagraph, when added to fees for such submissions that are not paid at the reduced rate, will equal such revenue amount for the fiscal year.
(D)
Request for reduction
An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a) of this section. The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.
(f)
Effect of failure to pay fees
A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid.
(g)
Conditions
(1)
Performance goals through fiscal year 2005; termination of program after fiscal year 2005
With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products:
(A)
(i)
For each of the fiscal years 2003 and 2004, the Secretary is expected to meet all of the goals identified for the fiscal year involved in any letter referred to in section 101(3) of the Medical Device User Fee and Modernization Act of 2002 (referred to in this paragraph as “performance goals”) if the amount so appropriated for such fiscal year, excluding the amount of fees appropriated for such fiscal year, is equal to or greater than $205,720,000 multiplied by the adjustment factor applicable to the fiscal year.
(ii)
For each of the fiscal years 2003 and 2004, if the amount so appropriated for the fiscal year involved, excluding the amount of fees appropriated for such fiscal year, is less than the amount that applies under clause (i) for such fiscal year, the following applies:
(I)
The Secretary is expected to meet such goals to the extent practicable, taking into account the amounts that are available to the Secretary for such purpose, whether from fees under subsection (a) of this section or otherwise.
(II)
The Comptroller General of the United States shall submit to the Congress a report describing whether and to what extent the Secretary is meeting the performance goals identified for such fiscal year, and whether the Secretary will be able to meet all performance goals identified for fiscal year 2005. A report under the preceding sentence shall be submitted to the Congress not later than July 1 of the fiscal year with which the report is concerned.
(B)
(i)
For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the amount so appropriated for such fiscal year, excluding the amount of fees appropriated for such fiscal year, is equal to or greater than $205,720,000 multiplied by the adjustment factor applicable to the fiscal year.
(ii)
For fiscal year 2005, if the amount so appropriated for such fiscal year, excluding the amount of fees appropriated for such fiscal year, is more than 1 percent less than the amount that applies under clause (i), the following applies:
(I)
The Secretary is expected to meet such goals to the extent practicable, taking into account the amounts that are available to the Secretary for such purpose, whether from fees under subsection (a) of this section or otherwise.
(II)
The Comptroller General of the United States shall submit to the Congress a report describing whether and to what extent the Secretary is meeting the performance goals identified for such fiscal year, and whether the Secretary will be able to meet all performance goals identified for fiscal year 2006. The report under the preceding sentence shall be submitted to the Congress not later than July 1, 2005.
(C)
For fiscal year 2006, fees may not be assessed under subsection (a) of this section for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if the total of the amounts so appropriated for fiscal years 2005 and 2006, excluding the amount of fees appropriated for such fiscal years, is more than 1 percent less than the sum of—
(D)
For fiscal year 2007, fees may not be assessed under subsection (a) of this section for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—
(2)
Authority
If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of subparagraph (C) or (D) of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid.
(h)
Crediting and availability of fees
(1)
In general
Fees authorized under subsection (a) of this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.
(2)
Collections and appropriation acts
(A)
In general
The fees authorized by this section—
(i)
shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and
(ii)
shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2002 multiplied by the adjustment factor.
(B)
Compliance
(i)
In general
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of device applications—
(3)
Authorization of appropriations
There are authorized to be appropriated for fees under this section—
as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by application fees.
(4)
Offset
Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.
(j)
Written requests for refunds
To qualify for consideration for a refund under subsection (a)(2)(D) of this section, a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.
(k)
Construction
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
[1] See References in Text note below.
[2] So in original. The period probably should be a comma.
Prev | Next
LII has no control over and does not endorse any external Internet site that contains links to or references LII.