[Congressional Record Volume 140, Number 89 (Tuesday, July 12, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: July 12, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. KENNEDY:
  S. 2276. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
authorize a device application fee, and for other purposes; to the 
Committee on Labor and Human Resources.


                  medical device user fee act of 1994

  Mr. KENNEDY. Mr. President, today I am introducing the Medical Device 
User Fee Act of 1994. The purpose of this measure is to improve the 
procedures used by the Food and Drug Administration to review such 
devices.
  The rapid pace of innovations in American health care makes such 
legislation essential. The medical device industry is one of our 
cutting-edge growth industries, and holds great promise for better 
health care in the years ahead. Devices range from tongue depressors 
and syringes to cardiac pacemakers and ultrasound scanners. 
Increasingly sophisticated technologies continue to improve physicians' 
ability to diagnose and treat illness and enhance the quality of life 
for large numbers of individuals. Exports of U.S. medical devices have 
made the American industry the world leader and enhanced our balance of 
trade.
  Too often, however, the bottleneck to progress is the FDA clearance 
process. Agency resources to review new devices have actually declined 
in recent years. The mismatch between mushrooming investment and 
research on these devices and declining FDA resources is seriously 
delaying medical advances, and some remedy must be found.
  Without additional funds, the FDA cannot dispose of its large and 
growing backlog of device approval and notification decisions, let 
alone process new device applications expeditiously. The current 
Federal budget offers little prospect that adequate resources will be 
available to the FDA to do the job it should be doing. Without more 
assistance, the agency can't keep up with innovation.
  User fees from medical device manufacturers is the obvious answer. 
The idea has already proved successful for prescription drugs in a 
landmark Federal law enacted in 1992. The concept of user fees was 
endorsed by the Edwards Committee report on FDA reform in 1991, which 
urged Congress and the private sector to supplement the agency's annual 
Federal appropriation with industry funds.
  With the help of the new resources available through prescription 
drug user fees, the FDA has hired new reviewers and come closer to the 
goal it has set of cutting review times in half. The pharmaceutical 
industry has worked closely with the FDA to ensure that the user fees 
are implemented in a fair and timely manner.
  The legislation I am offering today provides a similar opportunity 
for the medical device industry. The bill reflects a consensus that has 
emerged from discussions in Congress and the Clinton administration and 
with the industry and consumers. All of us who have worked on this 
legislation are gratified by the support of medical device 
manufacturers for this approach, since industry support is essential 
for a user fee to be successful. Health Industry Manufacturers 
Association, the national trade association whose members manufacture 
more than 90 percent of the health technology purchased in the United 
States, has endorsed this legislation.
  The statutory framework has been carefully designed to ensure that 
the fees are reasonable, and that all funds go only for activities 
directly related to the FDA review and approval process for medical 
devices. The legislation I am introducing authorizes FDA to collect 
approximately $100 million over the next 5 years for this purpose.
  These funds will be dedicated specifically to FDA action on medical 
devices. A key part of this compact is that these funds will not be 
available for any other purpose or priority, including deficit 
reduction.
  The fees are set to reflect the relative length and complexity of the 
product submissions, and the size of companies making the submissions.
  Most of the premarket submissions--known as 510(K) submissions--
seeking FDA's determination of substantial equivalence to existing 
devices come from small companies. The fee for these submissions would 
be $3,200.
  The longer premarket approval or [PMA] submissions for new devices 
require clinical data and are more frequently submitted by larger 
companies. The legislation sets the fee for these submissions at 
$52,000.
  In contrast, the prescription drug user fees were set as high as 
$100,000 for a submission for new drug approval.
  In return for these resources, FDA Commissioner Kessler has set 
specific performance goals to cut reviews times dramatically. The new 
personnel needed to review medical devices will be hired within a year 
of enactment. With these new reviewers, FDA has committed to a 95-
percent completion rate for all premarket [510(K)] notifications within 
the statutory 90-day deadline and 90 percent of all premarket approvals 
within the required 180 days.
  Commissioner Kessler has also committed to a timetable for 
eliminating backlogs of overdue applications. The number of overdue 
510(k) submissions soared from 330 in 1992 to 1,895 in 1993. The FDA 
has committed to eliminating 95 percent of this backlog within 2 years 
of enactment of this legislation, and will seek to reduce the backlog 
of premarket approvals by 90 percent.
  These actions will have a significant, long-term impact on health 
care. Faster device approvals will save lives and benefit the industry, 
too.
  We have also included provisions to help user fees from becoming 
disincentives to the development of new devices by small businesses. 
Such businesses constitute the majority of innovative device firms. The 
legislation allows a complete waiver of fees for a company's first 
premarket notification submission to FDA--the time when a start-up 
company may be financially most vulnerable.
  This legislation offers a worthwhile opportunity to improve health 
care by improving FDA's performance. Congressmen Dingell and Waxman 
have introduced an identical measure today in the House of 
Representatives, and I look forward to working with them and many other 
colleagues in the Senate and House on this important legislation.
  I ask unanimous consent that the text of the bill may be printed in 
the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2276

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE AND REFERENCE.

       (a) Short Title.--This Act may be cited as the ``Medical 
     Device User Fee Act of 1994''.
       (b) Reference.--Whenever in this Act an amendment or repeal 
     is expressed in terms of an amendment to, or repeal of, a 
     section or other provision, the reference shall be considered 
     to be made to a section or other provision of the Federal 
     Food, Drug, and Cosmetic Act.

     SEC. 2. FINDINGS.

       The Congress finds that--
       (1) prompt approval and clearance of safe and effective 
     devices is critical to the improvement of the public health 
     so that patients may enjoy the benefits of devices to 
     diagnose, treat, and prevent disease;
       (2) the public health will be served by furnishing 
     additional funds for the review of devices so that 
     statutorily mandated deadlines may be met, and
       (3) the fees authorized by the amendment made by section 3 
     will be dedicated--
       (A) toward expediting the review of device applications, 
     supplements, and substantial equivalence submissions, and
       (B) for related activities as defined in section 741(3) of 
     the Federal Food, Drug, and Cosmetic Act,

     as set forth in goals identified in the letter of July 8, 
     1994, from the Commissioner of Food and Drugs to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Labor and Human 
     Resources of the Senate.

     SEC. 3. FEES RELATING TO DEVICES.

       Chapter VII is amended by adding at the end of subchapter C 
     the following:

                   ``PART 3--FEES RELATING TO DEVICES

     ``SEC. 741. DEFINITIONS.

       ``For purposes of this subchapter:
       ``(1) The term--
       ``(A) `device application' means an application for 
     approval of a device submitted under section 515(c) or 
     section 351 of the Public Health Service Act, a supplement to 
     such an application, or a device substantial equivalence 
     submission made under section 510(k); and
       ``(B) `section 351 application' means a device application 
     submitted under section 351 of the Public Health Service Act.
       ``(2) The term `supplement' means a request to the 
     Secretary to approve a change in a device application which 
     has been approved under section 515(d) or section 351 of the 
     Public Health Service Act.
       ``(3) The term `process for the review of device 
     applications and related activities' means the following 
     activities of the Secretary with respect to the review of 
     device applications and related activities:
       ``(A) The activities necessary for the review of device 
     applications and related activities.
       ``(B) The issuance of action letters which allow marketing 
     of devices or which set forth in detail the specific 
     deficiencies in such applications and, where appropriate, the 
     actions necessary to place such applications in condition for 
     approval.
       ``(C) The inspection of device establishments and other 
     facilities undertaken as part of the Secretary's review of 
     pending device applications.
       ``(D) Activities necessary for the review of applications 
     for licensure of devices subject to section 351 of the Public 
     Health Service Act, for the licensure of establishments where 
     such devices are manufactured, and for the release of lots of 
     such devices.
       ``(E) Review of device applications for an investigational 
     new drug exemption under section 505(i) and for an 
     investigational device exemption under section 520(g) and 
     activities conducted in anticipation of the submission of an 
     application under sections 505(i) and 520(g).
       ``(F) The development of guidance and policy documents to 
     improve the process for the review of device applications.
       ``(G) The development of test methods and standards in 
     connection with the review of device applications and related 
     activities.
       ``(H) The provision of technical assistance to device 
     manufacturers in connection with the submission of a device 
     application.
       ``(I) Activities undertaken in connection with the export 
     of a device.
       ``(J) Activities undertaken under sections 513 and 515(i) 
     in connection with the initial classification and 
     reclassification of a device and under section 515(b) in 
     connection with any requirement for premarket approval of a 
     device.
       ``(K) Monitoring of research.
       ``(L) Activities undertaken under sections 519(a) and 
     519(b).
       ``(M) Postmarket studies required as a condition of an 
     approval of a device application under section 515(d) or 
     section 351 of the Public Health Service Act.
       ``(N) Postmarket surveillance required under section 522.
       ``(4) The term `costs of resources allocated for the 
     process for the review of device applications and related 
     activities' means the expenses incurred in connection with 
     the process for the review of device applications and related 
     activities for--
       ``(A) officers and employees of the Food and Drug 
     Administration, employees under contract with the Food and 
     Drug Administration, advisory committees, and costs related 
     to such officers, employees, and committees,
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources,
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials, services, and supplies, and
       ``(D) collecting fees under section 742 and accounting for 
     resources allocated for the review of device applications and 
     related activities, including activities related to the 
     review of applications for fee exceptions, waivers, and 
     reductions.
       ``(5) The term `adjustment factor' applicable to a fiscal 
     year is the lower of--
       ``(A) the Consumer Price Index for all urban consumers (all 
     items; United States city average) for August of the 
     preceding fiscal year divided by such Index for August 1994, 
     or
       ``(B) the total budget authority provided for discretionary 
     programs for the immediately preceding fiscal year (as 
     reported in the Office of Management and Budget sequestration 
     preview report, if available, required under section 254(d) 
     of the Balanced Budget and Emergency Deficit Control Act of 
     1985) divided by such budget authority for fiscal year 1994 
     (as reported in the Office of Management and Budget final 
     sequestration report submitted after the end of the 103d 
     Congress, 2d Session).

     The term `budget authority' in subparagraph (B) is as defined 
     in the Balanced Budget and Emergency Deficit Control Act of 
     1985, as in effect as of January 1, 1994.

     ``SEC. 742. AUTHORITY TO ASSESS AND USE DEVICE USER FEES.

       ``(a) Fees.--Beginning in fiscal year 1995, the Secretary 
     shall assess and collect fees as follows:
       ``(1) General rule.--Except as provided in paragraph (2), 
     each person that submits, on or after 90 days before--
       ``(A) the date of the enactment of the Medical Device User 
     Fee Act of 1994, or
       ``(B) the date of the enactment of the first appropriation 
     under subsection (g)(4) for fees under this section.

     whichever occurs later, a device application shall be subject 
     to the fee prescribed by subsection (b).
       ``(2) Exception.--
       ``(A) Further manufacturing use.--No fee shall be required 
     for the submission of a section 351 application for a product 
     licensed for further manufacturing use only.
       ``(B) Exception for previously filed application or 
     supplement.--If a device application was--
       ``(i) submitted by a person that paid the fee for such 
     application,
       ``(ii) accepted for filing, and
       ``(iii) not approved or withdrawn (without a waiver under 
     subsection (d)),

     the submission of a device application for the identical 
     device by the same person (or the person's licensee, 
     assignee, or successor) shall not be subject to a fee under 
     paragraph (1).
       ``(3) Payment schedule.--
       ``(A) General rule.--Except as provided in subparagraph 
     (B), the fee prescribed by subsection (b) shall be due upon 
     the submission of the application.
       ``(B) Exceptions.--
       ``(i) Pending.--In the case of a device application for 
     which fees are required under paragraph (1) and which is 
     pending on the later of--
       ``(I) the date of the enactment of the Medical Device User 
     Fee Act of 1994, or
       ``(II) the date of the enactment of the first appropriation 
     under subsection (g)(4) for fees under this section,

     the fee required by paragraph (1) shall be due 90 days after 
     such later date of enactment.
       ``(ii) Excess of authorization.--A fee which is due after 
     an amount of fees equal to the authorization of 
     appropriations under subsection (g)(4) for the fiscal year in 
     which the fee is imposed has been collected shall be due on 
     November 1 in the following fiscal year.
       ``(4) Refund if application or supplement not accepted for 
     filing.--
       ``(A) 515(c) and 351.--The Secretary shall refund 85 
     percent of the fee paid under paragraph (3) for any 
     application submitted under section 515(c) or section 351 of 
     the Public Health Service Act which is not accepted for 
     filing.
       ``(B) Supplements.--The Secretary shall refund 85 percent 
     of the fee paid under paragraph (3) for any supplement with 
     required clinical data which is not accepted for filing and 
     shall refund the fee paid under such paragraph for any 
     supplement without required clinical data is not accepted for 
     filing.
       ``(C) 510(k).--The Secretary shall refund the fee paid 
     under paragraph (3) for any substantial equivalence 
     submission under section 510(k) which is not accepted for 
     filing.
       ``(b) Fee Amounts.--
       ``(1) Amount.--Except as provided in paragraph (2) and 
     subsections (c), (d), (f), and (g), the fees required under 
     subsection (a) are as follows:
       ``(A) $52,000 for applications submitted under section 
     515(c) and applications for devices submitted under section 
     351 of the Public Health Service Act,
       ``(B) $7,100 for a supplement with required clinical data,
       ``(C) $4.500 for a supplement without required clinical 
     data, and
       ``(D) $3,200 for a submission under section 510(k).
       ``(2) Small business exception.--
       ``(A) Applications and submissions.--Any person employing 
     fewer than 20 employees, including employees of affiliates, 
     and which does not have a device introduced or delivered for 
     introduction into interstate commerce under a device 
     application--
       ``(i) shall pay one-half the amount of the fee prescribed 
     by paragraph (1)(A) one year after the date of final action 
     by the Secretary on an application of such person which is 
     subject to such fee, and
       ``(ii) shall pay the fee prescribed by paragraph (1)(D) for 
     a submission made by such person under section 510(k) one 
     year after the date of final action by the Secretary on such 
     submission.
       ``(B) Certification.--The Secretary shall require any 
     person who applies to pay a fee in accordance with 
     subparagraph (A) to certify such person's qualification under 
     such subparagraph. The Secretary shall periodically publish 
     in the Federal Register a list of persons making such 
     certification.
       ``(C) Definition.--For purposes of this paragraph, a person 
     is an affiliate of another person when--
       ``(i) directly or indirectly, one person controls, or has 
     the power to control, the other person,
       ``(ii) directly or indirectly, a third party controls, or 
     has the power to control, both persons, or
       ``(iii) an identity of interest between or among such 
     persons exists such that affiliation may be found.
       ``(c) Adjustments.--
       ``(1) Fee adjustment.--Subject to the amount appropriated 
     for a fiscal year under subsection (g), the Secretary shall, 
     in a fiscal year beginning after fiscal year 1995, adjust the 
     fees due in the fiscal year following the fiscal year in 
     which the adjustment is made to reflect the greater of--
       ``(A) the total percentage increase that occurred during 
     the preceding fiscal year in the Consumer Price Index for all 
     urban consumers (all items; U.S. city average) that exceeds 
     3.5 percent, or
       ``(B) the total percentage increase for such preceding 
     fiscal year in basic pay under the General Schedule in 
     accordance with section 5332 of title 5, United States Code, 
     as adjusted by any locality-based comparability payment 
     pursuant to section 5304 of such title for Federal employees 
     stationed in the District of Columbia that exceeds 3.5 
     percent.

     The Secretary shall, by notice published in the Federal 
     Register, make an adjustment under this paragraph within the 
     first 60 days of a fiscal year.
       ``(2) Limit.--The total amount of fees charged, as adjusted 
     under paragraph (1), 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 and 
     related activities.
       ``(d) Fee Waiver or Reduction.--The Secretary shall grant a 
     waiver from or a reduction of a fee for a person under 
     subsection (a) if the person has submitted an application 
     under section 515(c) or section 351 of the Public Health 
     Service Act and if the Secretary finds--
       ``(1) that such application is a device application for a 
     device which has a humanitarian device exemption under 
     section 520(m), or
       ``(2)(A) such waiver or reduction is necessary to protect 
     the public health, and
       ``(B) the assessment of the fee would present a significant 
     barrier to innovation because of limited resources available 
     to such person or other circumstances.
       ``(e) Effect of Failure To Pay Fees.--A device application 
     or supplement submitted by a person subject to fees under 
     subsection (a) shall be considered incomplete and shall not 
     be accepted for review by the Secretary until all fees owed 
     by such person under subsection (a) have been paid. The 
     Secretary may discontinue review of any device application 
     submitted by a person if such person has not paid all fees 
     owed by such person such subsection (a).
       ``(f) Assessement of Fees.--
       ``(1) Limitation.--Fees may not be assessed under 
     subsection (a) for a fiscal year beginning after fiscal year 
     1995 unless appropriations for salaries and expenses of the 
     Food and Drug Administration for such fiscal year (excluding 
     the amount of fees appropriated under chapter 7, chapter 97 
     of title 31, United States Code, or other authority for such 
     fiscal year) are equal to or greater than the amount of 
     appropriations for the salaries and expenses of the Food and 
     Drug Administration for the fiscal year 1994 (excluding the 
     amount of fees appropriated under chapter 7, chapter 97 of 
     title 31, United States Code, or other authority for such 
     fiscal year) multiplied by the adjustment factor applicable 
     to the fiscal year involved.
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year 
     because of paragraph (1) and if at a later date in such 
     fiscal year the Secretary is authorized to assess such fees, 
     the Secretary may assess and collect such fees, without any 
     modification in the rate to account for the time in which the 
     Secretary could not collect such fees.
       ``(g) 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 Food 
     and Drug Administration and shall be available in accordance 
     with appropriation Acts until expended, without fiscal year 
     limitation.
       ``(2) Availability.--Not more than 5 percent of the 
     projected fee receipts in any fiscal year may be used for 
     activities described in subparagraphs (L) and (N) of section 
     741(3), except that up to 15 percent of the projected 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 notice the Food and Drug Administration is not meeting 
     such goals--
       ``(A) the Commissioner shall issue a public notice of the 
     Food and Drug Administration's actual performance level, and
       ``(B) not more than 5 percent of projected fee receipts may 
     be used for such activities until the Commissioner issues a 
     subsequent notice that the Food and Drug Administration 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 appropriation Acts for such 
     fiscal year, and
       ``(B) 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 and related 
     activities (including increases 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.--
       ``(1) General rule.--The number of full-time equivalent 
     employees in the Department of Health and Human Services not 
     engaged in the process of the review of device applications 
     and related activities, may not be reduced by the Secretary 
     to offset the number of officers, employees, and advisory 
     committees so engaged.
       ``(2) Executive order and other limits.--The number of 
     full-time equivalent employees engaged in the process of the 
     review of device applications and related activities are not 
     subject to counting or inclusion in the limits on hiring 
     Civilian Personnel set out in Executive Order 12839 for 
     February 10, 1993, any other current limit, or any limit that 
     may be implemented through September 30, 1999. The full-time 
     equivalent employees not so engaged may not be reduced by the 
     Secretary to offset the number of full-time equivalent 
     employees exempt from such limit.''.

     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 that 
     agency's future plans for meeting such goals. There shall be 
     included in such report--
       (1) a specific statement from the Secretary concerning the 
     Food and Drug Administration's actions to reduce the backlog 
     in the review of device applications and meeting statutory 
     review times applicable to submissions for devices, and
       (2) the following data from the Center for Devices and 
     Radiological Health and the Center for Biologics 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 submissions as 
     calculated by such Center.
       (D) Number of negative decisions for device submissions.
       (E) Number of non-approveable letters for device 
     submissions.
       (F) Number of deficiency letters for device submissions.
       (G) Information for subparagraphs (A) through (F) for 
     fiscal year 1994.
       (b) Second Report.--Within 120 days after the end of each 
     fiscal 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 the Food and Drug Administration 
     made of the fees collected during such fiscal year for which 
     the report is made.
       (c) Committees.--The reports described in subsections (a) 
     and (b) 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 which are appropriate for exemption from the 
     requirement of section 510(k) of such Act and exempts such 
     devices from such requirement following their 
     reclassification into class I.
       (b) Regulations.--
       (1) Proposed.--Not later than 30 days after the date of 
     enactment of this Act, the Secretary shall issue proposed 
     regulations that--
       (A) identify all devices in class I of the device 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 comment on such 
     proposed regulations for 60 days after their publication.
       (2) Final.--Not later than 30 days after the close of the 
     comment period provided under paragraph (1), the Secretary 
     shall issue final regulations which grant an exemption to the 
     devices identified in the proposed regulations which clearly 
     meet the criteria for exemption from the requirement of such 
     section 510(k) of the Federal Food, Drug, and Cosmetic Act.
       (c) Other Regulations.--Not later than June 30, 1995, the 
     Secretary shall issue final regulations for the remainder of 
     the devices from the list published in the proposed 
     regulations which exempts such devices from such requirement 
     or which continues the applicability of such requirement.
       (d) Fees.--An applicant under a 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 subsection (b)(1) shall 
     not be required to pay a fee for such submission unless the 
     Secretary issue a final regulation requiring 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 (b) 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.
                                 ______

      By Mr. SIMON:
  S. 2278. A bill to amend the Harmonized Tariff Schedule of the United 
States to extend certain provisions relating to the production 
incentive certificates for producers in the insular possessions, and 
for other purposes; to the Committee on Finance.


        legislation extending a production incentive certificate

 Mr. SIMON. Mr. President, today I am introducing a simple bill 
to assist an Illinois company that was damaged during Hurricane Hugo. 
The hurricane prevented the Hampden Watch Co. from utilizing a 
previously issued production incentive certificate. The certificate 
would exempt them from duties on certain watch parts.
  The bill I am introducing corrects the expiration date on S. 536. It 
also extends the expiration date on the section of the Haromized Tariff 
Schedule that authorized the production incentive certificate program. 
This date must be amended for the PIC extension to be valid.
  Hampden's contribution to the development of the U.S. Virgin Islands 
is a record to be noted and appreciated by both the insular and Federal 
Government. This bill simply allows Hampden to receive the duty 
exemption that was granted to them as both the Government and the 
company intended. The bill would do this on a one time basis only. I 
think we have a good case for the extension of the expiration date in 
these special circumstances.
  Mr. President, this is an important bill. I urge its adoption by the 
Senate.
                                 ______

      By Mr. COCHRAN:
  S.J. Res. 209. A joint resolution designating November 21, 1994, as 
``National Military Families Recognition Day''; to the Committee on the 
Judiciary.


               national military families recognition day

  Mr. COCHRAN. Mr. President, I am introducing legislation today to 
designate November 21, 1994, as ``National Military Families 
Recognition Day.''
  Military families deserve special recognition for the sacrifices they 
make and the hardships they often endure. Even in peacetime, frequent 
and extended separations, whether from husbands, wives, or children, 
often create special problems for the military family.
  Most active duty personnel are reassigned every few years, thereby 
reducing career opportunities for spouses and limiting their ability to 
establish roots in any location. Military children must adjust to new 
schools and new neighborhoods on a regular basis.
  This joint resolution would set aside a special day for the Nation to 
pay tribute to military families and thank them for their contributions 
to our Nation's security.
  Mr. President, I ask unanimous consent that a copy of the joint 
resolution be printed in the Record, and I urge my colleagues to 
support this legislation.
  Without objection, this bill was ordered to be printed in the Record, 
as follows:

                             S.J. Res. 209

       Whereas the Congress recognizes and supports the Department 
     of Defense policies to recruit, train, equip, retain, and 
     field a military force that is capable of preserving peace 
     and protecting the vital interests of the United States and 
     its allies;
       Whereas military families shoulder the responsibility of 
     providing emotional support for their service members;
       Whereas, in times of war and military action, military 
     families have demonstrated their patriotism through their 
     steadfast support and commitment to the Nation;
       Whereas the emotional and mental readiness of the United 
     States military personnel around the world is tied to the 
     well-being and satisfaction of their families;
       Whereas the quality of life that the Armed Forces provide 
     to military families is a key factor in the retention of 
     military personnel;
       Whereas the people of the United States are truly indebted 
     to military families for facing adversities, including 
     extended separations from their service members, frequent 
     household moves due to reassignments, and restrictions on 
     their employment and educational opportunities;
       Whereas 75 percent of officers and 57 percent of enlisted 
     personnel in the Armed Forces are married;
       Whereas families of active duty military personnel 
     (including individuals other than spouses and children) 
     comprise more than one-half of the active duty community of 
     the Armed Forces, and spouses and children of members of the 
     reserve component of the Armed Forces in paid status comprise 
     more than one-half of the individuals constituting the 
     reserve component of the Armed Forces community;
       Whereas hundreds of thousands of spouses, children, and 
     other dependents living abroad with members of the Armed 
     Forces face financial hardship and feelings of cultural 
     isolation;
       Whereas the significantly reduced global military tensions 
     following the end of the Cold War have resulted in a down-
     sizing of the national defense and a refocusing of national 
     priorities on strengthening the American economy and 
     increasing competitiveness in global marketplace;
       Whereas the Congress is grateful for the sacrifices of 
     military families and is committed to assisting the service 
     members and their families who undergo the transition from 
     active duty to civilian life; and
       Whereas military families are devoted to the overall 
     mission of the Department of Defense and have supported the 
     role of the United States as the military leader and 
     protector of the Free World; Now, therefore, be it
       Resolved by the Senate and House of Representatives of the 
     United States of America in Congress assembled, That November 
     21, 1994, is designated as ``National Military Families 
     Recognition Day'' in appreciation of the commitment and 
     devotion of present and former military families and the 
     sacrifices that such families have made on behalf of the 
     Nation and the President is authorized and requested to issue 
     a proclamation calling on the people of the United States to 
     observe the day with appropriate programs, ceremonies, and 
     activities.

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