[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1369 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                S. 1369

  To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
   development, approval, and use of medical devices to maintain and 
 improve the public health and quality of life of individuals, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 31, 1995

 Mr. Wellstone introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
   development, approval, and use of medical devices to maintain and 
 improve the public health and quality of life of individuals, and for 
                            other purposes.

    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 
Technology, Public Health, and Innovation Act of 1995''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or a 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 
(21 U.S.C. 321 et seq.).

SEC. 2. FINDINGS; MISSIONS STATEMENT.

    (a) Findings.--The Congress finds the following:
            (1) While the United States appropriately puts a top 
        priority on ensuring the safety and efficacy of medical 
        technologies that are introduced into the marketplace the 
        administration of such regulatory effort is causing the United 
        States to lose its leadership role in producing innovative, 
        top-quality medical devices.
            (2) One of the key components of the medical device 
        regulatory process that contributes to the United States losing 
        its leadership role in medical device development is the 
        inordinate amount of time it takes for medical technologies to 
        be reviewed by the United States Food and Drug Administration.
            (3) The most important result of the United States losing 
        its leadership role is that patients in the United States do 
        not have access to new medical technology in a timely manner.
            (4) Delayed patient access to new technology results in 
        lost opportunities to save lives, to reduce hospitalization and 
        recovery time, and to improve the quality of life of patients.
            (5) The economic benefits that the United States medical 
        device industry, which is composed principally of smaller 
        companies, has provided through growth in jobs and global trade 
        are threatened by the slow and unpredictable regulatory process 
        at the Food and Drug Administration.
            (6) The pace and predictability of the medical device 
        regulatory process, together with a perceived adversarial 
        relationship with the Food and Drug Administration, are in part 
        responsible for the increasing tendency of United States 
        medical device companies to shift research, product 
        development, and manufacturing offshore, at the expense of 
        American jobs, patients, and leading edge clinical research.
    (b) Mission Statement.--This legislation seeks to improve the 
timeliness, effectiveness, and predictability of the medical device 
approval process for the benefit of United States patients and the 
United States economy by--
            (1) providing for the use of nationally and internationally 
        recognized performance standards to assist the Food and Drug 
        Administration in determining the safety and effectiveness of 
        medical devices;
            (2) facilitating communication between medical device 
        companies and the Food and Drug Administration;
            (3) redefining clinical testing requirements to reflect the 
        nature of device evolution; and
            (4) targeting the use of Food and Drug Administration 
        resources on those devices that are likely to have serious 
        adverse health consequences.

SEC. 3. PERFORMANCE STANDARDS.

    Section 514 (21 U.S.C. 360d) is amended by adding at the end 
thereof the following new subsection:

            ``establishment and adoption of other standards

    ``(c)(1) The Secretary--
            ``(A) may establish pursuant to subsection (b) performance 
        standards to assist in determining the safety or effectiveness 
        of class III devices under section 515; and
            ``(B) may amend or revoke the performance standards 
        established under subparagraph (A).
    ``(2) The Secretary shall, within 365 days of the date of enactment 
of this subsection, adopt performance standards established by 
nationally and internationally recognized standard-setting entities and 
use the standards when applicable to assist in determining the safety 
and effectiveness of class III devices under section 515.
    ``(3) The Secretary may not require, as the condition for approving 
a premarket approval application under section 515, the conformity of a 
class III device with a performance standard established or adopted 
pursuant to paragraph (1) or (2), respectively, if the applicant 
submits data other than that required by the performance standard to 
demonstrate a reasonable assurance of the safety and effectiveness of 
the device.
    ``(4) The Secretary, in lieu of requiring data demonstrating the 
conformity of a class III device with a standard described in paragraph 
(1) and (2), shall accept certification by the applicant that the 
device conforms with each standard identified in the application.
    ``(5) The Secretary may revoke the performance standards adopted 
under paragraph (2).
    ``(6) A performance standard established under this subsection for 
a device--
            ``(A) shall include provisions to provide reasonable 
        assurance of the safe and effective performance of the device;
            ``(B) shall, where necessary to provide reasonable 
        assurance of the safe and effective performance of the device, 
        include--
                    ``(i) provisions with respect to the construction, 
                components, ingredients, and properties of the device 
                and the compatibility of the device with power systems 
                and connections to the systems;
                    ``(ii) provisions for the testing (on a sample 
                basis or, if necessary, on an individual basis) of the 
                device or, if it is determined that no other more 
                practicable means are available to the Secretary to 
                assure the conformity of the device to the standard, 
                provisions for the testing (on sample basis or, if 
                necessary, on an individual basis) of the device by the 
                Secretary or by another person at the direction of the 
                Secretary;
                    ``(iii) provisions for the measurement of the 
                performance characteristics of the device;
                    ``(iv) provisions requiring that the results of 
                each or certain of the tests of the device required to 
                be made under clause (ii) demonstrate that the device 
                is in conformity with those portions of the standard 
                for which the test or tests were required; and
                    ``(v) a provision requiring that the sale and 
                distribution of the device be restricted to the extent 
                that the sale and distribution of the device is 
restricted under a regulation under section 520(e); and
            ``(C) shall, where appropriate, require the use and 
        prescribe the form and content of labeling for the proper 
        installation, maintenance, operation, and use of the device.''.

SEC. 4. PREMARKET APPROVAL.

    (a) Application.--Section 515(c) (21 U.S.C. 360e(c)) is amended--
            (1) in paragraph (1)--
                    (A) by striking subparagraph (D); and
                    (B) by redesignating subparagraphs (E), (F), and 
                (G) as subparagraphs (D), (E), and (F), respectively; 
                and
            (2) by adding at the end thereof the following new 
        paragraphs:
    ``(3)(A) An applicant--
            ``(i) shall include in an application described in 
        paragraph (1) an identifying reference to any applicable 
        performance standard established or adopted under paragraph (1) 
        or (2) of section 514(c), respectively; and
            ``(ii) shall include in the application--
                    ``(I) a certification by the applicant as described 
                in section 514(c)(4), that the device complies with the 
                applicable performance standard; or
                    ``(II) data to support the safety or effectiveness 
                of the device.
    ``(B)(i) Except as provided in clause (ii), the Secretary may not 
require an applicant who submits an application for premarket approval 
for a class III device under paragraph (1) to submit preclinical data 
and information regarding the device relevant to a performance standard 
established or adopted under paragraph (1) or (2) of section 514(c), 
respectively, if such standard defines performance or other 
specifications for the device, and the applicant certifies that the 
device conforms to the standard.
    ``(ii) The Secretary may require an applicant described in clause 
(i) to submit preclinical data and information regarding a class III 
device if additional information or data are necessary to protect 
patient safety.
    ``(C) The Secretary shall require an applicant who certifies that a 
device conforms to an applicable performance standard established or 
adopted under paragraph (1) or (2) of section 514(c), respectively to 
maintain data demonstrating such conformance for a period of time that 
is equal to the period of time for the design and expected life of the 
device and to make the data available to the Secretary upon request.
    ``(D) The Secretary may deny, withdraw, or temporarily suspend 
approval of a premarket approval application for a class III device 
if--
            ``(i) the Secretary determines that the device does not 
        conform to an applicable performance standard (on which the 
        applicant relied) established or adopted under paragraph (1) or 
        (2) of section 514(c), respectively; and
            ``(ii) such conformance is considered by the Secretary to 
        be material in approving the device.
    ``(4) The Secretary shall accept retrospective or historical 
clinical data as a control or for use in determining whether there is a 
reasonable assurance of device safety and effectiveness if the data are 
available and the effects of the device on disease progression are 
clearly defined and well understood.
    ``(5) The Secretary may not require the sponsor of an application 
to conduct clinical trials for a device using randomized controls 
unless--
            ``(A)(i) such controls are scientifically and ethically 
        feasible;
            ``(ii) the effects of the device on disease progression are 
        not clearly defined and well understood as determined by the 
        Secretary; and
            ``(iii) retrospective or historical data are not available 
        that meet the standards of the Secretary for quality and 
        completeness; or
            ``(B) such controls are necessary to support specific 
        marketing claims.
    ``(6) The Secretary may not require in a supplement to a premarket 
approval application data from randomized clinical trials for a 
modification to a device if--
            ``(A) the modification does not substantially and adversely 
        affect safety or effectiveness; and
            ``(B) the modified device has the same intended use and is 
        intended for similar patient populations as the approved 
        device.''.
    (b) Action on Application.--Section 515(d) (21 U.S.C. 360e(d)) is 
amended--
            (1) in paragraph (1)(A), by striking ``paragraph (2) of 
        this subsection'' each place it appears and inserting 
        ``paragraph (6)'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (6) and (7), respectively; and
            (3) by inserting after paragraph (1) the following new 
        paragraphs:
    ``(2) Each premarket approval application and supplement received 
by the Secretary under subsection (c) shall be reviewed in the 
following manner to achieve final action on the application within 180 
days of the receipt of the application:
            ``(A) The Secretary shall make a determination within 30 
        days of the receipt of an application filed under subsection 
        (c) of whether the application satisfies the content 
        requirements of paragraphs (1) and (3) of subsection (c) and 
        applicable regulations, and the Secretary shall notify the 
        applicant of the determination and whether the application has 
        been accepted or has not been accepted for review for premarket 
        approval. If the Secretary fails to notify the applicant within 
        the 30-day period that the application is not sufficiently 
        complete to permit a substantive review, the application shall 
        be considered as filed by the Secretary.
            ``(B) The Secretary shall, within 45 days after the date of 
        the acceptance of an application for review under subparagraph 
        (A)--
                    ``(i) provide the applicant the opportunity for a 
                meeting (or teleconference) with the Secretary to--
                            ``(I) inform the applicant of the general 
                        progress and status of the application;
                            ``(II) advise the applicant of deficiencies 
                        in the application that have not been 
                        communicated to the applicant.
        The applicant shall have the right to be informed in writing 
        with respect to the information communicated to the applicant 
        during the meeting or teleconference under subclauses (I) and 
        (II).
                    ``(ii) determine whether an advisory panel should 
                be convened by the Secretary to review the application 
                or to consider an issue related to the application.
            ``(C) The Secretary shall, within 90 days after the date of 
        the acceptance of an application for review under subparagraph 
        (A) provide an applicant the opportunity for a meeting (or 
        teleconference) with the Secretary to--
                    ``(i) inform the applicant of the general progress 
                and status of the application;
                    ``(ii) review actions taken by the applicant to 
                correct deficiencies identified at the 45-day meeting 
                described in subparagraph (B);
                    ``(iii) advise the applicant of the deficiencies in 
                the application that have not been communicated to the 
                applicant; and
                    ``(iv) review the proposed labeling for the device.
        The applicant shall have the right to be informed in writing 
        with respect to the information communicated to the applicant 
        during the meeting or teleconference under clauses (i) through 
        (iv).
            ``(D)(i) When an advisory panel is convened under 
        subparagraph (B)(ii) to review an application or to consider an 
        issue related to the application, the Secretary shall within 15 
        days after the close of the advisory panel meeting provide the 
        applicant the opportunity for a meeting (or teleconference) 
        with the Secretary to identify any remaining issues with 
        respect to the approval of the application.
            ``(ii) If an advisory panel is not convened under 
        subparagraph (B)(ii), the Secretary shall, within 120 days 
        after the date of the acceptance of an application for review 
        under subparagraph (A), provide the applicant the opportunity 
        for a meeting (or teleconference) with the Secretary to--
                    ``(I) inform the applicant of the general progress 
                and status of the application;
                    ``(II) review the actions taken to correct 
                deficiencies identified in the application at the 90-
                day meeting described in subparagraph (C); and
                    ``(III) advise the applicant of the deficiencies in 
                the application that have not been communicated to the 
                applicant.
            ``(iii) The applicant shall have the right to be informed 
        in writing with respect to the information communicated to the 
        applicant during the meeting or teleconference under clauses 
        (i) and (ii).
            ``(E) The Secretary shall, within 150 days after the date 
        of the acceptance of an application for review under 
        subparagraph (A), notify the applicant of the decision of the 
        Secretary to approve or disapprove the application.
            ``(F) The Secretary shall exclude the time that an 
        applicant takes to respond to the Secretary's requests for 
        additional data or information in determining when the 45-day, 
        90-day, 120-day and 150-day periods described in subparagraphs 
        (B), (C), (D), and (E) expire.
    ``(3) To permit better treatment or better diagnoses of life-
threatening or irreversibly debilitating diseases or conditions, the 
Secretary shall expedite the review for devices--
            ``(A) representing breakthrough technologies;
            ``(B) offering significant advantages over existing 
        approved alternatives; or
            ``(C) for which accelerated availability is in the best 
        interest of the public health.
    ``(4)(A) The Secretary shall annually publish a status report on 
the premarket clearance or approval of applications and other device 
submissions.
    ``(B) The report described in subparagraph (A) shall include--
            ``(i) a specific statement from the Secretary concerning 
        the performance of the Food and Drug Administration in reducing 
        the backlog in the reviewing of applications for premarket 
        clearance or approval for a device and meeting statutory time 
        limitations applicable to the review of the applications;
            ``(ii) with respect to devices, data (which shall be 
        provided by the Center for Devices and Radiological Health and 
        each division of the Office of Device Evaluation of the Center 
        for Devices and Radiological Health) on--
                    ``(I) the number of premarket approval 
                applications, supplements, premarket notifications, and 
                applications for investigational device exemptions, not 
accepted for filing by the Secretary;
                    ``(II) the total time (beginning on the date of the 
                filing of an application and ending on the date of the 
                clearance or approval of the application) required to 
                review the premarket approval applications, 
                supplements, premarket notifications, and applications 
                for investigational device exemptions;
                    ``(III) the total time (excluding the time periods 
                permitted for an applicant to prepare and submit to the 
                Secretary responses or additional information or data 
                requested by the Secretary) as calculated by the Food 
                and Drug Administration to complete the review of each 
                premarket approval application, supplement, premarket 
                notification, and application for investigational 
                device exemption;
                    ``(IV) the number of adverse decisions made with 
                respect to the applications and supplements described 
                in subclause (II);
                    ``(V) the number of nonapprovable letters for 
                device submissions;
                    ``(VI) the number of deficiency letters for device 
                submissions;
                    ``(VII) the number of times applicants are required 
                to supply information during the review of an 
                application or supplement described in subclause (II); 
                and
                    ``(VIII) the performance of the actions described 
                in paragraph (2), including performance information 
                with respect to the number of premarket approval 
                applications that were or were not reviewed within the 
                time limitations described in such paragraph and the 
                time necessary to carry out each of the actions; and
            ``(iii) baseline data for the data described in subclauses 
        (I) through (VII) of clause (ii) for the preceding year.
    ``(5) The Secretary shall complete the review of all premarket 
approval supplements that do not contain clinical data within 90 days 
of the receipt of a supplement that has been accepted for filing.''.
    (c) Elimination of Premarket Approval of Supplements.--The 
Secretary of Health and Human Services shall eliminate premarket 
approval of supplements that relate to manufacturing and product 
changes of a device that can be demonstrated through appropriate 
protocols or other methods to not affect adversely the safety or 
effectiveness of a device. The Secretary of Health and Human Services 
shall require the manufacturer of a device to submit to the Secretary 
of Health and Human Services any information relied upon to support a 
device-related change that is not subject to premarket approval of a 
supplement to an application approved under section 515 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e). The information shall be 
made a part of the device master record. The information shall be 
maintained for a period of time equal to the period of time for the 
design and expected life of the device, but not less than 2 years after 
the date of release of the device for commercial distribution by the 
manufacturer.

SEC. 5. PREMARKET NOTIFICATION REQUIREMENTS.

    (a) Exemption for Class I and II Devices.--Section 510 (21 U.S.C. 
360) is amended by adding at the end thereof the following new 
subsection:
    ``(l) Within 365 days of the date of enactment of this section, the 
Secretary shall exempt from the notification requirement under 
subsection (k) class I and II devices that should not be subject to the 
notification requirement because such notification is not necessary to 
provide a reasonable assurance of the safety and effectiveness of the 
devices. Prior to making such determination, the Secretary shall 
provide an opportunity for notice and comment with respect to the 
appropriateness of the exemption for the class I and II devices.''.
    (b) Limitation on Notification.--
            (1) In general.--The Secretary of Health and Human Services 
        shall not enforce the requirement for additional notifications 
        under section 510(k) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360(k)) for a change or modification to a device 
        initially classified under section 513(f) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360c(f)) that--
                    (A) is other than a major change or a major 
                modification in the intended use;
                    (B) is supported by nonclinical data or 
                information, when appropriate; and
                    (C) can be shown to not adversely affect the safety 
                and effectiveness of the device.
            (2) Maintenance of notification data.--The Secretary of 
        Health and Human Services shall require the manufacturer of a 
        device to submit to the Secretary of Health and Human Services 
        all data and information relied upon to document that a change 
        or modification of a device described in paragraph (1) does not 
        require an additional notification under section 510(k). The 
        data and information shall be made a part of the device master 
        record. The data and information shall be maintained for a 
        period of time equal to the period of time for the design and 
        expected life of the device, but not less than 2 years after 
        the date of release of the device for commercial distribution 
        by the manufacturer.

SEC. 6. INVESTIGATIONAL DEVICE EXEMPTION.

    (a) Regulations.--Section 520(g) (21 U.S.C. 360j(g)) is amended--
            (1) by redesignating paragraphs (4) and (5) as paragraphs 
        (5) and (6), respectively; and
            (2) by inserting after paragraph (3) the following new 
        paragraph:
    ``(4) The Secretary shall, within 120 days of the date of enactment 
of this paragraph, by regulation amending the content of part 812 of 
title 21 of the Code of Federal Regulations, amend the procedures with 
respect to the approval of studies under this subsection as follows:
            ``(A) The regulation shall include provisions that require 
        the Secretary to permit the sponsor to meet with the Secretary 
        prior to the submission of an application to develop a protocol 
        for a study subject to the regulation, that require that the 
        protocol shall be agreed upon in writing by the sponsor and the 
        Secretary, and that set forth a time limitation for the sponsor 
        to conduct a followup of a study.
            ``(B) The regulation shall require the Secretary to permit 
        developmental changes in devices subject to the regulation in 
        response to information gathered during the course of an 
        investigation without requiring an additional approval of an 
        application for an investigational device exemption, or the 
        approval of a supplement to the application, if the changes 
        meet the following requirements:
                    ``(i) The changes do not constitute a significant 
                change in the design of the product or a significant 
                change in basic principles of operation.
                    ``(ii) The changes do not adversely affect patient 
                safety.
        The regulation shall require that such a change be documented 
        in records the applicant is required to maintain with respect 
        to the investigational device exemption.
            ``(C) The regulation shall provide for the use of an 
        investigational device for diagnosis or treatment use under a 
        protocol or investigational device exemption if the following 
        requirements are met:
                    ``(i) The device is intended to treat or diagnose a 
                serious or immediately life-threatening disease.
                    ``(ii) There is no comparable or satisfactory 
                device or other therapy available to treat or diagnose 
                that disease in the intended patient population.
                    ``(iii) The device is under investigation in a 
                controlled clinical trial under an investigational 
                device exemption in effect for the trial or all 
                clinical trials for the device have been completed.
                    ``(iv) The sponsor of the controlled clinical trial 
                is actively pursuing marketing approval of the 
                investigational device with due diligence.
            ``(D) The regulation shall require the Secretary to consult 
        with advisory panels, which have the appropriate expertise, 
        with respect to the establishment of an appropriate time 
        limitation for the conduct of a followup study by the sponsor 
        of the study.
    (b) Conforming Amendments.--Section 517(a)(7) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360g(a)(7)) is amended--
            (1) by striking ``section 520(g)(4)'' and inserting 
        ``section 520(g)(5)''; and
            (2) by striking ``section 520(g)(5)'' and inserting 
        ``section 520(g)(6)''.

SEC. 7. ESTABLISHMENT OF A POLICY AND PERFORMANCE REVIEW PANEL.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
901 et seq.) is amended by adding at the end thereof the following new 
section:

``SEC. 906. POLICY AND PERFORMANCE REVIEW PANEL.

    ``(a) Establishment.--There is established a panel to be known as 
the Food and Drug Policy and Performance Review Panel (hereafter 
referred to in this section as the `Panel').
    ``(b) Membership.--The members of the Panel shall be appointed by 
the Secretary in accordance with subsection (d)(1) and shall include--
            ``(1) individuals with expertise in medical, scientific, 
        and health policy and regulatory issues;
            ``(2) representatives of industry, voluntary health 
        associations, and patient advocacy groups; and
            ``(3) representatives of the Food and Drug Administration.
    ``(c) Terms.--
            ``(1) In general.--Each member of the Panel shall serve for 
        a term of not more than 3 years and the terms of office of such 
        members shall be staggered.
            ``(2) Reappointment.--Each member of the Panel may be 
        reappointed, but may not serve more than 3 consecutive terms.
            ``(3) Vacancies.--Any vacancy in the Panel shall not affect 
        the powers of the Panel and shall be filled in the same manner 
        as the original appointment.
    ``(d) Organizational Structure.--
            ``(1) In general.--The Chairperson of the Panel shall 
        organize the Panel in a manner that will ensure that there is a 
        portion of the membership of the Panel monitoring the 
        activities of each Center within the Food and Drug 
        Administration. The membership of the Panel shall be composed 
        of individuals with expertise necessary to ensure appropriate 
        review of the performance of each Center.
            ``(2) Definition.--For the purposes of this section, the 
        term `Center' means the Center for Devices and Radiological 
        Health, Center for Drug Evaluation and Research, Center for 
        Biologics Evaluation and Research, Center for Food Safety and 
        Applied Nutrition, Center for Veterinary Medicine, and Center 
        for Toxicological Research.
    ``(e) Chairperson and Vice Chairperson.--The Secretary shall select 
a Chairperson and Vice Chairperson from among the members of the Panel.
    ``(f) Initial Meeting.--Not later than 30 days after the date on 
which all members of the Panel have been appointed, the Panel shall 
hold its first meeting.
    ``(g) Meetings.--The Panel shall meet at the call of the 
Chairperson.
    ``(h) Quorum.--A majority of the members of the Panel shall 
constitute a quorum, but a lesser number of members may hold hearings.
    ``(i) Duties.--The Panel shall--
            ``(1) monitor the activities carried out by the Secretary 
        through the Commissioner of Food and Drugs;
            ``(2) review the performance of the Food and Drug 
        Administration to determine if the Food and Drug Administration 
        is carrying out its mission to protect and promote the public 
        health and is developing appropriate policy and effective 
        regulations to carry out its mission;
            ``(3) review the performance of each Center in accordance 
        with subsection (d)(1);
            ``(4) meet at least twice annually with appropriate 
        management officials of the Food and Drug Administration and 
        representatives of each Center;
            ``(5) participate in the development of agency guidelines; 
        and
            ``(6) seek to facilitate the international harmonization of 
        regulatory requirements, while ensuring that a product that is 
        subject to the provisions of this Act, and that is marketed in 
        the United States, is safe and effective.
    ``(j) Report.--The Panel shall annually prepare and submit to the 
Committee on Commerce of the House of Representatives and the Committee 
on Labor and Human Resources of the Senate a report that evaluates the 
performance of the Food and Drug Administration (including a 
description of the activities that the Food and Drug Administration has 
successfully or unsuccessfully carried out) and includes a 
recommendation on the administrative modifications needed to improve 
such performance.
    ``(k) Hearings.--The Panel may hold such hearings, sit and act at 
such times and places, take such testimony, and receive such evidence 
as the Panel considers advisable to carry out the purposes of this Act.
    ``(l) Information From Federal Agencies.--The Panel may secure 
directly from any Federal department or agency such information as the 
Panel considers necessary to carry out the provisions of this Act. Upon 
request of the Chairperson of the Panel, the head of such department or 
agency shall furnish such information to the Panel.
    ``(m) Postal Services.--The Panel may use the United States mails 
in the same manner and under the same conditions as other departments 
and agencies of the Federal Government.
    ``(n) Detail of Government Employees.--Any Federal Government 
employee may be detailed to the Panel without reimbursement, and such 
detail shall be without interruption or loss of civil service status or 
privilege.
    ``(o) Procurement of Temporary and Intermittent Services.--The 
Chairperson of the Panel may procure temporary and intermittent 
services under section 3109(b) of title 5, United States Code, at rates 
for individuals which do not exceed the daily equivalent of the annual 
rate of basic pay prescribed for level V of the Executive Schedule 
under section 5316 of such title.
    ``(p) Termination of the Panel.--The termination provisions of 
section 14 of the Federal Advisory Committee Act (5 U.S.C. App.) shall 
not apply to the Panel.''.
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