Sets performance goals with respect to the amount appropriated for the Food and Drug Administration for devices and radiological products providing that the appropriations reach a certain level.
Restricts the medical device user fees collected to being used to defray increases in the costs of the resources allocated for the review of device applications. Authorizes appropriations. Exempts certain entities submitting premarket reports from being subject to a fee, including a person filing his first such report if before October 1, 2002, the person submitted a premarket application for the same device.
(Sec. 103) Establishes requirements for reporting by the Secretary concerning performance goals and fees.
(Sec. 104) Authorizes appropriations for the postmarket surveillance of medical devices.
Directs the Secretary to conduct a study regarding the medical device user-fee program established under this Act.
(Sec. 105) Directs the Secretary to consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and various other entities in: (1) developing recommendations to Congress for goals and plans related to the review of medical device applications for fiscal years after 2007; and (2) completing the reauthorization of parts of the Federal Food, Drug, and Cosmetic Act.
(Sec. 107) Sets a sunset date of October 1, 2007, for the amendments regarding fees related to medical devices, except that the reporting requirements shall cease to be effective January 31, 2008.
Title II: Amendments Regarding Regulation of Medical Devices - (Sec. 201) Directs the Secretary to accredit persons who are not Federal employees to conduct the inspections required under the Act for establishments that manufacture, prepare, propagate, compound, or process class II or class III devices. Requires the Secretary to publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform such inspections. Sets forth minimum requirements for inspectors and qualifications establishments must meet to receive inspectors.
Directs the Comptroller General to determine the amount obligated by the Secretary for fiscal year 2002 for FDA compliance activities with respect to devices, and of such amount, the amount obligated for inspections of device establishments. Establishes reporting requirements for the Comptroller General. Sets a sunset date of October 1, 2012, for the provisions of this section.
(Sec. 202) Sets a sunset date of October 1, 2007, for the third-party accreditation program authority. Establishes a requirement for the Secretary to report to Congress after conducting a study based on the experience under such program.
(Sec. 203) Requires the Secretary to establish within the Office of the Commissioner of Food and Drugs an Office to perform various functions, including to ensure the timely premarket review of combination products. Directs the Office to consult with the relevant component within the Office of the Commissioner of Food and Drugs in performing its duties.
Directs the Secretary, acting through the office, to review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers to verify compliance with the requirements of this Act. Establishes reporting requirements for the Secretary.
(Sec. 204) Directs the Secretary to report to Congress on the timeliness and effectiveness of device premarket reviews by centers other than the Center for Devices and Radiological Health.
(Sec. 205) Allows labeling for prescription devices intended for use in health care facilities to be made available solely by electronic means, provided that a manufacturer furnishes a paper copy for free upon request by a health care facility.
(Sec. 206) Requires that specified submissions regarding registration of producers of drugs and devices shall be made electronically, upon a finding by the Secretary that such action is feasible. Permits the Secretary to grant waivers of such requirement.
(Sec. 207 ) Eliminates the sunset for certain provisions regarding intended (human) use for substantial equivalence determinations.
(Sec. 208) Provides for modular review by the Secretary of applications for premarket approval of class III devices.
(Sec. 209) Directs the Secretary to require that a panel advising on premarket approval of a class III device must include, or consult with, one or more pediatric experts if there is a reasonable likelihood of the device being used in a pediatric population.
(Sec. 210) Requires the Secretary to publish on the Internet lists of each type of class II device not requiring a report in order to provide reasonable assurance of the devices' safety and effectiveness.
(Sec. 211) Requires the Secretary to request the Institute of Medicine to conduct a study to determine whether the system under the Federal Food, Drug, and Cosmetic Act for postmarket surveillance regarding pediatric populations is adequate.
(Sec. 212) Directs the Secretary to provide guidance on ensuring safety of pediatric devices and providing protections for pediatric subjects in clinical investigations into the safety and effectiveness of such devices.
(Sec. 213) Requires the Comptroller General to conduct a study of breast implants, including to determine the number of adverse events that have been reported and whether such events have been adequately investigated. Establishes reporting requirements.
(Sec. 214) Requires the Director of the National Institutes of Health to submit to Congress a report describing the status of research on breast implants. Requires the Director to conduct or support prospective or retrospective research to examine the long-term health implications of both saline and silicone breast implants.
Title III: Additional Amendments - (Sec. 301) Requires the identification of the manufacturer of a medical device to be displayed on the device or an attachment thereto, with exemptions allowed to be issued by the Secretary.
(Sec. 302) Requires reprocessed single-use devices to carry prominently on the label a statement identifying the product as such, along with the name of the person responsible for reprocessing and the manufacturer. States that such provision shall cover devices introduced or delivered for introduction into interstate commerce after the date 15 months following the passage of this Act.
Amends provisions regarding registration of producers of drugs and devices, including with respect to: (1) certain reprocessed single-use devices that require reports preceding introduction into interstate commerce; (2) such devices that do not require reports; and (3) such devices classified as class III and for which a premarket application is required.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3580 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 3580
To amend the Federal Food, Drug, and Cosmetic Act to make improvements
in the regulation of medical devices, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 20, 2001
Mr. Greenwood (for himself, Ms. Eshoo, Mr. Upton, Mr. Pallone, Mr.
Deutsch, Mr. Towns, Mr. Bryant, and Mr. Barton of Texas) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to make improvements
in the regulation of medical devices, 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 TO ACT.
(a) Short Title.--This Act may be cited as the ``Medical Device
Amendments of 2001''.
(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. DESIGNATION AND REGULATION OF COMBINATION AND SINGLE ENTITY
PRODUCTS.
Section 503(g) is amended by redesignating paragraph (4) as (5) and
inserting after paragraph (3) the following paragraph:
``(4)(A) Within six months after the date of the enactment of the
Medical Device Amendments of 2001, the Secretary shall establish within
the Office of the Commissioner of Food and Drugs an office to be known
as the Office of Combination Products and Product Jurisdiction
(referred to in this paragraph as the `Office'), which shall be
responsible for designating the Center with primary or exclusive
responsibility for the premarket and postmarket regulation of drugs,
devices and biological products. The Office shall be managed by a
person with appropriate scientific expertise and shall oversee the
regulation of such products to ensure timely and effective premarket
reviews, and predictable and consistent postmarket requirements.
``(B) The Office shall assign for regulation all products subject
to this Act based on the primary mode of action. The component within
the Food and Drug Administration with primary or exclusive
responsibility for regulating a product shall be determined according
to the requirements of subparagraphs (A) through (C) of paragraph (1).
All products which meet the definition of device or drug within the
meaning of section 201, or biological product as defined under section
351(i) of the Public Health Service Act shall be regulated only by the
persons within the Food and Drug Administration who are primarily
charged with the regulation of such products. In vitro reagents, as
that term is used in section 201(h), shall be regulated by those
persons within the Food and Drug Administration primarily charged with
reviewing devices.
``(C)(i) The assignment of a product to a component of the Food and
Drug Administration shall be for purposes of premarket and postmarket
regulation.
``(ii) After such an assignment, all persons associated with shared
premarket reviews, including reviews with input from a consulting
agency component or reviews in which more than one premarket clearance
is necessary, shall be responsible to and under the supervision of the
Office for purposes of such reviews.
``(iii) Any disputes regarding the timeliness or substance of such
reviews may be presented to the Office for resolution. The decision of
the Office shall be subject exclusively to review by the Commissioner
of Food and Drugs and such review shall not be delegated.
``(iv) The postmarket regulatory requirements for combination
products shall be under the same type of product authorities as those
relied upon to approve, clear, or license such products, unless two
types of product authorities are necessary to permit the commercial
distribution of a combination product. When more than one type of
product authority is necessary to permit the commercial distribution of
a combination product, each component of such product shall be subject
to the postmarket requirements of the regulatory authority relied upon
to permit the commercial distribution of each such component comprising
the combination product.
``(D) The Office shall not be bound by any existing agreement,
guidance or agency practice recommending assignment or assigning any
device, drug, biological product, or combination product to any
component of the Food and Drug Administration, unless the product is
assigned to the agency component primarily charged with regulating each
such product. The Office shall review each agency agreement, guidance
or practice and determine whether they are consistent with the
requirements of this subsection. As part of the review process, the
Office shall publish for comment each such agreement, guidance or
statement of practices. After receipt and analysis of comments, the
Office shall determine whether to adopt, and to what extent, any of the
agency's existing agreements, guidance documents or practices.
``(E) One year after the date of the enactment of the Medical
Device Amendments of 2001 and for each year thereafter, the Secretary
shall report to the appropriate committees of Congress the
accomplishments, including the impact on the efficiency and quality of
product regulation, of the Office. Among other things, such report
shall describe the activities of the Office, identify the number of
premarket reviews involving more than one review component of the Food
and Drug Administration, discuss the timeliness and consistency of
combination product premarket reviews, and demonstrate the Office's
progress or lack of progress in ensuring timely and effective reviews
of such products.''.
SEC. 3. STRENGTHENING THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.
Section 523 (21 U.S.C. 360m) is amended--
(1) in subsection (a), by striking paragraph (3) and
inserting the following:
``(3) Eligible devices.--
``(A) In general.--Each type of device subject to
the requirement of premarket notification under section
510(k) shall be eligible for review by persons
accredited under subsection (a), unless the Secretary
after notice and comment promulgates a regulation
excluding a type of device or specific devices within a
type from review by accredited persons under this
section.
``(B) Exception.--Any type of device or specific
device that was eligible for premarket notification
review by persons accredited under this section six
months prior to the date of the enactment of the
Medical Device Amendments of 2001 shall continue to be
eligible for such review, unless the Secretary
determines that premarket notification by the Secretary
is necessary to assure reasonable assurance of safety
and effectiveness. After making this determination, the
Secretary shall promulgate a regulation after notice
and comment rulemaking to exclude such a type of device
or specific device from review under this section.'';
and
(2) by striking subsection (c).
SEC. 4. AUGMENTING EXPERTISE.
(a) Center for Devices Fellowship Program.--The Federal Food, Drug
and Cosmetic Act is amended by adding at the end the following:
``SEC. 908. DEVICES FELLOWSHIP PROGRAM.
``(a) In General.--Without regard to the provisions of title 5,
United States Code, governing appointments in the competitive service
and without regard to the provisions of chapter 51 and subchapter III
of chapter 53 of such title relating to classification and General
Schedule pay rates, the Commissioner of Food and Drugs may establish a
fellowship program within the component of the agency responsible for
regulating devices for the purpose of augmenting and enriching the
scientific expertise of that agency component. Any person receiving
such a fellowship shall be available to participate in any matter in
which the participation of such person would not create a conflict of
interest, and shall be subject to the same requirements applicable to
full time employees regarding the protection and use of trade secret
and confidential commercial or financial information.
``(b) Eligibility.--Any qualified person not an employee of the
Federal or a state government may be eligible for the fellowship
identified in subsection (a). The granting of a fellowship to the
candidate shall be the result of the unanimous agreement of a group of
five (5) senior officials designated by the Commissioner, including at
least three from the component of the Food and Drug Administration
responsible for regulating devices. These officials shall evaluate the
technical background and achievements of each candidate, the
significance of the candidate's expertise to the agency's needs, and
the candidate's character and likely contributions to the agency.''.
(b) Outside Expert Reviews.--Section 515(c) (21 U.S.C. 360e(c) is
amended by adding at the end the following:
``(3)(A) Either at the initiation of the Secretary or the
applicant, any person who is (i) not an employee of the Federal or a
state government, and (ii) an expert in a subject matter germane to an
application under paragraph (1) may be selected by the Secretary to
review all or part of a premarket approval application submitted under
this section, after considering recommendations of experts from
applicants, if any. The decision to use such an expert shall be made by
agreement between the Secretary and the applicant, and the applicant
may choose not to retain an expert for any reason, including the cost
of the expert's compensation. The compensation for such an expert
review shall be determined by the expert and the applicant.
``(B) The Secretary shall prescribe the terms of the review,
including the amount of time allocated to such experts to submit to the
Secretary and the applicant a report and recommendation evaluating that
portion of the application the Secretary designated for review.
``(C) The Secretary shall promptly consider the recommendation of
an expert reviewer and provide a detailed written explanation of any
portion of the recommendation with which the Secretary disagrees.''.
(c) Inspections by Accredited Persons.--Section 704 (21 U.S.C. 374)
is amended by adding at the end the following:
``(g)(1) Not later than one year after the date of the enactment of
the Medical Device Amendments of 2001, the Secretary shall accredit
persons to conduct inspections authorized under subsection (a) at
facilities designated as eligible for inspections by accredited persons
who are not employees of the Federal or a state government. The owner
or operator of an eligible facility shall have the option to use an
accredited person in lieu of officers or employees designated by the
Secretary to conduct such inspections, including inspections to satisfy
the good manufacturing practice requirements of section 515.
``(2) Not later than 180 days after the date of the enactment of
the Medical Device Amendments of 2001, the Secretary shall publish in
the Federal Register criteria to accredit or deny accreditation to
persons who request to perform the duties specified in paragraph (1).
Thereafter, the Secretary shall respond to a request for accreditation
within 60 days of the receipt of a request. The accreditation shall
state that such person is accredited to conduct device facility
inspections under subsection (a).
``(3) An accredited person shall, at a minimum, meet the following
requirements:
``(A) Such person shall be an independent organization
which is not owned or controlled by a manufacturer, supplier,
or vendor of articles regulated under the Act and which has no
organizational, material, or financial affiliation with such a
manufacturer, supplier, or vendor.
``(B) Such person shall be a legally constituted entity
permitted to conduct the activities for which it seeks
accreditation.
``(C) Such person shall not engage in the design,
manufacture, promotion, or sale of articles regulated under the
Act.
``(D) The operations of such person shall be in accordance
with generally accepted professional and ethical business
practices and such persons shall agree in writing that as a
minimum it will--
``(i) certify that reported information accurately
reflects data reviewed;
``(ii) limit work to that for which competence and
capacity are available;
``(iii) treat information received, records,
reports, and recommendations as confidential commercial
or financial information or trade secret information;
and
``(iv) protect against the use, in carrying out
paragraph (1), of any officer or employee of the
accredited person who has a financial conflict of
interest regarding any product regulated under the Act,
and annually make available to the public disclosures
of the extent to which the accredited person, and the
officers and employees of the person, have maintained
compliance with requirements under this clause relating
to financial conflicts of interest.
``(4) The Secretary shall publish a list of accredited persons to
conduct inspections under subsection (a) on the Food and Drug
Administration's web page. Those who elect to employ an accredited
person shall select such a person from the list posted by the
Secretary. Such list shall be periodically updated to ensure that the
identity of each accredited person is known to the public. The updating
of such list shall be no later than one month after the accreditation
of a person under this subsection.
``(5) To ensure that persons accredited under this subsection
continue to meet the standards of accreditation, the Secretary shall
(i) audit the performance of such persons on a periodic basis; and (ii)
take such additional measures as the Secretary deems appropriate,
including the withdrawal of accreditation when persons accredited under
this subsection fail to maintain compliance with the accreditation
criteria established by the Secretary.
``(6) Device facilities in which the Secretary classified the
results of the facility's most recent inspection under subsection (a)
as ``no action indicated'' or ``voluntary action indicated'', or those
facilities in which after the most recent inspection, the Secretary
determines that satisfactory compliance with section 520(f) supports
the approval of a device under section 515, shall be eligible for
inspections by persons accredited by the Secretary under paragraph (2).
The Federal Food and Drug Administration shall not inspect an eligible
facility unless--
``(A) the facility is not inspected by an accredited person
for the 2 year period following the date of a ``no action
indicated'' or ``voluntary action indicated'' finding by the
Secretary;
``(B) after an inspection by the Secretary, or after the
Secretary's review of a report of an inspection from an
accredited person, the Secretary determines in writing that a
facility is no longer eligible for inspections by accredited
persons; or
``(C) the Secretary has good cause for conducting an
inspection.
``(7) Persons accredited under this subsection to conduct
inspections shall record in writing their inspection observations and
shall present to the device facility's designated representative and
discuss each observation. Additionally, such accredited person shall
prepare an inspection report in a form and manner consistent with such
reports prepared by employees and officials designated by the Secretary
to conduct inspections under subsection (a). At a minimum, such reports
shall identify the persons responsible for good manufacturing practice
compliance at an inspected establishment, discuss in detail each
observation identified by the accredited person, identify other matters
that relate or may influence compliance with the Act, and discuss any
recommendations made during the inspection or at the inspection's
closing meeting. The report of the inspection shall be sent to the
Secretary and the designated representative of an inspected facility at
the same time, but under no circumstances later than 3 weeks after the
last day of the inspection.
``(8) Compensation for an accredited person shall be determined by
agreement between the accredited person and the person who engages the
services of the accredited person, and shall be paid by the person who
engages such services.''.
SEC. 5. SPECIAL PROCESS FOR BREAKTHROUGH TECHNOLOGIES.
Section 515(d)(5) (21 U.S.C. 360e(d)(5)) is amended--
(1) by redesignating subparagraphs (A) through (D) as
clauses (i) through (iv), respectively;
(2) by inserting ``(A)'' after ``(5)''; and
(3) by adding at the end the following subparagraph:
``(B)(i) In order to provide patients with the benefits of devices
referenced in subparagraph (A) in the treatment and diagnosis of
serious diseases or conditions, the Secretary shall within six months
after the date of the enactment of the Medical Device Amendments of
2001 promulgate a regulation setting forth a process to designate
devices as `priority devices'. Such regulation shall include, among
other things, requirements for (I) the specification of the contents of
submissions requesting priority status; (II) a meeting to fully discuss
the submission; (III) a written response no later than 30 days after
the receipt of a submission granting or denying priority status; and
(IV) an administrative appeal before the director or a deputy director
of the Office of Device Evaluation, or any successor unit, within 10
days of a written determination denying a device a priority
designation. A request for a priority device designation may be made at
any time, including times prior to the investigation of a device.
``(ii) A device which the Secretary designates as a priority device
shall be subject to a review period of no longer than 120 days
following the designation determination, at which time the Secretary
shall approve or deny the application submitted to support approval of
the device. The determination to approve or deny a premarket
application for a priority device shall take into consideration the
following in determining a reasonable assurance of device safety and
effectiveness:
``(I) Whether the likely risk to expected health of
patients is less from using a priority device than the risk of
not having the device available to treat or diagnose a disease
or condition.
``(II) Whether the amount of benefit from a priority device
would exceed the benefit for an individual patient relative to
no treatment or diagnosis, or to alternative means of treatment
or diagnosis.
``(III) A comparison of risk to benefit as described in
subclauses (I) and (II), respectively.
``(iii)(I) The Secretary, in the context of a meeting under section
520(g)(7), shall agree, when appropriate, to review data at an interim
point in a clinical trial for purposes of determining reasonable
assurance of device safety and effectiveness. Such interim reviews
shall be subject to the conditions that the Secretary deems
appropriate, including that the approval will become null and void if
it is demonstrated at a consultation with the Director of the Office of
Device Evaluation (or any successor unit) that the conclusions based on
data from the completed clinical trial are inconsistent with those from
the interim analysis and such conclusions would have resulted in denial
of the application.
``(II) The Secretary shall rely on appropriate endpoints, including
surrogate endpoints, when evaluating an application for a priority
device to determine whether there exists a reasonable assurance of
safety and effectiveness.
``(iv) To ensure a complete, fully informed and timely review of
applications for priority devices, the Secretary shall include in the
regulation referenced in subparagraph (B)(i) a provision requiring
persons responsible for reviewing applications for such devices to meet
with applicants to jointly consider such applications. Such meetings
shall commence not later than the ninetieth day after receipt of an
application that satisfies the criteria for completeness set forth in
subsection (c). Such meetings shall provide adequate time for
applicants and government employees to review an entire submission to
ensure that applicants can quickly and effectively supplement
applications for priority devices.''.
SEC. 6. INCREASING REPORTING EFFECTIVENESS.
Section 519(a)(1) (21 U.S.C. 360i(a)(1)) is amended by inserting
after and below subparagraph (B) the following:
``except that such reports shall only be required when the
Secretary identifies a type of device in the Federal Register
for which the Secretary intends to require malfunction
reporting, which malfunction reporting shall be in effect after
a 60 day comment period and the Secretary's Federal Register
announcement that a type of device is subject to such
reporting, and which malfunction reporting shall be on a
quarterly basis, and shall be limited to information describing
the device and the event, the date and location of the event,
and the identity of the person at the facility or place where
the event occurred upon whom the reporter relied for
information;''.
SEC. 7. INDICATIONS FOR USE.
(a) Premarket Notification Proposed Intended Use.--Section
513(i)(1)(E) (21 U.S.C. 360c(i)(1)(E)) is amended by striking clause
(iv).
(b) Premarket Approval Proposed Conditions of Use.--Section
515(d)(1)(A) (21 U.S.C. 360e(d)(1)(A)) is amended by adding at the end
the following: ``Whenever the Secretary determines that proposed
labeling is false or misleading, the Secretary shall, no later than 150
days after receipt of an application filed under subsection (c), notify
the applicant in writing of the basis for such a determination.''.
(c) Supplements for Certain Conditions of Use.--Section 515(d)(6)
(21 U.S.C. 360e(d)(6)) is amended by adding at the end the following
subparagraph:
``(C)(i) Subject to clause (ii), in reviewing any supplement to an
approved application, which is submitted to obtain the additional
specification of a subpopulation under an approved condition of use,
the Secretary shall approve such supplement without additional clinical
data when--
``(I) the underlying conditions of use of the device are
otherwise unchanged from that approved by the Secretary; and
``(II) preclinical and clinical data exist in the approved
application applicable to the safe and effective use of the
device in the specified subpopulation, or a bona fide peer
review journal article reporting clinical experience with the
device in the subpopulation demonstrates that there is
reasonable assurance of the device's safety and effectiveness.
``(ii) In evaluating an indication for such a patient
subpopulation, the Secretary may require, when necessary, the
submission of clinical data to determine whether there is a reasonable
assurance of safety and effectiveness.''.
SEC. 8. IMPROVING COLLABORATION.
(a) Least Burdensome Determinations.--Section 513(a)(3)(D) (21
U.S.C. 360c(a)(3)(D)) is amended--
(1) in clause (i), by inserting ``within 20 days of such a
request'' after ``section 515, shall''; and
(2) by striking clause (ii) and inserting the following:
``(ii) Any clinical data and other valid scientific evidence,
specified in writing by the Secretary to demonstrate reasonable
assurance of device effectiveness shall represent a determination by
the Secretary that such evidence is the least burdensome information
necessary to satisfy a finding of effectiveness for purposes of
approving a device under subsection 515(d).''.
(b) Investigational Plan Agreement Meetings.--Section 520(g)(7) (21
U.S.C. 360j(g)(7)) is amended--
(1) in subparagraph (A)--
(A) by striking the first sentence and inserting
the following: ``In the case of a person intending to
investigate the safety and effectiveness or substantial
equivalence of a device, and such investigation
includes the undertaking of a clinical trial, the
Secretary shall ensure that such person has an
opportunity, prior to submitting an application under
section 515 or a premarket notification under section
510(k) to the Secretary or an institutional review
committee, to submit to the Secretary an
investigational plan (including a clinical protocol)
for review.''; and
(B) by striking the last sentence and inserting the
following: ``The written request shall include a
detailed description of the device, including the
device's proposed indications or conditions of use, and
a proposed investigational plan or any part of such
plan to which the submitter seeks review and
agreement.''; and
(2) in subparagraph (B), in the matter preceding clause
(i), by inserting after ``applicant shall'' the following:
``reflect the least burdensome information necessary to support
an approval under section 515 or a substantial equivalence
determination under section 513(f)(1), and shall''.
(c) Improving Interim PMA Review Meetings.--Section 515(d)(3)(A)
(21 U.S.C. 360e(d)(3)(A)) is amended--
(1) in clause (i), by inserting at the end the following:
``The term application, as used in this paragraph, shall
include any submission made under this section, or regulations
implementing this section, which is subject to a 180 day review
period.''; and
(2) in clause (ii), by inserting at the end the following:
``The written identification of deficiencies and the specific
information that is required to correct such deficiencies shall
be provided to the applicant no later than 10 days prior to the
meeting.''.
SEC. 9. GUIDANCE.
(a) In General.--Section 701(h)(1)(C) (21 U.S.C. 371(h)(1)(C)) is
amended--
(1) by inserting ``(i)'' after ``(C)''; and
(2) by adding at the end the following:
``(ii)(I) After a request for participation from individuals or
groups not employed or associated with Federal or State governments to
participate in the development of specific guidance or policy
documents, the Secretary shall meet with such individuals or groups to
obtain input into the guidance development process when such persons or
groups have expertise germane to the subject matter of potential
guidance or policy documents and, in the opinion of the Secretary, such
persons or groups can provide information that will enhance the
Secretary's public health assessment of the impact of a potential
guidance or policy document.
``(II) Any request under subclause (I) shall identify the
expertise, and relevance of such expertise, to the development of a
guidance or policy document, or the information that would justify a
meeting because of the expected benefit to the public health resulting
from such information.
``(III) Each meeting with an individual or group under subclause
(I) shall be promptly identified through publication of the Secretary's
calendar.''.
SEC. 10. MODULAR REVIEW.
Section 515(c) (21 U.S.C. 360e(c)), as amended by section 4(b) of
this Act, is further amended by adding at the end the following:
``(4)(A) Prior to the submission of an application under this
subsection, the Secretary shall accept and review portions of such
applications that applicants and the Secretary agree are complete and
ready for review.
``(B) Each portion of a submission reviewed under subparagraph (A)
and found acceptable by the Secretary shall not be further reviewed
after receipt of an application that satisfies the requirements of
paragraph (1), unless new information provides the Secretary cause to
review such accepted portion.
``(C) Whenever the Secretary determines that a portion of a
submission under subparagraph (A) is unacceptable, the Secretary shall
specifically identify, in writing, the deficiency of such portion and
describe in detail the means by which it may be made acceptable.''.
SEC. 11. REGISTRATION.
(a) In General.--Section 510(b) (21 U.S.C. 360(b)) is amended to
read as follows:
``(b)(1) Every second year after initially registering, every
person who owns or operates any establishment in any State, territory,
or foreign country engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs or a device
or devices shall register with the Secretary his name, place of
business, and such establishment.
``(2) Every person who registers under this section shall update
such person's registration information within 30 days of any change or
event, when information about such change or event is required by
regulations promulgated by the Secretary.
``(3) Initial registrations and registration updates shall be
submitted to the Secretary by electronic means, unless the Secretary
grants a request for waiver of this requirement because use of
electronic communications is not reasonable for the regulated person
requesting such waiver.''.
(b) Conforming Amendment.--Section 510(d) (21 U.S.C. 360(d)) is
amended by striking ``immediately''.
SEC. 12. ELECTRONIC LABELING.
Section 201(m) (21 U.S.C. 321(m)) is amended by adding at the end
the following: ``For purposes of providing adequate directions for use,
labeling may also include written, printed, or graphic matter which is
displayed by electronic means and is intended as labeling by the person
responsible for labeling an article.''.
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-728.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-728.
Placed on the Union Calendar, Calendar No. 455.
Mr. Burr moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H7153-7164)
DEBATE - The House proceeded with forty minutes of debate on H.R. 3580.
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At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed until Oct. 8.
Considered as unfinished business. (consideration: CR H7308)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 406 - 3 (Roll no. 450).(text: CR 10/7/2002 H7153-7160)
Roll Call #450 (House)On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 406 - 3 (Roll no. 450). (text: CR 10/7/2002 H7153-7160)
Roll Call #450 (House)Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.
Supplemental report filed by the Committee on Energy and Commerce, H. Rept. 107-728, Part II.
Supplemental report filed by the Committee on Energy and Commerce, H. Rept. 107-728, Part II.