Home > 106th Congressional Bills > H.R. 4152 (ih) To amend title XI of the Social Security Act to revise the performance standards and certification process for organ procurement organizations. [Introduced in House] ...H.R. 4152 (ih) To amend title XI of the Social Security Act to revise the performance standards and certification process for organ procurement organizations. [Introduced in House] ...
108th CONGRESS
2d Session
H. R. 4151
To amend the Public Health Service Act to authorize the Commissioner of
Food and Drugs to conduct oversight of any entity engaged in the
recovery, screening, testing, processing, storage, or distribution of
human tissue or human tissue-based products.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 2, 2004
Mr. Kline (for himself, Mr. Kennedy of Minnesota, Ms. McCollum, Mr.
Ramstad, Mr. Peterson of Minnesota, Mr. Gutknecht, Mr. Sabo, Mr.
Oberstar, Mrs. Musgrave, Mr. McInnis, Mr. Hefley, and Mr. Beauprez)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to authorize the Commissioner of
Food and Drugs to conduct oversight of any entity engaged in the
recovery, screening, testing, processing, storage, or distribution of
human tissue or human tissue-based products.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Brian Lykins Human Tissue Transplant
Safety Act of 2004''.
SEC. 2. OVERSIGHT OF ENTITIES ENGAGING IN ACTIVITIES RELATING TO HUMAN
CELL, TISSUE, OR CELLULAR OR TISSUE-BASED PRODUCTS.
Section 361 of the Public Health Service Act (42 U.S.C. 264) is
amended--
(1) by striking the section heading and all that follows
through ``(a) The'' and inserting the following:
``SEC. 361. CONTROL OF COMMUNICABLE DISEASES.
``(a) Prevention of Communicable Diseases.--
``(1) In general.--The'';
(2) in subsection (b), by striking ``(b) Regulations
prescribed under this section'' and inserting the following:
``(2) Limitation on purpose.--Regulations prescribed under
this subsection'';
(3) in subsection (c), by striking ``(c) Except as provided
in subsection (d), regulations prescribed under this section''
and inserting the following:
``(3) Limitation on individuals.--Except as provided in
paragraph (4), regulations prescribed under this subsection'';
(4) in subsection (d)--
(A) by striking the third sentence and all that
follows through the end and inserting the following:
``(B) Definitions.--In this paragraph:
``(i) Qualifying stage.--The term
`qualifying stage', with respect to a
communicable disease, means that such disease--
``(I) is in a communicable stage;
or
``(II) is in a precommunicable
stage, if the disease would be likely
to cause a public health emergency if
transmitted to other individuals.
``(ii) State.--The term `State' includes,
in addition to the several States, only the
District of Columbia.'';
(B) in paragraph (1), by redesignating
subparagraphs (A) and (B) as clauses (i) and (ii),
respectively; and
(C) by striking ``(d)(1) Regulations prescribed
under this section'' and inserting the following:
``(4) Circumstances of quarantine.--
``(A) In general.--Regulations prescribed under
this subsection'';
(5) in subsection (e)--
(A) by striking ``(e) Nothing in this section'' and
inserting the following:
``(5) Construction.--Nothing in this subsection'';
(B) by striking ``such sections'' and inserting
``this subsection or section 363''; and
(C) by striking ``under this section'' and
inserting ``under this subsection''; and
(6) by adding at the end the following:
``(b) Oversight of Entities Engaging in Activities Relating to
Human Cell, Tissue, or Cellular or Tissue-Based Products.--
``(1) Definitions.--In this subsection:
``(A) Commissioner.--The term `Commissioner' means
the Commissioner of Food and Drugs.
``(B) Covered entity.--The term `covered entity'
means any entity or person (as defined in section 201
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321)) that engages in the recovery, screening or
testing (including donor eligibility screening or
testing), processing, storage, labeling, packaging, or
distribution of a human cell, tissue, or cellular or
tissue-based product in a manner that affects
interstate commerce.
``(C) Human cell, tissue, or cellular or tissue-
based product.--The term `human cell, tissue, or
cellular or tissue-based product' means 1 of the
articles defined as `human cells, tissues, or cellular
or tissue-based products' in section 1271.3(d)(2) of
title 21, Code of Federal Regulations.
``(2) Oversight of entities.--
``(A) In general.--No covered entity shall engage
in an activity described in paragraph (1)(B) unless the
entity is in compliance with this paragraph and the
regulations promulgated under paragraph (3).
``(B) Registration and listing.--Each covered
entity shall submit to the Commissioner a request for
registration and listing and shall submit, for such
registration and listing, such information relating to
the identity and operations of the covered entity as
the Commissioner may require.
``(C) Inspection.--The Commissioner may conduct
such inspections of covered entities as the
Commissioner determines are appropriate to evaluate and
ensure compliance with--
``(i) this paragraph; and
``(ii) regulations promulgated under
paragraph (3).
``(D) Adverse reactions.--
``(i) In general.--If an adverse reaction
(as defined by the Commissioner) relating to a
human cell, tissue, or cellular or tissue-based
product occurs at the facility of a covered
entity and the covered entity receives
notification of the adverse reaction, the
covered entity shall report the adverse
reaction to the Commissioner not later than 15
calendar days after the date on which the
covered entity receives the notification.
``(ii) Reporting mechanism; database.--As
soon as practicable, the Commissioner, in
consultation with the Director of the Centers
for Disease Control and Prevention, shall
develop--
``(I) a single, simple reporting
mechanism for use in reporting adverse
reactions under clause (i); and
``(II) a database for information
received in relation to any adverse
reaction reported under clause (i).
``(3) Regulations.--
``(A) In general.--Not later than 90 days after the
date of enactment of the Human Tissue Transplant Safety
Act of 2003, the Commissioner shall promulgate
regulations to carry out this subsection, including--
``(i) regulations specifying a description
of the information required to be submitted for
the registration and listing of a covered
entity under paragraph (2)(B);
``(ii) regulations specifying a definition
of the term `adverse reaction' for purposes of
paragraph (2)(D);
``(iii) regulations specifying procedures
for donor eligibility screening and testing,
good tissue practices, and procedures for
inspection, enforcement, and any other
reasonable means to ensure that a human cell,
tissue, or cellular or tissue-based product is
free from communicable disease and maintains
function and integrity during recovery,
screening, testing, processing, storage,
labeling, packaging, and distribution to a
patient; and
``(iv) such other regulations relating to
the operation of covered entities as the
Commissioner determines are necessary.
``(B) Enforcement.--If the Commissioner determines
that a covered entity has violated paragraph (2) or a
regulation promulgated under subparagraph (A), the
Commissioner (including a designee of the Commissioner)
may after providing notice and an opportunity for a
hearing--
``(i) issue an order requiring--
``(I) any person that distributed
the human cell, tissue, or cellular or
tissue-based product involved in the
violation to recall or destroy the
cell, tissue, or product, as
appropriate; and
``(II) any covered entity in
possession of the cell, tissue, or
product to retain it until--
``(aa) the cell, tissue or
product is recalled by the
manufacturer or is destroyed or
disposed of as specified by the
Commissioner; or
``(bb) the safety of the
cell, tissue, or product is
confirmed by the Commissioner;
``(ii) condemn, and seize or destroy, the
cell, tissue, or product;
``(iii) issue an order requiring the
covered entity to cease the activity that
resulted in the violation so that the covered
entity is in compliance with the regulation; or
``(iv) suspend or revoke the registration
and listing under this subsection of the
covered entity that violated the regulation.
``(4) Applicability.--Nothing in this subsection shall be
construed to affect the regulation of human cell, tissue, or
cellular or tissue-based products as biological products under
section 351 or drugs or devices under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
``(5) Authorization of appropriations.--There are
authorized to be appropriated to carry out this subsection such
sums as may be necessary.''.
SEC. 3. CONFORMING AMENDMENTS.
(a) Federal Food, Drug, and Cosmetic Act.--Section 801(d)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)(4)) is amended
by striking ``section 361'' and inserting ``section 361(a)''.
(b) Public Health Service Act.--
(1) Section 2(f) of the Public Health Service Act (42
U.S.C. 201(f)) is amended by striking ``361(d),'' and inserting
``361(a)(4),''.
(2) Section 363 of the Public Health Service Act (42 U.S.C.
266) is amended by striking ``subsection (b) of section 361''
and inserting ``section 361(a)(2)''.
(3) Section 368 of the Public Health Service Act (42 U.S.C.
271) is amended by striking ``361'' and inserting ``361(a)''.
(c) Title 49, United States Code.--Section 24301(m)(2) of title 49,
United States Code is amended by striking ``Section 361'' and inserting
``Section 361(a)''.
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