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.

Summary: Brian Lykins Human Tissue Transplant Safety Act of 2003 - Amends the Public Health Service Act to provide for oversight by the Commissioner of Food and Drugs of entities engaged in activities relating to human tissue or human tissue-based products, requiring their registration and authorizing their inspection. Requires the reporting of any adverse incidents. Requires the Commissioner to develop a reporting mechanism and a database to store such information. Allows the Commissioner, in an instance in which this Act is violated, to: (1) issue an order requiring any distributor of a human cell, tissue, or cellular or tissue-based product to recall or destroy such product; (2) condemn, seize, and destroy such product; (3) require a covered entity to cease the activity that resulted in the violation; or (4) suspend or revoke the registration and listing of the covered entity involved.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Brian Lykins Human Tissue Transplant 
Safety Act of 2003''.

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)''.