I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Brian Lykins Human 

5 Tissue Transplant Safety Act of 2004’’. 
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1 SEC. 2. OVERSIGHT OF ENTITIES ENGAGING IN ACTIVITIES 

2 RELATING TO HUMAN CELL, TISSUE, OR CEL3 LULAR OR TISSUE-BASED PRODUCTS. 

4 Section 361 of the Public Health Service Act (42 

5 U.S.C. 264) is amended— 

6 (1) by striking the section heading and all that 

7 follows through ‘‘(a) The’’ and inserting the fol8 lowing: 

9 ‘‘SEC. 361. CONTROL OF COMMUNICABLE DISEASES. 

10 ‘‘(a) PREVENTION OF COMMUNICABLE DISEASES.— 

11 ‘‘(1) IN GENERAL.—The’’; 

12 (2) in subsection (b), by striking ‘‘(b) Regula13 tions prescribed under this section’’ and inserting 

14 the following: 

15 ‘‘(2) LIMITATION ON PURPOSE.—Regulations 

16 prescribed under this subsection’’; 

17 (3) in subsection (c), by striking ‘‘(c) Except as 

18 provided in subsection (d), regulations prescribed 

19 under this section’’ and inserting the following: 

20 ‘‘(3) LIMITATION ON INDIVIDUALS.—Except as 

21 provided in paragraph (4), regulations prescribed 

22 under this subsection’’; 

23 (4) in subsection (d)— 

24 (A) by striking the third sentence and all 

25 that follows through the end and inserting the 

26 following: 
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1 ‘‘(B) DEFINITIONS.—In this paragraph: 

2 ‘‘(i) QUALIFYING STAGE.—The term 

3 ‘qualifying stage’, with respect to a com4 municable disease, means that such dis5 ease— 

6 ‘‘(I) is in a communicable stage; 

7 or 

8 ‘‘(II) is in a precommunicable 

9 stage, if the disease would be likely to 

10 cause a public health emergency if 

11 transmitted to other individuals. 

12 ‘‘(ii) STATE.—The term ‘State’ in13 cludes, in addition to the several States, 

14 only the District of Columbia.’’; 

15 (B) in paragraph (1), by redesignating 

16 subparagraphs (A) and (B) as clauses (i) and 

17 (ii), respectively; and 

18 (C) by striking ‘‘(d)(1) Regulations pre19 scribed under this section’’ and inserting the 

20 following: 

21 ‘‘(4) CIRCUMSTANCES OF QUARANTINE.— 

22 ‘‘(A) IN GENERAL.—Regulations pre23 scribed under this subsection’’; 

24 (5) in subsection (e)— 
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1 (A) by striking ‘‘(e) Nothing in this sec2 tion’’ and inserting the following: 

3 ‘‘(5) CONSTRUCTION.—Nothing in this sub4 section’’; 

5 (B) by striking ‘‘such sections’’ and insert6 ing ‘‘this subsection or section 363’’; and 

7 (C) by striking ‘‘under this section’’ and 

8 inserting ‘‘under this subsection’’; and 

9 (6) by adding at the end the following: 

10 ‘‘(b) OVERSIGHT OF ENTITIES ENGAGING IN ACTIVI11 TIES RELATING TO HUMAN CELL, TISSUE, OR CELLULAR

12 OR TISSUE-BASED PRODUCTS.— 

13 ‘‘(1) DEFINITIONS.—In this subsection: 

14 ‘‘(A) COMMISSIONER.—The term ‘Commis15 sioner’ means the Commissioner of Food and 

16 Drugs. 

17 ‘‘(B) COVERED ENTITY.—The term ‘cov18 ered entity’ means any entity or person (as de19 fined in section 201 of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 321)) that en21 gages in the recovery, screening or testing (in22 cluding donor eligibility screening or testing), 

23 processing, storage, labeling, packaging, or dis24 tribution of a human cell, tissue, or cellular or 
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1 tissue-based product in a manner that affects 

2 interstate commerce. 

3 ‘‘(C) HUMAN CELL, TISSUE, OR CELLULAR

4 OR TISSUE-BASED PRODUCT.—The term 

5 ‘human cell, tissue, or cellular or tissue-based 

6 product’ means 1 of the articles defined as 

7 ‘human cells, tissues, or cellular or tissue-based 

8 products’ in section 1271.3(d)(2) of title 21, 

9 Code of Federal Regulations. 

10 ‘‘(2) OVERSIGHT OF ENTITIES.— 

11 ‘‘(A) IN GENERAL.—No covered entity 

12 shall engage in an activity described in para13 graph (1)(B) unless the entity is in compliance 

14 with this paragraph and the regulations pro15 mulgated under paragraph (3). 

16 ‘‘(B) REGISTRATION AND LISTING.—Each 

17 covered entity shall submit to the Commissioner 

18 a request for registration and listing and shall 

19 submit, for such registration and listing, such 

20 information relating to the identity and oper21 ations of the covered entity as the Commis22 sioner may require. 

23 ‘‘(C) INSPECTION.—The Commissioner 

24 may conduct such inspections of covered enti-
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1 ties as the Commissioner determines are appro2 priate to evaluate and ensure compliance with— 

3 ‘‘(i) this paragraph; and 

4 ‘‘(ii) regulations promulgated under 

5 paragraph (3). 

6 ‘‘(D) ADVERSE REACTIONS.— 

7 ‘‘(i) IN GENERAL.—If an adverse re8 action (as defined by the Commissioner) 

9 relating to a human cell, tissue, or cellular 

10 or tissue-based product occurs at the facil11 ity of a covered entity and the covered en12 tity receives notification of the adverse re13 action, the covered entity shall report the 

14 adverse reaction to the Commissioner not 

15 later than 15 calendar days after the date 

16 on which the covered entity receives the 

17 notification. 

18 ‘‘(ii) REPORTING MECHANISM; DATA19 BASE.—As soon as practicable, the Com20 missioner, in consultation with the Direc21 tor of the Centers for Disease Control and 

22 Prevention, shall develop— 

23 ‘‘(I) a single, simple reporting 

24 mechanism for use in reporting ad25 verse reactions under clause (i); and 
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1 ‘‘(II) a database for information 

2 received in relation to any adverse re3 action reported under clause (i). 

4 ‘‘(3) REGULATIONS.— 

5 ‘‘(A) IN GENERAL.—Not later than 90 

6 days after the date of enactment of the Human 

7 Tissue Transplant Safety Act of 2003, the 

8 Commissioner shall promulgate regulations to 

9 carry out this subsection, including— 

10 ‘‘(i) regulations specifying a descrip11 tion of the information required to be sub12 mitted for the registration and listing of a 

13 covered entity under paragraph (2)(B); 

14 ‘‘(ii) regulations specifying a defini15 tion of the term ‘adverse reaction’ for pur16 poses of paragraph (2)(D); 

17 ‘‘(iii) regulations specifying proce18 dures for donor eligibility screening and 

19 testing, good tissue practices, and proce20 dures for inspection, enforcement, and any 

21 other reasonable means to ensure that a 

22 human cell, tissue, or cellular or tissue23 based product is free from communicable 

24 disease and maintains function and integ25 rity during recovery, screening, testing, 
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1 processing, storage, labeling, packaging, 

2 and distribution to a patient; and 

3 ‘‘(iv) such other regulations relating 

4 to the operation of covered entities as the 

5 Commissioner determines are necessary. 

6 ‘‘(B) ENFORCEMENT.—If the Commis7 sioner determines that a covered entity has vio8 lated paragraph (2) or a regulation promul9 gated under subparagraph (A), the Commis10 sioner (including a designee of the Commis11 sioner) may after providing notice and an op12 portunity for a hearing— 

13 ‘‘(i) issue an order requiring— 

14 ‘‘(I) any person that distributed 

15 the human cell, tissue, or cellular or 

16 tissue-based product involved in the 

17 violation to recall or destroy the cell, 

18 tissue, or product, as appropriate; and 

19 ‘‘(II) any covered entity in pos20 session of the cell, tissue, or product 

21 to retain it until— 

22 ‘‘(aa) the cell, tissue or 

23 product is recalled by the manu24 facturer or is destroyed or dis-
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1 posed of as specified by the Com2 missioner; or 

3 ‘‘(bb) the safety of the cell, 

4 tissue, or product is confirmed by 

5 the Commissioner; 

6 ‘‘(ii) condemn, and seize or destroy, 

7 the cell, tissue, or product; 

8 ‘‘(iii) issue an order requiring the cov9 ered entity to cease the activity that re10 sulted in the violation so that the covered 

11 entity is in compliance with the regulation; 

12 or 

13 ‘‘(iv) suspend or revoke the registra14 tion and listing under this subsection of 

15 the covered entity that violated the regula16 tion. 

17 ‘‘(4) APPLICABILITY.—Nothing in this sub18 section shall be construed to affect the regulation of 

19 human cell, tissue, or cellular or tissue-based prod20 ucts as biological products under section 351 or 

21 drugs or devices under the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 301 et seq.). 

23 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 

24 There are authorized to be appropriated to carry out 

25 this subsection such sums as may be necessary.’’. 
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1 SEC. 3. CONFORMING AMENDMENTS. 

2 (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 

3 Section 801(d)(4) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 381(d)(4)) is amended by striking 

5 ‘‘section 361’’ and inserting ‘‘section 361(a)’’. 

6 (b) PUBLIC HEALTH SERVICE ACT.— 

7 (1) Section 2(f) of the Public Health Service 

8 Act (42 U.S.C. 201(f)) is amended by striking 

9 ‘‘361(d),’’ and inserting ‘‘361(a)(4),’’. 

10 (2) Section 363 of the Public Health Service 

11 Act (42 U.S.C. 266) is amended by striking ‘‘sub12 section (b) of section 361’’ and inserting ‘‘section 

13 361(a)(2)’’. 

14 (3) Section 368 of the Public Health Service 

15 Act (42 U.S.C. 271) is amended by striking ‘‘361’’ 

16 and inserting ‘‘361(a)’’. 

17 (c) TITLE 49, UNITED STATES CODE.—Section 

18 24301(m)(2) of title 49, United States Code is amended 

19 by striking ‘‘Section 361’’ and inserting ‘‘Section 361(a)’’. 

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