This bill requires the Food and Drug Administration to update its regulations relating to the manufacture of human cells, tissue, and cellular and tissue-based products (HCT/Ps), including an update to the definition of minimal manipulation. (The regulations are commonly referred to as the tissue rules; HCT/Ps that are minimally manipulated and meet other criteria are not regulated as drugs, devices, or biologics and therefore are not subject to premarket review.)
To direct the Secretary of Health and Human Services, acting through 
   the Commissioner of Food and Drugs, to promulgate rules to update 
certain regulations relating to human cells, tissues, and cellular and 
             tissue-based products, 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. UPDATING CERTAIN REGULATIONS RELATING TO HUMAN CELLS, 
              TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall update the 
regulations in part 1271 of title 21, Code of Federal Regulations (as 
in effect on the date of the enactment of this Act), including such 
revisions as may be necessary to update the definition of the term 
``minimal manipulation'' specified in section 1271.3 of title 21, Code 
of Federal Regulations (as in effect on such date of enactment).
    (b) Timeline.--The Secretary shall--
            (1) issue proposed regulations to carry out the updates 
        required under subsection (a) not later than 1 year after the 
        date of the enactment of this Act; and
            (2) finalize such proposed regulations not later than 1 
        year after the date on which such proposed regulations are 
        issued.
                                 <all>
To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.
To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.
Official Titles - House of Representatives
Official Title as Introduced
To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.
Rep. Crenshaw, Dan