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.

Bill: 117-hr-6948
Sponsor: full_name: Rep. Crenshaw, Dan [R-TX-2]
Introduced: 2022-03-07
Policy area: Health
Latest action: action_date: 2022-03-08
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2022-03-07
action_desc: Introduced in House
text: <p>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 <i>minimal manipulation</i>. (The regulations are commonly referred to as the<i> tissue rules</i>; HCT/Ps that are <i>minimally manipulated</i> and meet other criteria are not regulated as drugs, devices, or biologics and therefore are not subject to premarket review.)</p>

tv_txt: I 117th CONGRESS 2d Session H. R. 6948 IN THE HOUSE OF REPRESENTATIVES March 7, 2022 Mr. Crenshaw (for himself and Mr. Burgess ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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.

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.