S.Amdt. 3162

SA 3162. Mr. SPECTER (for himself and Mrs. Hagan) submitted an
amendment intended to be proposed to amendment SA 2786 proposed by Mr.
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the
first-time homebuyers credit in the case of members of the Armed Forces
and certain

[[Page S12968]]

other Federal employees, and for other purposes; which was ordered to
lie on the table; as follows:

On page 1925, between lines 14 and 15, insert the
following:

Subtitle C--Provisions Relating to the Safety of Drugs and Biological
Products

SEC. 7201. ENSURING THE SAFETY OF DRUGS AND BIOLOGICAL
PRODUCTS CONTAINING BLOOD, BLOOD COMPONENTS,
AND BLOOD DERIVATIVES.

Section 351 of the Public Health Service Act (42 U.S.C.
262), as amended by section 7002, is further amended by
adding at the end the following:
``(m) Blood, Blood Components, and Blood Derivatives.--
``(1) Regulation and licensure.--The Secretary shall issue
regulations that--
``(A) require a person seeking approval of any drug or
licensure of a biological product that contains blood, blood
components, or blood derivatives to--
``(i) submit an application for licensure pursuant to this
section; and
``(ii) demonstrate the clinical safety, purity, and potency
of such drug or product; and
``(B) provide analytical methods and standards to evaluate
the quality of the blood, blood components, or blood
derivatives contained in the new drug or biological product
throughout the manufacturing process.
``(2) Biological products and drug products containing
blood, blood components, or blood derivatives.--A drug or
biological product described in paragraph (1) that contains
blood, blood components, or blood derivatives shall include
any drug or biological product that includes an active or
inactive ingredient that--
``(A) contains blood, blood components, or blood
derivatives and has the potential to--
``(i) transmit infectious agents, such as of a prion or a
microbial origin; or
``(ii) cause an adverse immune reaction due to the presence
of blood, blood components, or blood derivatives; and
``(B) is--
``(i) essential to the manufacture of the drug or product;
``(ii) determinate of the absorption and distribution of
the drug or product when administered; and
``(iii) essential to the safety and efficacy of the drug or
product.
``(3) Other products containing blood, blood products, or
blood derivatives.--In addition to the drugs and biological
products that meet the criteria described in paragraph (2),
the Secretary may issue regulations to include other products
containing blood, blood products, or blood derivatives as
biological products subject to paragraph (1).
``(4) Consistency of definitions.--Notwithstanding any
other provision of this Act or the Federal Food, Drug, and
Cosmetic Act, after the date of enactment of the Patient
Protection and Affordable Care Act, a drug or biological
product that has been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act and that meets the
criteria described in paragraph (2) shall be treated by the
Secretary as a biological product approved under a biologics
license application under this section.''.
______