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[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H. Con. Res. 196 Referred in Senate (RFS)]

  1st Session
H. CON. RES. 196

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           November 13, 1997

  Received and referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                         CONCURRENT RESOLUTION

 
             To correct the enrollment of the bill S. 830.

    Resolved by the House of Representatives (the Senate concurring), 
That, in the enrollment of the bill (S. 830) to amend the Federal Food, 
Drug, and Cosmetic Act and the Public Health Service Act to improve the 
regulation of food, drugs, devices, and biological products, and for 
other purposes, the Secretary of the Senate shall make the following 
corrections:
            (1) In section 119(b) of the bill:
                    (A) Strike paragraph (2) (relating to conforming 
                amendments).
                    (B) Strike ``(b) Section 505(j).--'' and all that 
                follows through ```(3)(A) The Secretary shall''' and 
                insert the following:
    ``(b) Section 505(j).--Section 505(j) (21 U.S.C. 355(j)) is amended 
by adding at the end the following paragraph:
            ```(9)(A) The Secretary shall'''.
            (2) In section 123 of the bill, strike subsection (g) and 
        insert the following:
    ``(g) Application of Federal Food, Drug, and Cosmetic Act.--
            ``(1) In general.--Section 351 of the Public Health Service 
        Act (42 U.S.C. 262), as amended by subsection (d), is further 
        amended by adding at the end the following:
    ```(j) The Federal Food, Drug, and Cosmetic Act applies to a 
biological product subject to regulation under this section, except 
that--
            ```(1) a product for which a license has been approved 
        under subsection (a) shall not be required to have an approved 
        application under section 505 of such Act; and
            ```(2) the amendments made to section 505 of such Act by 
        title I of Public Law 98-417 shall not apply to a biological 
        product for which a license has been approved under subsection 
        (a).'.
            ``(2) Rule of construction.--Nothing in this Act or the 
        amendments made by this Act shall affect the question of the 
        applicability of any provision of section 505 of the Federal 
        Food, Drug, and Cosmetic Act to a biological product for which 
        an application has been approved under section 505 of such 
        Act.''.
            (3) In section 125(d)(2) of the bill, in the matter 
        preceding subparagraph (A), insert after ``antibiotic drug'' 
        the second place such term appears the following: ``(including 
        any salt or ester of the antibiotic drug)''.
            (4) In section 127(a) of the bill: In section 503A of the 
        Federal Food, Drug, and Cosmetic Act (as proposed to be 
        inserted by such section 127(a)), in the second sentence of 
        subsection (d)(2), strike ``or other criteria'' and insert 
        ``and other criteria''.
            (5) In section 412(c) of the bill:
                    (A) In subparagraph (1) of section 502(e) of the 
                Federal Food, Drug, and Cosmetic Act (as proposed to be 
                amended by such section 412(c)), in subclause (iii) of 
                clause (A), insert before the period the following: 
                ``or to prescription drugs''.
                    (B) Strike ``(c) Misbranding.--Subparagraph (1) of 
                section 502(e)'' and insert the following:
    ``(c) Misbranding.--
            ``(1) In general.--Subparagraph (1) of section 502(e)''.
                    (C) Add at the end the following:
            ``(2) Rule of construction.--Nothing in this Act or the 
        amendments made by this Act shall affect the question of the 
        authority of the Secretary of Health and Human Services 
        regarding inactive ingredient labeling for prescription drugs 
        under sections of the Federal Food, Drug, and Cosmetic Act 
        other than section 502(e)(1)(A)(iii).''.
            (6) Strike section 501 of the bill and insert the 
        following:

``SEC. 501. EFFECTIVE DATE.

    ``(a) In General.--Except as otherwise provided in this Act, this 
Act and the amendments made by this Act shall take effect 90 days after 
the date of enactment of this Act.
    ``(b) Immediate Effect.--Notwithstanding subsection (a), the 
provisions of and the amendments made by sections 111, 121, 125, and 
307 of this Act, and the provisions of section 510(m) of the Federal 
Food, Drug, and Cosmetic Act (as added by section 206(a)(2)), shall 
take effect on the date of enactment of this Act.''.

            Passed the House of Representatives November 13, 1997.

            Attest:

                                                ROBIN H. CARLE,

                                                                 Clerk.
```