III

105TH CONGRESS

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.

1 Resolved by the House of Representatives (the Senate

2 concurring), That, in the enrollment of the bill (S. 830)

3 to amend the Federal Food, Drug, and Cosmetic Act and

4 the Public Health Service Act to improve the regulation

5 of food, drugs, devices, and biological products, and for
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1 other purposes, the Secretary of the Senate shall make

2 the following corrections:

3 (1) In section 119(b) of the bill:

4 (A) Strike paragraph (2) (relating to con5 forming amendments).

6 (B) Strike ‘‘(b) SECTION 505(j).—’’ and

7 all that follows through ‘‘ ‘(3)(A) The Secretary

8 shall’ ’’ and insert the following:

9 ‘‘(b) SECTION 505(j).—Section 505(j) (21 U.S.C.

10 355(j)) is amended by adding at the end the following

11 paragraph:

12 ‘‘ ‘(9)(A) The Secretary shall’ ’’.

13 (2) In section 123 of the bill, strike subsection

14 (g) and insert the following:

15 ‘‘(g) APPLICATION OF FEDERAL FOOD, DRUG, AND

16 COSMETIC ACT.—

17 ‘‘(1) IN GENERAL.—Section 351 of the Public

18 Health Service Act (42 U.S.C. 262), as amended by

19 subsection (d), is further amended by adding at the

20 end the following:

21 ‘‘ ‘(j) The Federal Food, Drug, and Cosmetic Act ap22 plies to a biological product subject to regulation under

23 this section, except that—

24 ‘‘ ‘(1) a product for which a license has been ap25 proved under subsection (a) shall not be required to
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1 have an approved application under section 505 of

2 such Act; and

3 ‘‘ ‘(2) the amendments made to section 505 of

4 such Act by title I of Public Law 98–417 shall not

5 apply to a biological product for which a license has

6 been approved under subsection (a).’.

7 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in

8 this Act or the amendments made by this Act shall

9 affect the question of the applicability of any provi10 sion of section 505 of the Federal Food, Drug, and

11 Cosmetic Act to a biological product for which an

12 application has been approved under section 505 of

13 such Act.’’.

14 (3) In section 125(d)(2) of the bill, in the mat15 ter preceding subparagraph (A), insert after ‘‘anti16 biotic drug’’ the second place such term appears the

17 following: ‘‘(including any salt or ester of the anti18 biotic drug)’’.

19 (4) In section 127(a) of the bill: In section

20 503A of the Federal Food, Drug, and Cosmetic Act

21 (as proposed to be inserted by such section 127(a)),

22 in the second sentence of subsection (d)(2), strike

23 ‘‘or other criteria’’ and insert ‘‘and other criteria’’.

24 (5) In section 412(c) of the bill:
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1 (A) In subparagraph (1) of section 502(e)

2 of the Federal Food, Drug, and Cosmetic Act

3 (as proposed to be amended by such section

4 412(c)), in subclause (iii) of clause (A), insert

5 before the period the following: ‘‘or to prescrip6 tion drugs’’.

7 (B) Strike ‘‘(c) MISBRANDING.—Subpara8 graph (1) of section 502(e)’’ and insert the fol9 lowing:

10 ‘‘(c) MISBRANDING.—

11 ‘‘(1) IN GENERAL.—Subparagraph (1) of sec12 tion 502(e)’’.

13 (C) Add at the end the following:

14 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in

15 this Act or the amendments made by this Act shall

16 affect the question of the authority of the Secretary

17 of Health and Human Services regarding inactive

18 ingredient labeling for prescription drugs under sec19 tions of the Federal Food, Drug, and Cosmetic Act

20 other than section 502(e)(1)(A)(iii).’’.

21 (6) Strike section 501 of the bill and insert the

22 following:

23 ‘‘SEC. 501. EFFECTIVE DATE.

24 ‘‘(a) IN GENERAL.—Except as otherwise provided in

25 this Act, this Act and the amendments made by this Act
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1 shall take effect 90 days after the date of enactment of

2 this Act.

3 ‘‘(b) IMMEDIATE EFFECT.—Notwithstanding sub4 section (a), the provisions of and the amendments made

5 by sections 111, 121, 125, and 307 of this Act, and the

6 provisions of section 510(m) of the Federal Food, Drug,

7 and Cosmetic Act (as added by section 206(a)(2)), shall

8 take effect on the date of enactment of this Act.’’.

Passed the House of Representatives November 13,

1997.

Attest: ROBIN H. CARLE,

Clerk.