SUBCOMMITTEE ACTION

Subcommittee on Health

Tuesday, June 19, 2007

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The Subcommittee on Health considered, pursuant to notice, the following nine Committee Prints and took the following actions:

PDUFA

Committee Print on H.R. _____, the Prescription Drug User Fee Amendments of 2007 (PDUFA) was favorably forwarded to the full Committee, amended, by a voice vote. 

The following amendments were offered:

• An amendment in the nature of a substitute to the Committee Print offered by Mr. Pallone, #1, was adopted by a voice vote:

The following amendments were offered to the Pallone amendment in the nature of a substitute:

• An amendment offered by Mr. Burgess, #1A, was defeated by a voice vote;
  
  
• An amendment offered by Mr. Deal, #1B, was defeated by a yea-nay vote: 14 – 18.
  

MDUFA

Committee Print on H.R. ______, the Medical Device User Fee Amendments of 2007 (MDUFA) was favorably forwarded to the full Committee, amended, by a voice vote.

The following amendments were offered:

• A manager's amendment offered by Mr. Pallone, #1, was adopted by a voice vote;
  
  
  • An amendment offered to the Pallone amendment by Mr. Murphy, #1A, was withdrawn without objection.
    

PED-DEVICES

Committee Print on H.R. ______, the Pediatric Medical Device Safety and Improvement Act of 2007 was favorably forwarded to the full Committee, without amendment, by a voice vote.

PED-RULES

Committee Print on H.R. ______, the Pediatric Research Equity Act of 2007, was favorably forwarded to the full Committee, amended, by a voice vote.

The following amendments were offered:

• A manager's amendment offered by Mr. Pallone, #1, was adopted by a voice vote.

PED-EXCLUSIV (BPCA)

Committee Print on H.R. ______, the Best Pharmaceuticals for Children Act of 2007, was favorably forwarded to the full Committee, amended, by a voice vote.

The following amendments were offered:

• A manager's amendment offered by Mr. Pallone, #1, was adopted by a voice vote;
  
  
  • An amendment to the Pallone amendment offered by Mr. Murphy, # 1A, was withdrawn without objection;
    
    
  • An amendment to the Pallone amendment offered by Ms. Eshoo, #1B, was adopted by a yea-nay vote: 21 – 10.
    

REAGAN-UDALL INSTITUTE (CRITICAL PATH)

Committee Print on H.R. _______, to amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of the Reagan-Udall Institute for Applied Biomedical Research, and for other purposes, was favorably forwarded to the full Committee, amended, by a voice vote.

The following amendments were offered:

• An amendment in the nature of a substitute to the Committee Print was offered by Mr. Pallone, #1, was adopted by a voice vote.

CONFLICTS OF INTEREST

Committee Print on H.R. _______, to amend the Federal Food, Drug, and Cosmetic Act with respect to conflicts of interest, and for other purposes, was favorably forwarded to the full Committee, without amendment, by a voice vote.

The following amendments were offered:

• An amendment offered by Mr. Burgess, #1, was defeated by a voice vote;
  
  
• An amendment offered by Mr. Green of Texas, #2, was withdrawn without objection.
  

CLINICAL TRIALS

Committee Print on H.R. _______, to amend the Public Health Service Act to provide for the establishment of a clinical trial registry database and a clinical trial results database, and for other purposes, was favorably forwarded to the full Committee, amended, by a voice vote:

• An amendment in the nature of a substitute offered by Mr. Pallone, #1, was adopted by a voice vote;

The following amendments were offered to the Pallone amendment in the nature of a substitute:

• An amendment offered by Mr. Deal, #1A, was withdrawn without objection.
  

REMS

Committee Print on H.R. _______, to amend the Federal Food, Drug, and Cosmetic Act to improve drug safety, and for other purposes, was favorably forwarded to the full Committee, amended, by a voice vote.

The following amendments were offered:

• An amendment in the nature of a substitute to the Committee Print offered by Mr. Pallone, #1, was adopted, amended, by a voice vote;

The following amendments were offered to the Pallone amendment in the nature of a substitute:

• An amendment offered by Mr. Deal, #1A, was defeated by a yea-nay vote: 13 – 17;
  
  
• An amendment offered by Ms. Schakowsky, #1B, was adopted by a voice vote;
  
  
• An amendment offered by Mr. Burgess, #1C, was withdrawn without objection;
  
  
• An amendment offered by Mr. Matheson, #1D, was withdrawn without objection;
  
  
• An amendment to the Pallone amendment offered by Mr. Towns, #1E, was adopted by a yea-nay vote: 23 – 9.

THE SUBCOMMITTEE ON HEALTH ADJOURNED SUBJECT TO THE CALL OF THE CHAIR