P.L. 98-417

TITLE: Drug Price Competition and Patent Term Restoration Act of 1984

DATE: Sept. 24, 1984  
LENGTH: 21 p.  
ENACTED-BILL: 98 S. 1538  
STAT: 98 Stat. 1585  
CONG-SESS: 98-2  

SUMMARY:
"To amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes."
 
Generic drug approval procedures revision; patent term extension to compensate for Govt regulatory delay

BILLS: 98 H.R. 3605; 96 S. 2892; 97 H.R. 1937; 97 H.R. 6444; 97 S. 255; 98 H.R. 3502; 98 S. 1306; 98 S. 1816; 98 S. 2748; 98 S. 2926

REFERENCES:
 
DEBATE:
 
127 Congressional Record, 97th Congress, 1st Session - 1981
   July 9, Senate consideration and passage of S. 255, p. S7354-56.
 
128 Congressional Record, 97th Congress, 2nd Session - 1982
   Sept. 13, House consideration of H.R. 6444, p. H6916-24.
   Sept. 15, House consideration and failure to pass H.R. 6444, p. H6986-87.
 
130 Congressional Record, 98th Congress, 2nd Session - 1984
   June 29, Senate consideration and passage of S. 1538, p. S8915-21.
   Aug. 10, Senate consideration and passage of S. 2926, p. S10503-13.
   Sept. 6, House consideration and passage of H.R. 3605, passage of S. 1538, as amended, and tabling of H.R. 3605, p. H9105-51.
   Sept. 12, Senate agreement to the House amendments to S. 1538, p. S10981-90.
 
 
REPORTS:
 
97th Congress
 
S. Rpt. 97-138 on S. 255, "Patent Term Restoration Act of 1981," June 16, 1981.
   LENGTH: 23 p.
   SUDOC: Y1.1/5:97-138
 
H. Rpt. 97-696 on H.R. 6444, "Patent Term Restoration Act of 1982," Aug. 4, 1982.
   LENGTH: 23 p.
   SUDOC: Y1.1/8:97-696
 
98th Congress
 
H. Rpt. 98-857, pt. 1 on H.R. 3605, "Drug Price Competition and Patent Term Restoration Act of 1984," June 21, 1984.
   LENGTH: 76 p.
   SUDOC: Y1.1/8:98-857/pt.1
 
S. Rpt. 98-529 on S. 1816, "Labeling of Textile Fiber and Wool Products," June 25, 1984.
   LENGTH: 10 p.
   SUDOC: Y1.1/5:98-529
 
H. Rpt. 98-857, pt. 2 on H.R. 3605, "Drug Price Competition and Patent Term Restoration Act of 1984," Aug. 1, 1984.
   LENGTH: 61 p.
   SUDOC: Y1.1/8:98-857/pt.2
 
 
HEARINGS:
 
97th Congress
 
"Health and the Environment Miscellaneous, Part 2," hearings before the Subcommittee on Health and the Environment, Committee on Energy and Commerce. House, Mar. 9, 24, Apr. 1, 1981.
   LENGTH: iv+454 p. il.
   SUDOC: Y4.En2/3:97-17
 
"Competition in the Drug Industry," hearings before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce. House, Mar. 10, 1981.
   LENGTH: iii+80 p.
   SUDOC: Y4.En2/3:97-35
 
"Patent Term Restoration Act of 1981: S. 255," hearings before the Committee on the Judiciary. Senate, Apr. 30, 1981.
   LENGTH: v+304 p. il.
   SUDOC: Y4.J89/2:J-97-21
 
98th Congress
 
Hearings on H.R. 3605 before the Subcommittee on Courts, Civil Liberties and the Administration of Justice, House Judiciary Committee, June 27, 1984.
 
Hearings on S. 2748 before the Senate Labor and Human Resources Committee, June 28, 1984.
 
"Patent Term Restoration Act of 1983," hearings before the Subcommittee on Patents, Copyrights, and Trademarks, Committee on the Judiciary. Senate, June 22, July 19, Aug. 2, 1983.
   LENGTH: v+361 p. il.
   SUDOC: Y4.J89/2:S.hrg.98-578
 
"Drug Legislation," hearings before the Subcommittee on Health and the Environment, Committee on Energy and Commerce. House, July 25, Oct. 3, 1983.
   LENGTH: iv+262 p.
   SUDOC: Y4.En2/3:98-67
 
"Textile Fiber and Wool Products Identification Improvement Act," hearings before the Subcommittee on Consumer, Committee on Commerce, Science, and Transportation. Senate, Apr. 25, 1984.
   LENGTH: iii+50 p.
   SUDOC: Y4.C73/7:S.hrg.98-863
 
 
RELATED HEARINGS:
 
97th Congress
 
"Pharmaceutical Innovation: Promises and Problems," hearings before the Subcommittee on Natural Resources, Agricultural Research, and Environment and the Subcommittee on Investigations and Oversight, Committee on Science, Space, and Technology. House, Apr. 27, 1981.
   LENGTH: iii+237 p. il.
   SUDOC: Y4.Sci2:97/145
 
98th Congress
 
"Agriculture, Rural Development and Related Agencies Appropriations for 1985. Part 7: Agricultural Programs," hearings before the Subcommittee on Agriculture, Rural Development, and Related Agencies Appropriations, Committee on Appropriations. House, Mar. 21, 26, 1984.
   LENGTH: ii+668+ix p. il. Index.
   SUDOC: Y4.Ap6/1:Ag8/985/pt.7
 
 
MISCELLANEOUS PUBLICATIONS:
 
Weekly Compilation of Presidential Documents, Vol. 20, No. 39 (1984): Sept. 24, Presidential statement.