80N-0208

REF 1

Volume 126

 

Cover Letter

Tab 1 - February 13, 1973 (38 FR 4319); "Procedures for Review of Safety, Effectiveness, and Labeling," Biological Products.

Tab 2 - November 20, 1973 (38 FR 32048 at 32052); Biological Products General, "Reorganization and Republication."

Tab 3 - June 19, 1974 (39 FR 21176); Certain Biological Products, "Request for Data and Information Regarding Safety, Effectiveness, and Labeling Review."

Tab 4 - November 21,1980 (45 FR 77135).

Part A - Bacterial Vaccines and Toxoids; Blood and Blood Derivatives; Availability of Final Reports of Advisory Review Panels.

Part B - Panel Report, part 2, part 3, part 4, part 5, part 6.

Tab 5 - Notifiable Diseases - Summary of reported cases, United States, Historical Tables - 1943-1992.

Tab 6 - October 5, 1982 (47 FR 44062); Licensing; Reclassification Procedures To Determine That Licensed Biological Products Are Safe, Effective, and Not Misbranded Under Prescribed, Recommended or Suggested Conditions of Use.

Tab 7 - May 15,2000 (65 FR 3 1003); Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Proposed Order.

Tab 8 - May 29,200 1 (66 FR 29 148); Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses.

Tab 9 - Docket # 0lP-0471

Part A - Citizen Petition dated October 12,2001) submitted by Russell E. Dingle.

Part B - FDA’s response dated August 28,2002, inclusive of three attachments.

Tab 10 - Pittman, P.R., et al., “Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans,” Vaccine, 20: 14 12- 1420, 2002.

Tab 11- Berlex Laboratories, Inc. v. FDA, 942 F. Supp. 19 (D.D.C. 1996).

Tab 12 - 61 FR 40153 (August 1, 1996); Revocation of Certain Regulations; Biological Products.