Dockets:

1980N-0208
BKG 7
Volume 226

Reference 1 - “Table of’ Reportable Events Following Vaccination,” http://www.vaers.hhs.gov/reportable.htm. (FDA has verified the Web site address, but we note subsequent changes to the Web site might occur after this document publishes in the FEDERAL REGISTER).

Reference 2 - “Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)“, September 1998, http://www.fda.gov/cber/gdlns/vaers-1.pdf. (FDA has verified the Web site
address, but we note subsequent changes to the Web site might occur after this document publishes in the FEDERAL REGISTER).

Reference 3 - “Estimated Vaccination Coverage With 3+DTP Among Children 19-35 Months od Age by Race/Ethnicity, and by State and Immunization Action Plan Area-U.S., National Immunization Survey, Q3/2000 - Q2/2001”, http://www.cdc.gov/nip/coverage/NIS/00-01/tab19-3dpt_race_iap.htm. (FDA has verified the Web site address, but we note subsequent changes to the Web site might occur after this document publishes in the FEDERAL REGISTER).

Reference 4 - Protecting Our Kids: What Is Causing the Current Shortage in Childhood Vaccines?-Testimony Before the Committee on Governmental Affairs, United States Senate, June 12, 2002, http://www.cdc.gov/nip/news/testimonies/vac-shortages-walt-6-12-2002.htm. (FDA has verified the Web site address, but we note subsequent changes to the Web site might occur after this document publishes in the FEDERAL REGISTER).

Reference 5 - August 1, 1996 (61 FR 40153); Revocation of Certain Regulations; Biological Products; Final Rule.

Reference 6 - Colditz, et al., “Efficacy of BCG Vaccine in the Prevention of Tuberculosis: Meta Analysis of the Published Literature”, Journal of the American Medical Association, 271: 698-702, 1994. Published Material

Reference 7 - FDA/CBER VRBPAC Meeting Transcript (February 17, 2005), http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4087T2.htm

Reference 8 - FDA/CBER VRBPAC Meeting Transcript (May 6, 2004), http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4038t1.htm

Reference 9 - FDA/CBER VRBPAC Meeting Transcript (May 8, 2003), http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3948t1.txt

Reference 10 - Guidance for FDA Staff: The Leveraging Handbook; June 2003, http://www.fda.gov/cber/gdlns/leverhnbk.pdf