FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back


1980N-0208
BKG 7
Volume 226

Memorandum

Table of Contents

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


Top | Back

Page last updated December 28, 2005 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management