Document ID: FDA-1980-N-0049-0086
Agency: fda
Document Type: Notice
Title: Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction
Posted Date: 2004-02-20T05:00Z

[Federal Register: February 13, 2004 (Volume 69, Number 30)]
[Rules and Regulations]               
[Page 7114-7115]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe04-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 610

[Docket No. 1980N-0208]

 
Biological Products; Bacterial Vaccines and Toxoids; 
Implementation of Efficacy Review; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule and final order; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule and final order that appeared in the Federal Register of January 
5, 2004 (69 FR 255). The document amended the biologics regulations and 
categorized certain biological products licensed before July 1, 1972, 
based on their safety, effectiveness, and labeling. The document was 
published with some typographical errors in the reference section. This 
document corrects those errors.

DATES: Effective February 13, 2004.

FOR FURTHER INFORMATION CONTACT: Astrid Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In FR Doc. 03-32255, appearing on page 255, 
in the

[[Page 7115]]

Federal Register of January 5, 2004, the following corrections are 
made:
    1. On page 265, in the third column, the second reference is 
corrected to read ``Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. 
Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and 
Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National 
Academies Press, Washington, DC, April 2002, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nap.edu/catalog/10310.html
 (FDA has verified the Web site address, but we are 

not responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register).''
    2. On page 266, in the first column, the third reference is 
corrected to read ``Fellows, P. F., M. K. Linscott, B. E. Ivins, M. L. 
M. Pitt, C. A. Rossi, P. H. Gibbs and A. M. Friedlander, `Efficacy of a 
Human Anthrax Vaccine in Guinea Pigs, Rabbits, and Rhesus Macaques 
Against Challenge by Bacillus Anthracis Isolates of Diverse 
Geographical Origin,' Vaccine, 19(23/24):3241-3247, 2001.''
    3. On page 266, in the first column, the fourth reference is 
corrected to read ``Ivins, B. E., P. F. Fellows, M. L. M. Pitt, J. E. 
Estep, S. L. Welkos, P. L. Worsham and A. M. Friedlander, `Efficacy of 
a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol 
Spore Challenge in Rhesus Monkeys,' Salisbury Medical Bulletin 
87(Suppl.):125-126, 1996.''
    4. On page 266, in the first column, the fifth reference is 
corrected to read ``Ivins, B. E.; M. L. M. Pitt; P. F. Fellows; J. W. 
Farchaus; G. E. Benner; D. M. Waag; S. F. Little; G. W. Anderson, Jr.; 
P. H. Gibbs; and A. M. Friedlander, `Comparative Efficacy of 
Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in 
Rhesus Macaques,' Vaccine, 16(11/12):1141-1148, 1998.''
    5. On page 266, in the first column, the seventh reference is 
corrected to read ``Wright, G. G.; Green, T. W.; and Kanode, Jr., R. 
G., `Studies on Immunity in Anthrax: V. Immunizing Activity of Alum-
Precipitated Protective Antigen,' Journal of Immunology, 73:387-391, 
1954.''
    6. On page 266, in the first column, the tenth reference is 
corrected to read ```Guidance for Industry: How to Complete the Vaccine 
Adverse Event Reporting System Form (VAERS-1)', September 1998, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/gdlns/vaers-1.pdf.
 (FDA has verified the Web site 

address, but we are not responsible for subsequent changes to the Web 
site after this document publishes in the Federal Register).''
    7. On page 266, in the first column, the eleventh reference is 
corrected to read ```Estimated Vaccination Coverage With 3+DTP Among 
Children 19-35 Months of Age by Race/Ethnicity,' and by State and 
Immunization Action Plan Area--U.S., National Immunization Survey, Q3/
2000 - Q2/2001, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cdc.gov/nip/coverage/NIS/00-01/tab19-3dpt_race_iap.htm.
 (FDA has verified the Web site address, but we are not 

responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register).''
    8. On page 266, in the second column, the twelfth reference is 
corrected to read ``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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cdc.gov/nip/news/testimonies/vac-shortages-walt-6-12-2002.htm.
 (FDA 

has verified the Web site address, but we are not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register).''

    Dated: February 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3135 Filed 2-12-04; 8:45 am]

BILLING CODE 4160-01-S