[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