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2010-09-23
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Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
Proposed Rules
D09002ee1bde4a025
D09002ee1bde4a15e
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is proposing to amend the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is proposing to classify these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). On December 13, 1985, FDA proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids. After reviewing the Panel's report and comments on the proposal, FDA published a final rule and final order on January 5, 2004. The court vacated the January 5, 2004 (69 FR 255) final rule. Therefore, elsewhere in this issue of the Federal Register, FDA is withdrawing the January 5, 2004, final rule. FDA is issuing this proposed rule and proposed order again to provide notice and to give interested persons an opportunity to comment.
69 FR 78281
https://www.govinfo.gov/app/details/FR-2004-12-29/04-28322
04-28322
fr29de04-32
4160-01-S
Docket No. 1980N-0208
https://www.govinfo.gov/app/details/FR-2004-12-29/04-28322
https://www.govinfo.gov/content/pkg/FR-2004-12-29/html/04-28322.htm
https://www.govinfo.gov/content/pkg/FR-2004-12-29/pdf/04-28322.pdf
13 p.
78281
78293
69 FR 78281
Code of Federal Regulations
Title 21 Part 201
21 CFR Part 201
Code of Federal Regulations
Title 21 Part 610
21 CFR Part 610
Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Federal Register Vol. 69, Issue
PRORULE
04-28322
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2005-03-29
Docket No. 1980N-0208
4160-01-S
04-28322
Proposed rule and proposed order.
The Food and Drug Administration (FDA) is proposing to amend the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is proposing to classify these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). On December 13, 1985, FDA proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids. After reviewing the Panel's report and comments on the proposal, FDA published a final rule and final order on January 5, 2004. The court vacated the January 5, 2004 (69 FR 255) final rule. Therefore, elsewhere in this issue of the Federal Register, FDA is withdrawing the January 5, 2004, final rule. FDA is issuing this proposed rule and proposed order again to provide notice and to give interested persons an opportunity to comment.
Submit written or electronic comments on the proposed rule and proposed order by March 29, 2005.
Astrid Szeto, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
Biological products:
Bacterial vaccines and toxoids; efficacy review implementation,
fdadockets@oc.fda.gov
http://www.cdc.gov/nip/coverage/NIS/00-01/tab19-3dpt_race_iap.htm
http://www.cdc.gov/nip/news/testimonies/vac-shortages-walt-6-12-2002.htm
http://www.fda.gov/cber/gdlns/vaers-1.pdf
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
http://www.nap.edu/catalog/10310.html
http://www.regulations.gov
http://www.vaers.org/reportable.htm
www.fda.gov/cber/gdlns/leverhnbk.pdf
www.fda.gov/ohrms//dockets/ac/02/transcripts/3842t1.pdf
www.fda.gov/ohrms/dockets/ac/01/transcripts/3755t1.pdf
www.fda.gov/ohrms/dockets/ac/01/transcripts/3805t2_01.pdf
www.fda.gov/ohrms/dockets/ac/01/transcripts/3805t2_02.pdf
Federal Register
Vol. 69, no. 249
Office of the Federal Register, National Archives and Records Administration
2004-12-29
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https://www.govinfo.gov/app/details/FR-2004-12-29
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https://www.govinfo.gov/content/pkg/FR-2004-12-29/pdf/FR-2004-12-29.pdf
https://www.govinfo.gov/content/pkg/FR-2004-12-29/xml/FR-2004-12-29.xml
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