Fw: Stop Anthrax Vaccine- URGENT

[Guest guest]

RE: Docket No. 01P-0471

>

> * * * * * * *

> Dockets Management Branch

> Department of Health and Human Services

> Food and Drug Administration; Room 1-23

> 12420 Parklawn Drive

> Rockville, land 20857

> CITIZEN PETITION:

> The undersigned submit this petition under Section 360bbb-2 of the Federal

> Food, Drug and Cosmetic Act, section 553(e) of the Administrative

Procedures

> Act, and Title 21 Subsection 10.30 of the Code of Federal Regulations to

> request the Commissioner of Food and Drugs to take the administrative

> actions

> listed below regarding anthrax vaccine adsorbed.

>

> A. Action requested

>

> (1) Issue a Final Rule on the drug category placement of anthrax vaccine

as

> Category II (unsafe, ineffective, or misbranded) amending the as yet to be

> finalized Proposed Rule as published in the Federal Register 13 December

> 1985.

> (2) Declare as adulterated all stockpiles of anthrax vaccine adsorbed in

the

> possession of BioPort Corporation and all doses in private, public, U.S.

or

> foreign government possession.

> (3) Enforce FDA Compliance Policy Guide, Section 400.200 Consistent

> Application of CGMP Determinations (CPG 7132.12) with respect to anthrax

> vaccine adsorbed (license #1260).

> (4) Revoke the anthrax vaccine adsorbed license (license #1260) held by

> BioPort Corporation.

>

> Other links of important interest:

> <A HREF= " http://www.anthraxvaccine.org/ " >ANTHRAX VACCINE HOME PAGE</A>

> http://www.anthraxvaccine.org/

>

> <A HREF= " http://www.anthraxvaccine.net/ " >Anthrax Vaccine Network</A>

> http://www.anthraxvaccine.net/ - Anthrax Heros. Please read their stories,

> and please pass these stories along to everyone you know. We are grateful

> for

> your interest and concern.

>

> <A HREF= " http://www.dallasnw.quik.com/cyberella/index.htm " >ANTHRAX VACCINE

> LINKS and INFORMATION</A> -

http://www.dallasnw.quik.com/cyberella/index.htm

>

> <A

HREF= " http://www.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html " >

> Anthrax Vaccine Immunization Program Process An.</A>

> http://www.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html

>

>

[Guest guest]

RE: Docket No. 01P-0471

>

> * * * * * * *

> Dockets Management Branch

> Department of Health and Human Services

> Food and Drug Administration; Room 1-23

> 12420 Parklawn Drive

> Rockville, land 20857

> CITIZEN PETITION:

> The undersigned submit this petition under Section 360bbb-2 of the Federal

> Food, Drug and Cosmetic Act, section 553(e) of the Administrative

Procedures

> Act, and Title 21 Subsection 10.30 of the Code of Federal Regulations to

> request the Commissioner of Food and Drugs to take the administrative

> actions

> listed below regarding anthrax vaccine adsorbed.

>

> A. Action requested

>

> (1) Issue a Final Rule on the drug category placement of anthrax vaccine

as

> Category II (unsafe, ineffective, or misbranded) amending the as yet to be

> finalized Proposed Rule as published in the Federal Register 13 December

> 1985.

> (2) Declare as adulterated all stockpiles of anthrax vaccine adsorbed in

the

> possession of BioPort Corporation and all doses in private, public, U.S.

or

> foreign government possession.

> (3) Enforce FDA Compliance Policy Guide, Section 400.200 Consistent

> Application of CGMP Determinations (CPG 7132.12) with respect to anthrax

> vaccine adsorbed (license #1260).

> (4) Revoke the anthrax vaccine adsorbed license (license #1260) held by

> BioPort Corporation.

>

> Other links of important interest:

> <A HREF= " http://www.anthraxvaccine.org/ " >ANTHRAX VACCINE HOME PAGE</A>

> http://www.anthraxvaccine.org/

>

> <A HREF= " http://www.anthraxvaccine.net/ " >Anthrax Vaccine Network</A>

> http://www.anthraxvaccine.net/ - Anthrax Heros. Please read their stories,

> and please pass these stories along to everyone you know. We are grateful

> for

> your interest and concern.

>

> <A HREF= " http://www.dallasnw.quik.com/cyberella/index.htm " >ANTHRAX VACCINE

> LINKS and INFORMATION</A> -

http://www.dallasnw.quik.com/cyberella/index.htm

>

> <A

HREF= " http://www.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html " >

> Anthrax Vaccine Immunization Program Process An.</A>

> http://www.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html

>

>