FW: [immunizations] Progress of FDA Citizens Petition

[Guest guest]

RE: Docket No. 01P-0471

Thank you for your time and concerns regarding the anthrax vaccine. If you

need more information or having difficulty please e-mail me at:

DaRocksMom@...

Sincerely,

Jane Tier

* * * * * * *

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.