EXTENSION OF EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX /VACCINATIONS

RTTUZYUW RUEWMCS0000 2162202-UUUU--RUCRNAD.
ZNR UUUUU
R 042202Z AUG 05
FM CNO WASHINGTON DC
TO NAVADMIN
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UNCLAS
NAVADMIN 188/05
MSGID/GENADMIN/CNO WASHINGTON DC/DNS/AUG//
SUBJ/EXTENSION OF EMERGENCY USE AUTHORIZATION TO RESUME ANTHRAX
/VACCINATIONS//



REF/A/DOC/FDA/YMD:20050722//
REF/B/MSG/CNO (N09) WASHINGTON DC/201855ZMAY2005//
NARR/REF A IS THE COMMISSIONER OF FOOD AND DRUGS LETTER EXTENDING
THE FDA'S EMERGENCY USE AUTHORIZATION (EUA) FOR USE OF ANTHRAX
VACCINE. REF B IS NAVADMIN 110/05 INITIATING THE EMERGENCY USE
AUTHORIZATION TO RESUME ANTHRAX VACCINATIONS//
POC/CATHLEEN DONOHUE/LCDR/CNO N931D5/LOC:WASHINGTON DC
/TEL:703-601-1716/TEL:DSN: 329-1716/EMAIL:CATHLEEN.DONOHUE@NAVY.MIL//
RMKS/1. PER REF A, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS
GRANTED AN EXTENSION TO THE CURRENT EMERGENCY USE AUTHORIZATION
(EUA) FOR DOD'S ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
A. THIS MESSAGE EXTENDS REF B, WITHOUT CHANGE.
B. ON 22 JULY 05 THE FDA APPROVED AN EXTENSION UNTIL 14 JAN 06.
2. PER REF B, COMMANDING OFFICERS AND OIC'S SHALL CONTINUE TO:
A. SUBMIT THE EUA COMPLIANCE AGREEMENT AND WEEKLY REPORTS TO MILVAX
AGENCY.
B. EDUCATE ALL INDIVIDUALS ELIGIBLE FOR ANTHRAX VACCINATION UNDER
THE EUA.
C. INFORM ALL INDIVIDUALS ELIGIBLE OF THE OPTION TO REFUSE ANTHRAX
VACCINATION WITHOUT PENALTY.
D. SUPPLEMENT THE TRIFOLD BROCHURE, WHENEVER POSSIBLE, WITH A BRIEF
USING STANDARD BRIEFING SLIDES, AVAILABLE ELECTRONICALLY AT
WWW.ANTHRAX.MIL/EUA.
E. MAINTAIN A ROSTER OF ALL INDIVIDUALS PROVIDED THE EUA TRIFOLD
BROCHURE AND BRIEF.
F. ENSURE APPROPRIATE MEDICAL EVALUATION IF INDIVIDUALS EXPERIENCE
SYMPTOMS FOLLOWING ANY VACCINATION.
3. MEDICAL ACTIVITIES OFFERING ANTHRAX IMMUNIZATIONS SHOULD EXERCISE
SPECIAL CARE TO CONFIRM, PRIOR TO ADMINISTERING IMMUNIZATION, THAT
THE INDIVIDUAL ELECTS TO RECEIVE ANTHRAX IMMUNIZATION.
4. PER REF B, ALL IMMUNIZATIONS WILL BE ENTERED INTO AN APPROVED
ELECTRONIC TRACKING SYSTEM (ETS) THAT TRANSMITS DATA TO DEFENSE
ENROLLMENT ELIGIBLITY REPORTING SYSTEM (DEERS). APPROVED NAVY
SYSTEMS ARE, SHIPBOARD NON-TACTICAL ADP PROGRAM (SNAP) AUTOMATED
MEDICAL SYSTEM (SAMS), THE MEDICAL READINESS REPORTING SYSTEM (MRRS)
AND COMPOSITE HEALTH CARE SYSTEM VERSION II (CHCS II).
A. DATA COLLECTED IN SAMS MUST BE TRANSMITTED TO THE NAVY MEDICAL
INFORMATION MANAGEMENT COMMAND (NMIMC) FOR FURTHER ENTRY INTO DEERS.
B. REFUSALS SHALL BE ENTERED INTO THE ETS UNDER THE CODE "MD" FOR
"MEDICALLY DECLINED".
C. IF THESE SYSTEMS ARE NOT ACCESSIBLE, ANNOTATE VACCINATION OR
REFUSAL ON SF 600 IN MEMBERS MEDICAL RECORD OR PHS 731 YELLOW SHOT
CARD.
5. THE AVIP REMAINS A COMMANDER'S FORCE HEALTH PROTECTION
RESPONSIBILITY. COMMANDERS WILL CONTINUE TO EXECUTE AVIP ACCORDING
TO GUIDANCE IN REF B.
6. SERVICE POCS:
A. ACTIVE POC: OPNAV (N931) LCDR C. DONOHUE, (COMM) 703 601-1716,
(DSN) 329-1716; E-MAIL: NIPR CATHLEEN.DONOHUE@NAVY.MIL; SIPR
DONOHUE.CATHLEEN@CNO.NAVY.SMIL.
B. RESERVE POC: OPNAV (N951) CDR M. JACOBSEN, (COMM) 703 614-4830,
(DSN) 224-4830; E-MAIL: NIPR MARY.JACOBSEN@NAVY.MIL; SIPR
JACOBSEN.MARY@CNO.NAVY.SMIL.MIL.
7. EXPIRATION DATE FOR THIS MESSAGE IS 14 JAN 06.
8. RELEASED BY VADM A. T. CHURCH III, DIRECTOR, NAVY STAFF.//
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