58242 Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Notices 

a federal declaration in support of an 

emergency use authorization under 

section 564 of the FDCA unless such 

declaration specifies otherwise. 

This first day of October, 2008. 

Michael O. Leavitt, 

Secretary of Health and Human Services. 

APPENDIX I—LIST OF U.S. GOVERNMENT CONTRACTS

Contract Manufacturer Covered countermeasure PL 85–804 

coverage* 

HHSO100200500007C ........................ Cangene ............................................. Anthrax immune globulin—AIG .............................. No. 

HHSO100200500006C ........................ HGS ................................................... Anthrax monoclonal antibody-ABThrax ................. No. 

HHSO100200600019C ........................ Emergent Biodefense Operations ...... BioThrax (Anthrax Vaccine Adsorbed, AVA) ......... Yes. 

HHSO100200700037C ........................ Emergent Biodefense Operations ...... BioThrax (Anthrax Vaccine Adsorbed, AVA) ......... No. 

W9113M–04–D–0002 .......................... BioPort (Emergent Biosolutions) ........ BioThrax (Anthrax Vaccine Adsorbed, AVA) ......... Yes. 

DAMD 17–97–D–00003 ....................... BioPort (Emergent Biosolutions) ........ BioThrax (Anthrax Vaccine Adsorbed, AVA) Shipping.Yes. 

HHSN 272200700035C ....................... Elusys ................................................. Anthrax monoclonal antibody—ETI–204 ............... No. 

HHSN 272200700033C ....................... Pharmathene ...................................... Anthrax monoclonal antibody—Valortim ................ No. 

HHSN 272200700034C ....................... Emergent BioSolutions ...................... Anthrax immune globulin—AIG .............................. No. 

NO1–A1–30052 .................................... Avecia (Pharmathene) ....................... Recombinant protective antigen (rPA) anthrax 

vaccine.

No. 

V797P–5777x ....................................... Shering Corp. ..................................... Cipro 250mg/5ml; 100ml suspension .................... No. 

V797P–5977x ....................................... Cobalt Pharmaceuticals ..................... Cipro 500mg tablets ............................................... No. 

V797P–5941x ....................................... Blu Pharmaceuticals .......................... Doxycycline 100mg tablets .................................... No. 

V797P–5883x ....................................... Pfizer, Inc ........................................... Doxycycline 25mg/5ml suspension 60ml ............... No. 

V797P–5669x ....................................... Abraxis Bioscience, Inc ...................... Doxycycline 100mg vial IV ..................................... No. 

V797–DSNS–8002 ............................... Sandoz, Inc ........................................ Amoxicillin 500mg capsules ................................... No. 

V797–DSNS–8002 ............................... Sandoz, Inc ........................................ Amoxicillin 400mg/5ml; 100ml suspension ............ No. 

V797BPA0015 ...................................... Bedford Labs ...................................... Rifampin 600mg vial IV .......................................... No. 

V797P–5396x ....................................... Hospira ............................................... Clindamycin 150mg/ml 6ml vial IV ......................... No. 

V797P–5669x ....................................... Abraxis Bioscience, Inc ...................... Vancomycin 1 g vial IV .......................................... No. 

V797P–1020x ....................................... McKesson .......................................... Penicillin GK 20 million unit vial IV ........................ No. 

V797P–5387x ....................................... Johnson and Johnson Healthcare ..... Levofloxacin 5mg/ml 150ml bag IV ........................ No. 

* Status of indemnification coverage under P.L. 85–804 (An Act to authorize the making, amendment and modification of contracts to facilitate 

the national defense.) 

[FR Doc. E8–23547 Filed 10–1–08; 4:15 pm] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Determination and Declaration 

Regarding Emergency Use of 

Doxycycline Hyclate Tablets 

Accompanied by Emergency Use 

Information 

AGENCY: Office of the Secretary (OS), 

HHS. 

ACTION: Notice. 

SUMMARY: The Secretary of the 

Department of Health and Human 

Services (HHS) is issuing this notice 

pursuant to section 564(b)(4) of the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), 21 U.S.C. 360bbb–3(b)(4), to 

justify the emergency use of 

doxycycline hyclate tablets 

accompanied by emergency use 

information, contained in emergency 

kits for eligible United States Postal 

Service (USPS) Cities Readiness 

Initiative (CRI) participants and their 

household members in advance of a 

potential attack involving Bacillus 

anthracis. Bacillus anthracis is a 

biological agent known to cause 

anthrax. The Secretary, HHS, provides 

notice of the determination of the 

Secretary of Homeland Security on 

September 23, 2008 that there is a 

significant potential for a domestic 

emergency involving a heightened risk 

of attack with a specified biological, 

chemical, radiological, or nuclear agent 

or agents—in this case, Bacillus 

anthracis, although there is no current 

domestic emergency involving anthrax, 

no current heightened risk of an anthrax 

attack, and no credible information 

indicating an imminent threat of an 

attack involving Bacillus anthracis. The 

Secretary also provides notice that, on 

the basis of such determination, he has 

declared an emergency justifying the 

authorization of emergency use of 

doxycycline hyclate tablets 

accompanied by emergency use 

information subject to the terms of any 

authorization issued by the Food and 

Drug Commissioner under 21 U.S.C. 

360bbb–3(a). 

DATES: This Notice and referenced HHS 

declaration are effective as of October 1, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

RADM W.C. Vanderwagen, M.D., 

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Washington, DC 20201, Telephone 

(202) 205–2882 (this is not a toll free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

The CRI, begun in 2004, is a federally 

supported effort to prepare 72 major 

U.S. metropolitan areas to effectively 

respond to a large-scale bioterrorist 

event by dispensing antibiotics to their 

entire identified population within 48 

hours of the decision to do so. Over the 

past several years, HHS and the USPS 

have developed and tested in three U.S. 

cities—Seattle, Philadelphia and 

Boston—the ability of letter carriers to 

quickly deliver door-to-door a few days’ 

worth of antibiotics to residential 

addresses. This quick-strike capability is 

intended to buy time for State and local 

public health authorities to set up 

points of dispensing for further 

provision of antibiotics across the 

community, as needed. 

Under Section 564 of the FFDCA, the 

Secretary of Homeland Security may 

determine that there is a domestic 

emergency, or a significant potential for 

a domestic emergency, involving a 

heightened risk of attack with a 

specified biological chemical, 

radiological or nuclear agent or agents. 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Notices 58243 

Based on such a determination, the 

Secretary of Health and Human Services 

may declare an emergency that justifies 

the authorization of a product that is not 

otherwise approved, licensed or cleared 

for commercial use (‘‘unapproved 

product’’) or is not approved, licensed, 

or cleared for a particular use 

(‘‘unapproved use of an approved 

product.’’). Following that declaration, 

the Commissioner of the Food and Drug 

Administration (FDA) may issue an 

Emergency Use Authorization (EUA). 

The Biomedical Advanced Research 

and Development Authority (BARDA) of 

the HHS Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR) has requested that 

FDA issue an EUA for doxycycline 

hyclate tablets accompanied by 

emergency use information for use by 

eligible USPS participants in the CRI 

and their household members. 

Doxycyline hyclate tablets are approved 

by the FDA for the post-exposure 

prophylaxis of anthrax. However, the 

doxycycline hyclate tablets for which 

BARDA seeks an EUA would be 

accompanied by emergency use 

information that is not included in any 

of the approved applications for 

doxyclycline hyclate tablets. For this 

reason, an EUA is necessary. The 

September 23, 2008 determination by 

the Secretary of Homeland Security that 

there is a significant potential for a 

domestic emergency, involving a 

heightened risk of attack with a 

specified biological, chemical, 

radiological, or nuclear agent or 

agents—in this case, Bacillus anthracis, 

and the October 1, 2008 declaration by 

the Secretary of Health and Human 

Services based on that determination 

that there is an emergency justifying the 

authorization of emergency use of 

doxycycline hyclate tablets 

accompanied by emergency use 

information, enables the FDA 

Commissioner to issue an EUA for 

doxycyline hyclate tablet emergency 

kits under section 564(a) of the FFDCA, 

21 U.S.C. 360bbb–3(a). 

With issuance of the EUA, eligible 

letter carriers participating in the CRI 

may receive the doxycycline hyclate 

tablet emergency kits, if not medically 

contraindicated, for future use by them 

and other members of their households 

during an anthrax emergency, subject to 

the terms of the authorization. The 

antibiotics and accompanying 

information may help protect these 

letter carriers and household members 

against contracting anthrax if, following 

an outdoor anthrax attack, the USPS is 

called upon to deliver the same or 

similar antibiotics to homes across their 

community where people may have 

been exposed to Bacillus anthracis. In 

an anthrax attack, time is of the essence 

in preventing illness and death by 

getting antibiotics to people who may 

have been exposed. By providing 

advance protection to letter carriers who 

willingly put themselves at risk by 

delivering antibiotics in an affected 

community, the unique capabilities of 

the USPS may be used to get antibiotics 

to those who need them quickly. 

The USPS initiative and EUA are one 

part of the Federal Government’s 

strategy to encourage preparedness at all 

levels of government to enable the 

nation to respond effectively in the 

event of an anthrax emergency. 

II. Determination of the Secretary of 

Homeland Security 

On September 23, 2008, pursuant to 

section 564(b)(1)(A) of the FFDCA, 21 

U.S.C. 360bbb–3(b)(1)(A), the Secretary 

of Homeland Security determined that 

there is a significant potential for a 

domestic emergency, involving a 

heightened risk of attack with a 

specified biological, chemical, 

radiological, or nuclear agent or 

agents—in this case, Bacillus anthracis. 

The Secretary of Homeland Security 

made this determination in a September 

23, 2008 memorandum addressed to the 

Secretary of Health and Human 

Services. In that memorandum, the 

Secretary of Homeland Security stated 

that there is not currently a domestic 

emergency involving anthrax, there is 

not currently a heightened risk of an 

anthrax attack, and his Department has 

no credible information indicating an 

imminent threat of an attack involving 

Bacillus anthracis. 

The Secretary of Homeland Security 

determined that there is a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with Bacillus anthracis, on two bases: 

(1) The Department of Homeland 

Security has already found that an 

anthrax attack poses a material threat to 

the United States population sufficient 

to affect national security, which allows 

the Secretary to conclude that there is 

a non-negligible possibility that a 

heightened risk of attack will arise. The 

finding that an anthrax attack poses a 

material threat to the United States 

population sufficient to affect national 

security was made on January 20, 2004 

regarding anthrax, and on September 22, 

2006 regarding multi-drug resistant 

Bacillus anthracis, pursuant to section 

319F–2(c)(2) of the Public Health 

Service (PHS) Act, 42 U.S.C. 247d– 

6b(c)(2). (2) Were the government to 

determine in the future that there is a 

heightened risk of an anthrax attack—if, 

for example, there were credible 

information about an imminent threat of 

such an attack—that would almost 

certainly result in a domestic 

emergency. That is so, among other 

important reasons, because those 

exposed to Bacillus anthracis need to 

take appropriate antimicrobials rapidly 

after exposure to avoid contracting 

anthrax and because of the significant 

challenges to rapidly delivering such 

antimicrobials to those at risk in an 

anthrax emergency. 

Given his determination that there is 

a significant potential for a domestic 

emergency, the Secretary of Homeland 

Security also urged the Secretary of 

Health and Human Services to employ 

all relevant emergency powers under 

section 564 of the FFDCA to ensure 

distribution of pre-need 

countermeasures that may be effective 

in preventing the contracting of anthrax 

by people in the delivery chain, such as 

USPS workers; first responders, 

including law enforcement; to essential 

government and non-government 

workers; and to the general public. 

III. Declaration of the Secretary of 

Health and Human Services 

On September 23, 2008, the Secretary 

of the Department of Homeland Security 

determined that there is a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with a specified biological, chemical, 

radiological, or nuclear agent or 

agents—in this case, Bacillus anthracis. 

Pursuant to section 564(b) of the Federal 

Food, Drug and Cosmetic Act, 21 U.S.C. 

360bbb–3(b), and on the basis of such 

determination, on October 1, 2008, I 

declared an emergency justifying the 

authorization of the emergency use of 

doxycycline hyclate tablets 

accompanied by emergency use 

information subject to the terms of any 

authorization issued under 21 U.S.C. 

360bbb–3(a). 

Dated: October 1, 2008. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E8–23544 Filed 10–1–08; 4:15 pm] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 


jlentini on PROD1PC65 with NOTICES