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
58244 Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Notices 

Name: National Committee on Vital and 

Health Statistics (NCVHS) Executive 

Subcommittee. 

Time and Date: 

October 14, 2008, 1 p.m.–5 p.m. 

October 15, 2008, 8:30 a.m.–4:30 p.m. 

Place: Radisson Hotel Reagan National 

Airport, 2020 Jefferson Davis Hwy, Arlington, 

VA 22202. 

Status: Open. 

Purpose: The NCVHS Executive 

Subcommittee will hold a day and a half 

meeting to review the past year’s 

accomplishments and conduct strategic 

planning for the coming year. On the 

afternoon of the first day, the Executive 

Subcommittee will review their 2008 

activities, update operational work plans, 

and review Committee objectives and 

strategic plan for future NCVHS directions. 

On the second day the Subcommittee will 

continue strategic planning for future NCVHS 

directions, discuss collaborative activities 

with the Board of Scientific Counselors at the 

National Center for Health Statistics, the 

plans for updating the 21st Century Health 

Statistics, and the upcoming NCVHS 60th 

anniversary. 

Contact Person for More Information: 

Substantive program information as well as 

summaries of meetings and a roster of 

committee members may be obtained from 

Marjorie S. Greenberg, Executive Secretary, 

NCVHS, National Center for Health Statistics, 

Centers for Disease Control and Prevention, 

3311 Toledo Road, Room 2402, Hyattsville, 

Maryland 20782, telephone (301) 458–4245. 

Information also is available on the NCVHS 

home page of the HHS Web site: http:// 

www.ncvhs.hhs.gov/, where further 

information including an agenda will be 

posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: September 29, 2008. 

James Scanlon, 

Deputy Assistant Secretary for Science and 

Data Policy, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. E8–23438 Filed 10–3–08; 8:45 am] 

BILLING CODE 4151–05–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. 

Name: National Committee on Vital and 

Health Statistics (NCVHS) Standards 

Subcommittee. 

Time and Date: October 14, 2008 

8:30 a.m.–12 p.m. 

Place: Radisson Hotel Reagan National 

Airport, 2020 Jefferson Davis Hwy., 

Arlington, VA 22202. 

Status: Open. 

Purpose: The NCVHS Standards 

Subcommittee will hold a half day meeting 

to plan and discuss upcoming topics for 

hearings and recommendations. 

Contact Person for More Information: 

Substantive program information as well as 

summaries of meetings and a roster of 

committee members may be obtained from 

Denise Buenning, lead staff for Standards 

Subcommittee, NCVHS, Centers for Medicare 

and Medicaid Services, Office of E-Health 

Standards and Services, 7500 Security 

Boulevard, Room S2–26–17, Baltimore, 

Maryland 21244, telephone (410) 786–6711; 

or Marjorie S. Greenberg, Executive 

Secretary, NCVHS, National Center for 

Health Statistics, Centers for Disease Control 

and Prevention, 3311 Toledo Road, Room 

2402, Hyattsville, Maryland 20782, telephone 

(301) 458–4245. Further information also is 

available on the NCVHS home page: http:// 

www.ncvhs.hhs.gov/, where an agenda will 

be posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: September 30, 2008. 

James Scanlon, 

Deputy Assistant Secretary for Science and 

Data Policy, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. E8–23532 Filed 10–3–08; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Secretary’s Advisory Committee on 

Re-Designation of Head Start Grantees 

AGENCY: U.S. Department of Health and 

Human Services. 

ACTION: Notice; Federal Advisory 

Committee Act Meetings 

Announcement. 

SUMMARY: Pursuant to Public Law 92– 

463, the Federal Advisory Committee 

Act, as amended (5 U.S.C. Appendix 2), 

notice is hereby given of the third 

meeting of the Secretary’s Advisory 

Committee on Re-designation of Head 

Start Grantees, Department of Health 

and Human Services (HHS). The 

meeting will be held on Tuesday, 

October 21, 2008, from 9 a.m. to 5:30 

p.m., and on Wednesday, October 22, 

2008, from 9 a.m. to 1 p.m. at the Hotel 

Palomar Arlington, 1121 North 19th 

Street, in Arlington, Virginia. The 

meeting will be open to the public; 

however, seating is limited and 

preregistration is encouraged (see 

below). 

FOR FURTHER INFORMATION CONTACT: 

Colleen Rathgeb, Office of Head Start, email colleen.rathgeb@acf.hhs.gov or 

(202) 205–7378. 

SUPPLEMENTARY INFORMATION: The 

Improving Head Start for School 

Readiness Act of 2007 (Pub. L. 110–134, 

Section 641(c)(2) [42 U.S.C. 9836]) 

requires the Secretary to develop a 

system for designation renewal to 

determine if Head Start agencies are 

delivering high-quality and 

comprehensive Head Start programs 

that meet the educational, health, 

nutritional, and social needs of the 

children and families they serve, and 

meet program and financial 

management requirements and the 

program performance standards. The 

Advisory Committee on Re-Designation 

of Head Start Grantees will provide 

advice and recommendations on the 

development of a transparent, reliable 

and valid system for designation 

renewal as required under the statute. 

The third meeting of the Advisory 

Committee will be held on October 21– 

22, 2008, at the Hotel Palomar 

Arlington, which is located at 1121 

North 19th Street, in Arlington, 

Virginia, one block from the Rosslyn 

Metro station. The Advisory Committee 

will review the results of the data 

analyses it requested from the Office of 

Head Start at its June meeting, discuss 

recommendations, and review a draft 

report. The meeting will be open to the 

public; however, seating is limited and 

preregistration is encouraged. To preregister, please e-mail 

AdvisoryCommittee@pal-tech.com with 

‘‘Meeting Registration’’ in the subject 

line, or call Tara Nordlander at 703– 

243–0495 by 5 p.m. EST, October 17, 

2008. Registration must include your 

name, affiliation, phone number, and 

days attending. If you require a sign 

language interpreter or other special 

assistance, please call Tara Nordlander 

at 703–243–0495 as soon as possible 

and no later than October 10, 2008. 

Written comments may be submitted 

electronically to 

AdvisoryCommittee@pal-tech.com with 

‘‘Public Comment’’ in the subject line. 

HHS recommends that you include your 

name, mailing address, and an e-mail 

address or other contact information in 

the body of your comment. This ensures 

that you can be identified as the 

submitter of the comment, and it allows 

HHS to contact you if further 

information on the substance of the 

comment is needed or if your comment 

cannot be read because of technical 

difficulties. HHS’s policy is that HHS 

will not edit your comment, and any 

identifying or contact information 

provided in the body of a comment will 

be included as part of the comment 

placed in the official public record. If 

HHS cannot read your comment because 

of technical difficulties and cannot 


jlentini on PROD1PC65 with NOTICES