4918 Federal Register / Vol. 71, No. 19 / Monday, January 30, 2006 / Notices 

ADDRESSES: Hubert H. Humphrey 

building (200 Independence Ave., SW., 

Washington, DC 20201), Conference 

Room 800. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit. 

SUPPLEMENTARY INFORMATION: A webcast 

of the third Community meeting will be 

available on the NIH Web site at: 

http://www.videocast.nih.gov/. If you 

have special needs for the meeting 

please contact Amanda Smith at 

Amanda.Smith@hhs.gov or (202) 690–

7385. 

Dated: January 23, 2006. 

Dana Haza, 

Office of Programs and Coordination, Office 

of the National Coordinator. 

[FR Doc. 06–832 Filed 1–27–06; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

American Health Information 

Community Consumer Empowerment 

Workgroup Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

first meeting of the American Health 

Information Community Consumer 

Empowerment Workgroup in 

accordance with the Federal Advisory 

Committee Act (Pub. L. 92–463, 5 

U.S.C., App.). 

DATES: January 30, 2006 from 1 p.m. to 

5 p.m. 

ADDRESSES: Hubert H. Humphrey 

Building (200 Independence Ave., SW., 

Washington, DC 20201), conference 

room 705A. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit. 

SUPPLEMENTARY INFORMATION: For 

information on how to access this 

workgroup meeting via the Web, 

including ensuring your PC’s 

compatibility, go to: http:// 

www.hsrnet.net/onc/workgroups/. 

This notice is published less than 15 

days in advance of the meeting due to 

logistical difficulties. 

Dated: January 23, 2006. 

Dana Haza, 

Office of Programs and Coordination, Office 

of the National Coordinator. 

[FR Doc. 06–833 Filed 1–27–06; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

American Health Information 

Community Electronic Health Record 

Workgroup Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

first meeting of the American Health 

Information Community Electronic 

Health Record Workgroup in accordance 

with the Federal Advisory Committee 

Act (Pub. L. 92–463, 5 U.S.C., App.). 

DATES: January 31, 2006 from 1 p.m. to 

5 p.m. 

ADDRESSES: Hubert H. Humphrey 

Building (200 Independence Ave., SW., 

Washington, DC 20201), conference 

room 800. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit. 

SUPPLEMENTARY INFORMATION: For 

information on how to access this 

workgroup meeting via the Web, 

including ensuring your PC’s 

compatibility, go to: http:// 

www.hsrnet.net/onc/workgroups/. 

This notice is published less than 15 

days in advance of the meeting due to 

logistical difficulties. 

Dated: January 23, 2006. 

Dana Haza, 

Office of Programs and Coordination, Office 

of the National Coordinator. 

[FR Doc. 06–834 Filed 1–27–06; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Amendment To Extend the January 24, 

2003, Declaration Regarding 

Administration of Smallpox 

Countermeasures, as Amended on 

January 24, 2004 and January 24, 2005 

AGENCY: Office of the Secretary (OS), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: Concern that terrorists may 

have access to the smallpox virus and 

attempt to use it against the American 

public and United States Government 

facilities abroad continues to exist. The 

January 24, 2003, declaration regarding 

administration of smallpox 

countermeasures is revised to 

incorporate statutory definitions from 

the Smallpox Emergency Personnel 

Protection Act of 2003 and extended for 

one year until and including January 23, 

2007. 

DATES: This notice and the attached 

amendment are effective as of January 

24, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Stewart Simonson, Assistant Secretary 

for the Office of Public Health 

Emergency Preparedness, 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: Section 

224(p) of the Public Health Service Act, 

which was established by section 304 of 

the Homeland Security Act of 2002 and 

amended by section 3 of the Smallpox 

Emergency Personnel Protection Act of 

2003 (‘‘SEPPA’’), is intended to alleviate 

certain liability concerns associated 

with administration of smallpox 

countermeasures and, therefore, ensure 

that the countermeasures are available 

and can be administered in the event of 

a smallpox-related actual or potential 

public health emergency such as a 

bioterrorist incident. 

On January 24, 2003, due to concerns 

that terrorists may have access to the 

smallpox virus and attempt to use it 

against the American public and U.S. 

Government facilities abroad, the 

Secretary issued a declaration making 

section 224’s legal protections available. 

The declaration was effective until and 

including January 23, 2004; it included 

in section VI a number of definitions, 

which are no longer appropriate because 

of the statutory amendments in section 

3 of SEPPA. 

On January 24, 2004, the Secretary 

amended the definitions contained in 

the January 24, 2003 declaration in light 

of the statutory amendments in section 

3 of SEPPA because such definitions 

were no longer appropriate, and 

extended the declaration for one year 

until January 23, 2005. On January 24, 

2005, the Secretary extended the 

declaration for another year through 

January 23, 2006. Pursuant to section 

224(p)(2)(A), the Secretary issues the 

amendment below to extend for one 

year, up to and including January 23, 

2007, the January 24, 2003 declaration, 

as amended. 

Amendment To Extend January 24, 

2003 Declaration Regarding 

Administration of Smallpox 

Countermeasures 

I. Policy Determination: The 

underlying policy determinations of the 

January 24, 2003 declaration continue to 

exist, including the heightened concern 

that terrorists may have access to the 

smallpox virus and attempt to use it 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 71, No. 19 / Monday, January 30, 2006 / Notices 4919 

against the American public and U.S. 

Government facilities abroad. 

II. Amendment of Declaration: I, 

Michael O. Leavitt, Secretary of the 

Department of Health and Human 

Services, have concluded, in accordance 

with the authority vested in me under 

section 224(p)(2)(A) of the Public Health 

Service Act, that a potential bioterrorist 

incident makes it advisable to extend 

the January 24, 2003 declaration 

regarding administration of smallpox 

countermeasures until and including 

January 23, 2007. The January 24, 2003, 

declaration as hereby amended may be 

further amended as circumstances 

require. 

III. Effective Dates: This extension is 

effective January 24, 2006 until and 

including January 23, 2007. The 

effective period may be extended or 

shortened by subsequent amendment to 

the January 24, 2003, declaration as 

hereby amended. 

Dated: January 24, 2006. 

Michael O. Leavitt, 

Secretary. 

Amendment To Extend January 24, 2003 

Declaration Regarding Administration of 

Smallpox Countermeasures as Amended on 

January 24, 2004 and January 24, 2005 

I. Policy Determination: The underlying 

policy determinations of the January 24, 2003 

declaration continue to exist, including the 

heightened concern that terrorists may have 

access to the smallpox virus and attempt to 

use it against the American public and U.S. 

Government facilities abroad. 

II. Amendment of Declaration: I, Michael 

O. Leavitt, Secretary of the Department of 

Health and Human Services, have concluded, 

in accordance with the authority vested in 

me under section 224(p)(2)(A) of the Public 

Health Service Act, that a potential 

bioterrorist incident makes it advisable to 

extend the January 24, 2003 declaration 

regarding administration of smallpox 

countermeasures until and including January 

23, 2007. The January 24, 2003, declaration 

as hereby amended may be further amended 

as circumstances require. 

III. Effective Dates: This extension is 

effective January 24, 2006 until and 

including January 23, 2007. The effective 

period may be extended or shortened by 

subsequent amendment to the January 24, 

2003, declaration as hereby amended. 

Dated: January 24, 2006. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 06–820 Filed 1–24–06; 4:50 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee on Immunization 

Practices: Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) announce 

the following Federal Committee 

meeting. 

Correction: This notice was published 

in the Federal Register on January 19, 

2006, volume 71, number 12, page 

3096–3097. ‘‘Additional Information’’

has been added. 

Name: Advisory Committee on 

Immunization Practices (ACIP). 

Times and Dates: 8 a.m.–6:15 p.m., 

February 21, 2006. 8 a.m.–5 p.m., February 

22, 2006. 

Place: Centers for Disease Control and 

Prevention, 1600 Clifton Road, NE., Building 

19, Room 232, Atlanta, Georgia 30333. 

Additional Information: In order to 

expedite the security clearance process at the 

CDC Clifton Road campus, all attendees at 

the ACIP meeting are now required to register 

on-line at http://www.cdc.gov/nip/acip, 

which can be found under the ‘‘Upcoming 

Meetings’’ tab. Please be sure to complete all 

of the required fields before submitting your 

registration. 

All non-US citizens who have not preregistered by January 25, 2006 will not be 

allowed access to the campus, and will not 

be allowed to register on site. All non-US 

citizens are required to complete the ‘‘Access 

Request Form’’ in addition to registering on 

line. This form can be obtained by contacting 

Demetria Gardner at (404) 639–8836 and 

should be e-mailed directly to her upon 

completion at dgardner@cdc.gov. 

Contact Person for More Information: 

Demetria Gardner, Epidemiology and 

Surveillance Division, National 

Immunization Program, CDC, 1600 Clifton 

Road, NE., (E–61), Atlanta, Georgia 30333, 

telephone 404/639–8836, fax 404/639–8616. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

CDC and the Agency for Toxic Substances 

and Disease Registry. 

Dated: January 24, 2006. 

Alvin Hall, 

Director, Management Analysis and Services 

Office Centers for Disease Control and 

Prevention. 

[FR Doc. E6–1095 Filed 1–27–06; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005E–0249] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENABLEX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ENABLEX and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6681. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 


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