Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 68465 

• Any unusual condition, such as a 

high fever or behavior changes. Signs of 

a serious allergic reaction can include 

difficulty breathing, hoarseness or 

wheezing, hives, paleness, weakness, a 

fast heart beat or dizziness. 

What should I do? 

• Call a doctor, or get the person to 

a doctor right away. 

• Tell your doctor what happened, 

the date and time it happened, and 

when the vaccination was given. 

• Ask your doctor, nurse, or health 

department to report the reaction by 

filing a Vaccine Adverse Event 

Reporting System (VAERS) form. 

Or you can file this report through the 

VAERS Web site at http:// 

www.vaers.hhs.gov, or by calling 1–800–

822–7967. 

VAERS does not provide medical 

advice. 

8. The National Vaccine Injury 

Compensation Program 

In the event that you or your child has 

a serious reaction to a vaccine, a Federal 

program has been created to help pay 

for the care of those who have been 

harmed. 

For details about the National Vaccine 

Injury Compensation Program, call 1–

800–338–2382 or visit their Web site at 

http://www.hrsa.gov/osp/vicp. 

9. How can I learn more? 

• Ask your immunization provider. 

They can give you the vaccine package 

insert or suggest other sources of 

information. 

• Call your local or state health 

department. 

• Contact the Centers for Disease 

Control and Prevention (CDC): 

—Call 1–800–232–4636 (1–800–CDC–

INFO). 

—Visit CDC’s Web site at http:// 

www.cdc.gov/flu. 

—Vaccine Information Statement. 

—Live, Attenuated Influenza Vaccine. 

(October 20, 2005) 

42 U.S.C. 300aa–26. 

Department of Health and Human Services, 

Centers for Disease Control and Prevention, 

National Immunization Program. 

Dated: November 4, 2005. 

James D. Seligman, 

Associate Director for Program Services, 

Centers for Disease Control and Prevention. 

[FR Doc. 05–22441 Filed 11–9–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2001D–0281] 

Medical Devices: A Pilot Program to 

Evaluate a Proposed Globally 

Harmonized Alternative for Premarket 

Procedures; Guidance for Industry and 

FDA Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘A 

Pilot Program to Evaluate a Proposed 

Globally Harmonized Alternative for 

Premarket Procedures; Guidance for 

Industry and FDA Staff.’’ The revised 

guidance extends the voluntary pilot 

premarket review program Summary 

Technical Documentation (STED pilot) 

until we have received an adequate 

number of submissions to evaluate the 

STED pilot. The pilot program is 

intended for evaluating the utility of an 

alternative submission procedure. 

DATES: Submit written or electronic 

comments on the guidance at any time. 

ADDRESSES: Submit written requests for 

single copies on a 3.5’’ diskette of the 

guidance document entitled ‘‘A Pilot 

Program to Evaluate a Proposed 

Globally Harmonized Alternative for 

Premarket Procedures; Guidance for 

Industry and FDA Staff’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance (HFZ–220), 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

1350 Piccard Dr., Rockville, MD 20850. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–443–

8818. See SUPPLEMENTARY INFORMATION

section for information on electronic 

access to the guidance. 

Submit written comments concerning 

this guidance 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Harry R. Sauberman, Center for Devices 

and Radiological Health (HFZ–480), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–443–4879, or Kenneth J. Cavanaugh 

Jr., Center for Devices and Radiological 

Health (HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–443–8517. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 26, 

2003 (68 FR 38068), FDA announced the 

availability of a guidance document 

entitled ‘‘A Pilot Program to Evaluate a 

Proposed Globally Harmonized 

Alternative for Premarket Procedures; 

Guidance for Industry and FDA Staff.’’

The guidance document announced a 

pilot program for a premarket review 

program and encouraged participation 

from the medical device industry. The 

pilot program is intended to evaluate 

the utility of an alternative submission 

procedure as described in the draft 

STED document prepared by Study 

Group 1 of the Global Harmonization 

Task Force (GHTF). The document seeks 

to harmonize the different requirements 

for premarket submissions in various 

countries. 

The June 26, 2003, guidance and 

notice of availability announced that the 

pilot program would be in effect for 1 

year from the date of publication of the 

notice of availability. In the Federal 

Register of July 23, 2004 (69 FR 44040), 

the pilot program was subsequently 

extended until June 25, 2005. FDA has 

received no comments on the guidance 

issued on June 26, 2003, or the updated 

version published on July 23, 2004. In 

this revised guidance, FDA is extending 

the pilot program until we have 

received a sufficient number of 

submissions to evaluate the pilot 

program. In addition, FDA is updating 

the contact information and the 

references to the GHTF documents, 

along with other minor editorial 

changes. The FDA guidance document 

is intended to assist the medical device 

industry in making submissions to FDA 

that use a proposed internationally 

harmonized format and content for 

premarket submissions, e.g., premarket 

approval applications and 510(k) 

submissions in the United States. The 

revised guidance is a level 2 guidance 

under FDA’s good guidance practices 

(GGPs) regulation (21 CFR 10.115). FDA 

made the guidance available on its Web 

site at http://www.fda.gov/cdrh/ode/ 

guidance/1347.html. 

The GHTF is a voluntary group 

comprised of medical device regulatory 

officials and industry representatives 

from the United States, Canada, 

Australia, the European Union, and 

Japan. The goals of the GHTF include 

the following items: (1) Encourage 

convergence in regulatory practices with 

respect to ensuring the safety, 

effectiveness, performance, and quality 

68466 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 

of medical devices; (2) promote 

technological innovation; and (3) 

facilitate international trade. GHTF 

provides further information concerning 

the structure, goals, and procedures at 

the GHTF Web site and can be accessed 

at http://ghtf.org. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s Good Guidance 

Practice (GGP) regulation (21 CFR 

10.115). The guidance represents the 

agency’s current thinking on the GHTF 

recommendations as related to 

premarket submission to FDA. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

To receive a copy of ‘‘A Pilot Program 

to Evaluate a Proposed Globally 

Harmonized Alternative for Premarket 

Procedures; Guidance for Industry and 

FDA Staff,’’ by fax call CDRH Facts-OnDemand system at 800–899–0381 or 

301–827–0111 from a touch-tone 

telephone. Press 1 to enter the system. 

At the second voice prompt press 1 to 

order a document. Enter the document 

number (1347) followed by the pound 

sign #. Follow the remaining voice 

prompts to complete your request. 

To receive ‘‘A Pilot Program to 

Evaluate a Proposed Globally 

Harmonised Alternative for Premarket 

Procedures; Guidance for Industry and 

FDA Staff,’’ you may either send a fax 

request to 301–443–8818 to receive a 

hard copy of the document, or send an 

e-mail request to gwa@cdrh.fda.gov to 

receive a hard copy or an electronic 

copy. Please use the document number 

1347 to identify the guidance you are 

requesting. 

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes: Device safety 

alerts, Federal Register reprints, 

information on premarket submissions 

(including lists of approved applications 

and manufacturers’ addresses), small 

manufacturer’s, information on video 

conferencing, and electronic 

submissions, Mammography Matters, 

and other device-related information. 

The CDRH web site home page may be 

accessed at http://www.fda.gov/cdrh. A 

search capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Comments 

received may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: November 2, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22387 Filed 11–9–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

Program Exclusions: October 2005 

AGENCY: Office of Inspector General, 

HHS. 

ACTION: Notice of program exclusions. 

During the month of October 2005, 

the HHS Office of Inspector General 

imposed exclusions in the cases set 

forth below. When an exclusion is 

imposed, no program payment is made 

to anyone for any items or services 

(other than an emergency item or 

service not provided in a hospital 

emergency room) furnished, ordered or 

prescribed by an excluded party under 

the Medicare, Medicaid, and all Federal 

Health Care programs. In addition, no 

program payment is made to any 

business or facility, e.g., a hospital, that 

submits bills for payment for items or 

services provided by an excluded party. 

Program beneficiaries remain free to 

decide for themselves whether they will 

continue to use the services of an 

excluded party even though no program 

payments will be made for items and 

services provided by that excluded 

party. The exclusions have national 

effect and also apply to all Executive 

Branch procurement and nonprocurement programs and activities. 

Subject name/address Effective 

date 

PROGRAM-RELATED CONVICTIONS 

ADAIR, KARISTA ..................... 11/20/2005 

LEWISBURG, TN 

AUSTIN, HOWARD .................. 11/20/2005 

OAKDALE, LA 

BAILEY, LAWRENCE ............... 11/20/2005 

SHREVEPORT, LA 

BESAW NALEN, KIMBERLY ... 11/20/2005 

MANCHESTER, NH 

BLACK, ANTONIA .................... 11/20/2005 

FLINT, TX 

CONVENIENT DENTAL CARE 

CENTER, PC ........................ 11/20/2005 

OKEMOS, MI 

DE LA CRUZ, ALFONSO ......... 11/20/2005 

LOS ANGELES, CA 

ERLICH, RUSSELL .................. 11/20/2005 

BROOKLYN, NY 

FLORES, SILVIA ...................... 11/20/2005 

ONTARIO, CA 

GARCIA, ROSEMARIE ............ 11/20/2005 

SAN DIEGO, CA 

HAMILTON BENNETT, 

MAISHA ................................ 11/20/2005 

CHICAGO, IL 

HAWKINS, KIMBERLY ............. 11/20/2005 

SHAKOPEE, MN 

HERNANDEZ, KAREN ............. 11/20/2005 

OKLAHOMA CITY, OK 

KATZ, RONALD ....................... 11/20/2005 

OTISVILLE, NY 

KEMMETT, BARBARA ............. 11/20/2005 

BRIDGEWATER, MA 

KUBRICKY, MARK ................... 11/20/2005 

OGDEN, UT 

LAKHTER, ALEXANDER ......... 11/20/2005 

E STROUDSBURG, PA 

LEBEL, ALEXANDER ............... 11/20/2005 

BROOKLYN, NY 

LEEDS, LORI ........................... 11/20/2005 

SHAKOPEE, MN 

LITTLE, MARK ......................... 11/20/2005 

ANTHONY, TX 

MALVAREZ, NORBERTO ........ 11/20/2005 

MIAMI, FL 

MARTINEZ, CESAR ................. 11/20/2005 

MIAMI, FL 

MORAN, PAT ........................... 11/20/2005 

WICHITA FALLS, TX 

SHUMATE, TAMMY ................. 11/20/2005 

LOUISVILLE, KY 

UTUK, BECALO ....................... 11/20/2005 

BRYAN, TX 

VU, PHOUA .............................. 11/20/2005 

SAN DIEGO, CA 

WALLACE, SHIRLEY ............... 11/20/2005 

JONESBORO, AR 

WILLIAMS-WRIGHT, MYRA .... 11/20/2005 

MIAMI, FL 

FELONY CONVICTION FOR HEALTH CARE 

FRAUD 

CHAVEZ, WILLIAM .................. 11/20/2005 

MIAMI, FL 

GONZALEZ, DUVIEL ............... 11/20/2005 

MIAMI, FL 

GORRIN, EDDY ....................... 11/20/2005 

MIAMI, FL 

KRZYS, PENNY ....................... 11/20/2005