Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 61135 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of September 

13, 2004 (69 FR 55163), FDA published 

a notice announcing the availability of 

a draft tripartite guidance entitled ‘‘E14 

Clinical Evaluation of QT/QTc Interval 

Prolongation and Proarrhythmic 

Potential for Non-Antiarrhythmic 

Drugs.’’ The notice gave interested 

persons an opportunity to submit 

comments by December 13, 2004. In 

response to a request for additional time 

to comment, FDA reopened the 

comment period until February 18, 2005 

(70 FR 823, January 5, 2005). On April 

11 and 12, 2005, FDA, the Drug 

Information Association, and the Heart 

Rhythm Society cosponsored a public 

meeting to discuss the draft guidance. 

Comments received at the meeting were 

made available to the Efficacy Expert 

Working Group. After consideration of 

the comments received and revisions to 

the guidance, a final draft of the 

guidance was submitted to the ICH 

Steering Committee and endorsed by the 

three participating regulatory agencies 

in May 2005. 

The guidance provides guidance on 

the design, conduct, analysis and 

interpretation of clinical studies to 

assess the potential of a new drug to 

cause cardiac arrhythmias, focusing on 

the assessment of changes in the QT/ 

QTc interval on the electrocardiogram 

as a predictor of risk. The guidance is 

intended to encourage the assessment of 

drug effects on the QT/QTc interval, 

along with the collection of adverse 

cardiac events related to arrhythmias, as 

a standard part of drug development, 

and to encourage the early discussion of 

this assessment with the FDA. The goal 

of such discussions is to reach a 

common understanding of the effects as 

early in development as practical, with 

the goal of enhancing the efficiency of 

data collection later in drug 

development. The guidance 

incorporates the following changes: (1) 

A fuller discussion of the factors that 

influence the clinical assessment of 

drug effects on the QT interval and (2) 

an adjustment in the statistical analysis 

of QT interval data obtained as a part of 

early thorough QT assessment. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. 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 statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance at anytime. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The guidance 

and received comments may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/publications.htm. 

Dated: October 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20971 Filed 10–19–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0362] 

Draft Guidance for Industry on 

Recommendations for Implementing a 

Collection Program for Source Plasma 

Containing Disease-Associated and 

Other Immunoglobulin Antibodies; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: 

Recommendations for Implementing a 

Collection Program for Source Plasma 

Containing Disease-Associated and 

Other Immunoglobulin (IgG) 

Antibodies,’’ dated October 2005. The 

draft guidance document is intended to 

assist source plasma manufacturers in 

submitting to FDA the appropriate 

information when implementing an IgG 

antibody collection program or when 

adding a new IgG antibody collection to 

an existing program. The draft guidance, 

when finalized, would supersede the 

draft reviewers’ guide entitled ‘‘Disease 

Associated Antibody Collection 

Program,’’ dated October 1, 1995. 

DATES: Submit written or electronic 

comments on the draft guidance by 

January 18, 2006 to ensure their 

adequate consideration in preparation of 

the final guidance. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835–

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit written comments on the draft 

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. 

FOR FURTHER INFORMATION CONTACT: 

Brenda R. Friend, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Recommendations for 

Implementing a Collection Program for 

Source Plasma Containing DiseaseAssociated and Other Immunoglobulin 

(IgG) Antibodies’’ dated October 2005. 

The draft guidance, when finalized, 

would supersede the draft reviewers’

guide, ‘‘Disease Associated Antibody 

Collection Program,’’ dated October 1, 

1995. The document provides guidance 

to source plasma manufacturers in 

submitting the appropriate information 

to FDA when implementing an IgG 

antibody collection program or when 

adding a new IgG antibody collection to 

an existing program. The guidance 

identifies changes in collection 

programs that must be documented as 

minor changes in an annual report to 

FDA under § 601.12(d) (21 CFR 

601.12(d)). These collection programs 

include disease-associated IgG 

61136 Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 

antibodies and other existing IgG 

antibodies. The guidance also identifies 

labeling changes to be submitted as a 

supplement for changes being effected 

under § 601.12(f)(2)(i)(E). The guidance 

neither includes recommendations 

related to implementing 

Immunoglobulin M antibody collection 

programs, nor does it include 

recommendations for donors who do 

not meet all donor suitability 

requirements under 21 CFR 640.63. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collection(s) of information 

in this guidance was approved under 

OMB control number 0910–0338. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. Submit written or electronic 

comments to ensure adequate 

consideration in preparation of the final 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: October 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20958 Filed 10–19–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

Program Exclusions: September 2005 

AGENCY: Office of Inspector General, 

HHS. 

ACTION: Notice of program exclusions. 

During the month of September 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: 

Agopian, Ovsanna ................................................................................................. Granada Hills, CA ..................................... 10/20/2005 

Altidor, Rejeanne ................................................................................................... Elmont, NY ................................................ 10/20/2005 

Andino, Rosario ..................................................................................................... Miami, FL .................................................. 10/20/2005 

Arnold, David ......................................................................................................... Athens, PA ................................................ 10/20/2005 

Arthur Avenue Pharmacy ...................................................................................... Bronx, NY ................................................. 10/20/2005 

Bagley, Barbara .................................................................................................... Los Angeles, CA ....................................... 10/20/2005 

Barragan, Elian ..................................................................................................... Bronx, NY ................................................. 10/20/2005 

Barrett, Nadine ...................................................................................................... Bronx, NY ................................................. 10/20/2005 

Blumberg, Gary ..................................................................................................... Deerfield, FL ............................................. 10/20/2005 

Brailsford, Philip .................................................................................................... Escondido, CA .......................................... 10/20/2005 

Brown, Roger ........................................................................................................ Trenton, NJ ............................................... 10/20/2005 

Burleson, Delpha ................................................................................................... Purcell, OK ................................................ 10/20/2005 

Butts, Frank ........................................................................................................... Texarkana, TX .......................................... 10/20/2005 

Cansler, Ronnie .................................................................................................... Los Angeles, CA ....................................... 10/20/2005 

Cardio Diagnostic Technology & Consultants, Inc ............................................... Westerville, OH ......................................... 10/20/2005 

Celestin, Andre ...................................................................................................... Elmont, NY ................................................ 10/20/2005 

Central Community Service, Inc ........................................................................... Los Angeles, CA ....................................... 10/20/2005 

Chaffin, Alisa ......................................................................................................... Lansing, MI ............................................... 10/20/2005 

Choi, Ricardo ........................................................................................................ Miami, FL .................................................. 10/20/2005 

Cifelli, Charles ....................................................................................................... The Villages, FL ........................................ 10/20/2005 

Cifelli, Darren ........................................................................................................ West Yarmouth, MA ................................. 10/20/2005 

Cifelli, Karen .......................................................................................................... West Yarmouth, MA ................................. 10/20/2005 

Clark, Harry ........................................................................................................... Pensacola, FL ........................................... 10/20/2005 

Clark, Shirley ......................................................................................................... Vallejo, CA ................................................ 10/20/2005 

Collins, Monique .................................................................................................... New Orleans, LA ...................................... 10/20/2005 

Davidson, Lee ....................................................................................................... Los Angeles, CA ....................................... 10/20/2005 

Davis, James ......................................................................................................... Irving, TX .................................................. 10/20/2005 

Du, Danny ............................................................................................................. Wasco, CA ................................................ 10/20/2005 

Estevez, Maria ...................................................................................................... Coleman, FL ............................................. 10/20/2005 

Fabian, Misty ......................................................................................................... Timpson, TX ............................................. 10/20/2005 

Flanigan, George .................................................................................................. Los Angeles, CA ....................................... 10/20/2005 

Flores, William ....................................................................................................... Los Angeles, CA ....................................... 10/20/2005