16024 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Donald W. 

Jehn or Pearline K. Muckelvene at least 

7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 20, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–6208 Filed 3–25–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0158] (formerly 

Docket No. FDA–2008–N–0131) 

Frozen Concentrate for Lemonade 

Deviating From Identity Standard; 

Temporary Permit for Market Testing; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

that appeared in the Federal Register of 

February 29, 2008 (73 FR 11095). The 

document announced that a temporary 

permit has been issued to Florida’s 

Natural Growers, to market test a 

product designated as ‘‘Frozen 

Concentrate for Lemonade 3+1 Ratio.’’

The document was published with an 

incorrect value for the Brix (measure of 

concentration of sugars in juice). This 

document corrects the error. 

FOR FURTHER INFORMATION CONTACT: 

Loretta A. Carey, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2371. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E8–3912, appearing on page 11095 in 

the Federal Register of Friday, February 

29, 2008, the following correction is 

made: 

1. On page 11095, in the second 

column, in the SUPPLEMENTARY

INFORMATION section, line twenty-two, 

the number ‘‘56°’’ is corrected to read 

‘‘37.6°’’. 

Dated: March 18, 2008. 

Barbara Schneeman, 

Director, Office of Nutritional Products, 

Labeling and Dietary Supplements, Center for 

Food Safety and Applied Nutrition. 

[FR Doc. E8–6056 Filed 3–25–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0178] 

International Conference on 

Harmonisation; Draft Guidance on 

S2(R1) Genotoxicity Testing and Data 

Interpretation for Pharmaceuticals 

Intended for Human Use; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘S2(R1) Genotoxicity Testing and Data 

Interpretation for Pharmaceuticals 

Intended for Human Use.’’ The draft 

guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance updates and 

combines information from two ICH 

guidances, ‘‘S2A Specific Aspects of 

Regulatory Genotoxicity Tests for 

Pharmaceuticals’’ and ‘‘S2B 

Genotoxicity: A Standard Battery for 

Genotoxicity Testing of 

Pharmaceuticals.’’ The draft guidance is 

intended to help facilitate drug 

development programs, ensure patient 

safety, and reduce animal usage. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by May 12, 2008. 

ADDRESSES: 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.regulations.gov. Submit written 

requests for single copies of the draft 

guidance to the Division of Drug 

Information (HFD–240), Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or 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. The draft 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send two self-addressed 

adhesive labels to assist the office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: David 

Jacobson-Kram, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6488, 

Silver Spring, MD 20993–0002, 301–

796–0175. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs (HFG–

1), Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 16025 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

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 February 2008, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘S2(R1) Genotoxicity Testing 

and Data Interpretation for 

Pharmaceuticals Intended for Human 

Use’’ should be made available for 

public comment. The draft guidance is 

the product of the Safety Expert 

Working Group of the ICH. Comments 

about this draft will be considered by 

FDA and the Safety Expert Working 

Group. 

The draft guidance provides guidance 

on optimizing the standard genetic 

toxicology battery for the prediction of 

potential human risks, and on 

interpreting the results. The ultimate 

goal of this guidance is to improve risk 

characterization for carcinogenic effects 

induced by changes in the genetic 

material. The draft guidance is intended 

to help facilitate drug development 

programs, ensure patient safety, and 

reduce animal usage. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent 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 regarding the draft 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 brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA through FDMS only. 

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: March 21, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 08–1076 Filed 3–21–08; 3:05 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0145] 

Preparation for International 

Conference on Harmonization 

Meetings in Portland, Oregon; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH Meetings in Portland, Oregon’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Portland, Oregon. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in 

Portland, Oregon, June 2–5, 2008, at 

which discussion of the topics 

underway and the future of ICH will 

continue. 

Date and Time: The meeting will be 

held on Friday April 4, 2008, from 12:30 

pm to 5 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, Conference 

Room G and H, Rockville, MD 20857. 

For security reasons, all attendees are 

asked to arrive no later than 12:25 p.m., 

as you will be escorted from the front 

entrance of 5600 Fishers Lane to 

Conference Room G and H. 

Contact Person: All participants must 

register with Tammie Bell, Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by e-mail: 

Tammie.bell@fda.hhs.gov or FAX: 301–

480–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material, and requests 

to make oral presentations, to the 

contact person by April 3, 2008. 

If you need special accommodations 

due to a disability, please contact 

Tammie Bell at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 

Europe, Japan, and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 


pwalker on PROD1PC71 with NOTICES