Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 35875 

McQuillan, Division of Health and 

Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, Room 

4204, Hyattsville, MD 20782, Phone: 

301–458–4371; Fax: 301–458–4028, email: gmm2@cdc.gov. 

Tanja Popovic, 

Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–17267 Filed 7–20–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0309] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Draft Guidance for Industry on 

Bracketing and Matrixing Designs for 

Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products (VICH GL45); Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry (#198) entitled ‘‘Draft Guidance 

for Industry on Bracketing and 

Matrixing Designs For Stability Testing 

of New Veterinary Drug Substances and 

Medicinal Products,’’ VICH GL45. This 

draft guidance has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). This draft guidance is an annex 

to a VICH guidance entitled ‘‘Stability 

Testing of New Veterinary Drug 

Substances and Medicinal Products 

(Revision),’’ VICH GL3(R), that 

published in the Federal Register of 

November 23, 2007 (72 FR 65751). This 

draft VICH guidance document is 

intended to provide guidance on the 

application of reduced designs (i.e., 

bracketing and matrixing) for stability 

studies conducted in accordance with 

the principles outlined in VICH GL3(R). 

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draft guidance by August 20, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Dennis Bensley, Center for Veterinary 

Medicine (HFV–140), Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–276–8268, email: dennis.bensley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry (#198) 

entitled ‘‘Draft Guidance for Industry on 

Bracketing and Matrixing Designs for 

Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products,’’ VICH GL45. In recent years, 

many important initiatives have been 

undertaken by regulatory authorities 

and industry associations to promote 

the international harmonization of 

regulatory requirements. FDA has 

participated in efforts to enhance 

harmonization and has expressed its 

commitment to seek scientifically based 

harmonized technical procedures for the 

development of pharmaceutical 

products. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies in different 

countries. 

FDA has actively participated in the 

International Conference on 

Harmonisation of Technical 

Requirements for Approval of 

Pharmaceuticals for Human Use for 

several years to develop harmonized 

technical requirements for the approval 

of human pharmaceutical and biological 

products among the European Union, 

Japan, and the United States. The VICH 

is a parallel initiative for veterinary 

medicinal products. The VICH is 

concerned with developing harmonized 

technical requirements for the approval 

of veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from: The European Commission, 

European Medicines Evaluation Agency, 

European Federation of Animal Health, 

Committee on Veterinary Medicinal 

Products, the U.S. FDA, the U.S. 

Department of Agriculture, the Animal 

Health Institute, the Japanese Veterinary 

Pharmaceutical Association, the 

Japanese Association of Veterinary 

Biologics, and the Japanese Ministry of 

Agriculture, Forestry, and Fisheries. 

Four observers are eligible to 

participate in the VICH Steering 

Committee: One representative from the 

government of Australia/New Zealand, 

one representative from the industry in 

Australia/New Zealand, one 

representative from the government of 

Canada, and one representative from the 

industry of Canada. The VICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation for Animal Health (IFAH). 

An IFAH representative also 

participates in the VICH Steering 

Committee meetings. 

II. Draft Guidance on Bracketing and 

Matrixing Designs for Stability Testing 

The VICH Steering Committee held a 

meeting on February 11, 2008, and 

agreed that the draft guidance document 

entitled ‘‘Draft Guidance for Industry on 

Bracketing and Matrixing Designs for 

Stability Testing of New Veterinary 

Drug Substances and Medicinal 

Products,’’ VICH GL45 should be made 

available for public comment. This draft 

VICH guidance document provides 

guidance on bracketing and matrixing 

study designs. Specific principles are 

defined in this guidance for situations 

in which bracketing or matrixing can be 

applied. This document is intended to 

address recommendations on the 

application of bracketing and matrixing 

to stability studies conducted in 

accordance with principles outlined in 

the VICH GL3(R), ‘‘Stability Testing of 

New Veterinary Drug Substances and 

Medicinal Products (Revision).’’ FDA 

and the VICH Expert Quality Working 

Group will consider comments about 

the draft guidance document. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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 collections 


jlentini on DSKJ8SOYB1PROD with NOTICES
35876 Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 

of information in sections 1–2 of this 

guidance have been approved under 

OMB Control No. 0910–0032. 

IV. Significance of Guidance 

This draft guidance, developed under 

the VICH process, has been revised to 

conform to FDA’s good guidance 

practices regulation (21 CFR 10.115). 

For example, the document has been 

designated ‘‘guidance’’ rather than 

‘‘guideline.’’ In addition, guidance 

documents must not include mandatory 

language such as ‘‘shall,’’ ‘‘must,’’ 

‘‘require,’’ or ‘‘requirement,’’ unless 

FDA is using these words to describe a 

statutory or regulatory requirement. 

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 applicable statutes and 

regulations. 

V. 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 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. 

VI. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cvm or http:// 

www.regulations.gov. 

Dated: July 10, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–17251 Filed 7–20–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Risk Communication Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Risk 

Communication Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on August 13, 2009, from 8 a.m. to 

5 p.m. and August 14, 2009, from 8 a.m. 

to 2 p.m. 

Location: National Transportation 

Safety Board (NTSB) Conference Center, 

429 L’Enfant Plaza SW., Washington, 

DC 20594 (at Metro’s L’Enfant Plaza 

station; parking is limited and public 

transportation is recommended.) 

Contact Person: Lee L. Zwanziger, 

Office of the Commissioner, Office of 

Policy, Planning and Preparedness, 

Office of Planning, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

14–90, Rockville, MD 20857, 301–827– 

2895, FAX: 301–827–4050, e-mail: 

RCAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

8732112560. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On August 13 and 14, 2009, 

the Committee will discuss FDA’s 

external research on, and internal 

assessment of, communications about 

food safety problems. This discussion 

will address research on consumer 

knowledge of food recalls and plans for 

how to monitor communication 

effectiveness during the course of a 

recall. The purpose of the discussion is 

to advise FDA on developing more 

effective communication strategies. Also 

on August 14, 2009, the RCAC will be 

briefed on the work of the FDA 

Transparency Task Force. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm, click on the year 2009 and 

scroll down to the appropriate advisory 

committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before August 7, 2009. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. on August 13th and 

10:30 to 11:30 a.m. on August 14th. 

Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before August 6, 

2009. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by August 7, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

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 Lee L. 

Zwanziger 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/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Dated: July 10, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–17222 Filed 7–20–09; 8:45 am] 

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