19096 Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Maribeth Badura, Director, Division of 

Healthy Start and Perinatal Services, 

Maternal and Child Health Bureau, 

HRSA, Room 18–12, Parklawn Building, 

5600 Fishers Lane, Rockville, Maryland 

20857; telephone (301) 443–0543; 

e-mail MBadura@hrsa.gov. 

Dated: April 21, 2009. 

Marcia K. Brand, 

Deputy Administrator. 

[FR Doc. E9–9517 Filed 4–24–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0430] (formerly 

Docket No. 2007D–0166) 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH); 

Guidance for Industry on ‘‘Target 

Animal Safety for Veterinary 

Pharmaceutical Products,’’ VICH GL43; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

(#185) entitled ‘‘Target Animal Safety 

for Veterinary Pharmaceutical 

Products,’’ VICH GL43. The purpose of 

this harmonized guidance is to provide 

recommendations regarding target 

animal safety (TAS) evaluation for 

regulatory submission of an 

Investigational Veterinary 

Pharmaceutical Product (IVPP), which 

is appropriate for determining the safety 

of an IVPP in the target animal. The 

guidance includes recommendations on 

including identification of target organs, 

where possible, and confirmation of 

margin of safety, using the minimum 

number of animals appropriate for the 

studies. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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 requests. 

Submit written comments on the 

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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Steven Vaughn, Center for Veterinary 

Medicine, (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 (VICH) 

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. Guidance on Target Animal Safety 

for Veterinary Pharmaceutical Products 

In the Federal Register of May 18, 

2007 (72 FR 28058), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Draft Guidance for Industry on 

Target Animal Safety for Veterinary 

Pharmaceutical Products,’’ which gave 

interested persons until June 18, 2007, 

to comment on the draft guidance. FDA 

received a few comments on the draft 

guidance and those comments as well as 

those received by other VICH member 

regulatory agencies were considered as 

the guidance was finalized. Based on 

the comments received, the VICH Expert 

Working Group on Target Animal Safety 

clarified the guidance’s 

recommendations regarding the 

development and conduct of TAS 

studies. In particular, the Expert 

Working Group revised the sections 

addressing necropsy and histopathology 

examinations and mammary gland 

studies to clarify the recommendations 

regarding these topics. At a meeting 

held in July 2008, the VICH Steering 

Committee endorsed the final guidance 

for industry, (VICH GL43). The guidance 

announced in this notice finalizes the 

draft guidance dated May 18, 2007. 

This guidance document is intended 

to cover TAS evaluation for any IVPP 

used in the following species: Bovine, 

ovine, caprine, feline, canine, porcine, 

equine, and poultry (chickens and 

turkeys). The recommendations in this 

guidance may not be appropriate for 

registration by national or regional 

authorities of products for use in minor 

species or minor uses. The guidance 

does not provide information for the 

design of TAS studies in other species, 

including aquatic animals. For other 

species and for minor uses, TAS studies 

should be designed following national 

or regional guidance. 

III. Significance of Guidance 

This guidance document, 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 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Notices 19097 

‘‘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 

guidance represents agency’s current 

thinking on the 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. 

IV. Paperwork Reduction Act of 1995 

This 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 of information in 

sections 1–5 of the guidance have been 

approved under OMB control no. 0910– 

0032 (expiration date April 30, 2010). 

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 guidance at either http:// 

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

www.regulations.gov. 

Dated: April 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9521 Filed 4–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Injury Prevention 

and Control, Initial Review Group, 

(NCIPC, IRG) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC announces the 

following meeting of the 

aforementioned review group: 

Times and Dates: 

8 a.m.–8:15 a.m., April 27, 2009 (Open). 

8:15 a.m.–4 p.m., April 27, 2009 (Closed). 

Place: Teleconference, Toll Free Number: 

(877) 468–4185, Participant Pass code: 447– 

5689. 

Status: Portions of the meetings will be 

closed to the public in accordance with 

provisions set forth in Section 552b(c)(4) and 

(6), Title 5, U.S.C., and the Determination of 

the Director, Management Analysis and 

Services Office, CDC, pursuant to Section 

10(d) of Public Law 92–463. 

Purpose: This group is charged with 

providing advice and guidance to the 

Secretary, Department of Health and Human 

Services, and the Director, CDC, concerning 

the scientific and technical merit of grant and 

cooperative agreement applications received 

from academic institutions and other public 

and private profit and nonprofit 

organizations, including State and local 

government agencies, to conduct specific 

injury research that focuses on prevention 

and control. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of applications submitted in 

response to Fiscal Year 2009 Requests for 

Applications related to the following 

individual research announcement: CE09– 

009, Youth Violence Prevention through 

Economic, Environmental, and Policy 

Change (U01). 

Agenda items are subject to change as 

priorities dictate. 

Due to programmatic issues that had to be 

resolved, the Federal Register notice is being 

published less than fifteen days before the 

date of the meeting. 

Contact Person for More Information: Lisa 

T. Garbarino, B.S., NCIPC, Extramural 

Research Program Office, CDC, 4770 Buford 

Highway, NE., M/S F62, Atlanta, Georgia 

30341–3724, Telephone: (404) 723–1527. 

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 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 21, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–9503 Filed 4–24–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Computational Modeling for 

Cardiovascular Devices; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Computational Modeling for 

Cardiovascular Devices.’’ FDA is cosponsoring the conference with the 

National Heart, Blood and Lung 

Institute of the National Institutes of 

Health and the National Science 

Foundation. The purpose of the public 

workshop is to facilitate discussion 

among FDA and other interested parties 

on the use of computational modeling in 

the design, development, and evaluation 

of cardiovascular medical devices. 

Date and Time: The public workshop 

will be held on June 1 and 2, 2009, from 

8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Hilton Washington DC/ 

Rockville Executive Meeting Center, 

1750 Rockville Pike, Rockville, MD 

20852. 

Contact Person: Donna R. Lochner, 

Center for Devices and Radiological 

Health (HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–4043, email: donna.lochner@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Holding This Public 

Workshop? 

The purpose of the public workshop 

is to facilitate discussion among FDA 

and other interested parties on the use 

of computational modeling in 

cardiovascular device design, 

development, and evaluation. 

II. What Are the Topics We Intend to 

Address at the Public Workshop? 

We hope to discuss a large number of 

issues at the public workshop, 

including, but not limited to: 

• Multi-scale modeling. 

• Imaging for cardiovascular device 

modeling. 

• Physiologic input data for 

cardiovascular device modeling. 

• Device-specific issues related to 

modeling, including a focus on heart 

valves, drug-eluting and bare metal 

stents, endovascular stents, cardiac 

rhythm management, and mechanical 

and circulatory support devices. 


pwalker on PROD1PC71 with NOTICES