28022 Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 

comments to the VICH Steering 

Committee. 

DATES: We will consider all comments 

that we receive on or before July 17, 

2007. 

ADDRESSES: You may submit comments 

by either of the following methods: 

Federal eRulemaking Portal: Go to 

http://www.regulations.gov, select 

‘‘Animal and Plant Health Inspection 

Service’’ from the agency drop-down 

menu, then click ‘‘Submit.’’ In the 

Docket ID column, select APHIS–2007–

0056 to submit or view public 

comments and to view supporting and 

related materials available 

electronically. After the close of the 

comment period, the docket can be 

viewed using the ‘‘Advanced Search’’

function in Regulations.gov. 

Postal Mail/Commercial Delivery: 

Please send four copies of your 

comment (an original and three copies) 

to Docket No. APHIS–2007–0056, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS–

2007–0056. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

http://www.aphis.usda.gov. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Albert P. Morgan, Center for Veterinary 

Biologics—Policy Evaluation and 

Licensing, VS, APHIS, 4700 River Road 

Unit 148, Riverdale, MD 20737–1231; 

(301) 734–8245. 

SUPPLEMENTARY INFORMATION: The 

International Cooperation on 

Harmonization of Technical 

Requirements for the Registration of 

Veterinary Medicinal Products (VICH) is 

a unique project conducted under the 

auspices of the World Organization for 

Animal Health that brings together the 

regulatory authorities of the European 

Union, Japan, and the United States and 

representatives from the animal health 

industry in the three regions. The 

purpose of VICH is to harmonize 

technical requirements for veterinary 

products (both drugs and biologics). 

Regulatory authorities and industry 

experts from Australia and New Zealand 

participate in an observer capacity. The 

World Federation of the Animal Health 

Industry (COMISA, the Confederation 

Mondiale de L’Industrie de la Sante 

Animale) provides the secretarial and 

administrative support for VICH 

activities. 

The United States Government is 

represented in VICH by the Food and 

Drug Administration (FDA) and the 

Animal and Plant Health Inspection 

Service (APHIS). The FDA provides 

expertise on veterinary drugs, while 

APHIS fills a corresponding role for 

veterinary biological products. As VICH 

members, APHIS and FDA participate in 

efforts to enhance harmonization and 

have expressed their commitment to 

seeking scientifically based, harmonized 

technical requirements for the 

development of veterinary drugs and 

biological products. One of the goals of 

harmonization is to identify and reduce 

the differences in technical 

requirements for veterinary drugs and 

biologics among regulatory agencies in 

different countries. 

The draft guideline 

‘‘Pharmacovigilance of Veterinary 

Medicinal Products: Controlled Lists of 

Terms’’ (VICH Topic GL30) has been 

made available by the VICH Steering 

Committee for comments by interested 

parties. The guideline is intended to 

provide guidance for the development 

and maintenance of the controlled lists 

of terms required to complete the 

controlled data fields contained in 

adverse event reports concerning the 

use of marketed veterinary medicinal 

products. Because the draft guideline 

applies to some veterinary biological 

products regulated by APHIS under the 

Virus-Serum-Toxin Act—particularly 

with regard to development and 

maintenance of the controlled lists of 

terms—we are requesting comments on 

its provisions so that we may include 

any relevant public input on the draft in 

the Agency’s comments to the VICH 

Steering Committee. 

The draft guideline reflects current 

APHIS thinking on the development 

and maintenance of the controlled lists 

of terms required to complete the 

controlled data fields used for the 

submission and exchange of 

spontaneous adverse events reports 

between marketing authorization 

holders (licensees/permittees) and 

regulatory authorities concerning the 

clinical effects of marketed veterinary 

medicinal products. In accordance with 

the VICH process, once a final draft of 

each document has been approved, the 

guideline will be recommended for 

adoption by the regulatory bodies of the 

European Union, Japan, and the United 

States. As with all VICH documents, 

each final guideline will not create or 

confer any rights for or on any person 

and will not operate to bind APHIS or 

the public. Further, the VICH guidelines 

specifically provide for the use of 

alternative approaches if those 

approaches satisfy applicable regulatory 

requirements. 

Ultimately, APHIS intends to consider 

the VICH Steering Committee’s final 

guideline for use by U.S. veterinary 

biologics licensees, permittees, and 

applicants. In addition, we may 

consider using the final guideline as the 

basis for proposed amendments to the 

regulations in 9 CFR chapter I, 

subchapter E (Viruses, Serums, Toxins, 

and Analogous Products; Organisms and 

Vectors). Because we anticipate that 

applicable provisions of the final 

versions of ‘‘Pharmacovigilance of 

Veterinary Medicinal Products: 

Controlled Lists of Terms’’ may be 

introduced into APHIS’ veterinary 

biologics regulatory program in the 

future, we encourage your comments on 

the draft guideline. 

The draft guideline may be viewed on 

the Regulations.gov Web site or in our 

reading room (see ADDRESSES above for 

instructions for accessing 

Regulations.gov and information on the 

location and hours of the reading room). 

You may request paper copies of the 

draft guideline by calling or writing to 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

Authority: 21 U.S.C. 151 et seq. 

Done in Washington, DC, this 11th day of 

May 2007. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E7–9556 Filed 5–17–07; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Federal Crop Insurance Corporation 

Crop Insurance Education in Targeted 

States (Targeted States Program) 

Announcement Type: Modification—

Competitive Cooperative Agreements. 

This announcement modifies the 

Request for Application Notice 

published in the Federal Register, 

March 14, 2007 (Vol. 72, No. 49, Pages 

11839–11846). The Dates and Summary 

portions have been modified. 

CFDA Number: 10.458. 

DATES: Applications are due 5 p.m. EDT, 

June 4, 2007. 

SUMMARY: The following paragraph has 

been added to the beginning of the 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 28023 

Summary portion of the March 14, 2007, 

Federal Register Notice: 

The Risk Management Agency (RMA) 

did not receive complete and valid 

application packages for the State of 

Maine under the original Request for 

Application Notice published in the 

Federal Register on March 14, 2007, for 

the Crop Insurance Education in 

Targeted States Program (Targeted 

States Program). RMA is re-announcing 

its Funding Opportunity—Request for 

Applications under the Targeted States 

Program for the State of Maine. 

Applicants who previously submitted 

an application under the March 14, 

2007, Targeted States Program Request 

for Applications Notice for Maine must 

reapply in accordance with the original 

Notice published in the Federal 

Register on March 14, 2007. 

All other portions and sections of the 

full text Notice remain unchanged. 

FOR FURTHER INFORMATION CONTACT: 

Applicants and other interested parties 

are encouraged to contact: Lon Burke, 

USDA–RMA–RME, phone: 202–720–

5265, fax: 202–690–3605, e-mail: 

RMA.Risk-Ed@rma.usda.gov. You may 

also obtain information regarding this 

announcement from the RMA Web site 

at: http://www.rma.usda.gov/aboutrma/ 

agreements/. 

Signed in Washington, DC on May 11, 

2007. 

Eldon Gould, 

Manager, Federal Crop Insurance 

Corporation. 

[FR Doc. E7–9561 Filed 5–17–07; 8:45 am] 

BILLING CODE 3410–08–P 

ARCHITECTURAL AND 

TRANSPORTATION BARRIERS 

COMPLIANCE BOARD 

Meeting 

AGENCY: Architectural and 

Transportation Barriers Compliance 

Board. 

ACTION: Notice of meeting. 

SUMMARY: The Architectural and 

Transportation Barriers Compliance 

Board (Access Board) has scheduled its 

regular business meetings to take place 

in Washington, DC., Wednesday 

through Friday, May 30–June 1, 2007, at 

the times and location noted below. 

DATES: The schedule of events is as 

follows: 

Wednesday, May 30, 2007 

10:30 a.m.–Noon—Electronic and 

Information Technology Ad Hoc 

Committee. 

1:30 p.m.–3:30 p.m.—Briefing on 

Outdoor Developed Areas Proposed 

Rule (Closed Session). 

3:30 p.m.–5 p.m.—Passenger Vessels 

Guidelines Ad Hoc Committee 

(Closed Session). 

Thursday, May 31, 2007 

9 a.m.–10:30 a.m.—Standard Taxi 

Demonstration. 

10:30 a.m.–Noon—Briefing on Public 

Rights-of-Way Rulemaking (Closed 

Session). 

1:30 p.m.–5 p.m.—Transportation 

Vehicle Guidelines Ad Hoc 

Committee (Closed Session). 

Friday, June 1, 2007 

9 a.m.–10:30 a.m.—Planning and 

Evaluation Committee. 

10:30 a.m.–Noon—Executive 

Committee. 

1:30 p.m.–3 p.m.—Board Meeting. 

ADDRESSES: All meetings will be held at 

The Madison Hotel, 1177 15th Street, 

NW., Washington, DC 20005. 

FOR FURTHER INFORMATION CONTACT: For 

further information regarding the 

meetings, please contact Lawrence W. 

Roffee, Executive Director, (202) 272–

0001 (voice) and (202) 272–0082 (TTY). 

SUPPLEMENTARY INFORMATION: At the 

Board meeting, the Access Board will 

consider the following agenda items: 

• Approval of the March 2007 draft 

Board Meeting Minutes. 

• Planning and Evaluation Committee 

Report. 

• Executive Committee Report. 

• Electronic and Information 

Technology Ad Hoc Committee Report. 

• Passenger Vessels Guidelines Ad 

Hoc Committee Report. 

• Transportation Vehicle Guidelines 

Ad Hoc Committee Report. 

All meetings are accessible to persons 

with disabilities. An assistive listening 

system, computer assisted real-time 

transcription (CART), and sign language 

interpreters will be available at the 

Board meetings. Persons attending 

Board meetings are requested to refrain 

from using perfume, cologne, and other 

fragrances for the comfort of other 

participants. 

Lawrence Roffee, 

Executive Director. 

[FR Doc. E7–9588 Filed 5–17–07; 8:45 am] 

BILLING CODE 8150–01–P 

COMMITTEE FOR PURCHASE FROM 

PEOPLE WHO ARE BLIND OR 

SEVERELY DISABLED 

Procurement List; Proposed Additions 

and Deletion 

AGENCY: Committee for Purchase from 

People Who Are Blind or Severely 

Disabled. 

ACTION: Proposed additions to and 

deletion from the procurement list. 

SUMMARY: The Committee is proposing 

to add to the Procurement List a product 

and services to be furnished by 

nonprofit agencies employing persons 

who are blind or have other severe 

disabilities, and to delete a service 

previously furnished by such agencies. 

Comments Must Be Received On Or 

Before: June 17, 2007. 

ADDRESSES: Committee for Purchase 

From People Who Are Blind or Severely 

Disabled, Jefferson Plaza 2, Suite 10800, 

1421 Jefferson Davis Highway, 

Arlington, VA 22202–3259. 

For Further Information Or To Submit 

Comments Contact: Kimberly M. Zeich, 

Telephone: (703) 603–7740, Fax: (703) 

603–0655, or e-mail 

CMTEFedReg@jwod.gov. 

Additions 

If the Committee approves the 

proposed additions, the entities of the 

Federal Government identified in this 

notice for each product or service will 

be required to procure the products and 

services listed below from nonprofit 

agencies employing persons who are 

blind or have other severe disabilities. 

Regulatory Flexibility Act Certification 

I certify that the following action will 

not have a significant impact on a 

substantial number of small entities. 

The major factors considered for this 

certification were: 

1. If approved, the action will not 

result in any additional reporting, 

recordkeeping or other compliance 

requirements for small entities other 

than the small organizations that will 

furnish the products and services to the 

Government. 

2. If approved, the action will result 

in authorizing small entities to furnish 

the products and services to the 

Government. 

3. There are no known regulatory 

alternatives which would accomplish 

the objectives of the Javits-WagnerO’Day Act (41 U.S.C. 46–48c) in 

connection with the products and 

services proposed for addition to the 

Procurement List. 

Comments on this certification are 

invited. Commenters should identify the 


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