Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Notices 28021 

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–

0057 to submit or view public 

comments and to view supporting and 

related materials available 

electronically. Information on using 

Regulations.gov, including instructions 

for accessing documents, submitting 

comments, and viewing the docket after 

the close of the comment period, is 

available through the site’s ‘‘User Tips’’

link. 

• Postal Mail/Commercial Delivery: 

Please send four copies of your 

comment (an original and three copies) 

to Docket No. APHIS–2007–0057, 

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–

2007–0057. 

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: For 

information on an information 

collection associated with the 

importation of animals and poultry, 

animal and poultry products, and 

animal germplasm, contact Dr. James 

Davis, Senior Staff Veterinarian, 

National Center for Import and Export, 

VS, APHIS, 4700 River Road Unit 39, 

Riverdale, MD 20737–1231; (301) 734–

0694. For copies of more detailed 

information on the information 

collection, contact Mrs. Celeste Sickles, 

APHIS’ Information Collection 

Coordinator, at (301) 734–7477. 

SUPPLEMENTARY INFORMATION: Title: 

Importation of Animals and Poultry, 

Animal and Poultry Products, Certain 

Animal Embryos, Semen, and 

Zoological Animals. 

OMB Number: 0579–0040. 

Type of Request: Extension of 

approval of an information collection. 

Abstract: The Animal and Plant 

Health Inspection Service (APHIS) of 

the United States Department of 

Agriculture is authorized, among other 

things, to prohibit or restrict the 

importation of animals, animal 

products, and other articles into the 

United States to prevent the 

introduction of animal diseases and 

pests. In connection with this mission, 

APHIS collects pertinent information 

from persons who import animals or 

poultry, animal or poultry products, or 

animal germplasm into the United 

States. 

This information includes data such 

as the origins of the animals or animal 

products to be imported, the health 

status of the animals or the processing 

methods used to produce animal 

products to be imported, and whether 

the animals or animal products were 

temporarily offloaded in another 

country during their transit to the 

United States. We need this information 

to help ensure that these imports do not 

introduce exotic animal diseases into 

the United States. 

We use a variety of information 

collection procedures, devices, and 

forms including, but not limited to: 

Health certificates, import permits, ear 

tags, leg bands, specimen submission 

forms, inspection reports, cooperative 

and trust fund agreements, and 

certification statements. 

We are asking the Office of 

Management and Budget (OMB) to 

approve our use of these information 

collection activities for an additional 3 

years. 

The purpose of this notice is to solicit 

comments from the public (as well as 

affected agencies) concerning our 

information collection. These comments 

will help us: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

Agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the 

information collection, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

information collection on those who are 

to respond, through use, as appropriate, 

of automated, electronic, mechanical, 

and other collection technologies, e.g., 

permitting electronic submission of 

responses. 

Estimate of burden: The public 

reporting burden for this collection of 

information is estimated to average 

0.41688779 hours per response. 

Respondents: Entities that import 

animals or poultry, animal or poultry 

products, and animal embryos, 

germplasm, and semen. 

Estimated annual number of 

respondents: 77,976. 

Estimated annual number of 

responses per respondent: 162.4330306. 

Estimated annual number of 

responses: 12,665,878. 

Estimated total annual burden on 

respondents: 528,025 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

All responses to this notice will be 

summarized and included in the request 

for OMB approval. All comments will 

also become a matter of public record. 

Done in Washington, DC, this 11th day of 

May 2007. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E7–9551 Filed 5–17–07; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2007–0056] 

Draft Guidelines on Pharmacovigilance 

of Veterinary Medicinal Products: 

Controlled Lists of Terms 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of availability and 

request for comments. 

SUMMARY: The International Cooperation 

on Harmonization of Technical 

Requirements for the Registration of 

Veterinary Medicinal Products (VICH) 

has developed a draft guideline titled 

‘‘Pharmacovigilance of Veterinary 

Medicinal Products: Controlled Lists of 

Terms.’’ This draft guideline provides 

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 veterinary medicinal products. 

Because the draft guideline applies to 

pharmacovigilance and adverse event 

reporting on veterinary vaccines 

regulated by the Animal and Plant 

Health Inspection Service under the 

Virus-Serum-Toxin Act, we are 

requesting comments on the scope of 

the guideline and its provisions so that 

we may include any relevant public 

input on the draft in the Agency’s 


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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 


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