30092 Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices 

laboratories and private inspection 

services) to be accredited by APHIS to 

perform specific laboratory testing or 

phytosanitary inspections that could 

serve as the basis for issuing Federal 

phytosanitary certificates, phytosanitary 

certificates for reexport, or export 

certificates for processed plant products. 

The accreditation process requires the 

use of several information collection 

activities to ensure that nongovernment 

facilities applying for accreditation 

possess the necessary qualifications. 

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 collection 

of information, 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 

collection of information 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 

3.4482758 hours per response. 

Respondents: Operators of 

nongovernment facilities who wish to 

be accredited to perform laboratory 

testing or phyosanitary inspection 

services in connection with APHIS’ 

export certification program and certain 

employees of such nongovernment 

facilities. 

Estimated annual number of 

respondents: 15. 

Estimated annual number of 

responses per respondent: 5.8. 

Estimated annual number of 

responses: 87. 

Estimated total annual burden on 

respondents: 300 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 18th day of 

May 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–12751 Filed 5–23–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0024] 

Notice of Request for Extension of 

Approval of an Information Collection; 

Select Agent Registration 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Extension of approval of an 

information collection; comment 

request. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995, this 

notice announces the Animal and Plant 

Health Inspection Service’s intention to 

request extension of approval of an 

information collection associated with 

regulations for the possession, use, and 

transfer of biological agents and toxins 

that have the potential to pose a severe 

threat to human and animal health, to 

animal health, to plant health, or to 

animal products and plant products. 

DATES: We will consider all comments 

that we receive on or before July 25, 

2011. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=APHIS2011&-0024 to submit or view 

comments and to view supporting and 

related materials available 

electronically. 

• Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS–2011–0024, 

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– 

2011–0024. 

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 regarding the select agent 

registration process associated with the 

possession, use, or transfer of biological 

agents and toxins in 7 CFR part 331, 

contact Dr. Charles Divan, Branch Chief, 

Agriculture Select Agent Program, 

RIPPS, PPQ, APHIS, 4700 River Road, 

Unit 2, Riverdale, MD 20737; (301) 734– 

8758. 

For information regarding the select 

agent registration process associated 

with the possession, use, or transfer of 

biological agents and toxins in 9 CFR 

part 121, contact Mr. Robert Rice, 

Security Manager, Agriculture Select 

Agent Program, Technical Trade 

Services Team, NCIE, VS, APHIS, 4700 

River Road, Unit 2, Riverdale, MD 

20737; (301) 734–5557. 

For copies of more detailed 

information on the information 

collection, contact Mrs. Celeste Sickles, 

APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

SUPPLEMENTARY INFORMATION: 

Title: Select Agent Registration. 

OMB Number: 0579–0213. 

Type of Request: Extension of 

approval of an information collection. 

Abstract: The Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002 provides for the 

regulation of certain biological agents 

and toxins by the Department of 

Agriculture (USDA) and the Department 

of Health and Human Services (HHS). 

Under section 212 of the Act, USDA 

regulates biological agents and toxins 

that have the potential to pose a severe 

threat to both human and animal health, 

to animal health, to plant health, or to 

animal and plant products. The Animal 

and Plant Health Inspection Service 

(APHIS) has the primary responsibility 

for implementing the provisions of the 

Act within USDA. Select agents and 

toxins that have been determined to 

pose a severe threat to both human and 

animal health or animal products are 

subject to regulation by both APHIS and 

the Centers for Disease Control and 

Prevention (CDC), HHS, which has the 

primary responsibility for implementing 

the provisions of the Act within HHS. 

APHIS regulations are contained in 7 

CFR part 331 (plant) and 9 CFR part 121 

(animal and overlap). They require an 

individual or entity (unless specifically 


jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices 30093 

exempted under the regulations) to 

register with APHIS or, for overlap 

agents or toxins, APHIS or CDC, in order 

to possess, use, or transfer biological 

agents or toxins. 

The registration process is designed to 

obtain critical information concerning 

individuals or entities in possession of 

certain agents or toxins, as well as the 

specific characteristics of the agents or 

toxins, including name, strain, and 

genetic information. These data are 

needed, in part, to allow APHIS to 

determine the biosafety and 

biocontainment level of an entity as 

well as the entity’s security situation. 

This, in turn, helps APHIS to ensure 

that appropriate safeguard, containment, 

and disposal requirements 

commensurate with the risk of the agent 

or toxin are present at the entity, thus 

preventing access to such agents and 

toxins for use in domestic or 

international terrorism. APHIS will also 

request information to determine that 

individuals seeking to register have a 

lawful purpose to possess, use, or 

transfer agents or toxins. Forms PPQ 

526, VS 16–3, and VS 16–7 are 

approved under this collection for use 

in the registration process. 

We are asking the Office of 

Management and Budget (OMB) to 

approve our use of the 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 

1.9544673 hours per response. 

Respondents: Researchers, 

universities, research and development 

organizations, diagnostic laboratories, 

and other interested parties who 

possess, use, or transfer select agents or 

toxins. 

Estimated annual number of 

respondents: 1,163. 

Estimated annual number of 

responses per respondent: 1.0008598. 

Estimated annual number of 

responses: 1,164. 

Estimated total annual burden on 

respondents: 2,275 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 18th day of 

May 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–12753 Filed 5–23–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0049] 

Effectiveness Indications Statements 

in Veterinary Biologics Labeling; 

Notice of Public Meeting and Request 

for Comments 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are issuing this notice to 

inform producers and users of 

veterinary biological products, as well 

as other interested individuals, that we 

will be holding a public meeting to 

discuss a draft guideline (concept paper) 

concerning effectiveness indications 

statements in veterinary biologics 

labeling. We are also making the 

concept paper available for review and 

comment. 

DATES: The public meeting will be held 

on Thursday, June 16, 2011, from 9 a.m. 

to 3 p.m. We will consider all comments 

that we receive on or before July 25, 

2011. 

ADDRESSES: The public meeting will be 

held at the National Centers for Animal 

Health, 1920 Dayton Avenue, Ames, IA. 

You may submit comments on the 

concept paper by either of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=APHIS2011-0049 to submit or view comments 

and to view the concept paper. 

• Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS–2011–0049, 

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– 

2011–0049. 

Reading Room: You may view the 

concept paper and any comments we 

receive on the Regulations.gov Web site 

(see link above) or 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. 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. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Dee McVey, Center for Veterinary 

Biologics, VS, APHIS, 1920 Dayton 

Avenue, Ames, IA 50010; phone (515) 

337–6100, fax (515) 337–6120, or e-mail: 

dee.mcvey@aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: The 

Animal and Plant Health Inspection 

Service (APHIS) administers and 

enforces the Virus-Serum-Toxin Act (the 

Act), as amended (21 U.S.C. 151–159). 

The regulations issued pursuant to the 

Act are intended to ensure that 

veterinary biological products are pure, 

safe, potent, and effective when used 

according to label instructions. The 

regulations in 9 CFR part 112 prescribe 

requirements for packaging and labeling 

veterinary biologics. The regulations in 

part 112 ensure that labeling provides 

adequate information concerning the 

expected effectiveness and safety of the 

product. Current APHIS guidelines 

(Veterinary Services Memorandum 

[VSM] No. 800.202—General Licensing 

Considerations: Efficacy Studies) 

provide examples of statements that 

may be used in labeling to describe the 

indications for use of a product, 

provided that the product has 

demonstrated a specified level of 

performance in an efficacy study that 

was the basis for issuance of the product 

license. VSM 800.202 specifies 

performance requirements and 

allowable indications statements for 

four different levels (tiers) of 

effectiveness. 

In July 2009, representatives of 

veterinary biologics manufacturers and 

the American Veterinary Medical 

Association met with APHIS to discuss 

the Agency’s current labeling guidance 

and to explore the possibility of 

developing a single indications 


jlentini on DSK4TPTVN1PROD with NOTICES