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
30094 Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices 

statement that would convey clinically 

useful information to veterinary 

practitioners and other consumers of 

veterinary biologics. At that meeting, 

the American Veterinary Medical 

Association, which represents the single 

largest group of consumers of veterinary 

biologics, informed APHIS that its 

members consider labeling indications 

statements that are based on the 

guidance provided in VSM 800.202 to 

be confusing and expressed a desire for 

indications statements that provide 

insight into the actual performance of 

the product, including summaries of 

safety and efficacy data. On the other 

hand, representatives of the trade 

associations representing veterinary 

biologics manufacturers have remarked 

that their members expend significant 

resources on studies to provide data to 

support labeling that includes 

indications statements that emphasize 

the unique properties of their product 

versus that of a competitor. They 

expressed concern about any change to 

the labeling regulations that would 

deemphasize product differences or 

require public disclosure of proprietary 

information that could compromise 

manufacturers’ competitive positions in 

the marketplace. 

In response to the concerns expressed 

by these stakeholders, APHIS has 

developed a draft policy guideline 

(concept paper) concerning the wording 

of indications statements used in 

veterinary biologics labeling. The draft 

guideline differs from current guidance 

regarding label claims in VSM 800.202 

in that a single indications statement 

(e.g., ‘‘This product has been shown to 

be effective for the vaccination of 

healthy animals X weeks of age or older 

against * * *’’) would replace current 

indications statements that may reflect 

any of four different levels of 

effectiveness. In addition to a 

standardized indications statement, the 

draft guideline also provides for the 

public disclosure of a summary (with 

confidential business information 

removed) of the efficacy and safety data 

submitted to APHIS in support of the 

issuance of the product license. The 

draft guideline may be viewed on the 

Regulations.gov Web site (see 

ADDRESSES above) or obtained from the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

We are holding a public meeting to 

solicit input and discussion of any 

issues that are pertinent to this concept. 

This meeting is scheduled for Thursday, 

June 16, 2011. Registration information 

and copies of the agenda for the meeting 

may be obtained from the person listed 

under FOR FURTHER INFORMATON

CONTACT. The public meeting will begin 

at 9 a.m. and is scheduled to end at 3 

p.m. but may end earlier if all persons 

wishing to comment have been heard. 

The meeting will be recorded, and 

information about obtaining a transcript 

will be provided at the meeting. If you 

require special accommodations, such 

as a sign language interpreter, please 

contact the person listed under FOR

FURTHER INFORMATION CONTACT. 

You may also submit comments 

regarding the concept paper using one 

of the methods described under 

ADDRESSES above. 

Done in Washington, DC, this 18th day of 

May 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–12762 Filed 5–23–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Central Montana Resource Advisory 

Committee 

AGENCY: Forest Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: The Central Montana 

Resource Advisory Committee will meet 

in Stanford, MT. The committee is 

authorized under the Secure Rural 

Schools and Community SelfDetermination Act (Pub. L. 110–343) 

(the Act) and operates in compliance 

with the Federal Advisory Committee 

Act. The purpose of the committee is to 

improve collaborative relationships and 

to provide advice and recommendations 

to the Forest Service concerning projects 

and funding consistent with the title II 

of the Act. The meeting is open to the 

public. This will be the second official 

meeting of the Central Montana 

Resource Advisory Committee. 

DATES: The meeting will be held June 1, 

2011, 7 p.m. 

ADDRESSES: The meeting will be held at 

the Judith Ranger District, 109 Central 

Ave. Written comments may be 

submitted as described under 

SUPPLEMENTARY INFORMATION. 

All comments, including names and 

addresses when provided, are placed in 

the record and are available for public 

inspection and copying. The public may 

inspect comments received at the Judith 

Ranger District. Please call ahead to 

(406) 566–2292 to facilitate entry into 

the building to view comments. 

FOR FURTHER INFORMATION CONTACT: Ron 

Wiseman, District Ranger, Lewis and 

Clark National Forest, (406) 566–2292, 

rwiseman@fs.fed.us. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

between 8 a.m. and 8 p.m., Eastern 

Standard Time, Monday through Friday. 

Requests for reasonable accommodation 

for access to the facility or proceedings 

may be made by contacting the person 

listed FOR FURTHER INFORMATION. 

SUPPLEMENTARY INFORMATION: The 

following business will be conducted: 

(1) Discussion and approval of RAC 

operating guidelines. (2) Discussion of 

project development and 

recommendation process. (3) Review 

and vote on projects. Anyone who 

would like to bring related matters to 

the attention of the committee may file 

written statements with the committee 

staff before or after the meeting. The 

agenda will include time for people to 

make oral statements of three minutes or 

less. Individuals wishing to make an 

oral statement should request in writing 

by May 18 to be scheduled on the 

agenda. Written comments and requests 

for time for oral comments must be sent 

to 109 Central Ave., Stanford, MT 

59479, or by e-mail to rwiseman@

fs.fed.us, or via facsimile to (406) 566– 

2408. 

Dated: May 9, 2011. 

Ron B. Wiseman, 

District Ranger. 

[FR Doc. 2011–12569 Filed 5–23–11; 8:45 am] 

BILLING CODE 3410–11–M 

DEPARTMENT OF AGRICULTURE 

Rural Utilities Service 

Announcement of Grant and Loan 

Application Deadlines and Funding 

Levels 

AGENCY: Rural Utilities Service, USDA. 

ACTION: Notice of funding availability 

and solicitation of applications. 

SUMMARY: The Rural Utilities Service 

(RUS) announces its Revolving Fund 

Program (RFP) application window for 

Fiscal Year (FY) 2011. In addition to 

announcing the application window, 

RUS announces the available funding of 

$496,000 for RFP competitive grants for 

the fiscal year. 

The RFP is authorized under section 

306(a)(2)(B) of the Consolidated Farm 

and Rural Development Act (Con Act), 

7 U.S.C. 1926(a)(2)(B). Under the RFP, 

qualified private, non-profit 

organizations receive RFP grant funds to 

establish a lending program for eligible 

entities. Eligible entities for the 

revolving loan fund will be the same 

entities eligible, under paragraph 1 or 2 


jlentini on DSK4TPTVN1PROD with NOTICES