[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30093-30094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12762]


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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.

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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=APHIS-2011-0049 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: [email protected].

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

[[Page 30094]]

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