2011-12762. 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=​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 [phone] before coming.

FOR FURTHER INFORMATION CONTACT:

Ms. Dee McVey, Center for Veterinary Biologics, VS, APHIS, 1920 Dayton Avenue, Ames, IA 50010; phone [phone], fax [phone], or e-mail: [e-mail].

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 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.