This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

22048 

Vol. 79, No. 76 

Monday, April 21, 2014 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 112 

[Docket No. APHIS–2011–0049] 

RIN 0579–AD64 

Viruses, Serums, Toxins, and 

Analogous Products; Single Label 

Claim for Veterinary Biological 

Products 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: We are proposing to amend 

the Virus-Serum-Toxin Act regulations 

to provide for the use of a simpler 

labeling format that would better 

communicate product performance to 

the user. We intend to replace the 

current label format, which reflects any 

of four different levels of effectiveness, 

with a single, uniform label format. We 

are also proposing to require biologics 

licensees to provide a standardized 

summary, with confidential business 

information removed, of the efficacy 

and safety data submitted to the Animal 

and Plant Health Inspection Service in 

support of the issuance of a full product 

license or conditional license. A simpler 

label format along with publicly 

available safety and efficacy data will 

help biologics producers to more clearly 

communicate product performance to 

their customers. 

DATES: We will consider all comments 

that we receive on or before June 20, 

2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!documentDetail;D=APHIS-2011-0049- 

0009. 

• Postal Mail/Commercial Delivery: 

Send 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. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at http://

www.regulations.gov/

#!docketDetail;D=APHIS-2011-0049 or 

in our reading room, which 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) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Donna Malloy, Operational Support 

Section, Center for Veterinary Biologics, 

Policy, Evaluation, and Licensing, VS, 

APHIS, 4700 River Road, Unit 148, 

Riverdale, MD 20737–1231; (301) 851– 

3426. 

SUPPLEMENTARY INFORMATION: 

Background 

The Animal and Plant Health 

Inspection Service (APHIS) administers 

and enforces the Virus-Serum-Toxin 

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 efficacious when used 

according to label instruction. The 

regulations in 9 CFR part 112, 

‘‘Packaging and Labeling,’’ (referred to 

below as the regulations) prescribe 

requirements for the packaging and 

labeling of veterinary biologics. The 

regulations ensure that labeling 

provides adequate information 

concerning the proper use and safety of 

the product, including vaccination 

schedules, warnings, and cautions. 

Current APHIS guidelines provide 

examples of label claims that may be 

used to reflect the expected performance 

of the product provided that appropriate 

efficacy data has been submitted and 

approved by APHIS. The guidelines 

describe 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 (AVMA) 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 AVMA, which represents the largest 

group of consumers of veterinary 

biologics, informed APHIS that its 

members consider labeling indications 

statements based on the current 

guidance to be confusing, and expressed 

a desire for indications statements to 

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 

emphasizing the unique properties of 

their product versus that of a 

competitor. They expressed concern 

about any change to the labeling 

regulations that would de-emphasize 

product differences or require public 

disclosure of proprietary information 

that could compromise a manufacturer’s 

competitive position in the marketplace. 

In response to the concerns expressed 

by these stakeholders, APHIS developed 

a draft guideline (concept paper) 

concerning the effectiveness indications 

statements used in veterinary biologics 

labeling. The draft guideline would 

replace current indications statements 

that may reflect any of four different 

levels of effectiveness with a single 

indications statement (e.g., a label claim 

stating that the product can be used ‘‘as 

an aid in the prevention of lll,’’ ‘‘as 

an aid in the control of lll,’’ ‘‘for the 

prevention of infection with lll,’’ or 

‘‘for the prevention of disease due to l

ll’’ would be replaced with the 

statement ‘‘This product has been 

shown to be effective for the vaccination 

of healthy animals lllweeks of age 

or older against lll’’). 

In addition to a standardized 

indications statement, the draft 

guideline would also require biologics 

licensees to provide a summary of their 

data, with confidential business 

information removed, of the efficacy 

and safety data submitted to APHIS in 

support of the issuance of the product 

license. These proposed changes would 

not alter the current efficacy 

requirements for veterinary biological 

products and are not intended to 


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Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Proposed Rules 22049 

constitute re-licensure of currently 

licensed products. These changes would 

not apply to diagnostic products. 

On May 24, 2011, we published in the 

Federal Register (76 FR 30093–30094, 

Docket No. APHIS–2011–0049) a notice 

of a public meeting to discuss the draft 

guideline (concept paper) concerning 

effectiveness indications statements in 

veterinary biologics labeling. At the 

meeting, we received comments from 

national trade associations representing 

veterinary biologics manufacturers, the 

AVMA, a veterinary consulting group, 

private and academic veterinarians, pet 

owners, and manufacturers. There was 

general support to change the format in 

which expectations of product efficacy 

are communicated on labels. APHIS has 

carefully considered the comments 

received on the draft guideline and has 

taken these comments into account in 

the drafting of this proposed rule. 

Currently licensed products would 

not need to be re-licensed based on 

these proposed changes. This proposal 

is not intended to change the efficacy 

requirements for currently licensed 

veterinary biological products. Disease 

syndromes and primary parameters 

used in the case definitions would 

continue to be included in the 

indications statement where 

appropriate. 

The licensees would be required to 

provide the same data as is currently 

required under 9 CFR part 102. 

Summaries of these data will be made 

available to the public on the APHIS 

Center for Veterinary Biologics (CVB) 

Web site. We believe that providing 

safety and efficacy data combined with 

a simpler labeling format will allow the 

end user to better assess product 

performance. 

For the purposes of marketing, 

promotion, or advertising, the 

manufacturers could include a 

statement on promotional and 

advertising materials referring the user 

to the CVB Web site where additional 

efficacy and safety data may be found. 

Promotional studies would not be 

disclosed on the CVB Web site. We 

believe this is consistent with previous 

guidelines and regulations and would 

not confer an advantage to any 

particular manufacturer. 

The CVB Web site would also provide 

educational information to address the 

complex nature of efficacy studies as 

well as explanatory statistical 

information, where appropriate, related 

to individual data summaries. In 

addition, the Web site would include a 

statement advising users to consult with 

a licensed veterinarian for further 

information regarding the use of a 

veterinary biological product. We 

believe an educational component is an 

integral part of disseminating such 

complex information as efficacy and 

safety data. 

Biologics licensees would be 

responsible for providing data 

summaries with confidential business 

information removed. The licensee 

would be required to submit a summary 

of data with the efficacy/safety reports. 

If after reviewing the summary of data 

APHIS disagrees with the accompanying 

conclusions, APHIS would revise the 

summary and provide the licensee with 

the opportunity to review and comment 

on the revised summary prior to it being 

posted on the CVB Web site. 

The original efficacy and safety data 

for each component antigen in a product 

would remain on the Web site 

indefinitely. Post-licensure data 

supporting additional efficacy/safety 

claims, or changes in the time immunity 

is demonstrated (i.e., time interval 

between vaccination and challenge) 

would also be posted to the Web site 

alongside the original data summary. 

We believe that providing post-licensure 

efficacy and safety data alongside the 

original efficacy data would allow the 

end user to determine whether the 

manufacturer is maintaining, increasing, 

or decreasing the standards used to 

originally license the product. 

Several commenters requested 

information regarding how study design 

and results would be disclosed on the 

data summaries. Given the large number 

of diseases, vaccine types, and efficacy 

models, it is not possible to standardize 

the study design for all efficacy studies. 

Efficacy data summaries would include 

information regarding study design and 

associated raw data used to license the 

product. Parameters associated with 

study design would include: Minimum 

and maximum age of the target species; 

the diversity of target species; number of 

animals; whether animals were client 

owned; States where the study was 

conducted; serologic status of animals 

(including presence or absence of 

maternal antibody when appropriate); 

and dosage, timing, and route of 

administration. Information regarding 

the challenge organism would include 

the name of the organism (not strain) 

and concentration, time of challenge 

relative to the last vaccination, and 

whether the challenge organism is 

homologous or heterologous to the 

vaccine. Safety data summaries would 

include the same study design 

information as provided in efficacy data 

summaries and would include all 

adverse events that were observed 

throughout the course of the study. 

The primary outcome and clinically 

relevant outcomes of the study used for 

acceptance of the data by APHIS would 

have to be provided. The data summary 

would include neither case definitions 

nor statistical results of an inferential 

nature (e.g., confidence intervals and pvalues). The data would be sufficient to 

be reasonably understood by an 

individual with basic medical and 

scientific background yet contain 

sufficient information to allow a 

veterinarian to make an informed 

decision regarding the performance of 

the product(s). If the clinical sign is 

quantified rather than defined as either 

present or absent, the summary would 

provide sufficient information so the 

distribution of the responses could be 

understood. For example, in addition to 

the number of control and vaccinated 

animals with lung lesions, the summary 

could include such information as 

minimum, 25th percentile, median, 75th 

percentile, and maximum percent lung 

lesions for each group. We believe that 

presentation of efficacy and safety 

information as outlined above would 

appropriately reflect product 

performance in a standardized format 

without disclosing study information 

that may be confidential business 

information. 

After demonstrating the efficacy for a 

product that contains a combination of 

many antigens, the manufacturer often 

mixes those antigens into smaller 

combinations. Smaller combinations 

can then be licensed as fall-out 

products. With regard to the 

presentation of data for large 

combination products with fall-out 

products, in general, efficacy and safety 

studies are conducted on the largest 

combination product and not on fall-out 

products. Efficacy would have to be 

established for each component antigen 

in the largest combination product. 

Safety data summaries would have to be 

provided for the largest combination 

product. Efficacy data summaries would 

be posted for each component antigen 

on the large combination (parent) 

product with a list of all smaller fall-out 

products. Similarly, each fall-out 

product from a larger combination 

product would have to reference the 

parent product under which the efficacy 

data summary may be found. An 

educational component would be 

included on the efficacy and safety data 

summaries clarifying that fall-out 

products have been licensed based on 

efficacy and safety data of a larger 

combination product. We believe this 

would bridge data from larger 

combination products to their 

associated fall-out products. In order to 

provide a manageable workload for both 

the manufacturers and CVB, we will 


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22050 Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Proposed Rules 

provide manufacturers with the 

opportunity to prioritize the submission 

of product families. 

Products that are not yet licensed but 

are within 6 months of licensure at the 

time these proposed regulations may 

become effective would be expected to 

be fully compliant no later than 1 year 

after licensure. Products that are more 

than 6 months away from licensure at 

the time these proposed regulations may 

become effective would be expected to 

be fully compliant at the time of 

licensure. 

For products that are currently 

licensed, the standardized summary of 

efficacy and safety data and the revised 

labels would have to be submitted to 

APHIS within 4 years of the time these 

proposed regulations may become 

effective. Licensees could request an 

extension of up to 2 years for submitting 

these materials. Extension requests, 

which would have to include the reason 

for the extension and a proposed 

implementation schedule, would have 

to be submitted in writing to the CVB 

Director. Contact information for the 

Director can be found on the CVB Web 

site. 

Products whose original efficacy data 

are not available would require a 

statement on their data summary stating 

‘‘Original efficacy data is not available 

because the product was licensed ‘‘x’’ 

years ago.’’ Regardless of the date of 

licensure of the product, any additional 

efficacy claims, including new routes of 

administration, or reference 

qualification data involving vaccinationchallenge studies would be posted to 

the Web site. We believe that these 

timelines are appropriate for 

implementation of this proposed action 

and do not unnecessarily pose a 

hardship on the regulated industry or 

CVB. 

Executive Orders 12866 and 13563 and 

Regulatory Flexibility Act 

This proposed rule has been 

determined to be significant for the 

purposes of Executive Order 12866 and, 

therefore, has been reviewed by the 

Office of Management and Budget. 

We have prepared an economic 

analysis for this rule. The economic 

analysis provides a cost-benefit analysis, 

as required by Executive Orders 12866 

and 13563, which direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and equity). Executive Order 

13563 emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. The 

economic analysis also provides an 

initial regulatory flexibility analysis that 

examines the potential economic effects 

of this rule on small entities, as required 

by the Regulatory Flexibility Act. The 

economic analysis is summarized 

below. Copies of the full analysis are 

available by contacting the person listed 

under FOR FURTHER INFORMATION

CONTACT or on the Regulations.gov Web 

site (see ADDRESSES above for 

instructions for accessing 

Regulations.gov). 

Based on the information we have, 

there is no reason to conclude that 

adoption of this proposed rule would 

result in any significant economic effect 

on a substantial number of small 

entities. However, we do not currently 

have all of the data necessary for a 

comprehensive analysis of the effects of 

this proposed rule on small entities. 

Therefore, we are inviting comments on 

potential effects. In particular, we are 

interested in determining the number 

and kind of small entities that may 

incur benefits or costs from the 

implementation of this proposed rule. 

Further, we are interested in receiving 

information that could be used to 

further quantify the benefits of this 

proposed rule. 

APHIS is proposing to amend the 

Virus-Serum-Toxin Act regulations to 

require the use of a simpler labeling 

format. This simpler uniform format 

would allow biologics licensees and 

permittees to more clearly communicate 

product performance to the user. 

Biologics licensees and permittees 

would also be required to provide a 

standardized summary of the efficacy 

and safety data that are submitted to 

APHIS in support of the issuance of a 

full product license or conditional 

product license. The summary of 

efficacy and safety data would be made 

available to the public on the APHIS 

CVB Web site. We believe that the 

benefits of this rule justify the costs. 

A simpler, uniform format would 

allow biologics licensees and permittees 

to more clearly communicate product 

performance information to the end 

user. Veterinarians, the largest group of 

consumers of veterinary biologics, often 

find labeling indications statements 

based on the current guidance to be 

confusing, and have expressed a desire 

for indications statements to provide 

insight into the actual performance of 

the product, including summaries of 

safety and efficacy data. In addition, the 

rule would simplify the evaluation of 

efficacy studies, focusing on a basic 

claim of effectiveness compared to the 

more complex, tiered approach 

historically used by APHIS. The 

proposed rule would reduce the amount 

of time required by CVB to evaluate 

study data. Because complex claims 

require more complex studies, the rule 

would likely result in fewer studies 

being found unacceptable. A study that 

is determined to be unacceptable by 

APHIS can lead to significant costs to 

manufacturers. These costs include 

those associated with duplication of 

efforts and materials (facilities and 

animals) used when a study must be 

redone, and lost marketing 

opportunities when initial licensing 

applications are not approved. A novel 

veterinary biological product can 

generate revenue in the neighborhood of 

$5 to $10 million per year. Therefore, 

lost opportunities due to delays in 

bringing a product to market can be 

significant. 

This rule would affect all veterinary 

biologics licensees and permittees. 

There are approximately 98 veterinary 

biological establishments, including 

permittees. These companies produce 

about 1,900 different products, and 

there are about 11,700 active approved 

labels for veterinary biologics. There 

were about 3,100 labels submitted for 

approval in the last 12 months by about 

two-thirds of the companies. 

Costs for licensees and permittees of 

the proposed rule are not expected to be 

significant, whether the affected entity 

is small or large. APHIS anticipates that 

the only costs associated with the 

proposed labeling format would be onetime costs incurred by licensees and 

permittees in having labels for existing 

licensed products reformatted in 

accordance with the proposed rule. 

Most biologics companies, in the course 

of normal business, use a just-in-time 

method for producing new labels and 

readily alter their content. Labels are 

regularly altered, for example, to 

enhance marketing through changes in 

design. 

Products that are not yet licensed but 

are within 6 months of licensure at the 

time these proposed regulations may 

become effective would be expected to 

be fully compliant no later than 1 year 

after licensure. Products that are more 

than 6 months away from licensure at 

the time these proposed regulations may 

become effective would be expected to 

be fully compliant at the time of 

licensure. For products that are 

currently licensed, the standardized 

summary of efficacy and safety data and 

the revised labels would have to be 

submitted to APHIS within 4 years of 

the time these proposed regulations may 

become effective. CVB would consider 

written requests to extend the time 


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Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Proposed Rules 22051 

period for submitting the summaries by 

an additional 2 years if necessary. 

In many instances manufacturers 

would not have to produce new labeling 

materials before they would do so in the 

normal course of business, and would 

only incur additional administrative 

costs to track the changes. Costs 

incurred for minor label changes that 

are coordinated with planned label 

changes are estimated to range between 

$99 and $500 per product with labels 

needing to be changed. We estimate that 

there are about 6,200 labels associated 

with about 1,000 products for which 

there would be this type of coordinated 

change. For these label changes, the 

total cost is estimated to range between 

$99,000 and $500,000. 

We expect that about 5,500 of the 

active labels, associated with 900 

products, would be changed other than 

in conjunction with a planned change. 

In these cases, manufacturers would 

incur costs for prepress, graphic design, 

and printing in addition to 

administrative costs. All labels for a 

specific product would be changed at 

the same time. Based on these activities, 

the costs of minor label changes that are 

not coordinated with planned label 

changes could range from $465 to 

$1,613 in administrative and labor costs 

for each product with labels needing to 

be changed and from $100 to $275 per 

new label in materials cost. Because 

veterinary biologics manufacturers are 

likely to make changes for groups of 

products, all cattle products for 

example, there are likely to be savings 

in administrative and labor costs for 

those grouped changes. However, based 

on the above ranges, the total cost for 

these uncoordinated label changes is 

estimated to be between $968,000 and 

$3 million. 

Minor costs may be incurred in 

producing the standardized summaries 

of efficacy and safety data for currently 

licensed products within the 4-year 

implementation period. We estimate 

that about 1,700 summaries would need 

to be completed as a result of this rule 

because efficacy and safety studies are 

frequently provided for multiple 

products. The estimated cost would be 

about $55 per summary, or about 

$94,000 in total. 

Executive Order 12372 

This program is listed in the category 

of Federal Domestic Assistance under 

No 10.025 and is subject to Executive 

Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. It is not intended to have 

retroactive effect. This rule would not 

preempt any State or local laws, 

regulations, or policies unless they 

present an irreconcilable conflict with 

this rule. The Virus-Serum-Toxin Act 

does not provide administrative 

procedures which must be exhausted 

prior to a judicial challenge to the 

provisions of this rule. 

Paperwork Reduction Act 

This proposed rule contains no new 

information or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects in 9 CFR Part 112 

Animal biologics, Exports, Imports, 

Labeling, Packaging and containers, 

Reporting and recordkeeping 

requirements. 

Accordingly, we propose to amend 9 

CFR part 112 as follows: 

PART 112—PACKAGING AND 

LABELING 

■ 1. The authority citation for part 112 

continues to read as follows: 

Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 2. Section 112.2 is amended as 

follows: 

■ a. In paragraph (a)(5), by adding a new 

first sentence. 

■ b. By adding a new paragraph 

(a)(9)(v). 

The additions read as follows: 

§ 112.2 Final container label, carton label, 

and enclosure. 

(a) * * * 

(5) An indications statement to read 

‘‘This product has been shown to be 

effective for the vaccination of healthy 

animals lll weeks of age or older 

against lll.’’ * * * 

* * * * * 

(9) * * * 

(v) A statement similar to ‘‘For more 

information regarding efficacy and 

safety data, go to http://

www.aphis.usda.gov/wps/portal/aphis/

ourfocus/animalhealth?1dmy&urile=

wcm%3apath%3a%2FAPHIS_Content_

Library%2FSA_Our_Focus%2FSA_

Animal_Health%2FSA_Vet_Biologics.’’ 

* * * * * 

■ 3. Section 112.5 is amended as 

follows: 

■ a. In the introductory text, by 

removing the words ‘‘paragraph (c) of 

this section and under the master label 

system provided in paragraph (d)’’ and 

adding the words ‘‘paragraph (d) of this 

section and under the master label 

system provided in paragraph (e)’’ in 

their place. 

■ b. By redesignating paragraphs (b) 

through (g) as paragraphs (c) through 

(h). 

■ c. By adding a new paragraph (b). 

■ d. In newly redesignated paragraph 

(d)(1), by removing the citation 

‘‘§ 112.5(d)’’ and adding the citation 

‘‘§ 112.5(e)’’ in its place. 

■ e. In newly redesignated paragraph 

(e)(1)(ii), by removing the citation 

‘‘§ 112.5(d)(1)(iii)’’ and adding the 

citation ‘‘§ 112.5(e)(1)(iii)’’ in its place. 

■ f. In newly redesignated paragraph 

(e)(1)(iii), by removing the citation 

‘‘§ 112.5(d)(1)(i)’’ and adding the 

citation ‘‘§ 112.5(e)(1)(i)’’ in its place. 

■ g. In newly redesignated paragraph 

(e)(1)(iv), by removing the citation 

‘‘§ 112.5(d)(1)(ii)’’ and adding the 

citation ‘‘§ 112.5(e)(1)(ii)’’ in its place. 

■ h. In newly redesignated paragraph 

(h), by removing the citation 

‘‘§ 112.5(c)’’ and adding the citation 

‘‘112.5(d)’’ in its place. 

The addition reads as follows: 

§ 112.5 Review and approval of labeling. 

* * * * * 

(b) A data summary, available on the 

Internet at http://www.aphis.usda.gov/

wps/portal/aphis/ourfocus/animal

health?1dmy&urile=wcm%3apath%3

a%2FAPHIS_Content_Library%2FSA_

Our_Focus%2FSA_Animal_

Health%2FSA_Vet_Biologics, shall be 

used with each submission of efficacy 

and safety data in support of a label 

claim. Manufacturers will submit the 

efficacy and safety data information 

with either the efficacy and safety 

studies or at the time of label 

submission. This information will be 

posted at http://www.aphis.usda.gov/

wps/portal/aphis/ourfocus/animal

health?1dmy&urile=wcm%3apath%3

a%2FAPHIS_Content_Library%2FSA_

Our_Focus%2FSA_Animal_

Health%2FSA_Vet_Biologics to allow 

public disclosure of product 

performance. 

* * * * * 

Done in Washington, DC, this 21st day of 

March 2014. 

Gary Woodward, 

Deputy Under Secretary for Marketing and 

Regulatory Programs. 

[FR Doc. 2014–08995 Filed 4–18–14; 8:45 am] 

BILLING CODE 3410–34–P 


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