[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Rules and Regulations]
[Pages 59427-59436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20749]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 101, 103, 112, 113, and 114

[Docket No. APHIS-2008-0008]
RIN 0579-AD19


Viruses, Serums, Toxins, and Analogous Products; Packaging and 
Labeling

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the Virus-Serum-Toxin Act regulations 
regarding the packaging and labeling of veterinary biological products 
to provide for the use of an abbreviated true name on small final 
container labeling for veterinary biologics; require labeling to bear a 
consumer contact telephone number; change the format used to show the 
establishment or permit number on labeling and require such labeling to 
show the product code number; change the storage temperature 
recommended in labeling for veterinary biologics; require vaccination 
and revaccination recommendations in labeling to be consistent with 
licensing data; require labeling information placed on carton tray 
covers to appear on the outside face of the tray cover; remove the 
restriction requiring multiple-dose final containers of veterinary 
biologics to be packaged in individual cartons; require labeling for 
bovine virus diarrhea vaccine containing modified live virus to bear a 
statement warning against use in pregnant animals; reduce the number of 
copies of each finished final container label, carton label, or 
enclosure required to be submitted for review and approval; require 
labels for autogenous biologics to specify the organism(s) and/or 
antigen(s) they contain; and require labeling for conditionally 
licensed veterinary biologics to bear a statement concerning efficacy 
and potency requirements. In addition, we are also amending the 
regulations concerning the number of labels or label sketches for 
experimental products required to be submitted for review and approval, 
and the recommended storage temperature for veterinary biologics at 
licensed establishments. These changes are necessary in order to update 
and clarify labeling requirements and to ensure that information 
provided in labeling is accurate with regard to the expected 
performance of the product.

DATES: Effective October 31, 2016.

FOR FURTHER INFORMATION CONTACT: Dr. Donna L. Malloy, Section Leader, 
Operational Support, 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

    Under the Virus-Serum-Toxin Act (the Act, 21 U.S.C. 151-159) and 
regulations issued under the Act, the Animal and Plant Health 
Inspection Service (APHIS) grants licenses or permits for biological 
products which are pure, safe, potent, and efficacious when used 
according to label instructions. 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 
biological products including requirements applicable to final 
container labels, carton labels, and enclosures. The main purpose of 
the

[[Page 59428]]

regulations in part 112 is to regulate the packaging and labeling of 
veterinary biologics in a comprehensive manner, which includes ensuring 
that labeling provides adequate instructions for the proper use of the 
product, including vaccination schedules, warnings, and cautions. 
Complete labeling (either on the product or accompanying the product) 
must be reviewed and approved by APHIS in accordance with the 
regulations in part 112 prior to their use.
    Although the science of immunology and our understanding of how 
veterinary biologics work have advanced substantially in recent years, 
communicating such information to consumers and veterinarians by way of 
updated labeling claims, cautions, and warnings is a top priority of 
APHIS. Therefore, on January 13, 2011, we published in the Federal 
Register (76 FR 2268-2277, Docket No. APHIS-2008-0008) a proposal \1\ 
to amend the regulations to make veterinary biologics labeling 
requirements more consistent with current science and veterinary 
practice.
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    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0008.
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    We solicited comments concerning our proposal for 60 days ending 
March 14, 2011. We received six comments from five commenters by that 
date. The comments were from licensees, permittees, veterinary 
biologics industry associations, and a veterinary medical association. 
All of the commenters were generally supportive of the proposed rule, 
but raised a number of questions and concerns about its provisions. 
They are discussed below by topic.

True Name, Abbreviated True Names, Functional/Chemical Name

    Two commenters noted that the proposed rule states that the 
abbreviated true name must be identical to that shown on the product 
license. One commenter stated that the use of abbreviations for true 
names on small labels would be beneficial only if they are 
standardized. This commenter expressed concern that without 
standardization, the use of such abbreviations could result in 
confusion. The other commenter stated that it was unclear whether the 
proposal means that a standardized abbreviation that corresponds to the 
true name shown on the license must be used, that the abbreviation will 
be negotiated on a case-by-case basis and noted on the product license, 
or that no abbreviations may be used unless they are also reflected on 
the product license. The commenter further stated that reissuing 
licenses for every approved biologic product simply to add 
abbreviations is unreasonable, and that APHIS should issue a memorandum 
with a list of standardized abbreviations for use by licensees.
    APHIS will assign abbreviated true names when issuing new product 
licenses, when there is a need to reissue a product license (e.g., 
renewal of Conditional Licenses, or change in ownership) or upon 
specific request.
    One commenter stated that container labels for diagnostic kits 
should not be required to include both the true name of the kit and the 
functional and/or chemical name of the reagent. The commenter noted 
that the proposed rule includes a requirement to add product code 
numbers and that this will provide consumers with a reference to 
connect the component with the specific kit. The commenter further 
stated that adding the true name would not give consumers any 
additional useful information, but would significantly increase the 
amount of text required on the label.
    APHIS agrees that reagents can be linked to a particular kit 
through the product code as well as the true name, and we have amended 
Sec.  112.2(a)(3)(ii) to specify that the product code number may be 
used in lieu of the true name on small containers for critical 
components of diagnostic kits. In the case of small reagent containers 
within a diagnostic kit, those reagents that should not be used with 
other kits must bear functional/chemical name of the reagent and the 
applicable kit product code, but not necessarily the true name of the 
kit. Reagents that are considered interchangeable need not have the kit 
product code, but must bear the functional/chemical name of the 
reagent.
    One commenter stated that the proposed rule's ``Background'' 
section indicates that carton labels and enclosures would be required 
to contain both the full true name and the associated abbreviation, but 
that the regulatory text does not include such a provision. Two 
commenters also stated that if a licensee does not use an abbreviation 
on the final container label, then an explanation of the abbreviation 
should not be required on the carton label and enclosure.
    APHIS acknowledges that there was an inconsistency between the 
preamble and regulatory text in the proposed rule; the provisions in 
the regulatory text are correct. APHIS also agrees with the commenters 
that an explanation of an abbreviation should not be required on the 
carton label and enclosure when the abbreviation is not used on the 
final container label. We note that Sec.  112.2(a)(1)(i) states that 
the abbreviation may be used on small final containers, provided that 
the complete true name must appear on the carton label and enclosures, 
but does not require explanations of abbreviation if abbreviations are 
not used.
    One commenter stated that firms should be allowed to use existing 
abbreviated names and have input on newly assigned abbreviated names. 
The commenter noted that abbreviated names are currently used as part 
of foreign registrations and that any changes would require significant 
submission and label review (including registration fees) by several 
authorities. The commenter also noted that these names are often part 
of corporate branding strategies that are costly to develop and 
implement. The commenter stated that unless there are specific concerns 
with an existing or requested abbreviated name (e.g., mislabeling), 
APHIS should not require changes in existing products nor reject 
reasonable suggestions by the firms.
    APHIS is aware that there are a variety of issues associated with 
changing established abbreviations and may allow licensees to use 
established abbreviations on export labels on a case-by-case basis.

Consumer Contact Telephone Number

    Two commenters stated that in the case of small final container 
labels, the requirement for a consumer contact telephone number in 
Sec.  112.2(a)(2) should be waived when the telephone number is 
included on the carton label or enclosure. Another commenter stated 
that there will likely be instances where it will be difficult to 
include all contact information on a small final container without 
rendering the text illegible. This commenter stated that in these 
instances, there should be an exception allowing this information to be 
provided on a minimum of one labeling component (e.g., carton label or 
enclosure).
    For small, single-dose containers, APHIS will consider this 
requirement to be satisfied if all contact information, including the 
telephone number, is provided on the carton and enclosure labeling 
materials. We have amended the regulatory text to read ``Provided, that 
in the case of a biological product exported from the United States in 
labeled final containers, a consumer contact telephone number is not 
required; however, small single dose containers marketed in the United 
States must include contact telephone

[[Page 59429]]

information on carton and enclosures,'' to clarify this requirement.

Veterinary License/Permit Number and Product Code Number

    Two commenters opposed requiring a product code number on labeling 
materials. The commenters stated that instead of facilitating product 
identification in the field, it would more likely add to confusion by 
those trying to identify a product in distribution channels and in the 
field. The commenters stated that historically there has been no 
difficulty using a licensee's product serial number to trace it back to 
a specific product code.
    APHIS disagrees with the commenters. We believe that adding the 
product code will provide a valuable piece of information that will 
allow the consumer to differentiate between products with the same 
trade name. For example, if a company makes a product which contains a 
dye, and another which does not, the products would have different 
products codes but the same true name. If a consumer reports a problem 
with one of these products, we would not be able to identify which 
product caused the problem using only the true name.
    One commenter asked whether peel-off labels intended for insertion 
in medical records would be required to contain the veterinary license 
number or veterinary permit number, the Product Code number, and the 
serial number. The commenter expressed concern that this may not be 
possible without rendering text illegible.
    APHIS notes that there are currently no regulations that specify 
the information that must appear on a peel-off portion of a label, nor 
would this final rule establish any. Instead, it requires certain 
information appear on container labels, with exceptions given to small 
final containers and containers of interchangeable reagents included in 
diagnostic test kits.
    One commenter asked how the proposal addresses combination 
packages, where the product code for the combination package is 
different from the product code for the lyophilized cake, which is 
different from the product code for the diluent vaccine. Similarly, one 
commenter stated that if the requirement for the product code number is 
kept, then biological product container labels should also be exempt 
from the requirement unless they are stand-alone presentations. The 
commenter stated that there are situations in which desiccated and 
diluent components can be used in multiple licensed combinations.
    APHIS agrees with the commenters that having different product 
codes on components and a combination package carton could be confusing 
to consumers. We have amended the regulatory text by adding a new 
paragraph (iii) to Sec.  112.2(a)(3) that allows container labels for 
components of combination packages to read ``see carton for product 
code.'' In addition, we are adding a definition of ``combination 
package'' to Sec.  101.3. Because combination packages, which contains 
two or more licensed biological products, are not a new concept to the 
regulated industry, and further, the term ``combination package'' is 
used in the regulations, specifically in Sec.  101.3(h) and Sec.  
112.2(a)(9)(iv), we believe that it would be beneficial to define this 
term in order to clarify these new packaging and labeling requirements.

Instructions for Use of the Product

    One commenter did not object to the revision of the description of 
``full directions for use'' in Sec.  112.2(a)(5)(i) but suggested two 
changes. The commenter stated first that the phrase ``very small'' 
should be deleted in the first line, because this would make the 
question of applicability needlessly complicated and second that 
``carton tray covers'' should be added to the list of locations that 
may be too small. Another commenter suggested revising Sec.  
112.2(a)(5)(i) to read ``In case of limited space on final container 
labels, cartons, or carton tray covers, a statement shall be used as to 
where such information is to be found . . .''. This commenter stated 
that APHIS currently allows the reference to a carton or insert for 
complete information, and requested the revision to ensure that the 
practice can be continued.
    APHIS does not agree that limited space is a problem with cartons 
or carton tray covers. We believe that with the exception of small 
containers, there is ample space for this information. We agree with 
the second commenter that limited space on final container labels may 
present a problem and have amended the requirements to allow a 
statement referring to a carton or insert on final container labels. We 
have also removed the words ``very small'' as requested by the first 
commenter. The provisions now appear in Sec.  112.2(a)(5).

Disposal of Containers and Warnings

    One commenter stated that as written, the proposed requirements in 
Sec.  112.2(a)(7) would apply to both viable and killed products, but 
that they should instead apply only to products containing viable 
organisms because there is no rationale for requiring inactivation of 
inactivated products.
    APHIS agrees with the commenter. We have amended the regulatory 
text to clarify that the requirement to inactivate applies only to 
product containing viable organisms.
    One commenter stated that Sec.  112.2(a)(7) should give licensees 
the added flexibility of recognizing situations in which the warning 
would not be on the container label. The commenter suggested rephrasing 
the warning to read ``Do not mix with other biological products except 
as specified on this label [or carton, or insert, as applicable].''
    APHIS agrees that minor modifications of the text in the 
regulations may be appropriate. We have amended the introductory text 
of Sec.  112.2(a)(7) to allow added flexibility for statements of 
equivalent intent.
    Two commenters stated that there should be a shortened version of 
the warning for small-label situations, such as, ``Do not mix with 
other products.'' This would allow for use of a larger, more legible 
font size for the warning. The same two commenters stated that the 
warning in Sec.  112.2(a)(7)(ii) should be revised to read ``In case of 
human exposure, contact a physician.'' The commenters stated that this 
language would convey the same information, would be more concise, and 
would allow the use of a larger, more legible font size for the 
warning.
    APHIS agrees with the commenters that these shorter warning 
statements are appropriate. We have amended the recommended statements 
to read ``Do not mix with other products, except as specified on this 
label'' and ``In case of human exposure, contact a physician.'' As we 
explained above, we have also amended the introductory text of Sec.  
112.2(a)(7) to allow equivalent statements.
    Two commenters stated that there should be a shortened version of 
the inactivation notice for small-container labels, such as 
``Inactivate unused contents.'' This would allow for use of a larger, 
more legible font size for the warning. Another commenter stated that 
the additional statements will contribute to space and legibility 
issues on labels. The commenter stated that the additional statements 
should be allowed to be included on an insert or carton label.
    APHIS will consider shortened versions on a case-by-case basis to 
accommodate space issues.
    One commenter stated that the preamble of the proposed rule states 
that chemical treatment will be required prior to disposal of 
containers

[[Page 59430]]

containing viable or dangerous organisms or viruses; however, Sec.  
112.2(a)(7)(iii) states ``inactivate'' which suggests that other forms 
of inactivation other than chemical will be allowed. The commenter 
asked if that was the intent.
    The commenter is correct that there was a discrepancy between the 
preamble and proposed regulatory text. Consumers may use any suitable 
means to inactivate unused contents.
    One commenter stated that the proposed changes to Sec.  112.7(g)(4) 
would require changes in revaccination recommendations for all 
instances in which there are not sufficient data for specific 
recommendations. The commenter stated that these changes should be 
applied only prospectively as the labeling for such products are 
otherwise modified.
    APHIS does not agree that this rule should apply only to new labels 
that are submitted for approval, and not to labels that are currently 
approved. We believe that having two standards for information that 
appears on labels would be confusing to the public and to the industry. 
We note that we have made nonsubstantive, editorial changes to Sec.  
112.7 and this requirement now appears in paragraph (f) rather than 
paragraph (g)(4).
    One commenter supported the proposed changes to Sec.  112.6(a) to 
allow flexibility in the packaging of diluent with biological products. 
The commenter stated, however, that proposed Sec.  112.2(f)(1) has not 
been revised to authorize this flexibility, and recommended that it be 
changed accordingly.
    The commenter is correct. We have amended the paragraph to read 
``If a carton label or an enclosure is required to complete the 
labeling for a multiple-dose final container of liquid biological 
product, only one final container, with a container of diluent if 
applicable, shall be packaged in each carton: Provided, That if the 
multiple-dose final container is fully labeled without a carton label 
or enclosure, two or more final containers, and a corresponding number 
of diluent containers, may be packaged in a single carton which shall 
be considered a shipping box. Labels or stickers for shipping boxes 
shall not contain false or misleading information, but need not be 
submitted to APHIS for approval.''

Non-Antibiotic Preservatives

    One commenter stated that the term ``non-antibiotic preservative'' 
is not defined in Sec.  101.3 and asked for additional clarification so 
that firms could comply with the labeling requirement.
    The regulations previously restricted disclosure to antibiotic 
preservatives, but APHIS believes that non-antibiotic preservatives may 
need to be disposed of properly (e.g., merthiolate, phenol) or have 
consumer safety impact (e.g., sodium azide). This information needs to 
be readily available to consumers. Any preservative, regardless of 
nature, should be disclosed. We have amended Sec.  112.2(a)(10) to 
remove the specific references to antibiotic and non-antibiotic 
preservatives.
    One commenter asked whether residual traces of an inactivating 
agent would be considered a preservative under proposed Sec.  
112.2(a)(10).
    Under Sec.  112.2(a)(10), inactivants are not considered 
preservatives.
    One commenter also asked whether, if this change is adopted, there 
would not be any reason to maintain a distinction between antibiotic 
and non-antibiotic preservatives.
    APHIS agrees that there is no need to maintain that distinction. We 
have amended Sec.  112.2(a)(10) to specify only that a statement naming 
the preservative used must appear on the final container label, or on 
cartons and enclosures, if used.
    Two commenters noted that there are differing opinions about what 
is or is not a preservative. Both commenters stated these concerns 
could be resolved by revising the paragraph to state that the labeling 
will include the preservatives as listed in section IV.B of the Outline 
of Production. One commenter stated that if APHIS does not modify the 
proposed rule to identify only those items in section IV.B of the 
Outline of Production, label identification should not apply simply 
because a non-antibiotic preservative is used at any step in the 
production process. The commenter stated that such materials may be 
used in stages of the manufacturing process, yet through a dilution 
effect or processes the residual levels are determined to be nominal. 
The commenter stated that APHIS should consider the establishment of a 
threshold for determining the level of non-antibiotic preservatives at 
which this requirement is triggered.
    Any preservatives still remaining at detectable levels in completed 
products should be declared on labeling. We have amended Sec.  
112.2(a)(10) to clarify this requirement. We will develop guidance on 
this issue and make it available in an update to VS Memorandum 800.54 
(Guidelines for the Preparation and Review of Labeling Materials). This 
memorandum is available on the APHIS Web site at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologics-regulations-and-guidance/ct_vb_vs_memos.
    One commenter stated that concerns for potential residues in food 
and unfavorable reactions in animals are not applicable to diagnostic 
test kits, regardless of whether the preservatives used are antibiotic 
or non-antibiotic.
    APHIS agrees, but describing the potentially hazardous ingredients 
in any biological product is also important from a standpoint of proper 
disposal. For this reason, this rule applies to diagnostic test kits.
    One commenter stated that potential environmental harm is not based 
on whether the preservative is antibiotic or non-antibiotic. The 
commenter further stated that the distinction is arbitrary in assessing 
environmental harm and does not support a requirement to include non-
antibiotic preservatives but rather to exempt antibiotic preservatives. 
The commenter also expressed concern that extending the rule to include 
considerations of environmental harm seems to go beyond the scope of 
the Virus-Serum-Toxin Act.
    Several States and municipalities have legislation regarding the 
disposal of certain products, such as those containing mercury. 
Disclosing all preservatives facilitates proper disposal of products in 
accordance with State laws and local ordinances.

For Animal Use Only

    Two commenters stated that the preamble of the proposed rule 
indicates that the change in Sec.  112.2(d)(3) to require the statement 
``for use in animals only'' instead of ``for veterinary use only'' is 
intended to clarify that the product is for use in animals rather than 
for use in humans. The commenters stated that they did not believe this 
was an issue of significant confusion. One commenter further stated 
that because this change is not related to concerns regarding the 
purity, potency, safety, or efficacy of veterinary biological products, 
APHIS should allow for the use of alternative similar statements, 
including the current ``for veterinary use only.'' The other commenter 
stated that providing for alternatives would allow the use of a single 
label, both domestically and internationally, for a product that may be 
exported to a jurisdiction where minor differences in wording are 
required. The commenter stated that such a policy would promote the 
export of veterinary biologics from the United States. The commenter 
also noted that Canada requires the label statement ``Veterinary use 
only.''
    APHIS prefers the warning ``for animal use only'' as a replacement 
for

[[Page 59431]]

``for veterinary use only'' on domestic labeling but Sec.  112.2(d)(3) 
states that ``for animal use'' may be used, not that it must be used. 
This does not preclude alternative wording where justified.
    Two commenters stated that it is not clear why the proposed 
regulations direct the licensee to put the warning on ``carton labels 
and enclosures'' rather than the more general ``labeling as 
appropriate.'' The commenter recommended that the more general language 
be used.
    APHIS agrees with the commenters and has amended Sec.  112.2(d)(3) 
to use the more general language suggested.

Special Labels for Export

    Three commenters noted that proposed Sec.  112.2(e) contains 
requirements that differ significantly from the provisions of VS 
Memorandum 800.208 (Special Labels for Product for Export). One 
commenter stated that this section should not be amended at all and the 
proposed changes should be rejected. Another commenter stated that the 
section needs to be rewritten to reflect the more practical policy of 
the memorandum. One commenter also stated that the proposed rule does 
not include consideration for foreign-language portions of multi-
language kit labeling. The commenter pointed out that a variation in a 
test protocol might be required in a specific country and asked that 
APHIS allow the protocol to appear in the specific language with an 
accompanying statement that it is approved only in the identified 
country.
    APHIS is aware that some foreign regulatory authorities do not 
provide label approvals per se. We have amended Sec.  112.2(e) to 
provide flexibility in the type of foreign documentation provided and 
to be consistent with established guidelines currently in VS Memorandum 
800.208.

Carton Tray Covers

    Two commenters raised concerns about the proposed requirements for 
carton tray covers. One commenter stated that it is appropriate to 
address labeling on tray covers, but that the language of proposed 
Sec.  112.2(f)(2) would require all labeling to be on the outside face 
of the tray. The commenter stated that in the case of small covers, 
there should be flexibility to allow a sentence referring the user to 
another location of full labeling information. The commenter also 
stated that Sec.  112.2(f)(2) should be amended to be consistent with, 
or combined with Sec.  112.2(a)(5). The commenter further stated that 
the regulations should indicate which information should be immediately 
visible to the consumer and which could be provided elsewhere with 
reference to that location on the carton. The other commenter stated 
that Sec.  112.2(f)(2) should be amended to read ``In case of limited 
space on final container labels, carton labels, or carton tray covers, 
a statement shall be used as to where such information is to be found . 
. .'' This commenter stated that APHIS currently allows the reference 
to an enclosure for complete information and the proposal should be 
amended to allow that practice to continue.
    As we explained in the proposed rule, carton tray covers have come 
to be extensively used in the packaging of diagnostic test kits. They 
are also used in the packaging of multi-packs of single-dose vaccine. 
The proposed change would ensure that the information shown on carton 
tray covers is equivalent to other types of cartons and is presented in 
a manner that is accessible to the consumer without having to open the 
product. We are making no changes in response to this comment.

Packaging Multiple-Dose Final Containers

    The commenter stated that, according to the preamble of the 
proposed rule, the changes to Sec.  112.6(a) are intended to remove the 
requirement for a multiple-dose final product to be packaged with only 
one vial of diluent. The commenter stated, however, that the last 
sentence as proposed requires ``a carton or enclosure in order to 
provide all information required under the regulations.''
    The regulatory provisions are intended to allow multiple containers 
in one carton if the container labels contain all the information 
required by regulations. If the containers do not have all the 
information, and instead rely on a carton or enclosure for additional 
information, then the containers must continue to be packaged one per 
carton to ensure complete labeling for each product unit.

Special Additional Requirements

    One commenter stated that the proposed revisions to Sec.  112.7(f) 
would require a pregnancy warning on all modified live and inactivated 
vaccines for use in mammals unless the vaccine has been shown to be 
safe in pregnant animals. The commenter stated that this requirement 
should be applied only to new products and to products with antigens 
recognized as having a risk in pregnant animals. The commenter stated 
further that these changes should be applied only prospectively as the 
labeling for such products are otherwise modified.
    APHIS believes that it is appropriate for the label to convey 
information on whether or not the product has been tested in pregnant 
animals in order to convey meaningful care information regarding the 
health of the fetus. We have amended the required statement to read 
``This product has not been tested in pregnant animals'' and we will 
continue to allow equivalent statements acceptable to APHIS. As a 
result of editorial changes made to Sec.  112.7, these requirements now 
appear in paragraph (e).
    One commenter stated that the preamble of the proposed rule states 
that the regulations would require labeling to bear the following 
statement: ``A specific revaccination schedule has not been established 
for this product; consultation with a veterinarian is recommended.'' 
The commenter agreed that this is an appropriate label statement, but 
noted that the actual language proposed is different, stating ``The 
need for annual booster vaccinations has not been established for this 
product.'' The commenter requested that the language be amended to 
allow for the use of equivalent statements and to be provided in an 
enclosure or other location, with an appropriate reference to the 
location, when space is limited on labels or outer packaging. The 
commenter stated that this would allow flexibility to tailor statements 
where necessary to meet differences unique to species and/or antigens. 
Another commenter stated that the requirement for a revaccination 
statement should only be applied prospectively as the labeling for such 
products is otherwise modified.
    APHIS has amended the regulatory text to agree with the preamble, 
as the latter is more inclusive. We disagree that the requirement 
should be applied prospectively. Having two standards for the 
information that appears on labels would be confusing to the public and 
to the industry.

Miscellaneous Changes

    Three commenters asked that the implementation schedule be changed 
from 3 years to 5 years. One commenter stated that the proposed changes 
have in most cases been under discussion for more than a decade, which 
argues against the need for urgency in the implementation of the new 
requirements. This commenter stated further that APHIS underestimates 
the magnitude of the tasks required to implement the changes.
    APHIS notes that a recent final rule (80 FR 39669-39675, Docket No. 
APHIS-2011-0049), which amended the regulations to provide for the use 
of a

[[Page 59432]]

simpler labeling format, provided for a 4-year phase-in of the labeling 
and data summary requirements, with additional extensions of up to 2 
years allowed under certain conditions. In order to be consistent with 
that rule and to minimize sequential label changes, we will also adopt 
a 4-year phase-in of the packaging and labeling requirements in this 
rule, with additional extensions of up to 2 years allowed under certain 
conditions. As we explained in that final rule, we intend to implement 
that rule and this one concurrently, and we will coordinate 
implementation with industry.
    Section 103.3(d) currently requires that a request for 
authorization to ship an unlicensed biological product for experimental 
study include, among other things, two copies of labels or label 
sketches which show the name or identification of the product and bear 
the statement ``Notice! For experimental use only--Not For Sale'' or 
equivalent statement. However, most applicants submit these requests 
electronically, and those that still arrive on paper are scanned upon 
receipt. The requirement that two copies be submitted is no longer 
necessary, and we are amending this paragraph to require only one copy 
of the labels or label sketches.
    We are amending Sec.  112.5(a) to indicate that transmittal forms 
to be used with submissions of sketches and labels may be found on the 
APHIS Web page.
    We proposed to amend Sec.  112.7(j)(1) and (2) to require that all 
but very small final container labels for feline panleukopenia vaccines 
contain recommendations for use. Specifically, we would have required 
that these recommendations state that for healthy cats vaccinated at 
less than 12 weeks of age, a second dose of the vaccine should be given 
at 12 to 16 weeks of age. Since the proposed rule was published, 
however, research has shown that the booster for the feline 
panleukopenia vaccine should not be given earlier than 16 weeks. 
Therefore we are amending the requirements in new paragraphs (i)(1) and 
(2) to read ``. . . a second dose should be given no earlier than 16 
weeks of age.''
    We are amending Sec.  113.206(d)(2) to update a reference to 
labeling requirements that now appear in Sec.  112.7(h).

Issues Outside the Scope of the Rulemaking

    One commenter stated that the current ``true name'' system fails to 
uniquely and accurately identify products. The commenter stated that 
the system should be changed to correct this problem but did not 
specify how.
    We did not propose to make any changes to the true name system in 
this rulemaking. We are aware of issues associated with the current 
system and will consider addressing this issue in a future action.
    One commenter asked that APHIS remove the restriction upon the use 
of trade names for conditionally licensed products. Two commenters 
requested changes to Sec.  112.8(c), which sets out requirements for 
labels on shipping containers of products for export. These issues are 
outside the scope of this rulemaking.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This final 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 a final 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 on the Regulations.gov 
Web site (see footnote 1 in this document for a link to 
Regulations.gov) or by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    APHIS is amending the Virus-Serum-Toxin Act regulations regarding 
the packaging and labeling requirements for veterinary biologics 
products. Most of the changes are intended to increase the information 
readily available to consumers (such as veterinarians, livestock and 
dairy producers, pet stores, and animal health technicians). These 
changes are necessary to update and clarify labeling requirements for 
veterinary biologics licensees (manufacturers of veterinary biologics) 
and permittees (importers of veterinary biologics) to ensure that 
information provided in labeling is accurate with regard to the 
expected performance of the product.
    This action will affect all veterinary biologics product licensees 
and permittees. Currently, there are approximately 100 veterinary 
biological establishments, including permittees, and the majority of 
them are small entities. 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 from June 2012 through May 2013 by about two-thirds of the 
companies. The average number of labels submitted per company over that 
time frame was 46 and the median was 8.
    The veterinary biologics industry has grown substantially in the 
United States in recent years; the Census Bureau's Annual Survey of 
Manufacturers (ASM) reports that the annual shipment value of 
veterinary biological products increased by $2.06 billion (or 88 
percent) from $2.34 billion in 2006 to $4.40 billion in 2010 and have 
been stable at around $4.33 to $4.60 billion from 2010 to 2014. In 
2015, the United States exported about $1.2 billion and imported about 
$0.9 billion of veterinary biologic products, including exports and 
imports of veterinary medicaments which were packaged for retail sale.
    The action will benefit consumers of veterinary biologic products 
and, ultimately, the animals they treat with those products. This is 
because the action aims to ensure that consumers have complete and up-
to-date instructions for the proper use of those products, including 
vaccination schedules, warnings, and cautions.
    We anticipate that the costs associated with this rule will be one-
time costs to the industry that will overlap with the expected one-time 
costs of the single label claim rule (80 FR 39669-39675, Docket No. 
APHIS-2011-0049), which became effective on September 8, 2015. APHIS is 
allowing the manufacturers to delay implementing the single label claim 
rule until this rule becomes effective, so that the required label 
revisions by these two rules are being carried out concurrently. As 
addressed in the economic analysis of the single label claim rule, we 
expect the industry's one-time implementation costs associated with the 
labeling changes in these two rules will fall between about $1.1 
million and $4.1

[[Page 59433]]

million, with a median estimate of about $2.4 million. Labor costs to 
plan and implement the required changes (about one-third of the total) 
and material costs for labeling and packaging (about 40 percent of the 
total) are key cost components. Other costs are: Label designing (about 
20 percent of the total) and standardized summaries for efficacy and 
safety that are necessary for the single label claim rule (about 6 
percent of the total, based on the median cost estimate). We expect 
that the costs for the industry will not cause significant economic 
impacts for most veterinary biologics licensees and permittees, and the 
benefits of this rule justify the costs.

Executive Order 12372

    This program/activity is listed in the Catalog 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 2 CFR chapter IV.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. It is not intended to have retroactive effect. 
This rule will not preempt any State or local laws, regulations, or 
policies where they are necessary to address local disease conditions 
or eradication programs. However, where safety, efficacy, purity, and 
potency of biological products are concerned, it is the Agency's intent 
to occupy the field. This includes, but is not limited to, the 
regulation of labeling. Under the Act, Congress clearly intended that 
there be national uniformity in the regulation of these products. There 
are no administrative proceedings which must be exhausted prior to a 
judicial challenge to the regulations under this rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' Executive Order 13175 requires Federal agencies 
to consult and coordinate with tribes on a government-to-government 
basis on policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    The Animal and Plant Health Inspection Service has assessed the 
impact of this rule on Indian tribes and determined that this rule does 
not, to our knowledge, have tribal implications that require tribal 
consultation under Executive Order 13175.

Paperwork Reduction Act

    There are information collection activities in this rule. 
Therefore, in accordance with section 3507(d) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.), we published a notice 
\2\ in the Federal Register (80 FR 59725, Docket No. APHIS-2015-0066), 
announcing our intention to initiate this information collection to 
solicit comments. We are asking the Office of Management and Budget 
(OMB) to approve our use of this information collection for 3 years. 
When OMB notifies us of its decision, we will publish a document in the 
Federal Register providing notice of the assigned OMB control number.
---------------------------------------------------------------------------

    \2\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0066.
---------------------------------------------------------------------------

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2727.

List of Subjects

9 CFR Part 101

    Animal biologics.

9 CFR Parts 103 and 114

    Animal biologics, Reporting and recordkeeping requirements.

9 CFR Part 112

    Animal biologics, Exports, Imports, Labeling, Packaging and 
containers, Reporting and recordkeeping requirements.

9 CFR Part 113

    Animal biologics, Exports, Imports, Reporting and recordkeeping 
requirements.

    Accordingly, we are amending 9 CFR parts 101, 103, 112, 113, and 
114 as follows:

PART 101--DEFINITIONS

0
1. The authority citation for part 101 continues to read as follows:

    Authority:  21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

0
2. In Sec.  101.3, paragraph (q) is added to read as follows:


Sec.  101.3   Biological products and related terms.

* * * * *
    (q) Combination package. Biological product consisting of two or 
more licensed biological products. Each completed product in final 
container is packaged together and mixed prior to administration. A 
combination package is issued a separate U.S. Veterinary Biological 
Product License and assigned a product code number to distinguish it 
from its component products, which also may be marketed individually 
unless otherwise restricted.

PART 103--EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF 
BIOLOGICAL PRODUCTS PRIOR TO LICENSING

0
3. The authority citation for part 103 continues to read as follows:

    Authority:  21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

0
4. In Sec.  103.3, paragraph (d) is revised to read as follows:


Sec.  103.3  Shipment of experimental biological products.

* * * * *
    (d) A copy of the labels or label sketches which show the name or 
identification of the product and bear the statement ``Notice! For 
experimental use only-Not For Sale'' or equivalent. Such statement 
shall appear on final container labels, except that it may appear on 
the carton in the case of very small final container labels and 
labeling for diagnostic test kits. The U.S. Veterinary License legend 
shall not appear on such labels; and
* * * * *

PART 112--PACKAGING AND LABELING

0
5. 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.

0
6. Section 112.2 is amended as follows:
0
a. By revising paragraphs (a)(1), (a)(2), (a)(3), (a)(4), (a)(5), 
(a)(7), and (a)(10).
0
b. At the end of paragraphs (a)(6) and (a)(9)(iv), by removing the 
semicolon and adding a period in its place.

[[Page 59434]]

0
c. By revising paragraphs (d)(3), (e), and (f).
    The revisions read as follows:


Sec.  112.2  Final container label, carton label, and enclosure.

    (a) * * *
    (1) The complete true name of the biological product which name 
shall be identical with that shown in the product license under which 
such product is prepared or the permit under which it is imported, 
shall be prominently lettered and placed giving equal emphasis to each 
word composing it. Descriptive terms used in the true name on the 
product license or permit shall also appear. Abbreviations of the 
descriptive terms may be used on the final container label if complete 
descriptive terms appear on the carton label and enclosure. The 
following exceptions are applicable to small final containers, and 
containers of interchangeable reagents included in diagnostic test 
kits:
    (i) For small final containers, an abbreviated true name of the 
biological product, which shall be identical with that shown in the 
product license under which the product is prepared or the permit under 
which it is imported, may be used: Provided, That the complete true 
name of the product must appear on the carton label and enclosures;
    (ii) In addition to the true name of the kit, the functional and/or 
chemical name of the reagent must appear on labeling for small final 
containers of reagents included in diagnostic kits: Provided, That the 
true name is not required on labeling for small final containers of 
interchangeable (non-critical) components of diagnostic kits.
    (2) For biological product prepared in the United States or in a 
foreign country, the name and address of the producer (licensee, or 
subsidiary) or permittee and of the foreign producer, and an 
appropriate consumer contact telephone number: Provided, That in the 
case of a biological product exported from the United States in labeled 
final containers, a consumer contact telephone number is not required; 
however, small single dose containers marketed in the United States 
must include contact telephone information on carton and enclosures.
    (3) The United States Veterinary Biologics Establishment License 
Number (VLN) or the United States Veterinary Biological Product Permit 
Number (VPN), and the Product Code Number (PCN) assigned by the 
Department, which shall be shown only as ``VLN/PCN'' and ``VPN/PCN,'' 
respectively, except that:
    (i) Only the VLN or VPN is required on container labels of 
interchangeable (non-critical) components of diagnostic kits and 
container labels for individual products packaged together for co-
administration.
    (ii) The PCN may be used in lieu of the true name of the kit on 
small container labels for critical components of diagnostic kits.
    (iii) Container labels for individually licensed biological 
products, when marketed as components of combination packages, must 
include a statement referring the consumer to the carton or enclosure 
for the PCN of the combination package.
    (4) Storage temperature recommendation for the biological product 
stated as 2 to 8 [deg]C or 35 to 46 [deg]F, or both.
    (5) Full instructions for the proper use of the product, including 
indications for use, target species, minimum age of administration, 
route of administration, vaccination schedule, product license 
restriction(s) that bear on product use, warnings, cautions, and any 
other vital information for the product's use; except that in the case 
of limited space on final container labels, a statement as to where 
such information is to be found, such as ``See enclosure for complete 
directions,'' ``Full directions on carton,'' or comparable statement.
* * * * *
    (7) The following warning statements, or equivalent statements, 
shall appear on the labeling as applicable:
    (i) Products other than diagnostic kits: ``Do not mix with other 
products, except as specified on this label.''
    (ii) Injectable products and other products containing hazardous 
components: ``In case of human exposure, contact a physician.''
    (iii) Products containing viable organisms: ``Inactivate unused 
contents before disposal.''
* * * * *
    (10) In the case of a product that contains a preservative that is 
added during the production process and is not reduced to undetectable 
levels in the completed product through the production process, the 
statement ``Contains [name of preservative] as a preservative'' or an 
equivalent statement must appear on cartons and enclosures, if used. If 
cartons are not used, such information must appear on the final 
container label.
* * * * *
    (d) * * *
    (3) The statement ``For use in animals only'' may appear on the 
labeling as appropriate for a product to indicate that the product is 
recommended specifically for animals and not for humans.
    (e) When label requirements of a foreign country differ from the 
requirements as prescribed in this part, special labels may be approved 
by APHIS for use on biological products to be exported to such country 
upon receipt of written authorization, acceptable to APHIS, from 
regulatory officials of the importing country, provided that:
    (1) If the labeling contains claims or indications for use not 
supported by data on file with APHIS, the special labels for export 
shall not bear the VLN.
    (2) All other labels for export shall bear the VLN unless the 
importing country provides documentation that the VLN is specifically 
prohibited. When laws, regulations, or other requirements of foreign 
countries require exporters of biological products prepared in a 
licensed establishment to furnish official certification that such 
products have been prepared in accordance with the Virus-Serum-Toxin 
Act and regulations issued pursuant to the Act, such certification may 
be made by APHIS.
    (f) Multiple-dose final containers of liquid biological product and 
carton tray covers showing required labeling information are subject to 
the requirements in this paragraphs.
    (1) If a carton label or an enclosure is required to complete the 
labeling for a multiple-dose final container of liquid biological 
product, only one final container, with a container of diluent if 
applicable, shall be packaged in each carton: Provided, That if the 
multiple-dose final container is fully labeled without a carton label 
or enclosure, two or more final containers, and a corresponding number 
of diluent containers, may be packaged in a single carton which shall 
be considered a shipping box. Labels or stickers for shipping boxes 
shall not contain false or misleading information, but need not be 
submitted to APHIS for approval.
    (2) When required labeling information is shown on a carton tray 
cover, it must be printed on the outside face of such tray cover where 
it may be read without opening the carton. The inside face of the tray 
cover may contain information suitable for an enclosure.
* * * * *

0
7. In Sec.  112.3, paragraph (f)(2) is revised to read as follows:


Sec.  112.3   Diluent labels.

* * * * *
    (f) * * *
    (2) The biological product is composed of viable or dangerous

[[Page 59435]]

organisms or viruses, the notice, ``Inactivate unused contents before 
disposal.''
* * * * *

0
8. Section 112.5 is amended as follows:
0
a. In paragraph (a), by removing the words ``available on the Internet 
at (http://www.aphis.usda.gov/animalhealth/cvb/forms)'' and adding in 
their place the words ``available on the APHIS Web page at http://www.aphis.usda.gov/animalhealth/cvb/forms''.
0
b. By revising paragraphs (d)(2)(ii) and (d)(2)(v), and at the end of 
paragraph (d)(2)(vi), by removing the period and adding a semicolon in 
its place.
0
c. By adding paragraphs (d)(2)(vii) through (d)(2)(x).
0
d. By revising paragraphs (e)(1)(iii), (e)(1)(iv), (e)(4), and (f)(1).
0
e. By removing paragraph (f)(2) and redesignating paragraph (f)(3) as 
new paragraph (f)(2).
    The additions and revisions read as follows:


Sec.  112.5   Review and approval of labeling.

* * * * *
    (d) * * *
    (2) * * *
    (ii) Changes in the color of label print or background, provided 
that such changes do not affect the legibility of the label;
* * * * *
    (v) Adding, changing, deleting, or repositioning label control 
numbers, universal product codes, or other inventory control numbers;
* * * * *
    (vii) Changing the telephone contact number;
    (viii) Adding, changing, or deleting an email and/or Web site 
address;
    (ix) Changing the establishment license or permit number assigned 
by APHIS, and/or changing the name and/or address of the manufacturer 
or permittee, provided that such changes are identical to information 
on the current establishment license or permit; and
    (x) Adding or changing the name and/or address of a distributor.
    (e) * * *
    (1) * * *
    (iii) For finished labels, submit two copies of each finished final 
container label, carton label, and enclosure: Provided, That when an 
enclosure is to be used with more than one product, one extra copy 
shall be submitted for each additional product. One copy of each 
finished label will be retained by APHIS. One copy will be stamped and 
returned to the licensee or permittee. Labels to which exceptions are 
taken shall be marked as sketches and handled under paragraph (e)(1)(i) 
of this section.
    (iv) For finished master labels, submit for each product two copies 
each of the enclosure and the labels for the smallest size final 
container and carton. Labels for larger sizes of containers or cartons 
of the same product that are identical, except for physical dimensions, 
need not be submitted. Such labels become eligible for use concurrent 
with the approval of the appropriate finished master label, provided 
that the marketing of larger size final containers is approved in the 
filed Outline of Production, and the appropriate larger sizes of 
containers or cartons are identified on the label mounting sheet. When 
a master label enclosure is to be used with more than one product, one 
extra copy for each additional product shall be submitted. One copy of 
each finished master label will be retained by APHIS. One copy will be 
stamped and returned to the licensee or permittee. Master labels to 
which exception are taken will be marked as sketches and handled under 
paragraph (e)(1)(ii) of this section.
* * * * *
    (4) To appear on the bottom of each page in the lower left hand 
corner, if applicable:
    (i) The dose size(s) to which the master label applies.
    (ii) The APHIS assigned number for the label or sketch to be 
replaced.
    (iii) The APHIS assigned number for the label to be used as a 
reference for reviewing the submitted label.
    (f) * * *
    (1) An accurate English translation must accompany each foreign 
language label submitted for approval. A statement affirming the 
accuracy of the translation must also be included.
* * * * *

0
9. In Sec.  112.6, paragraph (a) is revised to read as follows:


Sec.  112.6  Packaging biological products.

    (a) Multiple-dose final containers of a biological product with 
final container labeling including all information required under the 
regulations may be packaged one or more per carton with a container(s) 
of the proper volume of diluent, if required, for that dose as 
specified in the filed Outline of Production: Provided, That cartons 
containing more than one final container of product must comply with 
the conditions set forth in paragraphs (c)(1) through (4) of this 
section. Multiple-dose final containers of a product that require a 
carton or enclosure in order to provide all information required under 
the regulations shall be packaged one container per carton with the 
proper volume of diluent, if required, for that dose as specified in 
the filed Outline of Production.
* * * * *

0
10. Section 112.7 is amended as follows:
0
a. By revising paragraphs (e), (f), (i), and (l).
0
b. By adding paragraph (n).
    The addition and revisions read as follows:


Sec.  112.7   Special additional requirements.

* * * * *
    (e) Labeling for all products for use in mammals must bear an 
appropriate statement concerning use in pregnant animals.
    (1) For bovine rhinotracheitis vaccine or bovine virus diarrhea 
vaccine containing modified live virus, all labeling except small final 
container labels shall bear the following statement: ``Do not use in 
pregnant cows or in calves nursing pregnant cows.'': Provided, That 
such vaccines which have been shown to be safe for use in pregnant cows 
may be excepted from this label requirement by the Administrator.
    (2) For other modified live and inactivated vaccine, labeling shall 
bear a statement appropriate to the level of safety that has been 
demonstrated in pregnant animals.
    (i) Products known to be unsafe in pregnant animals shall include 
statements such as ``Do not use in pregnant animals,'' or ``Unsafe for 
use in pregnant animals,'' or an equivalent statement acceptable to 
APHIS.
    (ii) Products without safety documentation acceptable to APHIS, but 
not known to be unsafe, labeling shall include the statement ``This 
product has not been tested in pregnant animals'' or an equivalent 
statement acceptable to APHIS.
    (3) For modified live vaccines containing agents with potential 
reproductive effects but having acceptable pregnant animal safety data 
on file with APHIS, labeling still must bear the following statement 
concerning residual risk: ``Fetal health risks associated with the 
vaccination of pregnant animals with this vaccine cannot be 
unequivocally determined during clinical trials conducted for 
licensure. Appropriate strategies to address the risks associated with 
vaccine use in pregnant animals should be discussed with a 
veterinarian.''
    (f) For biological products recommending annual booster

[[Page 59436]]

vaccinations, such recommendations must be supported by data acceptable 
to APHIS. In the absence of data that establish the need for booster 
vaccination, labeling must bear the following statement: ``The need for 
annual booster vaccinations has not been established for this product; 
consultation with a veterinarian is recommended.''
* * * * *
    (i) All but very small final container labels for feline 
panleukopenia vaccines shall contain the following recommendations for 
use:
    (1) Killed virus vaccines. Vaccinate healthy cats with one dose, 
except that if the animal is less than 12 weeks of age, a second dose 
should be given no earlier than 16 weeks of age.
    (2) Modified live virus vaccines. Vaccinate healthy cats with one 
dose, except that if the animal is less than 12 weeks of age, a second 
dose should be given no earlier than16 weeks of age.
* * * * *
    (l) All labels for autogenous biologics must specify the name of 
the microorganism(s) or antigen(s) that they contain, and shall bear 
the following statement: ``Potency and efficacy of autogenous biologics 
have not been established. This product is prepared for use only by or 
under the direction of a veterinarian or approved specialist.''
* * * * *
    (n) All labels for conditionally licensed products shall bear the 
following statement: ``This product license is conditional; efficacy 
and potency have not been fully demonstrated.''
* * * * *

PART 113--STANDARD REQUIREMENTS

0
11. The authority citation for part 113 continues to read as follows:

    Authority:  21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.


Sec.  113.206   [Amended]

0
12. In Sec.  113.206, paragraph (d)(2) is amended by removing the 
reference ``Sec.  112.7(i)'' and adding the reference ``Sec.  
112.7(h)'' in its place.

PART 114--PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS

0
13. The authority citation for part 114 continues to read as follows:

    Authority:  21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

0
14. Section 114.11 is revised to read as follows:


Sec.  114.11  Storage and handling.

    Biological products at licensed establishments must be protected at 
all times against improper storage and handling. Completed product must 
be kept under refrigeration at 35 to 46 [deg]F (2 to 8 [deg]C), unless 
the inherent nature of the product makes storage at different 
temperatures advisable, in which case, the proper storage temperature 
must be specified in the filed Outline of Production. All biological 
products to be shipped or delivered must be securely packed.

    Done in Washington, DC, this 24th day of August 2016.
Elvis S. Cordova,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2016-20749 Filed 8-29-16; 8:45 am]
 BILLING CODE 3410-34-P