[Federal Register Volume 61, Number 113 (Tuesday, June 11, 1996)]
[Rules and Regulations]
[Pages 29462-29465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14772]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

9 CFR Parts 101 and 112

[Docket No. 93-167-2]


Viruses, Serums, and Toxins and Analogous Products; Master Labels

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations regarding the packaging and 
labeling of veterinary biologicals to implement the use of a master 
label. The use of a master label system will reduce the number of 
copies of labels that are required to be submitted for review and 
approval, and allow labels with certain minor revisions to be used 
sooner than would be possible under the current regulations. A 
definition of ``master label'' is added to the regulations. In the 
final rule, the provision for the use of labels with certain minor 
changes prior to APHIS approval is extended to include previously 
approved lebels.
    The amendments are necessary in order to improve label approval 
procedures by establishing a master label system. The effect of the 
amendment will be to streamline the procedure for requesting and 
receiving approval to use new or revised labels for veterinary 
biologicals.

EFFECTIVE DATE: July 11, 1996.

FOR FURTHER INFORMATION CONTACT:
Dr. David A. Espeseth, Deputy Director, Veterinary Biologics, APHIS, 
BBEP, 4700 River Road, Unit 148, Riverdale, MD 20737-1237, (301) 734-
8245.


SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 112 pertain to the packaging and 
labeling of veterinary biologicals. The regulations require that all 
labels for veterinary biologicals be submitted and reviewed for 
compliance with the regulations and approved in writing prior to use. 
The Animal and Plant Health Inspection Service (APHIS) has issued 
licenses under the Virus-Serum-Toxin Act (21 U.S.C. 151-159) for some 
2300 veterinary biological products. Each licensed biological product 
is required to have approved packaging and labeling applicable to a 
variety of container sizes, trade names, producers, subsidiaries, and 
distributors.
    On March 17, 1995, we published in the Federal Register (60 FR 
14392-14395, Docket No. 93-167-1) a proposal to amend the regulations 
regarding the packaging and labeling of veterinary biologicals to 
implement the use of a master label system. The use of a master label 
system would reduce the number of copies of labels that are required to 
be submitted for review and approval, and would allow labels with 
certain minor revisions to be used sooner than would be possible under 
the current regulations. A definition of ``master label'' would be 
added to the regulations. The amendments are necessary in order to 
improve label approval procedures by establishing a master label 
system. The effect of the amendment would be to steamline the procedure 
for requesting and receiving approval to use new or revised labels for 
veterinary biologicals.
    We solicited comments concerning our proposal for 60 days ending 
May 16, 1995. We received six comments by that date. They were from 
producers of veterinary biologics. The comments are discussed below.

Analysis of Comments and APHIS' Response

    Two commenters supported the proposed rule without change. Four 
commenters commended the agency for its efforts to streamline and 
modernize the labeling regulations.
    Two commenters suggested that changes to the manufacturer's name 
and address should be considered minor label changes that would allow 
label use prior to its submission to and approval by APHIS. APHIS does 
not agree with this comment. A change to the name and address of the 
manufacturer is deemed a major label change. Every applicant for a 
veterinary biologics establishment license must file an APHIS Form 
2001, Application for United States Veterinary Biologics Establishment 
License. The information required by this form includes the name and 
address of the applicant, all subsidiaries and divisions, and locations 
of all premises to be used for preparation, testing, and initial 
shipping. This information is included in the establishment license 
when issued. A change to the name and address of the manufacturer 
requires a new APHIS Form 2001 to be filed (9

[[Page 29463]]

CFR 102.3(a)(6)) to effect a change in the establishment license before 
such label changes would be approved.
    Also, the name and address of the manufacturer provides consumers 
with one of the necessary items of identification of a product if they 
wish to file a consumer complaint about a particular product. APHIS has 
issued veterinary biologics establishment licenses to 114 manufacturers 
for some 2300 veterinary biological products, including bacterins, 
vaccines, and diagnostic test kits. Consumers report complaints of 
veterinary biological products to the licensee, Veterinary Biologics 
Field Operations, other units within APHIS, and to the U.S. 
Practitioners Reporting System of the American Veterinary Medical 
Association. The minimum amount of information that these entities need 
to initiate an investigation of these complaints is the name and 
address of the manufacturer and the name of the product. For the 
reasons states above, this information must first be submitted to APHIS 
before such information appears on the label.
    APHIS is aware that mergers and acquisitions often result in the 
need to submit hundreds of new labels to change the manufacturer's name 
and address. This final rule will reduce the number of new labels that 
will need to be submitted in such cases, but will not permit the use of 
such labels until they have been reviewed and filed by APHIS. APHIS is 
aware of the inconvenience that this may cause, but believes that this 
is a necessary requirement. No change to the regulations is made in 
response to this comment.
    The same commenter also requested that changes to the distributor's 
name, address, and phone number be included under minor label changes. 
APHIS does not agree. Products sold through a distributor are often 
traced under the distributor's name, address, and phone number. Thus, 
APHIS should be aware of and have on file the most current name, 
address, and phone number of distributors of biological products and 
not have to wait 60 days for the submission of this information. No 
change is made in response to this comment.
    In addition, the commenter requested that label changes to type 
font, font size (so long as the size change does not cause any element 
to overshadow the true name), and trade name be included among minor 
label changes. Again, APHIS does not agree. Changes to the type font 
often lead to a difference in interpretation of the meaning of 
``prominence'' in that no element on a label may be more ``prominent'' 
than the true name. Trade names often allow consumers to recognize a 
specific product. Trade names also may suggest special qualities or 
ingredients about products which may render the product label false or 
misleading. Thus, APHIS feels that a pre-review of trade names will 
assure that labels are not false and misleading. Consumer contacts or 
reports about biological products are often based on a product's trade 
name. APHIS is informed of new trade names through the label approval 
process. If new trade names are used on product labels before approval, 
APHIS may not be able to identify the product if the product becomes 
involved in a complaint. No change to the regulations is made in 
response to this comment.
    One commenter remarked that the master label concept will lead to 
the submission of master labels for all labels in order to take 
advantage of the provision allowing label use prior to APHIS approval. 
The commenter concluded that this would lead to more paperwork 
submission for the firm. This is not the intent of the rule. The 
proposed rule may have been drawn too narrowly in its focus on master 
labels and the use of certain labels prior to approval by APHIS. There 
is no good reason why the provision allowing the use of certain labels 
prior to APHIS approval should be restricted to labels filed as master 
labels. In response to the commenter, we are amending the proposal so 
that it will apply to either ``approved labels or master labels.'' The 
introductory paragraph in Sec. 112.5 is also amended to be consistent 
with this change. This amendment will make unnecessary the resubmission 
of currently approved labels for reapproval as master labels to take 
advantage of the provision of allowing use prior to approval, will 
avoid the additional paperwork that could result, and is consistent 
with our original intent.
    One commenter requested that the rule continue to specify that ``at 
least'' a certain number of copies of labels be submitted for approval 
since manufacturers sometimes need additional approved copies of labels 
when machine copies are not acceptable. In response to this comment, 
the proposed rule merely specifies the minimum number of copies that 
need to be submitted to APHIS for review and approval. APHIS will 
process additional copies if requested by a manufacturer. No change to 
the regulations is made in response to this comment.
    Finally, one commenter believed that there was a discrepancy 
between the proposed rule and Veterinary Services Memorandum 800.54, 
dated August 31, 1988, concerning small labels. APHIS does not agree. 
APHIS' intent in this rule is to have the master label be based on the 
smallest size label that is identical in text to that of all other size 
labels. In the case of labels that are too small for full instructions 
for use, these exceptionally small labels may differ in text from the 
labels referred to under the rule and would not qualify as master 
labels. Such labels would be required to be submitted separately for 
review. No change to the regulations is made in response to this 
comment.
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposal as 
a final rule, with the changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been determined to be not significant for purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    Pursuant to requirements set forth in the Regulatory Flexibility 
Act (5 U.S.C. 601 et seq.), APHIS has considered the economic impact on 
small entities.
    The rule amends the regulations for the review and approval of 
veterinary biological product labels by providing for a master label 
system. The current regulations in part 112 require the submission and 
approval of all labels for each biological product to be marketed. The 
approval of the smallest size container label for the product as a 
prototype master label would reduce the need for licensees producing 
veterinary biologicals to submit for approval additional copies of 
labels for each size of the product.
    The approval of a master label eliminates the need to submit labels 
for larger container sizes of the same product, provided that such 
labels are identical to the master label, except for physical 
dimensions, and provided that additional container sizes are authorized 
in a filed Outline of Production.
    This rule also allows certain specified minor revisions to be made 
in labels for products with approved labels or master labels and the 
revised labels used without prior written approval from APHIS with the 
provision that new labels or master labels be submitted to APHIS for 
review and approval within 60 days use of the revised label.
    One effect of the rule will be to reduce the number of copies of 
labels that need to be submitted and reviewed. Most biological products 
are marketed in two or three different size containers. Currently, each 
label for each container

[[Page 29464]]

must be submitted for approval. Under the master label system, only 
labels for the smallest size container need to be submitted, thus 
reducing by two to three-fold the number of labels that need to be 
submitted by manufacturers for review by APHIS. Another effect will be 
to eliminate the delay required in obtaining APHIS approval prior to 
the use of labels with certain specified minor changes.
    The rule will not have any adverse economic impact since the 
submission of product labels for approval is already required under 
Sec. 112.5 of the regulations. Section 112.5 currently specifies that 
all labels shall be reviewed and approved prior to use. The amendments 
will simplify the process of label approvals and reduce the time and 
expense needed to get a product to market, particularly in the case of 
certain minor revisions of labels.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12778

    This final rule has been reviewed under Executive Order 12778, 
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. There are no administrative procedures which must be exhausted 
prior to a judicial challenge to the provisions of this rule.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB), and there are no new requirements. The assigned OMB 
control number is 0579-0013.

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 7 CFR part 3015, subpart V.)

List of Subjects

9 CFR Part 101

    Animal biologics.

9 CFR Part 112

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

    Accordingly, 9 CFR parts 101 and 112 are amended as follows:

PART 101--DEFINITIONS

    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 371.2(d).

    2. Section 101.4 is amended by adding a new paragraph (h) to read 
as follows:


Sec. 101.4  Labeling terminology.

* * * * *
    (h) Master label. The finished carton, container, or enclosure 
label for the smallest size final container that is authorized for a 
biological product, that serves as the Master template label applicable 
to all other size containers or cartons of the same product that is 
marketed by a licensee, subsidiary, division, or distributor.

PART 112--PACKING AND LABELING

    3. 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 371.2(d).

    4. Section 112.5 is amended as follows:
    a. The introductory text is revised to read as set forth below.
    b. Paragraph (c) is revised to read as set forth below.
    c. Paragraphs (d)(1) is revised.
    d. Paragraph (d)(2)(iii)(a) is revised to read as set forth below.
    e. Paragraph (d)(3)(ii)(a) is revised to read as set forth below.
    f. In Sec. 112.5, paragraph (d)(2)(iii)(b) is redesignated 
paragraph (d)(2)(iii)(B), paragraph (d)(3)(i)(a) is redesignated 
paragraph (d)(3)(i)(A), paragraph (d)(3)(i)(b) is redesignated 
paragraph (d)(3)(i)(B), and paragraph (d)(3)(ii) is revised to read as 
set forth below.
    g. Paragraph (d)(3)(iii) is revised to read as set forth below.
    h. Paragraph (d)(4) is revised to read as set forth below.
    i. Paragraph (g) is added to read as set forth below.
    j. Section 112.5 is amended by adding at the end of the section an 
OMB control number as set forth below.


Sec. 112.5  Review and approval of labeling.

    Labels used with biological products prepared at licensed 
establishments or imported for general distribution and sale must be 
submitted to the Animal and Plant Health Inspection Service for review 
for compliance with the regulations and approval in writing prior to 
use, except as provided in paragraph (c) of this section and under the 
master label system provided in paragraph (d) of this section.
* * * * *
    (c) (1) Labels must be submitted to the Animal and Plant Health 
Inspection Service for review and written approval. Only labels which 
are approved as provided in Sec. 112.5(d) may be used. When changes are 
made in approved labels, the new labels shall be subject to review and 
approval before use: Provided, That certain minor changes may be made 
in labels for products with approved labels or master labels, and the 
revised labels may be used prior to review by APHIS, with the provision 
that a new label or master label bearing these changes is submitted to 
APHIS for review and written approval within 60 days of label use, and 
that such minor changes do not render the product mislabeled or the 
label false and misleading in any particular.
    (2) Minor label changes that may be made under the provision for 
products with approved labels or master labels are:
    (i) Changes in the physical dimensions of the label provided that 
such change does not affect the legibility of the label;
    (ii) Change in the color of label print, provided that such change 
does not affect the legibility of the label;
    (iii) The addition or deletion of a Trade Mark (TM) or Registered 
(R) symbol;
    (iv) The correction of typographical errors;
    (v) Adding or changing control numbers of bar codes; and
    (vi) Revising or updating logos.
* * * * *
    (d) (1) * * *
    (i) For label sketches, submit two copies of each sketch of a final 
container label, carton label, and enclosure. Sketches must be legible, 
and must include all information specified in Sec. 112.2. One copy of 
each sketch will be returned with applicable comments, and one copy 
will be held on file by APHIS for no more than one year after 
processing, until replaced by a finished label: Provided, That sketches 
submitted in support of an application for a license or permit shall be 
held as long as the application is considered active.
    (ii) For master label sketches, submit for each product two copies 
of each sketch of an enclosure, label for the smallest size final 
container, and carton label; Provided, That labels for larger

[[Page 29465]]

size containers and/or cartons that are identical, except for physical 
dimensions, need not be submitted. One copy of each master label sketch 
will be returned with applicable comments, and one copy will be held on 
file by APHIS for one year after processing, until replaced by a 
finished master label that is submitted according to 
Sec. 112.5(d)(1)(iii): Provided, That master label sketches submitted 
in support of an application for license or permit shall be held as 
long as the application is considered active.
    (iii) For finished labels, submit three 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. Two copies of each 
finished label will be retained by APHIS. One copy will be stamped and 
returned to the licensee. Labels to which exceptions are taken shall be 
marked as sketches and handled under Sec. 112.5(d)(1)(i).
    (iv) For finished master labels, submit for each product three 
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 sizes of 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. Two copies 
of each finished master label will be retained by APHIS. One copy will 
be stamped and returned to the licensee. Master labels to which 
exceptions are taken will be marked as sketches and handled under 
Sec. 112.5(d)(1)(ii).
* * * * *
    (2) * * *
    (iii)(A) When two final containers are packaged together in a 
combination package, the labels for each shall be mounted on the same 
sheet of paper and shall be treated as one label. For diagnostic test 
kits, the labels for use on the individual reagent containers to be 
included in the kit shall be mounted together on a single sheet of 
paper, if possible; if necessary, a second sheet of paper may be used. 
The carton label and enclosure shall be mounted on separate individual 
sheets.
* * * * *
    (3) * * *
    (ii)(A) Designation of the specimen as a label or master label: 
sketch, final container label, carton label, or enclosure.
    (B) If two final container labels or multiple parts are on one 
sheet, each shall be named, and the label or part being revised shall 
be designated.
    (iii) Size of package (dose, ml., cc., or units) for which the 
labels or enclosures are to be used.
    (4) To appear on the bottom of each page: The reason for and 
information relevant to the submission shall be stated in the lower 
left hand corner as:
    (i) Master label dose sizes approved for code ____________.
    (ii) Replacement for label, master label, and/or sketch No. 
____________.
    (iii) Reference to label or master label No. ____________.
    (iv) Addition to label No. ____________.
    (v) License Application Pending ____________.
    (vi) Foreign Language copy of Label No. ____________.
* * * * *
    (g) At the time of an inspection, or when requested by APHIS, 
licensees or permittees shall make all labels and master labels, 
including labels approved for use but exempted from filing under the 
master label system, available for review by authorized inspectors. 
Such labels shall be identical to the approved label or master label 
except for physical dimensions, reference to recoverable volume or 
doses and/or certain minor differences permitted in accordance with 
Sec. 112.5(c).

(Approved by the Office of Management and Budget under control 
number 0579-0013)

    5. In Sec. 112.7, paragraphs (c)(2) and (d)(6) are revised to read 
as follows:


Sec. 112.7  Special additional requirements.

* * * * *
    (c) * * *
    (2) Subsequent revaccination as determined from the results of 
duration of immunity studies conducted as prescribed in Sec. 113.209, 
paragraph (b) or (c), or both.
* * * * *
    (d) * * *
    (6) Subsequent revaccination as determined from the results of 
duration of immunity studies conducted as prescribed in Sec. 113.312, 
paragraph (b) or (c), or both.
* * * * *


Sec. 112.7  [Amended]

    6. Section 112.7 is amended by adding at the end of the section the 
following: ``(Approved by the Office of Management and Budget under 
control number 0579-0013).''

    Done in Washington, DC, this 5th day of June 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-14772 Filed 6-10-96; 8:45 am]
BILLING CODE 3410-34-M