[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
