[Federal Register Volume 60, Number 52 (Friday, March 17, 1995)]
[Proposed Rules]
[Pages 14392-14395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6650]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 /
Proposed Rules
[[Page 14392]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 101 and 112
[Docket No. 93-167-1]
Viruses, Serums, and Toxins and Analogous Products; Master Labels
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations regarding the
packaging and labeling of veterinary biologicals to require the use of
a master label. 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 allow labels with certain minor revisions to be used
sooner than would be possible without the use of a master label. A
definition of ``master label'' would be added to the regulations. The
proposed amendments are necessary in order to improve label approval
procedures by establishing a master label system. The effect of the
proposed amendment would be to streamline the procedure for requesting
and receiving approval to use new or revised labels for veterinary
biologicals.
DATES: Consideration will be given only to comments received on or
before May 16, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 93-167-1, Animal and Plant Health Inspection Service, Policy
and Program Development, Regulatory Analysis and Development, 4700
River Road Unit 118, Riverdale, MD 20737-1228. Please state that your
comments refer to Docket No. 93-167-1. Comments received may be
inspected at USDA, room 1141, South Building, 14th Street and
Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m.,
Monday through Friday, except holidays. Persons wishing to inspect
comments are requested to call ahead (202) 690-2817) to facilitate
entry into the comment reading room.
FOR FURTHER INFORMATION CONTACT:
Dr. David A. Espeseth, Deputy Director, Animal and Plant Health
Inspection Service, Biotechnology, Biologics, and Environmental
Protection, Veterinary Biologics, 4700 River Road Unit 148, Riverdale,
MD 20737-1228, telephone number (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The regulations pertaining to the packaging and labeling of
veterinary biologicals are in 9 CFR part 112. 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. APHIS has issued licenses under the Virus-Serum-Toxin Act (21
U.S.C. 151-159) for some 2000 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.
Current regulations require each product label to be reviewed and
approved individually prior to use. Several nearly identical labels for
one product are often required to be reviewed and approved by APHIS. A
minor revision in the labeling of a product can result in the
additional review and approval of all revised labels for that product.
Due to the large number of label submissions and the requirement
for label review prior to the marketing of a biological product, an
inordinate amount of program time and resources may be expended in the
review and approval of label submissions. Many label submissions
constitute only minor revisions.
An analysis of the time and resources currently required to review,
file, and store label submissions involving minor revisions, and the
accompanying delay experienced by some manufacturers in receiving
approval and written notification suggest that the process by which
labels are approved may be simplified. We propose to institute the use
of a master label system that would reduce redundant review and
approval of submissions involving only minor revisions of approved
labels. Under the proposed master label system, only the container and
carton label for the smallest size final container that is approved by
APHIS and any insert for the product would be required to be submitted
for review, approval, and filing as master labels. Certain specified
revisions could be made on labels under the Master Label system without
prior written approval, provided that such revisions are submitted to
APHIS for review, approval, and filing within 60 days of use of the
revised label.
We are proposing to amend the definition in Sec. 101.4 by adding a
new paragraph (h) as follows:
(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.
We are also proposing to revise several paragraphs of the
regulations in Sec. 112.5 pertaining to the review and approval of
labels to add specific provisions related to the use of master labels
(see introductory paragraph, paragraphs (d)(1)(ii), (d)(1)(iv),
(d)(3)(ii)(a), (d)(4), and (g)).
Certain revised labels could be used on products with approved
master labels prior to review and approval by APHIS as provided under
proposed paragraph (c) of Sec. 112.5.
Two copies of master label sketches would be submitted for each
enclosure and the labels for the smallest approved size of carton and
container. A master label sketch would be held on file for one year, or
as long as a license application was active.
For finished master labels, three copies of each enclosure and of
each label for the smallest size carton and final container would be
submitted. Labels for larger size containers or cartons of the same
product would not be submitted, provided that the larger size container
or carton is approved in the Outline of Production and the larger size
container or carton is identified on the label mounting sheet. When the
master label enclosure is used with more than one product, an extra
copy of the enclosure for each additional product would have to be
submitted. Finally, the information that must be submitted on the lower
left hand corner of each page of the label submission
[[Page 14393]] would include the reason for the submission, a reference
to the master label, its replacement, and the dose sizes for which the
master label is to be used.
We are proposing to add a provision in Sec. 112.5(c) to allow for
specified minor label changes without prior approval by APHIS for
products with approved master labels. Minor label changes that would be
allowed include changes in physical dimensions of the label or the
color of the label print that do not affect legibility; the addition,
deletion, or change of a trademark or registered symbol, label control
number or bar code, or logo; and the correction of typographical
errors. Such minor changes would, of course, not be appropriate if they
cause the label to be false or misleading. In addition, there would be
a requirement that a new master label bearing such minor changes be
submitted to APHIS for review and written approval within 60 days of
label use.
We are also proposing to revise Sec. 112.5(d)(2)(iii)(a) to add a
provision for the labeling of individual reagent containers included
with diagnostic test kits. Such labeling of individual reagent
containers would be mounted together on a single sheet of paper, when
possible. Carton labels and enclosures would be mounted on separate
individual sheets.
Finally, we are proposing to add a provision in Sec. 112.5(g) that
provides for inspection of labels and master labels by authorized
inspectors.
We would also correct the references in Sec. 112.7, paragraph
(c)(2), by changing ``Sec. 113.129'' to read ``Sec. 113.209'' and in
paragraph (d)(6) by changing ``Sec. 113.147'' to read ``Sec. 113.312''.
In addition, in Sec. 112.5(d), paragraph (2)(iii)(b) would be
redesignated paragraph (2)(iii)(B), paragraph (3)(i)(a) would be
redesignated paragraph (3)(i)(A), paragraph (3)(i)(b) would be
redesignated paragraph (3)(i)(B), and paragraph (3)(ii)(b) would be
redesignated paragraph (3)(ii)(B).
This proposed amendment was developed through the cooperative
efforts of the manufacturers of veterinary biologicals, the Animal
Health Institute, and APHIS. The overall effect of this regulation
would be to simplify the process whereby labels are approved by
reducing the number of copies of labels needed to be submitted for
review.
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.
The proposed rule would amend the regulations for the review and
approval of 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 a prototype master label for each product would reduce the
need for licensees producing veterinary biologicals to submit for
approval additional copies of labels for each product.
The approval of a master label would apply to labels for larger
containers sizes of the same product, provided that the 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 proposed rule would also allow certain approved labels with
specified minor revisions to be used without prior written approval
with the provision that new master labels be submitted to APHIS for
review and approval within 60 days use of the revised label.
The proposed rule has its major effect in reducing the number of
copies of labels that need to be submitted and reviewed. Most products
are marketed in two or three different size containers. Currently, each
label for each container must be submitted for approval. Under the
proposed master label concept, only labels for the smallest size
container would need to be submitted, thus reducing by two to three
fold the number of labels that would need to be submitted by
manufacturers and processed by APHIS.
The proposed rule would not have any adverse economic impact, since
the submission of product labels for approval is already required under
Sec. 112.5 of the regulations, which currently specifies that all
labels shall be reviewed and approved prior to use. The proposed
amendments would simplify the process of label approvals and would
reduce the time and expense necessary to get a product to market 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 would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
The proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1980
(44 U.S.C. 3501 et seq.).
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 would be amended as follows:
PART 101--DEFINITIONS
1. The authority citation for part 101 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
2. Section 101.4 would be 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--PACKAGING AND LABELING
3. The authority citation for part 112 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).
4. Section 112.5 would be amended as follows:
a. The introductory paragraph would be revised to read as set forth
below.
b. Paragraph (c) would be revised to read as set forth
below. [[Page 14394]]
c. Paragraphs (d)(1)(i) and (d)(1)(ii) would be revised to read as
set forth below.
d. Paragraphs (d)(1)(iii) and (d)(1)(iv) would be added to read as
set forth below.
e. Paragraph (d)(2)(iii)(a) would be revised to read as set forth
below.
f. Paragraph (d)(3)(ii)(a) would be revised to read as set forth
below.
g. Paragraph (d)(4) would be revised to read as set forth below.
h. Paragraph (g) would be added to read as set forth below.
i. In Sec. 112.5, paragraph (d)(2)(iii)(b) would be redesignated
paragraph (d)(2)(iii)(B), paragraph (d)(3)(i)(a) would be redesignated
paragraph (d)(3)(i)(A), paragraph (d)(3)(i)(b) would be redesignated
paragraph (d)(3)(i)(B), and paragraph (d)(3)(ii)(b) would be
redesignated paragraph (d)(3)(ii)(B).
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 under the master label system as provided in paragraph (c)
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 master labels, and the
revised labels, may be used prior to review by APHIS, with the
provision that a new 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 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 label control numbers or 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 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 of 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). [[Page 14395]]
5. In Sec. 112.7, paragraphs (c)(2) and (d)(6) would be revised 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,
paragraphs (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,
paragraphs (b) or (c), or both.
* * * * *
Done in Washington, DC, this 13 day of March 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-6650 Filed 3-16-95; 8:45 am]
BILLING CODE 3410-34-M
