[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