[Federal Register Volume 64, Number 52 (Thursday, March 18, 1999)]
[Proposed Rules]
[Pages 13365-13368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6593]
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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. 64, No. 52 / Thursday, March 18, 1999 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 112
[Docket No. 96-034-1]
Viruses, Serums, Toxins, and Analogous Products; Packaging and
Labeling
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations concerning packaging
and labeling of veterinary biological products by requiring the Animal
and Plant Health Inspection Service product code number as well as an
appropriate consumer contact telephone number to appear on labeling.
The amendments would also clarify label requirements with respect to
overshadowing the true name of the product and requirements for
products shipped to a foreign country. In addition, this proposal
contains label requirements concerning minimum age for product
administration and the potential for maternal antibody interference.
The effect of the proposed rule would be to update the regulations by
providing additional information to users of veterinary biologics and
to make regulatory labeling provisions more consistent with current
practices.
DATES: Consideration will be given only to comments received on or
before May 17, 1999.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 96-034-1, Regulatory Analysis and Development, PPD, APHIS,
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 96-034-1. 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, Special
Assistant to the Deputy Administrator, VS, APHIS, 4700 River Road Unit
148, Riverdale, MD 20737-1231, (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 112 set forth packaging and labeling
requirements for veterinary biological products. To make the
regulations more consistent with current practices and provide for more
completeness and uniformity in label instructions, we are proposing to
require the Animal and Plant Health Inspection Service (APHIS) product
code number and a consumer contact telephone number to appear on
labeling, clarify label requirements with respect to overshadowing of
the true name of the product, clarify label requirements for product
shipped to a foreign country, and provide requirements for addressing
minimum age for product administration and the potential for maternal
antibody interference with vaccination.
Product Code Number and Consumer Contact Telephone Number
Section 112.2 includes requirements relating to product
identification. According to this section, labeling must include the
true name of the product, the producer's name and address (and the name
and address of the permittee in the case of an imported product), the
license or permit number associated with the domestic producer or
permittee, and a serial number. Although this information is normally
sufficient to uniquely identify a particular serial of a particular
product, in some instances it may not be. Because two or more products
of the same manufacturer may have the same true name, and the same
serial number may be applied to a serial of each of these products, the
current label regulations allow for serials of different products, and
the products themselves, to be undifferentiable.
Administratively, APHIS uniquely identifies a product serial by
serial number, license (or permit) number, and product code number
(PCN). The PCN is a number APHIS assigns a product when a license
application for the product is received and sufficient information on
the product is provided. The PCN is unique for the product and its
manufacturer--a given manufacturer has no more than one product with a
particular PCN. The combination of PCN, license or permit number, and
serial number provides a unique identification for any serial of any
product. Accurate serial identification is essential to the proper
reporting and handling of adverse events with veterinary biologicals.
To ensure accurate serial identification, we propose to amend the
regulations in Sec. 112.2(a) to require that all labeling, except final
container labels for diagnostic test kits, bear the PCN that APHIS
assigned to the product. An exception is made for container labels for
diagnostic kits because they are associated with components that often
are common to several kits of the manufacturer and that are very
unlikely to become separated from the kit as packaged (the carton label
as well as the enclosure, if one is used, must carry the PCN).
Further on the subject of adverse events, APHIS believes it would
be in the best interest of consumers and industry if the reporting of
adverse events could be facilitated. To this end, we propose to amend
Sec. 112.2(a)(2) by requiring that an appropriate consumer contact
telephone number appear on all labeling.
Overshadowing of the True Name
Section 112.2(c) currently states that veterinary biological
product labels ``shall not include any statement, design, or device,
which overshadows the true name of the product * * *'' In approving
labels, APHIS requires that the true name be presented prominently and
in a manner that renders it no less conspicuous than any trade name
that may be used. Since questions have occasionally arisen concerning
the interpretation of Sec. 112.2(c), we propose to amend the section by
requiring that labels bear the true name of the product in a prominent
fashion and not bear any trade name more prominently than the true
name.
Product Shipped to a Foreign Country
The first sentence of Sec. 112.2(e) provides that labels which do
not conform to part 112 requirements may
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be approved for use with product shipped to a foreign country only if
the label requirements of the foreign country conflict with those of
this country. In APHIS' view, it does not appear that this limitation
is necessary to properly regulate biological products. Therefore, we
propose to amend Sec. 112.2(e) by specifying that labels which do not
conform to all part 112 requirements may be used with exported product
as long as they are acceptable to the appropriate regulatory officials
of the foreign country and do not contain false or misleading
information. In addition, we propose to amend Sec. 112.2(e) by
specifying how the licensee or permittee should make APHIS aware that
foreign regulatory acceptance of a nonconforming label has been
received, namely, through the submission of a label mounting prepared
as described in Sec. 112.5(d)(2) and bearing a stamp or other mark of
approval of the appropriate foreign regulatory agency.
Minimum Age and Maternal Antibody Interference
Section 112.2(a)(5) states that full instructions for the proper
use of a product must appear on product labeling. APHIS believes that
for all relevant product types, these instructions should include
directions relating to the minimum age for product administration that
are consistent with the efficacy and safety data developed for the
product and that take into account the potential for maternal antibody
interference with product efficacy. Currently, except for specific
label regulations for rabies vaccines and feline panleukopenia
vaccines, the label regulations provide no directive on how to address
minimum age for administration. This has resulted in significant
inconsistency in label recommendations, with the potential for product
misuse. We propose to amend Sec. 112.7(i) by replacing the current
special label requirements, which cover only feline panleukopenia
vaccines, with general label requirements regarding the minimum age for
product administration as well as the potential for maternal antibody
interference with vaccination. We propose to indicate that unless
otherwise provided in the regulations or in a filed Outline of
Production for the product, labels for vaccines, bacterins, bacterial
extracts, toxoids, and combinations thereof, as well as
immunomodulators, must specify a minimum age for product administration
consistent with the efficacy and safety data developed for the product.
Labels for products for the vaccination of dams to protect progeny need
not specify a minimum age if it is clear from other label
recommendations that animals are to be of breeding age when vaccinated.
Furthermore, we propose that if a vaccine, bacterin, bacterial extract,
toxoid, or combination thereof is recommended for use in animals of an
age when maternal antibodies would be expected to cause interference
[defined by proposed Sec. 112.7(i) as less than 12 weeks of age in the
case of canine and feline products (17 weeks in the case of canine
parvovirus vaccines), 3 months of age in the case of products for other
mammalian species, or 3 weeks of age in the case of products for avian
species (except Marek's disease vaccines)], labels must recommend
revaccination at appropriate intervals through the applicable age. If
two doses of product are required for primary immunization, labels must
indicate that two doses are to be given after the applicable age. The
above revaccination recommendation will not be required for labels for
products intended for the prevention or alleviation of diseases that
are considered afflictions of only very young animals, for products
where maternal antibodies do not interfere with efficacy, or for
products where traditional U.S. animal industry practice is clearly
inconsistent with such a recommendation. Such products include, but are
not limited to, those for rotaviral and coronaviral enteritis,
mammalian colibacillosis, and atrophic rhinitis in swine.
We believe our proposed rule will provide the consumer with more
uniform and complete label instructions for product use without being
overly burdensome to the veterinary biologics industry.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The 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 Regulatory Flexibility Act requires that agencies consider the
economic impact of rule changes on small businesses and governmental
jurisdictions. The proposed rule changes would primarily affect
manufacturers of veterinary biological products. At this time, there
are no more than about 100 such manufacturers in the U.S. The number of
those manufacturers that are considered small entities under the
standards of the Small Business Administration (SBA) is unknown, since
information as to their size (in terms of number of employees) is not
available. However, based on composite data for manufacturers of the
same and similar products in the U.S., it is reasonable to assume that
most would be categorized as small entities. In 1993, only 25 percent
of all 652 firms in standard industrial classification (SIC) category
2834 (SIC 2834; ``Pharmaceutical Preparations,'' which includes
manufacturers of preparations for veterinary use) had 100 or more
employees. Similarly, only 25 percent of all 205 firms in SIC 2836
(``Biological Products, Except Diagnostic Substances,'' which includes
manufacturers of products for veterinary use) had 100 or more employees
in 1993. According to SBA criteria, a business in SIC 2836 is
considered a small entity if it has 500 or fewer employees, and a
business in SIC 2834 is considered a small entity if it has 750 or
fewer employees. It is very likely, therefore, that the potential
impact of the proposed rule would fall primarily on small entities.
The proposal which would require the APHIS product code number and
an appropriate consumer contact telephone number to appear on labels
should result in easier and more accurate reporting of adverse events.
This should be viewed positively by consumers and the veterinary
biologics industry.
The proposal regarding labels for product shipped to a foreign
country and overshadowing of the true name would amend the regulations
by providing for the use of nonconforming labels with product shipped
to a foreign country even if the label requirements of the foreign
country do not conflict with ours and by specifying that the true name
be prominent and that any trade name that may be used not appear more
prominent than the true name. Since the proposed requirements would be
less restrictive than the requirements currently in place, the economic
impact of the proposal on veterinary biologics manufacturers should be
positive.
The proposal regarding the requirement that a minimum age be
specified for product administration should provide consumers with more
uniform and precise information concerning use of these products to
ensure safety and efficacy. Furthermore, the Agency does not intend to
require that, for currently licensed mammalian products other than
swine products, the minimum recommended age for administration be
supported by efficacy and safety data from controlled laboratory
studies or formal field trials as long as the age recommended is not
less than 9 weeks for canine and feline products or 3 months for
products for
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other species (data to support the recommended minimum age for
vaccination have been required for avian and swine products for many
years). With this allowance, we believe the impact of the proposed rule
on veterinary biologics manufacturers involved should be negligible.
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 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.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
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. The Act does not provide administrative procedures which must be
exhausted prior to a judicial challenge to the provisions of this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. 96-034-1.
Please send a copy of your comments to: (1) Docket No. 96-034-1,
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River
Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,
OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW.,
Washington, DC 20250. A comment to OMB is best assured of having its
full effect if OMB receives it within 30 days of publication of this
proposed rule.
If these proposed amendments to the regulations are adopted,
manufacturers of veterinary biological products currently licensed
would need to revise labels not in conformance and, in accordance with
9 CFR 112.5, submit the revised labels to APHIS for review and
approval. Labels must be submitted with a transmittal form (APHIS Form
2015 or similar; one form for all labels submitted on the same date for
the same product). Adopting the proposed amendments would constitute a
one-time paperwork burden (viz., completion of transmittal forms) for
manufacturers of currently licensed products with labels that are not
in conformance.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. We need this outside input to help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average .12 hour per response.
Respondents: Veterinary Biologics Licensees and Permittees.
Estimated number of respondents: 88.
Estimated number of responses per respondent: 42.
Estimated number of responses: 3,696.
Estimated total burden on respondents: 444 hours.
Copies of this information collection can be obtained from:
Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence
Avenue SW., Washington, DC 20250.
List of Subjects in 9 CFR Part 112
Animal biologics, Exports, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 9 CFR part 112 as follows:
PART 112--PACKAGING AND LABELING
1. The authority citation for part 112 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).
2. In Sec. 112.2, paragraph (a)(2), paragraph (c), and the first
sentence of paragraph (e) would be revised to read as follows:
Sec. 112.2 Final container label, carton label, and enclosure.
(a) * * *
(1) * * *
(2) The Product Code Number and an appropriate consumer contact
telephone number (except for container labels for diagnostic test
kits); and, if the biological product is prepared in the United States,
the name and address of the manufacturer (licensee or subsidiary) or,
if the product is prepared in a foreign country, the name and address
of the permittee and of the foreign manufacturer.
* * * * *
(c) Labels shall bear the true name of the product in a prominent
fashion and not bear any trade name more prominently than the true
name. Labels shall not bear anything that is false or misleading or
that may otherwise deceive the purchaser.
* * * * *
(e) For product shipped to a foreign country, labels that do not
bear false or misleading information but that do not otherwise conform
to the regulations in this part may be approved for use if evidence of
acceptability to the foreign country is provided. This evidence shall
consist of a label mounting prepared as described in Sec. 112.5(d)(2)
and bearing the stamp or other mark of approval of the appropriate
foreign regulatory agency. * * *
* * * * *
3. In Sec. 112.7, paragraph (i) would be revised to read as
follows:
Sec. 112.7 Special additional requirements.
* * * * *
(i) Unless otherwise provided in the regulations or in the filed
Outline of Production for the product:
(1) Labels for vaccines, bacterins, bacterial extracts, toxoids,
and combinations thereof, as well as immunomodulators, shall specify a
minimum age for product administration consistent with the efficacy and
safety data developed for the product: Provided, That, labels for
products for administration to dams to protect progeny need not specify
a minimum age if it is clear from other
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label recommendations that the animals are to be of breeding age when
treated.
(2) Labels for vaccines, bacterins, bacterial extracts, toxoids,
and bacterin-toxoids which recommend product use in animals younger
than 12 weeks of age in the case of canine and feline products (17
weeks in the case of canine parvovirus vaccine), or 3 months of age in
the case of products for other mammalian species, must also recommend
revaccination at intervals of 2-3 weeks through the applicable age
(viz., 12 weeks, 17 weeks, or 3 months). In the case of avian products
(except Marek's disease vaccines) recommended for use in birds under 2
weeks of age, revaccination at 3 weeks of age shall be recommended. If
two doses of product are required for primary immunization, labels
shall recommend that two doses be given after the applicable age (viz.,
12 weeks, 17 weeks, 3 months, or 3 weeks). The revaccination
recommendation is not required for labels for products intended for the
prevention or alleviation of diseases that are considered afflictions
of only very young animals, for products where maternal antibodies do
not interfere with efficacy, or for products where traditional U.S.
animal industry practice is clearly inconsistent with such a
recommendation. Such products include, but are not limited to, those
for rotaviral and coronaviral enteritis, mammalian colibacillosis, and
atrophic rhinitis in swine.
* * * * *
Done in Washington, DC, this 12th day of March 1999.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-6593 Filed 3-17-99;8:45am]
BILLLING CODE 3410-34-P