[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
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 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  

[[Page 13365]]


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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

[[Page 13366]]

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

[[Page 13367]]

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

[[Page 13368]]

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