Tuesday May 14, 1985

122 Pages·2017·18.33 MB·English

5-14-85 Tuesday
Vol. 50 No. 93 May 14, 1985
Pages 20085-20190
Animal Biologies
Animal and Plant Health Inspection Service
Aviation Safety
Federal Aviation Administration
Banks, Banking
Farm Credit Administration
Electric Utilities
Federal Energy Regulatory Commission
Fluoride
Environmental Protection Agency
Government Property Management
General Services Administration
Marketing Agreements
Agricultural Marketing Service
Mortgage Insurance
Housing and Urban Development Department
Motor Vehicle Safety
National Highway Traffic Safety Administration
Motor Vehicles
Federal Trade Commission
National Parks
National Park Service
Navigation (Water)
Navy Department
CONTINUED INSIDE
II Federal Register / Vol. 50* No. 93 / Tuesday, May 14, 1985 / Selected Subjects
Selected Subjects
FEDERAL REGISTER Published daily, Monday through Friday, Reporting and Recordkeeping Requirements
(not published on Saturdays, Sundays, or on official holidays), Federal Energy Regulatory Commission
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Federal Trade Commission
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The Federal Register provides a uniform system for making
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There are no restrictions on the republication of material
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Questions and requests for specific information may be directed
to the telephone numbers listed under INFORMATION AND
ASSISTANCE in the READER AIDS section of this issue.
How To Cite This Publication: Use the volume number and the
page number. Example: 50 FR 12345.
Contents
Federal Register
Vol. 50, No. 93
Tuesday, May 14, 1985
Agricultural Marketing Service 20120 DIA Scientific Advisory Committee; cancellation
RULES
20085 Oranges (Valencia) grown in Arizona and Drug Enforcement Administration
California NOTICES
Registration applications, etc.; controlled
Agriculture Department substances:
See Agricultural Marketing Service; Animal and 20143 Cusmano, Joseph V., M.D.
Plant Health Inspection Service.
Education Department
Air Force Department NOTICES
NOTICES Grants; availability, etc.:
Meetings: 20122 Regional educational laboratories and research
20121 Scientific Advisory Board (2 documents) and development centers program
Meetings:
Alcohol, Drug Abuse, and Mental Health 20121 Continuing Education National Advisory Council
Administration
NOTICES Employment and Training Administration
Meetings; advisory committees: NOTICES
20131 June Adjustment assistance:
20143 Aeolian American Corp. et al.
Alcohol, Tobacco and Firearms Bureau 20143 Houdaille Industries et al.
RULES 20144 Teledyne Columbia-Summerial et al.
20098 Denatured alcohol and rum and tax-free alcohol; 20143 Wilker Brothers Co., Inc.
distribution and use; correction
Energy Department
Animal and Plant Health Inspection Service See also Federal Energy Regulatory Commission.
RULES NOTICES
Meetings:
Viruses, serums, toxins, etc.:
20085 Rabies vaccines; packaging, labeling, and 20125 National Petroleum Council
Patent licenses, exclusive:
standard requirements
20125 Rockwood Systems Corp.
Army Department 20126 University of Wyoming Research Corp.
NOTICES
Environmental Protection Agency
Meetings:
20121 Armed Forces Epidemiological Board (2 PROPOSED RULES
Water pollution control:
documents)
20164 Drinking water; maximum contaminant levels for
Arts and Humanities, National Foundation fluoride
NOTICES NOTICES
Meetings: Air pollution control; new motor vehicles and
20155 Visual Arts Advisory Panel engines:
20126 California pollution control standard; hearing
Coast Guard Toxic substances:
NOTICES 20126 Methylene Chloride; accelerated review
Meetings:
20158 Towing Safety Advisory Committee (2 Farm Credit Administration
RULES
documents)
20091 Farm credit system; examinations, audits, and
Commerce Department investigations
See International Trade Administration; National
Oceanic and Atmospheric Administration. Federal Aviation Administration
RULES
Customs Service 20091 Control zones and transition areas
NOTICES 20092, Transition areas (2 documents)
Senior Executive Service: 20093
20160 Performance Review Boards; membership 20092 VOR Federal airways, jet routes, and reporting
points; correction
Defense Department PROPOSED RULES
See also Air Force Department; Army Department; 20106 Jet routes
Navy Department. 20105 VOR Federal airways
NOTICES NOTICES
Meetings: Meetings:
20120 DIA Scientific Advisory Committee 20159 Aeronautics Radio Technical Commission
IV Federal Register / Vol. 50, No. 93 / Tuesday, May 14, 1985 / Contents
20158 Exemption petitions; summary and disposition Health and Human Services Department
See Alcohol, Drug Abuse, and Mental Health
Federal Communications Commission Administration; Food and Drug Administration;
NOTICES Health Care Financing Administration.
Hearings, etc.:
20128 Roever, Alfred H., Ill, et al. Health Care Financing Administration
NOTICES
Federal Energy Regulatory Commission Medicare:
RULES 20178 Home health agency costs per visit; schedule of
Electric utilities (Federal Power Act): limits
20095 Licensed hydropower development recreation
report (Form No. 80); filing requirement cancelled Historic Preservation, Advisory Council
PROPOSED RULES NOTICES
Natural gas companies (Natural Gas Act): Programmatic memorandums of agreement:
20109 Underground gas storage report (Form No. 8) and 20117 Cumberland River Basin, KY
gas supply and requirement report (Form No. 16)
Housing and Urban Development Department
Federal Maritime Commission RULES
RULES Mortgage and loan insurance programs:
Tariffs filed by common carriers in foreign 20096 Mutual mortgage insurance and rehabilitation
commerce of U.S.: loans; mortgage insurance endorsement on
20103 Co-loading practices by non-vessel-operating proposed or new dwelling in new subdivision or
common carriers; effective date deferred improved area
NOTICES
20129 Agreements filed, etc.: Interior Department
See Fish and Wildlife Service; Land Management
Federal Reserve System Bureau; Minerals Management Service; National
NOTICES Park Service.
Bank holding company applications, etc:
20129 Marshall & Illsley Corp. International Trade Administration
20129 Pemi Bancorp, Inc., et al. notices'
20161 Meetings; Sunshine Act Countervailing duties:
20117 Converted paper-related school and office
Federal Trade Commission supplies from Mexico
RULES 20118 Export trade certificates of review
20094 Motor vehicles, used; trade rule for sales; effective Meetings:
date stayed for Wisconsin 20119 Management-Labor Textile Advisory Committee
PROPOSED RULES
Prohibited trade practices: Interstate Commerce Commission
20107 Decorating Products Association of Central NOTICES
Florida Railroad operation, acquisition, construction, etc.:
NOTICES 20142 Illinois Central Gulf Railroad Company
20130 Premerger notification waiting periods; early 20142 Missouri-Kansas-Texas Railroad Co.
terminations
Justice Department
Fish And Wildlife Service See also Drug Enforcement Administration.
NOTICES NOTICES
20138 Agency information collection activities under Pollution control; consent judgments:
OMB review 20143 Toronto Paperboard Co., Inc.
20139 Endangered and threatened species permit
applications (2 documents) Labor Department
See Employment and Training Administration;
Food and Drug Administration Mine Safety and Health Administration;
NOTICES Occupational Safety and Health Administration;
Human drugs: Pension and Welfare Benefit Programs Office.
20135 Cortisporin cream; correction
Meetings: Land Management Bureau
20135 Advisory committees, panels, etc. NOTICES
Coal leases, exploration licenses, etc.:
General Services Administration 20138 Wyoming
RULES Exchange of public lands:
Acquisition regulations (GSAR); 20137 New Mexico
20103 Restriction on procurement of hand and Meetings:
measuring tools; temporary; correction 20137 Green River-Hams Fork Regional Coal Team
Property management: 20136 Phoenix District Advisory Council
20101 Transportation documentation and audit; use of Withdrawal and reservation of lands:
cash 20137 New Mexico
Federal Register / Voi. 50, No. 93 / Tuesday, May 14, 1985 / Contents V
am
Maritime Administration NOTICES
RULES Meetings:
Subsidized vessels and operators: 20121. Naval War College, Board of Advisors to
20102 Construction-differential subsidy repayments; President
total payment policy; correction
Nuclear Regulatory Commission
Mine Safety and Health Administration NOTICES
RULES Environmental statements; availability, etc.:
Metal and nonmetal mine safety and health: 20157 Georgia Power Co. et al.
20099 Safety and health standards; recodification; 20156 Omaha Public Power District
technical amendments and corrections 20161 Meetings; Sunshine Act
Safety analysis and evaluation reports; availability,
Minerals Management Service etc.:
NOTICES 20157 Southern California Edison Co.
Meetings:
20140 Outer Continental Shelf Advisory Board Occupational Safety and Health Administration
Outer Continental Shelf operations: NOTICES
20140 Oil and gas leasing; 5-year program development; State plans; standards approval, etc.:
confidentiality period extension 20144 Nevada
20150 Washington
National Highway Traffic Safety Administration Variance applications, etc.:
PROPOSED RULES 20145 Zurn Industries, Inc./Tileman & Co., Ltd.
Motor vehicle safety standards:
20113 Air brake systems; test rig modifications Pacific Northwest Electric Power and
NOTICES Conservation Planning Council
Motor vehicle safety standards; exemption NOTICES
petitions, etc.: Meetings:
20159 BF Goodrich Co. -, 20158 Hydropower Assessment Steering Committee
Pension and Welfare Benefit Programs Office
National Oceanic and Atmospheric
Administration NOTICES
Employee benefit plans; prohibited transaction
RULES
exemptions:
Fishery conservation and management:
20150 Baton Rouge Building & Construction Industry et
20103 Atlantic mackerel, squid, and butterfish
al.
20103 Western Pacific spiny lobster; interim; correction
NOTICES 20152 Century Graphics Corp. et al.
Environmental statements; availability, etc.:
20119 National Marine Fisheries Service Textile Agreements Implementation Committee
Permits: NOTICES
20119 Marine mammals Cotton, wool, and man-made textiles:
20120 Marine mammals; correction 20120 Brazil
Transportation Department
National Park Service
See Coast Guard; Federal Aviation Administration;
PROPOSED RULES
Maritime Administration; National Highway Traffic
Special regulations:
Safety Administration.
20111 Zion National Park, UT; oversize vehicle
regulations
Treasury Department
NOTICES
See Alcohol, Tobacco and Firearms Bureau;
Concession contract negotiations:
Customs Service.
20141 Fort Sumter Tours, Inc. ,,
Historic Places National Register; pending
nominations:
20141 Alabama et al. Separate Parts in This Issue
Management and development plans, etc.:
20141 Fort Smith National Historic Site, AR and OK Part II
20164 Environmental Protection Agency
National Science Foundation
Partili
NOTICES
20178 Department of Health and Human Services,
Meetings:
Health Care Financing Administration
20156 Design, Manufacturing & Computer Engineering
Advisory Committee
Reader Aids
Navy Department Additional information, including a list of public
RULES laws, telephone numbers, and finding aids, appears
Navigation, COLREGS compliance exemptions: in the Reader Aids section at the end of this issue.
20100 USS Dahlgren
VI Federal Register / Vol. 50, No. 93 / Tuesday, May 14,1985 / Contents
CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in
the Reader Aids section at the end of this issue.
7 CFR
908....................................20085
9 CFR
112 .......... 20085
113 ........................ ...20085
12 CFR
617.. ........... 20091
14 CFR
71 (4 documents)........ 20091-
?nn93
Proposed Rules:
71___ 20105
75......................................20106
16 CFR
455................ ...20094
Proposed Rules:
13 ......................... 20107
18 CFR
8 ...................................20095
Proposed Rules:
260...................................20109
24 CFR
200.......... ......20096
203.. .:................... 20096
27 CFR
19 . ...20098
20 ......„.......................20098
22................... 20098
200________ 20098
250...................................20098
30 CFR
56 .................................20099
57 ............................ 20099
32 CFR
706................. 20100
36 CFR
Proposed Rules:
7......................................20111
40 CFR
Proposed Rules:
141............. 20164
41 CFR
101-41............................20101
46 CFR
276.......................... 20102
580............................ 20103
48 CFR
525....................................20103
552_________________20103
49 CFR
Proposed Rules:
571............. 20113
50 CFR
655...................................20103
681....................................20103
LIST OF PUBLIC LAWS
Note: No public bills which
have become law were
received by the Office of the
Federal Register for inclusion
in today’s List of Public
Laws.
Last List May 3, 1985
20085
Rules and Regulations
Federal Register
Vol. 50,' No. 93
Tuesday, May 14, 1985
This section of the FEDERAL REGISTER major” rules. William T. Manley, Deputy PART 908— [AMENDED]
contains regulatory documents having Administrator, Agricultural Marketing
general applicability and legal effect, most Service, has certified that these actions 1. The authority citation for 7 CFR
of which are keyed to and codified in Part 908 continues to read as follows:
will not have a significant economic
the Code of Federal Regulations, which is
impact on a substantial number of small Authority: (Secs. 1-19, 48 Stat. 31, as
published under 50 titles pursuant to 44
entities. amended; 7 U.S.C. 601-674).
U.S.C. 1510.
The Code of Federal Regulations is sold These amendments and the 2. Section 908.642 is revised to read as
by the Superintendent of Documents. regulations are issued under Marketing follows:
Prices of new books are listed in the Order No. 908, as amended (7 CFR Part
first FEDERAL REGISTER issue of each § 908.642 Valencia Orange Regulation 342.
908), regulating the handling of Valencia
week. oranges grown in Arizona and The quantities of Valencia oranges
designated part of California. The order grown in California and Arizona which
DEPARTMENT OF AGRICULTURE is effective under the Agricultural may be handled during the period May
Marketing Agreement Act of 1937, as 3.1985, through May 9,1985, are
Agricultural Marketing Service amended (7 U.S.C. 601-674). The actions established as follows:
are based upon the recommendation (a) District 1: 285,000 cartons;
7 CFR Part 908 and information submitted by the (b) District 2:465,000 cartons;
[Valencia Orange Regs. 342 and 343, Arndt. Valencia Orange Administrative (c) District 3: Unlimited cartons.
1; Valencia Orange Reg. 344] Committee (VOAC) and upon other 3. Section 908.643 is revised to read as
available information. It is hereby found follows:
Valencia Oranges Grown in Arizona that these actions will tend to effectuate
§ 908.643 Valencia Orange Regulation 343.
and Designated Part of California; the declared policy of the act.
The quantities of Valencia oranges
Limitation of Handling The amendments and the regulations
grown in California and Arizona which
are consistent with the marketing policy
agency: Agricultural Marketing Service, may be handled during the period May
USDA. for 1984-85. The marketing policy was 10.1985, through May 16,1985, are
recommended by the committee
ACTION: Final rules. established as follows:
following discussion at a public meeting
(a) District 1: 360,000 cartons;
summary: Amendment 1 of Regulation on March 26,1985. The committee met (b) District 2: 540,000 cartons;
342 increases the quantity of fresh again publicly on May 7,1985, to (c) District 3: Unlimited cartbns.
California-Arizona Valencia oranges consider the current and prospective 4. Section 908.644 is added to read as
that may be shipped to market during conditions of supply and demand and follows:
the period May 3-May 9,1985. recommended a quantity of Valencia
Amendment 1 of Regulation 343 oranges for the specified weeks. The § 908.644 Valencia Orange Regulation 344.
increases the quantity of such fruit that committee reports the demand for The quantities of Valencia oranges
may be shipped during the period May Valencia oranges is improving. grown in California and Arizona which
10-May 16,1985. Regulation 344 It is further found that it is may be handled during the period May
establishes the quantity of such fruit impracticable and contrary to the public 17.1985, through May 23,1985, are
that may be shipped to market during interest to give preliminary notice, established as follows:
the period May 17-May 23,1985. These engage in public rulemaking, and (a) District 1: 340,000 cartons;
amendments and regulations are needed postpone the effective date until 30 days (b) District 2: 510,000 cartons;
to provide for orderly marketing of fresh after publication in the Federal Register (c) District 3: Unlimited cations.
Valencia oranges for the periods (5 U.S.C. 553), because there is
Dated: May 8,1985.
specified due to the marketing situation insufficient time between the date when
Thomas R. Clark,
confronting the orange industry. information upon which these actions
Deputy Director, Fruit and Vegetable
date: Regulation 342, Amendment 1 are based became available and the Division, Agricultural Marketing Service.
(§ 908.642) is effective for the period effective date necessary to effectuate .
[FR Doc. 85-11568 Filed 5-13-85; 8:45 am]
May 3-9,1985. Regulation 343, the declared policy of the act.
BILLING CODE 3410-02-M
Amendment 1 (§ 908.643) is effective for Interested persons were given an
the period May 11-16,1985. Regulation opportunity to submit information and
344 (§ 908.644) is effective for the period views on the amendments and the Animal and Plant Health Inspection
May 17-23,1985. regulation at an open meeting. To Service
FOR FURTHER INFORMATION CONTACT: effectuate the declared policy of the act,
William J. Doyle, Chief, Fruit Branch, it is necessary to make the regulatory 9 CFR Parts 112 and 113
F&V, AMS, USDA, Washington, D.C. provisions effective as specified, and
[Docket No. 85-015]
20250, telephone: [phone]. handlers have been notified of the
SUPPLEMENTARY INFORMATION: amendments and the regulations and Viruses, Serums, Toxins, and
their effective dates.
Findings Analogous Products; Packaging and
List of Subjects in 7 CFR Part 908 Labeling and Standard Requirements
These rules have been reviewed under
USDA procedures and Executive Order Marketing agreements and orders, AGENCY: Animal and Plant Health
12291 and have been designated “non­ California, Arizona, Oranges (Valencia). Inspection Service, USDA.
20086 Federal Register / Vol. 50, No. 93 / Tuesday, May 14, 1985 / Rules and Regulations
ACTION: Final rule. result in a major increase in costs or difficulties for administrators of State
prices for consumers, individual and local regulatory programs for rabies
summary: A conference was held over 1 industries, Federal, State, or local control. In a conference involving
year ago to review regulatory control government agencies, or geographic licensed manufacturers, Federal, State,
over Rabies Vaccines. This conference regions: or significant adverse effects on and local regulatory authorities, and
included representives of the animal competition, employment, investment, interested scientists, agreement was
industry, professional organizations, productivity, innovation, or on the reached on uniform language which
biologies manufacturers, and Federal ability of the United States-based would provide adequate label
and State agencies involved with rabies enterprises to compete with foreign- recommendations. As a result of such
control. A number of changes in the based enterprises, in domestic or export agreement, the Department has revised 9
parts of Title 9, Code of Federal markets. CFR 112.7 (c)(2) and (d)(6) to provide for
Regulations, related to Rabies Vaccines uniform age and repeat dose
were proposed. These proposed changes Certification Under the Regulatory recommendations.
included the deletion of the requirement Flexibility Act
Label requirements in 9 CFR 112.7
that inactivated Rabies Vaccine must be The Administrator of the Animal and (c)(4) and (d)(1) contain
administered only at the one site in the Plant Health Inspection Service, has recommendations for annual
thigh. The Department agreed to determined that this action will not revaccination with Rabies Vaccines in
consider many of these and published result in an adverse economic impact on high risk areas. This recommendation is
them as proposed rulemaking on a substantial number of small entities. now considered unnecessary. Animals
September 5,1984. As part of the Small entities are defined as
vaccinated with products shown to
proposed rulemaking, a complete review independently owned firms not
confer immunity for more than 1 year
of § 112.7 was made. As a result, § 112.7 dominant in the field of veterinary
have not been shown to be more
of the regulations which contains special biologies manufacturing.
susceptible to rabies during the period
label provisions for Rabies Vaccines
Background of immunity than those revaccinated
and other products, and the standard
annually.
requirements for Rabies Vaccines in At the time § 112.7(b) of Part 112—
Inclusion of the annual revaccination
Part 113 are amended herein. This action Packaging and Labeling was published,
provision on the labels has been the
amends the special labeling protection against specific serotypes of
source of considerable difficulty in areas
requirements for Rabies Vaccines, avian infectious bronchitis could only be
where an increased incidence of rabies
including the requirement that achieved by including each specific
exists in wild species. Varying
inactivated Rabies Vaccine must be serotype in the product. With the advent
interpretations of “high risk areas”
administered only at one site in the of new production methods, it should
tended to interfere with rabies control
thigh. This action also revises the not be necessary to use specific
by State and local health authorities.
special labeling requirements for other serotypes to ensure protection.
This revision of 9 CFR 112.7 (c) and (d)
products by deleting or revising various However, it remains essential to have
deletes this recommendation.
provisions which have been determined label information to indicate the
to be obsolete or unnecessary. The serotypes for which protection is The requirement for a label statement
Standard Requirements in Part 113 of claimed. Revision of 9 CFR 112.7(b) by regarding accidental human exposure to
Title 9 for Rabies Vaccine are revised to changing from “serotypes used” to modified live virus Rabies Vaccine in 9
eliminate certain restrictions and testing “serotypes for which protection is CFR 112.7(d)(5) is probably insufficient
steps. claimed” has been made. to ensure that all users will be
Presently, inactivated Rabies adequately warned. Although all
EFFECTIVE DATE: This amendment Vaccines labels and enclosures are currently approved labeling contains the
becomes effective July 15,1985. required to contain recommendations warning, the regulation does not apply
FOR FURTHER INFORMATION CONTACT: for intramuscular administration at one to cartons containing one multiple dose
Dr. David F. Long, Chief Staff site in the thigh. This requirement was container where no enclosure is
Veterinarian, Veterinary Biologies Staff, thought to be necessary to ensure provided. This revision requires
VS, APHIS, USDA, Room 834, Federal effectiveness and to guard against prominent placement of the warning on
Building, 6505 Belcrest Road, improper use of vaccines by providing all cartons and enclosures, regardless of
Hyattsville, MD 20782, 301-436-6674. for a single method of administration. size of the container.
SUPPLEMENTARY INFORMATION: Inactivated products are now available The specific repeat dose requirements
which are known to be equally effective in 9 CFR 112.7(f) applicable to aqueous
Paperwork Reduction Act when administered by other, more and adjuvanted inactivated bacterial
This final rule contains no new or desirable routes. Adequate instructions products in general, as well as to
amended recordkeeping, reporting or and controls have been developed to specific fractions in 9 CFR 112.7(f) (1)
application requirements or any type of ensure proper administration of Rabies and (3), have been found inappropriate
information collection requirement Vaccines. Therefore, this revision of 9 in the case of certain products either
subject to the Paperwork Reduction Act CFR 112.7(c)(1) deletes the requirement prepared by advanced methods or from
of 1980. for the recommendation that inactivated different ingredients, or both, and
Rabies Vaccines be administered administered pursuant to new
Executive Order 12291
intramuscularly at one site in the thigh. husbandry practices. This revision
This action has been reviewed under Because of minor variations in deletes the requirements for a repeat
USDA procedures established in conducting immunogenicity and dose at 7 days for aqueous products and
Secretary’s Memorandum No. 1512-1 to duration of immunity tests on Rahies at 14 days for adjuvanted products. The
implement Executive Order 12291 and Vaccines and because of individual special requirements for Clostridium
has been classified as a “Nonmajor choices of language by licensees, chauvoei, septicum, and novyi fractions
Rule." variations in recommended dosage and are also deleted. Appropriate
The rule will not have a significant immunization schedules have arisen. recommendations are required to be
effect on the economy and will not These variations have resulted in included on labels in accordance with
Federal Register / Vol. 50, No. 93 / Tuesday, May 14, 1985 / Rules and Regulations 20087
Specific characteristics of each product are conducted and product evaluations The regulations in 9 CFR
and conditions surrounding its use. made in a manner which will support 113..129(b) (3)(iv) and 113.147(b)(3)(iii)
Paragraphs are renumbered accordingly. licensure and acceptance for use in with regard to Rabies Vaccines require
I Substantial concern for human safety rabies control programs, it is essential challenge using street virus with a
existed when the restrictions on the that a protocol be approved before such recommendation of injection in the
loute of administration for Marek’s tests of Rabies Vaccines are initiated. masseter muscles. These requirements
Disease Vaccine 9 CFR 112.7(k) were This revision changes 9 CFR 113.129(b) tend to preclude use of equally effective
Introduced. Procedures using spray and 113.147(b) to require submission of a challenges which might not be
Equipment were under investigation at protocol for each immunogenicity test of considered to be street viruses. These
laverai research institutions without Rabies Vaccine. requirements also preclude equally
adequate knowledge of public health Rabies Vaccines are vitally important effective and simpler methods of
■nplications. As a result, to animal and public health. When in administration into muscles other than
lecommendations were limited to combination with other fractions, the masseter. These revisions provide
Subcutaneous or intramuscular routes; freedom from interference with the for use of challenge virus to be furnished
Subsequently, substantial information establishment of protection from rabies or approved by Veterinary Services and
has been obtained indicating that these by presence of the pther fractions is delete the masseter muscle
viruses are not implicated in human essential. These revisions of 9 CFR recommendation.
disease. Newer methods of ; 113.129(b) and 113.147(b) codify the The requirement for observation of
administration are being evaluated and requirement that the Rabies Vaccine animals during the rabies test
Should be approved if they are shown to component in combination with other postchallenge period in accordance with
be safe and effective. Therefore, this fractions provide the same protective 9 CFR 113.5(b) has been found to be
lestriction is deleted. The paragraph value established for single fraction inadequate. In order to ensure the
lurrently identified as (1) would be Rabies Vaccines. validity of test results, additional
redesignated as (k). specific tests to ascertain that deaths of
Killed virus Rabies Vaccines can be
■ The alternate statement regarding test animals are due to rabies by
prepared so that administration by
corneal opacity in 9 CFR 112.7(m) which examination of brain material for the
routes other than intramuscularly will
clan occur in vaccinated animals has presence of rabies virus are considered
provide protection which is at least
iesulted in frequent misunderstanding necessary. Therefore, this revision adds
equal to that obtained by intramuscular
and is unnecessary. This statement an examination of brain tissue to ensure
administration. These other routes are
attempts to point out that corneal that deaths from challenge are due to
frequently less painful and less difficult
obacity may occur as an event not rabies. Currently licensed products have
to administer. Acceptance of vaccines
related to vaccination. When it occurs been adequately evaluated and are not
administered by other routes in the past
cpincidentally with administration of affected by this revision.
was resisted because of a desire on the
vaccine, even though the vaccine is not The regulations in 9 CFR 113.129(b)(4)
part of regulatory officials to have all
ajt fault, the alternate statement may be and 9 CFR 113.147(b)(4) with regard to
vaccines administered by a single,
misunderstood. This revision Rabies Vaccine provide for reduced
uniform method. This restriction has
redesignates 9 CFR 112.7 (m) as (1), numbers of certain species of animals to
since been shown to be unnecessary
requires a warning statement only be challenged in immunogenicity test.
because of better instructions,
where adequate data regarding corneal Reduction is permitted only for cattle,
information, and controls. This revision
obacity had not been filed, and deletes horses, sheep, and goats. Because of
of 9 CFR 113.129{b)(3)(i) permits ^
the requirement for the alternate widespread need and interest in
administration by any method shown to
statement in cases where adequate data products to protect many species from
were filed. safely provide adequate protection. rabies, it may become necessary to
■ The immunogenicity and duration of Measurement of serological response evaluate Rabies Vaccines, m animals not
■nmunity tests necessary for evaluation in test animals administered Rabies considered at the time when this
Oif Rabies Vaccines require 15 to 39 Vaccine is required six times during the Standard Requirement was established.
months to conclude. In some tests, even prechallenge period» Adequate Some of these species present problems
under excellent conditions and care, evaluation of serological response can in restraint and confinement during the
deaths of test animals occur during the be determined when this is reduced to postchallenge period similar to those
pjrechallenge period. In order to ensure five times. This revision of 9 CFR associated with challenge of those
that a suitable number of test subjects 113.129{b)(3Kiii) and 113.147(b)(3)(iii) currently excluded. This revision allows
ajre available for challenge, some deletes the requirements for these for the reduction of test animals when
njianufacturers have found it necessary determinations at 60 days domestic species other dogs and cats
to include extra test animals at the time postvaccination and therefore are challenged. It also allows for more
off vaccination. However, to prevent eliminates one measurement of the adequate selection of vaccinates to be
compromising the results, it remains present six. challenged by considering SN titers at
essential for all test animals to be The regulation in 9 CFR 113.129(b)(1) the last two bleedings instead of
challenged. This revision of 9 CFR makes reference to the NIH Test in restricting the selection only from those
l|3.129(b)(3j(i) and 113.147(b)(3)(i) Chapter 33 of "Laboratory Techniques in lowest at the last bleeding. This revision
removes the upper limit of 30 vaccinates. Rabies." The test, as described in that also changes thb serological response
Revision of 9 CFR 113.129(b)(3)(ii) and publication, specifies that the challenge considered to be sufficient to ensure
H3.147(b)(3)(ii) permits use of more than dose contain between 5 and 50 LDsa. protection from challenge to a higher
lo controls. The basic number of However, this is not clearly stated and, titer. This is based on serology and
vaccinates required to survive the as a result, some manufacturers have challenge results involving over 900
challenge remains at 22 of 25 or 26 of 30 failed to observe this restriction. This animals. These studies demonstrate that
Hit provisions for acceptance of revision adds clarifying language in 9 titers of 1:10 by the mouse SN test or
equivalent results are added. In order to CFR 113.129(b)(1) to ensure that tests 1:16 by the rapid fluorescent focus
epsure that other aspects of the studies are run correctly. inhibition test are necessary to ensure
20088 Federal Register / Vol. 50, No. 93 / Tuesday, May 14, 1985 / Rules and Regulations
protection. The rapid fluorescent focus of authorities responsible for State and published information to support the
inhibition test, which was not available local rabies control programs. It was change. Although substantial
when present regulations were considered to be desirable to have all information has been published in
published, is added as an alternative Rabies Vaccine administered by a route scientific journals in other countries, the
method for determining serological and at a site known to provide safe, Department does not require publication
response. This method uses an in vitro effective protection regardless of the of test results in scientific journals to
test instead of mice to determine differences in the vaccines. In support acceptance for licensure. What
serological response with equal December, 1982, the National it does require is proof that a vaccine
assurance of accuracy. association of State Public Health will provide safe, effective protection of
The regulations in 9 CFR Veterinarians Rabies Compendium host animals when administered as
113.147(a)(5](ii) specify a 1.0 ml volume Committee, after considering all aspects recommended on the label. Therefore,
of high titer virus for the nerve of these restrictions, expressed this recommendation was not accepted
infiltration safety study. This could willingness to accept Rabies Vaccines One licensee objected to deletion of
result in inadequate or in excessive recommended for routes of the recommendations for annual
virus being used because of variations administration other than intramuscular, revaccination in high risk areas. This
in the titer inherent in various products. if they were shown to be safe and was based on a concern for animal and
This revision standardizes the amount effective. Information on this policy public health risks which might be
by specifying the equivalent of 10 doses change was supplied to the Department reduced by the additional vaccinations.
for cats and dogs and to one dose per and to a consultant to the Rabies Because of problems associated with
site in other species. Compendium Committee representing interpretations of “high risk area’’ and
Comments Received the interest of licensed manufacturers of difficulties in applying the extra
Rabies Vaccines. À conference was held vaccinations, as well as insufficient
On Wednesday, September 5,1984, a on January 31 and February 1,1984 to evidence that such extra vaccinations
notice of proposed rulemaking was review all aspects of regulatory control would reduce the incidence of disease,
published in the Federal Register at 49 of Rabies Vaccines. Representatives of the National Association of Public
FR 35022 discussing this revision and the animal industry, veterinary Health Veterinarians recommended
soliciting comments. professional organizations, each
deletion of this requirement in 1981.
Comments were received from nine licensed manufacturer of Rabies
They continued to recommend its
licensed manufacturers, two State Vaccines, and Federal and State
deletion at the Conference oh
departments of public health, and the agencies involved with rabies control
Regulatory Control of Rabies Vaccines.
Department of Health and Human were present. The subject of additional
Therefore, this requirement has been
Services. None opposed adoption of the routes of administration was discussed
amendments. The following is a at length. No one objected to a possible delete^.
discussion of the comments received approval of additional routes of One State public health agency
regarding the proposed rulemaking. administration. Some differences were recommended that a minimum relative
Because of concern about competition expressed as to the minimum acceptable potency value be imposed on killed
from a foreign-based firm, three licensed proof needed to support revision of virus Rabies Vaccine in 9 CFR
manufacturers commented that the labels for killed virus vaccines already 113.129(b)(3)(i). This recommendation
proposed revision of the regulations in 9 licensed. The Department’s declared was based on standards established for
CFR 112.7(c)(1) to permit willingness to accept and review vaccines to be used in humans and on
recommendations for additional routes protocols for this purpose following the recommendations by some experts. Such
of administration for Rabies Vaccine, conference was acknowledged in minimum relative potency may be
Killed Virus, would have a significant correspondence from a veterinary acceptable for products to be used
effect on competition, investment, professional organization (American where vaccination-challenge studies are
productivity, and innovation with Veterinary Medical Association) and in not feasible, but are not appropriate for
respect to U.S. firms not prepared to one of the licensees’ comments. No products where such protection studies
market the new vaccines. Commentors mention was made of a moratorium or can be conducted.
stated that in the past the Department delay in approval of revised label The State agency also recommended
had always adhered to a policy of recommendations at the conference or an increase in number of test animals to
allowing only a single route of in any Department communications ensure that a Rabies Vaccine would be
administration for all Rabies Vaccines. subsequent to the conference. However, 99 percent effective and would protect
Therefore, the proposed ehange would the Department recognizes that this all vaccinates against challenge. This is
put them at a disadvantage in the amendment represents an important not realistic for statistical or biological ;
marketplace. Because of this, three change for licensed manufacturers, State reasons. Certain immunologically
licensees and two others recommended and local regulatory authorities, users, unresponsive individuals could result in
delay in the effective date of the and APHIS regulatory personnel. In rejection of a satisfactory vaccine. A
recommended change until January 1, order to ensure that licensees, animal prohibitive number of test animals
1986, or later. In light of the events and public health agencies, veterinary would be needed, further increasing the
preceding the recommendation, the time practitioners and other vaccine users, likelihood of immunologically
the industry has had to develop new and Agency personnel have ample time unresponsive individuals. Therefore,
routes of administration, as well as to take all steps necessary for a smooth these recommendations were not
other considerations, the Department is transition, the effective date has been adopted.
not of the opinion that this change will established at 60 days following • The State Agency also recommended
have a significant adverse effect on publication of this final rule in the that vaccinates and controls be
competition, productivity, innovation, or Federal Register. challenged simultaneously using a
ability to compete with foreign One manufacturer recommended an separate syringe and needle for each
manufacturers. The policy of a single indefinite delay in approving additional animal. All tests of licensed Rabies
route of administration was in effect routes of administration for Rabies Vaccines have been and will continue to
because of consideration for the needs Vaccine, Killed Virus, based on lack of be conducted with challenge virus