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75398 Federal Register / Vol. 70, No.

243 / Tuesday, December 20, 2005 / Rules and Regulations

DEPARTMENT OF HEALTH AND ■ Therefore, under the Federal Food, (2) No. 058034 for capsules containing
HUMAN SERVICES Drug, and Cosmetic Act and under 100 or 250 mg chloramphenicol.
authority delegated to the Commissioner (c) Special considerations. Federal
Food and Drug Administration of Food and Drugs and redelegated to law prohibits the extralabel use of this
the Center for Veterinary Medicine, 21 product in food-producing animals.
21 CFR Parts 510 and 520 CFR parts 510 and 520 are amended as (d) Conditions of use in dogs—(1)
follows: Amount. 25 mg per pound of body
New Animal Drugs; Change of weight every 6 hours.
Sponsor; Chloramphenicol Capsules PART 510—NEW ANIMAL DRUGS (2) Indications for use. For treatment
AGENCY: Food and Drug Administration, of bacterial pulmonary infections,
■ 1. The authority citation for 21 CFR
HHS. bacterial infections of the urinary tract,
part 510 continues to read as follows:
ACTION: Final rule. bacterial enteritis, and bacterial
Authority: 21 U.S.C. 321, 331, 351, 352, infections associated with canine
SUMMARY: The Food and Drug 353, 360b, 371, 379e. distemper caused by susceptible
Administration (FDA) is amending the ■ 2. Section 510.600 is amended in the organisms.
animal drug regulations to reflect a table in paragraph (c)(1) by removing
change of sponsor for a new animal drug the entry for ‘‘Nylos Trading Co., Inc.’’ (3) Limitations. Federal law restricts
application (NADA) for and by alphabetically adding a new this drug to use by or on the order of
chloramphenicol capsules from Nylos entry for ‘‘Pharmaceutical Ventures, a licensed veterinarian.
Trading Co., Inc., to Pharmaceutical Ltd.’’; and in the table in paragraph
Dated: December 8, 2005.
Ventures, Ltd. (c)(2) by removing the entry for
Bernadette A. Dunham,
DATES: This rule is effective December ‘‘027454’’ and by numerically adding a
new entry for ‘‘050057’’ to read as Deputy Director, Office of New Animal Drug
20, 2005. Evaluation, Center for Veterinary Medicine.
FOR FURTHER INFORMATION CONTACT: follows:
[FR Doc. 05–24270 Filed 12–19–05; 8:45 am]
David R. Newkirk, Center for Veterinary § 510.600 Names, addresses, and drug BILLING CODE 4160–01–S
Medicine (HFV–100), Food and Drug labeler codes of sponsors of approved
Administration, 7500 Standish Pl., applications.
Rockville, MD 20855, 301–827–6967, e- * * * * * DEPARTMENT OF VETERANS
mail: david.newkirk@fda.gov. (c) * * * AFFAIRS
SUPPLEMENTARY INFORMATION: Nylos (1) * * *
Trading Co., Inc., P.O. Box 2, Route 202, 38 CFR Part 4
Pomona, NY 10970, has informed FDA Drug labeler
Firm name and address code RIN 2900–AM32
that it has transferred ownership of, and
all rights and interest in, NADA 65–150 * * * * * Use of Diagnostic Code Numbers;
for Chloramphenicol Capsules to Pharmaceutical Ventures, 050057 Schedule of Ratings-Neurological
Pharmaceutical Ventures, Ltd., P.O. Box Ltd., P.O. Box D1400, Conditions and Convulsive Disorders
D1400, Pomona, NY 10970. Pomona, NY 10970
Accordingly, the regulations are * * * * * AGENCY: Department of Veterans Affairs.
amended in § 520.390b (21 CFR ACTION: Final rule.
520.390b) to reflect this change of (2) * * *
sponsorship and a current format. In SUMMARY: This document amends the
addition, FDA is taking this opportunity Drug labeler Department of Veterans Affairs (VA)
Firm name and address
code
to revise § 520.390b to reflect the Schedule for Rating Disabilities by
prohibition of extralabel use of * * * * * updating references to diagnostic codes
chloramphenicol in food-producing 050057 Pharmaceutical Ventures, in two regulations. These amendments
animals under 21 CFR 530.41. Ltd., P.O. Box D1400, are necessary to correct outdated
Following these changes of Pomona, NY 10970 references in the Schedule for Rating
sponsorship, Nylos Trading Co., Inc., is * * * * * Disabilities.
no longer the sponsor of an approved DATES: Effective Date: December 20,
application. Accordingly, 21 CFR PART 520—ORAL DOSAGE FORM 2005.
510.600(c) is being amended to remove NEW ANIMAL DRUGS
the entries for Nylos Trading Co., Inc. FOR FURTHER INFORMATION CONTACT:
This rule does not meet the definition ■ 3. The authority citation for 21 CFR Maya Ferrandino, Consultant,
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because part 520 continues to read as follows: Compensation and Pension Service,
it is a rule of ‘‘particular applicability.’’ Policy and Regulations Staff, Veterans
Authority: 21 U.S.C. 360b.
Therefore, it is not subject to the Benefits Administration, 810 Vermont
■ 4. Revise § 520.390b to read as Avenue, NW., Washington, DC 20420,
congressional review requirements in 5
follows: (202) 273–7211.
U.S.C. 801–808.
§ 520.390b Chloramphenicol capsules. SUPPLEMENTARY INFORMATION: VA’s
List of Subjects
(a) Specifications. Each capsule Schedule for Rating Disabilities
21 CFR Part 510 contains 50, 100, 250, or 500 milligrams includes criteria for evaluating
Administrative practice and (mg) chloramphenicol. disabilities by analogy where there is no
procedure, Animal drugs, Labeling, (b) Sponsors. See sponsors in specific diagnostic code for the
Reporting and recordkeeping § 510.600(c) of this chapter for use as in disability being evaluated. In 38 CFR
requirements. paragraph (d) of this section. 4.27 and 38 CFR 4.124a, the rating
(1) Nos. 000069, 000185, and 050057 criteria reference examples of diseases
21 CFR Part 520 for capsules containing 50, 100, 250, or that can be rated by analogy to certain
Animal drugs. 500 mg chloramphenicol. specified diagnostic odes. Two of the

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Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Rules and Regulations 75399

diagnostic codes listed in 38 CFR 4.27 U.S.C. 601–612). Even so, the Secretary ENVIRONMENTAL PROTECTION
and 4.124a, for rheumatoid (atrophic) hereby certifies that this final rule will AGENCY
arthritis and for dementia, are outdated not have a significant economic impact
due to changes to the diagnostic criteria on a substantial number of small entities 40 CFR Parts 52 and 70
for evaluating these diseases. Therefore, as they are defined in the Regulatory [EPA–R07–OAR–2005–IA–0006; FRL–8010–
we are amending 38 CFR 4.27 and Flexibility Act. 9]
4.124a to replace outdated references
with the current diagnostic codes for Unfunded Mandates Approval and Promulgation of
ankylosing spondylitis, a disability Implementation Plans and Operating
The Unfunded Mandates Reform Act
similar to rheumatoid arthritis, and for Permits Program; State of Iowa
dementia. of 1995 requires, at 2 U.S.C. 1532, that
Section 4.27, Use of diagnostic code agencies prepare an assessment of AGENCY: Environmental Protection
numbers, includes as an example: anticipated costs and benefits before Agency (EPA).
‘‘Thus, rheumatoid (atrophic) arthritis issuing any rule that may result in the ACTION: Direct final rule.
rated as ankylosis of the lumbar spine expenditure by State, local, and tribal
SUMMARY: EPA is approving the State
should be coded 5002–5289.’’ However, governments, in the aggregate, or by the
private sector, of $100 million or more Implementation Plan (SIP) revision
Diagnostic Code 5289 was removed
submitted by the state of Iowa. This
from 38 CFR 4.71a, Schedule of ratings- (adjusted annually for inflation) in any
revision includes the general
musculoskeletal system, by a year. This final rule would have no such
rulemaking that Iowa completes for the
rulemaking published on August 27, effect on State, local, and tribal purpose of updating and clarifying
2003, at 68 FR 51454. Therefore, the governments, or on the private sector. various rules, and making other minor
reference to 5289 for ankylosis of the Catalog of Federal Domestic Assistance revisions as generally described in this
lumbar spine is outdated. We will Numbers: The Catalog of Federal Domestic document. EPA is also proposing
replace the outdated reference to Assistance program numbers and titles for approval of revisions to the Iowa
Diagnostic Code 5289 with the current this proposal are 64.104, Pension for Non- Operating Permits Program for the
Diagnostic Code for ankylosing Service-Connected Disability for Veterans, purpose of updating and clarifying
spondylitis, 5240, which is a disability and 64.109, Veterans Compensation for various rules included in the general
similar to rheumatoid arthritis. Service-Connected Disability. rulemaking. These revisions add new
Similarly, in § 4.124a, Schedule of
definitions, as well as an administrative
ratings-neurological conditions and List of Subjects in 38 CFR Part 4
correction to a previously submitted
convulsive disorders, the paragraph
Disability benefits, Pensions, rule. Approval of these revisions will
discussing Mental Disorders in
Veterans. ensure consistency between the state
Epilepsies which appears after
and Federally-approved rules, and
Diagnostic Code 8914 includes Approved: December 14, 2005.
ensure Federal enforceability of the
references to Diagnostic Codes 9304 and Gordon H. Mansfield, State’s revised air program rules.
9307 for dementia: ‘‘(e.g., 9304 or
Deputy Secretary of Veterans Affairs. DATES: This direct final rule will be
9307)’’ and ‘‘(e.g., Diagnostic Code 9304
or 9307)’’. However, Diagnostic Code effective February 21, 2006, without
■ For the reasons set out in the
9307 was removed by a rulemaking further notice, unless EPA receives
preamble, 38 CFR part 4 is amended as
published on October 8, 1996, at 61 FR adverse comment by January 19, 2006.
set forth below:
52695. Therefore, the reference to If adverse comment is received, EPA
Diagnostic Code 9307 currently in 38 PART 4—SCHEDULE FOR RATING will publish a timely withdrawal of the
CFR 4.124a is outdated. We will remove direct final rule in the Federal Register
DISABILITIES
the reference to Diagnostic Code 9307 informing the public that the rule will
and insert a reference to Diagnostic ■ 1. The authority citation for part 4 not take effect.
Code 9326, which replaced Diagnostic continues to read as follows: ADDRESSES: Submit your comments,
Code 9307. identified by Docket ID No. EPA–R07–
Authority: 38 U.S.C. 1155, unless OAR–2005–IA–0006, by one of the
Administrative Procedures Act otherwise noted. following methods:
This final rule merely replaces § 4.27 [Amended]
1. http://www.regulations.gov. Follow
inaccurate examples and does not alter the on-line instructions for submitting
the content of the regulations. ■ 2. Amend § 4.27 by removing ‘‘5002– comments.
Accordingly, there is a basis for 5289’’ and adding, in its place, ‘‘5002– 2. E-mail: Heather Hamilton at
dispensing with prior notice and 5240’’. hamilton.heather@epa.gov.
comment and the delayed effective date 3. Mail: Heather Hamilton,
provisions of 5 U.S.C. 553. § 4.124a [Amended] Environmental Protection Agency, Air
Planning and Development Branch, 901
Paperwork Reduction Act ■ 3. Amend § 4.124a following the North 5th Street, Kansas City, Kansas
This document contains no provisions undesignated center heading ‘‘The 66101.
constituting a collection of information Epilepsies’’ at the conclusion of the 4. Hand Delivery or Courier. Deliver
under the Paperwork Reduction Act (44 table in the undesignated paragraph your comments to Heather Hamilton,
U.S.C. 3501–3521). ‘‘Mental Disorders in Epilepsies’’ Environmental Protection Agency, Air
remove ‘‘9307’’ and add in its place Planning and Development Branch, 901
Regulatory Flexibility Act North 5th Street, Kansas City, Kansas
‘‘9326’’.
Because no notice of proposed 66101.
[FR Doc. 05–24272 Filed 12–19–05; 8:45 am]
rulemaking is required in connection Instructions: Direct your comments to
with the adoption of this final rule, no BILLING CODE 8320–01–P Docket ID No. EPA–R07–OAR–2005–
regulatory flexibility analysis is required IA–0006. EPA’s policy is that all
under the Regulatory Flexibility Act (5 comments received will be included in

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