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Federal Register / Vol. 72, No.

76 / Friday, April 20, 2007 / Rules and Regulations 19797

of Food and Drugs, 21 CFR part 522 is Administration, 7500 Standish Pl., This rule does not meet the definition
amended as follows: Rockville, MD 20855, 301–827–7571, e- of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
mail: joan.gotthardt@fda.gov. it is a rule of ‘‘particular applicability.’’
PART 522—IMPLANTATION OR SUPPLEMENTARY INFORMATION: Schering- Therefore, it is not subject to the
INJECTABLE DOSAGE FORM NEW Plough Animal Health Corp., 556 Morris congressional review requirements in 5
ANIMAL DRUGS Ave., Summit, NJ 07901, filed a U.S.C. 801–808.
■ 1. The authority citation for 21 CFR supplement to NADA 141–246 that List of Subjects
part 522 continues to read as follows: provides for use of AQUAFLOR
(florfenicol), a type A medicated article, 21 CFR Part 556
Authority: 21 U.S.C. 360b. by VFD to formulate type C medicated
■ 2. In § 522.558, paragraph (a) is feed for the control of mortality in Animal drugs, Foods.
revised to read as follows: freshwater-reared salmonids due to 21 CFR Part 558
coldwater disease associated with F.
§ 522.558 Dexmedetomidine. psychrophilum. The supplemental Animal drugs, Animal feeds.
(a) Specifications. Each milliliter of application is approved as of March 19, ■ Therefore, under the Federal Food,
solution contains 0.5 milligram (mg) of 2007, and the regulations are amended Drug, and Cosmetic Act and under
dexmedetomidine hydrochloride. in 21 CFR 556.283, 558.4, and 558.261 authority delegated to the Commissioner
* * * * * to reflect the approval. of Food and Drugs and redelegated to
Dated: April 13, 2007.
The single VFD order form for the Center for Veterinary Medicine, 21
florfenicol includes both catfish and CFR parts 556 and 558 are amended as
Bernadette Dunham,
freshwater-reared salmonid indications follows:
Deputy Director, Center for Veterinary because each comprises multiple
Medicine.
species and is approved in each for use PART 556—TOLERANCES FOR
[FR Doc. E7–7594 Filed 4–19–07; 8:45 am] under similar directions and conditions RESIDUES OF NEW ANIMAL DRUGS
BILLING CODE 4160–01–S of use. IN FOOD
In accordance with the freedom of
information provisions of 21 CFR part ■ 1. The authority citation for 21 CFR
DEPARTMENT OF HEALTH AND 20 and 21 CFR 514.11(e)(2)(ii), a part 556 continues to read as follows:
HUMAN SERVICES summary of safety and effectiveness
Authority: 21 U.S.C. 342, 360b, 371.
data and information submitted to
Food and Drug Administration support approval of this application ■ 2. In § 556.283, add paragraph (b)(4) to
may be seen in the Division of Dockets read as follows:
21 CFR Parts 556 and 558 Management (HFA–305), Food and Drug
§ 556.283 Florfenicol.
New Animal Drugs; Florfenicol Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9 * * * * *
AGENCY: Food and Drug Administration, a.m. and 4 p.m., Monday through (b) * * *
HHS. Friday. (4) Salmonids. The tolerance for
ACTION: Final rule. Under section 573(c) of the Federal florfenicol amine (the marker residue) in
Food, Drug, and Cosmetic Act (the act) muscle/skin (the target tissues) is 1
SUMMARY: The Food and Drug (21 U.S.C. 360ccc-2), this supplemental ppm.
Administration (FDA) is amending the approval qualifies for 7 years of * * * * *
animal drug regulations to reflect the exclusive marketing rights beginning
approval of a supplemental new animal March 19, 2007, because the new animal PART 558—NEW ANIMAL DRUGS FOR
drug application (NADA) filed by drug has been declared a designated USE IN ANIMAL FEEDS
Schering-Plough Animal Health Corp. new animal drug by FDA under section
The supplemental NADA provides for 573(a) of the act. ■ 3. The authority citation for 21 CFR
the use of florfenicol by veterinary feed The agency has carefully considered part 558 continues to read as follows:
directive (VFD) for the control of the potential environmental impact of
this action and has concluded that the Authority: 21 U.S.C. 360b, 371.
mortality in freshwater-reared
salmonids due to coldwater disease action will not have a significant impact ■ 4. In paragraph (d) of § 558.4, in the
associated with Flavobacterium on the human environment and that an ‘‘Category II’’ table, revise the entry in
psychrophilum. environmental impact statement is not alphabetical order for ‘‘Florfenicol’’ to
required. FDA’s finding of no significant read as follows:
DATES: This rule is effective April 20, impact and the evidence supporting that
2007. finding, contained in an environmental § 558.4 Requirement of a medicated feed
FOR FURTHER INFORMATION CONTACT: Joan assessment, may be seen in the Division mill license.
C. Gotthardt, Center for Veterinary of Dockets Management between 9 a.m. * * * * *
Medicine (HFV–130), Food and Drug and 4 p.m., Monday through Friday. (d) * * *

CATEGORY II
Assay limits percent 1 Assay limits percent1
Drug Type B maximum (100x)
Type A Type B/C2
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* * * * * * *

Florfenicol 90–110 Swine feed: n/a Swine feed: 85–115


Catfish feed: n/a Catfish feed: 80–110
Salmonid feed: n/a Salmonid feed: 80–110

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19798 Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations

CATEGORY II—Continued
Assay limits percent 1 Assay limits percent1
Drug Type B maximum (100x)
Type A Type B/C2

* * * * * * *
1 Percentof labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a
Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for
the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.

* * * * * BROADCASTING BOARD OF resources, minimize the possibility of


GOVERNORS involving the BBG in issues unrelated to
■ 5. In § 558.261, revise paragraph
its responsibilities, promote uniformity
(a)(2), paragraph (c)(2)(i), and the first 22 CFR Part 504 in responding to subpoenas and like
two sentences of paragraph (e)(2)(iii); requests, and maintain the impartiality
and add new paragraph (e)(3) to read as Testimony by BBG Employees, of the BBG in matters that are in dispute
follows: Production of Official Records, and between other parties. It will also serve
Disclosure of Official Information In the BBG’s interest in protecting
§ 558.261 Florfenicol. Legal Proceedings sensitive, confidential, and privileged
(a) * * * AGENCY: Broadcasting Board of information and records that are
(2) 500 grams per kilogram for use as Governors. generated in fulfillment of the BBG’s
in paragraphs (e)(2) and (e)(3) of this ACTION: Final rule. statutory responsibilities.
section. The final rule is internal and
SUMMARY: The Broadcasting Board of
* * * * * procedural rather than substantive. It
Governors (BBG) is publishing as a final does not create a right to obtain official
(c) * * * rule a regulation governing access to records or the official testimony of a
(2) * * * BBG information and records in BBG employee nor does it create any
connection with legal proceedings in additional right or privilege not already
(i) For catfish and freshwater-reared which neither the United States nor the
salmonids, must not exceed 15 days available to the BBG to deny any
BBG is a party. The proposed rule was
from the date of issuance; demand or request for testimony or
published for comment in 72 FR 10954
documents. Failure to comply with the
* * * * * dated March 12, 2007. The BBG
procedures set out in these regulations
(e) * * * received no responses to the proposed
would be a basis for denying a demand
rule. The final rule and corresponding
(2) * * * or request submitted to the BBG.
regulation establishes guidelines for use
(iii) * * * Feed containing florfenicol in determining whether BBG employees List of Subjects in 22 CFR Part 504
shall not be fed for more than 10 days. are permitted to testify or to provide
Following administration, fish should records relating to their official duties Administrative practice and
be reevaluated by a licensed and procedures that requesters must procedure.
veterinarian before initiating a further follow when making demands on, or ■ For the reasons stated in the preamble,
course of therapy. * * * requests to, a BBG employee for official the Broadcasting Board of Governors
(3) Freshwater-reared salmonids—(i) documents or to provide testimony. amends 22 CFR, Chapter V, by adding
Amount. 10 milligrams florfenicol per DATES: The effective date of the part 504, as follows:
kilogram of fish daily for 10 consecutive regulation is April 23, 2007.
days. FOR FURTHER INFORMATION CONTACT: PART 504—TESTIMONY BY BBG
Christopher Veith, Assistant General EMPLOYEES, PRODUCTION OF
(ii) Indications for use. For the control OFFICIAL RECORDS, AND
Counsel, Broadcasting Board of
of mortality due to coldwater disease Governors, 330 Independence Ave., DISCLOSURE OF OFFICIAL
associated with Flavobacterium SW., Washington, DC 20237, phone: INFORMATION IN LEGAL
psychrophilum. (202) 203–4550 or fax at (202) 203–4585. PROCEEDINGS
(iii) Limitations. Feed containing SUPPLEMENTARY INFORMATION: Briefly,
florfenicol shall not be fed for more than Subpart A—General Provisions
the final rule prohibits disclosure of
10 days. Following administration, fish nonpublic official records or testimony Sec.
should be reevaluated by a licensed 504.1 Scope and purpose.
by the BBG’s employees, as defined in 504.2 Applicability.
veterinarian before initiating a further Part 504.4, unless there is compliance 504.3 Definitions.
course of therapy. The effects of with the rule. The final rule sets out the
florfenicol on reproductive performance information that requesters must Subpart B—Demands or Requests for
have not been determined. Feeds provide and the factors that the BBG Testimony and Production of Documents
containing florfenicol must be will consider in making determinations 504.4 General prohibition.
withdrawn 15 days prior to slaughter. in response to requests for testimony or 504.5 Factors the BBG will consider.
the production of documents. 504.6 Filing requirements for litigants
Dated: April 9, 2007. seeking documents or testimony.
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The final rule applies to a range of


Bernadette Dunham, 504.7 Service of requests or demands.
matters in any legal proceeding in 504.8 Processing requests or demands.
Deputy Director, Center for Veterinary which the BBG is not a named party and 504.9 Final determinations.
Medicine. applies to current and former BBG 504.10 Restrictions that apply to testimony.
[FR Doc. E7–7475 Filed 4–19–07; 8:45 am] employees. The final rule will ensure a 504.11 Restrictions that apply to released
BILLING CODE 4160–01–S more efficient use of the BBG’s records.

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