Federal Register / Vol. 72, No. 76 / Friday, April 20, 2007 / Rules and Regulations 19797 

of Food and Drugs, 21 CFR part 522 is 

amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In § 522.558, paragraph (a) is 

revised to read as follows: 

§ 522.558 Dexmedetomidine. 

(a) Specifications. Each milliliter of 

solution contains 0.5 milligram (mg) of 

dexmedetomidine hydrochloride. 

* * * * * 

Dated: April 13, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–7594 Filed 4–19–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 556 and 558 

New Animal Drugs; Florfenicol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

approval of a supplemental new animal 

drug application (NADA) filed by 

Schering-Plough Animal Health Corp. 

The supplemental NADA provides for 

the use of florfenicol by veterinary feed 

directive (VFD) for the control of 

mortality in freshwater-reared 

salmonids due to coldwater disease 

associated with Flavobacterium 

psychrophilum. 

DATES: This rule is effective April 20, 

2007. 

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov. 

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 556 Morris 

Ave., Summit, NJ 07901, filed a 

supplement to NADA 141–246 that 

provides for use of AQUAFLOR 

(florfenicol), a type A medicated article, 

by VFD to formulate type C medicated 

feed for the control of mortality in 

freshwater-reared salmonids due to 

coldwater disease associated with F. 

psychrophilum. The supplemental 

application is approved as of March 19, 

2007, and the regulations are amended 

in 21 CFR 556.283, 558.4, and 558.261 

to reflect the approval. 

The single VFD order form for 

florfenicol includes both catfish and 

freshwater-reared salmonid indications 

because each comprises multiple 

species and is approved in each for use 

under similar directions and conditions 

of use. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Under section 573(c) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360ccc-2), this supplemental 

approval qualifies for 7 years of 

exclusive marketing rights beginning 

March 19, 2007, because the new animal 

drug has been declared a designated 

new animal drug by FDA under section 

573(a) of the act. 

The agency has carefully considered 

the potential environmental impact of 

this action and has concluded that the 

action will not have a significant impact 

on the human environment and that an 

environmental impact statement is not 

required. FDA’s finding of no significant 

impact and the evidence supporting that 

finding, contained in an environmental 

assessment, may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects 

21 CFR Part 556 

Animal drugs, Foods. 

21 CFR Part 558 

Animal drugs, Animal feeds. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 556 and 558 are amended as 

follows: 

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD 

■ 1. The authority citation for 21 CFR 

part 556 continues to read as follows: 

Authority: 21 U.S.C. 342, 360b, 371. 

■ 2. In § 556.283, add paragraph (b)(4) to 

read as follows: 

§ 556.283 Florfenicol. 

* * * * * 

(b) * * * 

(4) Salmonids. The tolerance for 

florfenicol amine (the marker residue) in 

muscle/skin (the target tissues) is 1 

ppm. 

* * * * * 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 3. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 4. In paragraph (d) of § 558.4, in the 

‘‘Category II’’ table, revise the entry in 

alphabetical order for ‘‘Florfenicol’’ to 

read as follows: 

§ 558.4 Requirement of a medicated feed 

mill license. 

* * * * * 

(d) * * * 

CATEGORY II 

Drug Assay limits percent 1

Type A Type B maximum (100x) Assay limits percent1

Type B/C2

* * * * * * * 

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 

Drug Assay limits percent 1

Type A Type B maximum (100x) Assay limits percent1Type B/C2

* * * * * * * 

1Percent of labeled amount. 

2Values 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. 

* * * * * 

■ 5. In § 558.261, revise paragraph 

(a)(2), paragraph (c)(2)(i), and the first 

two sentences of paragraph (e)(2)(iii); 

and add new paragraph (e)(3) to read as 

follows: 

§ 558.261 Florfenicol. 

(a) * * * 

(2) 500 grams per kilogram for use as 

in paragraphs (e)(2) and (e)(3) of this 

section. 

* * * * * 

(c) * * * 

(2) * * * 

(i) For catfish and freshwater-reared 

salmonids, must not exceed 15 days 

from the date of issuance; 

* * * * * 

(e) * * * 

(2) * * * 

(iii) * * * Feed containing florfenicol 

shall not be fed for more than 10 days. 

Following administration, fish should 

be reevaluated by a licensed 

veterinarian before initiating a further 

course of therapy. * * * 

(3) Freshwater-reared salmonids—(i) 

Amount. 10 milligrams florfenicol per 

kilogram of fish daily for 10 consecutive 

days. 

(ii) Indications for use. For the control 

of mortality due to coldwater disease 

associated with Flavobacterium 

psychrophilum. 

(iii) Limitations. Feed containing 

florfenicol shall not be fed for more than 

10 days. Following administration, fish 

should be reevaluated by a licensed 

veterinarian before initiating a further 

course of therapy. The effects of 

florfenicol on reproductive performance 

have not been determined. Feeds 

containing florfenicol must be 

withdrawn 15 days prior to slaughter. 

Dated: April 9, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–7475 Filed 4–19–07; 8:45 am] 

BILLING CODE 4160–01–S 

BROADCASTING BOARD OF 

GOVERNORS 

22 CFR Part 504 

Testimony by BBG Employees, 

Production of Official Records, and 

Disclosure of Official Information In 

Legal Proceedings 

AGENCY: Broadcasting Board of 

Governors. 

ACTION: Final rule. 

SUMMARY: The Broadcasting Board of 

Governors (BBG) is publishing as a final 

rule a regulation governing access to 

BBG information and records in 

connection with legal proceedings in 

which neither the United States nor the 

BBG is a party. The proposed rule was 

published for comment in 72 FR 10954 

dated March 12, 2007. The BBG 

received no responses to the proposed 

rule. The final rule and corresponding 

regulation establishes guidelines for use 

in determining whether BBG employees 

are permitted to testify or to provide 

records relating to their official duties 

and procedures that requesters must 

follow when making demands on, or 

requests to, a BBG employee for official 

documents or to provide testimony. 

DATES: The effective date of the 

regulation is April 23, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Veith, Assistant General 

Counsel, Broadcasting Board of 

Governors, 330 Independence Ave., 

SW., Washington, DC 20237, phone: 

(202) 203–4550 or fax at (202) 203–4585. 

SUPPLEMENTARY INFORMATION: Briefly, 

the final rule prohibits disclosure of 

nonpublic official records or testimony 

by the BBG’s employees, as defined in 

Part 504.4, unless there is compliance 

with the rule. The final rule sets out the 

information that requesters must 

provide and the factors that the BBG 

will consider in making determinations 

in response to requests for testimony or 

the production of documents. 

The final rule applies to a range of 

matters in any legal proceeding in 

which the BBG is not a named party and 

applies to current and former BBG 

employees. The final rule will ensure a 

more efficient use of the BBG’s 

resources, minimize the possibility of 

involving the BBG in issues unrelated to 

its responsibilities, promote uniformity 

in responding to subpoenas and like 

requests, and maintain the impartiality 

of the BBG in matters that are in dispute 

between other parties. It will also serve 

the BBG’s interest in protecting 

sensitive, confidential, and privileged 

information and records that are 

generated in fulfillment of the BBG’s 

statutory responsibilities. 

The final rule is internal and 

procedural rather than substantive. It 

does not create a right to obtain official 

records or the official testimony of a 

BBG employee nor does it create any 

additional right or privilege not already 

available to the BBG to deny any 

demand or request for testimony or 

documents. Failure to comply with the 

procedures set out in these regulations 

would be a basis for denying a demand 

or request submitted to the BBG. 

List of Subjects in 22 CFR Part 504 

Administrative practice and 

procedure. 

■ For the reasons stated in the preamble, 

the Broadcasting Board of Governors 

amends 22 CFR, Chapter V, by adding 

part 504, as follows: 

PART 504—TESTIMONY BY BBG 

EMPLOYEES, PRODUCTION OF 

OFFICIAL RECORDS, AND 

DISCLOSURE OF OFFICIAL 

INFORMATION IN LEGAL 

PROCEEDINGS 

Subpart A—General Provisions 

Sec. 

504.1 Scope and purpose. 

504.2 Applicability. 

504.3 Definitions. 

Subpart B—Demands or Requests for 

Testimony and Production of Documents 

504.4 General prohibition. 

504.5 Factors the BBG will consider. 

504.6 Filing requirements for litigants 

seeking documents or testimony. 

504.7 Service of requests or demands. 

504.8 Processing requests or demands. 

504.9 Final determinations. 

504.10 Restrictions that apply to testimony. 

504.11 Restrictions that apply to released 

records. 


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