Professional Documents
Culture Documents
AMS is committed to compliance § 1207.507 Administrative Committee. under NADA 103–037. The ANADA is
with the Government Paperwork (a) The Board shall annually select approved as of November 17, 2006, and
Elimination Act (GPEA), which requires from among its members an the regulations in 21 CFR 522.1044 are
Government agencies in general to Administrative Committee composed of amended to reflect the approval and a
provide the public the option of producer members as provided for in current format. The basis of approval is
submitting information or transacting the Board’s bylaws, one or more discussed in the freedom of information
business electronically to the maximum importer members, and the public summary.
extent possible. member. Selection shall be made in In accordance with the freedom of
In addition, USDA has not identified such manner as the Board may information provisions of 21 CFR part
any relevant Federal rules that prescribe: Except that such committee 20 and 21 CFR 514.11(e)(2)(ii), a
duplicate, overlap or conflict with this shall include the Chairperson and seven summary of safety and effectiveness
rule. Vice-Chairpersons, one of whom shall data and information submitted to
Further, the Board’s meetings were also serve as the Secretary and Treasurer support approval of this application
widely publicized throughout the potato of the Board. may be seen in the Division of Dockets
industry and all interested persons were * * * * * Management (HFA–305), Food and Drug
invited to attend the meetings and Administration, 5630 Fishers Lane, rm.
Dated: December 18, 2006.
participate in Board deliberations. Like 1061, Rockville, MD 20852, between 9
Lloyd C. Day, a.m. and 4 p.m., Monday through
all Board meetings, the March 18, 2006,
Administrator, Agricultural Marketing Friday.
meeting was a public meeting and all
Service. FDA has determined under 21 CFR
entities, both large and small, were able
[FR Doc. E6–21911 Filed 12–21–06; 8:45 am] 25.33(a)(1) that this action is of a type
to express their views on this issue.
Finally, interested persons are invited to BILLING CODE 3410–02–P that does not individually or
submit information on the regulatory cumulatively have a significant effect on
and informational impacts of this action the human environment. Therefore,
on small businesses. DEPARTMENT OF HEALTH AND neither an environmental assessment
This rule invites comments on a HUMAN SERVICES nor an environmental impact statement
change to the Administrative Committee is required.
Food and Drug Administration This rule does not meet the definition
structure as currently prescribed under
the Plan. Any comments timely received of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
21 CFR Part 522 it is a rule of ‘‘particular applicability.’’
will be considered prior to finalization
of this rule. Therefore, it is not subject to the
Implantation or Injectable Dosage congressional review requirements in 5
Pursuant to 5 U.S.C. 553, it is also Form New Animal Drugs; Gentamicin
found and determined upon good cause U.S.C. 801–808.
that it is impracticable, unnecessary, AGENCY: Food and Drug Administration, List of Subjects in 21 CFR Part 522
and contrary to the public interest to HHS.
ACTION: Final rule. Animal drugs.
give preliminary notice prior to putting
■ Therefore, under the Federal Food,
this rule into effect and that good cause
SUMMARY: The Food and Drug Drug, and Cosmetic Act and under
exists for not postponing the effective
Administration (FDA) is amending the authority delegated to the Commissioner
date of this rule until 30 days after
animal drug regulations to reflect of Food and Drugs and redelegated to
publication in the Federal Register
approval of an abbreviated new animal the Center for Veterinary Medicine, 21
because: (1) Making this change
drug application (ANADA) filed by CFR part 522 is amended as follows:
effective prior to that date will facilitate
Sparhawk Laboratories, Inc. The
Committee operations; (2) this issue has PART 522—IMPLANTATION OR
ANADA provides for use of a
been widely discussed at various INJECTABLE DOSAGE FORM NEW
gentamicin sulfate injectable solution in
industry and association meetings, and ANIMAL DRUGS
piglets for treatment of porcine
interested persons have had time to
colibacillosis.
determine and express their positions; ■ 1. The authority citation for 21 CFR
and (3) this rule provides a 60-day DATES: This rule is effective December part 522 continues to read as follows:
comment period and any comments 22, 2006.
Authority: 21 U.S.C. 360b.
received will be considered prior to FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary ■ 2. In § 522.1044, revise the section
finalization of this rule.
Medicine (HFV 104), Food and Drug heading and paragraphs (a) and (b) to
List of Subjects in 7 CFR Part 1207 read as follows:
Administration, 7500 Standish Pl.,
Advertising, Agricultural research, Rockville, MD 20855, 301–827–0169, e- § 522.1044 Gentamicin.
Imports, Potatoes, Reporting and mail: john.harshman@fda.hhs.gov. (a) Specifications. Each milliliter of
recordkeeping requirements. SUPPLEMENTARY INFORMATION: Sparhawk solution contains gentamicin sulfate
■ For the reasons set forth in the Laboratories, Inc., 12340 Santa Fe Trail equivalent to 5, 50, or 100 milligrams
preamble, 7 CFR part 1207 is amended Dr., Lenexa, KS 66215, filed ANADA (mg) gentamicin.
as follows: 200–394 for the use of Gentamicin (b) Sponsors. See sponsors in
Sulfate Injection in piglets up to 3 days § 510.600(c) of this chapter for use as in
PART 1207—POTATO RESEARCH old for treatment of porcine paragraph (d) of this section.
AND PROMOTION PLAN colibacillosis caused by strains of (1) No. 000061 for use of 5 mg per
Escherichia coli sensitive to gentamicin. milliliter (/mL) solution in swine as in
■ 1. The authority citation for 7 CFR
Sparhawk Laboratories, Inc.’s paragraph (d)(4), 50 mg/mL solution in
jlentini on PROD1PC65 with RULES
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76902 Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations
(2) No. 058005 for use of 5 mg/mL has regulatory responsibility for the question of whether the investigator is
solution in swine as in paragraph (d)(4) medical device subject to this regulation entitled to receive investigational
of this section. is responsible for corresponding with devices.
(3) No. 000010 for use of 50 mg/mL the investigator of the study concerning * * * * *
solution in dogs as in paragraph (d)(5) any possible violations of the applicable Dated: December 12, 2006.
of this section. requirements. Therefore, FDA is
(4) No. 059130 for use of 100 mg/mL Jeffrey Shuren,
updating this regulation to include the
solution in turkeys as in paragraph references to CBER and CDER. Assistant Commissioner for Policy.
(d)(2) and in chickens as in paragraph Publication of this document [FR Doc. E6–21952 Filed 12–21–06; 8:45 am]
(d)(3) of this section. constitutes final action under the BILLING CODE 4160–01–S
investigator. Currently, only a reference but not accepted by the Center, the As published, the final and temporary
to the Center for Devices and investigator will be given an regulations (TD 9278) contains errors
Radiological Health is listed in this opportunity for a regulatory hearing that may prove to be misleading and are
regulation. The appropriate Center that under part 16 of this chapter on the in need of clarification.
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