Implantation or Injectable Dosage Form New Animal Drugs; Estradiol Benzoate, 8457-8458 [06-1488]

Download as PDF Federal Register / Vol. 71, No. 33 / Friday, February 17, 2006 / Rules and Regulations Issued in Renton, Washington, on February 1, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 06–1412 Filed 2–16–06; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 47 and 49 [Docket No.: FAA–2004–19944; Amendment Nos. 47–27 and 49–10] RIN 2120–AI48 Cape Town Treaty Implementation Federal Aviation Administration (FAA), DOT. ACTION: Final rule; confirmation of effective date; approval for collection of public information. AGENCY: This document confirms the effective date of the January 3, 2005, final rule amending 14 CFR parts 47 and 49 to comply with the Cape Town Treaty Implementation Act of 2004. This document also confirms the approval by the Office of Management and Budget (OMB) for the collection of public information contained in the final rule. EFFECTIVE DATE: The effective date for the final rule amending 14 CFR parts 47 and 49 published at 70 FR 240, January 3, 2005, is March 1, 2006. FOR FURTHER INFORMATION CONTACT: Mr. Mark D. Lash, Civil Aviation Registry, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169, telephone (405) 954– 4331. SUMMARY: SUPPLEMENTARY INFORMATION: wwhite on PROD1PC61 with RULES Confirmation of Effective Date The FAA published a final rule, with a request for comment on the information collection requirements, in the Federal Register on January 3, 2005 (70 FR 240). This final rule revised the regulations concerning registering aircraft and recording security documents as directed by Section 4 of the Cape Town Treaty Implementation Act of 2004. The Cape Town Treaty (the Treaty) establishes a new International Registry for registering interests against certain aircraft and aircraft engines. These amendments enable persons to send information to the International Registry concerning certain aircraft and aircraft engines by making the FAA Aircraft Registry the U.S. authorizing entry point to the International Registry. VerDate Aug<31>2005 18:49 Feb 16, 2006 Jkt 208001 When published, the final rule indicated that these amendments become effective concurrent with the date the Treaty enters into force with respect to the United States. Under the terms of the Treaty, it enters into force three months after the eighth country deposits formal instruments with the International Institute for the Unification of Private Law depositary in Rome. FAA advised that it would publish a document announcing the effective date of this final rule. As of January 1, 2006, eight countries, including the United States, have deposited instruments of ratification. Thus, the Treaty enters into force with respect to the United States and the final rule becomes effective on March 1, 2006. OMB Approval for the Collection of Public Information When published, the final rule indicated that the FAA had submitted the information requirements associated with this final rule to OMB with a request for clearance. The effective date for the collection of this public information should be concurrent with the date the Treaty enters into force with respect to the United States, once approved by OMB. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this collection is 2120–0697. Notwithstanding any other provisions of law, no person is subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. OMB Control Number: 2120–0697. OMB Approval Date: 03/29/05. OMB Expiration Date: 03/31/08. Title: FAA Entry Point Filing Form— International Registry. Form Number: AC Form 8050–135. Respondents: Law firms, technical level personnel (paralegals), and the public. Number of Respondents: 15,000. Estimated Time per Response: 30 minutes. Needs and Uses: Public Law 108–297 designates the FAA Aircraft Registry as the U.S. entry point for authorizing the transmission of information relating to civil aircraft of the United States, aircraft for which a United States identification has been assigned (but only with respect to notices of prospective assignments, interests, and sales), and aircraft engines, to the International Registry. It also provides for the filing of notices of prospective PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 8457 interests. To transmit certain types of interests or prospective interests to the International Registry, interested parties must file a completed FAA Entry Point Filing Form—International Registry, AC Form 8050–135, with the FAA Civil Aviation Registry. Upon receipt of the completed form, the FAA Civil Aviation Registry will issue the unique authorization code. The FAA did not receive any adverse comments on the proposed information collection, and it was approved by OMB. Issued in Washington, DC on February 10, 2006. Anthony F. Fazio, Director, Office of Rulemaking. [FR Doc. 06–1484 Filed 2–16–06; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Estradiol Benzoate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by PR Pharmaceuticals, Inc. The supplemental NADA provides for subcutaneous injection, in the ear only, of a suspension implant of estradiol benzoate microspheres for increased rate of weight gain in suckling beef calves. It also adds the indication for use for increased rate of weight gain in steers fed in confinement for slaughter, previously approved at a lower dose, to the higher approved dose level. DATES: This rule is effective February 17, 2006. FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary Medicine (HFV–126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0232, email: eric.dubbin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., Fort Collins, CO 80524, filed a supplement to NADA 141–040 that provides for use of DURALEASE (estradiol benzoate) Microencapsulated Suspension Implant by subcutaneous injection in the ear for increased rate of E:\FR\FM\17FER1.SGM 17FER1 8458 Federal Register / Vol. 71, No. 33 / Friday, February 17, 2006 / Rules and Regulations weight gain in suckling beef calves. The supplemental NADA also adds the indication for use for increased rate of weight gain in steers fed in confinement for slaughter, previously approved at a lower dose, to the higher approved dose level. The supplemental NADA is approved as of January 19, 2006, and the regulations are amended in 21 CFR 522.841 to reflect the approval. The basis of approval is discussed in the freedom of information summary. 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. The agency has determined under 21 CFR 25.33(c) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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 in 21 CFR Part 522 Animal drugs. I 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 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: I Authority: 21 U.S.C. 360b. 2. In § 522.841, revise paragraph (d) to read as follows: I § 522.841 Estradiol benzoate. wwhite on PROD1PC61 with RULES * * * * * (d) Conditions of use. It is used by subcutaneous injection as follows: (1) Amount and indications for use— (i) Suckling beef calves. 10 mg (1 mL of product described in paragraph (a)(1) of this section or 0.5 mL of product described in paragraph (a)(2) of this section) for increased rate of weight gain. VerDate Aug<31>2005 18:49 Feb 16, 2006 Jkt 208001 VI. Procedural Determinations (ii) Cattle fed in confinement for slaughter. 20 mg (1 mL of product described in paragraph (a)(2) of this section) for increased rate of weight gain and improved feed efficiency. (2) Limitations. For subcutaneous injection in the ear only. Do not use in calves intended for reproduction or calves less than 30 days old. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Dated: February 8, 2006. David R. Newkirk, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 06–1488 Filed 2–16–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 [Docket No. TX–055–FOR] Texas Regulatory Program Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. AGENCY: SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to the Texas Surface Coal Mining and Reclamation Act (TSCMRA) and the Texas Administrative Code (TAC) regarding the State’s annual fees that are required from coal mining permit holders. Texas proposed to change the requirement for the current annual fee and to add two new annual fees. Texas intends to revise its program to reduce the economic cost to the coal mining industry as a whole and to require coal mining permit holders that have ceased mining to pay annual fees. EFFECTIVE DATE: February 17, 2006. FOR FURTHER INFORMATION CONTACT: Michael C. Wolfrom, Director, Tulsa Field Office. Telephone: (918) 581– 6430. E-mail: mwolfrom@osmre.gov. SUPPLEMENTARY INFORMATION: I. Background on the Texas Program II. Submission of the Amendment III. OSM’s Findings IV. Summary and Disposition of Comments V. OSM’s Decision PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 I. Background on the Texas Program Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, ‘‘a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.’’ See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Texas program effective February 16, 1980. You can find background information on the Texas program, including the Secretary’s findings, the disposition of comments, and the conditions of approval, in the February 27, 1980, Federal Register (45 FR 12998). You can find later actions on the Texas program at 30 CFR 943.10, 943.15, and 943.16. II. Submission of the Amendment By letter dated October 6, 2005 (Administrative Record No. TX–660), Texas sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq.). Texas sent the amendment at its own initiative. We announced receipt of the proposed amendment in the November 29, 2005, Federal Register (70 FR 71441). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on December 29, 2005. We received comments from one industry group. III. OSM’s Findings Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below. Any revisions that we do not specifically discuss below concern nonsubstantive wording or editorial changes. A. TSCMRA Section 134.055. Annual Fee Section 134.055 of Texas’ statute currently requires each permit holder to pay an annual fee for each acre of land in the permit area on which the permit holder actually conducted operations E:\FR\FM\17FER1.SGM 17FER1

Agencies

[Federal Register Volume 71, Number 33 (Friday, February 17, 2006)]
[Rules and Regulations]
[Pages 8457-8458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1488]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Estradiol Benzoate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by PR Pharmaceuticals, Inc. The supplemental 
NADA provides for subcutaneous injection, in the ear only, of a 
suspension implant of estradiol benzoate microspheres for increased 
rate of weight gain in suckling beef calves. It also adds the 
indication for use for increased rate of weight gain in steers fed in 
confinement for slaughter, previously approved at a lower dose, to the 
higher approved dose level.

DATES: This rule is effective February 17, 2006.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: eric.dubbin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., 
Fort Collins, CO 80524, filed a supplement to NADA 141-040 that 
provides for use of DURALEASE (estradiol benzoate) Microencapsulated 
Suspension Implant by subcutaneous injection in the ear for increased 
rate of

[[Page 8458]]

weight gain in suckling beef calves. The supplemental NADA also adds 
the indication for use for increased rate of weight gain in steers fed 
in confinement for slaughter, previously approved at a lower dose, to 
the higher approved dose level. The supplemental NADA is approved as of 
January 19, 2006, and the regulations are amended in 21 CFR 522.841 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    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.
    The agency has determined under 21 CFR 25.33(c) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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 in 21 CFR Part 522

    Animal drugs.


0
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 part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.841, revise paragraph (d) to read as follows:


Sec.  522.841  Estradiol benzoate.

* * * * *
    (d) Conditions of use. It is used by subcutaneous injection as 
follows:
    (1) Amount and indications for use--(i) Suckling beef calves. 10 mg 
(1 mL of product described in paragraph (a)(1) of this section or 0.5 
mL of product described in paragraph (a)(2) of this section) for 
increased rate of weight gain.
    (ii) Cattle fed in confinement for slaughter. 20 mg (1 mL of 
product described in paragraph (a)(2) of this section) for increased 
rate of weight gain and improved feed efficiency.
    (2) Limitations. For subcutaneous injection in the ear only. Do not 
use in calves intended for reproduction or calves less than 30 days 
old. A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

    Dated: February 8, 2006.
David R. Newkirk,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 06-1488 Filed 2-16-06; 8:45 am]
BILLING CODE 4160-01-S

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