New Animal Drugs For Use in Animal Feed; Withdrawal of Approval of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine, 19665-19666 [E7-7460]

Download as PDF Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Rules and Regulations paragraph (1)(i), redesignating (1)(ii) and (1)(iii) as (1)(i) and (1)(ii), respectively, and revising paragraph (12) to read as follows: § 1.1 General definitions. * * * * * Light-sport aircraft * * * * * * * * (12) Fixed or retractable landing gear, or a hull, for an aircraft intended for operation on water. * * * * * Issued in Washington, DC, on April 9, 2007. Marion C. Blakey, Administrator. [FR Doc. E7–7453 Filed 4–18–07; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of NADAs; Estradiol Benzoate AGENCY: Food and Drug Administration, HHS. cprice-sewell on PROD1PC66 with RULES ACTION: List of Subjects Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations that reflect approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, and in suckling beef calves for increased rate of weight gain. In a notice published elsewhere in this issue of the Federal Register, FDA has withdrawn approval of the NADAs. DATES: This rule is effective April 19, 2007. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276– 9067; e-mail: pamela.esposito@fda.hhs.gov. SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., Fort Collins, CO 80524, has requested that FDA withdraw approval of NADA 141–040 for DURALEASE (estradiol benzoate), a suspension implant of estradiol benzoate VerDate Aug<31>2005 15:04 Apr 18, 2007 microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency and NADA 141–041 for CELERIN-C (estradiol benzoate), a similar product used in suckling beef calves for increased rate of weight gain. This action is requested because the products are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 141– 040 and NADA 141–041 and all supplements and amendments thereto, were withdrawn, as of September 29, 2006. Following the withdrawal of approval of these NADAs, PR Pharmaceuticals, Inc., is no longer a sponsor of an approved application. Therefore, 21 CFR 510.600(c) is amended to remove entries for this firm. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect the withdrawal of approval. 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. Jkt 211001 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 522 Animal drugs. 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 510 and 522 are amended as follows: I PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. § 510.600 [Amended] 2. In § 510.600, in the table in paragraph (c)(1), remove the entry for ‘‘PR Pharmaceuticals, Inc.’’; and in the table in paragraph (c)(2) remove the entry for ‘‘067210’’. I PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 19665 PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. § 522.841 I [Removed] 4. Remove § 522.841. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–7458 Filed 4–18–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 558 New Animal Drugs For Use in Animal Feed; Withdrawal of Approval of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for intermediate premixes used to manufacture Type C medicated feeds. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs. DATES: This rule is effective April 30, 2007. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276– 9067, e-mail: pamela.esposito@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 68701, has requested that FDA withdraw approval of NADA 121– 200 for Tylosin 10 Premix (tylosin), NADA 129–159 for TYLAN 40 Sulfa-G (tylosin and sulfamethazine), and NADA 137–484 for Swine Guard-BN (pyrantel). All are intermediate premixes used to manufacture Type C medicated feeds. This action is requested because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA gives notice that approval of NADA E:\FR\FM\19APR1.SGM 19APR1 19666 Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Rules and Regulations 121–200, NADA 129–159, and NADA 137–484 and all supplements and amendments thereto, is withdrawn, effective April 30, 2007. Following the withdrawal of approval of these NADAs, Custom Feed Services Corp. is no longer a sponsor of an approved application. Therefore, 21 CFR 510.600(c) is amended to remove entries for this firm. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect the withdrawal of approval. 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. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–7460 Filed 4–18–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [CGD08–06–013] RIN 1625–AA09 List of Subjects Drawbridge Operation Regulation; Illinois Waterway, Illinois 21 CFR Part 510 AGENCY: Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. ACTION: 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 510 and 558 are amended as follows: I PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: I Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. [Amended] 2. In § 510.600, in the table in paragraph (c)(1), remove the entry for ‘‘Custom Feed Services Corp.’’; and in the table in paragraph (c)(2) remove the entry for ‘‘017473’’. I PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 3. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. § 558.485 [Amended] 4. In § 558.485, in paragraph (b)(3), remove ‘‘017473’’. cprice-sewell on PROD1PC66 with RULES I § 558.625 [Amended] 5. In § 558.625, remove and reserve paragraph (b)(68). I § 558.630 [Amended] 6. In § 558.630, in paragraph (b)(10), remove ‘‘017473’’. I VerDate Aug<31>2005 15:04 Apr 18, 2007 Jkt 211001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 Mr. Roger K. Wiebusch, Bridge Administrator, (314) 269–2378. SUPPLEMENTARY INFORMATION: Regulatory History On June 26, 2006, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation, Illinois Waterway, IL in the Federal Register (71 FR 36295). On November 16, 2006, we published a Supplemental notice of proposed rulemaking (SNPRM) entitled Drawbridge Operation Regulation, Illinois Waterway, IL in the Federal Register (71 FR 66713). We received no letters commenting on the proposed rules. No public hearing was requested, and none was held. Background and Purpose The Coast Guard is revising the drawbridge operations for the Pekin Railroad Drawbridge, Mile 151.2, at Pekin, Illinois and the Chessie Railroad Drawbridge, Mile 254.1 at Seneca, Illinois across the Illinois Waterway. The present regulation found in § 117.393(b) is being revised to reflect the actual procedures that have always been followed. That regulation was intended to be temporary, for test purposes only, and was inadvertently permanently included in the Code of Federal Regulations. This rule eliminates the ‘‘Specific Requirements’’ for remote operation, and the bridge will continue to operate, as required by the Coast Guard, under the ‘‘General Requirements’’. In addition, the Coast Guard is revising the regulation governing the operation of the Chessie Railroad Drawbridge across the Illinois Waterway, Mile 254.1, at Seneca, Illinois. The existing regulation requires the drawspan to open on signal. This revision is necessary to reflect a change in operating procedure. DATES: This rule is effective on May 21, 2007. ADDRESSES: Comments and material received from the public, as well as documents indicated in the preamble as being available in the docket, are part of docket CGD8–06–013 and are available for inspection or copying at room 2.107(f), in the Robert A. Young Federal Building, Eighth Coast Guard District, 1222 Spruce Street, St. Louis, MO 63103–2832, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. Commander (dwb), Eighth Coast Guard District, Bridge Branch maintains the public docket for this rulemaking. SUMMARY: 21 CFR Part 558 § 510.600 Coast Guard, DHS. Final rule. FOR FURTHER INFORMATION CONTACT: A test period to remotely operate the Pekin Railroad Drawbridge, Mile 151.2, across the Illinois Waterway was proposed by the bridge owner. After that test period, it was determined that remote operation was not feasible. The bridge owner withdrew the proposal and the Coast Guard required the continued on-site operation of the bridge. The bridge is not remotely operated. The bridge owner has always maintained an on-site bridge operator for the bridge. However, the regulation allowing the test period was inadvertently published as a permanent change, and can be found in 33 CFR 117.393(b). This rulemaking corrects the drawbridge operating regulations to reflect Coast Guard approved operating conditions presently adhered to by the bridge owner and waterway users. 33 CFR 117.5 requires the Chessie Railroad Drawbridge, mile 254.1, Illinois Waterway at Seneca, Illinois to open on signal for the passage of vessels. Due to reduced train use, the bridge owner removed the bridgetender, maintains the drawspan in the fully open position and allows train operators to close the bridge. This action was taken without proper Coast Guard notification or approval. The rule improves the navigation safety of bridge operations by establishing a method of operation and communication between vessels and bridge closure personnel. Discussion of Comments and Changes The Coast Guard received no comment letters in response to either the NPRM or the SNPRM. There were no requests for public meetings. No changes have been made to this final rule. E:\FR\FM\19APR1.SGM 19APR1

Agencies

[Federal Register Volume 72, Number 75 (Thursday, April 19, 2007)]
[Rules and Regulations]
[Pages 19665-19666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-7460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


New Animal Drugs For Use in Animal Feed; Withdrawal of Approval 
of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADAs) for intermediate premixes 
used to manufacture Type C medicated feeds. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADAs.

DATES: This rule is effective April 30, 2007.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail: 
pamela.esposito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Custom Feed Services Corp., 2100 N. 13th 
St., Norfolk, NE 68701, has requested that FDA withdraw approval of 
NADA 121-200 for Tylosin 10 Premix (tylosin), NADA 129-159 for TYLAN 40 
Sulfa-G (tylosin and sulfamethazine), and NADA 137-484 for Swine Guard-
BN (pyrantel). All are intermediate premixes used to manufacture Type C 
medicated feeds. This action is requested because the products are no 
longer manufactured or marketed.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA gives notice that approval of NADA

[[Page 19666]]

121-200, NADA 129-159, and NADA 137-484 and all supplements and 
amendments thereto, is withdrawn, effective April 30, 2007.
    Following the withdrawal of approval of these NADAs, Custom Feed 
Services Corp. is no longer a sponsor of an approved application. 
Therefore, 21 CFR 510.600(c) is amended to remove entries for this 
firm. As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect the withdrawal of approval.
    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 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 558

    Animal drugs, Animal feeds.

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 parts 510 and 
558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry 
for ``Custom Feed Services Corp.''; and in the table in paragraph 
(c)(2) remove the entry for ``017473''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec.  558.485  [Amended]

0
4. In Sec.  558.485, in paragraph (b)(3), remove ``017473''.


Sec.  558.625  [Amended]

0
5. In Sec.  558.625, remove and reserve paragraph (b)(68).


Sec.  558.630  [Amended]

0
6. In Sec.  558.630, in paragraph (b)(10), remove ``017473''.

    Dated: April 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-7460 Filed 4-18-07; 8:45 am]
BILLING CODE 4160-01-S

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