Certain Other Dosage Form New Animal Drugs; Sevoflurane, 25507-25508 [E8-10153]

Download as PDF Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations Subpart BB—[Reserved] 2. Add and reserve subpart BB, consisting of §§ 121.1200 through 121.1399. I Subpart CC—[Reserved] 3. Add and reserve subpart CC, consisting of §§ 121.1400 through 121.1499. I Issued in Washington, DC on May 1, 2008. Pamela Hamilton-Powell, Director, Office of Rulemaking. [FR Doc. E8–10205 Filed 5–6–08; 8:45 am] BILLING CODE 4910–13–P SOCIAL SECURITY ADMINISTRATION 20 CFR Parts 401 and 402 [Docket No. SSA–2007–0067] RIN 0960–AG14 Privacy and Disclosure of Official Records and Information AGENCY: Social Security Administration (SSA). ACTION: security of our employees who are victims, or potential victims, of domestic violence. In order to safeguard their anonymity we will not disclose their work location and/or phone number to individuals who pose a threat to their personal safety. This final rule will strengthen our privacy and disclosure rules to better safeguard atrisk employees by amending 20 CFR Part 401, Appendix A (c)(4) to remove the sentence, ‘‘Location of duty station, including room number and telephone number.’’ We are also revising 20 CFR 402.45 to add a new paragraph (e) describing the rules governing the release of personally identifiable information. The changes in our rule will allow us to implement the Identity Protection Program (IPP). The IPP enhances the safety and security of our employees who reasonably believe that they are at risk of injury or other harm if certain employment information about them is disclosed. As it is a national program, the IPP ensures uniform application of the policy for atrisk employees. Public Comments Final rule. SUMMARY: We are issuing this final rule to adopt without change the final rules with request for comment published on December 10, 2007, at 72 FR 69616. This final rule amends the regulation at 20 CFR Part 401, Appendix A, which requires us to release an employee’s location of duty station upon request. This final rule also revises the regulation at 20 CFR 402.45 that describes the availability of records. DATES: Effective Date: This rule is effective May 7, 2008. FOR FURTHER INFORMATION CONTACT: Edie McCracken, Social Insurance Specialist, Office of Public Disclosure, 3–A–6 Operations Building, 6401 Security Boulevard, Baltimore, MD 21235–6401, (410) 965–6117. For information on eligibility or filing for benefits, call our national toll-free numbers, 1–800–772– 1213 or TTY 1–800–325–0778, or visit our Internet Web site, Social Security Online, at https:// www.socialsecurity.gov. The final rule with request for public comments that was published on December 10, 2007, and effective January 9, 2008, provided the public with a 60-day comment period. We received no comments. Regulatory Procedures Executive Order 12866, as Amended We have consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order (E.O.) 12866, as amended. Thus, it is not subject to OMB review. Regulatory Flexibility Act We certify that this final rule does not have a significant economic impact on a substantial number of small entities because it affects individuals. Thus, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required. Paperwork Reduction Act Electronic Version jlentini on PROD1PC65 with RULES SUPPLEMENTARY INFORMATION: This final rule imposes no reporting or record keeping requirements subject to OMB clearance. The electronic file of this document is available on the date of publication in the Federal Register at https:// www.gpoaccess.gov/fr/. Background We are implementing a nationwide program to enhance the safety and VerDate Aug<31>2005 16:44 May 06, 2008 Jkt 214001 (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security— Disability Insurance; 96.002, Social Security—Retirement Insurance; 96.004, Social Security—Survivors Insurance; 96.006, Supplemental Security Income) PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 25507 List of Subjects 20 CFR Parts 401 and 402 Administrative practice and procedure, Freedom of information, Privacy. Dated: April 30, 2008. Michael J. Astrue, Commissioner of Social Security. Accordingly, the final rule with request for comments, amending parts 401 and 402 of chapter III of title 20 of the Code of Federal Regulations that was published at 72 FR 69616 on December 10, 2007, is adopted as a final rule without change. I [FR Doc. E8–9998 Filed 5–6–08; 8:45 am] BILLING CODE 4191–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 Certain Other Dosage Form New Animal Drugs; Sevoflurane 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 an abbreviated new animal drug application (ANADA) filed by Minrad, Inc. The ANADA provides for the use of sevoflurane inhalant anesthetic in dogs. DATES: This rule is effective May 7, 2008. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Minrad, Inc., 836 Main St., 2nd floor, Buffalo, NY 14202, filed ANADA 200–438 that provides for use of PETREM (sevoflurane) inhalant anesthetic in dogs. Minrad, Inc.’s PETREM is approved as a generic copy of SEVOFLO, sponsored by Abbott Laboratories, under NADA 141–103. The ANADA is approved as of April 3, 2008, and the regulations are amended in § 529.2150 to reflect the approval. 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 E:\FR\FM\07MYR1.SGM 07MYR1 25508 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations 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(a)(1) 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. Dated: April 28, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–10153 Filed 5–6–08; 8:45 am] Dated: April 23, 2008. Stephen P. Metruck, Captain, U.S. Coast Guard, Captain of the Port, Puget Sound. [FR Doc. E8–10240 Filed 5–6–08; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4910–15–P DEPARTMENT OF HOMELAND SECURITY POSTAL SERVICE 39 CFR Part 111 Effective Date: This final rule is effective on May 7, 2008. The incorporation by reference of Issue 300, dated January 8, 2006, of the DMM and Issue 300 dated July 15, 2007, of the DMM is approved by the Director of the Federal Register as of May 7, 2008. FOR FURTHER INFORMATION CONTACT: Sharon Daniel, (202) 268–7304. SUPPLEMENTARY INFORMATION: The most recent Issue 300 of the Domestic Mail Manual was issued on July 15, 2007. It replaced the previous Issue 300 of the DMM and contained all DMM revisions from January 8, 2006 through July 15, 2007. The Issue 300 of the DMM that preceded that issue, was issued on January 8, 2006 and contained all DMM revisions from January 5, 2005 through January 8, 2006. These new Issues of the DMM contain all USPS domestic mailing standards, organized in a way that is more intuitive to the user. These new issues continue to (1) increase the user’s ability to find information, (2) increase confidence that users have found all the information they need, and (3) reduce the need to consult multiple chapters of the Manual to locate necessary information. Issue 300, dated July 15, 2007, set forth specific changes, such as new standards throughout the DMM to support the pricing changes recommended by the Postal Regulatory Commission in Docket No. R2006–1 and approved by the Governors of the United States Postal Service. New prices were implemented on May 14, 2007 for all classes of mail except Periodicals. Issue 300, dated January 8, 2006, also set forth specific changes such as new prices throughout the DMM to adopt the postal rates and fees resulting from the R2005–1 rate case. Changes to mailing standards will continue to be published through Federal Register notices and the Postal Bulletin, and will appear in the next printed version of Mailing Standards of the United States Postal Service, Domestic Mail Manual, and in the online version available via Postal Explorer https://pe.usps.com. Coast Guard General Information on Postal Service List of Subjects in 39 CFR Part 111 Postal Service. ACTION: Final rule. Administrative practice and procedure, Incorporation by reference. I In view of the considerations discussed above, the Postal Service hereby amends 39 CFR part 111 as follows: List of Subjects in 21 CFR Part 529 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 part 529 is amended as follows: I PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 529 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. In § 529.2150, revise paragraphs (a) and (b) to read as follows: I § 529.2150 Sevoflurane. (a) Specifications. Sevoflurane liquid. (b) Sponsors. See Nos. 000074 and 060307 in § 510.600(c) of this chapter. * * * * * AGENCY: 33 CFR Part 100 [Docket No. USCG–2008–0313] National Maritime Week Tugboat Races Coast Guard, DHS. Notice of enforcement of regulation. jlentini on PROD1PC65 with RULES AGENCY: ACTION: SUMMARY: The Coast Guard will enforce the National Maritime Week Tugboat Races Special Local Regulations in VerDate Aug<31>2005 16:44 May 06, 2008 Elliott Bay from 12 p.m. through 4:30 p.m. on May 10, 2008. This action is necessary to ensure the safety of participants and spectators during the National Maritime Week Tugboat Races. During the enforcement period, entry into, transit through, mooring, or anchoring within the regulated area is prohibited unless authorized by the Captain of the Port, Puget Sound or his designated representatives. DATES: The regulations in 33 CFR Part 100.1306 will be enforced from 12 p.m. through 4:30 p.m. on May 10, 2008. FOR FURTHER INFORMATION CONTACT: Lieutenant James M. Dupureur, c/o Captain of the Port Puget Sound, Coast Guard Sector Seattle, 1519 Alaskan Way South, Seattle, WA 98134 at (206) 217– 6045. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special local regulations for the annual National Maritime Week Tugboat Races in 33 CFR Part 100.1306 on May 10, 2008, from 12 p.m. to 4:30 p.m. Under the provisions of 33 CFR 100.1306, entry into, transit through, mooring, or anchoring within the regulated area is prohibited unless authorized by the Captain of the Port, Puget Sound or his designated representatives. Spectator vessels may safely transit outside the regulated area but may not anchor, block, loiter in, or impede the transit of race participants or official patrol vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation. This notice is issued under authority of 33 CFR 100.1306(c) and 5 U.S.C. 552(a). Jkt 214001 SUMMARY: The Postal Service announces the issuance of Issue 300, dated January 8, 2006; Issue 300, dated March 15, 2007; and Issue 300, dated May 14, 2007, of the Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), and their incorporation by reference in the Code of Federal Regulations. PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 DATES: PART 111—GENERAL INFORMATION ON POSTAL SERVICE 1. The authority citation for part 111 continues to read as follows: I E:\FR\FM\07MYR1.SGM 07MYR1

Agencies

[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Rules and Regulations]
[Pages 25507-25508]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10153]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


Certain Other Dosage Form New Animal Drugs; Sevoflurane

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 an abbreviated new animal drug 
application (ANADA) filed by Minrad, Inc. The ANADA provides for the 
use of sevoflurane inhalant anesthetic in dogs.

DATES:  This rule is effective May 7, 2008.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Minrad, Inc., 836 Main St., 2nd floor, 
Buffalo, NY 14202, filed ANADA 200-438 that provides for use of PETREM 
(sevoflurane) inhalant anesthetic in dogs. Minrad, Inc.'s PETREM is 
approved as a generic copy of SEVOFLO, sponsored by Abbott 
Laboratories, under NADA 141-103. The ANADA is approved as of April 3, 
2008, and the regulations are amended in Sec.  529.2150 to reflect the 
approval.
    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

[[Page 25508]]

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(a)(1) 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 529

    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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
2. In Sec.  529.2150, revise paragraphs (a) and (b) to read as follows:


Sec.  529.2150   Sevoflurane.

    (a) Specifications. Sevoflurane liquid.
    (b) Sponsors. See Nos. 000074 and 060307 in Sec.  510.600(c) of 
this chapter.
* * * * *

    Dated: April 28, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-10153 Filed 5-6-08; 8:45 am]
BILLING CODE 4160-01-S

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