Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine Suspension, 53685-53686 [E8-21625]

Download as PDF 53685 Rules and Regulations Federal Register Vol. 73, No. 181 Wednesday, September 17, 2008 The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. FEDERAL RESERVE SYSTEM 12 CFR Part 202 [Regulation B; Docket No. R–1327] Equal Credit Opportunity Board of Governors of the Federal Reserve System. ACTION: Final rule; technical amendment. AGENCY: The Board is publishing amendments to Regulation B (Equal Credit Opportunity Act) to update the address where questions should be directed concerning creditors for which the Office of Thrift Supervision administers compliance with the regulation. SUMMARY: Effective Date: October 17, 2008. Compliance is optional until September 17, 2009. FOR FURTHER INFORMATION CONTACT: Jamie Z. Goodson, Attorney, Division of Consumer and Community Affairs, Board of Governors of the Federal Reserve System, at (202) 452–3667. For the users of Telecommunications Device for the Deaf (‘‘TDD’’) only, contact (202) 263–4869. SUPPLEMENTARY INFORMATION: The Equal Credit Opportunity Act (ECOA), 15 U.S.C. 1691–1691f, makes it unlawful for a creditor to discriminate against an applicant in any aspect of a credit transaction on the basis of the applicant’s national origin, marital status, religion, sex, color, race, age (provided the applicant has the capacity to contract), receipt of public assistance benefits, or the good faith exercise of a right under the Consumer Credit Protection Act, 15 U.S.C. 1601 et seq. The ECOA is implemented by the Board’s Regulation B. In addition to the general prohibition against discrimination, Regulation B contains specific rules concerning the taking and evaluation of credit mstockstill on PROD1PC66 with RULES DATES: VerDate Aug<31>2005 16:59 Sep 16, 2008 Jkt 214001 applications, including procedures and notices for credit denials and other adverse actions. Under section 202.9 of Regulation B, notification given to an applicant when adverse action is taken must contain the name and address of the federal agency that administers compliance with respect to the creditor. Appendix A of Regulation B contains the names and addresses of the enforcement agencies where questions concerning a particular creditor shall be directed. This amendment updates the address for the Office of Thrift Supervision. Creditors for which the Office of Thrift Supervision administers compliance with Regulation B must include this new address on their adverse action notices starting September 17, 2009. Secretary of the Board under delegated authority, September 11, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8–21629 Filed 9–16–08; 8:45 am] List of Subjects in 12 CFR Part 202 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. AGENCY: Aged, Banks, Banking, Civil rights, Consumer protections, Credit, Discrimination, Federal Reserve System, Marital status discrimination, Penalties, Religious discrimination, Sex discrimination. Authority and Issuance For the reasons set forth in the preamble, the Board amends 12 CFR part 202 to read as follows: ■ PART 202—EQUAL CREDIT OPPORTUNITY ACT (REGULATION B) 1. The authority citation for part 202 continues to read as follows: ■ Authority: Section 15 U.S.C. 1691–1691f. 2. Appendix A is amended by removing the fifth and sixth paragraphs and adding a new paragraph in their place to read as follows: ■ APPENDIX A TO PART 202—FEDERAL ENFORCEMENT AGENCIES * * * * * Savings institutions under the Savings Association Insurance Fund of the FDIC and federally chartered savings banks insured under the Bank Insurance Fund of the FDIC (but not including state-chartered savings banks insured under the Bank Insurance Fund): Office of Thrift Supervision, Consumer Response Unit, 1700 G Street, NW., Washington, DC 20552. * * * * * By order of the Board of Governors of the Federal Reserve System, acting through the PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA–2008–N–0039] Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine Suspension 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 Animal Health Pharmaceuticals, LLC. The supplemental NADA provides for a revised human food safety warning on labeling for an oral suspension of sulfadiazine and pyrimethamine used for the treatment of equine protozoal myeloencephalitis (EPM). DATES: This rule is effective September 17, 2008. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO 64506, filed a supplement to NADA 141–240 for use of REBALANCE (sulfadiazine/pyrimethamine) Antiprotozoal Oral Suspension for the treatment of EPM caused by Sarcocystis neurona. The supplement provides for a revised human food safety warning on labeling. The supplemental NADA is approved as of August 27, 2008, and 21 CFR 520.2215 is amended to reflect the approval. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or E:\FR\FM\17SER1.SGM 17SER1 53686 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations information. Therefore, a freedom of information summary is not required. 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 520 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 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 2. In 520.2215, revise paragraph (c)(3) to read as follows: ■ § 520.2215 Sulfadiazine/pyrimethamine suspension. * * * * * (c) * * * (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: September 5, 2008. William T. Flynn, Acting Director, Center for Veterinary Medicine. [FR Doc. E8–21625 Filed 9–16–08; 8:45 am] BILLING CODE 4160–01–S MILLENNIUM CHALLENGE CORPORATION List of Subjects in 22 Part 1304 Freedom of Information Act Procedures. ■ For the reasons set forth in the preamble, the Millennium Challenge Corporation adds 22 CFR part 1304 as follows: [Docket No. FDA–2008–N–0310] Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date Food and Drug Administration, HHS. Direct final rule; confirmation of effective date. ACTION: Jkt 214001 PART 1304—FREEDOM OF INFORMATION ACT PROCEDURES Sec. 1304.1 General Provisions. 1304.2 Definitions. 1304.3 Records available to the public. 1304.4 Requests for records. 1304.5 Responsibility for responding to requests. 1304.6 Records not disclosed. 1304.7 Confidential commercial information. 1304.8 Appeals. 1304.9 Fees. Millennium Challenge Corporation. ACTION: Final rule. 21 CFR Part 803 mstockstill on PROD1PC66 with RULES Dated: September 11, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–21756 Filed 9–16–08; 8:45 am] AGENCY: Food and Drug Administration 16:59 Sep 16, 2008 Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, the amendments issued thereby become effective on October 27, 2008. Regulations Implementing the Freedom of Information Act DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Aug<31>2005 In the Federal Register of June 13, 2008 (73 FR 33692), FDA solicited comments concerning the direct final rule for a 75day period ending August 27, 2008. FDA stated that the effective date of the direct final rule would be on October 27, 2008, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments. SUPPLEMENTARY INFORMATION: Millennium Challenge Corporation public records. DATES: This final rule is effective on September 17, 2008. ADDRESSES: Send comments to John Mantini, FOIA Officer, Office of the General Counsel, Millennium Challenge Corporation, 875 Fifteenth Street, NW., Washington, DC 20005–2221. FOR FURTHER INFORMATION CONTACT: John Mantini, FOIA Officer, 202–521–3863. SUPPLEMENTARY INFORMATION: The Millennium Challenge Act (MCA) of 2003 established a new federal agency called the Millennium Challenge Corporation. Congress enacted the Freedom of Information Act (FOIA) in 1966 and last modified it with the Electronic Freedom of Information Act amendments of 1996. On August 28, 2007, the Millennium Challenge Corporation published a proposed rule in the Federal Register, 72 FR 49238, Aug. 28, 2007 to outline its procedures to implement the FOIA regulations and requested public comments. The Millennium Challenge Corporation received no comments during the 60day comment period. The Millennium Challenge Corporation’s final regulations are identical to those in the proposed rule. This final rule addresses electronically available documents, procedures for making requests, agency handling of requests, records not disclosed, changes in fees, and public reading rooms as well as other related provisions. 22 CFR Part 1304 BILLING CODE 4160–01–S AGENCY: SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of October 27, 2008, for the final rule that appeared in the Federal Register of June 13, 2008 (73 FR 33692). The direct final rule amends the Medical Device Reporting regulation by removing the requirement for baseline reports. This document confirms the effective date of the direct final rule. DATES: Effective date confirmed: October 27, 2008. FOR FURTHER INFORMATION CONTACT: Howard A. Press, Center for Devices and Radiological Health (HFZ–531), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240–276– 3457. SUMMARY: The Millennium Challenge Corporation is issuing a final rule to update its Freedom of Information Act regulations. The purpose of this final rule is to outline the procedures by which the Millennium Challenge Corporation proposes to implement the relevant provisions of the Freedom of Information Act as required under that statute. This document will assist interested parties in obtaining access to PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 Authority: 5 U.S.C. 552, as amended. § 1304.1 General Provisions. This part contains the regulations the Millennium Challenge Corporation (MCC) follows in implementing the E:\FR\FM\17SER1.SGM 17SER1

Agencies

[Federal Register Volume 73, Number 181 (Wednesday, September 17, 2008)]
[Rules and Regulations]
[Pages 53685-53686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]


Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine 
Suspension

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 Animal Health Pharmaceuticals, LLC. The 
supplemental NADA provides for a revised human food safety warning on 
labeling for an oral suspension of sulfadiazine and pyrimethamine used 
for the treatment of equine protozoal myeloencephalitis (EPM).

DATES: This rule is effective September 17, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Animal Health Pharmaceuticals, LLC, 1805 Oak 
Ridge Circle, suite 101, St. Joseph, MO 64506, filed a supplement to 
NADA 141-240 for use of REBALANCE (sulfadiazine/pyrimethamine) 
Antiprotozoal Oral Suspension for the treatment of EPM caused by 
Sarcocystis neurona. The supplement provides for a revised human food 
safety warning on labeling. The supplemental NADA is approved as of 
August 27, 2008, and 21 CFR 520.2215 is amended to reflect the 
approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or

[[Page 53686]]

information. Therefore, a freedom of information summary is not 
required.
    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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. In 520.2215, revise paragraph (c)(3) to read as follows:


Sec.  520.2215  Sulfadiazine/pyrimethamine suspension.

* * * * *
    (c) * * *
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: September 5, 2008.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E8-21625 Filed 9-16-08; 8:45 am]
BILLING CODE 4160-01-S
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