Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Developmental Disabilities Program
This rule proposes clarifications and new requirements to implement the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act of 2000). Of particular note, the proposed rule covers responsibilities of the Secretary in the area of program accountability and the indicators of progress. Under the proposal, one or more measures of progress must be used to measure the goal(s) developed for each area of emphasis. The areas of emphasis include: (1) Quality assurance activities; (2) education activities and early intervention activities; (3) child care-related activities; (4) health- related activities; (5) employment-related activities; (6) housing- related activities; (7) transportation-related activities; (8) recreation-related activities; and (9) other services available or offered to individuals in a community, including formal and informal community supports that affect their qualify of life.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Issuance of Final Policy Directive
The Administration for Native Americans (ANA) herein describes its issuance of final interpretive rules, general statements of policy and rules of agency procedure or practice relating to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental) programs, Environmental Mitigation (hereinafter referred to as Mitigation), and Native American Healthy Marriage Initiative (hereinafter referred to as NAHMI).
New Animal Drugs for Use in Animal Feed; Zilpaterol; Technical Amendment
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate in four-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Availability of Final Toxicological Profiles
This notice announces the availability of seven updated final toxicological profiles of priority hazardous substances. This is the 19th set of toxicological profiles that ATSDR has compiled.
Prospective Grant of Exclusive License: Codon Optimized IL-15 and IL-15R-Alpha Genes for Expression in Mammalian Cells
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Serial Numbers 60/758,819, filed January 13, 2006 and 60/812,566, filed June 9, 2006; PCT filed (PCT/US2007/000774) on January 12, 2007, entitled ``Codon Optimized IL-15 and IL-15RAlpha Genes for Expression in Mammalian Cells'' (HHS Ref. E-254-2005/2) to Marine Polymer Technologies, Inc., having a place of business in Danvers, Massachusetts. The patent rights in these inventions have been assigned to the United States of America.
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements for ``New Animal Drugs for Investigational Use.''
International Conference on Harmonisation; Guidance on E15 Pharmacogenomics Definitions and Sample Coding; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The guidance is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.
Organ Procurement and Transplantation Network
The Health Resources Services Administration (HRSA) published a notice in the Federal Register of March 3, 2008 (FR Doc. E8-3994), pages 11420-11421, requesting comments to assist in determining whether it should engage in rulemaking with respect to vascularized composite allografts, and also to announce a meeting for discussion and recommendations regarding that issue. The notice is to extend HRSA's deadline for receiving written comments to July 2, 2008, and to change the zip code of the address where the meeting will be held. Correction: In the Federal Register of March 3, 2008, in FR Doc. E8-3994, on page 11421, 1st column under the heading DATES: 1st line, change to read: Written comments must be received at HRSA by July 2, 2008. 10th line, change to read: The meeting will be held on Friday, April 4, 2008, from 10 a.m. to 4 p.m., at the Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
Fiscal Year (FY) 2008 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $996,000 (total costs) per year for up to two years to the Education Development Resource Center, Inc. Newton, Massachusetts. This is not a formal request for applications. Assistance will be provided only to the Education Development Resource Center, Inc. based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-08-014 Catalog of Federal Domestic Assistance (CFDA) Number: 93.243
Medicare Program; Standards for E-Prescribing Under Medicare Part D and Identification of Backward Compatible Version of Adopted Standard for E-Prescribing and the Medicare Prescription Drug Program (Version 8.1)
This final rule adopts uniform standards for medication history, formulary and benefits, and fill status notification (RxFill) for the Medicare Part D electronic prescribing (e-prescribing) drug program as required by section 1860D-4(e)(4)(D) of the Social Security Act (the Act). In addition, we are adopting the National Provider Identifier (NPI) as a standard for identifying health care providers in e-prescribing transactions. It also finalizes the June 23, 2006 interim final rule with comment period that identified the National Council for Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard, Implementation Guide, Version 8.1 (``NCPDP SCRIPT 8.1'') as a backward compatible update of the NCPDP SCRIPT 5.0 (``NCPDP SCRIPT 5.0''), until April 1, 2009. This final rule also retires NCPDP SCRIPT 5.0 and adopts the newer version, NCPDP SCRIPT 8.1, as the adopted standard. Finally, except as otherwise set forth herein, we are implementing our compliance date of 1 year after the publication of these final uniform standards. This is the second set in a continuing process of issuing e-prescribing final standards for the Medicare Part D program,
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal
The Food and Drug Administration (FDA) is withdrawing a direct final rule that published in the Federal Register of December 4, 2007 (72 FR 68064), to amend certain regulations as the first phase of an incremental approach to modernize or clarify some of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December 4, 2007, as a companion to the direct final rule (72 FR 68113).
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications (NADAs) because FDA is withdrawing approval of the NADAs.
Privacy Act of 1974, New OIG Privacy Act System of Records: Administrative Files
The Office of Inspector General (OIG) is proposing a new system of records, entitled ``Administrative Files'' (09-90-0076). This proposed notice is in accordance with the Privacy Act requirement that agencies publish their systems of records in the Federal Register when there is a revision, change, or addition. This system of records contains certain administrative files for the purpose of maintaining, archiving, and filing records.