Department of Health and Human Services April 19, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine
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 final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs.
New Animal Drugs For Use in Animal Feed; Withdrawal of Approval of NADAs; Pyrantel; Tylosin; Tylosin and Sulfamethazine
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.
Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of NADAs; Estradiol Benzoate
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 In a notice published elsewhere in this issue of the Federal Register, FDA has withdrawn approval of the NADAs.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Post-Acute Care Payment Reform / Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC-CARE), System No. 09-70-0569.'' The program is authorized under Section 5008 of the Deficit Reduction Act of 2005, which allows for the establishment of a demonstration program for purposes of understanding costs and outcomes across different post- acute care sites. The PAC-CARE will collect information that will enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post-acute care related costs in the Medicare program. Anticipated results of the PAC- CARE include a standardized assessment instrument for post-acute care patients and a proposal for site-neutral payment for post-acute care services. The purpose of this system is to collect and maintain demographic, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support the functions of Quality Improvement Organizations; (5) support the functions of national accrediting organizations; (6) support litigation involving the agency; and (7) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI),'' System No. 09-70- 0591. This notice serves as the Master system for all demonstrations, evaluation, and research studies administered by ORDI. Fifteen existing ORDI demonstration, evaluation, and research studies will be included under this notice and the separate, existing systems of records notices for those studies will be deleted upon the effective date of this notice. DERS will become effective 30 days from the publication of the notice in the Federal Register, or 40 days from the date submitted to OMB and the Congress, whichever is later. With the publication of this master system, ORDI will only be deleting the systems of records listed below as separate stand alone notices to the public. Retention and destruction of the data contained in these systems will follow the schedules listed in this DERS system notice. The existing ORDI systems of records to be included under DERS and which will be deleted by this notice are as follows: ``Municipal Health Services Program System No. 09-70- 0022,'' 65 Federal Register (FR) 37792 (June 16, 2000); ``Monitoring of the Home Health Agency Prospective Payment Demonstration,'' System No. 09-70-0048, 65 FR 37792 (June 16, 2000); ``Person-Level Medicaid Data System, System No. 09-70- 0507'' last published at 71 FR 60726 (October 16, 2006); ``Medicare Cancer Registry Record System,'' System No. 09- 70-0509, last published at 71 FR 67133 (November 20, 2006); ``Evaluations of the Medicaid Reform Demonstrations,'' System No. 09-70-0523, last published at 71 FR 60540 (October 13, 2006); ``MMA Section 641 Prescription Drug Benefit Demonstration,'' System No. 09-70-0545, last published at 69 FR 32587 (June 10, 2004); ``Medicare Physician Group Practice Demonstration,'' System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005); ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities,'' System No. 09-70-0560, last published at 70 FR 57602 (October 3, 2005); ``Medicare Care Management Performance Demonstration,'' System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005); ``Rural Hospice Demonstration,'' System No. 09-70-0563, last published at 71 FR 57968 (October 2, 2006); ``Medicare Chiropractic Coverage Demonstration and Evaluation,'' System No. 09-70-0577, last published at 71 FR 41450 (July 21, 2006); ``Low Vision Rehabilitation Demonstration,'' System No. 09-70-0582, last published at 71 FR 58621 (October 4, 2006); ``Medicare Lifestyle Modification Program Demonstration,'' System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006); ``Competitive Bidding for Clinical Laboratory Services,'' System No. 09-70-0589, last published at 71 FR 60713 (October 16, 2006); and ``Senior Risk Reduction Demonstration and Evaluation,'' System No. 09-70-0592, last published at 71 FR 60718 (October 16, 2006). The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or CMS grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Date'' section for comment period.
Privacy Act of 1974; Retraction of a New System of Records
The Centers for Medicare & Medicaid Services CMS inadvertently published a new system of records titled ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI)'' System No. 09-70-0591 in the Federal Register (FR) on Tuesday, April 10, 2007 (72 FR 17918). CMS is withdrawing the Tuesday, April 10, 2007 notification due to the inadvertent inclusion of an existing system of records that should not be deleted from the existing inventory, ``End Stage Renal Disease Program Management and Medical Information System,'' System No. 09-70- 0520, last published at 67 FR 41244 (June 17, 2002). The notice of a new system of records will be republished.
Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate
The Food and Drug Administration (FDA) has withdrawn 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 final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs.
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