Department of Health and Human Services July 2005 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 291
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption From Preemption
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption From Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Oral Dosage Form New Animal Drugs; Tiamulin Liquid Concentrate
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 Phoenix Scientific, Inc. The ANADA provides for use of tiamulin concentrate solution to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia.
Determination of Regulatory Review Period for Purposes of Patent Extension; CLARINEX
The Food and Drug Administration (FDA) has determined the regulatory review period for CLARINEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Listing of Color Additives Exempt From Certification; Tomato Lycopene Extract and Tomato Lycopene Concentrate
The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of tomato lycopene extract and tomato lycopene concentrate as color additives in foods. This action is in response to a petition filed by LycoRed Natural Products Industries.
Ophthalmic and Topical Dosage Form New Animal Drugs; Doramectin
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 Pfizer, Inc. The supplemental NADA provides for a period of protection from reinfestation with two species of external parasites following topical administration of doramectin solution on cattle.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Privacy Act of 1974; Computer Match No. 2005-03
In accordance with the requirements of the Privacy Act of 1974, as amended, this Notice announces the establishment of a CMP that CMS plans to conduct with the Washington Department of Social and Health Services (DSHS). We have provided background information about the proposed Matching Program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this Matching Program if we receive comments that persuade us to defer implementation. See DATES section below for comment period.
Privacy Act of 1974; Computer Match No. 2005-02
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a CMP that CMS plans to conduct with the Ohio Department of Jobs & Family Services (ODJFS). We have provided background information about the proposed matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See DATES section below for comment period.
Head Start Family Literacy Program
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Head Start Bureau, under the authority of Sections 640(a)(2)(C) and 648(c)(4) (42 U.S.C. 9843), is making available $3 million annually for each of the next five years, to support a cooperative agreement to provide family literacy training and technical assistance to Head Start and Early Head Start programs based on proven effective practices substantiated by research findings. This project will help grantees and delegate agencies nationwide to improve the quality and positive outcomes of family literacy services they provide. This includes programs serving American Indians, Alaska Natives, migrant and seasonal workers, and English language learners.
Grants and Cooperative Agreements; Availability, etc.: Child Development Associate Credentialing Program
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF) announces the availability of $1,000,000 annually for each of five years to support staff development for all individuals employed in local Head Start, Early Head Start, and other child care programs to increase the understanding and skills necessary to carry out their jobs, as well as professional development leading to credentials and degrees. A cooperative agreement is a form of Federal financial assistance that allows substantial Federal involvement in the activities for which funds are awarded.
Medicare Program; Proposed Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates
This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. This proposed rule would also change the requirement for physician oversight of mid-level practitioners in critical access hospitals (CAHs). These changes would be applicable to services furnished on or after January 1, 2006.
Medicare Program; Evaluation Criteria and Standards for Quality Improvement Program Contracts
This final notice describes the evaluation criteria we will use to evaluate the Quality Improvement Organizations (QIOs) under their contracts with us, for efficiency and effectiveness in accordance with the Social Security Act. These evaluation criteria are based on the tasks and related subtasks set forth in the QIO's Scope of Work (SOW). The current 7th SOW includes Tasks 1 through 4, with subtasks included under all tasks, excluding Task 4. QIOs were awarded contracts for the 7th SOW, or 7th Round, for 3 years, with staggered starting dates beginning August 2002, November 2002, and February 2003. This final notice also responds to the public comments received regarding the evaluation criteria published in July 2004.
Amendment to the Interim Final Regulation for Mental Health Parity
This document contains an amendment to the interim final regulation that implements the Mental Health Parity Act (MHPA) to conform the sunset date of the regulation to the sunset date of the statute under legislation passed by the 108th Congress.
Prospective Grant of Exclusive License: Use of HIV-Dependent Expression Constructs and Uses Therefor for the Development of FDA-Approvable HIV Diagnostic Kits
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 to practice the invention embodied in PCT/US04/ 31967 filed September 28, 2004 from U.S. provisional application 60/ 507,034 (E-276-2003/0-US-01), entitled ``HIV-Dependent Expression Constructs and Uses Therefor'' (E-276-2003/0-PCT-02), (Inventors: Yuntao Wu and Jon Marsh), to Revix Technology LLC (hereafter Revix), having a place of business in Manassas, Virginia. The patent rights in these inventions have been assigned to the United States of America.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing and Cooperative Research and Development Agreement (CRADA): Aminoflavone Prodrug
The inventions described below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 in association with collaborative research via a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) of the National Institutes of Health. This opportunity is being offered to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Proposed Collection; Comment Request; The National Diabetes Education Program Survey of the Public
Under provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on September 9, 2003, pages 53176-53177, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The National Diabetes Educations Program Survey of the Public. Type of Information Collection Request: New. Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goals of the NDEP are to improve the treatment and health outcomes of people with diabetes, to promote early diagnosis, and, ultimately, to prevent the onset of diabetes. The NDEP objectives are: (1) To increase awareness of the seriousness of diabetes, its risk factors, and strategies for preventing diabetes and its complications among people at risk for diabetes; (2) to improve understanding about diabetes and its control and to promote better self-management behaviors among people with diabetes; (3) to improve health care providers' understanding of diabetes and its control and to promote an integrated approach to care; (4) to promote health care policies that improve the quality of and access to diabetes care. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Creating partnerships with other organizations concerned about diabetes; (2) developing and implementing awareness and education activities with special emphasis on reaching the racial and ethnic populations disproportionately affected by diabetes; (3) identifying, developing, and disseminating educational tools and resources for the program's diverse audiences; (4) promoting policies and activities to improve the quality of and access to diabetes care. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This clearance request is for the collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Approval is requested for survey of the public including people at risk for diabetes, people with diabetes and their families. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 1600; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .25; and Estimated Total Annual Burden Hours Requested: 400. The annualized cost to respondents is estimated at: $8,000.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Administration on Children, Youth and Families; Family and Youth Services Bureau; Notice of the Availability of Financial Assistance and Request for Applications To Establish and Operate the National Domestic Violence Hotline
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF) announces the availability of funds in fiscal year 2005 for the award of one grant on a competitive basis to operate a national, toll-free telephone hotline to provide information and assistance to victims of domestic violence.
Listing of Color Additives Exempt from Certification; Mica-Based Pearlescent Pigments
The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. This action is in response to a petition filed by EM Industries, Inc.
Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.'' This guidance provides a description and basis for a process by which to select a maximum recommended starting dose (MRSD) for a first-in-human clinical trial of a therapeutic in adult healthy volunteers.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.