Department of Health and Human Services August 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 271
Presidential Interagency Working Group on Import Safety; Public Meeting
The Interagency Working Group on Import Safety (Working Group) is announcing a public meeting to identify actions the public and private sectors can take to promote the safety of products imported into the United States. The Working Group was created by the Executive order on July 18, 2007.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional 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 information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for the collection ``Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.''
Medicare Program; Hospice Wage Index for Fiscal Year 2008
This final rule sets forth the hospice wage index for fiscal year 2008. This final rule also revises the methodology for updating the wage index for rural areas without hospital wage data and provides clarification of selected existing Medicare hospice regulations and policies.
Proposed Data Collection; Comment Request; National Physician Survey of Practices on Diet, Physical Activity, and Weight Control
Under the provision of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), National Cancer Institute (NCI), 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 June 28, 2007, page 43609 and allowed 60-days for public comment. One public comment was received asking about the possibility of doing studies of autism rather than the proposed survey. The comment was out of the scope of this current project. 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.
Medicaid Program and State Children's Health Insurance Program (SCHIP); Payment Error Rate Measurement
This final rule sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and SCHIP. The Improper Payments Information Act of 2002 (IPIA) requires heads of Federal agencies to estimate and report to the Congress annually these estimates of improper payments for the programs they oversee, and submit a report on actions the agency is taking to reduce erroneous payments. This final rule responds to the public comments on the August 28, 2006 interim final rule (71 FR 51050) and sets forth State requirements for submitting claims and policies to the CMS Federal contractors for purposes of conducting fee-for-service and managed care reviews. This final rule also sets forth the State requirements for conducting eligibility reviews and estimating case and payment error rates due to errors in eligibility determinations.
Medicare and Medicaid Programs; Ambulatory Surgical Centers, Conditions for Coverage
This proposed rule would revise some of the existing conditions for coverage (CfCs) that ambulatory surgical centers must meet to participate in the Medicare and Medicaid programs. The proposed modifications are intended to update the existing CfCs to reflect current practice and set forth new requirements to promote and protect patient health and safety.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 16, 2007 (72 FR 27573). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The document was published with an error. This document corrects that error.
Companion to Guidance for Industry on Pharmacogenomic Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Pharmacogenomic Data SubmissionsCompanion Guidance.'' The guidance is intended as a companion to the guidance of the same name, which was issued in 2005 (70 FR 14698; March 23, 2005). It reflects experience gained since the issuance of that guidance with voluntary genomic data submissions as well as with review by FDA of numerous protocols and data submitted under investigational new drug (IND) applications, new drug applications (NDAs), and biologics license applications (BLAs). The recommendations are intended to facilitate scientific progress in the field of pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Orphan Drugs'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Notice of Availability of Draft Policy Documents for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PINs referenced above. After review and consideration of all comments received, the PINs may be amended to incorporate recommendations from the public. Once the PINs are finalized, they will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' The ``Response to Public Comments'' will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PINs. Where comments do not result in a revision to the PINs, explanations will be provided. Background: HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver preventive and primary care services to patients regardless of their ability to pay. Charges for health care services are set according to income. The purpose of the recently published draft PINs is to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project, including requests to include new specialty services and/or a new target population within the scope of the Federal project.
Draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims; Availability; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 9, 2007 (72 FR 37246). The document announced the availability for public comment of a draft guidance entitled ``Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.'' The document was published with an incorrect Internet address for submitting electronic comments and an incorrect telephone number. This document corrects those errors.
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.
Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008
This final rule with comment period sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health services, effective on January 1, 2008. As part of this final rule with comment period, we are also rebasing and revising the home health market basket to ensure it continues to adequately reflect the price changes of efficiently providing home health services. This final rule with comment period also sets forth the refinements to the payment system. In addition, this final rule with comment period establishes new quality of care data collection requirements. Finally, this final rule with comment period allows for further public comment on the 2.71 percent reduction to the home health prospective payment system payment rates that are scheduled to occur in 2011, to account for changes in coding that were not related to an underlying change in patient health status (section III.B.6).
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Mound Plant, Dayton, OH, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Mound Plant, Dayton, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mound Plant. Location: Dayton, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: February 1, 1949 through the present.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Texas City Chemicals, Texas City, TX, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Texas City Chemicals, Texas City, Texas, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Texas City Chemicals. Location: Texas City, Texas. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1952 through December 31, 1956.
Proposed Collection; Comment Request; Pretesting of NIAID's HIV Vaccine Research Communications Messages
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Pretesting of NIAID's HIV Vaccine Research Communications Messages. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for clearance to pretest messages, materials and program activities produced for the NIAID HIV Vaccine Research Education Initiative (NHVREI). The primary objectives of the pretests are to (1) Assess audience knowledge, attitudes, behaviors and other characteristics for the planning/development of health messages, education products, communication strategies, and public information programs; and (2) pretest these health messages, products, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. The information obtained from audience research and pretesting results in more effective messages, materials, and programmatic strategies. By maximizing the effectiveness of these messages and strategies for reaching targeted audiences, the frequency with which publications, products, and programs need to be modified is reduced. Frequency of Response: On occasion. Affected Public: Individuals. Type of Respondents: Adults at risk for HIV/AIDS, particularly those who are Black/African-American, Hispanic/Latino, or men who have sex with men; healthcare providers; representatives of organizations disseminating HIV-related messages or materials. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. 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 this NADA.
New Animal Drugs For Use in Animal Feeds; Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of this NADA.
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.
Prospective Grant of Exclusive License: Method for Determining the Redox Status of a Tissue
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 inventions embodied in: PCT Application No. PCT/US2006/031208 (E-258-2005/0-PCT-02) filed August 10, 2006 claiming priority to U.S. Provisional Application No. 60/ 707,518 (E-258-2005/0-US-01), titled ``Method for Determining the Redox Status of a Tissue'' (Inventors: Dr James Mitchell et al.) to Mitos Pharmaceutical, Inc. (hereafter Mitos), having a place of business in Newport Beach, California. The patent rights in these inventions have been assigned to the United States of America.
Prospective Grant of Exclusive License: FDA Cleared Pediatric Cancer Diagnostics and Prognostics
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 Patent Applications U.S. 10/133,937, filed 04/25/2002, entitled ``Methods for Analyzing High Dimensional Data for Classifying, Diagnosing, Prognosticating and/or Predicting Diseases and Other Biological States''; and U.S. 10/159,563, filed 05/31/2002, entitled ``Selections of Genes And Methods of Using The Same For Diagnosis And For Targeting The Therapy of Select Cancers''; to Althea Technologies, Inc. having a place of business in San Diego, California. The patent rights in this invention have been assigned to the United States of America (PHS ref E-324-2001/0,1).
Possession, Use, and Transfer of Select Agents and Toxins
The select agents and toxins listed in 42 CFR part 73 include those regulated only by the U.S. Department of Health and Human Services (HHS) (42 CFR 73.3), as well as those overlap select agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) (42 CFR 73.4). In response to USDA's proposal to no longer regulate ten select agents and toxins currently listed as ``overlap'' agents and toxins, we are proposing to move those ten select agents and toxins from the overlap select agents and toxins section to the HHS select agents and toxins section.
Preparation for International Conference on Harmonization Meetings in Yokohama, Japan; Public Meeting; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on August 13, 2007 (72 FR 45250). The document announced a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan, October 27 through November 1, 2007, at which discussion of the topics underway and the future of ICH will continue.
Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph
The Food and Drug Administration (FDA) is issuing a proposed rule that would amend the final monograph (FM) for over-the-counter (OTC) sunscreen drug products as part of FDA's ongoing review of OTC drug products. This amendment addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection. FDA is issuing this proposed rule after considering public comments and new data and information that have come to FDA's attention. This rule proposes to lift the stays of 21 CFR 347.20(d) and 21 CFR Part 352 when FDA publishes a final rule based on this proposed rule.
Notice To Award a Grant
The Office of Refugee Resettlement, Anti-Trafficking in Persons Office, will award a non-competitive grant to Polaris Project, P.O. Box 77892, Washington DC, 20013, in the amount of $394,452 in Fiscal Year 2007 due to urgent and compelling circumstances. The award will be used to improve the systemic response to protect victims of human trafficking in the United States through the Training, Technical Assistance, and Strategic Planning (TTASP) Program. The specific goal of the TTASP program is to raise the standards of the anti-trafficking field through the development of new and cutting edge strategies, best practices, improved national levels of coordination and strategic planning, and capacity building for the field through practitioner-based training and technical assistance. The services obtained are intended to increase levels of victim identification through the creation of improved direct outreach strategies, enable localized best practice strategies to be shared on a national scale, provide around the clock technical assistance from leading human trafficking experts, and be a resource for strategic planning assistance at the local, State and Federal levels. Services will be provided via a centralized online clearinghouse of training and technical assistance resources, a dedicated technical assistance telephone hotline, on-site training and consulting services, and a peer-to-peer training and strategic planning event. Grant and Cooperative Agreement Program Authority for this activity is contained in section 106(b) and section 107(b)(1)(B) of the Trafficking Victims Protection Act of 2000 (TVPA), Public Law 106-386, Division A, 114 Stat. 1464 (2000) and in section 412(c)(1)(A) of the Immigration and Nationality Act (INA), (8 U.S.C. 1522(c)(1)(A)). The Recipient will: 1. Develop anti-trafficking materials covering topics not currently in circulation; 2. Create an online clearing house of training and technical assistance resources, including all TTASP training manuals, briefing materials, model strategic plans, sample outreach materials, user- driven worksheets, and summaries of best practices and model programs; 3. Provide targeted training and technical assistance on effective anti-trafficking strategies to anti-trafficking coalitions, task forces, direct outreach organizations, service providers, and others as needed; 4. Provide around the clock technical assistance via telephone on an emergency or on-demand basis for service providers or law enforcement officials that encounter trafficking victims; 5. Create a comprehensive strategic planning document for use by new and existing anti-trafficking coalitions that consolidates national best practices for implementing anti-trafficking activities at the local level; 6. Provide technical review of third-party materials, including, but not limited to client service protocols and forms, outreach protocols and materials, and organizational training documents; and 7. Provide consulting services to ORR in areas of strategic planning, staying abreast of the latest trends in the field, and any other technical assistance requested. After the appropriate reviews, it has been determined that the need to improve the systemic response to protect victims of human trafficking in the United States through the training, technical assistance, and strategic planning is urgent and compelling. The project period is September 30, 2007 to September 29, 2010.
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