Department of Health and Human Services May 2012 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 280
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Demonstration of a Health Literacy Universal Precautions Toolkit.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 9th, 2012 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Workflow Assessment for Health IT Toolkit Evaluation.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 9th, 2012 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Medicare Program; Solicitation for Proposals for the Medicare Graduate Nurse Education Demonstration-Deadline Extension
This notice extends the deadline for submission of proposals to apply to participate in the Medicare Graduate Nurse Education (GNE) Demonstration.
Decision To Evaluate a Petition To Designate a Class of Employees From Joslyn Manufacturing and Supply Co., in Ft. Wayne, IN, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Joslyn Manufacturing and Supply Co., in Ft. Wayne, Indiana, 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: Joslyn Manufacturing and Supply Co. Location: Ft. Wayne, Indiana. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1944 to December 31, 1952.
Decision To Evaluate a Petition To Designate a Class of Employees From the Hanford Site in Richland, WA, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Hanford site in Richland, Washington, 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: Hanford site. Location: Richland, Washington. Job Titles and/or Job Duties: All employees of the Department of Energy, its predecessor agencies, and its contractors and subcontractors. Period of Employment: July 1, 1972 to December 31, 1983.
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.
Determination That PITRESSIN TANNATE IN OIL (Vasopressin Tannate) Injection, 5 Pressor Units/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for vasopressin tannate injection, 5 pressor units/mL, if all other legal and regulatory requirements are met.
International Conference on Harmonisation; Addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals'' (S6 addendum). The S6 addendum was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to incorporate new knowledge and experience gained since the implementation of the ICH guidance entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals'' (ICH S6) and to clarify and provide greater detail to enable the development of safe and effective biopharmaceuticals.
Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
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 Form FDA 3397, User Fee Cover Sheet, which must be submitted along with certain drug and biologic product applications and supplements.
Announcement of the Award of Single Source Expansion Supplement Grants to 11 Personal Responsibility Education Program Innovative Strategies (PREIS) Grantees
The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS) announces the award of single source expansion supplement grants to 11 PREIS grantees for the purpose of expanding program participation and/or sites to support the increase of data necessary to determine the level of program effectiveness. In FY 2010, FYSB awarded thirteen cooperative agreement grants under Funding Opportunity Announcement (FOA) number: OPHS/OAH/TPP PREP Tier 2-2010. Under this FOA a total of $9.7 million was made available on a competitive basis to implement and test innovative strategies. The award of 11 single source expansion supplement grants to PREIS grantees is required because of the necessary expansion of the original scope of approved activities. In the provision of evaluation related technical assistance to grantees during the first year of the project, it was determined by FYSB that all grantees needed to increase the number of program participants and/or sites for program implementation. Increased funding will help the grantee programs obtain the minimal statistical power required to report significant outcome data that can be utilized to determine the effectiveness of the implemented pregnancy prevention models. Thus, the increased number of program participants supports the evaluation requirements outlined in the FOA and by ACA. Additionally, grantees are required to report on performance measures that were specifically defined by FYSB and are pending approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501-3520). The data collection will require additional staff time and other resources to compile and report on performance indicators. Performance indicators are based upon the performance measures established by HHS, to include: (a) The number of youth served and hours of service delivery; (b) fidelity to the program model or adaptation of the program model for the target population; (c) community partnerships and competence in working in working with the target population; (d) reported gains in knowledge and intentions and changes in self-reported behaviors of participants; and (e) community data, like birth rates and the incidence of sexually transmitted infections. The 11 single source expansion supplement grants will support activities from September 30, 2011 through September 29, 2012. The grantees are:
Proposed Collection; Comment Request; Population Assessment of Tobacco and Health (PATH) Study
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 on Drug Abuse (NIDA), 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: Population Assessment of Tobacco and Health (PATH) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a large national longitudinal cohort study on tobacco use behavior and health in the United States. It is scheduled to begin in the fall of 2013 under the direction of the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA), and in partnership with the Food and Drug Administration (FDA). Using annual interviews and the collection of bio-specimens from adults, the study is designed to establish a population-based framework for monitoring and evaluating the behavioral and health impacts of regulatory provisions by FDA as it meets its mandate under the Family Smoking Prevention and Tobacco Control Act (FSPTCA) to regulate tobacco-product advertising, labeling, marketing, constituents, ingredients, and additives. These regulatory changes are expected to influence tobacco-product risk perceptions, exposures, and use patterns in the short term, and to reduce tobacco- related morbidity and mortality in the long term. By measuring and accurately reporting tobacco product use behaviors and health effects associated with these regulatory changes, this study will provide an empirical evidence base to inform the development, implementation, and evaluation of tobacco-product regulations in the U.S. Frequency of Response: Annually. Affected Public: Individuals or households. Type of Respondents: Youth (ages 12-17) and Adults (ages 18+). The annual reporting burden for the field test is presented in Table 1, and the annual reporting burden for the baseline data collection is presented in Table 2. The annualized cost to respondents for the field test is estimated at: $24,495; and the annualized cost to respondents for the baseline data collection is: $1,947,567. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2012
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment; Correction
This document corrects a technical error that appeared in the final rule with comment period published in the Federal Register on March 23, 2012 entitled, ``Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment.''
Meeting of the Community Preventive Services Task Force (CPSTF)
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (CPSTF). The Task Forcean independent, nonfederal body of nationally known leaders in public health practice, policy, and research, who are appointed by the CDC Directorwas convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting, the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Comparing Data Obtained From Landline Telephone and Cell Phone Surveys
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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 information collection provisions of FDA's requirements for food irradiation processors.
Statement of Organization, Functions, and Delegations of Authority; Office of The National Coordinator for Health Information Technology
The Office of the National Coordinator for Health Information Technology has reorganized its office in order to more effectively meet the mission outlined by The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA). The reorganization includes one change and five functional realignments.
Cooperative Agreement To Support Innovation in Vaccine Clinical Trial Design and Collaboration in Pharmacovigilance To Advance Global Access to Safe and Effective Vaccines
The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for an award of a cooperative agreement to the World Health Organization (WHO) in support of collaborative efforts to advance innovative approaches to vaccine clinical trial design and to enhance the utilization of a range of pharmacovigilance tools as a means to further vaccine safety and potentially facilitate more rapid introduction of new vaccines. The goal of FDA's Center for Biologics Evaluation and Research (CBER) is to enhance technical collaboration and cooperation between FDA, WHO, and its Member States to facilitate strengthening regulatory capacity globally.
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