Department of Health and Human Services June 2012 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 291
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Secure Supply Chain Pilot Program
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Disease Information in Branded Promotional Material
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.
Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 204 entitled ``Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals.'' This draft guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal drugs for use in companion animals. The intent of the guidance is to provide information to clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles.
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: ``Synthesis of AHRQ-Funded HAI Projects.'' 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 April 6th, 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.
Proposed Requirements-Race to the Top-Early Learning Challenge; Phase 2
The Secretary of Education and the Secretary of Health and Human Services (hereafter ``the Secretaries'') propose requirements for Phase 2 of the Race to the TopEarly Learning Challenge (RTT-ELC) program. In this phase (Phase 2 of the RTT-ELC program), we would make awards to certain States that applied for, but did not receive, funding under Phase 1 of the RTT-ELC competition held in fiscal year (FY) 2011 (FY 2011 RTT-ELC competition). Specifically, we would consider eligible the five highest-scoring applicants that did not receive funding in the FY 2011 RTT-ELC competition, each of which received approximately 75 percent or more of the available points under the competition. We take this action to fund down the slate of the FY 2011 RTT-ELC competition and to establish the information and assurances that the eligible applicants would need to provide in order to receive funding under Phase 2 of the RTT-ELC program.
Indian Health Service; Reimbursement Rates for Calendar Year 2012 Correction
The Indian Health Service published a document in the Federal Register on June 6, 2012, concerning rates for inpatient and outpatient medical care provided by Indian Health Service facilities for Calendar Year 2012 for Medicare and Medicaid beneficiaries of other Federal Programs. The document contained five incorrect rates.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013-2022)
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey entitled ``Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2013-2022).''
Nursing Workforce Diversity Invitational Summit-“Nursing in 3D: Workforce Diversity, Health Disparities, and Social Determinants of Health”
HRSA's Bureau of Health Professions, Division of Nursing, will host an invitational summit that focuses on Nursing Workforce Diversity (NWD), Health Disparities, and the Social Determinants of Health. The goal of this summit is to convene experts, thought leaders, and key workforce diversity stakeholders to identify the full range of academic and health system factors, as well as the social, economic, political, and environmental determinants that influence our ability to diversify the nursing workforce. The goal of the summit is to utilize the social determinants of health frameworks to examine the impact of workforce diversity on health disparities. These activities will inform a broader and formal evaluation of the NWD program.
Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a Funding Opportunity Announcement (FOA) entitled ``Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24).'' In this FOA, FDA announces its intention to accept and consider a single source application for an award to the University of Texas Medical Branch (UTMB) Galveston National Laboratory (GNL) for the development and implementation of a certified, academic training course for instruction in Good Laboratory Practices (GLP) in a Biosafety Level (BSL) 4 High Containment Environment. FDA seeks to support an effort to design a robust, collaborative, and educational program using problem- based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792
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.
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.
Solicitation of Information and Recommendations for Revising OIG's Provider Self-Disclosure Protocol
This Federal Register notice informs the public that OIG: (1) Intends to update the Provider Self-Disclosure Protocol (63 FR 58399, October 30, 1998) and (2) solicits input from the public for OIG to consider in updating the Protocol.
Notice of Intent To Award Affordable Care Act (ACA) Funding, HM10-1001
This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the Association of Public Health Laboratories. These activities are proposed by the above- mentioned grantee in their FY 2012 applications submitted under funding opportunity HM10-1001, ``APHL-CDC Partnership for Quality Laboratory Practice,'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.065. Approximately $20,076 in ACA funding will be awarded to the grantee for communication and education activities designed to raise awareness among public health laboratories about the Environmental Public Health Tracking Network. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 [42 U.S.C. 300u-11]; (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement of HM10-1001:
Medicare Program; Medicare Secondary Payer and “Future Medicals”
This advance notice of proposed rulemaking solicits comment on standardized options that we are considering making available to beneficiaries and their representatives to clarify how they can meet their obligations to protect Medicare's interest with respect to Medicare Secondary Payer (MSP) claims involving automobile and liability insurance (including self-insurance), no-fault insurance, and workers' compensation when future medical care is claimed or the settlement, judgment, award, or other payment releases (or has the effect of releasing) claims for future medical care.
Conditionally Approved New Animal Drugs for Minor Use and Minor Species; Masitinib
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a conditionally approved supplemental application for conditional approval of a new animal drug (CNADA) intended for a minor use filed by AB Science. The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs.
Determination That PARAPLATIN (Carboplatin) Injection and SUSTIVA (Efavirenz) Capsules Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the two drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Guidance for Industry on Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ``Toll- Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications; Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with the requirements of the final rule regarding labeling of drugs with a toll-free number for adverse event reporting, which was published in the Federal Register on October 28, 2008 (final rule). The guidance describes certain requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. FDA prepared this guidance in accordance with the Small Business Regulatory Fairness Act.
Agency Information Collection Activities; Proposed Collection; Comment Request; Eye Tracking Experimental Studies To Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study entitled ``Eye Tracking Experimental Studies to Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys.''
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
