Department of Health and Human Services June 19, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 24 of 24
Dental Preventive and Clinical Support Centers Program; Correction
The Indian Health Service published a document in the Federal Register on June 5, 2015 for the FY 2015 New and Competing Continuation Funding Announcement for the Dental Preventive and Clinical Support Centers Program. The notice contained incorrect dates.
Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
The Social Security Act prohibits a physician-owned hospital from expanding its facility capacity, unless the Secretary of the Department of Health and Human Services (the Secretary) grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community in which the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.
Medicare Program; Oncology Care Model: Request for Applications; Extension of the Submission Deadline for Applications
This notice extends the application submission deadline for organizations to participate in the Oncology Care Model (OCM) beginning in 2016. The new deadline for receipt of online applications from payers and practices is 5:00 p.m. Eastern Daylight Time (EDT) on June 30, 2015. Only those payers and practices that submitted timely, complete Letters of Intent (LOIs) are eligible to apply to participate in OCM, and only the submission of web-based applications will be accepted.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Announcement of Food and Drug Administration Demo Day for the 2014 Food and Drug Administration Food Safety Challenge; Public Meeting
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Demo Day for the 2014 FDA Food Safety Challenge.'' The 2014 FDA Food Safety Challenge (https:// www.foodsafetychallenge.com) is a prize competition under the America COMPETES Reauthorization Act of 2010 which granted us (and other federal Agencies) broad authority to conduct prize competitions to spur innovation, solve tough problems, and advance our core mission. The purpose of the public meeting is for each of the five challenge finalists to present their concepts to the judges for selection of one or more winners.
Food Allergen Labeling Exemption Petitions and Notifications; Guidance for Industry; Availability
The Food and Drug Administration (``FDA'' or ``we'') is announcing the availability of a guidance for industry entitled ``Food Allergen Labeling Exemption Petitions and Notifications.'' This guidance explains FDA's current thinking on the preparation of regulatory submissions for obtaining exemptions for ingredients from the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (FD&C Act) through submission of either a petition or a notification.
Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food 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 must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's procedures for early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
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.
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes.
Head Start Performance Standards
This NPRM proposes to update Head Start program performance standards, last revised in 1998, to meet Congress's requirements and improve the quality of Head Start. In the Improving Head Start for School Readiness Act of 2007, Congress instructed the Office of Head Start to update its performance standards by regulation and ``ensure that any such revisions in the standards [do] not result in the elimination of or any reduction in quality, scope, or types of health, educational, parental involvement, nutritional, social, or other services.'' The proposed performance standards incorporate extensive consultation with experts and findings from scientific research, reflect best practices, lessons from program input and innovation, integrate recommendations from the Secretary's Advisory Committee Final Report on Head Start Research and Evaluation, and reflect this Administration's deep commitment to improving the school readiness of young children. The proposed program performance standards will improve the quality of services, reduce bureaucratic burden on programs, and improve regulatory clarity and transparency. They provide a clear road map for current and prospective grantees to provide high quality Head Start services and to strengthen the outcomes of the children and families they serve.
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