Department of Health and Human Services June 2015 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 370
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: (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.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The proposed rule sets forth the calculation of the ceiling price and application of civil monetary penalties.
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several nonsubstantive changes. These technical amendments are being made to improve the accuracy of the regulations.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the FoodNet Population Survey which is a telephone-based survey to gather information to estimate the total number of acute diarrheal illnesses in the U.S. and assess the frequency of exposures commonly associated with foodborne illness.
Food Additives Permitted for Direct Addition to Food for Human Consumption; TBHQ
The Food and Drug Administration (FDA or we) is amending the food additive regulations by removing the upper bound of the melting point range in the regulation for the antioxidant tertiary butylhydroquinone (TBHQ) and adding a purity acceptance criterion. This action is in response to a petition submitted by Eastman Chemical Company.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Summary of Benefits and Coverage and Uniform Glossary
This document contains final regulations regarding the summary of benefits and coverage (SBC) and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. It finalizes changes to the regulations that implement the disclosure requirements under section 2715 of the Public Health Service Act to help plans and individuals better understand their health coverage, as well as to gain a better understanding of other coverage options for comparison.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Allergen Labeling and Reporting
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Allergen Labeling and Reporting'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices; Exemption From Premarket Notification: Electric Positioning Chair
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for an electric positioning chair with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Determination of Regulatory Review Period for Purposes of Patent Extension; XELJANZ
The Food and Drug Administration (FDA) has determined the regulatory review period for XELJANZ 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Recommendations for Preparation and Submission of Animal Food Additive Petitions; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #221 entitled ``Recommendations for Preparation and Submission of Animal Food Additive Petitions.'' This guidance describes the types of information that FDA's Center for Veterinary Medicine recommends for inclusion in food additive petitions submitted for food additives intended for use in food for animals. It is intended to help the petitioner submit this information in a consistent and appropriate manner.
Assessment of Male-Mediated Developmental Risk for Pharmaceuticals; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.'' This draft guidance provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient (API) to males either through an effect on the male germ cell or from fetal exposure following seminal transfer of a potentially developmental toxicant to pregnant females. The need for measures to mitigate the risk to embryo/fetal development posed by males participating in clinical trials is also addressed.
Cell-Based Products for Animal Use; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #218 (GFI #218) entitled ``Cell-Based Products for Animal Use.'' FDA is aware that many potential veterinary therapies may be produced using cell-based products. GFI #218 describes FDA's Center for Veterinary Medicine's current thinking on cell-based products for animal use that meet the definition of a new animal drug. This guidance is for persons developing, manufacturing, or marketing cell-based products, including ``animal stem cell-based products''.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority
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; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
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.
Statement of Organization, Functions, and Delegations of Authority
This notice amends Part K of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (DHHS), Administration for Children and Families (ACF), as follows: Office of the Assistant Secretary for Children and Families, as last amended by77 FR 61002, September 21, 2012, and Office of Refugee Resettlement, as last amended by 80 FR 3614, January 23, 2015. This notice adds a new office, the Office on Trafficking in Persons to the Office of the Assistant Secretary for Children and Families and transfers the functions of the Division of Anti- Trafficking in Persons to this office. The changes are as follows:
Office of Community Services; Notice of Meeting
The Department of Health and Human Services, Administration for Children and Families, Office of Community Services (OCS) will host a virtual Tribal Consultation to consult on the Assets for Independence (AFI) program proposed Performance Progress Report (PPR).
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