Department of Health and Human Services February 2016 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 347
Request for Nominations of Candidates To Serve on the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)
Document Number: 2016-03931
Type: Notice
Date: 2016-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, Announces the Following Meeting
Document Number: 2016-03930
Type: Notice
Date: 2016-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2016-03929
Type: Notice
Date: 2016-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2016-03928
Type: Notice
Date: 2016-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention: Notice of Charter Renewal
Document Number: 2016-03927
Type: Notice
Date: 2016-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
Document Number: 2016-03922
Type: Notice
Date: 2016-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On Wednesday, February 10, 2016 (81 FR 7124), the Centers of Medicare & Medicaid Services (CMS) published a Notice document titled ``Agency Information Collection Activities; Proposed Collection; Comment Request''. That notice invited public comments on four separate information collection requests. Through the publication of this correction document, we are notifying the public that we are no longer requesting or accepting public comments on the information collection request that published on Wednesday, February 10, 2016 (81 FR 7124), and is titled ``Medicare Prior Authorization of Home Health Services Demonstration.'' Form number: CMS-10599 (OMB control number: 0938New). All public comments regarding CMS-10599 should be submitted via the instructions listed in the original notice. The original notice for CMS-10599 published on Friday, February 5, 2016 (81 FR 6275). The original 60-day comment period for the notice that published on February 5, 2016 (81 FR 6275) remains in effect and ends on April 5, 2016.
Request for Expressions of Interest From Coverage Organizations; Coverage Organizations Interested in Providing Input Regarding Private Payer Coverage to Medical Device Sponsors Who Request Their Participation in a Pre-Submission Meeting With the Food and Drug Administration
Document Number: 2016-03909
Type: Notice
Date: 2016-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting expressions of interest from organizations that evaluate clinical evidence used to support private payer coverage decisions for medical devices (coverage organizations) that wish to provide input to medical device developers (sponsors) on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. These coverage organizations include third-party commercial health insurance organizations, payer/provider organizations, health technology assessment groups and various organizations that evaluate clinical evidence and make coverage recommendations to and decisions for private payers and health plans. The Center for Devices and Radiological Health (CDRH) is taking this step to assist sponsors in identifying such organizations and soliciting clinical trial design or other evidence-gathering input from them. If coverage organizations express interest, FDA intends to provide a mechanism for such organizations to identify themselves so that medical device sponsors who would like to obtain coverage input can voluntarily contact them to participate in a FDA Pre-Submission meeting. Early input from payers regarding their evidentiary needs can streamline the process from FDA approval or clearance to payer coverage and improve public health by facilitating earlier access to innovative, safe, and effective medical devices.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-03908
Type: Notice
Date: 2016-02-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 require; 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-03875
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Availability of Draft Toxicological Profiles; Jet Fuels and 1-Bromopropane
Document Number: 2016-03861
Type: Notice
Date: 2016-02-24
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice, prepared by the Agency for Toxic Substances and Disease Registry (ATSDR) for the Department of Defense, announces the availability of two new draft toxicological profile on unregulated hazardous substances for review and comment. All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. We are seeking public comments and additional information or reports on studies about the health effects of Jet Fuels and 1- Bromopropane for review and potential inclusion in the profile. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and our clients. Comments can include additional information or reports on studies about the health effects of Jet Fuels and 1-Bromopropane. Although ATSDR will consider key studies for these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-03821
Type: Notice
Date: 2016-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2016-03820
Type: Notice
Date: 2016-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 Study to Explore Early Development (SEED) Phase 3.
Agency Information Collection Activities; Proposed Collection; Comment Request; Outcomes Evaluation Survey for Graduates of the Food and Drug Administration Commissioner's Fellowship Program
Document Number: 2016-03791
Type: Notice
Date: 2016-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
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 Outcomes Evaluation Survey for Graduates of the FDA Commissioner's Fellowship Program.
National Cancer Institute Notice of Closed Meetings
Document Number: 2016-03786
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health Notice of Closed Meetings
Document Number: 2016-03785
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-03784
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-03783
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Notice of Closed Meeting
Document Number: 2016-03782
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering: Notice of Closed Meetings
Document Number: 2016-03781
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-03780
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-03779
Type: Notice
Date: 2016-02-24
Agency: Department of Health and Human Services, National Institutes of Health
Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period
Document Number: 2016-03716
Type: Proposed Rule
Date: 2016-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
In the Federal Register of November 18, 2015, the Food and Drug Administration (FDA) published a proposed rule entitled ``Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' The proposed rule would establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. We are taking this action to reopen the comment period in response to requests to allow interested persons additional time to submit comments.
Waterpipes and Waterpipe Tobacco; Public Workshop; Establishment of a Public Docket
Document Number: 2016-03712
Type: Notice
Date: 2016-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing a public workshop to gather scientific information on waterpipes and waterpipe tobacco and to identify areas of research that may inform CTP's regulation of these tobacco products. The workshop will include presentations and panel discussions about the current state of the science, and will focus on product use and design, smoke constituents, environmental impacts, and the impact of marketing these products on population health, including on both users and nonusers. FDA is also opening a public docket to receive data, information, and comments on this topic.
Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition; Extension of Comment Period
Document Number: 2016-03708
Type: Proposed Rule
Date: 2016-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of filing that appeared in the Federal Register of January 4, 2016. In the notice, FDA requested comments on a filed food additive petition (FAP 5A4810), submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Medicare Program; Public Meetings in Calendar Year 2016 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
Document Number: 2016-03703
Type: Notice
Date: 2016-02-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2016 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. As indicated in this notice, we are reorganizing public meeting content under two main headings: (1) Drugs/Biologics, Radiopharmaceuticals/Radiologic Imaging Agents, and (2) Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and Other.
Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; Small Entity Compliance Guide; Availability
Document Number: 2016-03697
Type: Rule
Date: 2016-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled ``Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids.''
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
Document Number: 2016-03696
Type: Notice
Date: 2016-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period provided in the notice entitled ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability'' that appeared in the Federal Register of January 26, 2016. That notice announced the availability of a draft guidance for industry and FDA staff and requested comments by March 28, 2016. FDA is extending the draft guidance's comment period by 30 days in response to requests for an extension to allow interested persons additional time to submit comments.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-03687
Type: Notice
Date: 2016-02-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-03654
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2016-03652
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-03651
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-03650
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2016-03649
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Center; Notice of Meeting
Document Number: 2016-03648
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-03647
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2016-03646
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-03645
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-03644
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Center For Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-03643
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-03637
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-03636
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-03635
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October Through December 2015
Document Number: 2016-03634
Type: Notice
Date: 2016-02-23
Agency: Department of Health and Human Services
This quarterly notice lists of the OMHA Case Processing Manual (OCPM) manual instructions that were published from October through December, 2015. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Nonprescription Drugs Advisory Committee; Notice of Meeting
Document Number: 2016-03573
Type: Notice
Date: 2016-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; BREO ELLIPTA
Document Number: 2016-03551
Type: Notice
Date: 2016-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for BREO ELLIPTA 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Document Number: 2016-03549
Type: Notice
Date: 2016-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
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; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Document Number: 2016-03543
Type: Notice
Date: 2016-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension.
Determination of Regulatory Review Period for Purposes of Patent Extension; SUPERA PERIPHERAL STENT SYSTEM
Document Number: 2016-03542
Type: Notice
Date: 2016-02-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for SUPERA PERIPHERAL STENT SYSTEM 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 medical device.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2016-03512
Type: Notice
Date: 2016-02-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2016-03511
Type: Notice
Date: 2016-02-22
Agency: Department of Health and Human Services, National Institutes of Health