Department of Health and Human Services March 2017 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 265
Announcement of the Award of One Single-Source Expansion Supplement Grant Within the Office of Refugee Resettlement's Unaccompanied Children's Program
ACF, ORR, announces the award of one single-source expansion supplement grant for a total of $1,768,571 under the UC Program.
Proposed Substances To Be Evaluated for Set 31 Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR) located in the Department of Health and Human Services (HHS) is initiating the development of its 31st set of toxicological profiles (Set 31). Today's announcement invites voluntary public nominations of substances for profile development. ATSDR is soliciting public nominations of substances found on the Substance Priority List (SPL) at https://www.atsdr.cdc.gov/spl.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This publication corrects a notice that was published in the Federal Register on March 9, 2017 Volume 82, Number 45, page 13119. The meeting announcement and matters for discussion should read as follows: The meeting announced below concerns the Centers for Disease Control and Prevention (CDC) initial review of applications in response to Funding Opportunity Announcements (FOA) GH13-001, Strengthening Disease Prevention Research Capacity for Public Health Action in Guatemala and the Central American Region; FOA GH14-002, Addressing Emerging Infectious Diseases in Bangladesh; and FOA GH16-003, Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH). Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``Strengthening Disease Prevention Research Capacity for Public Health Action in Guatemala and the Central American Region'', FOA GH13- 001; ``Addressing Emerging Infectious Diseases in Bangladesh'', FOA GH14-002; and ``Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH)'', FOA GH16-003.
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 donor registration form in support of the project titled ``Acquisition of Freshly Drawn Whole Blood/Blood Products for Reference Diagnostic and Research Use.''
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; Corrections
This document corrects technical errors in the addenda to the final rule published in the November 15, 2016, Federal Register entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements.''
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that a webinar meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place and will be open to the general public to listen in via a toll free number.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0955-0009 which expires on May 31, 2017. 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.
Notice of Availability of the Draft Environmental Assessment and Public Meeting
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of the Draft Environmental Assessment (Draft EA) for the CDC Chamblee Campus 2025 Master Plan for public review and comment. This notice also announces the date, location and time for the public meeting. The Draft EA analyzes the potential impacts associated with the implementation of the CDC Chamblee Campus 2025 Master Plan (Master Plan) for HHS/CDC's Chamblee Campus located at 4770 Buford Highway, Chamblee, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500- 1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.
World Trade Center Health Program; Request for Nominations of Scientific Peer Reviewers of Proposed Additions to the List of WTC-Related Health Conditions
The CDC is soliciting nominations, including self-nominations, for scientific peer reviewers of proposed additions of conditions to the List of World Trade Center (WTC)-Related Health Conditions (List). Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, Public Law 111-347 (Jan. 2, 2011), amended by Public Law 114-113 (Dec. 18, 2015), added Title XXXIII to the Public Health Service Act (PHS Act), establishing the WTC Health Program within HHS (42 U.S.C. 300mm to 300mm-61). When the Administrator proposes to add a condition to the List, he must publish the proposed rule in accordance with the Administrative Procedure Act (5 U.S.C. 553). Additionally, as required by the James Zadroga 9/11 Health and Compensation Reauthorization Act in section 3312(a)(6)(F), prior to issuing a final rule to add a health condition to the List, the Administrator must provide for an independent peer review of the scientific and technical evidence that would be the basis for issuing such final rule.
Food and Drug Administration Center for Drug Evaluation and Research Small Business and Industry Assistance Regulatory Education for Industry Generic Drugs Forum; Public Conference
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is sponsoring a 2-day public conference entitled ``FDA CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Generic Drugs Forum.'' The goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of the generic drug development process. Our primary audience is that of small manufacturers within the generic drug industry. However, anyone involved in the pharmaceutical industry may attend.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces the cancellation of a meeting of the National Advisory Council for Healthcare Research and Quality.
Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of January 23, 2017. In the proposed rule, FDA requested comments on its proposal to establish a limit of N- nitrosonornicotine (NNN) in finished smokeless tobacco products. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. The Agency is also providing notice of a typographical error in a formula in the Laboratory Information Bulletin (LIB) titled, ``Determination of N-nitrosonornicotine (NNN) in Smokeless Tobacco and Tobacco Filler by HPLC-MS/MS'' (LIB No. 4620, January 2017). In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review'', the Agency is also taking this opportunity to provide notice that, as with all regulatory actions subject to such memorandum, this proposed rule is being reviewed consistent with the memorandum.
Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective Date
This interim final rule with comment period (IFC) further delays the effective date of the final rule entitled ``Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model'' published in the January 3, 2017 Federal Register (82 FR 180) from March 21, 2017 until May 20, 2017. This IFC also delays the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to October 1, 2017 and effective date of the specific CJR regulations itemized in the DATES section from July 1, 2017 to October 1, 2017. We seek comment on the appropriateness of this delay, as well as a further applicability date delay until January 1, 2018.
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: 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: 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 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: 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 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.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on April 26-27, 2017. The topic for this meeting will be ``Opportunities for Research Supported by the Special Statutory Funding Program for Type 1 Diabetes Research.'' The meeting is open to the public. Non-federal individuals planning to attend the workshop should register by email to Charlemae Clarke, The Scientific Consulting Group, Inc. (cclarke@scgcorp.com; please put ``Registration DMICC T1D Meeting'' in the subject line) at least 7 days prior to the workshop.
Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting for Custom Device Exemption
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 information collection associated with the annual reporting for custom devices.
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments
The Food and Drug Administration (FDA or we) is further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding ``intended uses'' and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to ``intended uses'' generally.
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.'' The January 5, 2017 final rule sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This interim final rule delays the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. Commenters are also invited to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate.
Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, December 29, 2016. The document announced a public workshop entitled ``Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.'' The document was published with an error in the Web site address to access the transcript of the workshop. This document corrects that error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals
The Food and Drug Administration (FDA or Agency) 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 submission of reports of corrections and removals that are associated with medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
The Food and Drug Administration (FDA or we) 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 the Voluntary National Retail Food Regulatory Program Standards.
Presiding Officer for an Appeal and Informal Hearing; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug Director, who is designated to preside over administrative appeals and at informal hearings on appeal, with references to Office of Regulatory Affairs Program Directors. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of 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.
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) reapprove the information collection project: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database.'' 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 December 22, 2016 and allowed 60 days for public comment. Since AHRQ did not receive any substantive comments during this period, this notice allows for an additional 30 days for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification
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.
Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the National Advisory Committee on Rural Health and Human Services (NACRHHS). This meeting will be open to the public. Information about NACRHHS and the agenda for this meeting can be obtained by accessing the following Web site: https://www.hrsa.gov/advisorycommittees/rural.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions
The Food and Drug Administration (FDA, Agency, or we) 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 resulting from the submission to the Agency of pharmacogenomic data during the drug development process.
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