Department of Health and Human Services October 2015 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 354
Announcement of Requirements and Registration for the National Heart, Lung, and Blood Institute “Novel, Innovative Tools To Increase Public Awareness and Knowledge of Sickle Cell Disease Undergraduate Challenge”
The National Heart, Lung, and Blood Institute (NHBLI), a component of the National Institutes of Health (NIH) announces the ``Novel, Innovative Tools to Increase Public Awareness and Knowledge of Sickle Cell Disease Undergraduate Challenge'' to help address the lack of awareness about sickle cell disease and its associated complications and to improve successful implementation of effective interventions for sickle cell disease (SCD) in real world settings. In addition, by directing the Challenge at undergraduate students, the Challenge also aims to advance the field of implementation science through research training, mentoring, and highlighting the contributions of a new generation of undergraduate researchers using a systems science approach to address multi-faceted problems.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by our 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. This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes
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 processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH) employees.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults
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.
Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device
The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program
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 Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601
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 Form FDA 3601, entitled ``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Administrative Practices and Procedures; Formal Evidentiary Public Hearing'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions
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 paperwork associated with food additive petitions regarding animal food and Investigation Food Additive Exemptions.
Manufacturing Site Change Supplements: Content and Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Manufacturing Site Change Supplements: Content and Submission''. This draft guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider to determine whether a preapproval inspection is necessary before approval of the PMA supplement. This draft guidance is not final nor is it in effect at this time.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period
The Food and Drug Administration (FDA or we) is announcing the reopening of the comment period for certain documents associated with the proposed rule to amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices. We also are reopening the comment period for a supplemental proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are taking this action due to technical difficulties at the Federal eRulemaking Portal.
Privacy Act of 1974; System of Records Notice
In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), the Office of Medicare Hearings and Appeals (OMHA) within the Office of the Secretary of Health and Human Services (HHS) is establishing a new system of records, System No. 09- 90-1501, entitled ``Administrative Law Judge (ALJ) Working File, Office of Medicare Hearings and Appeals,'' to cover OMHA ALJ working files previously maintained as part of the Social Security Administration's (SSA) ALJ Working File system of records 60-0005 (last published at 74 FR 19617). The working files covered under new System of Records Notice (SORN) 09-90-1501 are created and used by OMHA ALJs and members of their staffs for internal purposes, to document actions taken by OMHA at the hearing level in each Medicare appeal case that OMHA reviews. The working files are separate from the official case files, which are covered under other SORNs (i.e., HHS SORN 09-70-0566 covers case files on Medicare claims appeals, and SSA SORN 60-0089 covers case files on Medicare entitlement appeals).
Statement of Organization, Functions, and Delegations of Authority
Statement of Organization, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized. The reorganization adds the Chief of Staff, the Deputy Assistant Secretary for External Affairs, and the Associate Deputy Assistant Secretary for Early Childhood Development positions to the Office of the Assistant Secretary. It also renames the Inter-Departmental Liaison for Early Childhood Development position to the Deputy Assistant Secretary for Early Childhood Development. It eliminates the Office of the Deputy Assistant Secretary for Policy and External Affairs. The reorganization removes the Office of Human Services Emergency Preparedness and Response from within the Office of the Assistant Secretary and creates the Office of Human Services Emergency Preparedness and Response as a direct report to the Assistant Secretary. It renames the Office of Public Affairs to the Office of Communications. Lastly, it changes the reporting relationship of the Office of Regional Operations and the Office of Communications from the Assistant Secretary to a direct report to the Deputy Assistant Secretary for External Affairs. This notice amends Part K of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), as follows: Chapter K, Administration for Children and Families (ACF), as last amended in 77 FR 2325023260, April 18, 2012; Chapter KA, Office of the Assistant Secretary, as last amended in 80 FR 3326933270, June 11, 2015; Chapter KJ, Office of Regional Operations, as last amended in 71 FR 59117-59123, October 6, 2006; and Chapter KN, Office of Public Affairs, as last amended in 77 FR 61002-61003, October 5, 2012. I. Under Chapter K, Administration for Children and Families, delete K.00 Mission in its entirety and replace with the following:
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with 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 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 0945-0002, which expires on 12/31/2015. 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.
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC reviews and evaluates medical literature and technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.
Medicare Program; Request for Information Regarding Implementation of the Merit Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models
This document extends the comment period for the October 1, 2015 document entitled ``Request for Information Regarding Implementation of the Merit-based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models'' (80 FR 59102, referred to in this document as ``the October 1 RFI''). The comment period for the October 1 RFI, which would have ended on November 2, 2015, is extended for an additional 15 days. This document also advises the public and stakeholders of CMS priorities for the information sought in the October 1 RFI, and suggests that commenters may choose to focus their attention and comments accordingly.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
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