Department of Health and Human Services May 2014 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 349
Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items
This proposed rule would establish a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items that are frequently subject to unnecessary utilization and would add a contractor's decision regarding prior authorization of coverage of DMEPOS items to the list of actions that are not initial determinations and therefore not appealable.
National Institutes of Health Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes
The National Institutes of Health (NIH) proposes to issue regulations to implement provisions of the Public Health Service Act authorizing the NIH Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes (UGSP). The purpose of the program is to recruit appropriately qualified undergraduate students from disadvantaged backgrounds to conduct research in the intramural research program as employees of the NIH by providing scholarship support.
Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Comment Period
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule that appeared in the Federal Register of March 3, 2014. In the proposed rule, FDA requested comments on FDA's regulations for serving sizes for the Nutrition Facts Label. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Extension of Comment Period
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule that appeared in the Federal Register of March 3, 2014. In the proposed rule, FDA requested comments on FDA's revision of the Nutrition and Supplement Facts Labels. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Certification of Maintenance of Effort on Help America Vote Act
The Administration for Community Living (ACL) 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.
Announcement of Public Hearing and Request for Comment: National Center for Complementary and Alternative Medicine Proposed Name Change
The National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (NCCAM) is seeking feedback from stakeholders and other interested parties on a proposal to change the Center's name to National Center for Research on Complementary and Integrative Health. The public is invited to attend a public hearing and provide comments on the NCCAM Web site.
Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond
This final rule addresses various requirements applicable to health insurance issuers, Affordable Insurance Exchanges (``Exchanges''), Navigators, non-Navigator assistance personnel, and other entities under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, the rule establishes standards related to product discontinuation and renewal, quality reporting, non-discrimination standards, minimum certification standards and responsibilities of qualified health plan (QHP) issuers, the Small Business Health Options Program, and enforcement remedies in Federally-facilitated Exchanges. It also finalizes: A modification of HHS's allocation of reinsurance collections if those collections do not meet our projections; certain changes to allowable administrative expenses in the risk corridors calculation; modifications to the way we calculate the annual limit on cost sharing so that we round this parameter down to the nearest $50 increment; an approach to index the required contribution used to determine eligibility for an exemption from the shared responsibility payment under section 5000A of the Internal Revenue Code; grounds for imposing civil money penalties on persons who provide false or fraudulent information to the Exchange and on persons who improperly use or disclose information; updated standards for the consumer assistance programs; standards related to the opt-out provisions for self-funded, non-Federal governmental plans and related to the individual market provisions under the Health Insurance Portability and Accountability Act of 1996 including excepted benefits; standards regarding how enrollees may request access to non- formulary drugs under exigent circumstances; amendments to Exchange appeals standards and coverage enrollment and termination standards; and time-limited adjustments to the standards relating to the medical loss ratio (MLR) program. The majority of the provisions in this rule are being finalized as proposed.
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 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.
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 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.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting June 10-11, 2014. The meeting is open to the public. However, pre- registration is required for both public attendance and public comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac. Participants may also register by emailing nvpo@hhs.gov or by calling 202-690-5566 to provide your name, organization, and email address.
Announcement of the Fourth 2015 Dietary Guidelines Advisory Committee Meeting
As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S. Department of Agriculture (USDA), is hereby giving notice that a meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held and will be open to the public.
Sanitary Transportation of Human and Animal Food; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of February 5, 2014, entitled ``Sanitary Transportation of Human and Animal Food'' and its information collection provisions. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on April 25, 2014 (79 FR 22975). The time and date should read as follows: Time and Date: 10 a.m.-5 p.m., June 17, 2014 (Closed).
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.
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.
Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record Incentive Programs for 2014; and Health Information Technology: Revisions to the Certified EHR Technology Definition
This proposed rule would change the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT). It would also change the requirements for the reporting of clinical quality measures for 2014.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining a List of United States Dairy Product Manufacturers/Processors With Interest in Exporting
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LINZESS
The Food and Drug Administration (FDA) has determined the regulatory review period for LINZESS 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; INLYTA
The Food and Drug Administration (FDA) has determined the regulatory review period for INLYTA 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Increasing the Quality and Efficiency of Clinical Trials
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the efforts of the Center for Drug Evaluation and Research/Office of Medical Policy to increase the quality and efficiency of clinical trials. The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy is announcing its intent to accept and consider a single-source application for the award of a grant to the Duke University's Duke Translational Medicine Institute (DTMI).
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.'' The guidance announced in this document discusses regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA's jurisdiction is transferred from one IRB to another IRB. The guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health
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.
Announcement of the Re-Approval of AABB (Foremerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the application of AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 6 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.