Department of Health and Human Services November 2014 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 265
Submission for OMB Review; Comment Request
Document Number: 2014-26733
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2014-26729
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, Administration for Children and Families
Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems
Document Number: 2014-26726
Type: Proposed Rule
Date: 2014-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls); require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the dynamic stabilization systems, currently a subtype of pedicle screws, regardless of the indication for use; and clarify the device identification of pedicle screw spinal systems, to more clearly delineate between rigid pedicle screw systems and dynamic stabilization systems. FDA is proposing this action based on new information pertaining to the device type. This proposed action implements certain statutory requirements.
Submission for OMB Review; Comment Request
Document Number: 2014-26723
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, Administration for Children and Families
Nominations to the Presidential Advisory Council on HIV/AIDS
Document Number: 2014-26715
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four-year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature.
DSM Nutritional Products; Food Additive Petition (Animal Use); Ethoxyquin; Environmental Assessment
Document Number: 2014-26709
Type: Notice
Date: 2014-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of an environmental assessment filed by DSM Nutritional Products in support of their petition proposing that the food additive regulations be amended to provide for the safe use of ethoxyquin in vitamin D formulations, including 25-hydroxyvitamin D3, used in animal food.
Submission for OMB Review; Comment Request
Document Number: 2014-26708
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
Document Number: 2014-26698
Type: Notice
Date: 2014-11-12
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 research entitled, ``Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads.'' This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads.
Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-26694
Type: Notice
Date: 2014-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Molecular Diagnostic Instruments with Combined Functions.'' This guidance document provides industry and Agency staff with FDA's current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions.
Submission for OMB Review; Comment Request
Document Number: 2014-26683
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2014-26672
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-26671
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2014-26667
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2014-26653
Type: Notice
Date: 2014-11-12
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
Document Number: 2014-26699
Type: Notice
Date: 2014-11-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2014-26608
Type: Notice
Date: 2014-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2014-26607
Type: Notice
Date: 2014-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2014-26606
Type: Notice
Date: 2014-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-26605
Type: Notice
Date: 2014-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-26604
Type: Notice
Date: 2014-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Document Number: 2014-26596
Type: Notice
Date: 2014-11-10
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 current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Armando Santos: Debarment Order
Document Number: 2014-26562
Type: Notice
Date: 2014-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Armando Santos from providing services in any capacity to a person that has an approved or pending drug product application for a period of 12 years. FDA bases this order on a finding that Mr. Santos was convicted of seven felony counts under Federal law for conduct involving health care fraud, conspiracy to commit health care fraud, and false statements related to health care matters and that this pattern of conduct is sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Mr. Santos was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Santos failed to respond. Mr. Santos's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: CMS-Identified Overpayments Associated with Submitted Payment Data
Document Number: 2014-26146
Type: Rule
Date: 2014-11-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2015 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In this document, we also are making changes to the data sources permitted for expansion requests for physician-owned hospitals under the physician self-referral regulations; changes to the underlying authority for the requirement of an admission order for all hospital inpatient admissions and changes to require physician certification for hospital inpatient admissions only for long-stay cases and outlier cases; and changes to establish a formal process, including a three- level appeals process, to recoup overpayments that result from the submission of erroneous payment data by Medicare Advantage (MA) organizations and Part D sponsors in the limited circumstances in which the organization or sponsor fails to correct these data.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2014-26584
Type: Notice
Date: 2014-11-07
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 required to publish notice in the Federal Register concerning each proposed collection of information. 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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR Part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the information collection request (ICR) currently approved under Office of Management and Budget (OMB) control number 0938-1119 in order to collection additional information during the 2015 open enrollment periods from the 14 operational SBMs (including Washington, DC) to enhance the agency's understanding of the demographic makeup of the citizens enrolling in the various health plans as well as the affordability of those plans. Existing collections gather information from the grant awardee to ensure the CMS is able to conduct their statutory oversight responsibilities. The revision to the weekly reporting requirement is necessary to obtain more accurate and consistent enrollment data during the upcoming Open Enrollment Period which begins November 15, 2014. The immediate need for this revision is due to the State-Based Marketplaces (SBM) maturing business processes and the requirement for more precise reporting of comparison data between the first and second years of ACA implementation. The changes to the revised format of the Weekly Report have been presented to all participating states. CMS is requesting an emergency modification to the weekly reporting template in order to capture certain demographic data and information on new versus re-enrolled individuals in accordance with uniform definitions so as not to produce misleading results.
Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing
Document Number: 2014-26559
Type: Proposed Rule
Date: 2014-11-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the proposed rule would remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2014-26511
Type: Notice
Date: 2014-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)
Document Number: 2014-26510
Type: Notice
Date: 2014-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Council for the Elimination of Tuberculosis Meeting (ACET)
Document Number: 2014-26509
Type: Notice
Date: 2014-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2014-26479
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2014-26478
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-26477
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-26475
Type: Notice
Date: 2014-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-26474
Type: Notice
Date: 2014-11-07
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-26473
Type: Notice
Date: 2014-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-26442
Type: Notice
Date: 2014-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2014-26421
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-26420
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-26419
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-26418
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-26417
Type: Notice
Date: 2014-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Adoption of Administration for Native Americans Program Policies and Procedures
Document Number: 2014-26426
Type: Notice
Date: 2014-11-06
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Native Americans (ANA) invites public comment pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, which requires ANA to provide members of the public with the opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice that affect programs, projects, and activities authorized under the NAPA, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposal to fund projects, beginning in Fiscal Year (FY) 2015, under Alaska-Specific SEDS.
Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort
Document Number: 2014-26425
Type: Notice
Date: 2014-11-06
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from the Simonds Saw and Steel Company in Lockport, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Office of the Director, Program on Biosecurity and Biosafety Policy; Notice of Meeting
Document Number: 2014-26422
Type: Notice
Date: 2014-11-06
Agency: Department of Health and Human Services, National Institutes of Health
The Iams Company; Filing of Food Additive Petition (Animal Use)
Document Number: 2014-26405
Type: Proposed Rule
Date: 2014-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that The Iams Company has filed a petition proposing that the food additive regulations be amended to provide for the safe use of a Salmonella- specific bacteriophage preparation as a food additive as an antimicrobial processing aid to reduce Salmonella in the production of dry dog and cat pet food.
Specification of the Unique Facility Identifier System for Drug Establishment Registration; Guidance for Industry; Availability
Document Number: 2014-26397
Type: Notice
Date: 2014-11-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.'' This guidance specifies the UFI system for registration of domestic and foreign drug establishments. The guidance addresses provisions set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This guidance finalizes the draft guidance issued on September 6, 2013.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-26383
Type: Notice
Date: 2014-11-06
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), 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 reinstatement of a previously-approved information collection assigned OMB control number 4040-0016SF-429 Real Property Status Report, which expired on July 31, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-26382
Type: Notice
Date: 2014-11-06
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), 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 issuance of a new expiration date of a previously-approved information collection assigned OMB control number 4040-0014-SF-425 Federal Financial Report, which expires on February 28, 2015. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-26381
Type: Notice
Date: 2014-11-06
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), 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 reinstatement of a previously-approved information collection assigned OMB control number 4040-0013SF-LLL Disclosure of Lobbying Activities, which expired on December 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-26380
Type: Notice
Date: 2014-11-06
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), 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 reinstatement of a previously-approved information collection assigned OMB control number 4040-0012SF-270: Request for Advance or Reimbursement, which expired on October 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.