Department of Health and Human Services July 2015 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring
Document Number: 2015-17318
Type: Notice
Date: 2015-07-14
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 collection of information concerning the development of comprehensive monitoring plans in the guidance.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-17285
Type: Notice
Date: 2015-07-14
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 (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.
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-17250
Type: Notice
Date: 2015-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This draft guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This draft guidance is not final nor is it in effect at this time.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2015-17219
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services
Document Number: 2015-17190
Type: Proposed Rule
Date: 2015-07-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule proposes to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CCJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement or reattachment of a lower extremity. All related care within 90 days of hospital discharge from the joint replacement procedures will be included in the episode of care. We believe this model will further our goals in improving the efficiency and quality of care for Medicare beneficiaries for these common medical procedures.
Submission for OMB Review; Comment Request
Document Number: 2015-17166
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, Administration for Children and Families
Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments
Document Number: 2015-17165
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. The meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/32822.
National Institute of Environmental Health Sciences Notice of Closed Meeting
Document Number: 2015-17164
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2015-17163
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2015-17162
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2015-17161
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2015-17160
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2015-17159
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meeting
Document Number: 2015-17158
Type: Notice
Date: 2015-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Coverage of Certain Preventive Services Under the Affordable Care Act
Document Number: 2015-17076
Type: Rule
Date: 2015-07-14
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. These regulations finalize provisions from three rulemaking actions: Interim final regulations issued in July 2010 related to coverage of preventive services, interim final regulations issued in August 2014 related to the process an eligible organization uses to provide notice of its religious objection to the coverage of contraceptive services, and proposed regulations issued in August 2014 related to the definition of ``eligible organization,'' which would expand the set of entities that may avail themselves of an accommodation with respect to the coverage of contraceptive services.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-17037
Type: Notice
Date: 2015-07-13
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 (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.
Submission for OMB Review; Comment Request
Document Number: 2015-17030
Type: Notice
Date: 2015-07-13
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-17017
Type: Notice
Date: 2015-07-13
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 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 a proposed revisions of the National HIV Surveillance System (NHSS) information collection. This data collection provides the primary population-based data used to describe the epidemiology of HIV in the United States.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-17011
Type: Notice
Date: 2015-07-13
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-17010
Type: Notice
Date: 2015-07-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Extension of Comment Period for the Office of the Assistant Secretary for Preparedness and Response Public Access Plan to Federally Funded Research: Publications and Data
Document Number: 2015-16969
Type: Notice
Date: 2015-07-13
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) is extending the comment period on the Assistant Secretary for Preparedness and Response (ASPR) Public Access Plan for Federally Funded Research: Publications and Data. The document is available to the public via https://www.phe.gov/Preparedness/planning/science/Pages/Access Plan.aspx. The comment period was previously scheduled to end June 25, 2015. The public comment period is extended until July 13, 2015.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-16960
Type: Notice
Date: 2015-07-13
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Notice of Closed Meeting
Document Number: 2015-16959
Type: Notice
Date: 2015-07-13
Agency: Department of Health and Human Services, National Institutes of Health
Science Board to the Food and Drug Administration; Notice of Meeting
Document Number: 2015-16957
Type: Notice
Date: 2015-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education-Health Reform Cooperative Agreement; Correction
Document Number: 2015-16953
Type: Notice
Date: 2015-07-13
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a document in the Federal Register on June 19, 2015, for the FY 2015 National Indian Health Outreach and Education, Health Reform Cooperative Agreement Program. The notice contained two incorrect dates.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
Document Number: 2015-16952
Type: Notice
Date: 2015-07-13
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.
Determining Mental Health Professional Shortage Areas of Greatest Need; Correction
Document Number: 2015-16964
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of section 333A(b)(1) of the Public Health Service (PHS) Act, as amended by the Health Care Safety Net Amendments of 2002, 42 U.S.C. 254f-1(b)(1), the Secretary of HHS shall establish the criteria which she will use to make determinations under section 333A(a)(1)(A) of the Health Professional Shortage Areas (HPSAs) with the greatest shortages. The Health Resources and Services Administration published a notice in the Federal Register, FR 2015-00398 (January 14, 2015), which sets forth revised criteria for determining mental health HPSAs with the greatest shortage.
World Trade Center Health Program; Petition 008-Autoimmune Diseases; Finding of Insufficient Evidence
Document Number: 2015-16942
Type: Proposed Rule
Date: 2015-07-10
Agency: Department of Health and Human Services
On May 11, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 008) to add autoimmune diseases to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 008 is not substantially different from Petition 007, which also requested the addition of autoimmune diseases. The Administrator recently published a response to Petition 007 in the Federal Register and has determined that Petition 008 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
National Institute of Allergy and Infectious Diseases: Notice of Closed Meeting
Document Number: 2015-16937
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-16895
Type: Notice
Date: 2015-07-10
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 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 proposed extension of the information collection entitled Evaluating the Effectiveness of Occupational Safety and Health Program Elements in the Wholesale Retail Trade Sector. The National Institute for Occupational Safety and Health seeks to continue its scientific intervention effectiveness research to support the evidenced based prevention of occupational injuries and illnesses in the wholesale/retail sector.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-16894
Type: Notice
Date: 2015-07-10
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 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 a proposed field survey to assess safety and health hazards to workers in oil and gas (O&G) extraction.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-16893
Type: Notice
Date: 2015-07-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2015-16871
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2015-16870
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, Office of the Secretary
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 a revision to the use of the approved information collection assigned OMB control number 0990-0281, which expires on November 30, 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.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date
Document Number: 2015-16865
Type: Rule
Date: 2015-07-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for further clarification of the rule's requirements.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-16842
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2015-16841
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2015-16840
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; Notice of Charter Renewal
Document Number: 2015-16839
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2015-16838
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-March Through June 2015
Document Number: 2015-16824
Type: Notice
Date: 2015-07-10
Agency: Department of Health and Human Services
This notice announces the implementation of the OMHA Case Processing Manual (OCPM). 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.
Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
Document Number: 2015-16790
Type: Proposed Rule
Date: 2015-07-10
Agency: Department of Health and Human Services, Center for Medicare & Medicaid Services
This proposed rule would update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2016. As required by the Affordable Care Act, this proposed rule implements the third year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This proposed rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments. This proposed rule also proposes: reductions to the national, standardized 60-day episode payment rate in CY 2016 and CY 2017 of 1.72 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014; a HH value-based purchasing (HHVBP) model to be implemented beginning January 1, 2016 in which all Medicare-certified HHAs in selected states will be required to participate; changes to the home health quality reporting program requirements; and minor technical regulations text changes. Finally, this proposed rule would update the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking and provide an update on the Report to Congress regarding the home health (HH) study.
Office of Clinical and Preventive Services; Division of Behavioral Health; Domestic Violence Prevention Initiative
Document Number: 2015-16750
Type: Notice
Date: 2015-07-08
Agency: Department of Health and Human Services, Indian Health Service
National Institute on Alcohol Abuse and Alcoholism; Notice of Presentation
Document Number: 2015-16708
Type: Notice
Date: 2015-07-08
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will host an online presentation to enable public discussion of the Institute's proposal to create a new division; Division of Medications Development. The proposal seeks to better reflect the NIAAA priorities by increasing the emphasis on medications development efforts on treating alcohol use disorders (AUD). The change is budget neutral and will use existing resources within the institute. The information was discussed at the public portion of the National Advisory Council on Alcohol Abuse and Alcoholism held on June 10, 2015.
National Cancer Institute; Notice of Closed Meeting
Document Number: 2015-16707
Type: Notice
Date: 2015-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2015-16706
Type: Notice
Date: 2015-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2015-16705
Type: Notice
Date: 2015-07-08
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: 2015-16704
Type: Notice
Date: 2015-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2015-16703
Type: Notice
Date: 2015-07-08
Agency: Department of Health and Human Services, National Institutes of Health
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