Department of Health and Human Services March 1, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-04463
Type: Notice
Date: 2016-03-01
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 require; 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-04462
Type: Notice
Date: 2016-03-01
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: 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.
National Eye Institute; Notice of Closed Meeting
Document Number: 2016-04447
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-04446
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-04431
Type: Notice
Date: 2016-03-01
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 2017 and 2019 National Youth Risk Behavior Surveys (YRBS). The goal of the study is to assess priority health-risk behaviors related to the major preventable causes of mortality, morbidity, and social problems among both youth and adults in the United States. CDC is requesting a 3-year approval to reinstate with change the data collection for the National YRBS.
Substance Abuse and Mental Health Services Administration
Document Number: 2016-04420
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-04419
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-04418
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2016-04415
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Battelle LaboratoriesKing Avenue site in Columbus, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
Document Number: 2016-04411
Type: Proposed Rule
Date: 2016-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is publishing in this document the recommendations of the Blood Product Advisory Committee regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.
Submission for OMB Review; Comment Request
Document Number: 2016-04410
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, Administration for Children and Families
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-04408
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry; Availability
Document Number: 2016-04372
Type: Notice
Date: 2016-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry.'' The draft guidance document provides members of the medical and scientific community and other interested persons with notice that, when finalized, we intend to exercise enforcement discretion under limited conditions, regarding the investigational new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat C. difficile infection not responding to standard therapies. The draft guidance replaces the draft guidance of the same title dated March 2014 and, when finalized, is intended to supersede the document of the same title, dated July 2013.
Determination of Regulatory Review Period for Purposes of Patent Extension; ANORO ELLIPTA
Document Number: 2016-04370
Type: Notice
Date: 2016-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ANORO ELLIPTA 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 the U.S. Patent and Trademark Office (USPTO), 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; INVOKANA
Document Number: 2016-04369
Type: Notice
Date: 2016-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for INVOKANA 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-04366
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-04365
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; iWin: Navigating Your Path to Well-Being
Document Number: 2016-04364
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Belinda Sims, Health Scientist, DESPR, PRB, NIDA, NIH, 6001 Executive Boulevard, Room 5153, Bethesda, Maryland 20892, or call non-toll-free number (301) 402-1533, or Email your request, including your address to: bsims@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: iWin: Navigating your Path to Well-Being, 0925-NEW, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: The overarching objective of this proposal is to conduct a randomized trial to evaluate the effectiveness of the Individual Well- Being Navigator (iWin) mobile application, a substance abuse prevention and well-being enhancement program designed specifically for military personnel. This mobile application provides an innovative, tailored mobile application using best practices in behavior change science and innovative technology to assist military personnel in preventing substance abuse and enhancing well-being by providing them with the most appropriate intervention content at the right time. It integrates Trans-theoretical Model of Behavior Change based tailoring, SMS messaging, stage of change matched activities, and engaging game-like features in a cutting edge multiple behavior change program. The first year of this project will focus on the completion of development and beta testing of the app. In year 2, the efficacy of the iWin program will be determined by tests of statistical significance indicating that participants in the Treatment condition had lower scores on an index of substance use and other behavioral risks than the control group at 6 and 9 month follow-up. The overall design is a 2 group (treatment and control group) by 3 Occasions with repeated measures across occasions. Once shown to be effective, the iWin program will assist organizations that serve military personnel to meet the directives of both the Department of Defense and the Chairman of the Joint Chiefs of Staff indicating that prevention programs be evidence based, evaluated by the specified populations and address full Total Force Fitness paradigm rather than a single behavior. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,557.
Proposed Collection; 60-Day Comment Request; The Study of Center of Global Health's (CGH) Workshops (NCI)
Document Number: 2016-04363
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Sudha Sivaram, Program Director, Center for Global Health, 9609 Medical Center Drive, RM 3W528 Rockville, MD, 20850 or call non-toll-free number (240) 276-5810 or Email your request, including your address to: sudha.sivaram@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Study of the Center of Global Health's (CGH) Workshops (NCI), 0925-0722, Expiration Date 06/30/2018, REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this study is to collect stakeholder feedback from past and future workshops; to assess the effectiveness of the Center of Global Health (CGH) workshops, which seek to assess abilities of the workshop attendees and respective countries to implement national cancer control programs; inform content and improve delivery of future workshops, and to systematically assess CGH's contribution. The workshops to be studied are the Symposiums on Global Cancer Research, Workshops in Cancer Control Planning and Implementation, the Summer Curriculum in Cancer Prevention, Women's Cancer Program Summit, Regional Grant Writing and Peer Review Workshops, and Workshops on Tobacco Control. While these workshops differ in content and delivery style, their underlying goals are the same; they intend to initiate and enhance cancer control efforts, increase capacity for cancer research, foster new partnerships, and create research and cancer control networks. The proposed study requests information about the outcomes of each of these workshops including (1) new cancer research partnerships and networks (2) cancer control partnerships and networks, (3) effects on cancer research, and (4) effect on cancer control planning and implementation efforts. Information will be collected in two phases where Phase 1 will collect information from attendees of past workshops (1998-2015) and Phase 2 will collect information from attendees of future workshops over the next three years. The surveys will enable CGH to better understand the impact the workshops have had on their partnerships and networks, research, and cancer control planning and implementation efforts. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 941.
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-04361
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, National Institutes of Health
Pediatric Advisory Committee; Amendment of Notice
Document Number: 2016-04360
Type: Notice
Date: 2016-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of February 19, 2016. The amendment is being made to reflect a change in the Location portion of the document. There are no other changes.
Medicare, Medicaid, and Children's Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process
Document Number: 2016-04312
Type: Proposed Rule
Date: 2016-03-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement sections of the Affordable Care Act that require Medicare, Medicaid, and Children's Health Insurance Program (CHIP) providers and suppliers to disclose certain current and previous affiliations with other providers and suppliers. This proposed rule would also provide CMS with additional authority to deny or revoke a provider's or supplier's Medicare enrollment. In addition, this proposed rule would require that to order, certify, refer or prescribe any Part A or B service, item or drug, a physician or, when permitted, an eligible professional must be enrolled in Medicare in an approved status or have validly opted-out of the Medicare program.
Request for Information on Updates to the ONC Voluntary Personal Health Record Model Privacy Notice
Document Number: 2016-04239
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, Office of the Secretary
The Office of the National Coordinator for Health Information Technology (ONC) seeks comments on the scope and content of the voluntary Personal Health Record Model Privacy Notice (MPN) developed by ONC and published in 2011. In response to stakeholder requests for an electronic means to inform consumers about how health technology products store, use, and share health information (especially products of health technology developers not covered by the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191), we have initiated a process to update the MPN to better align with the current consumer health technology landscape.
Health IT Policy Committee and Health IT Standards Committee: Schedule and Recommendations
Document Number: 2016-04238
Type: Notice
Date: 2016-03-01
Agency: Department of Health and Human Services, Office of the Secretary
This notice fulfills obligations under the Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), which amended the Public Health Service Act (PHSA). Section 3003(b)(3) of the PHSA mandates that the Health IT Standards Committee (HITSC) develop an annual schedule for the assessment of policy recommendations developed by the Health IT Policy Committee (HITPC) and publish the schedule in the Federal Register. This notice fulfills the requirements of section 3003(b)(3) and updates the HITSC schedule posted in the Federal Register on August 10, 2015. This notice also meets the requirements under sections 3002(e) and 3003(e) for publication in the Federal Register of recommendations made by the HITPC and HITSC, respectively. Further, this notice serves to meet the requirements of section 3004(a)(3) for publication in the Federal Register of determinations by the Secretary of Health and Human Services regarding HITSC-recommended certification criteria endorsed by the National Coordinator for Health Information Technology.