Department of Health and Human Services June 2016 – Federal Register Recent Federal Regulation Documents

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.

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 If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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 https:// www.samhsa.gov/workplace.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice entitled ``Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments'' that appeared in the Federal Register of March 4, 2016. The notice requested scientific data, information, and comments that would assist in the development of a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). In the Federal Register notice of April 22, 2016, the comment period for this request was initially extended to July 5, 2016. We are taking this action due to maintenance on the Federal eRulemaking portal in early July 2016.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of May 5, 2016. In the notice, FDA announced an opportunity for public comment on the proposed collection of certain information by the Agency. We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.

Notice is hereby given that I delegate to the Assistant Secretary for the Administration for Children and Families (ACF) the following authorities vested in the Secretary of Health and Human Services under the Trafficking Victims Protection Act of 2000 (TVPA), Public Law 106-386, as amended. Authority under section 107(b)(1)(B)(i) of the TVPA (22 U.S.C. 7105(b)(1)(B)(i)) to expand benefits and services to victims of severe forms of trafficking in persons in the United States, without regard to immigration status. In the case of non-entitlement programs funded by the Secretary of Health and Human Services, such benefits and services may include services to assist potential victims of trafficking in achieving certification and to assist minor dependent children of victims of severe forms of trafficking in persons or potential victims of trafficking. Authority under section 107(b)(1)(B)(ii) of the TVPA (22 U.S.C. 7105(b)(1)(B)(ii)) to make grants for a national communication system to assist victims of severe forms of trafficking in persons in communicating with service providers. Authority under section 107(f) of the TVPA (22 U.S.C. 7105(f)) to establish a program to assist United States citizens and aliens lawfully admitted for permanent residence who are victims of severe forms of trafficking. In addition to the authority to provide such victims with specialized services, the program also has the authority to identify current providers and provide a means to make referrals to programs for which such victims are already eligible. In the course of exercising the authority to conduct activities, personnel in the Administration for Children and Families will consult with the Attorney General, the Secretary of Labor, and non-governmental organizations that provide services to victims of severe forms of trafficking in the United States. These authorities may be redelegated. These authorities shall be exercised under the Department's policy on regulations and the existing delegation of authority to approve and issue regulations. These delegations shall be exercised under financial and administrative requirements applicable to the Administration for Children and Families authorities. I hereby affirm and ratify any actions taken by the Assistant Secretary for Children and Families, or your subordinates, which involved the exercise of these authorities delegated herein prior to the effective date of this delegation. This delegation supersedes all existing delegations of these authorities.

This document corrects technical errors that appeared in the final rule published in the Federal Register on May 4, 2016, entitled ``Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities.''

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring.

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.

The Administration on Community Living, Administration on Aging (ACL/AoA) 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 information collection requirements relating to conflict of interest reporting per the Code of Federal Regulations and Older Americans Act Title VII.

This rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017 as well as proposing to implement policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also proposes to set forth requirements for the ESRD Quality Incentive Program, and proposes to establish and revise requirements for quality reporting and measurement, including the inclusion of new quality measures for payment year (PY) 2020 and beyond and updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also proposes to implement statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also proposes to expand suppliers' appeal rights in the event of a breach of contract action by CMS. In particular, this rule proposes a revision to current regulations to provide that the appeals process is applicable to all breach of contract actions taken by CMS, rather than just for the termination of a competitive bidding contract. It also proposes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from Competitive Bidding Programs and for submitting bids and establishing single payment amounts under the Competitive Bidding Programs for certain groupings of similar items with different features. Changes are also proposed to the methodology for establishing bid limits for items under the DMEPOS Competitive Bidding Programs. In addition, this rule also solicits comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule announces a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for the public and FDA staff entitled ``Gifts to FDA: Evaluation and Acceptance.'' The Secretary of the Department of Health and Human Services (HHS) has the authority to accept conditional or unconditional gifts on behalf of the United States. The Secretary has delegated this gift authority to the Commissioner of Food and Drugs. This guidance provides the process and principles we will use in implementing this authority.

The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use 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 electrosurgical device for over-the-counter aesthetic use'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.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from the public related to the Senior Medicare Patrol (SMP) Program. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish a 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.

Representatives of the Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), will be conducting a federal review of the Oklahoma Disability Law Center (ODLC) on August 16-18, 2016. AIDD is soliciting comments from interested parties on your experiences with the work, program, and strategies employed by ODLC in meeting the needs of individuals with developmental disabilities and their families in Oklahoma. You are encouraged to share your experiences by way of any of the following methods: Email: Clare.Barnett@acl.hhs.gov. Telephone: 202-795-7301. Mail Comments to: Clare Barnett Huerta, Program Specialist, Administration on Intellectual and Developmental Disabilities, Administration for Community Living, 330 C Street SW., 1st Floor, Washington, DC 20201. Comments should be received by August 18, 2016 in order to be included in the final report.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the UM-JMH Center for Patient Safety PSO of its status as a PSO, and has delisted the PSO accordingly.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to Pro Arc Diagnostics, Inc., which is located in Missouri, to practice the inventions embodied in the following patents: U.S. Patent Application 14/408,919, filed December 17, 2014 (HHS reference E-088-2012/0-US-03). The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive license territory may be worldwide and the field of use may be limited to FDA premarket approved (PMA) diagnostics for the detection of JC Virus.