Department of Health and Human Services July 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 (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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c) (2) (A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Idaho National Laboratory in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

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 related to certain regulations that provide protection for human subjects of clinical investigations conducted in support of applications or submissions to FDA for FDA-regulated products. The regulations provide protection of the rights, safety, and welfare of human subjects involved in research activities within FDA's jurisdiction.

The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation ReportQuestions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.

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.

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 Food and Drug Administration (FDA or we) is amending certain regulations pertaining to registration and process filings related to acidified foods and thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as ``low-acid canned foods'' or ``LACF''). The amendments reflect new FDA process filing form numbers, make changes to addresses or locations where such forms can be found or must be sent, remove obsolete references to the effective dates that occurred years ago, and update a reference to another Federal Agency.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.'' The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization.

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 ``Monitoring Changes in Attitudes and Practices among Family Planning Providers and Clinics,'' a survey to assess dissemination and use of guidance documents about the use of contraceptives and the delivery of quality family planning services.

In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF) is establishing five new systems of records: 09-80-0321 ORR Division of Children's Services Records; 09-80-0325 ORR Internet Refugee Arrivals Data System (iRADS); 09-80-0327 ORR Repatriation Program Records; 09- 80-0329 ORR Unaccompanied Refugee Minors Records; and 09-80-0388 ORR Refugee Suicide Database. ORR is deleting one system of records, 09-60- 0217 ORR Cuban Refugee Data System, which is being replaced by the new iRADS system of records. Four of the five new systems of records are ``mixed,'' in that they contain records pertaining to both U.S. persons (i.e., individuals who are citizens of the United States or aliens lawfully admitted for permanent residence in the United States) and non-U.S. persons. The Privacy Act applies only to U.S. persons (citizens of the United States or aliens lawfully admitted for permanent residence in the United States). As a matter of discretion, ORR will treat information that it maintains in its mixed systems of records as being subject to the provisions of the Privacy Act, regardless of whether the information relates to U.S. persons covered by the Privacy Act. This policy implements a 1975 Office of Management and Budget (OMB) recommendation to apply, as a matter of policy, the administrative provisions of the Privacy Act to records about non-U.S. persons in mixed systems of records (referred to as the non-U.S. persons policy).

This document corrects a typographical error that appeared in the final rule published in the Federal Register on May 18, 2016, entitled ``Nondiscrimination in Health Programs and Activities.''

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2015 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that was awarded in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/ sites/default/files/omb/procurement/memo/service-contract-inv entories- guidance-11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: https:// www.hhs.gov/grants/contracts/get-ready-to-do-business/service -contract- inventory/.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Council on Graduate Medical Education (COGME). COGME is authorized by Section 762 of the Public Health Service (PHS) Act (42 U.S.C. 294o), as amended. The Advisory Council is governed by the provisions of the Federal Advisory Act (FACA) (5 U.S.C. Appendix 2), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 762.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.'' This draft guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. This draft guidance is also intended to assist FDA staff participating in the review of such IVD companion diagnostics or their associated therapeutic products. This draft guidance is not final nor is it in effect at this time.

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: Kalina Duncan, Program Director, Center for Global Health, 9609 Medical Center Drive, 3W258, Rockville, MD 20850 or call non-toll-free number (240) 276-5804 or Email your request, including your address to: kalina.duncan@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 Global Cancer Project Map, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a new information collection request for the Study of the Global Cancer Project Map (GCPM) for three years. Information will be collected from health care professionals and researchers in an effort to catalog international efforts related to cancer research, care, and outreach by integrating cancer control program and research project information from various organizations worldwide. The Global Cancer Project Map (GCPM) is a new, interactive, web- based tool that enables healthcare professionals and researchers to make informed decisions, initiate partnerships, and develop ideas for collaborations in cancer control. Its features allow people to (1) search for collaborators and projects by cancer type, project type, and country; (2) visualize information pertinent to each project on an interactive world map; (3) initiate contact with principal investigators and program directors; and (4) overlay heat maps of epidemiological measures that provide a representation of the burden of cancer by country. The primary goals of GCPM are to facilitate the building of collaborations across organizations; accelerate progress, ensure a balanced investment of resources, and align global cancer care and control efforts; and continue data collection from national and international organizations to develop the Map as a resource to view and better understand international efforts in cancer research and control. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 167.

This major proposed rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes proposals related to the Medicare Shared Saving Program, and the release of certain pricing data from Medicare Advantage bids and medical loss ratio reports from Medicare health and drug plans. In addition, this rule proposes to expand the Medicare Diabetes Prevention Program model.