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.

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.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``General Wellness: Policy for Low Risk Devices.'' The guidance is intended to provide clarity to industry and FDA staff on Center for Devices and Radiological Health's (CDRH) compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). By clarifying the policy on general wellness products, we hope to improve the predictability, consistency, and transparency on CDRH's regulation of these products. For purposes of the guidance, CDRH defines ``general wellness products'' as products which meet the following factors: They are intended for only general wellness use as defined in the guidance and present a low risk to the safety of users and other persons.

The Food and Drug Administration (FDA or we) is amending our regulations to reflect a change in the address for the Center for Food Safety and Applied Nutrition (CFSAN). This action is editorial in nature and is intended to improve the accuracy of our regulations.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs 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. The meeting will be open to the public.

This meeting was announced in the Federal Register on July 14, 2016, 81 FR 45506. This meeting is canceled in its entirety.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2017 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2017.

The Food and Drug Administration (FDA or Agency) is establishing a public docket for comment on the Agency's blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry'' dated December 2015. Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2016, and will remain in effect through September 30, 2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices.'' FDA is issuing this draft guidance to clarify how we evaluate real- world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in regulatory decisionmaking for medical devices. This guidance also clarifies when an investigational device exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public to attend in person at the FDA White Oak campus in Silver Spring, MD. Members will participate via teleconference.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty-sixth meeting on August 31, 2016. At this meeting, the Commission will reflect on the past, present, and future impact of national bioethics advisory bodies. Topics will include the history of national bioethics advisory bodies and their contributions to health policy, perspectives about similar bodies elsewhere, and discussion about what the future holds for groups like the Commission.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.

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 Well- Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System. The WISEWOMAN program aims to reduce cardiovascular disease in women ages 40-64 by providing screening services, referrals to medical care, and lifestyle intervention programs.

The Food and Drug Administration (FDA or we) 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 invites comments on the information collection provisions of our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products.

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.

The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on August 2, 2016, to solicit comments regarding the supplemental notice of proposed rulemaking, ``Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements.'' The session will be held in Rockville, MD, to obtain direct public input from stakeholders on the proposed reporting requirements.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Zhiyu Li, Ph.D., Mount Sinai School of Medicine: Based upon the evidence and findings of an investigation report by the Mount Sinai School of Medicine (MSSM) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Zhiyu Li, former Postdoctoral Fellow, MSSM, engaged in research misconduct in research that was supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R21 CA120017. ORI found that falsified and/or fabricated data were included in the following published papers, submitted manuscript, poster presentation, and grant applications:

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: 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.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.

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 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry #3 entitled ``General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals.'' This draft revised guidance describes the type of information that FDA's Center for Veterinary Medicine (CVM) recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals.

The Food and Drug Administration (FDA) is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.

The Food and Drug Administration (FDA) is announcing the renewal of the Science Board to the Food and Drug Administration by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Board to the Food and Drug Administration for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 26, 2018.

This document corrects a technical error that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability.'' The effective date for the rule was July 5, 2016.

Pursuant to 42 U.S.C. 300u and 42 U.S.C. 237a (Sec. 3509 of the Patient Protection and Affordable Care Act), notice is given that the Office on Women's Health (OWH) is soliciting proposals from entities and organizations for the opportunity to sustain the implementation of the Know The Facts First public health awareness and education campaign.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0025, scheduled to expire on November 30, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

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.

The Food and Drug Administration (FDA or Agency) is amending the Agency's regulations by removing certain regulations that include obsolete references. FDA is taking this action to improve the accuracy of the regulations.

The Food and Drug Administration (FDA or Agency) has determined that PARAFON FORTE DSC (chlorzoxazone) tablets, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and this determination will allow FDA to continue to approve ANDAs for chlorzoxane tablets, 500 mg, if all other legal and regulatory requirements are met.

This document amends the notice published in Federal Register, Friday July 8, 2016, volume 81, pages 44639-44640. This notice updates and extends the submission period to August 8, 2016, limits an investigator or co-investigator to one submission and adds prize details. The ``Use of Blockchain in Health IT and Health-related Research'' Ideation Challenge solicits white papers on the topic of Blockchain Technology and the potential use in Health IT to address privacy, security and scalability challenges of managing electronic health record and resources. Up to 15 winners will be awarded a cash prize and up to 8 winners may be invited to present their papers at an upcoming industry-wide workshop co-hosted with the National Institute of Standards and Technology (NIST). The statutory authority for this Challenge is section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed 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 proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, in this proposed rule, we are proposing to make changes to tolerance thresholds for clinical outcomes for solid organ transplant programs; to Organ Procurement Organizations (OPOs) definitions, outcome measures, and organ transport documentation; and to the Medicare and Medicaid Electronic Health Record Incentive Programs. We also are proposing to remove the HCAHPS Pain Management dimension from the Hospital Value-Based Purchasing (VBP) Program. In addition, we are proposing to implement section 603 of the Bipartisan Budget Act of 2015 relating to payment for certain items and services furnished by certain off-campus outpatient departments of a provider.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on August 3, 2016. The subject of the meeting will be ``An Update on the National Diabetes Prevention Program.'' The meeting is open to the public.

This notice of proposed rulemaking (NPRM) proposes changes to the Department of Health and Human Services' (HHS) adoption of the Office of Management and Budget's (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (``Uniform Administrative Requirements'') published on December 19, 2014 (79 FR 75871) and the technical amendments published by HHS on January 20, 2016 (81 FR 3004). HHS codified the OMB language, with noted modifications as explained in the preamble to the December promulgation, in 45 CFR part 75. The HHS-specific modifications to the Uniform Administrative Requirements adopted prior regulatory language that was not in conflict with OMB's language, and provided additional guidance to the regulated community. Unlike all of the other modifications to the Uniform Administrative Requirements, these proposed changes, although based on existing law or HHS policy, were not previously codified in regulation. This NPRM seeks comments on these important proposed regulatory changes.

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 of Nursing Research (NINR), 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*: Ms. Diana Finegold, Office of Communications and Public Liaison, NINR, NIH, Building 31, Suite 5B03, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0209, or Email your request, including your address to: Diana.Finegold@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: Palliative Care: Conversations Matter[supreg] Phase Two Evaluation, 0925-NEW, National Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: The NINR Palliative Care: Conversations Matter[supreg] initiative, which launched in FY 2014, is now in its second phase. The first phase was focused on providing materials and tools to assist health care providers in having sometimes difficult conversations with children and families about palliative care. The second phase of the campaign, launched in FY 2015, focuses on children, parents, and families. The Palliative Care: Conversations Matter[supreg] Phase Two evaluation will assess the information and materials being disseminated to children, parents, and families. Survey findings will help (1) determine if the campaign is effective, relevant, and useful to the families and caregivers of children living with serious illnesses; (2) to better understand the information needs of families and caregivers to inform future campaign efforts; and (3) examine how effective the campaign materials are in providing families and caregivers with information on palliative care. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 400 hours.

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 ``Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Hospitals.'' This data collection will provide information on the burden and types of healthcare-associated infections, including infections due to antimicrobial-resistant pathogens, and antimicrobial drugs in U.S. short-term acute care hospitals.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB) will be holding a public teleconference.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms ``commercially available,'' ``essentially a copy of a commercially available drug,'' and ``regularly or in inordinate amounts.''

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 relating to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device.'' This guidance describes the types of information that should be provided to support a claim of EMC in a premarket submission for an electrically powered medical device. Electromagnetic disturbance is electronic product radiation that may interfere with the performance of an electrically powered medical device in its intended environment (i.e., cause an electromagnetic interference (EMI)). EMC assessment helps to ensure that a device is able to function in its intended environment without introducing excessive electromagnetic disturbances that might interfere with other devices.