Department of Health and Human Services September 2017 – Federal Register Recent Federal Regulation Documents

This notice requests nominations to fill vacancies on the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel). The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on issues related to clinical diagnostic laboratory tests (CDLTs). As announced in the notice published in the Federal Register on June 16, 2017, entitled ``Medicare Program; Rechartering, Membership, and Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on August 1, 2017'' (82 FR 27705), the Secretary approved the rechartering of the Panel on April 25, 2017 for a 2-year period effective through April 25, 2019.

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On August 21, 2017, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 39553). HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2018.

The Food and Drug Administration (FDA or Agency) is establishing a public docket to solicit suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, on questions relevant to FDA's newly established Opioid Policy Steering Committee (OPSC). Opioid addiction and the resulting overdoses and deaths have created a national crisis, which requires action by federal agencies that may in some instances be unprecedented in order to address the situation and attempt to turn the tide on the crisis. As a public health agency responding to the crisis, FDA seek public input as it considers how its authorities can or should be used to address this crisis. This information will help the Agency understand areas of focus important to the public and identify and address opioid product and policy issues that need clarification. FDA is especially interested in hearing from interested parties in three key areas: What more can FDA do to ensure that the full range of available information, including about possible public health effects, is considered when making opioid-related regulatory decisions; what steps can FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice; and should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products, and if so, how should such a system be implemented?

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2018. The calendar year 2018 AIC threshold amounts are $160 for ALJ hearings and $1,600 for judicial review.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2018.

The Food and Drug Administration (FDA or we) 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 Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on October 25, 2017. The subject of the meeting will be ``Enhancing Opportunities in Addressing Obesity and Type 2 Diabetes Disparities.'' The meeting is open to the public.

This non-competitive supplemental funding award will provide a phone consultation line staffed by clinicians dedicated to providing technical support and real-time clinical consultation to health professionals who treat people living with HIV (PLWH) who are coinfected with the hepatitis C virus (HCV).

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp-committee/meetings/ .

The Department of Health and Human Services (HHS) is seeking public comment on its draft Strategic Plan for Fiscal Years 2018-2022.

In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0036, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act. This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to the Office of Management and Budget (OMB) for approval and solicits comments on specific aspects for the proposed information collection. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001-[insert number]).

This non-competitive award will provide Secretary's Minority AIDS Initiative Fund (SMAIF) supplemental funding to the Jurisdictional Approach to Curing Hepatitis C among HIV/HCV Coinfected People of ColorEvaluation and Technical Assistance Center (ETAC), RAND Corporation. This supplemental funding will allow RAND Corporation to provide evaluation and technical assistance to cooperative agreement recipients and subrecipient clinical sites under HRSA-17-047 Curing Hepatitis C among People of Color Living with HIV.

This non-competitive supplemental award to the University of California, San Francisco (UCSF), the Evaluation and Technical Assistance Center (ETAC) for the Culturally Appropriate Interventions of Outreach, Access and Retention among Latino/a Populations initiative, will support the costs of analysis, publication, and dissemination of findings and best practices learned from the initiative.

The Health Resources and Services Administration's (HRSA's) Maternal and Child Health Bureau (MCHB) announces a prize competition to support the development and testing of low-cost, scalable technology-based innovations to improve the ability of prenatal care providers to monitor the health and wellbeing of pregnant women remotely, especially women who live in rural and medically-underserved areas who have limited access to on-site prenatal care. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010. This challenge, structured in three phases, will reach a diverse population of innovators and problem solvers including families, coders, public health experts, community leaders, individuals affiliated with academic institutions, research and development communities in the private sector, and others. All submissions will be evaluated; separate prizes will be awarded for each of the three phases below.