Department of Health and Human Services January 2018 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.

This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT) referral. In addition, we are seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its PT samples to another laboratory and has reported the other laboratory's result as their own. This request for information also seeks public comment regarding the updating of fees for determination of program compliance and additional fees for laboratories established under the CLIA regulations. We are also seeking public comment regarding the collection of other fees we are authorized to collect such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions. We intend to consider public comments (including information such as evidence, research, and trends) received in response to this request for information when we draft proposals, in consultation, as appropriate, with the Centers for Disease Control and Prevention (CDC), to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.

HRSA is requesting nominations to fill vacancies on the National Advisory Council on Migrant Health (NACMH). The NACMH is authorized and governed under the Public Health Service (PHS) Act, as amended.

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 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 Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.'' This guidance states agency compliance policy regarding certain entities and/or activities related to the ``farm'' definition, written assurances, food contact substances, and human food by-products for use as animal food.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on February 14- 15, 2018, in Atlanta, Georgia.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Good ANDA Submission Practices.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This draft guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.

This document corrects technical errors in the December 4, 2017 Federal Register notice titled ``Provider Enrollment Application Fee Amount for Calendar Year 2018''.

This final rule makes changes to the Substance Abuse and Mental Health Services Administration's (SAMHSA) regulations governing the Confidentiality of Substance Use Disorder Patient Records. These changes are intended to better align the regulations with advances in the U.S. health care delivery system while retaining important privacy protections for individuals seeking treatment for substance use disorders. This final rule addresses the prohibition on re-disclosure notice by including an option for an abbreviated notice. This final rule also addresses the circumstances under which lawful holders and their legal representatives, contractors, and subcontractors may use and disclose patient identifying information for purposes of payment, health care operations, and audits and evaluations. Finally, this final rule is making minor technical corrections to ensure accuracy and clarity in SAMHSA's regulations.

The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 provisions associated with export certificate applications for FDA-regulated food and cosmetic products.

The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 24, 2017. The document announced the withdrawal of approval of 54 abbreviated new drug applications (ANDAs) from two applicants, effective November 24, 2017. The notice inadvertently announced the withdrawal of approval for ANDA 087296 for Chlorthalidone Tablets USP, 25 milligrams, held by Watson Laboratories, Inc., a subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. FDA confirms that the approval of ANDA 087296 is still in effect.