Department of Health and Human Services February 14, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.'' This guidance describes a proposed program at FDA's Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. This program, once established, will facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition. CDER believes that this informal program, which is different than the formal recognition standards program in FDA's Center for Devices and Radiological Health, will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications for products regulated by CDER. CDER is issuing this draft guidance to obtain public comments on the proposed program.

The Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) has scheduled public meetings for the 2019 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https:// www.hrsa.gov/advisory-committees/primarycare-dentist/index.ht ml.

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 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 Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces the availability of a Draft Environmental Impact Statement (EIS) for the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement for the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The proposed acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania, and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia (Site). The Draft EIS and this notice are published pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). In parallel with the NEPA process, CDC is also conducting consultation under Section 106 of the National Historic Preservation Act to evaluate the potential effects, if any, of the Proposed Action on historic properties. A Notice of Intent for this Draft EIS was published in the Federal Register on June 14, 2018 (83 FR 27781).