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

The invention listed below is jointly owned by an agency of the U.S. Government with Vanderbilt University, University of Alabama and University of Pennsylvania 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.

Representatives of the Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), will be conducting a federal review of the Puerto Rico State Council on Developmental Disabilities (SCDD) and the Protection and Advocacy System (P&A) on September 17-21, 2018. AIDD is soliciting comments from interested parties on your experiences with the work, program, and strategies employed by P&A and SDCC in meeting the needs of individuals with developmental disabilities and their families in Puerto Rico. You are encouraged to share your experiences by way of any of the following methods: Email: Clare.huerta@acl.hhs.gov. Telephone: 202-795-7301. Mail Comments To: Clare Huerta, Program Specialist, Administration on Intellectual and Developmental Disabilities, Administration for Community Living, 330 C Street SW, 1st Floor, Washington, DC 20201. Comments should be received by September 10, 2018 in order to be included in the final report.

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on FDA's approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.

This notice acknowledges the Secretary of the Department of Health and Human Services' (the Secretary) receipt and review of the National Quality Forum 2017 Annual Report to Congress and the Secretary submitted by the consensus-based entity under contract with the Secretary in accordance with the Social Security Act. The Secretary has reviewed and is publishing the report in the Federal Register together with the Secretary's comments on the report not later than 6 months after receiving the report in accordance with the Act.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.'' The purpose of the public workshop is to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight potential endpoints that can be used in both nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for drugs impacting auditory and vestibular functions. This public workshop will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular endpoints.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.'' This draft guidance describes FDA's current recommendations regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating inborn errors of metabolism (IEM) for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products.

NIOSH announces the availability of the final National Occupational Research Agenda for Construction.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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 or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on May 21, 2018. In that document, FDA requested comments on the draft revised guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Surveillance of Nonfatal Injuries Among On-Duty Law Enforcement Officers.'' The purpose of this project is to collect follow-back telephone interview data from injured and exposed law enforcement officers treated in emergency departments (EDs) and produce a descriptive summary of these injuries and exposures.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Knowledge, Attitudes, and Practices of US Large Animal Veterinarians Concerning Common Veterinary Infection Control Measures When Working with Animal Obstetric Cases. The goals of this survey are to better describe veterinarians' current knowledge of zoonotic infectious diseases that cause abortion in large animals, determine common veterinary infection control practices when working up obstetric cases, and identify common barriers to personal protective equipment use.

The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the ``Metered Dose Inhaler and Dry Powder Inhaler Drug ProductsQuality Considerations; Draft Guidance for Industry,'' published in the Federal Register of April 19, 2018. FDA is reopening the comment period to allow interested persons additional time to submit comments.

The inventions listed below are owned by an agency of the U.S. Government and are 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.

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.

Notice is hereby given of the meeting on August 2, 2018, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC).

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Per- or Polyfluoroalkyl Substances (PFAS) Exposure Assessments.'' ATSDR and the CDC National Center for Environmental Health (NCEH) will conduct a minimum of eight exposure assessments (EAs) at current or former military installations with known PFAS contamination in drinking water, groundwater, or another water source.