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

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 Paul Coverdell National Acute Stroke Program (PCNASP) reporting system, which was established to improve quality of care for acute stroke patients from onset of signs and symptoms through hospital care and rehabilitation and recovery.

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 ``School-Associated Violent Deaths Surveillance System (SAVD.'' The U.S. Department of Education (DOE) requested assistance from the Centers for Disease Control and Prevention (CDC)/National Center for Injury Prevention and Control (NCIPC) to establishing an ongoing surveillance system of school-associated violent deaths (SAVD) in the United States in order to track and monitor school-associated violence, particularly homicides and suicides that occur in schools on an ongoing basis.

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 Improving Performance Measurement and Monitoring by CDC programs. The purpose of this project is to evaluate the progress of CDC partners that receive awards distributed via cooperative agreements from the Office of Grants Services (OGS)

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) 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 FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. Consistent with FDA's regulation, notice is being published with less than 15 days prior to the date of the meeting based on a determination that an immediate meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is needed. This Federal Register notice could not be published 15 days prior to the date of the meeting due to the lapse of appropriations that began on December 22, 2018. Notice was provided on the Agency website on February 1, 2019, at https://www.fda.gov/AdvisoryCommittees/Calendar/ ucm630167.htm.

The Centers for Disease Control and Prevention (CDC) is soliciting nominations for possible membership on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) in the National Center for Injury Prevention and Control (NCIPC), the National Center for Environmental Health (NCEH), and the Agency for Toxic Substances and Disease Registry (ATSDR).

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Health Statistics, Department of Health and Human Services, has been renewed for a 2-year period through January 19, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Principles of Premarket Pathways for Combination Products.'' This draft guidance presents FDA's current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. FDA is publishing this draft guidance as part of its efforts to implement the 21st Century Cures Act (Cures Act) and in keeping with the Agency's long-standing commitment to transparency, efficiency, and regulatory consistency to facilitate development of safe and effective combination products.

The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), proposes to modify an existing system of records subject to the Privacy Act, System No. 09-70-0541, titled Medicaid Statistical Information System (MSIS). This system of records covers the national Medicaid dataset, consisting of standardized enrollment, eligibility, and paid claims data about Medicaid recipients which is used to administer Medicaid at the federal level, produce statistical reports, support Medicaid related research, and assist in the detection of fraud and abuse in the Medicare and Medicaid programs. CMS is changing the name of the system of records to Transformed-Medicaid Statistical Information System (T-MSIS) and making other modifications which are explained below.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 061579 for nonsterile neomycin sulfate powder for prescription compounding. The basis for the withdrawal is that the product is no longer considered safe as labeled due to clinical evidence that systemic exposure to neomycin sulfate can induce significant toxicity, including ototoxicity (manifested as sensorineural hearing loss), nephrotoxicity, and neuromuscular blockade. The holder of this ANDA has waived its opportunity for a hearing.

The President's Committee for People with Intellectual Disabilities (PCPID) will host a face to face meeting for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public.

In compliance with the Paperwork Reduction Act of 1995, 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.

This final notice announces our decision to approve National Dialysis Accreditation Commission (NDAC) for recognition as a national accrediting organization (AO) for End Stage Renal Disease (ESRD) Facilities that wish to participate in the Medicare or Medicaid programs.