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

In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,'' published in the January 5, 2017, Federal Register. This document announces that the effective date is delayed until March 21, 2017.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on Tuesday, November 8, 2016 page 78609 Vol. 81 No. 216 FR 78609 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) has determined that prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and this determination will allow FDA to continue to approve ANDAs for fluticasone propionate nasal spray, 0.05 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that SPINRAZA (nusinersen), manufactured by Biogen Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of high purity carbon black for coloring ultra-high molecular weight polyethylene sutures for use in general surgery.

The Administration for Community Living published a proposed collection of information document in the Federal Register on February 23, 2017. (82 FR 11471 and 11472) The document contained an incorrect date and email address. In addition under the heading ``New Requirements'', the first paragraph was revised.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription 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 the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Centers for Medicare and Medicaid Services (CMS) is requesting that an information collection request (ICR) related to the Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies (HHAs) and Supporting Regulations at 42 CFR part 484, be processed under the emergency clearance process associated with 5 CFR 1320.13(a)(2)(i). Public harm is reasonably likely to ensue if the normal, non-emergency clearance procedures are followed. The approval of this information collection package is necessary because in the absence of such approval CMS will be unable to effectively enforce these essential health and safety requirements. Among other things, CMS will be unable to enforce requirements that HHAs must provide a notice of rights to each patient, assure the proper training of home health aides before those aides provide hands-on care to patients, and disclose the names and addresses of all individuals with an ownership or management position so that we can assure that those with a history of fraud are not involved in HHA operations. Being unable to enforce these rules would harm patient health and safety, as well as create risks to the integrity of the Medicare and Medicaid programs. Under the PRA, federal agencies are required to publish notice in the Federal Register concerning each proposed ICR. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this ICR including the necessity and utility of the proposed ICR 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), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection project titled ``Assessing the Infrastructure for Public Sexually Transmitted Disease (STD) Prevention Services.'' The primary goal of this study is to periodically monitor (i.e., every 3 years) STD preventive and treatment services provided by local and state health departments. This will allow CDC to understand the delivery of timely public STD preventive and treatment services to reduce the number of newly acquired STDs and prevent STD-related sequelae.