Department of Health and Human Services October 23, 2020 – Federal Register Recent Federal Regulation Documents

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 Agency) is announcing the availability of a final guidance for industry entitled ``Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate ProductCompliance Policies.'' This guidance explains that FDA intends to extend the delay in enforcement described in the guidance entitled ``Wholesale Distributor Verification Requirement for Saleable Returned Drug ProductCompliance Policy,'' published in the Federal Register on September 24, 2019 (the 2019 Compliance Policy), which relates to Drug Supply Chain Security Act (DSCSA) provisions requiring wholesale distributors to verify the product identifier prior to further distributing returned product beginning on November 27, 2019. In addition, this guidance announces FDA's intended enforcement policy with respect to DSCSA provisions requiring dispensers to verify the product identifier for suspect or illegitimate product in the dispenser's possession or control beginning on November 27, 2020.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Capt. Neill's Seafood, Inc. (Capt. Neill's or the Company) for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Capt. Neill's was convicted, as defined in the FD&C Act, of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. The Company was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of 30 days after receipt of the notice (July 13, 2020), Capt. Neill's has not responded. Capt. Neill's failure to respond and request a hearing constitutes a waiver of the Company's right to a hearing concerning this matter.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the reinstatement without change of the Title VI Program Performance Report.

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 National Notifiable Diseases Surveillance SystemRevisionCenter for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). The purpose of this data collection is to provide the official source of statistics in the United States for nationally notifiable conditions. Data will be used to monitor the occurrence and spread of nationally notifiable conditions. Data will be gathered through electronic submissions of case notifications to CDC from public health departments from 50 states, New York City, Washington DC, five U.S. territories, and three freely associated states.