Department of Health and Human Services April 29, 2016 – Federal Register Recent Federal Regulation Documents

This final notice announces our decision to approve the Institute for Medical Quality (IMQ) for recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. An ASC that participates in Medicaid must also meet the Medicare conditions for coverage (CfCs) as required under our regulations.

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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA or Agency), Center for Biologics Evaluation and Research (CBER) is announcing the availability of a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products (VAERS eSubmitter program). The VAERS eSubmitter program is a free software program for voluntary use that is intended to help persons subject to mandatory postmarketing requirements for vaccines including applicants, manufacturers, packagers, and distributors to electronically submit ICSRs and ICSR attachments as required by the final rule titled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.'' The VAERS eSubmitter program creates a simple and efficient mechanism for the secure electronic submission of postmarketing ICSRs and ICSR attachments into the VAERS database without the need for an internal database that is compatible with the International Conference on Harmonisation (ICH)-based direct database to database submission system.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Keller and Heckman LLP on behalf of 3M Corporation (Petitioner), requesting that we amend our food additive regulations to no longer provide for the use of two different perfluoroalkyl containing substances as water and oil repellents for paper and paperboard in contact with aqueous and fatty foods because these uses have been abandoned.