Department of Health and Human Services October 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled ``Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format: Guidance for Industry.'' This guidance describes the administrative procedures to be used by commercial processors that manufacture, process, or pack acidified foods (``AF'') and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as ``low-acid canned foods'' or ``LACF''). These changes include new registration and food process filing forms and a new ``smart form'' system for electronic submission of the process filing forms. Registration and process filing are required by the AF and LACF provisions of our regulations. This guidance also provides general information about how to use FDA's systems for electronic submission of the applicable forms. In addition, this guidance describes administrative procedures for voluntary registration and voluntary submissions when a commercial processor has determined that its product is not an acidified food or a low-acid canned food, and is therefore not subject to our regulations for AF and LACF. Further, this guidance describes a voluntary process whereby, upon request, we review data and other information that relate to a new processing method or new equipment.

The Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. The proposed regulation for both pediatric medical cribs and medical bassinets would also include the Consumer Product Safety Commission's (CPSC) mattress flammability standards for the mattresses intended for use with these devices. In addition, this proposed rule would require prescription use of pediatric medical cribs and bassinets.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for these outsourcing facilities.

The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of information by the agency. 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 of an existing collection of information, and to allow for public comment in response to the notice. This notice collects comments on the information collection requirements relating to an existing collection: Developmental Disabilities Protection and Advocacy Statement of Goals and Priorities (0985-0034).

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP), is announcing a public Town Hall Meeting to respond to questions related to the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking (NPRM) that HHS and fifteen other federal departments and agencies published in the Federal Register on September 8, 2015, (80 FR No. 173, pp. 53933-54061). The goal of the NPRM is to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM seeks comments on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. To be assured consideration, comments on the NPRM must be received no later than December 7, 2015. The purpose of the public Town Hall meeting is for OHRP, HHS agencies, and other Common Rule departments and agencies to provide responses to questions from the public about the NPRM during the open public comment period in order to clarify the NPRM proposals and better inform public comment on the NPRM. The public will be able to ask questions during the Town Hall Meeting, and to submit questions before the meeting. Details about how to submit questions before the Town Hall Meeting are provided below.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Version 1.0. The eCTD Technical Conformance Guide supplements the guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification'' and provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Acceptability of Draft Labeling to Support ANDA Approval.'' This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs). It explains FDA's interpretation of the regulatory provision related to submission of copies of applicants' proposed labeling and clarifies that FDA's Office of Generic Drugs (OGD) will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.

This document corrects technical and typographical errors in the final rule and interim final rule with comment period that appeared in the Federal Register on August 17, 2015 titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare- Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals.''

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 6, 2014 entitled ``Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.''