Department of Health and Human Services July 25, 2014 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of the final version of the guidance on that topic. The draft guidance outlines Electronic Common Technical Document (eCTD) specification requirements for certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) and is being issued for public comment. This draft guidance revises and replaces a previous draft guidance entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications'' that was issued in January 2013 (2013 draft guidance on eCTD Specifications). When finalized, this revised draft guidance will supersede the guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatHuman Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications'' that was issued in June 2008.

The Administration for Community Living (ACL) is announcing the application deadline and supplemental funding for the Eldercare Locator program. The Eldercare Locator program helps older adults and their families and caregivers find their way through the maze of services for older adults by linking to a trustworthy network of national, State, Tribal and community organizations and services through a nationally recognized toll-free number. The Eldercare Locator also provides older adults and caregivers who require more in depth support the opportunity to speak with highly trained eldercare consultants who can better triage the situation. The purpose of this notice is to award supplemental funds to the National Association of Area Agencies on Aging to provide for additional eldercare consultants. Program Name: Eldercare Locator. Award Amount: $250,000. Project Period: 6/1/2013 to 5/31/2018. Award Type: Cooperative Agreement.

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.

The Food and Drug Administration (FDA) is classifying the implantable transprostatic tissue retractor system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2014, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry Pharmacogenomic Data Submissions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of sodium formate as an acidifier in swine feed.