Document to Support Submission of an Electronic Common Technical Document-Specifications for File Format Types Using Electronic Common Technical Document Specifications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the following document that supports making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``Specifications for File Format Types Using eCTD Specification.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pretesting of Tobacco Communications
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Pretesting of Tobacco Communications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements
The Food and Drug Administration (FDA) is proposing to amend the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.
Solicitation of Nomination for Appointment to the Advisory Committee on Minority Health
The Department of Health and Human Service (HHS), Office of Minority Health (OMH), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (hereafter referred to as the ``Committee or ACMH''). In accordance with Public Law 105-392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health, on improving the health of each racial and ethnic minority group and on the development of goals and specific program activities of OMH designed to improve the health status and outcomes of racial and ethnic minorities. Nominations of qualified candidates are being sought to fill upcoming vacancies on the Committee.
Announcement of Requirements and Registration for “Apps4Tots Health Challenge”
As part of the Department of Health and Human Services digital services strategy, the Health Resources and Services Administration (HRSA), the Office of the National Coordinator for Health Information Technology (ONC), and Healthdata.gov are joining forces in an attempt to leverage two key assets recently made available to the public. The Apps4TotsHealth Challenge is a call for developers, researchers, and other innovators to make use of the Healthdata.gov data API and integrate the TXT4Tots message library into a new or existing platform. TXT4Tots is a library of short, evidence-based messages focused on nutrition and physical activity. The library is targeted to parents and caregivers of children, ages 1-5 years, and is available in English and Spanish. Content for the messages was derived from American Academy of Pediatrics (AAP) Bright Futures: Guidelines for Health Supervision of Infants, Children and Adolescents, which uses a developmentally based approach to address children's health needs in the context of family and community. Healthdata.gov (www.healthdata.gov) is the Department's open data catalog, housing metadata records on close to 400 HHS datasets. Recently, Healthdata.gov has enabled a publicly-accessible data application programming interface (API) that allows programmatic access to the TXT4Tots message library. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Public L. No 111-358).
Generic Drug Facilities, Sites, and Organizations
The Food and Drug Administration (FDA) is announcing that the generic drug facility self-identification reporting period for fiscal year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013. Generic drug facilities, certain sites, and organizations identified in a generic drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update, or reconfirm identification information to FDA annually.