Department of Health and Human Services September 2013 – Federal Register Recent Federal Regulation Documents

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 that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on July 22, 2013 (78 FR 43817).

The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern, prevention- oriented food safety practices called for by the Food Safety Modernization Act (FSMA) and achieving the same level of food safety as domestic growers and processors. The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies would strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains. The purpose of these public meetings is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. This guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonfederal, and uncompensated panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness and health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. During this meeting, the Task Force will consider the findings of systematic reviews on existing research and issue recommendations. These recommendations provide evidence-based options from which decision makers in communities, companies, health departments, health plans and healthcare systems, non-governmental organizations, and at all levels of government can choose what best meets the needs, preferences, available resources, and constraints of their constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 28th, 2013 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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 we) is announcing that we have filed a petition, submitted by the Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to expand the use of synthetic iron oxide to include soft and hard candy, mints, and chewing gum. The petition also proposes to lower the specification limit for lead in synthetic iron oxide for human food use.

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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 28, 2013, Vol. 78, No. 125, page 28996 and allowed 60- days for public comment. One public comment was received on June 29, 2013 which commented on the expense and topic of the study. An email response was sent on July 8, 2013 stating ``Your comments will be taken into consideration. The Division of Cancer Prevention at the NCI supports research that studies the potential impact from a cell, tissue or organism and the pathways associated with disease process.'' The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Linda Nebeling, Ph.D., Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Room 3E102, Bethesda, MD 20892-9671 or call non-toll-free number 240-276-6855 or Email your request, including your address to: nebelinl@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Family Life, Activity, Sun, Health, and Eating (FLASHE) Study (NCI), 0925-NEW, Expiration Date xx/xx/xxxx, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The FLASHE study seeks to examine psychosocial, generational (parent-adolescent), and environmental correlates of cancer preventive behaviors. FLASHE will examine the science of cancer and obesity prevention by examining correlates of cancer preventive behaviors, mainly diet, activity, and sedentary behaviors (but also examining other behaviors such as sleep, sun-safety, and tobacco) in new ways not previously addressed comprehensively on other surveys. The survey's goal is to advance understanding of the dynamic relationship between the environment, psychosocial factors, and behavior from a dyadic perspective. Data collected will ultimately be a public use dataset and resource to the research community. FLASHE will be collecting data from parents and their adolescent children through a web survey with a final sample size of 2,500 dyads with motion sensing data collected in a subsample of 900 adolescents. OMB approval is requested for 2 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,243.

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 Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of expansion supplement grants to the following current grantees for a total of $350,000:

The Department of Health and Human Services (HHS) seeks comment from interested parties on existing regulations HHS should consider reviewing in order to streamline or eliminate unnecessary, obsolete, or burdensome regulations or to modify others to increase their effectiveness, efficiency, and flexibility.