Department of Health and Human Services July 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma'' dated July 2011. The draft guidance document recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 1.0.1 dated December 2010, as an acceptable mechanism that is consistent with FDA's requirements and recommendations for collecting Source Plasma donor history information. The Plasma Protein Therapeutics Association (PPTA) Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) will provide blood establishments that collect Source Plasma with a specific process for administering questions to Source Plasma donors to determine their eligibility to donate.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Mobile Medical Applications.'' FDA is issuing this draft guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or ``mobile apps''). At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that the Agency is calling mobile medical applications (mobile medical apps). This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health associated with electrocardiograph electrodes: Adverse tissue reaction to the skin- contacting electrode materials and misdiagnosis. The guidance document provides information on how to mitigate these risks and recommends testing and labeling for these devices. This guidance document describes a means by which electrocardiograph electrodes may comply with the requirement of special controls for class II devices.

The Administration for Children and Families (ACF), Administration for Native Americans (ANA), announces the award of ten expansion supplement awards to Native American Tribes that are currently combating the epidemic of health issues in Native America. Expansion supplement funds will support activities associated with the First Lady's initiative, Let's Move! in Indian Country. Under the program, grantee Tribes have set forth goals and milestones that will benefit Native youth, children, and families. The following projects will be supported by the expansion supplement awards: Native Village of Afognak, Kodiak, AK ($20,000). The project will include Let's Move! activities as part of their summer youth camps. Pueblo of Tesuque, Santa Fe, NM ($20,025). The project will include Let's Move! activities in its existing project of building a comprehensive prevention and early intervention program that is focused on building community member awareness of, and ability to, confront challenges. Riverside-San Bernardino County Indian Health, Inc., Banning, CA ($20,000). The project will include healthy living and healthy lifestyles of the Let's Move! initiative in its already existing project that focuses on providing pre-marital, dating violence and communication education. The project also provides pre-marital education to pregnant and parenting adolescents. Yerington Paiute Tribe, Yerington, NV ($19,034). This project will include Let's Move! activities that support the development of a family/community wellness support system. The system provides prevention, intervention, referral and follow-up services to community members. Cornerstone Ministries, Inc., Crownpoint, NM ($20,001). This project will implement Let's Move! activities in its project to increase the awareness and value of healthy families and will include activities in its training of youth workers to conduct relationship education. Eastern Shawnee Tribe of Oklahoma, Wyandotte, OK ($17,490). This project will include Let's Move! activities in its project to encourage healthy eating and exercise to reduce the rate of diabetes among elderly tribal members. Leech Lake, Cass Lake, MN ($19,999). This project will include Let's Move! activities in its project to increase relevant academic and cultural content for an intensive in-service for teachers. Chickaloon Native Village, Chickaloon, AK ($16,948). This project will include Let's Move! activities in its project that encourages tribal governance and land stewardship of Chickaloon traditional lands by designing and implementing a trails and recreation planning, management, and ecotourism plan. White Earth Band of Chippewa, White Earth, MN ($19,940). This project will include Let's Move! activities in its project to improve child well-being and social stability by providing family support services to disadvantaged parents and their children. The American Indian Child Resource Center, Oakland, CA ($20,000). This project will include Let's Move! activities in its project to providing life skills training that fosters and promotes decision making, critical thinking, and independent living skills among young Native Americans living in urban environments.

The Food and Drug Administration (FDA) is announcing a public workshop on the adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems. The purpose of this workshop is to engage multiple stakeholders to obtain information and comments on issues confronting the effective and efficient incorporation of UDIs into appropriate data sets, to identify barriers and incentives to their adoption and use, and to understand the best solutions and practices to resolve open issues. Dates and Times: The public workshop will be held on September 12, 2011, from 1 to 5 p.m. and on September 13, 2011, from 9 a.m. to 5 p.m. Submit electronic and written comments by October 13, 2011. Location: The public workshop will be held at the Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD 20852; 301-822-9200. Contact Person: Jay Crowley, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-980-1936, e-mail: jay.crowley@fda.hhs.gov Registration: Registration is free and will be on a first-come, first-served basis. To register for the public workshopwhether attending in person or for the Web castplease visit https:// www.fda.gov/UDI (or go the FDA Medical Devices News & EventsWorkshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, and telephone number. For those without Internet access, please contact Jay Crowley (see Contact Person) to register. Registration requests should be received by 5 p.m. on September 5, 2011. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 11 a.m. Hotel reservations can be made by calling the hotel and requesting the group rate for the ``FDA UDI Public Workshop'' room block. If you need special accommodations due to a disability, please contact Jay Crowley (jay.crowley@fda.hhs.gov) at least 7 days in advance. The meeting will also be Web cast. Persons interested in participating by Web cast must register online by 5 p.m. on September 5, 2011. Web cast participants will be sent connection requirements. More information on the Web cast can be found on our Web site at http:/ /www.fda.gov/UDI. By August 12, 2011, and then as available, FDA will post the workshop agenda and discussion topics, registration information, information about lodging, and other relevant information on the Internet at https://www.fda.gov/UDI. Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments by October 13, 2011. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled, ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document describes a means by which focused ultrasound stimulator systems for aesthetic use may comply with the requirement of special controls for class II devices. This guidance document is being immediately implemented as the special control for focused ultrasound stimulator systems for aesthetic use, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, July 8, 2011 (76 FR 40374). The document announced that a proposed collection information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The document was published with an incorrect docket number. This document corrects that error.

The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Community Demonstration Programs announces the award of an Assets for Independence (AFI) demonstration grant to the United Way of Abilene, Inc. of Abilene, TX in the amount of $126,974. The purpose of this award is to enable the United Way of Abilene, Inc. to implement an Assets for Independence (AFI) project helping program participants save earned income in special-purpose, matched savings accounts called Individual Development Accounts (IDAs). Every dollar in savings deposited into an IDA by participants is matched, from $1 to $8 combined Federal and non-Federal funds, promoting savings and enabling participants to acquire a lasting economic asset. AFI project families use their IDA savings, including the matching funds, to achieve any of three objectives: Acquiring a first home; capitalizing a small business; or enrolling in postsecondary education or training. Additionally, the United Way of Abilene, Inc. provides basic financial management training and supportive services, such as financial education on owning and managing a bank account; credit counseling and repair; guidance in accessing refundable tax credits, including the Earned Income Tax Credit and the Child Tax Credit; and specialized training in owning particular economic assets for the long term.

This notice announces a forthcoming meeting of a public advisory committee of ACF. The meeting will be open to the public. Name of Committee: Advisory Committee for Head Start Research and Evaluation. General Function of Committee: The Advisory Committee for Head Start Research and Evaluation will provide feedback on the published final report for the Head Start Impact Study, offering interpretations of the findings, discussing implications for practice and policy, and providing recommendations on follow-up research, including additional analysis of the Head Start Impact Study data. The Committee will also be asked to provide recommendations to the Secretary regarding how to improve Head Start and other early childhood programs by enhancing the use of research-informed practices in early childhood. Finally, the Committee will be asked to provide recommendations on the overall Head Start research agenda, includingbut not limited tohow the Head Start Impact Study fits within this agenda. The Committee will provide advice regarding future research efforts to inform HHS about how to guide the development and implementation of best practices in Head Start and other early childhood programs around the country.

The Office of the Assistant Secretary for Health, Office on Women's Health, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics related to chronic fatigue syndrome (CFS). The appointments of three Committee members are scheduled to end during the 2012 calendar year. Nominations of qualified candidates are being sought to fill these future vacancies.