Department of Health and Human Services September 22, 2010 – Federal Register Recent Federal Regulation Documents

Part D Grant for Coordinated HIV Services and Access to Research for Women, Infants, Children, and Youth Part D Funds Under the Ryan White HIV/AIDS Program
Document Number: 2010-23715
Type: Notice
Date: 2010-09-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA will be awarding, non-competitively, Part D Funds to support family-centered primary medical care, treatment, and support services (directly or through contracts) for women, infants, children, and youth with HIV/AIDS, to the University of Utah in order to ensure continuity of critical HIV medical care and support services, to women, infants, children and youth in Salt Lake City, Utah and the surrounding counties.
Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members
Document Number: 2010-23713
Type: Notice
Date: 2010-09-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.
Privacy Act of 1974; Report of an Altered System of Records
Document Number: 2010-23711
Type: Notice
Date: 2010-09-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing a notice to alter the Correspondence Control System. This system of records is used to control and track all correspondence documents addressed or directed to, as well as initiated by, the Administrator, HRSA, or his/her subordinates, as well as other Agency documents, to assure timely and appropriate attention. The purposes of these alterations are to reflect a change in the system name and location; the system manager and address; policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system; contesting records procedures; and the addition of routine use number 3. The last update of this SORN 09-15-0059 was December 23, 1998 (63 FR 71145).
Preparation for International Conference on Harmonisation Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting
Document Number: 2010-23642
Type: Notice
Date: 2010-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH Steering Committee and Expert Working Group Meetings in Fukuoka, Japan'' to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Fukuoka, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Fukuoka, Japan, November 6 through 11, 2010, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The public meeting will be held on October 13, 2010, from 2:30 p.m. to 4:30 p.m. Location: The public meeting will be held at the Washington Theater at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: All participants must register with Jennifer Haggerty, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, email: jennifer.haggerty@fda.hhs.gov, or FAX: 301-595-7937. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material, and requests to make oral presentations to Jennifer Haggerty (see Contact Person) by 5 p.m. e.s.t. on October 11, 2010. If you need special accommodations due to a disability, please contact Jennifer Haggerty (see Contact Person) at least 7 days in advance. Transcripts: Please be advised that as soon as a transcript is available, it can be obtained in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.
Safe Use Initiative; Public Workshop; Request for Comments
Document Number: 2010-23641
Type: Notice
Date: 2010-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Safe Use Initiative.'' This public workshop, organized and hosted by FDA's Safe Use Initiative Team, will communicate the status of ongoing activities and the future vision for Safe Use Initiative projects. The workshop will also offer an opportunity for the Safe Use Initiative Team to gather input and perspectives for future directions and develop collaborative, cross- sector safe medication use activities with health care stakeholders.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act
Document Number: 2010-23633
Type: Notice
Date: 2010-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain 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 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the information collection in ``Medical Devices Third- Party Review under the Food and Drug Administration Modernization Act of 1997.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions
Document Number: 2010-23632
Type: Notice
Date: 2010-09-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions. This study is designed to investigate the impact of the presence of coupons offering purchase incentives such as free-trial offers, discounts, and money-back guarantees on consumers' perceptions of product risks and benefits in direct-to-consumer (DTC) print ads.\1\ Notice of proposed information collection for this project was previously published in the Federal Register of December 15, 2008 (73 FR 76034). This notice is being republished due to significant revisions in the burden and study design.
Head Start Program
Document Number: 2010-23583
Type: Proposed Rule
Date: 2010-09-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This regulation proposes to amend Head Start Program regulations to implement statutory provisions of the Improving Head Start for School Readiness Act of 2007 for establishing a system of designation renewal to determine if Head Start and Early Head Start agencies are delivering high-quality and comprehensive Head Start and Early Head Start programs that meet the educational, health, nutritional, and social needs of the children and families they serve, and meet program and financial management requirements and standards.
Submission for OMB Review; Comment Request
Document Number: 2010-23562
Type: Notice
Date: 2010-09-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
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