Department of Health and Human Services September 27, 2012 – Federal Register Recent Federal Regulation Documents

State Plan Approval and Grant Procedures
Document Number: 2012-23893
Type: Rule
Date: 2012-09-27
Agency: Department of Health and Human Services, Administration for Children and Families
Fiscal Year (FY) 2012 Funding Opportunity
Document Number: 2012-23817
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $485,780 (total costs) per year for one year to the Education Development Center, Inc. Waltham, Massachusetts. This is not a formal request for applications. Assistance will be provided only to the Education Development Center, Inc. based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-12-012.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2012-23788
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Determination That ENDURON (methyclothiazide) Tablets and Six Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2012-23779
Type: Notice
Date: 2012-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that the seven drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Food Defense; Public Workshop
Document Number: 2012-23778
Type: Notice
Date: 2012-09-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with Oklahoma State University (OSU), Robert M. Kerr Food & Agricultural Products Center (FAPC), is announcing a public workshop entitled ``Food Defense Workshop.'' This public workshop is intended to provide information about food defense as it relates to food facilities such as farms, manufacturers, processors, distributors, retailers, and restaurants. Date and Time: This public workshop will be held on November 7 and 8, 2012, from 7:45 a.m. to 4:15 p.m. Location: The public workshop will be held at the Robert M. Kerr Food & Agricultural Products Center, Oklahoma State University, 148 FAPC, Stillwater, OK 74078-6055. Contact: For information regarding the workshop: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, Fax: 214-253- 4970, email: david.arvelo@fda.hhs.gov. For information on accommodations: Karen Smith or Andrea Graves at the Robert M. Kerr Food & Agricultural Products Center, Oklahoma State University, 148 FAPC, Stillwater, OK 74078-6055, 405-744-6277, Fax: 405-744-6313, or email: karenl.smith@okstate.edu or andrea.graves@okstate.edu. More information is also available online at http://www.fapc.biz/fooddefense2012.html. Registration: You are encouraged to register by October 31, 2012. The workshop has a registration fee to cover the cost of facilities, materials, speakers, and breaks. The registration fee is $350 for companies with 10 or more employees or $250 for companies with less than 10 employees. Seats are limited; please submit your registration as soon as possible. To register, please complete the online registration form at http://www.fapc.biz/fooddefense2012.html. The workshop will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. Registration will close after the workshop is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:45 a.m. Make checks payable to: ``FAPC.'' If you need special accommodations due to a disability, please contact Karen Smith (see Contact) at least 7 days in advance. There are no registration fees for FDA employees. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested after the date of the public workshop by contacting Karen Smith or Andrea Graves (see Contact) at cost plus shipping.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2012-23776
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, Office of the Secretary
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, will submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0269, scheduled to expire on September 30, 2012. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. Deadline: Comments on the ICR must be received within 30 days of the issuance of this notice.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2012-23774
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, Office of the Secretary
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, will submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for extension of the approved information collection assigned OMB control number 0990-0294, scheduled to expire on September 30, 2012. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. Deadline: Comments on the ICR must be received within 30 days of the issuance of this notice.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2012-23773
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, Office of the Secretary
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. OS especially requests comments on (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. Deadline: Comments on the ICR must be received within 60 days of the issuance of this notice.
National Cancer Institute; Notice of Meeting
Document Number: 2012-23753
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute On Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2012-23752
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2012-23751
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Supplemental Funding for Cooperative Agreements to the New Mexico Department of Health, Office of Border Health; Arizona Department of Health Services, Office of Border Health; California Department of Public Health, Office of Binational Border Health; Texas Department of State Health Services, Office of Border Health to Improve the Health of Persons and Communities Along the U.S.-Mexico Border
Document Number: 2012-23722
Type: Notice
Date: 2012-09-27
Agency: Department of Health and Human Services
The Office of Global Affairs (OGA) announces that up to $150,000.00 ($37,500.00 to each State) in fiscal year (FY) 2012 funds are being awarded for supplemental funding to existing cooperative agreements to the Department of Health Services of the states of New Mexico, Arizona, Texas and California, whom will work through the U.S.- Mexico Border Health Commission, to improve the health of persons and communities along the U.S.-Mexico border. This initiative addresses Border Binational Health Week; Prevention and Health Promotion among Vulnerable Populations on the U.S.-Mexico Border; U.S.-Mexico Border Tuberculosis Consortium and Legal Issues Forum; Border Binational Obesity Prevention Summit; Border Health Research Forum, Work Group and Expert Panel Meeting; Healthy Border 2010/2020 Strategic Plan; the Outreach Office Planning Meeting, and programmatic and administrative support to the members and staff of the U.S.-Mexico Border Health Commissions. The budget period will be one year with a project period of five years for a total of $150,000.00 (including indirect costs).