Department of Health and Human Services May 2, 2012 – Federal Register Recent Federal Regulation Documents

Request for Information on Guidance for the Specification of a Secure, Online Reporting System for Streamlining Programmatic, Fiscal, and Other Data From DHHS-Funded HIV Prevention, Treatment, and Care Services Grantees
Document Number: 2012-10591
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services
The Department of Health and Human Services (DHHS) is seeking to identify interest and obtain information relevant to the design, deployment, operations, maintenance, and future enhancement of a centralized, secure, flexible data reporting system to streamline the collection, processing, and sharing of programmatic, funding, and other data reported to DHHS Operating Divisions (OpDivs) by grantees funded to provide HIV prevention, treatment, and care services.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-10585
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2012-10584
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-10577
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2012-10575
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Requirements and Registration for “Seeing My World through a Safer Lens: What Does Injury and Violence Look Like in My Community?” Video Contest
Document Number: 2012-10548
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Seeing My World through a Safer Lens: What Does Injury and Violence Look Like in My Community? video contest. The CDC National Center for Injury Prevention and Control (Injury Center) is reaching out to students, injury and violence professionals, and the general public throughout the United States to answer the question, ``What does injury and violence prevention look like in my community?'' Through the Seeing My World through a Safer Lens video contest, Contestants can create a short video that reflects injury and violence prevention activities that are in line with the Injury Center's key topics and messages. This Challenge will raise awareness that, despite the fact that injuries and violence are serious public health issues, they are actually preventable. By having Contestants create personalized videos to submit to the video contest, we will show how proven prevention strategies are being implemented in various forms of communities. Further, by showcasing the winning videos in each category of submission (Student View, General Public View, and Injury and Violence Professional View), we will show that steps for injury and violence prevention can be taken by anyone and anywhere in the U.S.
Prospective Grant of Exclusive License: P4 Peptide From Streptococcus Pneumoniae
Document Number: 2012-10547
Type: Notice
Date: 2012-05-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, exclusive license (excluding the nonexclusively licensed field of use entitled ``Use of P4 as either a carrier and/or immunoenhancer in a polysaccharide vaccine conjugate for prevention of Streptococcus pneumonia infection in humans'') to practice the inventions embodied in the patent application referred to below to Viper Therapeutics, having a place of business in Atlanta, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent(s) to be licensed are:
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2012-10546
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR
Document Number: 2012-10518
Type: Notice
Date: 2012-05-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for KALBITOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza
Document Number: 2012-10517
Type: Notice
Date: 2012-05-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for Victoza and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial Thermoplasty System
Document Number: 2012-10516
Type: Notice
Date: 2012-05-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for Alair Bronchial Thermoplasty System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
Document Number: 2012-10513
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues will conduct its ninth meeting in May. At this meeting, the Commission will discuss topics related to the ethical issues associated with the development of medical countermeasures for children as well as access to, and privacy of, human genome sequence data.
Ryan White HIV/AIDS Program Solicitation of Comments
Document Number: 2012-10508
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
This Federal Register Notice solicits comments on Parts A through F of the Ryan White HIV/AIDS Program. Comments are solicited to inform the 2013 reauthorization of the Program, which was most recently reauthorized under Title XXVI of the Public Health Service Act (PHS), as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White HIV/AIDS Program). Stakeholders will be invited to share written comments regarding reauthorization of the Ryan White HIV/AIDS Program through the Web portal at www.regulations.gov. HRSA's HIV/AIDS Bureau will also host listening sessions in the form of teleconferences or webinars to engage stakeholders across the U.S. At least four listening sessions will be conducted, each targeting different geographic areas. The listening sessions will offer stakeholders the opportunity to discuss reauthorization of the Ryan White HIV/AIDS Program. Listening sessions will be announced as dates are determined. Dates will be announced at https://hab.hrsa.gov/reauthorization/.
Healthy Tomorrows Partnership for Children Program
Document Number: 2012-10507
Type: Notice
Date: 2012-05-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) will be issuing a non-competitive one-year extension with funds for the National Healthy Tomorrows Technical Assistance Resource Center at the American Academy of Pediatrics (AAP). Up to $176,855 will be awarded over a one-year extended project period. The National Healthy Tomorrows Technical Assistance Resource Center provides support for the activities of the Healthy Tomorrows Partnership for Children Program (HTPCP), community-based grants that address priority issues determined by the community. Through a cooperative agreement, the Resource Center also offers consultation to HTPCP program participants to ensure successful implementation and sustainability of community-based initiatives; facilitates involvement of local partners such as pediatricians, State/local AAP chapters, State/local maternal and child health agencies, and other private sector partners in HTPCP projects to promote successful implementation of community-based maternal and child health initiatives; and conducts a national evaluation of HTPCP projects that assesses critical factors contributing to program sustainability, effectiveness and impact of community-based projects post HTPCP funding, and the ability of projects to develop meaningful evaluation and sustainability plans. A 2005 national evaluation found that 80 percent of HTPCP projects are fully or partially sustained 5 years post-Federal funding. The proposed extension with funds will allow the Maternal and Child Health Bureau (MCHB) to align the National Healthy Tomorrows Technical Assistance Resource Center with the National Center for Medical Home Implementation.
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