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

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: ``Workflow Assessment for Health IT Toolkit Evaluation.'' 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 March 9th, 2012 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

This notice extends the deadline for submission of proposals to apply to participate in the Medicare Graduate Nurse Education (GNE) Demonstration.

NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Joslyn Manufacturing and Supply Co., in Ft. Wayne, Indiana, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Joslyn Manufacturing and Supply Co. Location: Ft. Wayne, Indiana. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1944 to December 31, 1952.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals'' (S6 addendum). The S6 addendum was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to incorporate new knowledge and experience gained since the implementation of the ICH guidance entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals'' (ICH S6) and to clarify and provide greater detail to enable the development of safe and effective biopharmaceuticals.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS) announces the award of single source expansion supplement grants to 11 PREIS grantees for the purpose of expanding program participation and/or sites to support the increase of data necessary to determine the level of program effectiveness. In FY 2010, FYSB awarded thirteen cooperative agreement grants under Funding Opportunity Announcement (FOA) number: OPHS/OAH/TPP PREP Tier 2-2010. Under this FOA a total of $9.7 million was made available on a competitive basis to implement and test innovative strategies. The award of 11 single source expansion supplement grants to PREIS grantees is required because of the necessary expansion of the original scope of approved activities. In the provision of evaluation related technical assistance to grantees during the first year of the project, it was determined by FYSB that all grantees needed to increase the number of program participants and/or sites for program implementation. Increased funding will help the grantee programs obtain the minimal statistical power required to report significant outcome data that can be utilized to determine the effectiveness of the implemented pregnancy prevention models. Thus, the increased number of program participants supports the evaluation requirements outlined in the FOA and by ACA. Additionally, grantees are required to report on performance measures that were specifically defined by FYSB and are pending approval by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501-3520). The data collection will require additional staff time and other resources to compile and report on performance indicators. Performance indicators are based upon the performance measures established by HHS, to include: (a) The number of youth served and hours of service delivery; (b) fidelity to the program model or adaptation of the program model for the target population; (c) community partnerships and competence in working in working with the target population; (d) reported gains in knowledge and intentions and changes in self-reported behaviors of participants; and (e) community data, like birth rates and the incidence of sexually transmitted infections. The 11 single source expansion supplement grants will support activities from September 30, 2011 through September 29, 2012. The grantees are:

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

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 the information collection provisions of FDA's requirements for food irradiation processors.

The Office of the National Coordinator for Health Information Technology has reorganized its office in order to more effectively meet the mission outlined by The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA). The reorganization includes one change and five functional realignments.