Department of Health and Human Services May 18, 2012 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Solicitation for Proposals for the Medicare Graduate Nurse Education Demonstration-Deadline Extension
This notice extends the deadline for submission of proposals to apply to participate in the Medicare Graduate Nurse Education (GNE) Demonstration.
Decision To Evaluate a Petition To Designate a Class of Employees From Joslyn Manufacturing and Supply Co., in Ft. Wayne, IN, To Be Included in the Special Exposure Cohort
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.
Decision To Evaluate a Petition To Designate a Class of Employees From the Hanford Site in Richland, WA, To Be Included in the Special Exposure Cohort
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 the Hanford site in Richland, Washington, 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: Hanford site. Location: Richland, Washington. Job Titles and/or Job Duties: All employees of the Department of Energy, its predecessor agencies, and its contractors and subcontractors. Period of Employment: July 1, 1972 to December 31, 1983.
Government-Owned Inventions; Availability for Licensing
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.
Determination That PITRESSIN TANNATE IN OIL (Vasopressin Tannate) Injection, 5 Pressor Units/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for vasopressin tannate injection, 5 pressor units/mL, if all other legal and regulatory requirements are met.
International Conference on Harmonisation; Addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Availability
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.
Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
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 Form FDA 3397, User Fee Cover Sheet, which must be submitted along with certain drug and biologic product applications and supplements.
Announcement of the Award of Single Source Expansion Supplement Grants to 11 Personal Responsibility Education Program Innovative Strategies (PREIS) Grantees
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:
Proposed Collection; Comment Request; Population Assessment of Tobacco and Health (PATH) Study
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Population Assessment of Tobacco and Health (PATH) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a large national longitudinal cohort study on tobacco use behavior and health in the United States. It is scheduled to begin in the fall of 2013 under the direction of the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA), and in partnership with the Food and Drug Administration (FDA). Using annual interviews and the collection of bio-specimens from adults, the study is designed to establish a population-based framework for monitoring and evaluating the behavioral and health impacts of regulatory provisions by FDA as it meets its mandate under the Family Smoking Prevention and Tobacco Control Act (FSPTCA) to regulate tobacco-product advertising, labeling, marketing, constituents, ingredients, and additives. These regulatory changes are expected to influence tobacco-product risk perceptions, exposures, and use patterns in the short term, and to reduce tobacco- related morbidity and mortality in the long term. By measuring and accurately reporting tobacco product use behaviors and health effects associated with these regulatory changes, this study will provide an empirical evidence base to inform the development, implementation, and evaluation of tobacco-product regulations in the U.S. Frequency of Response: Annually. Affected Public: Individuals or households. Type of Respondents: Youth (ages 12-17) and Adults (ages 18+). The annual reporting burden for the field test is presented in Table 1, and the annual reporting burden for the baseline data collection is presented in Table 2. The annualized cost to respondents for the field test is estimated at: $24,495; and the annualized cost to respondents for the baseline data collection is: $1,947,567. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2012
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.
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