Department of Health and Human Services 2011 – 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: ``Evaluation of ARRA Comparative Effectiveness Research Dissemination Contractor Efforts.'' 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 July 27th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

HHS gives notice of a determination concerning a petition to add a class of employees from the Piqua Organic Moderated Reactor, Piqua, Ohio, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On October 26, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the approaches announced in this draft guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early clinical evaluations of devices to provide proof of principle and initial clinical safety data before the device design is finalized. This draft guidance addresses the information that should be provided to FDA in support of an early feasibility study IDE application and explains the requirements applicable to modifications to the device design or clinical protocol during the early feasibility study. This draft guidance is not final nor is it in effect at this time.

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families has reorganized the Office of Refugee Resettlement. This reorganization includes the organization and its substructure components as listed in this document. This reorganization establishes the Division of Refugee Health. It renames the Division of Community Resettlement to the Division of Refugee Services. It renames the Division of Unaccompanied Children's Services to the Division of Children's Services. It deletes the Division of Budget, Policy, and Data Analysis and moves the function to the Office of the Director. The notice also serves to establish an Associate Deputy Director position.

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 (insert name of NIH Institute or Center), 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: Application for collaboration with the NIH Center for Translational Therapeutics (NCTT). Type of Information Collection Request: NEW. Need and Use of Information Collection: Programs at the NCTT provide opportunities to partner with and gain access to both common and specifically rare and neglected disease through a variety of programs delivering assay development, screening, hit to lead chemistry, lead optimization, chemical biology studies, drug development capabilities, expertise, and clinical/regulatory resources in a collaborative environment with the goal of moving promising therapeutics into human clinical trials. NCTT uses an application and evaluation process to select collaborators. Selected investigators provide the drug project starting points and ongoing biological/disease expertise throughout the project. Frequency of Response: Four per year. Affected Public: Research scientists. Type of Respondents: Academic scientists, industry, not-for-profits, government organizations, patient groups. The annual reporting burden is as follows: Estimated Number of Respondents: 170. Estimated Number of Responses per Respondent: 1. Average Burden Hours Per Response: 4. Estimated Total Annual Burden Hours Requested: 680.

This final rule amends the Head Start Program regulations to implement statutory provisions of the Improving Head Start for School Readiness Act of 2007 to establish 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. This system of designation renewal will determine which grantees must compete for on-going funding. This final rule is consistent with Executive Order 13563 and in particular its requirement, in section 6, of ``periodic review of existing significant regulations.''

The Food and Drug Administration (FDA) is reopening until November 28, 2011, the comment period for the notice entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device; Availability,'' that appeared in the Federal Register of July 27, 2011 (76 FR 44935). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines'' dated October 2011. The guidance document provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine with recommendations on critical clinical considerations for investigational studies of these products. The guidance also provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to support a subsequent biologics license application (BLA) for marketing approval. The guidance applies to therapeutic cancer vaccines that are intended for the treatment of patients with an existing diagnosis of cancer. The guidance does not apply to vaccines for preventative and therapeutic infectious disease indications, to products intended to induce or augment a non-specific immune response, or to products intended to prevent or decrease the incidence of cancer in individuals without a prior history of that cancer. Furthermore, the guidance does not apply to adoptive immunotherapeutic products which may mediate their therapeutic effect by targeting the tumor directly, such as T cell or NK cell products. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2009.

The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Yersinia species (spp.) detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the recommendation(s) of the panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device.

This notice requests comments on proposed eligibility criteria for the Centers of Excellence (COE) program in health professions education for under-represented minority (URM) individuals (See Title VII, Section 736 of the Public Health Service Act, 42 U.S.C. 293 (2011) as amended by the Patient Protection and Affordable Care Act, Public Law 111-148, Sec. 5401 (2010)). When finalized, these eligibility criteria will be used to determine the eligibility of designated health professions schools to apply for COE funding in fiscal year (FY) 2012 and subsequent fiscal years. Funding is dependent on the availability of appropriated funds for the COE program. The designated health professions schools are schools of allopathic medicine, osteopathic medicine, dentistry, pharmacy, and graduate programs in behavioral or mental health. This does not apply to Historically Black Colleges and Universities (HBCUs) eligible to establish a COE, under PHS Act section 736(c)(2).