Department of Health and Human Services October 2011 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF), Office of Administration (OA), Office of Information Services (OIS) announces the award of $1,000,000 as a single-source expansion supplement grant to extend an award made to the Johns Hopkins University (JHU), Greenberg School of Public Health in Baltimore, MD. The grant will allow JHU, and its partner, JHU Applied Physics Laboratory, to continue the development of a Human Services National Interoperable Architecture (HSNIA). Under the supplement award, JHU and its partners will develop Phase III of an architectural framework that will be used as a model to facilitate State and local agencies in information exchanges among eligibility and verification services that are developed by the HHS/ Centers for Medicare and Medicaid Services (CMS) under the requirements of the Patient Protection and Affordable Care Act (ACA). To address issues related to implementation of the ACA and the Improper Payments Elimination and Recovery Act of 2010, the Administration has directed Federal Agencies to begin to design and execute plans related to the legislation. JHU and its partners will create the development of a conceptual information technology architecture with ACF/Office of Information Services. The project will produce a solution that supports information exchanges and interoperability that will lead to reductions in improper payments as a preventative step in the program integrity process.

This notice announces that the Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD) has awarded a single-source program expansion supplement grant of $159,679 for post-secondary education opportunities. The Institute for Community Inclusion at the University of Massachusetts in collaboration with seven ACF-ADD supported University Centers for Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs) in Delaware, Minnesota, Hawaii, South Carolina, Tennessee [Vanderbilt], Ohio, and California along with the Association of University Centers on Disabilities (AUCD) has established a consortium that will conduct research, provide training and technical assistance, and disseminate information on promising practices that support individuals with developmental disabilities to increase their independence, productivity, and inclusion through access to post-secondary education. Think College's goals are to improve long- term independent living and employment outcomes for individuals with developmental disabilities. The consortium is acting as a national resource for knowledge, training, materials, and dissemination of information on participation in post-secondary education of individuals with developmental disabilities.

The Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD), Office of Program Support (OPS) announces the award of a single-source grant of $620,000 to the National Association of Councils on Developmental Disabilities (NACDD), located in Washington, DC. The award will support a project to provide training and technical assistance (T/TA) to the designated State Councils on Developmental Disabilities (State Councils). The primary focus of the T/TA is to improve program performance, statutory compliance, and program outcomes across the network of State Councils. Toward this end, NACDD shall provide T/TA to the entities designated by ADD as State Councils. Under this project, it is expected that initiatives shall be identified and undertaken to support the improvement of State Council operations and performance.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-175-1995/0 and/1;

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 25, 2011 (76 FR 66074). The document announced the availability of a guidance for industry entitled ``Required Warnings for Cigarette Packages and AdvertisementsSmall Entity Compliance Guide'' for a final rule that published in the Federal Register of June 22, 2011 (76 FR 36628). The notice published with an incorrect docket number. This document corrects that error.

The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), announces the award of a single-source program expansion supplement grant of $311,997 to the National Runaway Switchboard (NRS) in Chicago, IL, for initiatives in the areas of quality assurance, comprehensive outreach and increased capacity through technology improvements. Through these initiatives, NRS will improve its outreach to youth through Web site enhancements such as, increased access to the ``Live Chat'' function; recruitment of additional Spanish-English bilingual volunteers; increased outreach and partnerships with local, regional and national organizations to enhance NRS' national impact in crisis intervention for youth and families. In terms of evidence-based programming, this funding will also enable NRS to conduct a study and evaluate efforts in the area of reconnecting runaway youth with their families.

The Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) are correcting a notice that appeared in the Federal Register of September 15, 2011 (76 FR 57050). In that notice, FDA and FSIS established dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium, as well as current and emerging approaches designed to promote sodium reduction. The document published with two typographical errors in the References section. This document corrects those errors.

This proposed notice with comment period acknowledges the receipt of a deeming application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

The Alliance for Nanotechnology in Cancer of the National Cancer Institute (NCI) is initiating a public private industry partnership called TONIC (Translation Of Nanotechnology In Cancer) to promote translational research and development opportunities of nanotechnology-based cancer solutions. An immediate consequence of this effort will be the formation of a consortium involving government and pharmaceutical, and biotechnology companies. This consortium will evaluate promising nanotechnology platforms and facilitate their successful translation from academic research to clinical environment, resulting in safe, timely, effective and novel diagnosis and treatment options for cancer patients. The purpose of this notice is to inform the community about the Alliance for Nanotechnology in Cancer of NCI's intention to form the consortium and to invite eligible companies (as defined in last paragraph) to participate.

The Presidential Commission for the Study of Bioethical Issues will conduct its seventh meeting in November. At this meeting, the Commission will continue discussing the current Federal standards regarding human subjects protection in scientific studies supported by the Federal government. The Commission will also develop and finalize recommendations regarding actions the Federal government should take to ensure that the health and well-being of participants in scientific studies supported by the Federal government are protected.

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 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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on August 17, 2011, pages 51042-51043, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, information that has been extended, revised or implemented on or after October 1, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: National Institutes of Health Construction GrantsB42 CFR part 52b (Final Rule). Type of Information Collection Request: Extension of No. 0925-0424, expiration date 8/31/ 2008. Need and Use of the Information Collection: This request is for OMB review and approval of an extension for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:

Under the provisions of Section (3507(a)(1)(D)) of the Paperwork Reduction Act of 1995, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 2, 2011, pages 24497-24498, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Neuro-developmental and Psycho-Social Measures Formative Research Studies for the National Children's Study (NCS). Type of Information Request: New. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states: (a) Purpose.It is the purpose of this section to authorize the National Institute of Child Health and Human Development* to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children's health and development. (b) In General.The Director of the National Institute of Child Health and Human Development* shall establish a consortium of representatives from appropriate Federal agencies (including the Centers for Disease Control and Prevention, the Environmental Protection Agency) to (1) Plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of both chronic and intermittent exposures on child health and human development; and (2) investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes. (c) Requirement.The study under subsection (b) shall (1) Incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of the physical, chemical, biological, and psychosocial environmental influences on children's well-being; (2) gather data on environmental influences and outcomes on diverse populations of children, which may include the consideration of prenatal exposures; and (3) consider health disparities among children, which may include the consideration of prenatal exposures. To fulfill the requirements of the Children's Health Act, the results of formative research will be used to maximize the efficiency (measured by scientific robustness, participant and infrastructure burden, and cost) of tools to assess language, behavior, and neurodevelopment, psychosocial stress, and health literacy and thereby inform data collection methodologies for the National Children's Study (NCS) Vanguard and Main Studies. With this submission, the NCS seeks to obtain OMB's generic clearance to conduct formative research featuring neuro-developmental and psycho-social measures. The results from these formative research projects will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of NCS Vanguard and Main Study neuro-developmental and psycho-social measures in a manner that minimizes public information collection burden compared to burden anticipated if these projects were incorporated directly into either the NCS Vanguard or Main Study. Frequency of Response: Annual [As needed on an on-going and concurrent basis]. Affected Public: Members of the public, researchers, practitioners, and other health professionals. Type of Respondents: Women of child-bearing age, infants, children, fathers, community leaders, members, and organizations, health care facilities and professionals, public health, environmental, social and cognitive science professional organizations and practitioners, hospital administrators, cultural and faith-based centers, and schools and child care organizations. These include both persons enrolled in the NCS Vanguard Study and their peers who are not participating in the NCS Vanguard Study. Annual reporting burden: See Table 1. The annualized cost to respondents is estimated at: $540,000 (based on $10 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) is requesting public comment on the draft 2012-2016 NIDCD Strategic Plan. The NIDCD supports and conducts research and research training in the areas of hearing and balance; smell and taste; and voice, speech, and language. The Strategic Plan serves as a guide to the NIDCD in prioritizing its research investment, illustrates the current state-of-the-science, and highlights recent advances in the communication sciences. The draft Plan presents a series of goals and objectives that represent the most promising research needs within the NIDCD's mission areas. The draft Plan is available for download at: https://www.nidcd.nih.gov/about/ plans/strategic/pages/publiccomments.aspx.