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

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.

October 31, 2011 marks the national release of the Healthy People 2020 leading health indicators (LHIs). The LHIs were developed to communicate high-priority health issues to the public, and actions that can be taken to address them. The Office of Disease Prevention and Health Promotion, in partnership with Health 2.0 and the Office of the National Coordinator of Health IT, is launching an LHI App Challenge to encourage teams of developers and health professionals to build an application that addresses one or more LHI topics on a community level. The overall purpose of the Challenge is to provide public health practitioners, business, elected officials, clinicians and the public with applications to help achieve national priority health goals.

The Food and Drug Administration (FDA) is announcing a review of the ``Bar Code Final Rule,'' under Executive Order 13563, ``Improving Regulation and Regulatory Review.'' The Bar Code Final Rule, which was published in 2004, requires certain human drug products and biological products to have a bar code. Information submitted can help FDA to reassess the costs and benefits of the rule and to identify any relevant changes in technology that have occurred since it went into effect. FDA is establishing a public docket to receive information relevant to reassessing the Bar Code Rule. This is an opportunity for interested persons to share information, research, and ideas on the need, maturity, and acceptability of alternative identification technologies for the identification, including the unique identification, of drugs and biological products. FDA will use the information received to assess whether the Bar Code Final Rule is achieving its intended benefits as effectively as possible or should be modified.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need to Know About Administrative Detention of Foods.'' This guidance provides information pertaining to FDA's authority to order the administrative detention of food for human or animal consumption under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety and Modernization Act (FSMA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Temporary Marketing Permit Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated October 2011. The draft guidance document recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated August 2011, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with FDA's requirements and recommendations for collecting donor history information. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate.