Department of Health and Human Services October 27, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 24 of 24
New Policies and Procedural Requirements for the Electronic Submission of Discretionary Grant Applications
The Administration for Children and Families (ACF), an Operating Division of HHS, announces the opportunity for public comment on its initial transition plan to implement required electronic submission of Federal discretionary grant applications and official grant file documents. In accordance with e-Government initiatives mandated by the Federal Financial Assistance Management Improvement Act of 1999, Public Law 106-107, ACF officially acknowledges that electronically generated and/or stored documents are recognized equivalents of an official paper grant file. Recognizing the equivalency of such documents eliminates duplicative effort and administrative burden for Federal grant applicants, recipients, and the awarding agency, by facilitating the submission and storage of official grant files. The ACF transition plan will begin with the required electronic submission of discretionary grant applications. ACF has previously afforded applicants and recipients the option of submitting Federal discretionary grant applications in both electronic and paper formats. This notice announces that during the initial transition phase and thereafter, discretionary grant applicants and recipients are now required to submit competing, and non-competing continuation, grant applications electronically. The electronic portals used to support this effort are https://www.Grants.gov and https:// www.GrantSolutions.gov.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
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.
Announcement of Requirements and Registration for the NIBIB DEsign by Biomedical Undergraduate Teams (DEBUT) Challenge
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) DEBUT Challenge is open to teams of undergraduate students working on projects that develop innovative solutions to unmet health and clinical problems. NIBIB's mission is to improve health by leading the development and accelerating the application of biomedical technologies. The goals of the DEBUT Challenge are (1) to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building, and debugging solutions for such open-ended problems; (2) to generate novel, innovative tools to improve health care, consistent with NIBIB's purpose to support research, training, dissemination of health information, and other programs with respect to biomedical imaging and engineering and associated technologies and modalities with biomedical applications; and (3) to highlight and acknowledge the contributions and accomplishments of undergraduate students.
Government-Owned Inventions; Licensing and Collaborative Research Opportunity for PANVAC-Cancer Vaccine for the Prevention and Treatment of Colorectal Cancer
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.
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.
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.
Submission for OMB Review; Comment Request: National Institutes of Health Construction Grants
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:
Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period to November 30, 2011, for the notice entitled, ``Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012'' that appeared in the Federal Register of August 1, 2011 (76 FR 45820). In that document, FDA announced the establishment of a docket to obtain comments that would be considered in establishing the fee rates for fiscal year (FY) 2013. In particular, the Agency provided the current FY 2012 fees and requested public comments to the document and intends to consider such comments, as well as experience and additional data gained in implementing these fees in FY 2012, in establishing the fee rates for FY 2013. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Submission for OMB Review; Comment Request: New Proposed Collection, Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study
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.
National Institute on Deafness and Other Communication Disorders Draft 2012-2016 Strategic Plan
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
