Submission for OMB Review; Comment Request: National Institutes of Health Information Collection Forms To Support Genomic Data Sharing for Research Purposes
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 October 5, 2012 (77 FR 61008), 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. NIH 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: National Institutes of Health Information Collection Forms to Support Genomic Data Sharing for Research Purposes; Type of Information Collection Request: New; Need and Use of Information Collection: The NIH mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The sharing of research data supports this mission and is essential to facilitate the translation of research results into knowledge, products, practices, and procedures that improve human health. By enabling secondary research questions to be addressed, data sharing maximizes the public benefit achieved through research investments. NIH's Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) was established to enable the full value of GWAS data to be realized. GWAS data are maintained in a central data repository, the database of Genotypes and Phenotypes (dbGaP), which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH. As stipulated in the NIH GWAS Policy, all principal investigators (PIs) who receive NIH funding to conduct genomic research are expected to register studies with genomic data in dbGaP. The nature of the genomic, phenotypic, and other associated data generated through large- scale human genomic studies requires responsible stewardship throughout research and data sharing activities. Since the data being collected and shared are from human research participants, the protection of participant interests is paramount. PIs submitting data to dbGaP must describe any limitations on sharing the data, as defined in the informed consent provided by the participants from whom the data were originally collected. PIs must also provide basic study information such as the type of data that will be submitted to dbGaP and a description of the study. Researchers interested in using dbGaP data for secondary research must submit a request through dbGaP and be granted permission from the relevant NIH Data Access Committees to access the data. As part of the request process, researchers must provide information such as a description of the proposed research use of the dbGaP datasets, a data security plan, and a Data Use Certification, in which the researcher agrees to the terms and conditions for use of the data. NIH has developed online forms, which will be available through dbGaP, in an effort to reduce the burden for researchers to complete the study registration, data submission, and data access processes. Frequency of Response: As necessary. Description of Respondents: PIs and senior officials from their institutions. Estimate of Burden: The burden associated with this information collection is calculated in two parts: (1) the burden associated with registering genomic studies and submitting data to dbGaP and (2) the burden associated with applying for genomic data in dbGaP. The annual reporting burden for study registration and data submission is as follows: Estimated Number of Respondents: 100; Estimated Number of Responses per Respondent: 1; and Estimated Total Annual Burden Hours Requested: 63. The annual cost to respondents is estimated at $2,506. The annual reporting burden for applying for genomic data in dbGaP is as follows: Estimated Number of Respondents: 1, 266; Estimated Number of Responses per Respondent: 2; and Estimated Total Annual Burden Hours Requested: 1,583. The annual cost to respondents is estimated at $63,452. There are no capital, operating, or maintenance costs to the respondents.
Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration (FDA), Office of Foods has modified its structure and reorganized to the Office of Foods and Veterinary Medicine (OFVM). This new organizational structure was approved by the Secretary of Health and Human Services on July 20, 2012, and implemented on October 1, 2012.
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.
Request for Information (RFI): Opportunities To Apply a Department of Health and Human Services Message Library To Advance Understanding About Toddler and Preschool Nutrition and Physical Activity
This Request for Information (RFI) solicits ideas and information related to ways in which the U.S. Department of Health and Human Services (HHS) can work with interested partners to disseminate and apply a library of short, evidence-based messages known as TXT4Tots. This library of brief informational nutrition and physical activity focused messages was developed and tested by the American Academy of Pediatrics (AAP) under a cooperative agreement with the Health Resources and Services Administration (HRSA). The TXT4Tots library is targeted to parents and caregivers of children, ages 1-5 years, and is available in both English and Spanish. Content for the messages was derived from AAP's ``Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents,'' which uses a developmentally based approach to address children's health needs in the context of family and community. The name TXT4Tots describes the library of developed messages and does not necessarily imply the need for dissemination through mobile, Short Message Service messaging. HRSA is issuing this RFI to solicit information and ideas on how to effectively incorporate the TXT4Tots library of messages into a wide variety of existing public and private programs and products that can best meet the needs of parents, caregivers, and child advocates, including health care providers. We recognize there are multiple ways this can occur and, therefore, are seeking input on how the TXT4Tots message library could be maximized to advance understanding about toddler and preschool nutrition and physical activity, and the interests of potential partners in working with HHS to do so. The intent is to build upon current programs, policies, and infrastructure to enhance education, disseminate the TXT4Tots message library, and leverage existing programs in innovative ways, particularly to support outreach to underserved communities where access to health education may be limited. The goal is to ensure that the TXT4Tots library of messages remains publicly available at no cost for noncommercial purposes. In addition to this RFI for written comments, HRSA intends to host a short, in-person forum in Washington, DC, to hear proposed comments from the public. Participation in the forum will also be possible through a dedicated conference call line and webinar capabilities. Further details on the forum are described below.
Smokeless Tobacco Product Warning Statements; Request for Comments and Scientific Evidence
The Food and Drug Administration (FDA) is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to the smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products.