Department of Health and Human Services July 29, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.
Request for Information: The National Institute of Environmental Health Sciences/National Toxicology Program Requests the Nomination and Prioritization of Environmentally Responsive Genes for Use in Screening Large Numbers of Substances Using Toxicogenomic Technologies
The National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP) is interested in the identification and prioritization of a comprehensive list of environmentally responsive genes that might be targets for screening cells or tissues obtained from humans, rats, mice, zebrafish, and Caenorhabditis elegans against large numbers of substances. The goal is to generate a minimum list of 1000 genes for each species that would provide the maximal toxicogenomic information on (1) effects that reflect general cellular responses, independent of cell type or species, and (2) gene expression changes that are specific by organ and/or cell type. The NIEHS/NTP also seeks recommendations on criteria to use for prioritizing the genes in order to identify those potentially most useful in a screening paradigm. Such a list of environmentally responsive genes may be useful also in biomarker development and basic research efforts.
Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
The Food and Drug Administration (FDA) is amending its regulations to provide for accreditation of third-party auditors/ certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA). Use of accredited third-party auditors/ certification bodies and food and facility certifications will help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply. FDA also expects that these regulations will increase efficiency by reducing the number of redundant food safety audits.
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
The Food and Drug Administration (FDA) is proposing to adopt regulations on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are proposing these regulations in accordance with the FDA Food Safety Modernization Act (FSMA). The proposed regulations would help ensure that imported food is produced in a manner consistent with U.S. standards.
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