Foreign Quarantine; Import Regulations for Infectious Biological Agents, Infectious Substances, and Vectors
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is issuing this final rule amending the regulations regarding the importation of infectious biological agents, infectious substances, and vectors. The amendments improve HHS/CDC's ability to prevent the introduction, transmission, or spread of communicable diseases into the United States.
Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending to May 13, 2013, the comment period for the notice entitled ``Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket,'' that appeared in the Federal Register of December 14, 2012 (77 FR 74485). In that document, we requested comments relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens as defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The document requested comments (including data) that we can use to design and carry out a quantitative risk assessment for establishing regulatory thresholds for major food allergens. We are extending the comment period in response to a request from an industry association.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of Pharmaceuticals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance includes criteria for initiation of and triggers for additional photosafety testing and should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the draft guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals.
Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products'' that appeared in the Federal Register of December 17, 2012 (77 FR 74670). In the document, FDA announced the availability of this draft guidance and explained that the comment period would close on February 15, 2013. The Agency is taking this action to allow interested persons additional time to submit comments.