Department of Health and Human Services August 23, 2010 – Federal Register Recent Federal Regulation Documents

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the De Soto Avenue Facility in Los Angeles County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Mound Plant in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Bethlehem Steel Corporation facility in Lackawanna, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Los Alamos National Laboratory in Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

As part of the commitment to maintaining current and scientifically accurate best practices, the National Cancer Institute (NCI) is seeking public comment on a revised version of the NCI Best Practices for Biospecimen Resources. This revised version of the NCI Best Practices is intended to both respond to comments received from the biospecimen resource community and provide more current and detailed recommendations related to biospecimen and data quality. Major revisions include the addition of new sections on Biospecimen Resource Management and Operations and Conflict of Interest, expansion of recommendations related to Custodianship and Informed Consent based on NCI workshops, addition of current references throughout the document and harmonization with current federal guidance documents and recommendations from international biospecimen organizations.

CERHR is evaluating the scientific evidence regarding the potential health effects associated with low-level lead exposure (defined as having blood lead levels < 10 [mu]g/dL). CERHR invites the submission of information about ongoing studies or upcoming publications on the health effects of low-level lead exposure that might be considered for inclusion in the evaluation. CERHR also invites the nomination of scientific experts to potentially serve as technical advisors in conducting the evaluation or as members of an ad hoc expert panel to be convened to peer review the draft NTP Monograph on Low- level Lead (see SUPPLEMENTARY INFORMATION below). This expert panel peer review meeting is tentatively scheduled for Spring 2011. When set, the date and location of the meeting will be announced in the Federal Register and posted on the CERHR Web site (https://cerhr.niehs.nih.gov). CERHR expert panel peer review meetings are open to the public with time scheduled for oral public comment.

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.

The Food and Drug Administration (FDA) is announcing a public conference entitled ``The New Paradigm: Quality and Compliance in Merging and Emerging Cultures.'' The conference, cosponsored with the Parenteral Drug Association (PDA), will focus on challenges facing the medical products industry in navigating regulatory compliance, achieving worldwide quality improvement, and enhancing quality system controls in an environment of merging and emerging cultures.

The Food and Drug Administration (FDA) New Jersey District Office, in cosponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRBs, and research sponsors.

The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or items that measure how well