Department of Health and Human Services August 21, 2018 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on inorganic lead, to develop updated recommendations on the potential health risks, medical surveillance, recommended measures for safe handling, and to establish an updated Recommended Exposure Limit (REL).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT), which collects information from people testing for HIV in order to compare the performance characteristics of new point of care HIV tests for detection of early HIV infection and to identify behavioral and clinical predictors of early HIV infection.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a continuing information collection project titled List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted a Supplemental Information Request (SIR) to the Office of Management and Budget (OMB) for review and approval. A 60-day Federal Register Notice was published in the Federal Register on April 24, 2018. There were seven public comments. Comments submitted during the first public review of this SIR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.'' This guidance is intended to assist sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. This guidance finalizes the draft guidance of the same name issued on September 13, 2017.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the U.S. General Services Administration (GSA), announces the availability of the Record of Decision (ROD) for the acquisition of a site in Cincinnati, Ohio, and development of this site into a new, consolidated CDC/National Institute for Occupational Safety and Health (NIOSH) campus (Proposed Action). The site to be acquired is bounded by Martin Luther King Drive East to the south, Harvey Avenue to the west, Ridgeway Avenue to the north, and Reading Road to the east. CDC published a Final Environmental Impact Statement (EIS) for this action on July 20, 2018 pursuant to the requirements of the National Environmental Policy Act (NEPA) of 1969 as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). CDC carefully considered the findings of the Final EIS when making its decision.