Submission for OMB Review; 30-Day Comment Request: Women's Health Initiative Observational Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI),0020the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 5, 2013 on pages 8152-8153 and allowed 60-days for public comment. One comment was received and an appropriate response was made. The purpose of this notice is to allow an additional 30 days for public comment. The NHLBI, National Institutes of Health, 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Announcement of the Award of 12 Single-Source Program Expansion Supplement Grants to Unaccompanied Alien Children's Shelter Care Grantees
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of twelve single-source program expansion supplement grants to the following ten current grantees, for a total of $33,653,092.
Request for Information About Diethanolamine (CAS No. 111-42-2)
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 diethanolamine, and develop appropriate communication documents, such as a Criteria Document, which will convey the potential health risks, recommended measures for safe handling, and establish an updated Recommended Exposure Limit (REL). The current NIOSH REL for diethanolamine is 3 parts per million (ppm) as a time-weighted average (TWA) concentration for up to a 10-hr work shift during a 40-hr workweek. NIOSH is requesting information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with diethanolamine; (2) information on possible health effects observed in workers exposed to diethanolamine, including exposure data and the method(s) used for sampling and analyzing exposures; (3) description of work tasks and scenarios with a potential for exposure to diethanolamine; (4) information on control measures (e.g. engineering controls, work practices, personal protective equipment, exposure data before and after implementation of control measures) that are being used in workplaces with potential exposure to diethanolamine; and (5) surveillance findings including protocol, methods, and results. Public Comment Period: Comments must be received by June 24, 2013.
Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.'' The draft guidance focuses on safety aspects of the container label and carton labeling design for prescription drug and biological products. The draft guidance provides sponsors of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product to minimize medication errors.
Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the regulations that provide protection for human subjects of clinical investigations conducted in support of applications or submissions to FDA for FDA-regulated products. The regulations provide protection of the rights, safety, and welfare of human subjects involved in research activities within FDA's jurisdiction.