Department of Health and Human Services May 14, 2012 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Hazardous Waste Worker Training42 CFR part 65. Type of Information Collection Request: Extension of OMB No. 0925-0348 and expiration date September 30, 2012. Need and Use of Information Collection: This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) was given major responsibility for initiating a worker safety and health training program under Section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting workers and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In twenty-four years (FY 1987-2011), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 2.7 million workers across the country and presented over 160,913 classroom and hands-on training courses, which have accounted for nearly 36 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4(a), (b), (c) and 65.6(a) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. Frequency of Response: Biannual. Affected Public: Non-profit organizations. Type of Respondents: Grantees. The annual reporting burden is as follows: Estimated Number of Respondents: 20; Estimated Number of Responses per Respondent: 2; Average Burden Hours per Response: 14; and Estimated Total Annual Burden Hours Requested: 560. The annualized cost to respondents is estimated at: $18,200. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

The ``Ocular Imaging Challenge'' is a multidisciplinary call to innovators and software developers to create an application that improves interoperability among office-based ophthalmic imaging devices, measurement devices, and EHRs. Documentation of the typical ophthalmology examination in an electronic health record (EHR) continues to be challenging. This creates barriers to full acceptance and use of EHRs within the medical community. Data and images are often stored on the acquisition devices in proprietary databases and file formats, and therefore have limited connectivity with EHR systems and ophthalmology-specific picture archiving and communication systems (PACS). There are often problems with redundant entry of demographic and clinical data into devices, data transfer from devices to EHRs and PACS without proprietary interfaces, workflow challenges, and difficulty connecting systems from different vendors. These same challenges occur in a plurality of other medical specialties that employ office-based testing and measurement. Given this fact, there is every expectation that the success of this challenge will be translatable to practices that use imaging and measurement devices such as otorhinolaryngology (ear, nose, and throat), physiatry (physical medicine and rehabilitation), and cardiology, among others. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five abbreviated new animal drug applications (ANADAs) for griseofulvin powder, levamisole hydrochloride soluble powder, and oxytetracycline hydrochloride soluble powder from Teva Animal Health, Inc., to Cross Vetpharm Group, Ltd.