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

This document corrects technical errors that appeared in the interim final rule published in the Federal Register on December 1, 2010, entitled ``Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under the Patient Protection and Affordable Care Act'' and in the correction notice published in the Federal Register on December 30, 2010, entitled ``Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Corrections to the Medical Loss Ratio Interim Final Rule With Request for Comments.''

This final rule revises the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are an integral part of our efforts to reduce procedural burdens on providers. This rule reflects the Centers for Medicare and Medicaid Services' (CMS) commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.''

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.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (77 FR 11558) on February 27, 2012 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Revision of currently approved information collection, 0917-0014, ``Indian Health Service Loan Repayment Program.'' The LRP application has been revised so that it is now available in an electronically fillable and fileable format. Form(s): The IHS LRP Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS LRP identifies health professionals with pre- existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract through which the IHS agrees to repay part or all of their indebtedness for professional training time in IHS health care facilities. This program is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS LRP. A two-year contract obligation is signed by both parties, and the individual agrees to work at an IHS location and provide health services to American Indian and Alaska Native individuals. The information collected via the on-line application from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant accepts employment at a location, they in turn ``pick-up'' the score of that location. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).

FDA is announcing the following public meeting on the draft guidance ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA has organized this meeting to solicit public feedback on the draft guidance and to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research.