Department of Health and Human Services November 17, 2010 – Federal Register Recent Federal Regulation Documents

This document is a request for comments regarding certain aspects of the policies and standards that will apply to accountable care organizations (ACOs) participating in the Medicare program under section 3021 or 3022 of the Affordable Care Act.

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 Allergy and Infectious Diseases (NIAID), 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: Pretesting of NIAID's Biomedical HIV Prevention Research Communication Messages. Type of Information Collection Request: Revision of a previously approved collection. Need and Use of Information Collection: This is a request for clearance to pretest messages, materials and program activities about biomedical HIV prevention research. The primary objectives of the pretests are to (1) Assess audience knowledge, attitudes, behaviors and other characteristics for the planning/development of health messages, education products, communication strategies, and public information programs; and (2) pretest these health messages, products, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. The information obtained from audience research and pretesting results in more effective messages, materials, and programmatic strategies. By maximizing the effectiveness of these messages and strategies for reaching targeted audiences, the frequency with which publications, products, and programs need to be modified is reduced. Frequency of Response: On occasion. Affected Public: Individuals. Type of Respondents: Adults at risk for HIV/AIDS; representatives of organizations disseminating HIV-related messages or materials. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), 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 was previously published in the Federal Register on August 16, 2010 (75 FR 49938) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow 30 days for public comment. The 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. Proposed Collection: Title: NIH NCI Central Institutional Review Board (CIRB). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The CIRB was created to reduce the administrative burden on local IRBs and investigators while protecting human research participants. To accomplish this, the CIRB uses several information collection tools to ensure that CIRB operations occur with high level of reviewer and board member satisfaction and is absent of conflicts of interest with the protocols under review. Tools utilized to accomplish this include the new member packets which are completed once a new member joins the CIRB to provide background information on workflow and processes of CIRB operations as well as a non-disclosure agreement. A conflict of interest form is completed occasionally or each time the reviewer is requested to serve as a reviewer for a study. CIRB helpdesk surveys measure satisfaction of helpdesk users and is conducted occasionally or each time the person contacts the helpdesk. Frequency of Response: Once, except for the SAE Reviewer Worksheet. Affected Public: Includes the Federal Government, business or other for-profits and not-for-profit institutions. Type of Respondents: Respondents include any customer who contacts the CIRB Helpdesk, institutional review board members and CIRB review participants. The annual reporting burden is estimated at 2209 hours (see Table 1 below for the estimated time burden). The total burden has decreased slightly as a result of corrected calculations from what was published in the 60-Day Federal Register Notice. The average annual cost to the government over a 12- month period is approximately $153,574 per year for a six year contract. This includes total annualized capital/start up costs of $25,108 and operating costs of $150,637.

The Food and Drug Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the guidance document entitled ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy.''

This document contains an amendment to interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding status as a grandfathered health plan; the amendment permits certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status.