Department of Health and Human Services April 15, 2011 – 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 Cancer Institute (NCI), 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: Food Reporting Comparison Study (FORCS) and Food and Eating Assessment Study (FEAST) (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The title of this collection was previously, ``24-hour Dietary Recall Method Comparison and the National Cancer Institute (NCI) Observational Feeding Studies.'' The objective of the two studies is to compare the performance of the newly developed computerized Automated Self- Administered 24-Hour Recall (ASA24) approach to collecting 24 hour recall (24HR) data with the current standard, the interviewer- administered Automated Multiple Pass Method (AMPM). The ultimate goal is to determine to what extent the new automated instrument can be used instead of the more expensive interviewer-administered instrument in the collection of dietary intake data. Frequency of Response: Twice. Affected Public: Individuals. Type of Respondents: For the FORCS study, approximately 1,200 adult members from three health maintenance organization plans (in Minnesota, California, and Michigan) between ages 20 and 70 years. For the FEAST study, approximately 90 adult residents from the Washington, DC metropolitan area between ages 20 and 70 years. The annual reporting burden is estimated at 866 hours (see table below). This amounts to an estimated 2,598 burden hours over the 3-year data collection period with a total cost to the respondents of $54,293. There are no Capital costs, Operating costs, and/or Maintenance Costs to report.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of existing FDA regulations regarding countries seeking to be designated as not subject to certain bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA-regulated human food and cosmetics.

The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.

This notice informs interested parties of an opportunity to apply to participate in the Medicare Community-based Care Transitions Program, which was authorized by section 3026 of the Affordable Care Act.

The Presidential Commission for the Study of Bioethical Issues will conduct its fifth meeting in May. At this meeting, the Commission will discuss the topic of Federal standards regarding human subjects protection in Federally funded scientific studies.

In accordance with the requirements of the Privacy Act of 1974, the Centers for Medicare and Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight (CCIIO) is establishing a new system of records (SOR) titled the ``Health Insurance Assistance Database (HIAD),'' System No. 09-70-0586. This SOR is established under the authority of Sections 2719, 2723, and 2761 of the Public Health Service Act (PHS Act) (Public Law (Pub. L.) 97-35) and Sec. 1321(c) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148). Section 1321(c) of the Affordable Care Act authorizes HHS (1) to ensure that States with Exchanges are substantially enforcing the Federal standards to be set for the Exchanges and (2) to set up Exchanges in States that elect not to do so or are not substantially enforcing related provisions. Sections 2723 and 2761 of the PHS Act authorize HHS to enforce provisions that apply to non-Federal governmental plans and to enforce PHS Act provisions that apply to other health insurance coverage in States that HHS has determined are not substantially enforcing those provisions. The HIAD database will be maintained by the Office of Consumer Support Health Insurance Assistance Team (the Team) to assist the Office of Oversight with its compliance activities. HIAD is the primary tool through which the Team will track information for the purposes of oversight. The primary purpose of this system is to collect and maintain information on consumer inquiries and complaints regarding insurance issuers that will permit CCIIO to exercise its direct enforcement authority over non-Federal governmental health plans, investigate any inquiries or complaints from enrollees of those plans, to determine which States may not be substantially enforcing the Affordable Care Act and PHS Act provisions and to determine whether complaints that indicate possible noncompliance with Federal law are resolved by the plans. In addition, information maintained will enable CCIIO to develop aggregate reports that will inform CMS and HHS about compliance issues. Information in this system will also be disclosed to: (1) Support regulatory and programmatic activities such as investigations and reporting activities performed by an Agency contractor, consultants, CMS grantees, student volunteers, interns and other workers who do not have the status of Federal employees; (2) assist another Federal and/or State agency, agency of a State government, or an agency established by State law; (3) support litigation involving the Agency; (4) combat fraud, waste, and abuse in certain health benefits programs, and (5) assist in a response to a suspected or confirmed breach of the security or confidentiality of information. We have provided background information about this new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for information about the comment period.