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

The Food and Drug Administration (FDA) is classifying the tissue adhesive with adjunct wound closure device intended for topical approximation into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.'' The agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type.

The Federal Medical Assistance Percentages (FMAP) and Enhanced Federal Medical Assistance Percentages (eFMAP) for Fiscal Year 2012 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2011 through September 30, 2012. This notice announces the calculated FMAP and eFMAP rates that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for state medical assistance (Medicaid) and Children's Health Insurance Program (CHIP) expenditures, Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for Federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Act require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8)(B), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits given in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states. Section 1905(b) of the Act specifies the formula for calculating FMAPs as follows:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from North American Nutrition Companies, Inc., to Provimi North America, Inc.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), 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 25, 2010 (Vol. 75, No. 164, p. 52349) and allowed 60-days for public comment. There was one public comments received during this time. The purpose of this notice is to allow an additional 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: NCCAM Office of Communications and Public Liaison Communications Program Planning and Evaluation Research. Type of Information Collection Request: Extension. Need and Use of Information Collection: To carry out NCCAM's legislative mandate to educate and disseminate information about complementary and alternative medicine (CAM) to a wide variety of audiences and organizations, the NCCAM Office of Communications and Public Liaison (OCPL) requests clearance to carry out (1) formative and (2) evaluative research of a variety of print and online materials, outreach activities, and messages to maximize their impact and usefulness. OCPL wishes to continue to carry out formative research to further understand the knowledge, attitudes, and behaviors of its core constituent groups: members of the general public, researchers, and providers of both conventional and CAM health care. In addition, it seeks to test newly formulated messages and identify barriers and impediments to the effective communication of those messages. With this formative audience research, OCPL test audience responses to NCCAM's fact sheets, Web content, and other materials and messages. Clearance is also requested to continue evaluative research on existing materials and messages, as part of OCPL's ongoing effort to develop a comprehensive program of testing and evaluation of all of its communications strategies. This evaluative research will include pilot testing of recently developed messages and information products such as consumer fact sheets and brochures. It will address the need to evaluate the processes by which new materials and messages were developed, the effectiveness of an outreach activity or the extent to which behaviors were changed by the message, and the impact of a message on health knowledge and behaviors. The tools to collect this information have been selected to minimize burden on NCCAM's audiences, produce or refine messages that have the greatest potential to influence target audience attitudes and behavior in a positive manner, and to use Government resources efficiently. They may include individual in-depth interviews, focus group interviews, intercept interviews, self-administered questionnaires, gatekeeper reviews, and omnibus surveys. The data will enhance OCPL's understanding of the unique information needs and distinct health-information-seeking behaviors of its core constituencies, and the segments within these constituencies with special information needs (for example, among the general public these segments include cancer patients, the chronically ill, minority and ethnic populations, the elderly, users of dietary supplements, and patients integrating complementary therapies with conventional medical treatments). Frequency of Response: On occasion. Affected Public: Individuals and households; non-profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Adult patients; members of the public; health care professionals; organizational representatives. The annual reporting burden is as follows: Estimated Number of Respondents: 2,500; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.58; and Estimated Total Burden Hours Requested: 2,109 for the 3-year clearance period (approximately 703 hours annually). The annualized cost to respondents is estimated at $18,123. There are no Capital Costs, Operating Costs, or Maintenance Costs to report.

This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2011. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2011 for these individuals will be $450. The reduced premium for certain other individuals as described in this notice will be $248.

Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to or are required to conduct.

This proposed rule would revise Medicaid regulations for Mechanized Claims Processing and Information Retrieval Systems. Specifically, we are proposing to amend the definition of Mechanized Claims Processing and Information Retrieval Systems to include systems used for eligibility determination, enrollment, and eligibility reporting activities. We propose to modify our regulations so that the enhanced Federal financial participation (FFP) is available for design, development and installation or enhancement of eligibility determination systems until December 31, 2015, with enhanced FFP for maintenance and operations available for such systems beyond that date in certain circumstances. We also propose that all Medicaid Management Information Systems (MMISs) meet certain defined standards and conditions in terms of timeliness, accuracy, efficiency, and integrity and that they achieve high positive levels of consumer experience, acceptance and satisfaction in order to receive enhanced FFP.

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Full-Field Digital Mammography System.'' FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.