Department of Health and Human Services July 2006 – Federal Register Recent Federal Regulation Documents

This notice announces the third meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Irradiation in the Production, Processing, and Handling of Food'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States and clarifying guidelines for the voluntary nutrition labeling of these foods. Availability of the updated nutrition labeling values in retail stores and on individually packaged raw fruits, vegetables, and fish will enable consumers to make better purchasing decisions to reflect their dietary needs.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the act).

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Medicare Lifestyle Modification Program (MLMP) Demonstration, System No. 09-70- 0585.'' The program is mandated by the Consolidated Appropriations Act of 2001 (Public Law (Pub. L.) 106-554). The MLMP Demonstration and evaluation will test the feasibility and cost effectiveness of proven and intensive programs designed to reduce or reverse the progression of cardiovascular disease of patients at risk for invasive treatment procedures. The programs may reduce the incidence of hospitalizations and invasive procedures among patients with substantial coronary occlusion. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who are potential participants in the MLMP Demonstration. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist Quality Improvement Organizations; (4) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain Federally-funded health benefits programs. We have provided background information about the 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 comment period.

Under the provisions of Section 3507(a) (1) (D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health 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 October 27, 2005 Vol. 70, No. 207, p61979), and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 March 1, 2006 [Pages 10539-10540] and allowed 60-days for public comment. No public comments were received. 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: The NIDA International Program Research Training Modules for International Application Needs Assessment Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to undertake an educational needs assessment survey of NIDA's collaborating international drug abuse researchers. The purpose of this survey is to more precisely define the educational needs of the international drug abuse research community before proceeding with the development of formal distance learning programs. Reviews of distance education programs in the developing world often reveal that systematically organized learning needs assessments are continually absent. (USAID 2001: The Use and Effect of Distance Education in Healthcare: What Do We Know? Operations Research Issue Paper 2). This survey will address that issue. The survey is based on recommendations received from current international drug abuse researchers and NIDA grantees. It is designed to be brief (2 pages) and succinct, asking respondents to prioritize their educational needs. The questions have been previously tested with persons who speak English as a second language. Total time to complete the survey is less than five minutes. The survey will cover the following elements: (1) Respondent background, including availability of educational technologies, (2) Educational needs, including a ranking of 10 proposed topics in drug abuse education, and (3) Collaborative needs, including an estimate of the value of online tools for research collaboration. The survey will not collect name, address, or other identifying information. Frequency of Response: This project will be conducted once. Affected Public: International drug abuse researchers who are currently affiliated with or wish to be affiliated with the U.S. drug abuse research community. Type of Respondents/Drug Abuse Researchers: physicians, scientists, mental health workers, and scientists-in-training. The reporting burden is as follows: Estimated Total Annual Number of Respondents: 250; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.09. Estimated Total Annual Burden Hours Requested: 22.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Medicare Chiropractic Coverage Demonstration and Evaluation (MCCDE), System No. 09-70-0577.'' The demonstration entitled, ``Expansion of Coverage of Chiropractic Services Demonstration'' was established under provisions of Section 651 (d) of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 (Public Law (Pub. L.) 108-173). The MCCDE will focus on selected beneficiaries, residing within the four demonstration regions or their respective control regions, who have Medicare chiropractic-eligible diagnoses [i.e., neuromusculoskeletal conditions (NMS)]. The system will contain: Demographic information from Medicare enrollment files; Medicare claims data on utilization of NMS-related Medicare services with associated costs, for demonstration participants and their matched, non-participant controls; and participant satisfaction survey data for the subset randomly surveyed. The MCCDE has four goals: (1) To determine whether eligible beneficiaries who use chiropractic services under the demonstration use a lesser overall amount of items and services for which payment is made under the Medicare program than eligible beneficiaries who do not use such services; (2) to determine the cost of providing payment for chiropractic services under the Medicare program; (3) to further determine whether the demonstration achieves budget neutrality, and if not, the amount of any cost excess to be recouped by Medicare from the chiropractic profession; and (4) finally, to ascertain the satisfaction of eligible beneficiaries participating in the demonstration projects and their perceived quality of care received. The primary purpose of the system is to collect and maintain individually identifiable information on beneficiaries, physicians, participating chiropractors, and providers of service participating in the demonstration and evaluation program. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud and abuse in certain Federally-funded health benefits programs. We have provided background information about the 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 comment period.

This notice announces an administrative hearing to be held on August 29, 2006, at the Blanchard Plaza Building, 2201 Sixth Avenue, 11th Floor Conference Room, Seattle, WA 98121, to reconsider CMS' decision to disapprove Alaska State plan amendment 05-06. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by August 7, 2006.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health 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 April 27, 2006 page 26381 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is responding to two objections that it received on the final rule that amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. After reviewing the objections, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. FDA is also establishing a new effective date for this color additive regulation, which was stayed by the filing of objections.