Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization and includes information concerning nonclinical assays and an integrated risk assessment. The guidance is intended to facilitate the nonclinical assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk.

We are adding reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments to the list of HHS select agents and toxins. We are taking this action for several reasons. First the pandemic influenza virus of 1918-19 killed up to 50 million people worldwide, including an estimated 675,000 deaths in the United States. Also, the complete coding sequence for the 1918 pandemic influenza A H1N1 virus was recently identified, which will make it possible for those with knowledge of reverse genetics to reconstruct this virus. In addition, the first published study on a reconstructed 1918 pandemic influenza virus demonstrated the high virulence of this virus in cell culture, embryonated eggs, and in mice relative to other human influenza viruses. Therefore, we have determined that the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments have the potential to pose a severe threat to public health and safety.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a SOR titled, ``Medicare Managed Care System (MMCS), No. 09-70-4001.'' MMCS processes beneficiary enrollment and creates beneficiary level payments for the Managed Care Organizations (MCO). We propose to broaden the scope of this system by adding the Medicare Part D Program under Title XVIII. The Medicare+Choices Program has been changed to the Medicare Advantage (MA) Program. The MA was mandated by the Balance Budget Act (BBA) of 1997 (Public Law (Pub. L.) 105-33). To more accurately reflect the changes proposed for this system, we will modify the name to read: ``Medicare Advantage Prescription Drug (MARx) System.'' The enhanced system will continue to perform all current MMCS processing requirements. In addition, MARx will be a stand alone system that will include the processing of all enrollment/disenrollment transactions associated with the Part D Program. MARx will include the following: Health Maintenance Organizations (HMO), Health Care Prepayment Plan (HCPP), Medicare Advantage Organizations (MAO), Medicare Advantage Prescription Drug (MAPD) Plans and Prescription Drug Plans (PDP). On December 8, 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173). MMA amends the Social Security Act (the Act) by adding the Medicare Part D Program under Title XVIII and mandate that CMS establish a voluntary Medicare prescription drug benefit program effective January 1, 2006. Under the new Medicare Part D benefit, the Act allows Medicare payment to MA plans that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 Code of Federal Regulations (CFR) 417 and 422. We are modifying the language in some of the routine uses to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will remain prioritized according to their proposed usage. Information previously retrieved from the Enrollment Database (System No. 09-70-0502) will now be retrieved by the Medicare Beneficiary Database (MBD) (System No. 09- 70-0536). We will also take the opportunity to update any sections of the system that were affected by the recent reorganization and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to maintain a master file of MA and MAPD plan members for accounting and payment control; expedite the exchange of data with MA and MAPD; control the posting of pro-rata amounts to the Part B deductible of currently enrolled MA members; and track participation of the prescription drug benefits provided under private prescription drug plans and Medicare employer plans. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by a contractor or consultant contracted by the Agency; (2) support another Federal or State agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist provider and suppliers of service directly or dealing through contractors, fiscal intermediaries (FI) or carriers for the administration of Title XVIII; (4) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs; (5) assist insurance companies, third party administrators, employers, self- insurers, managed care organizations, and other supplemental insurers; (6) facilitate research on the quality and effectiveness of care provided, as well as payment-related projects; (7) support constituent requests made to a congressional representative; (8) support litigation involving the Agency, and (9) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified 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.

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the eighth Policy Committee meeting concerning planning for the 2005 White House Conference on Aging. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting. This notice is being published less than 15 days prior to the meeting due to scheduling problems.

In compliance with the requirement of Section 3507(a)(1)(D) 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. The proposed information collection below was previously published in the Federal Register on May 18, 2005, page 28544-28545 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 after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: 5 A Day Customized Survey. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of the 5 A Day Customized Survey is to further the development of standardized measures of consumer knowledge, attitudes, and behaviors regarding the consumption of fruits and vegetables. Specifically, the Customized Survey will allow for validation of the new ``cup'' portion sizes (consistent with the 2005 Dietary Guidelines) and identify the most efficacious short screener methods of fruit and vegetable intake. In addition, the Customized Survey will measure established predictors of fruit and vegetable consumption at the national level and explore new predictors and constructs not previously examined for fruit and vegetable consumption. The sample will be drawn from a consumer opinion panel methodology using balancing techniques to mirror the U.S. general population on a set of key demographic variables. A separate sample of African Americans will be drawn from the panel. Prior to fielding the Customized Survey, two pilot studies will be completed as the first phase of this research. Pilot respondents will be drawn from the same consumer panel and have similar demographics as respondents in the main study. A brief description of the two pilot studies follows. In pilot study 1, respondents will initially complete a brief screener questionnaire, three 24-hour dietary recalls over the phone, followed by the Customized Survey by mail. To account for diversity in eating habits, dietary recalls will be obtained for 2 weekdays and 1 weekend per respondent. The recalls will be conducted via phone by trained interviewers using the University of Minnesota's Nutrition Data System (NDS). After completing the dietary recalls pilot respondents will be mailed the Customized Survey within 2 weeks. Fruit and vegetable consumption as assessed by the average of the three 24- hour recalls will be compared with the fruit and vegetable consumption measures from the Customized Survey. In pilot study 2, respondents will complete the Customized Survey by mail at two points in time, six to eight weeks apart. The analysis in pilot study 2 will focus on a rigorous evaluation of the psychometric properties of the Customized Survey instrument to ensure that item-level and instrument-level reliability and validity has been achieved before proceeding to the main data collection phase of the study. Based on the findings of the pilot studies, minor modifications may be made to the Customized Survey prior to the implementation of the main study. Frequency of response: Main study, one time response (5 A Day Customized Survey). Pilot study 1, five times (screener, three 24-hour dietary recalls, 5 A Day Customized Survey). Pilot study 2, two times (5 A Day Customized Survey at two points in time). Affected Public: Individuals. Type of Respondents: U.S. adults. The annual reporting burden is as follows: Estimated Number of Respondents: 5,875; Estimated Number of Responses per Respondent: 1, 2 or 5; Average Burden Hours per Response: .416; and Estimated Total Annual Burden Hours Requested: 2,467.90. The annualized cost to respondents is estimated at: $46,384.28. The annual reporting burden is summarized in exhibit 1 below. There are no Operating or Maintenance Costs to report.