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

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 contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.

The purpose of this notice is to announce that the National Institutes of Health (NIH) will hold a Town Hall meeting to hear comments and insights concerning possible revisions to certain fiscal policies that govern the Ruth L. Kirschstein National Research Service Awards (NRSA), which comprise institutional training grants (T32 and T34s) and individual fellowships (F30, F31, F32, F33). The meeting which is open to the public will focus primarily on the funding of educational costs such as tuition, fees and health insurance provided through institutional training grants. The meeting will be held November 30, 2005 in the Natcher Conference Center, Room E1/E2 on the NIH campus in Bethesda, Maryland. Background: NRSA programs currently support over 17,000 predoctoral and postdoctoral research training positions mostly in the nation's academic laboratories. While the budget for the NRSA programs grew smartly during the five years in which the overall appropriation for the NIH was doubled, since fiscal 2003, the last of the growth years, the appropriation for NRSA training programs has grown rather modestly. Given this reality, the NIH must re-examine aspects of its NRSA policies that may not be sustainable in a period of limited budget expansion. The largest of the NRSA programs funds institutional training grants that use the T32 mechanism to support both pre- and post- doctoral research training. Currently, the direct cost funding of these programs is segmented into four categories: stipend, tuition/fees/ health insurance (referred to collectively as tuition), travel, and training related expenses. The funding levels for three of these (stipend, travel, and training related expenses) are stipulated and controlled by NIH, although each can be adjusted as fiscal circumstances and program needs evolve. The funding for tuition, on the other hand, is not fully controlled by NIH; the funding for tuition is governed by a formula tied to the amount each institution requests for this expense. The formula provides for each T32 trainee the sum of $3,000 plus sixty percent of the requested tuition in excess of $3,000. This formula is used to determine the tuition level provided via each competing grant; that level, once established for a given competing grant, is used for the subsequent non-competing renewal awards during the project period. This formula has been employed since fiscal 1996 and has been modified once. During the five year growth period, the increased funding devoted to NRSA activities was used for meaningful, and long overdue, trainee stipend increases and for covering some of the escalating requests in the tuition category of training grants. However, in fiscal 2004 and 2005, when there was limited NRSA budget growth, the requests and outlays for tuition continued to rise substantially. Barring other adjustments, the continuation of this trend in tuition growth will result in a significant annual decrease in the number of NRSA trainee positions, and to fewer programs supported by T32 training grants. Since these outcomes could have a substantial disruptive effect on biomedical research training, NIH has frozen the tuition expenses on competing renewals of T32 awards in fiscal 2006. (See https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-05-059.html) Moreover, NIH training officials have decided to study various options for handling the funding of trainee tuition in the future. The goal of this effort is to find an approach that equips the agency both to adjust to budgetary challenges and to continue to provide appropriate support to institutions to help defray the educational costs of NRSA trainees. This town hall meeting is being held to gather the views of the training community on this issue. Among the options that will be studied are the following: 1. The current tuition formula could be applied in conjunction with a ceiling; the funds provided would be the amount dictated by the currently-used formula or the amount dictated by the ceiling, whichever is less. The magnitude of the ceiling would be based on the fiscal resources available as well as on applicable data. For the sake of discussion, those offering comments may assume the ceiling could be in the range of $16,000 to $18,000. 2. A fixed allowance could be provided for tuition; the same allowance per trainee would be provided to each grantee institution. This approach is employed by the National Science Foundation for its graduate research fellowship program. For the sake of discussion, those offering comments may assume the allowance could be in the range of $16,000 to $18,000. The allowance could be adjusted periodically by the NIH as fiscal circumstances warranted. 3. The current tuition formula could be retained without modification. Those offering comments may assume that under this option the number of NRSA trainees and funded training grant programs will likely experience a series of year-to-year decreases as long as the current fiscal patterns prevail. Participation: Those who wish to attend the Town Hall meeting are invited to submit a brief statement, not to exceed two pages, summarizing views and experiences relevant to the topic of the meeting. Some of those submitting statements will be asked to make brief oral presentations at the meeting. In selecting those to make presentations and in allocating time, the organizers hope to ensure that a full range of opinions is heard and that all parts of the NRSA constituency are represented. Those not asked to present will be welcome at the meeting and will be given a brief opportunity to contribute during two ``open mike'' sessions. Individuals should submit their statements along with their name, affiliation, and contact information to NRSATownHall@mail.nih.gov by November 4, 2005. Individuals chosen to make presentations at the Town Hall meeting will be notified on or around November 14, 2005. Those unable to attend but who wish to provide statements are welcome to do so. All statements will be considered by NIH staff. Those who do not submit statements but wish to observe the meeting will be admitted on a space-available basis. An NIH official will present background information on NRSA tuition support at the outset of the meeting. All individuals who wish to attend the meeting should register through the Town Hall meeting's Web site at https://pub.nigms.nih.gov/ nrsameeting, available on or about October 24, 2005. The detailed schedule for the meeting, when completed, will be posted on this Web site along with any meeting updates. Participants are responsible for their own expenses associated with participating in this meeting, such as for travel. Inquiries: Questions concerning this notice should be directed to: Dr. Warren Jones, National Institute of General Medical Sciences, National Institutes of Health, 301-594-3827, jonesw@nigms.nih.gov.

The NTP has developed and refined a vision for toxicology in the 21st century (``NTP Vision'') and a roadmap for implementing its vision (``NTP Roadmap'') to strategically place the program at the forefront of providing scientific data and its interpretation for use in public health decision-making (see NTP Web site https:// ntp.niehs.nih.gov select ``NTP Vision and Roadmap''). As part of the NTP Roadmap, the NTP will convene a series of workshops, including the High Throughput Screening Assays Workshop, to discuss test methods and approaches that will enhance the program's ability to efficiently evaluate the large number of substances in our environment for which there is little or no information about their potential hazard for human health. This workshop is scheduled for December 14-15, 2005, at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA and will focus on providing information about high throughput screening techniques and the potential utility of this technology for toxicology and the NTP. This meeting is open to the public and attendance is limited only by the space available. Individuals may register to attend the workshop on a first-come, first- served basis per the procedures outlined below. A copy of the agenda and any additional information about the workshop, including background materials and participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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.