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Code · REGISTER · 2007-12-28 · Agency for Toxic Substances and Disease Registry (ATSDR), U.S. Department of Health and Human Services (HHS) · Notices

Notices. Request for public comments on the identification of priority data needs for six priority hazardous substances and an ongoing call for voluntary research proposals

20,352 words·~93 min read·/register/2007/12/28/07-6208

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-237] Identification Of Priority Data Needs for Six Priority Hazardous Substances AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), U.S. Department of Health and Human Services (HHS). ACTION: Request for public comments on the identification of priority data needs for six priority hazardous substances and an ongoing call for voluntary research proposals.
SUMMARY: This notice makes available for public comment the priority data needs for six priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The exposure and toxicity priority data needs in this notice were distilled from the data needs identified in ATSDR's toxicological profiles by the logical scientific approach described in a decision guide published in the **Federal Register** on September 11, 1989 (54 FR 37618).
The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help to determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs identified in this notice reflect the opinion of ATSDR, in consultation with other federal programs, about the research needed pursuant to ATSDR's authority under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund), or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986
(SARA)[42 U.S.C. 9604(i)]. The needs identified here do not represent the priority data needs for any other agency or program. Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the President, the Administrator of ATSDR, or the Administrator of the Environmental Protection Agency
(EPA)from exercising any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976
(TSCA)and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. ATSDR worked with other federal programs to determine common substance-specific data needs and mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. When deciding the type of research that should be done, ATSDR considers the recommendations of the Interagency Testing Committee
(ITC)established under Section 4(e) of TSCA. Federally funded projects that collect information from 10 or more respondents and that are funded by cooperative agreements are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act. If the proposed project involves research on human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) regarding the protection of human subjects. The applicants must assure that the project will be subject to initial and continuing review by the appropriate institutional review committees. Overall, by providing additional scientific information for the risk assessment process, data generated from this research will support other researchers who are conducting human health assessments involving these six substances. Table 1 presents the priority data needs for six priority substances. The six substances are included in the ATSDR Priority List of Hazardous Substances (70 FR 72840, December 7, 2005). ATSDR invites comments from the public on the individual priority data needs and the priority data needs documents for these substances. After considering the comments, ATSDR will publish the final priority data needs for each substance. These priority data needs will be addressed by the mechanisms described in the “Implementation of Substance-Specific Applied Research Program” section of this **Federal Register** Notice. Table 1.—Substance-Specific Priority Data Needs for Six Priority Hazardous Substances Substance Priority data needs Aluminum Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Dose-response data for acute-duration
(1)oral exposure. Cresol Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Dose-response data for acute-duration
(1)oral exposure. Diazinon Developmental toxicity data for oral exposure. Dichloropropenes Dose-response data for acute-duration
(1)inhalation exposure. Immunotoxicity battery via inhalation exposure. Guthion Studies of developmental toxicity via oral exposure with emphasis on neurodevelopmental toxicity. Phenol Exposure levels in humans living near hazardous waste sites. Exposure levels in children. Two-year oral carcinogenicity bioassay.
(1)14 days or less. Note: Consult the priority data needs documents for details on how these priority data needs were determined. *Voluntary Research.* This notice also serves as a continuous call for voluntary research proposals. Private-sector organizations may volunteer to conduct research to address specific priority data needs in this notice by submitting a letter of intent to ATSDR (see ADDRESSES section of this notice). A Tri-Agency Superfund Applied Research Committee (TASARC), comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA, will review all proposals. The substance-specific priority data needs were based on, and determined from, information in corresponding ATSDR toxicological profiles. Background technical information and justification for the priority data needs in this notice are in the priority data needs documents. These documents are available on ATSDR's Web site at *http://www.atsdr.cdc.gov/pdns/* . Printed copies of these documents are also available for review by requesting them in writing from ATSDR (see ADDRESSES section of this notice). DATES: Comments concerning the priority data needs for the six substances must be received by *90 days from the publication date* . Regarding ATSDR's call for voluntary research proposals, the agency considers voluntary research crucial to the continuing development of SSARP and believes this effort should be an open and continuous one. Therefore, private-sector organizations are encouraged to volunteer to conduct research to address the identified priority data needs until ATSDR announces that other research has been initiated for a specific priority data need. ADDRESSES: The priority data needs documents are available on ATSDR's Web site at *http://www.atsdr.cdc.gov/pdns/* . Submit comments to Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333; e-mail: *NRoney@cdc.gov* . Information about pertinent ongoing or completed research that may fill priority data needs cited in this notice should be similarly addressed. Also, use the same address to request printed copies of the priority data needs documents and to submit proposals to conduct voluntary research. FOR FURTHER INFORMATION CONTACT: Nickolette Roney, Applied Toxicology Branch, Division of Toxicology and Environmental Medicine, ATSDR, 1600 Clifton Road, NE., Mailstop F-32, Atlanta, Georgia 30333; e-mail: *NRoney@cdc.gov* ; telephone:
(770)488-3332; fax:
(770)488-4178. SUPPLEMENTARY INFORMATION: Background CERCLA, as amended by SARA [42 U.S.C. 9604(i)], requires that ATSDR
(1)Develop jointly with EPA a list of hazardous substances found at National Priorities List
(NPL)sites (in order of priority),
(2)prepare toxicological profiles of these substances, and
(3)ensure the initiation of a research program to address identified priority data needs associated with the substances. *SSARP was initiated in 1991.* A list of priority data needs for 38 priority hazardous substances was announced in the **Federal Register** on October 17, 1991 (56 FR 52178). The list was subsequently revised, based on public comments, and was published in final form on November 16, 1992 (57 FR 54150). In 1997, after releasing for public comment, ATSDR finalized the priority data needs for a second list of 12 substances that priority data needs list was announced in the **Federal Register** on July 30, 1997 (62 FR 40820). ATSDR then identified priority data needs for a third list of 10 hazardous substances; this list was released as a draft for public comment and published in its final form on April 29, 2003 (68 FR 22704). On September 8, 2006, ATSDR released priority data needs for two hazardous substances as a draft for public comment (71 FR 53102). This ATSDR SSARP supplies the necessary information to improve the database to conduct public health assessments. This link between research and public health assessments, and the process for distilling priority data needs for ranked hazardous substances from the data needs identified in associated ATSDR toxicological profiles, are described in the ATSDR “Decision Guide for Identifying Substance-Specific Data Needs Related to Toxicological Profiles” (54 FR 37618, September 11, 1989). Implementation of Substance-Specific Applied Research Program In Section 104(i)(5)(D), CERCLA states that it is the sense of Congress that the costs for conducting this research program should be borne by the manufacturers and processors of the hazardous substances found under the Toxic Substances Control Act of 1976 (TSCA); by registrants under the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA); or by cost recovery from responsible parties under CERCLA. To execute this statutory intent, ATSDR developed a plan whereby parts of SSARP are being conducted through regulatory mechanisms (TSCA/FIFRA), private-sector voluntarism, and the direct use of CERCLA funds. CERCLA also requires that ATSDR consider recommendations of the Interagency Testing Committee, established under Section 4(e) of TSCA, on the types of research to be done. ATSDR actively participates on this committee. The mechanisms for implementing SSARP are discussed next. The status of SSARP in addressing priority data needs of the first 60 priority hazardous substances through these mechanisms was described in a **Federal Register** Notice on December 13, 2005 (70 FR 73749). A. TSCA/FIFRA In developing and implementing SSARP, ATSDR and EPA established procedures to identify those priority data needs of common interest to multiple Federal programs. Where practicable, these data needs will be addressed through a program of toxicologic testing under TSCA or FIFRA. This part of the research will be conducted according to established TSCA/FIFRA procedures and guidelines. B. Private-Sector Voluntarism As part of SSARP, on February 7, 1992, ATSDR announced a set of proposed procedures for conducting voluntary research (57 FR 4758). Revisions based on public comments were published on November 16, 1992 (57 FR 54160). ATSDR strongly encourages private-sector organizations to propose research to address priority data needs at any time until ATSDR announces that research has already been initiated for a specific priority data need. Private-sector organizations may volunteer to conduct research to address specific priority data needs identified in this notice by submitting a letter of intent. The letter of intent should be a brief statement (1-2 pages) that identifies the priority data need(s) to be filled and the methods to be used. TASARC will review these proposals and recommend to ATSDR the voluntary research projects that should be pursued- and how they should be conducted-with the volunteer organizations. ATSDR will enter into only those voluntary research projects that lead to high-quality, peer-reviewed scientific work. Additional details regarding the process for voluntary research are in the **Federal Register** Notices cited in this section. C. CERCLA Those priority data needs that are not addressed by TSCA/FIFRA or initial voluntarism will be considered for funding by ATSDR through its CERCLA budget. Much of this research program is envisioned to be unique to CERCLA—for example, research on substances not regulated by other programs or research needs specific to public health assessments. A current example of the direct use of CERCLA funds is a cooperative agreement with the Minority Health Professions Foundation
(MHPF)that supports the MHPF's Environmental Health, Health Services, and Toxicology Research Program. Mechanisms to address these priority data needs may include a second call for voluntarism. Again, scientific peer review of study protocols and results would occur for all research conducted under this auspice. Substance-Specific Priority Data Needs Table 1 identifies the priority data needs. ATSDR encourages private-sector organizations and other governmental programs to use ATSDR's priority data needs to plan their research activities. Dated: December 19, 2007. Ken Rose, Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E7-25213 Filed 12-27-07; 8:45 am] BILLING CODE 4163-70-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-222 and CMS-R-268] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services
(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of currently approved collection; *Title of Information Collection:* Independent Rural Health Center/Freestanding Federally Qualified Health Center Cost Report and Supporting Regulations 42 CFR 413.20 AND 42 CFR 413.24; *Use:* Providers of service in the Medicare program are required to submit annual information to achieve reimbursement for health care services rendered to Medicare beneficiaries. The Form CMS-222 cost report is needed to determine the amount of reasonable cost due to the providers for furnishing medical services to Medicare beneficiaries; *Form Number:* CMS-222 (OMB# 0938-0107); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 3,159; *Total Annual Responses:* 3,159; *Total Annual Hours:* 157,950. 2. *Type of Information Collection Request:* Revision of currently approved collection; *Title of Information Collection:* Survey Tool for *http://www.medicare.gov* and *http://www.cms.hhs.gov; Use:* The purpose of this submission is to request a revision of 0938-0756 (CMS-R-268) to continue to collect information from Internet users as they exit from the Websites Medicare.gov and CMS.hhs.gov. As part of the revised collection we are combining the content from the collection 0938-0900 that was discontinued on 5/31/2007. The packages are being combined to eliminate a duplication of effort. We are requesting a three-year clearance, so that the feedback received through the survey can be used continually to update and improve the sites. To ensure that we gather information about user reactions to the Websites, we have developed a survey tool that users can complete when they exit either site or by accessing a link on the bottom bar on the page. The responses on this survey tool will help CMS to make appropriate changes to the Websites in the future. The survey tool contains questions about the information that visitors are seeking from the sites, the degree to which either site was useful to them, the improvements that they would like to see in the sites, and their general comments. *Form Number:* CMS-R-268 (OMB# 0938-0756); *Frequency:* On occasion; *Affected Public:* Individuals and households, Private sector—Business or other for-profit; *Number of Respondents:* 7,000; *Total Annual Responses:* 7,000; *Total Annual Hours:* 1,167. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov,* or call the Reports Clearance Office on
(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on February 26, 2008. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: December 20, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-25289 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-7007-N] Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel) to fill current vacancies and vacancies that will become available in 2008. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program. DATES: *Deadline for Nominations by Regular Mail:* Friday, January 18, 2008 at 5 p.m., e.s.t. *Deadline for Nominations by Electronic Mail:* Friday, January 25, 2008 at 5 p.m., e.s.t. ADDRESSES: *Regular Mail:* Lynne G. Johnson, Office of External Affairs, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, S1-05-06, Baltimore, MD 21244-1850. *Electronic Mail:* *Lynne.Johnson@cms.hhs.gov* . FOR FURTHER INFORMATION CONTACT: Lynne G. Johnson, Health Insurance Specialist, Division of Forum and Conference Development,
(410)786-0090. Please refer to the CMS Advisory Committees Information Line (1-877-449-5659 toll free)/(410-786-9379 local) or the Internet ( *http://www.cms.hhs.gov/FACA/04_APME.asp* ) for additional information and updates on committee activities, or contact Ms. Johnson via e-mail at *Lynne.Johnson@cms.hhs.gov* . Press inquiries are handled through the CMS Press Office at
(202)690-6145. SUPPLEMENTARY INFORMATION: I. Background Section 9(a)(2) of the Federal Advisory Committee Act authorizes the Secretary of Health and Human Services (the Secretary) to establish an advisory panel if the Secretary determines that the panel is “in the public interest in connection with the performance of duties imposed * * * by law.” Section 1804 of the Social Security Act (the Act) requires the Secretary to provide informational materials to Medicare beneficiaries about the Medicare program, and section 1851(d) of the Act, requiring the Secretary to provide for “activities * * * to broadly disseminate information to Medicare beneficiaries * * * on the coverage options provided under [Medicare Advantage] in order to promote an active, informed selection among such options.” To help inform these activities, section 1114(f) of the Act and section 222 of the Public Health Service Act (42 U.S.C. 217a) authorize the creation of an advisory panel. The Secretary signed the charter establishing this Panel on January 21, 1999 and approved the renewal of the charter on November 14, 2006. The establishment of the charter and the renewal of charter were announced in the February 17, 1999 **Federal Register** (64 FR 7899), and the March 23, 2007 **Federal Register** (72 FR 13796), respectively. The Panel advises and makes recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (the Administrator) on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. The Secretary delegates authority to the Administrator. The goals of the Panel are as follows: • To provide recommendations on the development and implementation of a national Medicare education program that describes the options for selecting a health plan and prescription drug benefits under Medicare. • To enhance the Federal government's effectiveness in informing the Medicare consumer, including the appropriate use of public-private partnerships. • To make recommendations on how to expand outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of a national Medicare education program. • To assemble an information base of best practices for helping consumers evaluate health plan options and build a community infrastructure for information, counseling, and assistance. The Panel shall consist of a maximum of 20 members. The Chair shall either be appointed from among the 20 members, or a Federal official will be designated to serve as the Chair. The charter requires that meetings shall be held approximately 4 times per year. Members will be expected to attend all meetings. The members and the Chair shall be selected from authorities knowledgeable in the fields of senior citizen advocacy; outreach to minority communities; health communications; disease-related health advocacy; disability policy and access; health economics research; health insurers and plans; providers and clinicians; labor and retirement, and web education. Members of the general public are invited to apply. This notice is an invitation to interested organizations or individuals to submit their nominations for membership on the Panel. The Secretary or his designee will appoint new members to the Panel from among those candidates determined to have the expertise required to meet specific agency needs and in a manner to ensure an appropriate balance of membership. II. Nomination Requirements Each nomination must state that the nominee has expressed a willingness to serve as a Panel member and must be accompanied by a resume or description of the nominee's experience and a brief biographical summary. In order to permit an evaluation of possible sources of conflict of interest, potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts. Self-nominations will also be accepted. All nominations must be received at the appropriate address listed in the ADDRESSES section of this notice by the date specified in the DATES section of this notice. Authority: Sections 9(a) and 10 of Public L. 92-463 (5 U.S.C. App. 2, sections 9(a) and 10); 41 CFR Part 102-3; Sections 1114(f), 1804, and 1851(d) of the Social Security Act (42 U.S.C. 1314(f), 1395b-2, and 1394w-21(d)); and Section 222 of the Public Health Service Act (42 U.S.C. 217a). Dated: December 3, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-24273 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-2269-N] RIN 0938-AO75 Medicaid Program; Fiscal Year Disproportionate Share Hospital Allotments and Disproportionate Share Hospital Institutions for Mental Disease Limits AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces the final Federal share disproportionate share hospital
(DSH)allotments for Federal fiscal year
(FFY)2006 and the preliminary Federal share DSH allotments for FFY 2008. This notice also announces the final FFY 2006 and the preliminary FFY 2008 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FFY DSH allotments. DATES: *Effective Date:* December 28, 2007. FOR FURTHER INFORMATION CONTACT: Richard Strauss,
(410)786-2019. SUPPLEMENTARY INFORMATION: I. Background A. Disproportionate Share Hospital Allotments for Federal Fiscal Year 2003 Under section 1923(f)(3) of the Social Security Act (the Act), States' Federal fiscal year
(FFY)2003 disproportionate share hospital
(DSH)allotments were calculated by increasing the amounts of the FFY 2002 allotments for each State (as specified in the chart, entitled “DSH Allotment (in millions of dollars),” contained in section 1923(f)(2) of the Act) by the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) for the prior fiscal year. The allotment, determined in this way, is subject to the limitation that an increase to a State's DSH allotment for a fiscal year cannot result in the DSH allotment exceeding the greater of the State's DSH allotment for the previous fiscal year or 12 percent of the State's total medical assistance expenditures for the allotment year (this is referred to as the 12 percent limit). Most States' actual FY 2002 allotments were determined in accordance with the provisions of section 1923(f)(4) of the Act. However, as indicated previously, the calculation of States' FFY 2003 allotments was not based on the actual FFY 2002 DSH allotments; rather, section 1923(f)(3) of the Act requires that the States' FY 2003 allotments be determined using the amount of the States' FY 2002 allotments specified in the chart in section 1923(f)(2) of the Act. The exception to this is the calculation of the FFY 2003 DSH allotments for certain “Low-DSH States” (defined in section 1923(f)(5) of the Act). Under the Low-DSH State provision, there is a special calculation methodology for the Low-DSH States only. Under this methodology, the FFY 2003 allotments were determined by using (that is, increasing) States' actual FFY 2002 DSH allotments (not their FFY 2002 allotments specified in the chart in section 1923(f)(2) of the Act) by the percentage change in the CPI-U for the previous fiscal year. B. DSH Allotments for FFY 2004 Section 1001(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)(Pub. L. 108-173, enacted on December 8, 2003) amended section 1923(f)(3) of the Act to provide for a “Special, Temporary Increase In Allotments On A One-Time, Non-Cumulative Basis.” Under this provision, States' FFY 2004 DSH allotments were determined by increasing their FFY 2003 allotments by 16 percent, and the fiscal year DSH allotment amounts so determined were not subject to the 12 percent limit. C. DSH Allotments for Non-Low DSH States for FFY 2005, and Fiscal Years Thereafter Under the methodology contained in section 1923(f)(3)(C) of the Act, as amended by section 1001(a)(2) of the MMA, the non-Low-DSH States' DSH allotments for FFY 2005 and subsequent fiscal years continue at the same level as the States' DSH allotments for FFY 2004 until a “fiscal year specified” occurs. The “fiscal year specified” is the first fiscal year for which the Secretary estimates that a State's DSH allotment equals (or no longer exceeds) the DSH allotment as would have been determined under the statute in effect before the enactment of the MMA. We determine whether the fiscal year specified has occurred under a special parallel process. Specifically, under this parallel process, a “parallel” DSH allotment is determined for FFYs after 2003 by increasing the State's DSH allotment for the previous fiscal year by the percentage change in the CPI-U for the prior fiscal year, subject to the 12 percent limit. This is the methodology as would otherwise have been applied under section 1923(f)(3)(A) of the Act notwithstanding the application of the provisions of MMA. The “fiscal year specified,” is the fiscal year in which the parallel DSH allotment calculated under this special parallel process finally equals or exceeds the FY 2004 DSH allotment, as determined under the MMA provisions. Once the fiscal year specified occurs for a State, that State's fiscal year DSH allotment will be calculated by increasing the State's previous actual fiscal year DSH allotment (which would be equal to the FY 2004 DSH allotment) by the percentage change in the CPI-U for the previous fiscal year, subject to the 12 percent limit. The following example illustrates how the fiscal year DSH allotment would be calculated for fiscal years after FFY 2004. Example —In this example, we are determining the parallel FFY 2008 DSH allotment. A State's actual FFY 2003 DSH allotment is $100 million. Under the MMA, this State's actual FFY 2004 DSH allotment would be $116 million ($100 million increased by 16 percent). The State's DSH allotment for FFY 2005 and subsequent fiscal years would continue at the $116 million FFY 2004 DSH allotment for fiscal years following FFY 2004 until the “fiscal year specified” occurs. In the separate parallel process, we determine whether the fiscal year specified has occurred by calculating the State's DSH allotments in accordance with the statute in effect before the enactment of the MMA. Under this special process, we would continue to determine the State's parallel DSH allotment for each fiscal year by increasing the State's parallel DSH allotment for the previous fiscal year (as also determined under the special parallel process) by the percentage change in the CPI-U for the previous fiscal year, and subject to the 12 percent limit. Assume for purposes of this example that, in accordance with this special parallel process, the State's parallel FFY 2007 DSH allotment was determined to be $115 million and the percentage change in the CPI-U for FFY 2007 (the previous fiscal year) relevant for the calculation of the FFY 2008 DSH allotment was 2.3 percent. That is, the percentage change for the CPI-U for FFY 2007, the year before FFY 2008, was 2.3 percent. Therefore, the State's special parallel process FFY 2008 DSH allotment amount would be calculated by increasing the special parallel process FFY 2007 DSH allotment amount of $115 million by 2.3 percent; this results in a special DSH allotment process amount for FFY 2008 of $117.6 million. Since $117.6 million is greater than $116 million (the actual FFY 2004 DSH allotment calculated under the MMA), we would determine that FFY 2008 is the “fiscal year specified” (the first year that the FFY 2004 allotment equals or no longer exceeds the parallel process allotment). We would then determine the State's FFY 2008 allotment as the State's actual FFY 2007 DSH allotment ($116 million) increased by the percentage change in the CPI-U for FFY 2007 (2.3 percent). Therefore, the State's FFY 2008 DSH allotment would be $118.67 million ($116 million increased by 2.3 percent); for purposes of this example, the application of the 12 percent limit has no effect. Furthermore, for FFY 2009 and thereafter, the State's DSH allotment would be calculated by increasing the State's previous fiscal year's DSH allotment by the percentage change in the CPI-U for the previous fiscal year, subject to the 12 percent limit. However, as amended by section 1001(b)(4) of the MMA, section 1923(f)(5)(B) of the Act also contains new criteria for determining whether a State is a Low-DSH State, beginning with FFY 2004. This provision is described in section I.D. Finally, the provisions of section 6054 of the Deficit Reduction Act
(DRA)of 2005 Public Law 109-171, enacted February 8, 2006) affected the determination of the DSH allotment for the District of Columbia. Under section 6054 of the DRA, for purposes of determining only the FFY 2006 and subsequent fiscal year DSH allotments for the District of Columbia, the table in section 1923(f)(2) of the Act is amended by increasing the FFY DSH allotment amounts indicated in that table for the District of Columbia for FFYs 2000, 2001, and 2002 to $49 million for each of those fiscal years. Before the DRA amendment, the amount in the chart in section 1923(f)(2) of the Act for the District of Columbia for each of those fiscal years was $32 million. This DRA provision increases the fiscal year DSH allotment for the District of Columbia effective with the FFY 2006 DSH allotment. This change is because the DSH allotments for FFY 2003 were based on the amounts of States' DSH allotments for FFY 2002 as contained in the chart in section 1923(f)(2) of the Act. Since (for purposes of ultimately determining the FFY 2006 allotment) the DRA provision increased the FFY 2002 allotment for the District of Columbia, as indicated above, the FFY 2003 allotment was increased. Furthermore, for this purpose, the FFY 2004 allotment for the District of Columbia would then have been determined by increasing the FFY 2003 allotment (as so determined) by 16 percent. For fiscal years subsequent to FFY 2006, the DSH allotments are determined as described above. The final FFY 2006 DSH allotment and the preliminary FFY 2008 DSH allotment for the District of Columbia contained in this notice reflect the provision of section 6054 of the DRA. As described below, in accordance with section 6054 of the DRA, the final FFY 2006 DSH allotment for the District of Columbia is $57,692,600. As amended by section 6054 of the DRA, the FFY 2002 DSH allotment amount for the District of Columbia contained in the chart in section 1923(f)(2) of the Act was increased to $49,000,000. In accordance with section 1923(f)(3)(A) of the Act, the FFY 2003 DSH allotment is determined by increasing the $49,000,000 DSH Allotment for FFY 2002 (as referenced in section 1923(f)(2) of the Act) by the percentage change in the CPI-U for 2002 (in this case, 1.5 percent) to $49,735,000. In accordance with section 1923(f)(3)(C)(i) of the Act, the FFY 2004 DSH allotment is determined by increasing the $49,735,000 FFY 2003 DSH allotment amount by 16 percent to $57,692,600. In accordance with the provisions of section 1923(f)(3)(C) of the Act, the District of Columbia's DSH allotments for FFYs 2005, 2006, and 2007 are also $57,692,600. Finally, in accordance with section 6054 of the DRA, the District of Columbia's DSH allotment is increased as described above, effective beginning with FFY 2006. D. DSH Allotments for Low-DSH States for FFY 2004 and Fiscal Years Thereafter Section 1001(b)(1) of the MMA amended section 1923(f)(5) of the Act regarding the calculation of the fiscal year DSH allotments for “Low-DSH” States for FFY 2004 and subsequent fiscal years. Specifically, under section 1923(f)(5)(B) of the Act, as amended by section 1001(b)(4) of the MMA, a State is considered a Low-DSH State for FFY 2004 if its total DSH payments under its State plan for FFY 2000 (including Federal and State shares) as reported to CMS as of August 31, 2003, are greater than 0 percent and less than 3 percent of the State's total FFY 2000 expenditures under its State plan for medical assistance. For States that meet the new Low-DSH criteria, their FFY 2004 DSH allotments are calculated by increasing their FFY 2003 DSH allotments by 16 percent. Therefore, for FFY 2004, Low-DSH States' fiscal year DSH allotments are calculated in the same way as the DSH allotments for regular States, which under section 1923(f)(3) of the Act, get the special temporary increase for FFY 2004. Furthermore, for States meeting the MMA's Low-DSH definition, the DSH allotments for FFYs 2005 through 2008 will continue to be determined by increasing the previous fiscal year's DSH allotment by 16 percent. The Low-DSH States' DSH allotments for FFYs 2004 through 2008 are not subject to the 12 percent limit. The Low-DSH States' DSH allotments for FFYs 2009 and subsequent fiscal years are calculated by increasing those States' DSH allotments for the prior fiscal year by the percentage change in the CPI-U for that prior fiscal year. For FFYs 2009 and thereafter, the DSH allotments so determined would be subject to the 12 percent limit. E. Institutions for Mental Diseases DSH Limits for FFYs 1998 and Thereafter Under section 1923(h) to the Act, Federal financial participation
(FFP)is not available for DSH payments to institutions for mental diseases
(IMDs)and other mental health facilities that are in excess of State-specific aggregate limits. Under this provision, this aggregate limit for DSH payments to IMDs and other mental health facilities is the lesser of a State's FFY 1995 total computable (State and Federal share) IMD and other mental health facility DSH expenditures applicable to the State's FFY 1995 DSH allotment (as reported on the Form CMS-64 as of January 1, 1997), or the amount equal to the product of the State's current year total computable DSH allotment and the applicable percentage. Each State's IMD limit on DSH payments to IMDs and other mental health facilities was calculated by first determining the State's total computable DSH expenditures attributable to the FFY 1995 DSH allotment for mental health facilities and inpatient hospitals. This calculation was based on the total computable DSH expenditures reported by the State on the Form CMS-64 as mental health DSH and inpatient hospital as of January 1, 1997. We then calculate an “applicable percentage.” The applicable percentage for FFY 1998 through FFY 2000 (1995 IMD DSH percentage) is calculated by dividing the total computable amount of IMD and mental health DSH expenditures applicable to the State's FFY 1995 DSH allotment by the total computable amount of all DSH expenditures (mental health facility plus inpatient hospital) applicable to the FFY 1995 DSH allotment. For FFY 2001 and thereafter, the applicable percentage is defined as the lesser of the applicable percentage as calculated above (for FFYs 1998 through 2001) or 50 percent for FFY 2001; 40 percent for FFY 2002; and 33 percent for each subsequent FFY. The applicable percentage is then applied to each State's total computable FFY DSH allotment for the current FFY. The State's total computable FFY DSH allotment is calculated by dividing the State's Federal share DSH allotment for the FFY by the State's Federal medical assistance percentage
(FMAP)for that FFY. In the final step of the calculation of the IMD DSH Limit, the State's total computable IMD DSH limit for the FFY is set at the lesser of the product of a State's current fiscal year total computable DSH allotment and the applicable percentage for that fiscal year, or the State's FFY 1995 total computable IMD and other mental health facility DSH expenditures applicable to the State's FFY 1995 DSH allotment as reported on the Form CMS-64. The MMA legislation did not amend the Medicaid statute with respect to the calculation of the IMD DSH limit. F. DSH Allotments and IMD DSH Limits Published in the Federal Register on October 3, 2006 On October 3, 2006, we published a notice (71 FR 58398) in the **Federal Register** that announced the final Federal share DSH allotments for Federal fiscal year
(FFY)2005, and the preliminary Federal share DSH allotments for FFY 2006 and FFY 2007. It also announced the final FFY 2005, and the preliminary FFY 2006 and FFY 2007, limitations on aggregate DSH payments that States may make to institutions for mental disease
(IMDs)and other mental health facilities. G. Publication in the Federal Register of Preliminary and Final Notice for DSH Allotments and IMD DSH Limits In general, we initially determine States' DSH allotments and IMD DSH limits for a fiscal year using estimates of medical assistance expenditures, including DSH expenditures in their Medicaid programs. These estimates are provided by States each year on the August quarterly Medicaid budget reports (Form CMS-37) before the Federal fiscal year for which the DSH allotments and IMD DSH limits are being determined. The DSH allotments and IMD DSH limits determined using these estimates are referred to as *“preliminary.”* Only after we receive States” reports of the actual related medical assistance expenditures through the quarterly expenditure report (Form CMS-64), which occurs after the end of the fiscal year, are the “final” DSH Allotments and IMD DSH limits determined. As indicated in section I.F. of this notice, the notice published in the **Federal Register** on October 3, 2006 announced the final FFY 2005 DSH allotments and the final FFY 2005 IMD DSH limits (since they were based on the actual expenditures related to those years), the preliminary FFYs 2006 and 2007 DSH allotments (based on estimates), and the preliminary FFYs 2006 and 2007 IMD DSH limits (since they were based on the preliminary DSH allotments for FFYs 2006 and 2007). This notice announces the final FFY 2006 DSH allotments and the final FFY 2006 IMD DSH limits (since these are now based on the actual expenditures for those fiscal years), the preliminary FFY 2008 DSH allotments (based on estimates), and the preliminary IMD DSH limits for FFY 2008 (since they are based on the preliminary DSH allotments for FFY 2008). This notice does not include the final FFY 2007 DSH allotments or the final FFY 2007 IMD DSH limits, since the associated actual expenditures for FFY 2007 are not available at this time. II. Provisions of the Notice A. Calculation of the Final FFY 2006 Federal Share State DSH Allotments the Preliminary FFY 2008 Federal Share State DSH Allotments Chart 1 of the Addendum to this notice provides the States' “final” FFY 2006 DSH allotments. The final FFY 2006 DSH allotments for each State were computed in accordance with the provisions of the Medicaid statute as amended by the MMA. As required by the provisions of the MMA, the final FFY 2004 DSH allotments for the “Low-DSH” States and all the other States were calculated by increasing the FFY 2003 DSH allotments by 16 percent. In the notice published on March 26, 2004 in the **Federal Register** , we explained the definition and determination of the “Low-DSH” States under the MMA provisions. However, for following fiscal years, the DSH allotments are determined under a process which incorporates a parallel process described in section I.C. of this notice. Under that parallel process, States final FFY 2006 DSH allotments were determined using the States' expenditure reports (Form CMS-64) for FFY 2006. Chart 2 of the Addendum to this notice provides the States' “preliminary” FFY 2008 DSH allotments. These preliminary allotments were determined using the States' August 2007 expenditure estimates submitted by the States on the Form CMS-37. We will publish the final FFY 2008 DSH allotments for each State following receipt of the States' four quarterly Medicaid expenditure reports (Form CMS-64) for FFY 2008. B. Calculation of the FFYs 2006 and FFY 2008 IMD DSH Limits Section 1923(h) of the Act specifies the methodology to be used to establish the limits on the amount of DSH payments that a State can make to IMDs and other mental health facilities. FFP is not available for IMD or DSH payments that exceed the lesser of the State's FFY 1995 total computable mental health DSH expenditures applicable to the State's FFY 1995 DSH allotment as reported to us on the Form CMS-64 as of January 1, 1997; or the amount equal to the product of the State's current FFY total computable DSH allotment and the applicable percentage. We are publishing the final FFY 2006 IMD DSH limit, and the preliminary FFY 2008 IMD DSH limit, along with an explanation of the calculation of these limits. For FFY 2003 and following fiscal years, the applicable percentage is the lesser of 33 percent or the 1995 DSH IMD percentage of the amount computed for FFY 2000. This percentage was applied to the State's fiscal year total computable DSH allotment. This result was then compared to the State's FFY 1995 total computable mental health DSH expenditures applicable to the State's FFY 1995 DSH allotment as reported on the Form CMS-64 as of January 1, 1997. The lesser of these two amounts was the State's limitation on total computable IMD/DSH expenditures for FFY 2003 and following fiscal years. Charts 3 and 4 of the Addendum to this notice detail each State's final IMD/DSH limitation for FFY 2006 and the preliminary IMD/DSH limitation for FFY 2008, respectively, in accordance with section 1923(h) of the Act. III. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). IV. Regulatory Impact Statement We have examined the impact of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act
(RFA)(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis
(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This notice does not reach the economic threshold and thus is not considered a major rule. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this notice will not have significant economic impact on a substantial number of small entities. Specifically the effects of the various controlling statutes on providers are not impacted by a result of any independent regulatory impact and not this notice. The purpose of the notice is to announce the latest distributions as required by the statute. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Core-Based Statistical Area for Medicaid payment regulations and has fewer than 100 beds. We are not preparing analysis for section 1102(b) of the Act because we have determined and the Secretary certifies that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals. In addition, the MMA set statutorily defined limits on the amount of Federal share DSH expenditures available for FFY 2004 and subsequent fiscal years. Specifically, section 1001 of the MMA increased the DSH allotment for States beginning with fiscal year 2004. While overall the statute mandated some increases in DSH payments, we do not believe that this notice will have a significant economic impact on a substantial number of small entities. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $140 million. This notice will have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this notice does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. Addendum This addendum contains the charts 1 through 4 (preceeded by associated keys) that are referred to in the preamble of this notice. Key to Chart 1.—Final DSH Allotments for FY 2006 [Key to the Chart of the Final FFY 2005 DSH Allotments. The final FFY 2006 DSH Allotments for the regular States Are Presented in the Top Section of this chart and the final FFY 2005 DSH Allotments for the Low-DSH States Are presented in the Bottom Section of the chart.] Column Description For Non-Low-DSH States: Column A State. Column B Final FY 2004 DSH Allotment Federal Share—This column contains the final FFY 2004 DSH Allotments. Column C FY 2006 DSH Allotment Federal Share—This column contains the final FFY 2006 DSH Allotments. Column D MMA Low-DSH Status—This column indicates the MMA Low-DSH Status of each State. For Low-DSH States: Column A State. Column B Prior FY DSH Allotment—This column contains the final FFY 2005 DSH Allotments. Column C FY 2006 DSH Allotments Federal Share—This column contains the final FFY 2006 DSH Allotments = Column B multiplied by 1.16. Column D MMA Low-DSH Status—This column indicates the MMA Low-DSH Status of each State. Key to Chart 2.—Preliminary DSH Allotments for FY 2008 [Key to the Chart of the Preliminary FFY 2008 DSH Allotments. The preliminary FFY 2008 DSH Allotments for the regular States are presented in the top section of this chart and the preliminary FFY 2008 DSH Allotments for the Low-DSH States are presented in the bottom section of the chart.] Column Description For Non-Low-DSH States: Column A State. Column B Final FY 2004 DSH Allotment Federal Share—This column contains the final FFY 2004 DSH Allotments. Column C FY 2008 DSH Allotment Federal Share—This column contains the preliminary FFY 2008 DSH Allotments. Column D MMA Low-DSH Status—This column indicates the MMA Low-DSH Status of each State. For Low-DSH States: Column A State. Column B Prior FY DSH Allotment—This column contains the preliminary FFY 2007 DSH Allotments. Column C FY 2008 DSH Allotments Federal Share—This column contains the preliminary FFY 2008 DSH Allotments = Column B multiplied by 1.16. Column D MMA Low-DSH Status—This column indicates the MMA Low-DSH Status of each State. Key to Chart 3.—Final FFY 2006 IMD DSH Limits [Key to the Chart of the FFY 2006 IMD Limitations.—The final FFY 2006 IMD DSH Limits for the regular States are presented in the top section of this chart and the Final FFY IMD DSH Limits for the Low-DSH States are presented in the Bottom Section of the chart.] Column Description Column A State. Column B Inpatient Hospital Services FY 95 DSH Total Computable. This column contains the States' total computable FFY 1995 inpatient hospital DSH expenditures as reported on the Form CMS-64. Column C IMD and Mental Health Services FY 95 DSH Total Computable. This column contains the total computable FFY 1995 mental health facility DSH expenditures as reported on the Form CMS-64 as of January 1, 1997. Column D Total Inpatient & IMD & Mental Health FY 95 DSH Total Computable, Col B + C. This column contains the total computation of all inpatient hospital DSH expenditures and mental health facility DSH expenditures for FFY 1995 as reported on the Form CMS-64 as of January 1, 1997 (representing the sum of Column B and Column C). Column E Applicable Percentage Col C/D. This column contains the “applicable percentage” representing the total computable FFY 1995 mental health facility DSH expenditures divided by total computable all inpatient hospital and mental health facility DSH expenditures for FFY 1995 (the amount in Column C divided by the amount in Column D) Per section 1923(h)(2)(A)(ii)(II) of the Act, for FFYs after FY 2002, the applicable percentage can be no greater than 33 percent. Column F FY 2006 Federal Share DSH Allotment. This column contains the States' final FFY 2005 DSH allotments. Column G FFY 2006 FMAP. Column H FY 2006 DSH Allotments in TC. Col. F/G. This column contains FFY 2006 total computable DSH allotment (determined as Column F/Column G). Column I Col E * Col H in TC. This column contains the applicable percent of FFY 2006 total computable DSH allotment (calculated as Column E × Column H). Column J FY 2006 IMD DSH Limit Total Computable. Lesser of Col. C or I. The column contains the lesser of the lesser of Column I or C. Column K FY 2006 IMD DSH Limit Federal Share, Col. G × J. This column contains the total computable IMD DSH Limit from Col. J and converts that amount into a Federal share (calculated as Col. G × Col. J). Column L LOW DSH Status. This column contains Low DSH status for each State. Key to Chart 4.—Preliminary FFY 2008 IMD DSH Limits [Key to the Chart of the FFY 2008 IMD Limitations.—The preliminary FFY 2008 IMD DSH Limits for the regular States are presented in the top section of this chart and the preliminary FFY 2008 IMD DSH Limits for the Low-DSH States are presented in the Bottom Section of the Chart Column Description Column A State. Column B Inpatient Hospital Services FY 95 DSH Total Computable. This column contains the States' total computable FFY 1995 inpatient hospital DSH expenditures as reported on the Form CMS-64. Column C IMD and Mental Health Services FY 95 DSH Total Computable. This column contains the total computable FFY 1995 mental health facility DSH expenditures as reported on the Form CMS-64 as of January 1, 1997. Column D Total Inpatient & IMD & Mental Health FY 95 DSH Total Computable, Col. B + C. This column contains the total computation of all inpatient hospital DSH expenditures and mental health facility DSH expenditures for FFY 1995 as reported on the Form CMS-64 as of January 1, 1997 (representing the sum of Column B and Column C). Column E Applicable Percentage Col. C/D. This column contains the “applicable percentage” representing the total computable FFY 1995 mental health facility DSH expenditures divided by total computable all inpatient hospital and mental health facility DSH expenditures for FFY 1995 (the amount in Column C divided by the amount in Column D) Per section 1923(h)(2)(A)(ii)(II) of the Act, for FFYs after FY 2002, the applicable percentage can be no greater than 33 percent. Column F FY 2008 Federal Share DSH Allotment. This column contains the States' preliminary FFY 2008 DSH allotments. Column G FFY 2008 FMAP. Column H FY 2008 DSH Allotment Total Computable Col. F/G. This column contains FFY 2008 total computable DSH allotment (determined as Column F/Column G). Column I Col E * Col H in TC. This column contains the applicable percent of FFY 2008 total computable DSH allotment (calculated as Column E × Column H) Column J FY 2008 IMD DSH Limit Total Computable. Lesser of Col. C or I. The column contains the lesser of the lesser of Column I or C. Column K FY 2008 IMD DSH Limit Federal Share, Col. G × J. This column contains the total computable IMD DSH Limit from Col. J and converts that amount into a Federal share (calculated as Col. G × Col. J). Column L Low DSH Status. This column contains Low DSH status for each State. EN28DE07.000 EN28DE07.001 EN28DE07.002 EN28DE07.003 BILLING CODE 4120-01-P Authority: Section 1923(a)(2), (f), and
(h)of the Social Security Act ( *42 U.S.C. 1396r-4* (a)(2), (f), and (h), and Pub. L. 105-33) (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) Dated: October 23, 3007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: November 8, 2007. Michael O. Leavitt, Secretary. [FR Doc. E7-24486 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-C DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1556-N] Medicare Program; Notice of Supplemental Election Period for Participation in the Calendar Year
(CY)2008 Competitive Acquisition Program for Part B Drugs AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces an additional physician election period for physicians who are not currently participating in the competitive acquisition program
(CAP)for Medicare Part B drugs for calendar year
(CY)2008. The additional physician election period begins on January 15, 2008 and ends on February 15, 2008. Physicians who elect to join the CAP during this additional election period will enter into a physician election agreement effective April 1, 2008 through December 31, 2008. DATES: The additional CAP physician election period will begin on January 15, 2008 and end on February 15, 2008. Physicians electing to join the CAP during this period will participate in the CAP effective April 1, 2008 through December 31, 2008. FOR FURTHER INFORMATION CONTACT: Edmund Kasaitis
(410)786-0477. SUPPLEMENTARY INFORMATION: I. Background The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173)
(MMA)requires the implementation of a competitive acquisition program
(CAP)for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. Physicians who elect to participate in the CAP obtain certain Part B covered drugs from vendors selected through a competitive bidding process. Physicians who do not elect to participate in the CAP purchase these drugs themselves and are paid under the average sales price
(ASP)system. (For more information on the CAP, see the March 4, 2005 proposed rule (70 FR 10746), interim final rule with comment period (70 FR 39022), November 21, 2005 final rule (70 FR 70116), and the November 27, 2007 final rule with comment period (72 FR 66222)). In accordance with section 1874B(a) of the Social Security Act (the Act), statute and our regulations, the annual CAP physician election period for CY 2009 will occur in the fall of 2008. II. Provisions of the Notice Under the authority described in section 1847B(a)(5)(A)(i) of the Act and § 414.908(a)(2) of our regulations, which allows for physician election at times other than the regular, annual election period in such exigent circumstances as defined by CMS, we are designating an additional election period for physicians who wish to join the CAP for 2008. We are providing for this additional election period in recognition of the statutory changes we recently made to § 414.908(a)(2)(v) of our regulations. These changes were described and published in the November 27, 2007 final rule with comment period (72 FR 66265) with comment period. The changes will become effective on January 1, 2008. In the November 27, 2007 **Federal Register** (72 FR 66256), we published a final rule, that defined a new exigent circumstance that would allow a participating CAP physician to opt out of the CAP due to the burden that the CAP places on the physician's practice. We established a two-tiered process, under which a physician may opt out of the CAP up to and including the first 60 days after the effective date of his or her CAP election agreement if continuing participation will impose a burden on the physician's practice. A participating CAP physician may also opt out of CAP participation more than 60 days after the effective date of his or her CAP election agreement based on a change of circumstances which creates a new burden to the practice. The two-tiered process was developed in response to public comments to the CY 2008 Physician Fee Schedule proposed rule. However, the CY 2008 Physician Fee Schedule final rule was not issued until the end of the CY 2008 CAP physician election period, and therefore, we were not able to disseminate sufficient information to make the large number of Medicare physicians aware of this new and desirable program change before the election period closed. Thus, we believe this is an “exigent circumstance” for which we should allow physicians an additional opportunity to join the CAP for CY 2008. The additional election period— • Takes place from January 15, 2008 until February 15, 2008. • Is open to physicians as defined in section 1861(r) of the Act (The term “physician” includes persons who are authorized to provide services under the Act and who can, within their State's scope of practice, prescribe and order drugs covered under Medicare Part B. • Does not affect the terms of CAP participation for physicians who have already elected to participate in the CAP for 2008. • Uses the same procedures, forms, etc. as the regular, annual 2008 election period. Physicians who elect to participate in the CAP during the additional CY 2008 election period will have their CAP election agreement effective from April 1, 2008 through December 31, 2008. We note that participation in the CAP for CY 2009 requires renewal of CAP election during the regular fall election period, which will run from October 1, 2008 to November 15, 2008. Completed and signed forms must be returned by mail to the physician's local carrier (the carrier that processes the physician's Part B claims). Forms must be postmarked no later than February 15, 2008. Additional details about CAP physician election will be available on the CMS Web site at *http://www.cms.hhs.gov/CompetitiveAcquisforBios/02_infophys.asp#TopOfPage* . Authority: Section 1847B(a)(5)(A)(i) of the Social Security Act (42 U.S.C 1395w-3b(a)(5)(A)(i).) (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare-Supplementary Medical Insurance Program) Dated: December 18, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-25037 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3187-N] RIN 0938-Z Medicare Program; Quality Improvement Organization
(QIO)Contracts: Solicitation of Proposals From In-State QIOs—Alaska, Idaho, Maine, South Carolina, Vermont, and Wyoming AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice in accordance with section 1153(i) of the Social Security Act (the Act), gives at least 6 months advance notice of the expiration dates of contracts with out-of-State Quality Improvement Organizations (QIOs). It also specifies the period of time in which in-State QIOs may submit a proposal for those contracts. DATES: Interested offerors may submit a proposal to perform the QIO work in any of the States listed in this announcement. The Request for Proposal
(RFP)will be made available to all interested offerors through the Federal Business Opportunities ( *http://www.fedbizopps.gov* ) Web site. CMS anticipates that the RFP for the first group of QIO contracts will be released sometime during the month of February 2008. Interested offerors should monitor the Federal Business Opportunities Web site for all information relating to the RFP. ADDRESSES: Proposals for the contracts must be submitted to the Centers for Medicare & Medicaid Services, Acquisitions and Grants Groups, OAGM, Attn.: Naomi Ceresa-Haney, 7500 Security Boulevard, Mail Stop C2-21-15, Baltimore, Maryland 21244-1850. FOR FURTHER INFORMATION CONTACT: Alfreda Staton,
(410)786-4194. SUPPLEMENTARY INFORMATION: I. Background The Peer Review Improvement Act of 1982 (Title I, subtitle C of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Pub. L. 97-248) amended Part B of title XI of the Social Security Act (the Act) by establishing the Utilization and Quality Control Peer Review Organization program. Utilization and Quality Control Peer Review Organizations, now known as Quality Improvement Organizations (QIOs), currently review certain health care services furnished under Title XVIII of the Social Security Act (Medicare), to determine whether those services are reasonable, medically necessary, provided in the appropriate setting, and are of a quality that meets professionally recognized standards. QIO activities are a part of the Health Care Quality Improvement Program (HCQIP), a program that supports our mission to ensure health care quality for our beneficiaries. The HCQIP rests on the belief that a plan's, provider's, or practitioner's own internal quality management system is key to good performance. The HCQIP is carried out locally by the QIO in each State. Under the HCQIP, QIOs provide critical tools (for example, quality indicators and information) for plans, providers, and practitioners to improve the quality of care provided to Medicare beneficiaries. The Congress created the QIO program in part to redirect, simplify, and enhance the cost-effectiveness and efficiency of the peer review process. In June 1984, we began awarding contracts to QIOs. We currently maintain 53 QIO contracts with organizations that provide medical review activities for the 50 States, the District of Columbia, Puerto Rico, and the Virgin Islands. The organizations that are eligible to contract as QIOs have satisfactorily demonstrated that they are either physician-sponsored or physician-access organizations in accordance with section 1152 of the Act and our regulations at 42 CFR 475.102 and 475.103. A physician-sponsored organization is one that is both composed of a substantial number of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the respective review area and who are representative of the physicians practicing in the review area. A physician-access organization is one that has available to it, by arrangement or otherwise, the services of a sufficient number of licensed doctors of medicine or osteopathy practicing medicine or surgery in the review area to ensure adequate peer review of the services furnished by the various medical specialties and subspecialties. In addition, a QIO cannot be a health care facility, health care facility association, a health care facility affiliate, or in most cases a payor organization. (Statutes and regulations provide that, in the event CMS determines no otherwise qualified non-payor organization is available to undertake a given QIO contract, CMS may select a payor organization which otherwise meets certain requirements to be eligible to conduct Utilization and Quality Control Peer Review as specified in Part B of Title XI of the Act and its implementing regulations.) Section 1152(2) of the Act requires QIOs to perform review functions in an efficient and effective manner, and perform reviews of quality of care in an area of medical practice where actual performance is measured against objective criteria, which defines acceptable and adequate practice. The selected organization must have a consumer representative on its governing board. Section 1153(i) of the Act prohibits us from renewing the contract of any QIO that is not an in-State QIO without first publishing in the **Federal Register** a notice announcing when the contract will expire. This notice must be published no later than 6 months before the date the contract expires and must specify the period of time during which an in-State organization may submit a proposal for the QIO contract for that State. If one or more qualified in-State organizations submit a proposal for the QIO contract within the specified period of time, we cannot automatically renew the current contract on a noncompetitive basis, but must instead provide for competition for the contract in the same manner used for a new contract under section 1153(b) of the Act. An in-State QIO is defined at section 1153(i)(3) of the Act as a QIO that has its primary place of business in the State in which review will be conducted (or, that is owned by a parent corporation, the headquarters of which is located in that State). There are currently 6 QIO contracts with entities that do not meet the statutory definition of an in-State QIO. The areas affected for purposes of this notice along with the respective contract expiration dates are as follows: Vermont July 31, 2008 Wyoming July 31, 2008 Maine July 31, 2008 Alaska October 31, 2008 Idaho October 31, 2008 South Carolina January 31, 2009 II. Provisions of the Notice The notice announces the scheduled expiration dates of the current contracts between CMS and out-of-State QIOs responsible for review in the areas mentioned above. Interested offerors may submit a proposal to perform the QIO work in any of the States listed in this announcement. The Request for Proposal
(RFP)will be made available to all interested offerors through the Federal Business Opportunities Web site. CMS anticipates that the RFP for the first group of QIOs will be released sometime during the month of February 2008. Interested offerors should monitor the Federal Business Opportunities Web site for all information relating to the RFP. Section 1153(i)(3) of the Act requires that an in-State QIO have its primary place of business in the State in which review will be conducted (or, if a QIO is owned by a parent corporation, the headquarters of which is located in that State). In the proposal, each QIO must furnish, among other things, materials that demonstrate that it meets the following requirements under sections 1152(1)(A), (B), (2), and
(3)of the Act and the regulations at § 475.102 and § 475.103: A. Be Either a Physician-Sponsored or a Physician-Access Organization 1. Physician-Sponsored Organization To be eligible as a physician-sponsored organization, the organization must meet the following requirements: a. The organization must be composed of a substantial number of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area, who are representative of the physicians practicing in the review area. b. The organization must not be a health care facility, health care facility association, health care facility affiliate, payor organization, or affiliated with any of these entities. However, statutes and regulations provide that, in the event that we determine no otherwise qualified non-payor organization is available to undertake a given QIO contract, we may select a payor organization which otherwise meets requirements to be eligible to conduct Utilization and Quality Control Peer Review as specified in Part B of Title XI of the Act and its implementing regulations. c. In order to meet the “substantial number of doctors of medicine and osteopathy” requirement of paragraph A.1.a of this section, an organization must be composed of at least 10 percent of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area. In order to meet the representation requirement of paragraph A.1.a of this section, an organization must state and have documentation in its files demonstrating that it is composed of at least 20 percent of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area. Alternatively, if the organization does not demonstrate that it is composed of at least 20 percent of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area, the organization must demonstrate in its statement of interest through letters of support from physicians or physician organizations, or through other means, that it is representative of the area physicians. 2. Physician-Access Organization To be eligible as a physician-access organization, the organization must meet the following requirements: a. The organization must have available to it, by arrangement or otherwise, the services of a sufficient number of licensed doctors of medicine or osteopathy practicing medicine or surgery in the review area to ensure adequate peer review of the services furnished by the various medical specialties and subspecialties. b. The organization must not be a health facility, health care facility association, health care facility affiliate, payor organization, or be affiliated with any of these mentioned entities. c. An organization meets the requirements of paragraph A.2.a. of this section if it demonstrates that it has available to it at least one physician in every generally recognized specialty and has an arrangement or arrangements with physicians under which the physicians would conduct review for the organization. B. Have at Least One Individual Who Is a Representative of Consumers on Its Governing Board If one or more organizations meet the above requirements in a QIO area and submit proposals for the contracts in accordance with this notice, we will consider those organizations to be potential sources for the 6 contracts upon their expiration. These organizations will be entitled to participate in a full and open competition for the QIO contract to perform the QIO statement of work. III. Information Collection Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). Authority: Section 1153 of the Social Security Act (42 U.S.C. 1320c-2). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance Program; and No. 93.774, Medicare-Supplementary Medical Insurance Program) Dated: December 6, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-24477 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1323-N] Medicare Program; Semi-Annual Winter Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—March 5, 6, and 7, 2008 AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. SUMMARY: In accordance with section 10(a) of the Federal Advisory Committee Act
(FACA)(5 U.S.C. Appendix 2), this notice announces the first semi-annual winter meeting of the Advisory Panel on Ambulatory Payment Classification
(APC)Groups (the Panel) for 2008. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services
(DHHS)(the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services
(CMS)(the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the proposed rule that updates the hospital Outpatient Prospective Payment System
(OPPS)for CY 2009. DATES: *Meeting Dates:* We are scheduling the first semi-annual winter meeting in 2008 for the following dates and times: • Wednesday, March 5, 2008, 1 p.m. to 5 p.m. (e.s.t.) 1 1 The times listed in this notice are approximate times; consequently, the meetings may last longer than listed in this notice—but will not begin before the posted times. • Thursday, March 6, 2008, 8 a.m. to 5 p.m. (e.s.t.) 1 • Friday, March 7, 2008, 8 a.m. to 12 noon (e.s.t.) 2 2 If the business of the Panel concludes on Thursday, March 6, there will be no Friday meeting. *Deadlines:* *Deadline for Hardcopy Comments/Suggested Agenda Topics* —5 p.m. (e.s.t.), Thursday, February 7, 2008. *Deadline for Hardcopy Presentations* —5 p.m. (e.s.t.), Thursday, February 7, 2008. *Deadline for Attendance Registration* —5 p.m. (e.s.t.), Wednesday, February 27, 2008. *Deadline for Special Accommodations* —5 p.m. (e.s.t.), Wednesday, February 27, 2008. *Submission of Materials to the Designated Federal Officer (DFO):* Because of staffing and resource limitations, we cannot accept written comments and presentations by FAX, and we cannot print written comments and presentations received electronically for dissemination at the meeting. Only hardcopy comments and presentations can be reproduced for public dissemination. All hardcopy presentations must be accompanied by Form CMS-20017 (revised 01/07). The form is now available through the CMS Forms Web site. The Uniform Resource Locator
(URL)for linking to this form is as follows: *http://www.cms.hhs.gov/cmsforms/downloads/cms20017.pdf.* Presenters must use the most recent copy of CMS-20017 (updated 01/07) at the above URL. Additionally, presenters must clearly explain the action(s) that they are requesting CMS to take in the appropriate section on the form. They must also clarify their relationship to the organization that they represent in the presentation. Note: Issues that are vague, or that are outside the scope of the APC Panel's purpose, will not be considered for presentations and comments. There will be no exceptions to this rule. We appreciate your cooperation on this matter. We are also requiring electronic versions of the written comments and presentations, in addition to the hardcopies, to send electronically to the Panel members for their review prior to the meeting. In summary, presenters and/or commenters must do the following: • Send both electronic and hardcopy versions of their presentations and written comments by the prescribed deadlines. • Send electronic transmissions to the e-mail address below. • Do not send pictures of patients in any of the documents unless their faces have been blocked out. • Do not send documents electronically that have been archived. • Mail (or send by courier) to the DFO all hardcopies, accompanied by Form CMS-20017 (revised 01/07), if they are presenting, as specified in the FURTHER INFORMATION CONTACT section of this notice. • Commenters are not required to send Form CMS-20017 with their written comments. ADDRESSES: The meeting will be held in the Auditorium, CMS Central Office, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. FURTHER INFORMATION CONTACT: For further information, contact: Shirl Ackerman-Ross, DFO, CMS, CMM, HAPG, DOC, 7500 Security Boulevard, Mail Stop C4-05-17, Baltimore, MD 21244-1850. Phone:
(410)786-4474. Note: Please advise couriers of the following: When delivering hardcopies of presentations to CMS, if no one answers at the above phone number, please call
(410)786-4532 or
(410)786-9316.) E-mail address for comments, presentations, and registration requests is *CMS APCPanel@cms.hhs.gov.* **Note:** There is no underscore in this e-mail address; there is a space between CMS and APC Panel. News media representatives must contact our Public Affairs Office at
(202)690-6145. *Advisory Committees' Information Lines:* The phone numbers for the CMS Federal Advisory Committee Hotline are 1-877-449-5659 (toll free) and
(410)786-9379 (local). *Web Sites:* Please search the CMS Web site at *http://www.cms.&hhs.gov/FACA/05_AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp#TopOfPage* in order to obtain the following information: Note: There is an underscore after FACA/05 (like this_); there is no space. • Additional information on the APC meeting agenda topics, • Updates to the Panel's activities, • Copies of the current Charter, and • Membership requirements. You may also search information about the APC Panel and its membership in the FACA database at the following URL: *https://www.fido.gov/facadatabase/public.asp.* SUPPLEMENTARY INFORMATION: I. Background The Secretary is required by section 1833(t)(9)(A) of the Social Security Act (the Act), as amended by section 201(h) of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999
(BBRA)(Pub. L. 106-113), and re-designated by section 202(a)(2) of the BBRA] to establish and consult with an expert outside advisory panel regarding the clinical integrity of the APC groups and weights that are components of the hospital OPPS. The APC Panel meets up to three times annually. The Charter requires that the Panel must be fairly balanced in its membership in terms of the points of view represented and the functions to be performed. The Panel consists of up to 15 members who are representatives of providers and a chairperson. Each Panel member must be employed full-time by a hospital, hospital system, or other Medicare provider subject to payment under the OPPS. All Panel members must have technical expertise that enables them to participate fully in the work of the Panel. The expertise encompasses hospital payment systems, hospital medical-care delivery systems, provider billing systems, outpatient payment requirements, APC groups, Current Procedural Terminology codes, and the use and payment of drugs and medical devices in the outpatient setting, as well as other forms of relevant expertise. Details regarding membership requirements for the APC Panel are found on the CMS and FACA Web sites as listed above. The Panel presently consists of the following members: • E.L. Hambrick, M.D., J.D., Chair • Gloryanne Bryant, B.S., R.H.I.A., R.H.I.T., C.C.S. • Patrick Grusenmeyer, Ph.D. • Hazel Kimmel, R.N., C.C.S., C.P.C. • Michael Mills, Ph.D. • Thomas Munger, M.D. • Agatha Nolan, D.Ph., M.S. • Beverly Khnie Philip, M.D. • Louis Potters, M.D., F.A.C.R. • Russ Ranallo, M.S. • James V. Rawson, M.D. • Michael Ross, M.D. • Judie S. Snipes, R.N., M.B.A., F.A.C.H.E. • Patricia Spencer-Cisek, M.S., APRN-BC, AOCN®. • Kim Allan Williams, M.D., F.A.C.C., F.A.B.C. • Robert M. Zwolak, M.D., Ph.D. F.A.C.S. II. Agenda The agenda for the March 2008 meeting will provide the opportunity for discussion and comment on the following topics as designated in the Panel's Charter: • Reconfiguring APCs (for example, splitting of APCs, moving Healthcare Common Procedure Coding System (HCPCS) codes from one APC to another and moving HCPCS codes from new technology APCs to clinical APCs). • Evaluating APC weights. • Packaging device and drug costs into APCs methodology, effect on APCs, and the need for reconfiguring APCs based upon device and drug packaging. • Removing procedures for payment from the inpatient list under the OPPS. • Using single and multiple procedure claims data. • Addressing other APC structure technical issues. Note: The subject matter before the Panel will be limited to these and related topics. Issues related to calculation of the OPPS conversion factor, charge compression, pass-through payments, and wage adjustments are not within the scope of the Panel's purpose. Therefore, these issues will not be considered for presentations and/or comments. There will be no exceptions to this rule. We appreciate your cooperation on this matter. The Panel may use data collected or developed by entities and organizations, other than DHHS and CMS, in conducting its review. We urge organizations to submit data for the Panel's and CMS staff's review. III. Written Comments and Suggested Agenda Topics Send hardcopy and electronic written comments and suggested agenda topics to the DFO at the address indicated above. The DFO must receive these items by 5 p.m. (e.s.t.), Thursday, February 7, 2008. There will be no exceptions. We appreciate your cooperation on this matter. The written comments and suggested agenda topics submitted for the March 2008 APC Panel meeting must fall within the subject categories outlined in the Panel's Charter and as listed in the Agenda section of this notice. IV. Oral Presentations Individuals or organizations wishing to make 5-minute oral presentations must submit hardcopy and electronic versions of their presentations to the DFO by 5 p.m. (e.s.t.), Thursday, February 7, 2008, for consideration. The number of oral presentations may be limited by the time available. Oral presentations should not exceed 5 minutes in length for an individual or an organization. The Chairperson may further limit the time allowed for presentations due to the number of oral presentations, if necessary. V. Presenter and Presentation Information All presenters must submit Form CMS-20017 (revised 01/07). Hardcopies are required for oral presentations; however, electronic submissions of Form CMS-20017 are optional. The DFO must receive the following information from those wishing to make oral presentations: • Form CMS-20017 completed with all pertinent information identified on the first page of the presentation. • One hardcopy of presentation. • Electronic copy of presentation. • Personal registration information as described in the Meeting Attendance section below. • Those persons wishing to submit comments only must send hardcopy and electronic versions of their comments, but they are not required to submit Form CMS-20017. VI. Oral Comments In addition to formal oral presentations, there will be opportunity during the meeting for public oral comments, which will be limited to 1 minute for each individual and a total of 3 minutes per organization. VII. Meeting Attendance The meeting is open to the public; however, attendance is limited to space available. Attendance will be determined on a first-come, first-served basis. Persons wishing to attend this meeting, which is located on Federal property, must e-mail the Panel DFO to register in advance no later than 5 p.m. (e.s.t.), Wednesday, February 27, 2008. A confirmation will be sent to the requester(s) via return e-mail. The following personal information must be e-mailed to the DFO by the date and time above: • Name(s) of attendee(s), • Title(s), • Organization, • E-mail address(es), and • Telephone number(s). VIII. Security, Building, and Parking Guidelines The following are the security, building, and parking guidelines: • Persons attending the meeting—including presenters—must be registered and on the attendance list by the prescribed date. • Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. • Attendees must present photographic identification to the Federal Protective Service or Guard Service personnel before entering the building. • Security measures include inspection of vehicles, inside and out, at the entrance to the grounds. • In addition, all persons entering the building must pass through a metal detector. • All items brought into CMS—including personal items such as desktops, cell phones, palm pilots—are subject to physical inspection. • The public may enter the building 30-45 minutes before the meeting convenes each day. • All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. • The main-entrance guards will issue parking permits and instructions upon arrival at the building. IX. Special Accommodations Individuals requiring sign-language interpretation or other special accommodations must send a request for these services to the DFO by 5 p.m. (e.s.t.), Wednesday, February 27, 2008. Authority: Section 1833(t)(9) of the Act (42 U.S.C. 1395l(t)). The Panel is governed by the provisions of Pub. L. 92-463, as amended (5 U.S.C. Appendix 2). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare-Hospital Insurance; and Program No. 93.774, Medicare-Supplementary Medical Insurance Program). Dated: November 20, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-24265 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1490-N] Medicare Program; Town Hall Meeting on the Fiscal Year 2009 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment System, February 21, 2008 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces a Town Hall meeting in accordance with section 503 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)to discuss fiscal year
(FY)2009 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2009 new medical services and technologies applications meet the substantial clinical improvement criterion. DATES: *Meeting Date:* The Town Hall meeting announced in this notice will be held on Thursday, February 21, 2008 at 1:30 p.m., e.s.t. and check-in will begin at 1 p.m. e.s.t. *Deadline for Registration of Presenters of the Town Hall Meeting:* All presenters for the Town Hall Meeting, whether attending in person or by phone, must register and submit their agenda item(s) by February 7, 2008. *Deadline for Submission of Comments on the Town Hall Meeting:* Written comments for discussion at the Town Hall Meeting must be received by February 7, 2008. All other written comments on whether the service or technology represents a substantial clinical improvement must be received by March 10, 2008 for consideration before publication of the FY 2009 IPPS proposed rule. *Deadline for Registration of All Other Participants and Submitting Requests for Special Accommodations:* All other participants must register by February 14, 2008. Requests for special accommodations must be received no later than 5 p.m., e.s.t. on February 14, 2008. ADDRESSES: *Meeting Location:* The Town Hall meeting will be held in the main Auditorium in the central building of the Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. *Registration and Special Accommodations:* Individuals wishing to participate in the meeting must register by following the on-line registration instructions located in section III of this notice or by contacting staff listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Individuals who need special accommodations should contact staff listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Registration information and special accommodation requests may also be mailed to the address listed in the ADDRESSES section of this notice. *Submission of Agenda Item(s) or Written Comments:* Each presenter must submit an agenda item(s) regarding whether a FY 2009 application meets the substantial clinical improvement criterion. Agenda items or written comments, questions, or other statements must not exceed three single-spaced typed pages and must be sent to: Division of Acute Care, New Technology Team, Mailstop C4-07-08, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244-1850, Attention: Tiffany Swygert or Michael Treitel. Agenda items or written comments may also be sent via e-mail to *newtech@cms.hhs.gov* . FOR FURTHER INFORMATION CONTACT: Tiffany Swygert,
(410)786-4642, *tiffany.swygert@cms.hhs.gov,* or Michael Treitel,
(410)786-4552, *michael.treitel@cms.hhs.gov* or you may forward regular mail to the address listed in the ADDRESSES section of this notice. SUPPLEMENTARY INFORMATION: I. Background Sections 1886(d)(5)(K) and
(L)of the Social Security Act (the Act) require the Secretary to establish a process of identifying and ensuring adequate payments to acute inpatient hospitals for new medical services and technologies under Medicare. Effective for discharges beginning on or after October 1, 2001, section 1886(d)(5)(K)(i) required the Secretary to establish (after notice and opportunity for public comment) a mechanism to recognize the costs of new services and technologies under the inpatient hospital prospective payment system (IPPS). In addition, section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered “new” if it meets criteria established by the Secretary (after notice and opportunity for public comment). (See the FY 2002 proposed rule (66 FR 22693, May 4, 2001) and the final rule (66 FR 46912, September 7, 2001) for a more detailed discussion.) In the September 7, 2001 final rule (66 FR 46914), we noted that we evaluate a request for special payment for a new medical service or technology against the following criteria in order to determine if the new technology meets the substantial clinical improvement requirement: • The device offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments. • The device offers the ability to diagnose a medical condition in a patient population where that medical condition is currently undetectable or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods. There must also be evidence that use of the device to make a diagnosis affects the management of the patient. • Use of the device significantly improves clinical outcomes for a patient population as compared to currently available treatments. Some examples of outcomes that are frequently evaluated in studies of medical devices are the following: ++ Reduced mortality rate with use of the device. ++ Reduced rate of device-related complications. ++ Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process). ++ Decreased number of future hospitalizations or physician visits. ++ More rapid beneficial resolution of the disease process treatment because of the use of the device. ++ Decreased pain, bleeding, or other quantifiable symptoms. ++ Reduced recovery time. In addition, we indicated that the requester is required to submit evidence that the technology meets one or more of these criteria. Section 503 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)revised the process for evaluating new medical services and technology applications by requiring the Secretary to do the following: • Provide for public input regarding whether a new service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of Medicare beneficiaries before publication of a proposed rule. • Make public and periodically update a list of all the services and technologies for which an application is pending. • Accept comments, recommendations, and data from the public regarding whether the service or technology represents a substantial improvement. • Provide for a meeting at which organizations representing hospitals, physicians, manufacturers and any other interested party may present comments, recommendations, and data to the clinical staff of CMS whether the service or technology represents a substantial improvement before publication of a proposed rule. The opinions and alternatives provided during this meeting will assist us as we evaluate the new medical services and technology applications for FY 2009. In addition, they will help us to evaluate our policy on the IPPS new technology add-on payment process before the publication of the FY 2009 IPPS proposed rule. II. Meeting Format As noted in section I. of this notice, we are required to provide for a meeting at which organizations representing hospitals, physicians, manufacturers and any other interested party may present comments, recommendations, and data to the clinical staff of CMS concerning whether the service or technology represents a substantial improvement. This meeting will allow for a discussion of the substantial clinical improvement criteria on each of the FY 2009 new medical services and technology add-on payment applications. Information regarding the applications can be found on our Web site at *http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.* The majority of the meeting will be reserved for presentations of comments, recommendations, and data from registered presenters. The time for each presenter's comments will be approximately 10 to 15 minutes and will be based on the number of registered presenters. Presenters will be scheduled to speak in the order in which they register and grouped by new technology applicant. Therefore, individuals who would like to present must register and submit their agenda item(s) to the address specified in the ADDRESSES section of this notice by the date specified in the DATES section of this notice. Comments from participants will be heard after scheduled statements if time permits. Once the agenda is completed, it will be posted on the CMS IPPS Web site at *http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage* . For presenters or participants unable to attend the CMS for the meeting, an open toll-free phone line,
(888)970-4128, is available. Persons who call in will be asked for the conference code by the conference operator. The conference code is “New Tech.” In addition, written comments will also be accepted and presented at the meeting if they are received at the address specified in the ADDRESSES section of this notice by the date specified in the DATES section of this notice. Written comments may also be submitted after the meeting. If the comments are to be considered before the publication of the proposed rule, the comments must be received at the address specified in the ADDRESSES section of this notice by the date specified in the DATES section of this notice. III. Registration Instructions The Division of Acute Care in CMS is coordinating the meeting registration for the Town Hall Meeting. While there is no registration fee, individuals must register to attend the Town Hall Meeting. Registration may be completed on-line at the following Web address: *http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage* . Select the link at the bottom of the page “New Technology Town Hall Meeting” to complete the on-line registration. After completing the registration, on-line registrants should print the confirmation page and bring it with them to the meeting. If you are unable to register on-line, you may register by sending an email to the contacts listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Please include your name, address, telephone number, email address and fax number. If seating capacity has been reached, you will be notified that the meeting has reached capacity. IV. Security, Building, and Parking Guidelines Because this meeting will be located on Federal property, for security reasons, any persons wishing to attend this meeting must register by close of business by the date listed in the DATES section of this notice. Please allow sufficient time to go through the security checkpoints. It is suggested that you arrive at 7500 Security Boulevard no later than 1 p.m., e.s.t. so that you will be able to arrive promptly at the meeting by 1:30 p.m., e.s.t. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Passing through a metal detector and inspection of items brought into the building. We note that all items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Seating capacity is limited to the first 250 registrants. Authority: Section 503 of Public Law 108-173. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: December 6, 2007. Kerry Weems, Acting Administrator, Centers for Medicare and Medicaid Services. [FR Doc. E7-24267 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Statement of Organization, Functions, and Delegations of Authority Part F of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), ( **Federal Register** , Vol. 72, No. 123, pp. 35246-35247, dated Wednesday, June 27, 2007) is amended to reflect the abolishment of the 10 Regional Offices and the establishment of the Consortium for Medicare Health Plans Operations, the Consortium for Financial Management and Fee for Service Operations, the Consortium for Medicaid and Children's Health Operations, and the Consortium for Quality Improvement and Survey and Certification Operations. Part F is described below: • Section F.10. (Organization) reads as follows: 1. Office of External Affairs
(FAC)2. Center for Beneficiary Choices
(FAE)3. Office of Legislation
(FAF)4. Center for Medicare Management
(FAH)5. Office of Equal Opportunity and Civil Rights
(FAJ)6. Office of Research, Development, and Information
(FAK)7. Office of Clinical Standards and Quality
(FAM)8. Office of the Actuary
(FAN)9. Center for Medicaid and State Operations
(FAS)10. Consortium for Medicare Health Plans Operations
(FAU)11. Consortium for Financial Management and Fee for Service Operations
(FAV)12. Consortium for Medicaid and Children's Health Operations
(FAW)13. Consortium for Quality Improvement and Survey and Certification Operations
(FAX)14. Office of Operations Management
(FAY)15. Office of Information Services
(FBB)16. Office of Financial Management
(FBC)17. Office of Strategic Operations and Regulatory Affairs
(FGA)18. Office of E-Health Standards and Services
(FHA)19. Office of Acquisition and Grants Management
(FKA)20. Office of Policy
(FLA)21. Office of Beneficiary Information Services
(FMA)• Section F. 20. (Functions) reads as follows: 10. Consortium for Medicare Health Plans Operations
(FAU)• Serves as the Field focal point for all interactions with managed health care organizations, Medicare Advantage
(MA)plans, Medicare prescription drug plans
(PDPs)and Medicare Advantage Prescription Drug (Part D) plans for issues relating to Agency programs, policy and operations. • Serves as the Field's focal point for all Agency interactions with employers, employees, retirees and others operating on their behalf pertaining to issues related to Agency policies and operations concerning employer-sponsored prescription drug coverage for their retirees. • Serves as the Field focal point for all interactions with beneficiaries, their families, care givers, health care providers, and others operating on their behalf concerning improving beneficiaries' ability to make informed decisions about their health and about program benefits administered by the Agency. These activities include strategic and implementation planning, execution, assessment and communications. • Implements national policy for Medicare Parts C and D beneficiary eligibility, enrollment, entitlement, premium billing and collection, coordination of benefits, rights and protections, and dispute resolution process, as well as policy for managed care enrollment and disenrollment to assure the effective administration of the Medicare program. • Participates in the development of national policies and procedures related to the development, qualification, and compliance of health maintenance organizations, competitive medical plans and other health care delivery systems and purchasing arrangements (such as prospective pay, case management, differential payment, selective contracting, etc.) necessary to assure the effective administration of the Agency's programs, including the development of statutory proposals. • In conjunction with the Center for Beneficiary Choices (CBC), handles all phases of contracts with managed health care organizations eligible to provide care to Medicare beneficiaries. • Responds to inquiries regarding Parts C and D coverage and payment policies. • Implements national policies and procedures to support and assure appropriate State implementation of the rules and processes governing group and individual health insurance markets and the sale of health insurance policies that supplement Medicare coverage. • In conjunction with CBC, implements regulations, guidelines, and instructions required for the dissemination of appeals policies to Medicare beneficiaries, MA plans, PDPs, CMS Consortia, beneficiary advocacy groups and other interested parties. • Assures, in coordination with other Consortium Administrators and Central Office Centers and Offices, that the activities of Medicare managed care plans, agents, and State Agencies meet the Agency's requirements on matters concerning beneficiaries and other consumers. • In partnership with appropriate Central Office components, administers the contracts and grants related to beneficiary and customer service, including the State Health Insurance Assistance Program grants. • Participates in the formulation of strategies to advance overall beneficiary communications goals and coordinates the Field implementation of all beneficiary-centered information, education, and service initiatives. • Builds a range of partnerships with other national organizations for effective consumer outreach, awareness, and education efforts in support of Agency programs. • Serves as the Consortium focal point for emergency preparedness for the Field. • Provides oversight in the areas of human resource procurement and logistics. • Ensures the effective management of the Agency's information technology and information systems and resources in the Field. • Implements the privacy and confidentiality policies pertaining to the collection, use, and release of individually identifiable data. • Proactively establishes, manages, and fosters partnerships within the Consortium with State and Local governments, providers and provider associations, beneficiaries and their representatives, and the media that are focused on CMS' goals and objectives. • Serves as the primary point of contact to appropriate members of Congress, Federal, State, and Local officials and Tribal governments on matters concerning the Medicare program. • Oversees the coordination and integration of CMS' activities with other Federal, State, Local, and private health care agencies and organizations. • Counsels, advises, and collaborates with top Agency officials on policy matters and major considerations in developing, implementing, and coordinating CMS' programs as they interrelate in addressing national and regional strategies. • Advises the Office of the Administrator
(OA)on special programs as they relate to national initiatives and as they impact major constituents or their key representatives. • Promotes accountability, communication, coordination and facilitation of cooperative corporate decision-making among CMS' top senior staff on management, operational and programmatic issues cross-cutting organizational components with diverse functions and activities. 11. Consortium for Financial Management & Fee for Service Operations
(FAV)• Serves as the Field focal point for all interactions with the Office of Financial Management and assists in its overall responsibility for the fiscal integrity of all Agency programs. • Implements all benefit integrity policies and operations in coordination with other Agency components in the Field. Assists in the management of the Medicare program integrity contractors. • Performs the Field's activities regarding Medicare Secondary Payer. • Implements all civil money penalty policies in all CMS' programs. • Oversees and coordinates the Field's preparation of certification statements for the Federal Managers Financial Integrity Act and Government Performance and Results Act. • Serves as the Field focal point for all Agency interactions between health care providers and fee-for-service
(FFS)contractors for issues relating to Part A and Part B FFS policies and operations. • Coordinates provider and physician-centered Part A and Part B FFS information, education, and service initiatives in the Field. • Responds to inquiries regarding Part A and Part B coverage and payment policies. • Provides the Center for Medicare Managementwith comments on FFS current/proposed legislation in order to determine impact on providers. • Performs activities related to the Medicare Part A and Part B processes (42 CFR part 405, subparts G and H), Part C (42 CFR part 422, subpart M), Part D (42 CFR part 423, subpart M) and the Program for All-Inclusive Care for the Elderly
(PACE)for claims-related hearings, appeals, grievances and other dispute resolution processes that are beneficiary-centered. • Implements national policy for Medicare Parts A and B beneficiary eligibility, enrollment, entitlement; premium billing and collection; coordination of benefits; rights and protections; dispute resolution process to assure the effective administration of the Medicare program. • Serves as the Consortium focal point for emergency preparedness for the Field. • Provides oversight in the areas of human resource procurement and logistics. • Ensures the effective management of the Agency's information technology and information systems and resources in the Field. • Implements the privacy and confidentiality policies pertaining to the collection, use, and release of individually identifiable data. • Proactively establishes, manages, and fosters partnerships within the Consortium with State and Local governments, providers and provider associations, beneficiaries and their representatives, and the media that are focused on CMS' goals and objectives. • Serves as the primary point of contact to appropriate members of Congress, Federal, State, and Local officials and Tribal governments on matters concerning the Medicare program. • Oversees the coordination and integration of CMS' activities with other Federal, State, Local, and private health care agencies and organizations. • Counsels, advises, and collaborates with top Agency officials on policy matters and major considerations in developing, implementing, and coordinating CMS' programs as they interrelate in addressing national and regional strategies. • Advises OA on special problems as they relate to national initiatives and programs and as they impact major constituents or their key representatives. • Promotes accountability, communication, coordination and facilitation of cooperative corporate decision-making among CMS top senior staff on management, operational and programmatic issues cross-cutting organizational components with diverse functions and activities. 12. Consortium for Medicaid & Children's Health Operations
(FAW)• Serves as the Field focal point for all CMS activities relating to Medicaid and the State Children's Health Insurance Program (SCHIP) with States and Local governments (including the Territories). • Implements national Medicaid program and fiscal policies and procedures which support and assure effective State program administration and beneficiary protection. In partnership with States, evaluates the success of State Agencies in carrying out their responsibilities and, as necessary, assists States in correcting problems and improving the quality of their operations. • Implements, interprets, and applies specific laws, regulations, and policies that directly govern the financial operation and management of the Medicaid program and the related interactions with States. • Reviews, approves and conducts oversight of Medicaid managed care waiver programs. Provides assistance to States and external customers on all Medicaid managed care issues. • Implements national policies and procedures on Medicaid automated claims/encounter processing and information retrieval systems such as the Medicaid Management Information System and integrated eligibility determination systems. • Through administration of the home and community-based services program and policy collaboration with other Agency components and the States, promotes the appropriate choice and continuity of quality services available to frail elderly, disabled and chronically ill beneficiaries. • Coordinates with and provides input into the Medicaid Integrity Program (MIP). Develops strategies to prevent and detect improper payments, including fraud and abuse by providers and others, from Medicaid and SCHIP. Offers support and assistance to the States to combat provider fraud, waste, and abuse. Provides guidance and direction to State Medicaid programs based on the insights gained through MIP's efforts. • Serves as the Consortium focal point for emergency preparedness for the Field. • Provides oversight in the areas of human resource procurement and logistics. • Ensures the effective management of the Agency's information technology and information systems and resources in the Field. • Implements the privacy and confidentiality policies pertaining to the collection, use, and release of individually identifiable data. • Proactively establishes, manages, and fosters partnerships within the Consortium with State and Local governments, providers and provider associations, beneficiaries and their representatives, and the media that are focused on CMS' goals and objectives. • Serves as the primary point of contact to appropriate members of Congress, State Governors, Federal, State, and Local officials and Tribal governments on matters concerning the Medicaid program. • Oversees the coordination and integration of CMS' activities with other Federal, State, Local, and private health care agencies and organizations. • Counsels, advises, and collaborates with top Agency officials on policy matters and major considerations in developing, implementing, and coordinating CMS' programs as they interrelate in addressing national and regional strategies. • Advises OA on special problems as they relate to national initiatives and programs and as they impact major constituents or their key representatives. • Promotes accountability, communication, coordination and facilitation of cooperative corporate decision-making among CMS' top senior staff on management, operational and programmatic issues cross-cutting organizational components with diverse functions and activities. 13. Consortium for Quality Improvement & Survey & Certification Operations
(FAX)• Serves as the Field focal point for all quality, clinical and medical science issues and policies for the Agency's programs. Provides leadership and coordination for the development and implementation of a cohesive, Agency-wide approach to measuring and promoting quality and leads the Agency's priority-setting process for clinical quality improvement. Coordinates quality-related activities with outside organizations. Monitors quality of Medicare, Medicaid, and the Clinical Laboratory Improvement Amendments (CLIA). Evaluates the success of interventions. • Identifies and develops best practices and techniques in quality improvement; implementation of these techniques will be overseen by appropriate components. Develops and collaborates on demonstration projects to test and promote quality measurement and improvement. • Develops tests and evaluates, adopts and supports performance measurement systems (quality indicators) to evaluate care provided to CMS' beneficiaries except for demonstration projects residing in other components. • Assures that the Agency's quality-related activities (survey and certification, technical assistance, beneficiary information, payment policies and provider/plan incentives) are fully and effectively integrated in the Field. Carries out the Health Care Quality Improvement Program for the Medicare, Medicaid, and CLIA programs. • Assists in the specification and operational refinement of an integrated CMS quality information system, which includes tools for measuring the coordination of care between health care settings; analyzes data supplied by that system to identify opportunities to improve care and assess success of improvement interventions. • Enforces the requirements of participation for providers and plans in the Medicare, Medicaid, and CLIA programs. Recommends revisions of the requirements based on statutory change and input from other components. • Operates the Medicare Quality Improvement Organization and End Stage Renal Disease Network program, providing policies and procedures, contract design, program coordination, and leadership in selected projects. • Identifies, prioritizes and develops content for clinical and health related aspects of CMS' Consumer Information Strategy; and collaborates with other components to develop comparative provider and plan performance information for consumer choices. • Assists in the preparation of the scientific, clinical and procedural basis for, and recommends to the Administrator decisions regarding, coverage of new and established technologies and services. Maintains liaison with other Departmental components regarding the safety and effectiveness of technologies and services; prepares the scientific and clinical basis for, and recommends approaches to, quality-related medical review activities of contractors and payment policies. • Serves as the focal point for all CMS Field activities relating to CLIA and the survey and certification of health facilities with States and Local governments (including the Territories). • Implements, evaluates and refines standardized provider performance measures used within provider certification programs. Supports States in their use of standardized measures for provider feedback and quality improvement activities. Implements and supports the data collection and analysis systems needed by States to administer the certification program. • Serves as the Consortium focal point for emergency preparedness for the Field. • Provides oversight in the areas of human resource procurement and logistics. • Ensures the effective management of the Agency's information technology and information systems and resources in the Field. • Implements the privacy and confidentiality policies pertaining to the collection, use, and release of individually identifiable data. • Proactively establishes, manages, and fosters partnerships within the Consortium with State and Local governments, providers and provider associations, beneficiaries and their representatives, and the media that are focused on CMS' goals and objectives. • Serves as the primary point of contact to appropriate members of Congress, State Governors, Federal, State, and Local officials and Tribal governments on matters concerning the Medicare and Medicaid programs. • Oversees the coordination and integration of CMS' activities with other Federal, State, Local, and private health care agencies and organizations. • Counsels, advises, and collaborates with top Agency officials on policy matters and major considerations in developing, implementing, and coordinating CMS' programs as they interrelate in addressing national and regional strategies. • Advises OA on special problems as they relate to national initiatives and programs and as they impact major constituents or their key representatives. • Promotes accountability, communication, coordination and facilitation of cooperative corporate decision-making among CMS top senior staff on management, operational and programmatic issues cross-cutting organizational components with diverse functions and activities. Dated: November 23, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. [FR Doc. E7-25305 Filed 12-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. *Name of Committee* : Cellular, Tissue and Gene Therapies Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held by teleconference on February 5, 2008, from 12 noon to approximately 3:15 p.m. Eastern Time. *Location* : National Institutes of Health, Building 29B, Conference Room C, 9000 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location. A speakerphone will be provided at the specified location for public participation in the meeting, on site. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at *http://www.nih.gov/about/visitor/index.htm* . Visitors must show two forms of identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver's license, passport, green card, etc. If you are planning to drive to and park on the NIH campus, you must enter at the South Dr. entrance of the campus which is located on Wisconsin Ave. (the Medical Center Metro entrance), and allow extra time for vehicle inspection. Detailed information about security procedures is located at *http://www.nih.gov/about/visitorsecurity.htm* . Because of the limited available parking, visitors are encouraged to use public transportation. *Contact Person* : Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD, 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512389. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On February 5, 2008, the committee will meet in open session to hear updates of research programs in the Division of Therapeutic Proteins and the Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material will be available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2008 and scroll down to the appropriate advisory committee link. *Procedure* : On February 5, 2008, from 12 noon to approximately 2:30 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 29, 2008. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 21, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested person regarding their request to speak by January 22, 2008. *Closed Committee Deliberations* : On February 5, 2008, from approximately 2:30 p.m. to 3:15p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and issues related to personnel progress and promotion. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 18, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-25124 Filed 12-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0481] Draft Prescription Drug User Fee Act IV Information Technology Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability for public comment of the draft information technology
(IT)plan entitled “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan.” This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications to achieve the objectives defined in the PDUFA Performance Goals. DATES: Submit written or electronic comments on the draft IT plan by February 22, 2008. ADDRESSES: Submit written requests for single copies of the draft plan to the Office of the Chief Information Officer (HFA-080), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft IT plan to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the document. FOR FURTHER INFORMATION CONTACT: Suzanne Mitri, Office of the Chief Information Officer, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-255-6700. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing for public comment the availability of the draft IT plan entitled “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan.” This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications to achieve the objectives defined in section XIV, Information Technology Goals, of the PDUFA Performance Goals ( *http://www.fda.gov/oc/pdufa4/pdufa4goals.html* ). On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007, which includes the reauthorization and expansion of PDUFA. The reauthorization of PDUFA will significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public. The reauthorization also includes Information Technology Goals that are divided into four subsections: Objectives, Communications and Technical Interactions, Standards and IT Plan, and Metrics and Measures. In addition, there are information technology goals associated with the upgrade of the agency's drug safety program in section VIII, Enhancement and Modernization of the FDA Drug Safety System. The objectives of the PDUFA IV IT Goals are to move FDA towards the long-term goal of an automated standards-based information technology environment for the exchange, review, and management of information supporting the process for the review of human drug applications throughout the product life cycle. As part of this process, FDA will develop and periodically update a 5-year IT plan and will solicit and consider comments from the public on the draft IT plan. At the end of the comment period, FDA will review the comments, update the IT plan, and publish the final version no later than May 30, 2008. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: December 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-25310 Filed 12-27-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Clinical Center; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the NIH Advisory Board for Clinical Research. The meeting will be open to the public as indicated below, 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 notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended to discuss personnel matters, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* NIH Advisory Board for Clinical Research *Date:* January 28, 2008. *Open:* 10 a.m. to 1:15 p.m. *Agenda:* To review the 2008 Clinical Center Operating Plan and provide updates on selected organizational initiatives. *Place:* National Institutes of Health, Building 10, 10 Center Drive, CRC Medical Board Room 4-2551, Bethesda, MD 20892. *Closed:* 1:15 p.m. to 2 p.m. *Agenda:* To review and evaluate personnel matters. *Place:* National Institutes of Health, Building 10, 10 Center Drive, CRC Medical Board Room 4-2551, Bethesda, MD 20892. *Contact Person:* Maureen E Gormley, Executive Secretary, Mark O. Hatfield Clinical Research Center, National Institutes of Health, Building 10, Room 6-2551, Bethesda, MD 20892, 301-496-2897. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Dated: December 18, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-6208 Filed 12-27-07; 8:45 am]
Connectionstraces to 10
17 references not yet in our index
  • 45 CFR 46
  • 42 CFR 413.20
  • 42 CFR 413.24
  • Pub. L. 92-463
  • 41 CFR 102
  • Pub. L. 108-173
  • Pub. L. 109-171
  • 44 USC 35
  • Pub. L. 96-354
  • Pub. L. 104-4
  • Pub. L. 105-33
  • Pub. L. 97-248
  • 42 CFR 475.102
  • Pub. L. 106-113
  • 42 CFR 405
  • 42 CFR 422
  • 42 CFR 423
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cites case law
Notices
Request for public comments on the identification of priority data needs for six priority hazardous substances and an ongoing call for voluntary research proposals
U.S.C.§ 9604
U.S.C.§ 217a
U.S.C.§ 1314
Fed. Reg.Notices
Fed. Reg.Proposed Rules
U.S.C.§ 1396r–4
U.S.C.§ 1395w–3b
U.S.C.§ 1320c–2
U.S.C.§ 1395l
Cite45 CFR 46
Cite42 CFR 413.20
Cite42 CFR 413.24
Cites 27 · showing 12Cited by 0 across 0 sources
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