Department of Health and Human Services April 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is confirming the effective date of April 23, 2007, for the direct final rule that appeared in the Federal Register of December 7, 2006 (71 FR 70870). The direct final rule amends the regulation to remove beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide, used in oral pressurized metered- dose inhalers, from the list of essential uses of ozone-depleting substances. None of these products is currently being marketed. This document confirms the effective date of the direct final rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the veterinary prescription use of diclazuril oral pellets in horses for the treatment of equine protozoal myeloencephalitis.

The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Peter Pan Seafoods, Inc., to market test canned Pacific salmon that deviates from the U.S. standard of identity for canned Pacific salmon. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product and assess commercial feasibility.

This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

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

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the following draft document: ``Asbestos and Other Mineral Fibers: A Roadmap for Scientific Research.'' The document can be found at https:// www.cdc.gov/niosh/review/public/099/. Instructions are provided for submitting comments. Public Comment Period: February 28 through May 31, 2007. Public Meeting Date and Time: May 4, 2007, 9 a.m.-4 p.m. Place: Holiday Inn Capitol, 550 C Street SW., Washington, DC 20024. Purpose of Meeting: To discuss and obtain comments on the draft document, ``Asbestos and Other Mineral Fibers: A Roadmap for Scientific Research''. Special emphasis will be placed on discussion of the following: (1) Whether the hazard identification and discussion of health effects for asbestos and mineral fibers are a reasonable reflection of the current understanding of the evidence in the scientific literature, (2) The appropriateness and relevancy of the discussion of the current understanding of the analytical issues and the research needs for analysis of asbestos and mineral fibers, (3) The appropriateness and relevancy of the discussion of the current understanding of the epidemiological issues and the research needs for understanding the health effects of asbestos and mineral fibers, (4) The appropriateness and relevancy of the discussion of the current understanding of the toxicological issues and the research needs for understanding the health effects of asbestos and mineral fibers, and (5) The appropriateness and relevancy of the discussion of the path forward and whether the ultimate vision is a reasonable outcome for the proposed research strategy for asbestos and mineral fibers. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Persons wanting to attend and provide oral comments at the meeting are requested to notify Diane Miller no later than May 1, 2007 to reserve time for their comments. Those interested in attending without providing oral comments at the meeting also are requested to notify Ms. Miller by May 1, 2007 to reserve a seat. Ms. Miller can be reached by telephone at 513/533-8450 or by e-mail at niocindocket@cdc.gov. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come basis. Unreserved walk-in attendees will be accommodated on the day of the meeting if space is available. Persons wanting to provide oral comments will be permitted up to 15 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8450. All material submitted to the Agency should reference docket number NIOSH-099 and must be submitted by May 31, 2007 (public review closing date) to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-099. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, relevant to the characterization of exposures and possible health risks of occupational exposure to asbestos and other mineral fibers. Examples of requested information include, but are not limited to, the following: (1) Identification of industries, occupations, and processes where exposure to mineral fibers may occur, including exposure to fiber-like cleavage fragments and thoracic-sized fibers (as defined in the draft NIOSH document). (2) Current and historical mineral fibers exposure measurement data, including exposure to fiber-like cleavage fragments and thoracic- sized fibers at various types of industries and jobs. (3) Case reports or other health information demonstrating health effects in workers exposed to mineral fibers, including exposure to fiber-like cleavage fragments and thoracic-sized fibers. (4) Reports of experimental in vivo, in vitro, and inhalation studies with rodents that provide evidence of biopersistence and/or of a dose-relationship between the particle dimension (e.g., fiber) of the mineral and its biological activity. (5) Information on sampling and analytical methods that could be used to improve the identification and differentiation of ``fibers'' of different dimensions and composition. (6) Information on technologies that could be used to separate thoracic-sized fibers, including fiber-like cleavage fragments, into discrete size dimensions in quantities sufficient for conducting chronic rodent inhalation studies. NIOSH will use this information to assess the scientific basis for the draft document and the need to revise research recommendations. Contact Person for Technical Information: Paul Middendorf, telephone (513) 533-8606, M/S C-9, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Contact Person for Submitting Comments/Meeting Attendance: Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C-34, Cincinnati, Ohio 45226, telephone (513) 533-8450. All material submitted to the Agency should reference Docket Number NIOSH-099. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting and request for information: NIOSH Availability of Opportunity to Provide Input regarding the National Occupational Research Agenda (NORA) for the Mining Sector. Status: Meeting is open to the public, limited only by the space available. Participation is encouraged through the Web for those who cannot attend in person. Background: A large part of our lives is shaped by the work we do. NORA is a framework to guide occupational safety and health research for the nation. It is an ongoing endeavor to focus research to reduce work-related injury and illness. As the program entered its second decade, it was structured according to eight industry sector groups in order to encourage widespread adoption of effective practices developed through research. Each sector will have a NORA Sector Council consisting of NIOSH and stakeholder representatives. The initial task of the NORA Mining Council will be to draft a strategic plan for the nation addressing high priority needs in the sector. Following revisions based on public comment, the ongoing task of the Council will then be to encourage implementation of the plan by research and industry organizations in order to reduce occupational illnesses, injuries and fatalities in the sector. Given that NORA represents a broad-based partnership involving government, business, the worker community, academia, and others, public input is essential for planning future directions for the initiative. Some of the considerations for the Mining Sector are that NIOSH as the federal organization charged with conducting occupational safety and health research has established strategic goals in mining research. They are available for viewing: https://www.cdc.gov/niosh/ programs/mining/goals.html. Since development of these goals, the NIOSH research program has been enhanced according to the requirements of the MINER Act of 2006: https://www.cdc.gov/niosh/mining/mineract/ mineract.htm. Unlike other sectors, NIOSH can request advice from an Advisory Committee for mining: Mine Safety and Health Research Advisory Committee (MSHRAC). Besides these ongoing NIOSH activities, NORA provides the opportunity for NIOSH to work with partners and for partners to work with each other to effectively conduct additional research in mining safety and health and to move those research results into more effective workplace practice. The first meeting of the NORA Mining Sector Council will be held May 3, 2007, 1:30 p.m.-5 p.m. From 2:30 p.m.-4 p.m., the meeting will be structured to hear stakeholder comments on important occupational safety and health issues in the industry, especially those not adequately covered by NIOSH or other ongoing research; organizations that should participate in the research or in NORA activities; individuals who are willing to participate in NORA Mining Sector Council activities; and efficient ways to accomplish the NORA activities in light of ongoing organizational activities in the sector. Participants wishing to provide comments may do so via E-mail or may request an opportunity to make a five minute presentation. All participants are requested to register for the free meeting by sending an E-mail to MWerner@cdc.gov with their name, affiliation, whether they wish to attend in person or through the Web, whether they are requesting time to speak briefly, and, if so, the general topic(s) on which they wish to speak. Participants wishing to speak are encouraged to register early. The public meetings are open to everyone, including all workers, professional societies, organized labor, employers, researchers, health professionals, government officials and elected officials. Broad participation is desired. Summary: The NORA Mining Sector Council will accept public comments on the range of occupational safety and health issues that should be considered and the individuals and organizations who should be involved for the purpose of enhancing the effectiveness of the Council. Types of occupational safety and health issues might include diseases, injuries, exposures, populations at risk, and needs of occupational safety and health systems. For example, occupational musculoskeletal disorders in workers at small operations might be seen as important for a segment of the mining sector. If possible, please include as much information as necessary for understanding the safety or health research priority you identify. Such information could include characterization of the frequency and severity with which the injury, illness, or hazardous exposure is occurring and of the factors you believe might be causing the health or safety issue. Input is also requested on the types of research that you believe might make a difference and the partners (e.g., specific industry associations, labor organizations, research organizations, governmental agencies) who should be involved in forming research efforts and in solving the problem. All presentation text and other comments provided by e-mail will be entered into the searchable database of NORA comments, which will be publicly available and will be consulted by the NORA Mining Sector Council when drafting the strategic plan for the nation. The current version of the searchable database of NORA comments is available at: https://www2a.cdc.gov/niosh-comments/nora-comments/commentsrch .asp. For Technical Information Contact: Dr. Michael A. Werner, Senior ScientistMining, NIOSH, telephone 509-354-8014, Co-Chair, NORA Mining Sector Council.

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

The Health Resources and Services Administration (HRSA) is requesting nominations to fill 11 vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).

In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems,'' which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

The Indian Health Service published a document in the Federal Register on March 28, 2007. The document contained three errors. For further information Contact: Martha Redhouse, Grants Management Branch, Indian Health Service, Reyes Building, 801 Thompson Avenue, Rockville, MD 20852, Telephone (301) 443-5204. (This is not a toll-free number). Correction

This notice announces the 8th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 16th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 15th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nevada Test Site, Mercury, Nevada, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Nevada Test Site. Location: Mercury, Nevada. Job Titles and/or Job Duties: All employees of the Department of Energy (DOE), DOE contractors, and subcontractors in all areas. Period of Employment: September 1, 1963 through September 30, 1992.

The Substance Abuse and Mental Health Services Administration has revoked the certification to provide opioid assisted treatment for the three opioid treatment programs listed below.

The United States faces serious public health threats from the deliberate use of weapons of mass destruction (WMD)chemical, biological, radiological, or nuclear (CBRN)by hostile States or terrorists, and from naturally emerging infectious diseases that have a potential to cause illness on a scale that could adversely impact national security. Effective strategies to prevent, mitigate, and treat the consequences of CBRN threats is an integral component of our national security strategy. To that end, the United States must be able to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the American people. The HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has taken a holistic, end-to-end approach that considers multiple aspects of the medical countermeasures mission including research, development, acquisition, storage, maintenance, deployment, and guidance for utilization. Phase one of this approach established the HHS PHEMCE Strategy for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Strategy). The HHS PHEMCE Strategy, published in the Federal Register on March 20, 2007, described a framework of strategic policy goals and objectives for identifying medical countermeasure requirements and establishing priorities for medical countermeasure evaluation, development and acquisition. These strategic policy goals and objectives were used to establish the Four Pillars upon which this HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan (HHS PHEMCE Implementation Plan) is based. The HHS PHEMCE Implementation Plan considers the full spectrum of medical countermeasures-related activities, including research, development, acquisition, storage/maintenance, deployment, and utilization. The HHS PHEMCE Implementation Plan is consistent with the President's Biodefense for the 21st Century and is aligned with the National Strategy for Medical Countermeasures against Weapons of Mass Destruction.

Through this notice, the Secretary announces that meningococcal (conjugate and polysaccharide) and human papillomavirus (HPV) vaccines are covered vaccines under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This notice serves to include meningococcal and HPV vaccines as covered vaccines under Category XIV (new vaccines) of the Vaccine Injury Table (Table), which lists the vaccines covered under the VICP. This notice ensures that petitioners may file petitions relating to meningococcal and HPV vaccines with the VICP even before such vaccines are added as separate and distinct categories to the Table through rulemaking.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the use of florfenicol by veterinary feed directive (VFD) for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.

The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for intermediate premixes used to manufacture Type C medicated feeds. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs.

The Food and Drug Administration (FDA) is amending the animal drug regulations that reflect approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, and in suckling beef calves for increased rate of weight gain. In a notice published elsewhere in this issue of the Federal Register, FDA has withdrawn approval of the NADAs.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI),'' System No. 09-70- 0591. This notice serves as the Master system for all demonstrations, evaluation, and research studies administered by ORDI. Fifteen existing ORDI demonstration, evaluation, and research studies will be included under this notice and the separate, existing systems of records notices for those studies will be deleted upon the effective date of this notice. DERS will become effective 30 days from the publication of the notice in the Federal Register, or 40 days from the date submitted to OMB and the Congress, whichever is later. With the publication of this master system, ORDI will only be deleting the systems of records listed below as separate stand alone notices to the public. Retention and destruction of the data contained in these systems will follow the schedules listed in this DERS system notice. The existing ORDI systems of records to be included under DERS and which will be deleted by this notice are as follows: ``Municipal Health Services Program System No. 09-70- 0022,'' 65 Federal Register (FR) 37792 (June 16, 2000); ``Monitoring of the Home Health Agency Prospective Payment Demonstration,'' System No. 09-70-0048, 65 FR 37792 (June 16, 2000); ``Person-Level Medicaid Data System, System No. 09-70- 0507'' last published at 71 FR 60726 (October 16, 2006); ``Medicare Cancer Registry Record System,'' System No. 09- 70-0509, last published at 71 FR 67133 (November 20, 2006); ``Evaluations of the Medicaid Reform Demonstrations,'' System No. 09-70-0523, last published at 71 FR 60540 (October 13, 2006); ``MMA Section 641 Prescription Drug Benefit Demonstration,'' System No. 09-70-0545, last published at 69 FR 32587 (June 10, 2004); ``Medicare Physician Group Practice Demonstration,'' System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005); ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities,'' System No. 09-70-0560, last published at 70 FR 57602 (October 3, 2005); ``Medicare Care Management Performance Demonstration,'' System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005); ``Rural Hospice Demonstration,'' System No. 09-70-0563, last published at 71 FR 57968 (October 2, 2006); ``Medicare Chiropractic Coverage Demonstration and Evaluation,'' System No. 09-70-0577, last published at 71 FR 41450 (July 21, 2006); ``Low Vision Rehabilitation Demonstration,'' System No. 09-70-0582, last published at 71 FR 58621 (October 4, 2006); ``Medicare Lifestyle Modification Program Demonstration,'' System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006); ``Competitive Bidding for Clinical Laboratory Services,'' System No. 09-70-0589, last published at 71 FR 60713 (October 16, 2006); and ``Senior Risk Reduction Demonstration and Evaluation,'' System No. 09-70-0592, last published at 71 FR 60718 (October 16, 2006). The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or CMS grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Date'' section for comment period.

The Food and Drug Administration (FDA) has withdrawn approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, and in suckling beef calves for increased rate of weight gain. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public on both Thursday, May 10 and Friday, May 11, 2007.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss our proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I) for fiscal years (FY) 2008 through 2012, as well as other proposals to improve the review of medical devices and the third party inspection program. These proposed recommendations were developed after discussions with the regulated industry. Section 105 of MDUFMA I directs FDA to publish these proposed recommendations in the Federal Register, hold a meeting at which the public may present its views on the recommendations, and provide for a period of 30 days for the public to provide written comments on the recommendations. The public meeting and comment period will provide an opportunity for public input on the proposed recommendations from all interested parties, including the regulated industry, scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups.

AHRQ invites nominations of topics for evidence reports, technology assessments, and comparative and effectiveness reviews conducted by its Evidence-based Practice Centers (EPC) Program relating to the prevention, diagnosis, treatment and management of common diseases and clinical conditions, as well as topics relating to the organization and financing of health care. Previous evidence reports and comparative effectiveness reviews can be found at https:// www.ahrq.gov/clinic/epcix.htm and https://effectivehealthcare.ahrq.gov/ products/progress.cfm, respectively.

The NTP announces its scientific review process to review nominations for the 12th RoC. The process is available on the NTP Web site https://ntp.niehs.nih.gov (select ``Report on Carcinogens'') or by contacting Dr. C.W. Jameson at the address provided below.

As part of an effort to evaluate the NIEHS research portfolio of investigator-initiated research on children's environmental health, the NIEHS convened an independent panel to review the Centers for Children's Environmental Health and Disease Prevention Program (``Children's Centers'') in cooperation with the U.S. Environmental Protection Agency (EPA). The panel was convened as a working group to the NIEHS National Advisory Environmental Health Sciences Council (NAEHS). At this time, the NIEHS seeks public comment on the working group report for consideration by the NAEHS Council, the NIEHS, and EPA's Office of Research and Development (ORD) in evaluating the best approaches for future funding of children's environmental health research. The report is available at https://www.niehs.nih.gov/ conferences/od/cehr/report.htm.

This correcting amendment corrects several technical and typographical errors in the final rule with comment period that appeared in the December 1, 2006 Federal Register (71 FR 69624). The final rule with comment period addressed Medicare Part B payment policy, including the physician fee schedule (PFS) that is applicable for calendar year (CY) 2007; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; and policies related to independent diagnostic testing facilities (IDTFs). The final rule with comment period also updated the list of certain services subject to the physician self-referral prohibitions.

The Food and Drug Administration (FDA) is reopening until May 18, 2007, the comment period for a notice of public meeting that published in the Federal Register of January 5, 2007 (72 FR 574). In the notice, FDA announced a February 7, 2007, meeting to solicit input on issues that the agency should consider if it decides to propose revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements and other changes to approved marketing applications for human drugs. FDA is reopening the comment period in light of continued public interest in this topic.

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

This program is authorized by 42 U.S.C. 300u-2(a). The mission of the Office on Women's Health (OWH) is to promote the health of women and girls through gender-specific approaches. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide. These include supporting collaborative efforts to provide accurate prevention education to rural women living in the rural\1\ south\2\ rural South. The emphasis of these efforts is on educational and prevention counseling covering the full spectrum of primary and secondary prevention adapted to a female centered perspective. This initiative is intended to demonstrate a collaborative partnership approach between the grantee and local health or social service providers, e.g., community health centers, rural health centers, family planning clinics, the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), community based organizations, faith based organizations, public assistance programs and local health departments.

The Food and Drug Administration (FDA) is announcing that Durand-Wayland, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of a carbon dioxide laser for etching information on food, excluding meat and poultry.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI),'' System No. 09-70- 0591. This notice serves as the Master system for all demonstration, evaluation, and research studies administered by ORDI. Sixteen existing ORDI demonstration, evaluation, and research studies will be included under this notice and the separate, existing systems of records notices for those studies will be deleted upon the effective date of this notice. DERS will become effective 30 days from the publication of the notice in the Federal Register, or 40 days from the date submitted to OMB and the Congress, whichever is later. With the publication of this master system, ORDI will only be deleting the systems of records listed below as separate stand alone notices to the public. Retention and destruction of the data contained in these systems will follow the schedules listed in this DERS system notice. The existing ORDI systems of records to be included under DERS and which will be deleted by this notice are as follows: ``Municipal Health Services Program System No. 09-70- 0022,'' 65 Federal Register (FR) 37792 (June 16, 2000); ``Monitoring of the Home Health Agency Prospective Payment Demonstration,'' System No. 09-70-0048, 65 FR 37792 (June 16, 2000); ``Person-Level Medicaid Data System, System No. 09-70- 0507'' last published at 71 FR 60726 (October 16, 2006); ``Medicare Cancer Registry Record System,'' System No. 09- 70-0509, last published at 71 FR 67133 (November 20, 2006); ``End Stage Renal Disease Program Management and Medical Information System,'' System No. 09-70-0520, last published at 67 FR 41244 (June 17, 2002); ``Evaluations of the Medicaid Reform Demonstrations,'' System No. 09-70-0523, last published at 71 FR 60540 (October 13, 2006); ``MMA Section 641 Prescription Drug Benefit Demonstration,'' System No. 09-70-0545, last published at 69 FR 32587 (June 10, 2004); ``Medicare Physician Group Practice Demonstration,'' System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005); ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities,'' System No. 09-70-0560, last published at 70 FR 57602 (October 3, 2005); ``Medicare Care Management Performance Demonstration,'' System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005); ``Rural Hospice Demonstration,'' System No. 09-70-0563, last published at 71 FR 57968 (October 2, 2006); ``Medicare Chiropractic Coverage Demonstration and Evaluation,'' System No. 09-70-0577, last published at 71 FR 41450 (July 21, 2006); ``Low Vision Rehabilitation Demonstration,'' System No. 09-70-0582, last published at 71 FR 58621 (October 4, 2006); ``Medicare Lifestyle Modification Program Demonstration,'' System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006); ``Competitive Bidding for Clinical Laboratory Services,'' System No. 09-70-0589, last published at 71 FR 60713 (October 16, 2006); and ``Senior Risk Reduction Demonstration and Evaluation,'' System No. 09-70-0592, last published at 71 FR 60718 (October 16, 2006). The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or CMS grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

This notice announces the 13th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.). The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

This final rule establishes competitive bidding programs for certain Medicare Part B covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act. These competitive bidding programs, which will be phased in over several years, utilize bids submitted by DMEPOS suppliers to establish applicable payment amounts under Medicare Part B.