Notices. Notice of hearing

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BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-07-07AS] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Joan Karr, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . *Comments are invited on:*

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Focus Group Testing and Survey on Radiological Event Messages for Public Health Workers—New—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). Background and Brief Description In January 2003, CDC held a roundtable to specifically address communications needs likely to arise in the aftermath of a terrorist event involving mass casualties. Hospital administrators and clinicians, public health practitioners, and emergency planners emphasized the gaps in their training and in their knowledge of how to respond to nuclear or radiological events. Concurrent with this, CDC began working with the Association of Schools of Public Health

(ASPH)to assess knowledge, attitudes, and behaviors related to preparedness for a radiological or nuclear terrorist event in the United States. The strong and clear message delivered to the CDC was that both the professional (e.g., clinicians and public health workers) and the lay American public were unprepared to respond to such an event (Becker 2004). Specifically, clinicians who participated in the research acknowledged a lack of training and preparedness, a potential unwillingness to treat patients if they are perceived as radiologically contaminated, and concerns about public panic and consequent overwhelming of hospitals and other clinical systems. More importantly, findings from the meeting revealed a critical need to assess communication preparedness among public health workers in relation to radiological emergencies. This proposal addresses the need for the development of clear communication messages in the event of a radiological incident. As part of a cooperative agreement, CDC has contracted with the National Public Health Information Coalition (NPHIC) to collect data from public health workers in 6 states—California, Iowa, Kansas, Michigan, North Carolina and South Carolina—to evaluate a set of messages that have been developed by CDC for public health workers to use before, during and after a radiological event. The 5 communication messages focus on the main concerns expressed by representatives from these 6 states and other participants in audience research. The participating states volunteered for this project. Public health workers referenced in this proposal are nurses, physicians, clinical technicians, administrative, management and support staff and epidemiologists. CDC's primary goal is to protect the health and safety of the public. Since public health workers are usually first responders in various capacities in the event of a radiological emergency, the need to develop time-sensitive and consistent communication messages is vital. Developing clear messages that can be used by public health workers as an integral part of their radiological emergency plan is consistent with this goal. These message concepts, which range from how to protect the worker and family to the role of the public health worker during a radiological emergency will serve as a reference tool and guidance for state health departments in the event of such situations. This proposal seeks approval to obtain data using two methods—focus group testing and electronic surveys—to achieve greater results. Focus group testing will be conducted to obtain qualitative data that will be gathered through a series of six focus groups of public health workers, one in each participating state. Each focus group will consist of 12 participants to equal 72 respondents, and will be about 1 1/2 hour in length. The focus group testing will assess attitudes, knowledge and emotional response. Of particular interest will be how the participants might react to radiological concepts pertaining to their roles as public health workers and scenarios that will be included in the messages. Quantitative data will be obtained through a one-time electronic survey to randomly selected public health workers in the six states to equal 2,022 respondents. The participants who will be participating in the electronic survey will not be included in the focus group testing. CDC proposes to use this information to develop a final set of communication messages. The intent is for the messages to be disseminated using various methods and to provide a more consistent platform for states to respond to radiological emergencies. This research will help refine messages that have the ability to increase the percentage of workers who present to deliver services in a radiological emergency. Also, as a result of the study, CDC will have a set of tested public health messages that can allow public health workers to speak with one voice to the general public in a radiological emergency. In addition, the development of these messages will foster collaboration among the states and CDC. Therefore CDC requests approval to test one set of five messages among public health workers using focus group testing and electronic surveys. There are no costs to respondents except their time to participate in the survey. Estimated Annualized Burden Hours Respondents No. of Respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Focus Groups 72 1 1.5 108 Electronic Surveys 2,022 1 20/60 674 Total 782 Dated: March 29, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-6337 Filed 4-4-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-07-06BG] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Longitudinal follow-up of Youth with Attention-Deficit/Hyperactivity Disorder identified in Community Settings: Examining Health Status, Correlates, and Effects associated with treatment for Attention-Deficit/Hyperactivity Disorder—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description This project will collect data from proxy respondents and youths with and without ADHD. This program addresses the Healthy People 2010 focus area of Mental Health and Mental Disorders, and describes the prevalence, incidence, long-term outcomes, treatment(s), select co-morbid conditions, secondary conditions, and health risk behavior of youth with ADHD relative to youth without ADHD. In FY 2002-FY 2005 two cooperative agreements (transitioned to extramural research) were awarded to conduct community-based epidemiological research on ADHD among elementary-aged youth, known as the Project to Learn about ADHD in Youth (PLAY Study Collaborative). These studies informed community-based prevalence, rates of comorbidity, and rates of health risk behaviors among elementary-age youth with and without ADHD as determined by a rigorous case definition developed by the principal investigators and in collaboration with CDC scientists. The purpose of this program is to study the long-term outcomes and health status for children with Attention-Deficit/Hyperactivity Disorder

(ADHD)identified and treated in community settings through a systematic follow-up of the subjects who participated in the PLAY Study Collaborative. There is a considerable interest in the long-term outcomes of youth with ADHD as well as the effects of treatment, lack of treatment, and quality of care in average U.S. communities, emphasizing the public health importance of longitudinal research in this area. There is no cost to respondents other than their time. The total annual burden hours are 3994. Estimated Annualized Burden Hours Type of respondent Survey instruments No. of respondents No. of responses/ respondent Avg. burden/ response in hours Parent ADHD Communication and Knowledge (Attachment B3) 961 1 10/60 Parent ADHD Treatment, Cost, and Client Satisfaction Questionnaire (Attachment B4a) 961 1 10/60 Parent ADHD Treatment Quarterly Update (Attachment B4b) 961 3 3/60 Parent Brief Impairment Scale (Attachment B5) 961 1 4/60 Parent Critical School Events (elementary, middle) (Attachment B6) 823 2 6/60 Parent Critical School Events (high school) (Attachment B7) 138 2 6/60 Parent Demographic Survey (Attachment B8) 961 1 5/60 Parent Health Risk Behavior Survey (Elementary) 7-10 years (Attachment B9) 163 1 18/60 Parent Health Risk Behavior Survey (Middle School) 11-13 years (Attachment B10) 412 1 22/60 Parent Health Risk Behavior Survey (High School) 14+ years (Attachment B11) 386 1 28/60 Parent Parent-Child Relationship Inventory (Attachment B12) 961 1 15/60 Parent Parents' Questionnaire (Mental Health) (Attachment B13) 892 1 5/60 Parent Pediatric Quality of Life Young Child (Attachment B14) 5 2 4/60 Parent Pediatric Quality of Life Child (Attachment B15) 421 2 4/60 Parent Pediatric Quality of Life Teen (Attachment B16) 536 2 4/60 Parent Quarterly Update Events and Demographics (Attachment B17) 961 3 1/60 Parent Social Isolation/Support (Attachment B18) 892 1 2/60 Parent Strengths and Difficulties Questionnaire 4-10 (Attachment B19) 163 2 3/60 Parent Strengths and Difficulties Questionnaire 11-17 (Attachment B20) 798 2 3/60 Parent Vanderbilt Parent Rating Scale (Attachment B21) 961 2 10/60 Child Brief Sensation Seeking Scale (11+ years only) (Attachment B22) 798 1 1/60 Child Health Risk Behavior Survey (Elementary) 7-10 years (Attachment B23) 163 1 25/60 Child Health Risk Behavior Survey (Middle School) 11-13 years (Attachment B24) 412 1 30/60 Child Health Risk Behavior Survey (High School) 14+ years (Attachment B25) 386 1 35/60 Child MARSH—Self Description Questionnaire v I, 7-12 years (Attachment B26) 426 1 15/60 Child MARSH—Self Description Questionnaire v II, 13-15 years (Attachment B27) 398 1 20/60 Child MARSH—Self Description Questionnaire v III 16+ years (Attachment B28) 138 1 20/60 Child Pediatric Quality of Life Young Child (Attachment B29) 5 1 5/60 Child Pediatric Quality of Life Child (Attachment B30) 421 1 5/60 Child Pediatric Quality of Life Teen (Attachment B31) 536 1 5/60 Child People In My Life (Attachment B32) 426 1 15/60 Child People In My Life/Inventory of Parent and Peer Attachment (Attachment B33) 536 1 22/60 Child Youth Demographic Survey,16+ years only (Attachment B34) 138 1 1/60 Teacher Teacher Survey (Attachment B35) 4154 1 10/60 Total 961 children 892 parents 4154 teachers Dated: March 30, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-6339 Filed 4-4-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-07-07AU] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(MRSA)Prevention Programs among Hospitals Participating in CDC MRSA Surveillance Programs—New—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID) (proposed), Centers for Disease Control and Prevention. Background and Brief Description In October, 2006, CDC recommended specific strategies to reduce transmission of multi-drug resistant organisms, including MRSA, in U.S. hospitals. Currently detailed data on ongoing MRSA prevention efforts at hospitals reporting to CDC surveillance systems is unknown. CDC has developed a survey to assess MRSA prevention programs in place at health care facilities reporting MRSA infection data to CDC through established surveillance systems. In this project, infection control practitioners in all 220 hospitals that participate in the MRSA portion of the Active Bacterial Core Surveillance System will surveyed electronically three times. There will be an initial baseline survey and then two follow-up surveys, each a year apart. The surveys will determine if changes in infection control practice correlate with changes in rates of MRSA infections. The proposed survey will provide data that can be used to assess progress toward achieving CDC's Health Protection Goals. The survey will also provide data on facility-based MRSA prevention policies and procedures that may affect MRSA infection rates. These results will inform CDC in the prevention and control of MRSA. This proposed project supports CDC's Goal of “Healthy People in Healthy Places” and its Strategic Goal to “Increase the number of health care institutions that comply with evidence based guidelines for infection control.” There is no cost to respondents other than their time to complete the survey. Estimate of Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Hospital Infection Control Professionals 220 1 15/60 55 Total 55 Dated: March 30, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-6340 Filed 4-4-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-07-06AP] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-4766 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . *Comments are invited on:*

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Aerosol Generation by Cough—NEW—The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Federal Occupational Safety and Health Act of 1970, section 501, enables NIOSH to carry out research relevant to the health and safety of workers. NIOSH is conducting a two-year study of airborne clouds of particles or droplets called “aerosols”. Some diseases like influenza and Severe Acute Respiratory Syndrome

(SARS)can be spread when people produce infectious aerosols by coughing or sneezing. Aerosol transmission of infectious diseases is especially important to health-care workers and emergency responders, who face a much greater risk of exposure to these hazards than does the general public. Cough-generated aerosols are of particular concern because coughing is one of the most common symptoms of respiratory infections. However, substantial gaps exist in our understanding about the generation of aerosols during coughing. This lack of information hampers the ability of health scientists to model and predict the generation of infectious aerosols by coughing and to understand whether or not cough-generated aerosols are likely to be an important means of transmission of particular diseases. The purpose of this study is to gain a better understanding of the production of aerosols by coughing. The results of this research will give scientists and health professionals greater insight into the airborne transmission of disease and allow them to better assess the potential effectiveness of preventive measures. The first part of this study will measure the quantity and size distribution of aerosol produced during human coughs. To accomplish this, volunteers will cough into a spirometer, which is a commonly used piston-like medical device that measures the volume of air exhaled by a patient. After the volunteer coughs into the spirometer, the air in the spirometer will be drawn into a commercial aerosol measurement device. These experiments will also provide information on how much cough aerosols vary over time for individuals and how much aerosol generation varies between individuals. The second part of this study will determine how effectively surgical masks and N95 respirators block cough-generated aerosols. N95 respirators are dust masks that are certified to filter out at least 95% of airborne material during normal breathing. N95 respirators are known to be more effective than surgical masks at filtering out airborne particles during inhalation, but it is not known whether masks or respirators are more effective at blocking cough-generated aerosols. For this work, masks and respirators will be placed in a special holder with a disposable mouthpiece, and human subjects will cough into the mouthpiece and through the mask. The aerosol produced by each subject will be analyzed before and after flowing through the mask. These experiments will determine how effective each mask or respirator is at preventing the release of cough-generated aerosols. Volunteers from part 1 may also participate in part 2 if they wish. There will be no costs to study participants other than their time. Estimate of Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Part 1 participants 20 5 1.5 150 Part 2 participants 120 1 1.5 180 Total 330 Dated: March 29, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-6344 Filed 4-4-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Notice of Hearing: Reconsideration of Disapproval of Minnesota State Plan Amendment 05-10 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of hearing. SUMMARY: This notice announces an administrative hearing to be held on May 30, 2007, at 233 N. Michigan Avenue, Suite 600, the Indiana Room, Chicago, IL 60601, to reconsider CMS' decision to disapprove Minnesota State plan amendment 05-10. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by (15 days after publication). FOR FURTHER INFORMATION CONTACT: Kathleen Scully-Hayes, Presiding Officer, CMS, Lord Baltimore Drive, Mail Stop LB-23-20, Baltimore, Maryland 21244. Telephone:

(410)786-2055. SUPPLEMENTARY INFORMATION: This notice announces an administrative hearing to reconsider CMS' decision to disapprove Minnesota State plan amendment

(SPA)05-10 which was submitted on September 21, 2005. This SPA was disapproved on December 29, 2006. Under this SPA, the State proposed to revise coverage and reimbursement methodology for Early and Periodic Screening, Diagnosis, and Treatment services related to children's mental health rehabilitative services and rehabilitative services pursuant to an Individualized Education Plan or Individual Family Service Plan. The amendment was disapproved because CMS found that the amendment violated the statute for reasons set forth in the disapproval letter. *The issues to be decided at the hearing are:* • Whether the per diem (bundled) payment methodologies for mental health rehabilitative services described in Minnesota's SPA 05-10 accurately reflect true costs or reasonable fees for the services included in the bundles; • Whether the amount or scope of services reimbursed through the bundled rate is sufficiently constant so that the proposed methodologies would be an economic and efficient method of payment; • Whether all of the component parts of the service are delivered as recommended within the scope of practice of the physician or licensed practitioner of the healing arts; • Whether the actual practitioners who will be furnishing services can be readily identified; and • Whether the bundled rates provide for direct payment to the actual practitioners who provide the service. Section 1116 of the Social Security Act and Federal regulations at 42 CFR part 430, establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a State plan or plan amendment. CMS is required to publish a copy of the notice to a State Medicaid agency that informs the agency of the time and place of the hearing, and the issues to be considered. If we subsequently notify the agency of additional issues that will be considered at the hearing, we will also publish that notice. Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as *amicus curiae* must petition the presiding officer before the hearing begins in accordance with the requirements contained at 42 CFR 430.76(c). If the hearing is later rescheduled, the presiding officer will notify all participants. The Notice to Minnesota Announcing an Administrative Hearing To Reconsider the Disapproval of Its SPA Reads as Follows Ms. Christine Bronson, Medicaid Director, Minnesota Department of Human Services, P.O. Box 64998, St. Paul, MN 55164-0998 Dear Ms. Bronson: I am responding to your request for reconsideration of the decision to disapprove the Minnesota State plan amendment

(SPA)05-10, which was submitted on September 21, 2005, and disapproved on December 29, 2006. Under this SPA, the State proposed to revise coverage and reimbursement methodology for Early and Periodic Screening, Diagnosis, and Treatment services related to children's mental health rehabilitative services and rehabilitative services pursuant to an Individualized Education Plan or Individual Family Service Plan. The Centers for Medicare & Medicaid Services

(CMS)disapproved the SPA because the State did not document that its proposed reimbursement methodology meets the conditions specified in sections 1902(a)(10), 1902(a)(30), and 1902(a)(32) of the Social Security Act (the Act). At issue in this reconsideration is whether Minnesota has demonstrated that the bundled rate methodology proposed in SPA 05-10 is consistent with the requirements of section 1902(a)(30)(A) of the Act, which requires that States have methods and procedures to assure that payments to providers are consistent with efficiency, economy, and quality of care. A second issue is whether the State has shown that the payment methodology is for care and services that are within the scope, and meet the requirements, of section 1902(a)(10)(A) to make available “medical assistance,” which is defined at section 1905(a) and implementing requirements. Also at issue is whether the proposed payment methodology complies with the direct payment requirements of section 1902(a)(32) of the Act, which precludes payment to anyone other than the individual, person, or institution providing the care and service (with specified exceptions). We discuss each of these issues in more detail below in relation to SPA 05-10. Section 1902(a)(30)(A) of the Act requires that States have methods and procedures to assure that payments to providers are consistent with efficiency, economy, and quality of care. The per diem payment methodologies for mental health rehabilitative services described in SPA 05-10 represent bundled payment methodologies under which the State pays a single rate for one or more of a group of different services furnished to an eligible individual during a fixed period of time. The State has failed to demonstrate that its methodologies are in compliance with section 1902(a)(30)(A), in that it has not shown: that these methodologies accurately reflect true costs or reasonable fees for the services included in the bundles; and that the amount or scope of services reimbursed through the bundled rate is sufficiently constant so that the proposed methodologies would be an economic and efficient method of payment. Section 1902(a)(10)(A) requires that State plans make available medical assistance, which is defined at section 1905(a) and in implementing regulations. For a number of categories of medical assistance, there are provider standards applicable to different types of care and services, and for rehabilitative services there is a requirement that rehabilitative services must be recommended by a physician or other licensed practitioner of the healing arts. Minnesota did not provide evidence of a method to identify that providers of the component parts of the care and services would meet all applicable provider requirements. Nor did Minnesota demonstrate a method to ensure that all of the component parts of the care and services furnished under the bundled payment methodology proposed in SPA 05-10, would be delivered as recommended within the scope of practice of the physician or licensed practitioner of the healing arts. Furthermore, the information provided by the State did not demonstrate compliance with section 1902(a)(32) of the Act, requiring direct payment to the provider of care or services. Under the State's bundled payment methodology, the entities which would receive the proposed bundled rates for mental health rehabilitation services are not themselves providers of the service; they are not billing agents for such providers; nor are they recognized types of health care providers under Federal law. The underlying services represent different types of individual services that are furnished by individual practitioners. The State has failed to show that the proposed payment methodology is within one of the statutory exceptions as implemented by Federal regulations at 42 CFR 447.10. Indeed, the State has not shown that, under its proposed payment methodology, the actual practitioners furnishing services can even be readily identified. Thus, the State has not demonstrated that the use of bundled rates will comply with the requirement for direct payment to the actual practitioners who provide care or service. I am scheduling a hearing on your request for reconsideration to be held on May 30, 2007, at 233 N. Michigan Avenue, Suite 600, the Indiana Room, 5th Floor, Chicago, IL, 60601, to reconsider the decision to disapprove SPA 05-10. If this date is not acceptable, we would be glad to set another date that is mutually agreeable to the parties. The hearing will be governed by the procedures prescribed by Federal regulations at 42 CFR Part 430. I am designating Ms. Kathleen Scully-Hayes as the presiding officer. If these arrangements present any problems, please contact the presiding officer at

(410)786-2055. In order to facilitate any communication which may be necessary between the parties to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. Sincerely, Leslie V. Norwalk, Esq., *Acting Administrator.* Section 1116 of the Social Security Act (42 U.S.C. section 1316); (42 CFR section 430.18). (Catalog of Federal Domestic Assistance program No. 13.714, Medicaid Assistance Program) Dated: March 30, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-6312 Filed 4-4-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1270-RCN] RIN 0938-AN14 Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies; Extension of Timeline for Publication of Final Rule AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Extension of timeline for publication of final rule. SUMMARY: This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with section 1871(a)(3)(B) of the Social Security Act, which allows us to extend the timeline for publication of the final rule. EFFECTIVE DATE: This notice is effective on March 30, 2007. FURTHER INFORMATION CONTACT: Ralph Goldberg,

(410)786-4870. SUPPLEMENTARY INFORMATION: In the May 1, 2006 **Federal Register** (71 FR 25654), we published a proposed rule that would have implemented competitive bidding programs for certain 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 (the Act). These programs would change the way that Medicare pays for these items under Part B of the Medicare program by utilizing bids submitted by DMEPOS suppliers to establish applicable payment amounts. Section 1871(a)(3)(A) of the Act requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation, if the Secretary, no later than the regulation's previously established proposed publication date, causes to have published a notice with the new target date, and such notice includes a brief explanation of the justification for the variation. We announced in the December 2006 Unified Agenda (December 11, 2006, 71 FR 72734) that we would issue the final rule in March 2007. However, we are not able to meet the announced publication target date due to the number of extensive comments received on the proposed rule and interagency coordination. We received over 2,000 timely comments on the proposed rule. The commenters presented extremely complex policy and legal issues, which require extensive consultation and analysis. This final rule also is extremely complex because it will establish an entirely new program that will affect the DMEPOS industry as well as Medicare beneficiaries who use DMEPOS. This final rule will establish a new concept for Medicare payment for DMEPOS, which necessitates the development of new regulations and a competitive bidding process in addition to extensive payment system changes. This notice extends the timeline for publication of the final rule until April 30, 2007. Authority: Section 1871 of the Social Security Act (42 U.S.C. 201395hh). (Catalog of Federal Domestic Assistance Program No. 093.774, Medicare—Supplementary Medical Insurance Program) Dated: March 30, 2007. Ann Agnew, Executive Secretary to the Department. [FR Doc. 07-1658 Filed 3-30-07; 4:01 pm]

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U.S. Code

Administrative and judicial review of public assistance determinations
§ 1316

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42 CFR 430
42 CFR 430.76(b)(2)
42 CFR 430.76(c)
42 CFR 447.10
42 CFR 430.18
42 USC 201395hh

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Notices

Notice of hearing

U.S.C.§ 1316

Cite42 CFR 430

Cite42 CFR 430.76(b)(2)

Cite42 CFR 430.76(c)

Cite42 CFR 447.10

Cite42 CFR 430.18

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