Notices. Notice

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BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [Document Identifier: CMS-R-246] Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget

(OMB)AGENCY: Centers for Medicare and 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 and Medicaid Services (CMS), Department of Health and Human Services, 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. We are requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget

(MMA)of 2003 under section 1860D-4 (Information to Facilitate Enrollment) requires CMS to conduct consumer satisfaction surveys regarding the prescription drug plan or the Medicare Advantage prescription drug plan pursuant to section 1860D-4(d) and report the results to Part D eligible individuals at least 30 days prior to the enrollment period. This revised collection adds new Prescription Drug Plan questions as mandated in the MMA. Approval for this request will ensure that CMS is able to conduct the revised Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys in time to publicly report the data for the open enrollment period in Fall of 2007. 1. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Medicare CAHPS Survey; *Form Number:* CMS-R-246 (OMB#: 0938-0732); *Use:* The collection of CAHPS measures is necessary to hold health and prescription drug plans accountable for the quality of care and services they deliver. This requirement will allow CMS to obtain information for the proper oversight of the program. This information is used to help beneficiaries choose among plans, contribute to improved quality of care through identification of quality improvement opportunities, and assist CMS in carrying out its responsibilities; *Frequency:* Reporting—Annually; *Affected Public:* Individuals or households; *Number of Respondents:* 600,000; *Total Annual Responses:* 600,000; *Total Annual Hours:* 198,000. CMS is requesting OMB review and approval of this collection by *December 18, 2006,* with a 180-day approval period. Written comments and recommendations will be considered from the public if received by the individuals designated below by December 4, 2006. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS's 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. Interested persons are invited to send comments regarding the burden or any other aspect of these collections of information requirements. However, as noted above, comments on these information collection and recordkeeping requirements must be mailed and/or faxed to the designees referenced below by December 4, 2006: Centers for Medicare and Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: Bonnie L Harkless. and, OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: November 7, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-19133 Filed 11-16-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [Document Identifier: CMS-10137] Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget

(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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget

(OMB)the following requirements for emergency review. We are requesting an emergency review because the collection of this information is needed before the expiration of the normal time limits under OMB's regulations at 5 CFR part 1320. This is necessary to ensure compliance with an initiative of the Administration. We cannot reasonably comply with the normal clearance procedures because the use of normal clearance procedures is reasonably likely to cause a statutory deadline to be missed. For the 2008 contract year, CMS is taking several steps to reduce the person-hours necessary to complete the Part D solicitations. These steps include automating the majority of the Part D and Employer Group Waiver Plan solicitations within CMS' Health Plan Management System (HPMS), incorporating the Pharmacy Access Submission document into the underlying Part D solicitation, and streamlining key information that was previously requested by attachments into attestations in time to qualify applicants prior to the first Monday in June of 2006. 1. *Type of Information Collection Request:* Revision of a currently approved collection. *Title of Information Collection:* Application for Prescription Drug Plans (PDP); Application for Medicare Advantage Prescription Drug (MA-PD); Application for Cost Plans to Offer Qualified Prescription Drug Coverage; Application for Employer Group Waiver Plans to Offer Prescription Drug Coverage; Service Area Expansion Application for Prescription Drug Coverage. *Form Number:* CMS-10137 (OMB#: 0938-0936). *Use:* Collection of this information is mandated in Part D of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Coverage for the prescription drug benefit is provided through prescription drug plans (PDP's) that offer drug-only coverage, or through Medicare Advantage organizations that offer integrated prescription drug and health care coverage. PDPs must offer a basic drug benefit. Medicare Advantage Coordinated Care Plans must offer either a basic benefit or may offer broader coverage for no additional cost. Medicare Advantage Private Fee for Service Plans may choose to offer a Part D benefit. Cost Plans that are regulated under Section 1876 of the Social Security Act, and Employer Group Plans may also provide a Part D benefit. If any of the contracting organizations meet basic requirements, they may also offer supplemental benefits through enhanced alternative coverage for an additional premium. This collection will be used by CMS to:

(1)Insure that applicants meet CMS requirements and

(2)support the determination of contract awards. *Frequency:* Reporting—Once. *Affected Public:* Business or other for-profit and Not-for-profit institutions *Number of Respondents:* 216. *Total Annual Responses:* 216. *Total Annual Hours:* 5,316. CMS is requesting OMB review and approval of this collection by *December 15, 2006,* with a 180-day approval period. Written comments and recommendation will be considered from the public if received by the individuals designated below by December 1, 2006. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS's 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. Interested persons are invited to send comments regarding the burden or any other aspect of these collections of information requirements. However, as noted above, comments on these information collection and recordkeeping requirements must be mailed and/or faxed to the designees referenced below by December 1, 2006: Centers for Medicare and Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: Bonnie L Harkless, and, OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. November 9, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-19428 Filed 11-16-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10088 and CMS-R-13] Agency Information Collection Activities: Submission for OMB Review; 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), Department of Health and Human Services, 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 function;

(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:* Revision of a currently approved collection; *Title of Information Collection:* Notification of Fiscal Intermediaries

(FIs)and CMS of Co-located Medicare Providers and Supporting Regulations in 42 CFR 412.22 and 412.533; *Use:* Many long term care hospitals (LCTHs) are co-located with other Medicare providers (acute care hospitals, inpatient rehabilitation facilities, skilled nursing facilities, and psychiatric facilities), which leads to potential gaming of the Medicare system based on patient shifting. CMS is requiring LTCHs to notify fiscal intermediaries

(FIs)and CMS of co-located providers. In addition, CMS has established policies to limit payment abuse that will be based on FIs tracking patient movement among these co-located providers. *Form Number:* CMS-10088 (OMB#: 0938-0897; *Frequency:* Reporting—as needed; *Affected Public:* Business or other for profit and Not-for-profit institutions; *Number of Respondents:* 200; *Total Annual Responses:* 200; *Total Annual Hours:* 50. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Conditions of Coverage for Organ Procurement Organizations

(OPOs)and Supporting Regulations in 42 CFR 486.301-348; *Use:* Organ Procurement Organizations are required to submit accurate data to CMS through the Organ Procurement and Transplantation Network (OPTN). The data concerns the organ procurement activities, as well as various OPO business activities, including information on its designated service area; structure; various policies, procedures, and protocols; and its quality assessment and performance improvement

(QAPI)program. This information is necessary to assure maximum effectiveness in the procurement and distribution of organs. *Form Number:* CMS-R-13 (OMB#: 0938-0688; *Frequency:* Reporting—Every 4 years and as needed; *Affected Public:* Not-for-profit institutions; *Number of Respondents:* 58; *Total Annual Responses:* 58; *Total Annual Hours:* 21,427. 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. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: November 7, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-19430 Filed 11-16-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-235] 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 a currently approved collection; *Title of Information Collection:* Data Use Agreement Information Collection Requirements, Model Language and Supporting Regulations in 45 CFR part 5b. *Use:* The Data Use Agreement

(DUA)is needed as part of the review of each CMS data request to ensure compliance with the requirements of the Privacy Act for disclosure of data that contain individually-identifiable information. In addition, the DUA is used to maintain appropriate accounting and tracking of disclosures of records from Privacy Act systems of records. *Form Number:* CMS-R-235 (OMB#: 0938-0734); *Frequency:* Reporting-On occasion; *Affected Public:* Not-for-profit institutions; *Number of Respondents:* 1,500; Total *Annual Responses:* 1,500; *Total Annual Hours:* 750. 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 *January 16, 2007.* CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, Attention: William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: November 7, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-19431 Filed 11-16-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices 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). The meeting will be open to the public. *Name of Committee* : Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices 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 on December 6, 2006, from 8 a.m. to 4:30 p.m. *Location* : Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. *Contact Person* : Veronica J. Calvin, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0491, ext. 161, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512514. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will hear an update on the status of recent devices brought before the committee. The committee will also hear a presentation regarding the FDA Critical Path Initiative. The committee will discuss general issues concerning high and low density lipoprotein subfraction assays. Background information, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at *http://www.fda.gov/cdrh/panel/index.html* . *Procedure* : 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 November 24, 2006. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. Time allotted for each presentation may be limited. 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 November 24, 2006. 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 Shirley Meeks, Conference Management Staff, 301-827-7292 at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 8, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-19492 Filed 11-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Child Health and Human Development; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Board of Medical Rehabilitation Research. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* National Advisory Board on Medical Rehabilitation Research. *Date:* December 7-8, 2006. *Time:* December 7, 2006, 8:30 a.m. to 5 p.m. *Agenda:* NICHD Director's Report presentation, NCMRR Director's Report presentation and various reports on Medical Research Initiatives. *Place:* Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. *Time:* December 8, 2006, 8:30 a.m. to 12:00 p.m. *Agenda:* Other business dealing with the NABMRR Board. *Place:* Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda,MD 20814. *Contact Person:* Ralph M. Nitkin, PhD, Director, BSCD, National Center for Medical, Rehabilitation Research, National Institute of Child Health, and Human Development, NIH, 6100 Building, Room 2A03, Bethesda, MD 20892.

(301)402-4206. 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. Information is also available on the Institute's/Center's home page: *http://www.nichd.nih.gov/about/ncmrr.htm,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: November 13, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-9254 Filed 11-16-06; 8:45 am]

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4 references not yet in our index

5 CFR 1320
42 CFR 412.22
42 CFR 486.301-348
45 CFR 5

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Notices

Notice

Cite5 CFR 1320

Cite42 CFR 412.22

Cite42 CFR 486.301-348

Cite45 CFR 5

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