Gastrointestinal Drugs Advisory Committee; Notice of Meeting, 67605-67606 [E7-23177]

Download as PDF Federal Register / Vol. 72, No. 229 / Thursday, November 29, 2007 / Notices proposed paperwork collections referenced above, access CMS Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or email 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 by the OMB desk officer at the address below, no later than 5 p.m. on December 31, 2007. 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 21, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7–23163 Filed 11–28–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services, HHS [Document Identifier: CMS–10165, CMS– 2552–96 and CMS–10008] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. 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: Revision of a currently rmajette on PROD1PC64 with NOTICES AGENCY: VerDate Aug<31>2005 14:52 Nov 28, 2007 Jkt 211001 approved collection; Title of Information Collection: Electronic Health Record; Use: The purpose of this demonstration project is to reward the delivery of high-quality care supported by the adoption and use of electronic health records in small to medium-sized primary care physician practices. While this is separate and distinct from the Medicare Care Management Performance (MCMP) Demonstration, it expands upon the foundation created by the MCMP Demonstration, which was mandated by Section 649 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. The electronic health record demonstration will be operational for a 5-year period and will be operated under section 402 demonstration waiver authority. The information to be obtained as part of the application form is necessary to document basic information for physician practices that intend to participate in this demonstration initiative. Form Number: CMS–10165 (OMB#: 0938–0965); Frequency: Once; Affected Public: Private sector—Business or other forprofit; Number of Respondents: 2,400; Total Annual Responses: 2,400; Total Annual Hours: 520. 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Hospital and Health Care Complexes Cost Report and supporting Regulations in 42 CFR 413.20 and 413.24; Use: This Cost Report Form is filed annually by freestanding providers participating in the Medicare program to effect year end cost settlement for providing services to Medicare beneficiaries. The CMS–2552– 96 cost report is needed to determine the amount of reimbursable cost, based upon the cost limits, that is due these providers furnishing medical services to Medicare beneficiaries. Form Number: CMS–2552–96 (OMB #: 0938–0050); Frequency: Yearly; Affected Public: Private sector—Business or other forprofit and Not-for-profit institutions; Number of Respondents: 6,175; Total Annual Responses: 6,175; Total Annual Hours: 4,090,474. 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Process and Information Required to Determine Eligibility of Drugs, Biologicals, and Radiopharmaceutical Agents for Transitional Pass-Through Status Under the Hospital Outpatient Prospective Payment System (OPPS); Use: Section 1833(t)(6) of the Social Security Act provides for temporary additional payments or ‘‘transitional pass-through PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 67605 payments’’ for certain drugs and biological agents. Interested parties such as hospitals, pharmaceutical companies, and physicians can apply for transitional pass-through payment for drugs and biologicals used with services covered under the OPPS. CMS uses this information to determine if the criteria for making a transitional pass-through payment are met and if an interim Healthcare Common Procedure Coding System (HCPCS) code for a new drug or biological is necessary. Form Number: CMS–10008 (OMB #: 0938–0802); Frequency: Once; Affected Public: Private sector—Business or other forprofit; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160. 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 email 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 28, 2008. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: November 21, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7–23164 Filed 11–28–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Gastrointestinal Drugs 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. E:\FR\FM\29NON1.SGM 29NON1 rmajette on PROD1PC64 with NOTICES 67606 Federal Register / Vol. 72, No. 229 / Thursday, November 29, 2007 / Notices Name of Committee: Gastrointestinal Drugs 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 January 23, 2008, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD, 301– 589–5200. Contact Person: Mimi Phan, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, e-mail: Mimi.Phan@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512538. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss the safety and efficacy of new drug application (NDA) 21–775, ENTEREG (alvimopan), Adolor Corp., for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 8, 2008. Oral presentations from the public will be scheduled between approximately 1 VerDate Aug<31>2005 14:52 Nov 28, 2007 Jkt 211001 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 2, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonable accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 3, 2008. 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 Mimi Phan at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 26, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–23177 Filed 11–28–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE INTERIOR Bureau of Land Management [CO–200–1430–FR; COC–64330] Notice of Realty Action: Recreation and Public Purposes (R&PP) Act Classification; Logan County, CO Bureau of Land Management, Interior. ACTION: Notice of realty action. AGENCY: SUMMARY: The following public land parcel in Logan County, Colorado, has been examined and found suitable for classification for conveyance to the Colorado Division of Wildlife under the provision of the Recreation and Public PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 Purposes Act, as amended, 43 U.S.C. 869 et seq., and under sec. 7 of the Taylor Grazing Act, 43 U.S.C. 315f, and E.O. 6910. Sixth Principal Meridian, Colorado T. 7 N., R. 53 W., Sec. 26, NE1⁄4SE1⁄4. The area described contains 40 acres in Logan County. The Colorado Division of Wildlife (CDOW) has not applied for more than the 6,400 acre limitation for recreation uses in a year. The CDOW has submitted a statement in compliance with the regulations at 43 CFR 2741.4(b). The CDOW proposes to use the land as an addition to its existing Overland State Wildlife Park. The CDOW has not requested more land than is needed for their development and management plans. DATES: Comments as to the proposed classification and conveyance application must be received by BLM for a period of 45 days from the date of publication of this notice in the Federal Register. ADDRESSES: Detailed information, including but not limited to, a proposed development plan and documentation relating to compliance with applicable environmental and cultural resources laws is available for review at the Royal Gorge Field Office, Bureau of Land Management, 3170 East Main Street, Canon City, Colorado 81212. FOR FURTHER INFORMATION CONTACT: Debbie Bellew, Realty Specialist, at (719) 269–8514 or dbellew@co.blm.gov. SUPPLEMENTARY INFORMATION: The CDOW has filed a petition-application under the provisions of the Recreation and Public Purposes Act, as amended (43 U.S.C. 869 et seq.) for classification and conveyance. The land is not needed for any Federal purposes and has been identified for disposal in the Northeast Colorado Resource Management Plan (September 1986). Conveyance of the land for recreational or public purposes is consistent with current BLM land use planning and would complement the CDOW’s outdoor recreation program and would be in the public interest. All interested parties will receive a copy of this notice once it is published in the Federal Register. The notice will be published in a newspaper of local circulation for three consecutive weeks. The regulations do not require a public meeting. Upon publication of this notice in the Federal Register the parcel will be segregated from all other forms of appropriation under the public land laws, including the general mining laws, except for conveyance under the E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 72, Number 229 (Thursday, November 29, 2007)]
[Notices]
[Pages 67605-67606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23177]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Gastrointestinal Drugs 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.

[[Page 67606]]

    Name of Committee: Gastrointestinal Drugs 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 January 23, 2008, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, Maryland Ballroom, 
8727 Colesville Rd., Silver Spring, MD, 301-589-5200.
    Contact Person: Mimi Phan, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-
7001, FAX: 301-827-6776, e-mail: Mimi.Phan@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512538. Please call the Information Line 
for up-to-date information on this meeting. A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
meeting.
    Agenda: The committee will discuss the safety and efficacy of new 
drug application (NDA) 21-775, ENTEREG (alvimopan), Adolor Corp., for 
the proposed indication of acceleration of time to upper and lower 
gastrointestinal recovery following partial large or small bowel 
resection surgery with primary anastomosis.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
January 8, 2008. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those desiring to make formal 
oral presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before January 2, 2008. Time allotted for each presentation may 
be limited. If the number of registrants requesting to speak is greater 
than can be reasonable accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by January 
3, 2008.
    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 Mimi Phan at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 26, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-23177 Filed 11-28-07; 8:45 am]
BILLING CODE 4160-01-S