Notices. Notice

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

BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10243] 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

(CARE)Instrument; *Use:* The Medicare Continuity Assessment Record and Evaluation

(CARE)is a uniform patient assessment instrument designed to measure differences in patient severity, resource utilization, and outcomes for patients in acute and post-acute care settings. This tool will be used to

(1)standardize program information on Medicare beneficiaries' acuity at discharge from acute hospitals,

(2)document medical severity, functional status and other factors related to outcomes and resource utilization at admission, discharge, and interim times during post acute treatment, and

(3)understand the relationship between severity of illness, functional status, social support factors, and resource utilization. The CARE instrument will be used in the Post-Acute Care

(PAC)Payment Reform Demonstration program mandated by Section 5008 of the Deficit Reduction Act of 2005 to develop payment groups that reflect patient severity and related cost and resource use across post acute settings. Specifically, the data collected using the CARE instrument during the Post-Acute Care Payment Demonstration will be used by CMS to develop a setting neutral post-acute care payment model as mandated by the Congress. The data will be used to characterize patient severity of illness and level of function in order to predict resource use, post-acute care discharge placement, and beneficiary outcomes. CMS will use the data from the CARE instrument to examine the degree to which the items on the instrument can be used to predict beneficiary resource use and outcomes. CMS made over 150 changes and improvements to the CARE instrument following the 60 day public comment period. Many revisions were minor word changes or clarifications to item-coding instructions. A significant number of changes were made to delete unnecessary items and to add skip patterns to allow respondents to skip over items/sections that do not apply to a particular condition. The revised version of CARE retains its clinical integrity while allowing for greater response specificity. *Form Number:* CMS-10243 (OMB#: 0938-NEW); *Frequency:* Reporting—Daily; *Affected Public:* Private Sector—Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 388; *Total Annual Responses:* 244,292; *Total Annual Hours:* 179,341. 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 by the OMB desk officer at the address below, no later than 5 p.m. on *December 10, 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 2, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-21989 Filed 11-8-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10239 and CMS-R-48] 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:* New collection; *Title of Information Collection:* Conditions of Participation for Critical Access Hospitals; *Use:* With this submission, we are creating a new information collection request for critical access hospitals (CAH). Currently, the information collection requirements associated with the critical access hospital

(CAH)conditions of participation

(CoPs)are included with the hospital CoPs reported under CMS-R-48 (0938-0328). Because the CAH program has grown in scope of services and the number of providers, we have removed the CAH burden from the CMS-R-48 with the exception of the burden associated with the 101 CAHs that have distinct part units (DPUs), and created a separate information collection request for OMB review and approval. Section 1820(c)(2)(E)(i) of the Social Security Act states that if a CAH operates a distinct part psychiatric or rehabilitation unit it must have 10 beds or less in the DPU and it must comply with the hospital requirements specified in 42 CFR Subpart A, B, C, and D of part 482. Based on 2007 data from HRSA, 81 CAHs have psychiatric distinct part units

(DPUs)and 20 CAHs have rehabilitation DPUs. The burden associated with the 101 CAHs with DPUs is reported in CMS-R-48. *Form Number:* CMS-10239 (OMB#: 0938-New); *Frequency:* Yearly; *Affected Public:* Private sector—Business or other for-profit; *Number of Respondents:* 1,189; *Total Annual Responses:* 137,990; Total Annual Hours: 23,291. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Hospital Conditions of Participation and Supporting Regulations in 42 CFR 482.12, 482.13, 482.21, 482.22, 482.23, 482.24, 482.27, 482.30, 482.41, 482.43, 482.45, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, and 485.616 and 485.631; *Use:* The information collection requirements described in this information collection request are needed to implement the Medicare and Medicaid conditions of participation

(CoP)for 4,890 accredited and non-accredited hospitals and an additional 101 critical access hospitals

(CAHs)that have distinct part psychiatric or rehabilitation units (DPUs). CAHs that have DPUs must comply with all of the hospital CoPs on these units. Thus, this package reflects the paperwork burden for a total of 4,991 (that is, 4,890 hospitals and 101 CAHs which include 81 CAHs that have psychiatric DPUs and 20 CAHs that have rehabilitation DPUs). The information collection requirements for the remaining 1,183 CAHs have been reported in a separate package under CMS-10239. The CoPs and accompanying requirements specified in the regulations are used by our surveyors as a basis for determining whether a hospital qualifies for a provider agreement under Medicare and Medicaid. CMS and the health care industry believe that the availability to the facility of the type of records and general content of records, which this regulation specifies, is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. *Form Number:* CMS-R-48 (OMB#: 0938-328); *Frequency:* Yearly; *Affected Public:* Private sector—Business or other for-profit; *Number of Respondents:* 4,991; *Total Annual Responses:* 1,120,817; Total Annual Hours: 9,151,200.57. 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 8, 2008. 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 2, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-21990 Filed 11-8-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0422] Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the application for participation in the Medical Device Fellowship Program (MDFP). DATES: Submit written or electronic comments on the collection of information by January 8, 2008. ADDRESSES: Submit electronic comments on the collection of information to *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Application for Participation in the Medical Device Fellowship Program; 5 U.S.C. 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 (OMB Control Number 0910-0551)—Extension Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code, authorize Federal agencies to rate applicants for Federal jobs. Collecting applications for the MDFP will allow FDA's Center for Devices and Radiological Health

(CDRH)to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in CDRH activities. The process will reduce the time and cost of submitting written documentation to the agency and lessen the likelihood of applications being misrouted within the agency mail system. It will assist the agency in promoting and protecting the public health by encouraging outside persons to share their expertise with CDRH. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 5 U.S.C. Section/ FDA Form No. No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 1104, 1302, 3301, 3304, 3320, 3361, 3393, 3394/ Form No. 3608 250 1 250 1 250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA based these estimates on the number of inquiries that have been received concerning the program and the number of requests for application forms over the past 3 years. Dated: November 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21971 Filed 11-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0430] Agency Emergency Processing Under Office of Management and Budget Review; Orphan Drug Products; Common European Medicines Evaluation Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information is an amendment to OMB control number 0910-0167 and concerns the joint adoption by FDA and the European Medicines Evaluation Agency

(EMEA)of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671). DATES: Fax written comments on the collection of information by November 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number “0910-0167” and the title, “Orphan Drug Products; Common EMEA/FDA Application Form for Orphan Medicinal Product Designation.” Also include the FDA docket number found in brackets in the heading of this document. To obtain a copy of the draft form FDA 3671, please call Mary Grice at 301-827-3666 or submit written requests via fax to 301-827-0017. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: FDA is requesting emergency processing of this proposed collection of information under section 3507(j) of the PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13) to enable the agency to jointly announce with EMEA the adoption of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation at the European Union (EU)-wide Administrative Simplification Workshop on November 28, 2007. The information is essential to the agency's mission of protecting and promoting the public health. The use of the normal clearance procedures would likely result in the prevention or disruption of this collection of information. With respect to the collection of information, FDA invites comments on these topics:

(1)The clarity and ease of use of this proposed common application form;

(2)whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(3)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(5)ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques, when appropriate, and other forms of information technology. Orphan Drug Products; Common EMEA/FDA Application Form for Orphan Medicinal Product Designation—(OMB Congrol Number 0910-0167)—Amendment This common application form is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from both the European Commission and FDA by reducing the burden of preparing separate applications to meet the regulatory requirements in each jurisdiction. It highlights the regulatory cooperation between the United States and EU mandated by the Transatlantic Economic Council (TEC). The TEC mandate involves: Removal of barriers to transatlantic commerce; rationalizing, reforming, and, where appropriate, reducing regulations to empower the private sector; achieving more effective, systematic, and transparent regulatory cooperation to reduce costs associated with regulation to consumers and producers; removing unnecessary differences between jurisdictional regulations in order to foster economic integration; reinforcing the existing transatlantic dialogue structures in regulatory cooperation, both by intensifying our sector-by-sector United States-EU regulatory cooperation and our dialogue between OMB and the European Commission services on methodological issues. At present, when seeking orphan designation of the same drug for the diagnosis, treatment, or prevention of the same rare disease or condition in the United States and in the European Community, a sponsor must submit a designation request to FDA (in accordance with section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb)) and a separate designation application to EMEA (in accordance with Regulation

(EC)No. 141/2000 of December 16, 1999, and Commission Regulation

(EC)No. 847/2000). In most cases, the two documents are formatted differently to meet regulatory demands, but the required core information elements are similar with the exception of some unique regulatory requirements exclusive to each jurisdiction. Therefore, FDA and EMEA believe that a common application form will help reduce the sponsor's regulatory burden and costs to produce and submit a differently-formatted request/application. In addition, a common application form may also streamline the administrative and substantive regulatory review processes, and aid in information exchange between the agencies. In accordance with the Confidentiality Arrangements concluded on September 12, 2003, between the European Commission, EMEA, and FDA, 1 FDA and EMEA have agreed in principle to adopt a template for the common application form as proposed in form FDA 3671. 1 See “Confidentiality Arrangements Concluded Between the EU (EC and EMEA) and the US FDA/DHHS Implementation Plan for Medicinal Products for Human Use” at *http://www.fda.gov/oia/arrangements0904.html* . Any sponsor seeking orphan designation of the same drug for the same disease or condition from both FDA and EMEA may use this common application form for regulatory filing purposes. A sponsor may also use this common application form when seeking designation only from FDA. This common application form is intended to complement, not to supersede, the relevant regulatory frameworks currently in effect. The sponsor must comply with all applicable regulatory requirements in each jurisdiction in which it seeks designation when using this common application form. To use the common application form, the sponsor must provide the required information in each applicable section as instructed in the explanatory notes. Certain information elements are identified in the form as required exclusively by either FDA or EMEA regulations, and as such they must be included only in the application to that jurisdiction. Where additional explanations and/or supportive documents are necessary, the sponsor should sequentially append them at the end of the common application form in the order they appear in the form. The sponsor must also complete the declaration and signature page. For FDA, the completed common application form and required appended documents must be submitted to the Office of Orphan Products Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. For EMEA, the completed documents must be submitted to European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. FDA estimates the reporting burden of this common application form as follows. Between January 2000 and May 2006, FDA and EMEA received 226 comparable orphan designation requests/applications of the same drugs for the same diseases or conditions, or an average of 35 per year. With the ease of a common application form, FDA anticipates the number of such requests/applications may increase over time. Therefore, generally there is one request/application per respondent and as, at the extreme, all respondent are U.S.-based, FDA believes up to 40 such respondents may use the common application form each year. The respondents will be primarily pharmaceutical companies or other for-profit organizations. The collection of information for sponsors requesting orphan drug designation from FDA is currently covered by the Orphan Drug Regulations (21 CFR Part 316) and approved under OMB No. 0910-0167 (expires August 31, 2010). For applications submitted exclusively to FDA, we do not believe the new form will result in any increased burden on the respondents and therefore we estimate no additional burden for those respondents. FDA believes the information required for the EMEA submission, for the most part, is very similar to that in the FDA submission, which is already in the respondents' possession. The respondents, however, may have to search existing data sources or gather additional needed data, such as on the prevalence or the availability of alternative methods of diagnosis, prevention, and treatment of the rare disease or condition of interest in the European Community, to complete the EMEA submission. FDA estimates that it will take an additional 32 hours (16 hours of professional time and 16 hours of support time) to compile information required for the EMEA submission. Hence, the estimated total annual human resource hours, at most, would be 1,280 hours. **Table 1.—Estimated Annual Reporting Burden** 1 FDA Form No. Annual No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours FDA 3671 40 1 40 32 1,280 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21988 Filed 11-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007M-0366] Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is publishing a list of premarket approval applications

(PMAs)that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please include the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness data. FOR FURTHER INFORMATION CONTACT: Pamela Pope, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the **Federal Register** , providing instead to post this information on the Internet at *http://www.fda.gov* . In addition, the regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during the quarter. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the **Federal Register** , and FDA believes that the Internet is accessible to more people than the **Federal Register** . In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting administrative reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The following is a list of PMAs approved by CBER for which summaries of safety and effectiveness data were placed on the Internet from July 1, 2007, through September 30, 2007. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date. **Table 1. List of Summaries of Safety and Effectiveness Data for Approved PMAs Made Available July 1, 2007, through September 30, 2007.** PMA No./Docket No. Applicant Trade Name Approval Date BP060001/0/2007M-0366 ThermoGenesis Corp. CryoSeal FS System 7/26/2007 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cber/products.htm* . Dated: October 31, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21986 Filed 11-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology 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). At least one portion of the meeting will be closed to the public. *Name of Committee* : Obstetrics and Gynecology 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 13, 2007, from 8 a.m. to 5 p.m., and on December 14, 2007, from 8 a.m. to 1:15 p.m. *Location* : Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Michael Bailey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4100, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On December 13, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application for the Adiana Transcervical Sterilization System, sponsored by Cytyc Surgical Products. This device is indicated to be used as a permanent method for female sterilization. On December 14, 2007, the committee will have a general topic discussion of clinical trial design issues for endometrial ablation devices indicated for pre-menopausal women in whom childbearing is complete and who no longer desire menses (i.e., monthly period). The committee will also hear and discuss a post-approval study update for the ExAblate 2000 System from InSightec, Inc. The system is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. 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 2007 and scroll down to the appropriate advisory committee link. *Procedure* : On December 13, 2007, from 8 a.m. to 5 p.m., and on December 14, 2007, from 9 a.m. to 1:15 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 29, 2007. Oral presentations from the public will be scheduled on December 13, 2007, between approximately 8:15 a.m. and 8:45 a.m. and between approximately 3:30 p.m. and 4 p.m., and on December 14, 2007, between approximately 10 a.m. and 10:15 a.m. and between approximately 11:15 a.m. and 12:15 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 November 21, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 23, 2007. *Closed Presentation of Data* : On December 14, 2007, from 8 a.m. to 9 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The committee will hear an update on device submissions currently under review. 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 AnnMarie Williams, Conference Management Staff, at 240-276-8932, 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 2, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-21979 Filed 11-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0419] Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.” This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 8, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Badrul A. Chowdhury, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3316, Silver Spring, MD 20993-0002, 301-796-2300. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.” This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of COPD. The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD. There is pressing need to develop new drugs for COPD because the global prevalence of COPD is rising, the disease is associated with significant morbidity and mortality, and current treatment options are limited. The currently available drugs for COPD are mostly for symptomatic treatment and have not been conclusively shown to alter the underlying inflammation or to alter disease progression. The principles of development applied to COPD drugs have been generally derived from those used to develop drugs for asthma, with the primary focus aimed at demonstrating improvements in airway obstruction. With improved understanding of the pathophysiology and clinical manifestations of COPD, and the awareness of the importance of inflammation in COPD and how this inflammation differs from that occurring in asthma, this is an appropriate time to define characteristics of specific drug development programs for COPD. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on developing drugs for the treatment of COPD. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: November 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21985 Filed 11-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Nurse Education and Practice; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* National Advisory Council on Nurse Education and Practice (NACNEP). *Dates and Times:* November 15, 2007, 9 a.m.-5 p.m. November 16, 2007, 9 a.m.-4 p.m. *Place:* Doubletree Executive Hotel and Meeting Center, 8120 Wisconsin Avenue, Bethesda, MD 20814. *Status:* The meeting will be open to the public. *Agenda:* Agency and Bureau administrative updates will be provided. The purpose of the meeting will be to examine the issues facing nursing education in relation to teaching and learning strategies, the needs of employers and consumers for high quality professional nursing care across the lifespan and in a variety of settings, and nursing curricula to prepare the nursing student at the basic level (associate degree, diploma, and baccalaureate degree) to practice in a changing health care system. The objectives of the meeting are to:

(1)Examine the most effective and relevant teaching and learning methods and strategies focusing on Competency Outcomes and Performance Assessment for students in the practice disciplines;

(2)identify knowledge, skills, and abilities needed by the 21st century RN workforce as seen through the eyes of employers and consumers; and

(3)examine nursing curricula among all three basic RN programs {associate degree, diploma and baccalaureate programs} to understand similarities and differences in the respective programs and their ability to prepare the 21st century nursing student for professional practice. During this meeting, the NACNEP council members will deliberate as workgroups on the content presented and formulate recommendations to the Secretary of Health and Human Services and the Congress on teaching and learning strategies for future nursing students and nursing competencies required by employers and consumers. This meeting and the meeting held in April 2008 will form the basis for NACNEP's congressionally mandated Ninth Annual Report. *For Further Information Contact:* Anyone interested in obtaining a roster of members, minutes of the meeting, or other relevant information should write or contact Dr. Joan Weiss, Executive Secretary, National Advisory Council on Nurse Education and Practice, Parklawn Building, Room 9-35, 5600 Fishers Lane, Rockville, Maryland 20857, telephone

(301)443-5688. Due to a delay in confirming several key speakers, this notice will publish in the **Federal Register** less than 15 days before the date of the meeting. Dated: November 5, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-21978 Filed 11-8-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2007-0049] National Boating Safety Activities: Funding for National Nonprofit Public Service Organizations AGENCY: Coast Guard, DHS. ACTION: Notice of funds availability. SUMMARY: The Coast Guard seeks applications for fiscal year 2008 grants and cooperative agreements from national, nongovernmental, nonprofit public service organizations. These grants and cooperative agreements would be used to fund projects on various subjects promoting recreational boating safety on a national scope. This notice provides information about the grant and cooperative agreement application process and some of the subjects of particular interest to the Coast Guard. DATES: You may obtain application packages on or after November 1, 2007. Proposals for the fiscal year 2008 grant cycle must be received before 3 p.m. Eastern time, January 22, 2008. ADDRESSES: You may obtain application packages by calling the Coast Guard at 202-372-1060. Submit proposals to: Commandant (CG-54221), U.S. Coast Guard Headquarters, 2100 Second Street, SW., Room 3100, Washington, DC 20593-0001. This notice is available from the Coast Guard and on the Internet at the Web site for the Boating Safety Division at *http://www.uscgboating.org and at http://www.regulation.gov* . FOR FURTHER INFORMATION CONTACT: Ms. Vickie Hartberger, Boating Safety Division, U.S. Coast Guard (CG-54221), 2100 Second Street, SW., Room 3100, Washington, DC 20593-0001; 202-372-1060; e-mail *Vickie.L.Hartberger@uscg.mil* . The points of contact for the nine project areas are listed at the end of each project description. SUPPLEMENTARY INFORMATION: Title 46, United States Code, Chapter 131, provides for the allocation of available funds from the Sport Fish Restoration and Boating Trust Fund for State recreational boating safety grants. The majority of funds are allocated to the states and up to 5 percent of these funds may be distributed by the Coast Guard for grants and cooperative agreements for national recreational boating safety activities of national nonprofit public service organizations. We anticipate we will allocate approximately $5,400,000 among several organizations for fiscal year 2008. Thirty-seven awards totaling $5,219,380 were made in fiscal year 2007 ranging from $10,000 to $650,000. Nothing in this notice should be construed as committing the Coast Guard to dividing available funds among qualified applicants or awarding any specified amount. Applicants must be national, nongovernmental, nonprofit public-service organizations and must establish that their activities are national in scope. You may obtain an application package by writing or calling the point of contact listed in ADDRESSES on or after November 1, 2007. The application package contains all necessary forms, an explanation of how the grant program is administered, and a checklist for submitting a grant application. You can obtain specific information on organization eligibility, proposal requirements, award procedures, and financial administration procedures by contacting the person listed in FOR FURTHER INFORMATION CONTACT . The Boating Safety Financial Assistance Program is listed in section 97.012 of the Catalog of Federal Domestic Assistance. Prospective grantees may propose up to a 5-year grant with 12-month (fiscal year) increments identified. In effect, an award would be made for the first year and thereafter renewal is optional. Each annual increment would not be guaranteed. Under a continuation (multi-year) type of award, the Coast Guard agrees to support a grant project at a specific level of effort for a specified period of time, with a statement of intention to provide additional future support, provided funds are available, the project continues to support the needs of the government, and the achieved results warrant further support. Award of continuation grants will be made on a strict case-by-case basis to assist planning in certain large scale projects and ensure continuity. Procedures also provide for awarding noncompetitive grants or cooperative agreements on a case-by-case basis. This authority is judiciously used to fund recurring annual projects or events which can only be carried out by one organization, and projects that present targets of opportunity for timely action on new or emerging program requirements or issues. The following list includes items of specific interest to the Coast Guard, however, potential applicants should not be constrained by the list. We welcome any initiative that supports the mission of the USCG Office of Boating Safety, which is: To ensure the public has a safe, secure, and enjoyable recreational boating experience by implementing programs that minimize the loss of life, personal injury, and property damage while cooperating with environmental and national security efforts. The performance goal of the National Recreational Boating Safety Program is to reduce recreational boating casualties. To achieve this goal, our objectives, for which we need additional expertise from grant recipients, include: • Improving the reliability of boating accident reporting, which assists in identifying causal factors that could then be addressed through education and/or regulation. • Tracking and Increasing Awareness of Safe Boating Practices. • Increasing lifejacket wear. • Decreasing the number of alcohol-involved accidents. • Increasing operator compliance with Navigation Rules. • Increasing operator compliance with USCG safety equipment carriage requirements. • Tracking completion of advanced boating education courses with the future goal of using this data to increase said training. • Tracking and increasing the number of NASBLA-approved boating safety education certificates issued annually. Some project areas of continuing and particular interest for grant funding include the following: 1. Develop and Conduct a National, Year-Round, Safe Boating Campaign that addresses areas identified through the National RBS Program's Strategic Plan. The Coast Guard seeks a grantee to plan, develop and implement a 2008 National Safe Boating Campaign that promotes a concentrated effort to target specific boater market segments and recreational boating safety topics. This year-round campaign must coincide with the objectives of the National RBS Program. The nationwide activities of this public awareness campaign should be based on the support of the volunteers and professional groups at the grassroots (local) level. Key to this collaborative effort is how it will complement the Coast Guard's national outreach initiatives. The major focus of the effort will be to modify the behavior of all boaters with special focus on boat operators being responsible for their own safety as well as the safety of their passengers. Significant emphasis should be placed on lifejacket wear, boater education, safety and security issues, propeller injury prevention, and the dangers of carbon monoxide, as well as boating under the influence of alcohol or drugs. Efforts will also be coordinated, year-round, with other national safety initiatives and special media events. Point of Contact: Ms. Jo Calkin, 202-372-1065. 2. Develop and Conduct a National Recreational Boating Safety Outreach and Awareness Conference. The Coast Guard seeks a grantee to plan, implement, oversee, and conduct a National Recreational Boating Safety Outreach and Awareness Conference that supports the organizational objectives of the National Recreational Boating Safety Program. The overall conference focus should have promotional strategies with special emphasis on boat operators being responsible for their own safety as well as the safety of their passengers. Significant emphasis should be placed on offering multiple subjects that afford the participants professional development opportunities and educational enhancement. Subjects should focus on, but not be limited to: Lifejacket wear, safety and security issues, propeller injury prevention, the dangers of carbon monoxide, boater education, vessel safety, outreach and awareness efforts, as well as boating under the influence of alcohol or drugs. Point of Contact: Ms. Jo Calkin, 202-372-1065. 3. Federal/State Cooperative Partnering Efforts. The Coast Guard seeks a grantee to provide programs to measurably enhance uniformity and reciprocity in state boating safety laws/regulations and other state boating safety efforts. The grantee would provide a forum to encourage such uniformity and reciprocity among jurisdictions, and closer cooperation and assistance in developing, administering, and enforcing state laws and regulations pertaining to boating safety. The grantee would further provide a forum to encourage sufficient patrol and other activities to ensure adequate enforcement of state boating safety laws and regulations, provision of an adequate USCG recognized state boating safety education program, enhanced maintenance of USCG approved vessel numbering system and enhanced implementation of a USCG approved marine casualty reporting system. Point of Contact: Mr. W. Vann Burgess, 202-372-1071. 4. Develop and Conduct Boating Accident Investigation Seminars. The Coast Guard seeks a grantee to develop, provide instructional material, and conduct training courses nationwide for boating accident investigators, including four courses at the U.S. Coast Guard's Maritime Law Enforcement Academy in Charleston, South Carolina. Point of Contact: Mr. Mike Jendrossek, 202-372-1052. 5. National Estimate of Personal Flotation Device Wear Rate. The Coast Guard seeks a grantee to provide reliable and valid national estimates of personal flotation device (PFD or lifejacket) wear by recreational boaters. Wear rates of PFDs should be based on actual observations taken from a representative sample of boaters across a range of water venues that include lakes, rivers, and bays. It is essential that observation methods remain as close as possible to those used in previous years so the number of boats, types of boats, length of boats, operation and activity of boats, as well as the age and gender of the boaters observed remain consistent. Using the design of the National PFD Wear Rate Study as a base, a supplemental observational study is solicited to determine if PFD wear rates are higher in an area after the roll-out of the annual Safe Boating Campaign. The grantee shall conduct observations in areas around the country that have relatively high boating activity in the summer and therefore may be expected to have a reasonable level of activity to make conclusions about changes in wear rates more stable. Observation data for 2007 will be collected for inclusion in the baseline measure. In the summer of 2008, the post-campaign measurement will be conducted. Point of Contact: Mr. Jeff Ludwig, 202-372-1061. 6. Voluntary Standards Development Support. The Coast Guard seeks a grantee to carry out a program to encourage active participation by members of the public and other qualified persons in the development of technically sound voluntary safety standards for boats and associated equipment. Point of Contact: Mr. Po Chang, 202-372-1075. 7. Inflatable Lifejacket Testing for Children. The Coast Guard seeks a grantee to develop a test program and conduct appropriate testing to determine if children under 16 years of age are capable of safely using automatic inflatable lifejackets. At least two age groups should be considered,

(a)Children from 6-12 years old; and

(b)Children from 12 to 16 years old. Point of Contact: Mr. Dan McCormick, 202-372-1078. 8. Navigation Rules and State Violations. The Coast Guard seeks a grantee to conduct a survey or study of each state and territory to determine such things as, “Has the state adopted the COLREGS/Navigation Rules within their state code? If not, have they created their own set of Navigation Rules?” If not, do they at least use the Navigation Rules to determine other violations of state law ( *i.e.* reckless operation, failure to have proper look out, etc.) How do they document such cases? The outcome of this survey should help (clarify) how the Coast Guard determines the most common Navigation Rules violations (documented) in terms of a common definition. Point of Contact: Mr. W. Vann Burgess, 202-372-1071. 9. Practical “on the water” Course. The Coast Guard seeks a grantee to carry out a program to encourage and develop a small boat practical “on the water” course curriculum. The basic boat handling skills should take into consideration all types of weather conditions such as heavy winds and sea conditions. Close quarter maneuvering in congested harbor and waterways should also be taught. The operation of different types of vessels should also be taken into consideration, such as twin or single inboard engines with rudder steerage which would be considerably different from inboard/outboard engines or outboard motors. The course should address all these issues. Point of Contact: Mr. Wayne Stacey, 202-372-1067. We encourage proposals addressing other boating safety concerns. Potential grantees should focus on partnership, *e.g.* , exploring other sources, linkages, in-kind contributions, cost sharing, and partnering with other organizations or corporations. With your application, we encourage you to list and describe the tools you will use to measure your grant's performance toward achieving the goals of the National RBS Program Strategic Plan or toward achieving a specific objective that will result in the achievement of these goals. The Strategic Plan for the National RBS Program can be found on the Boating Safety Division Web site at *http://www.uscgboating.org* . For some examples of tools, we invite you to explore this CDC Web site: *http://www.cdc.gov/ncipc/pub-res/demonstr.htm* . This announcement is also available on the *www.grants.gov* Web site; we are also publishing the information in the **Federal Register** again this year to provide information to the public in a timely manner. Dated: October 31, 2007. Francis J. Sturm, Captain, U.S. Coast Guard, Acting Director of Prevention Policy. [FR Doc. E7-21972 Filed 11-8-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No.CGD08-07-041] Houston/Galveston Navigation Safety Advisory Committee AGENCY: Coast Guard, DHS. ACTION: Notice of Meeting. SUMMARY: The Houston/Galveston Navigation Safety Advisory Committee (HOGANSAC) will meet to elect a new committee chairperson, vice-chairperson and chairpersons for subcommittees. The meeting will not be a working meeting. This meeting will be open to the public. DATES: The meeting will be held on Tuesday, November 27, 2007 from 9-10 a.m. ADDRESSES: The meeting will be held at the Houston Pilots Association, 8150 South Loop East, Houston, Texas 77011-1747,

(713)645-9620. This notice is available on the Internet at *http://www.regulations.gov.* FOR FURTHER INFORMATION CONTACT: Commander Hal R. Pitts, Executive Secretary of HOGANSAC, telephone

(713)671-5164, e-mail *hal.r.pitts@uscg.mil,* or Lieutenant Sean Hughes, Assistant to the Executive Secretary of HOGANSAC, telephone

(713)678-9001, e-mail *sean.p.hughes@uscg.mil.* SUPPLEMENTARY INFORMATION: Notice of this meeting is given pursuant to the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). *Agenda of the Meeting:* *Houston/Galveston Navigation Safety Advisory Committee (HOGANSAC).* The tentative agenda includes the following:

(1)Opening remarks by Executive Director (CAPT Diehl) or Executive Director's representative.

(2)HOGANSAC membership election of chairperson and vice-chairperson.

(3)Membership election of seven

(07)subcommittee chairpersons. *Information On Services For The Handicapped:* For information on facilities or services for the handicapped or to request special assistance at the meetings, contact the Executive Secretary or Assistant to the Executive Secretary as soon as possible. November 5, 2007. J.R. Whitehead, Rear Admiral, U.S. Coast Guard Commander, Eighth Coast Guard District. [FR Doc. 07-5606 Filed 11-06-07; 2:13 pm]

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