Notices. Notice

8,682 words·~39 min read·/register/2007/09/21/07-4692

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

BILLING CODE 6560-50-M ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6691-2] Environmental Impacts Statements; Notice of Availability *Responsible Agency:* Office of Federal Activities, General Information

(202)564-7167 or *http://www.epa.gov/compliance/nepa/.* Weekly receipt of Environmental Impact Statements Filed 09/10/2007 through 09/14/2007. Pursuant to 40 CFR 1506.9. *EIS No. 20070388, Draft EIS, FHW, MI,* Blue Water Bridge Plaza Study and Improve to the I-94/1-69 Corridor, To Provide Safe, Efficient and Secure Movement of People and Goods across the Canadian—US Border, Port Huron Area, St. Clair County, MI. Comment Period Ends: 11/05/2007. Contact: Ryan Rizzo,

(517)702-1833. *EIS No. 20070389, Final EIS, FHW, CA,* Interstate 5 (Santa Ana Freeway) Project, Improvement from State Route 91 in Orange County to Interstate 605 in Los Angeles County, CA. Wait Period Ends: 10/22/2007. Contact: Steve Healow,

(916)498-5849. *EIS No. 20070390, Draft Supplement, AFS, ID,* Meadow Face Stewardship Pilot Project, Improvement to Aquatic and Terrestrial Vegetative Conditions, Supplement Information on the Cumulative Effects Analysis, Nez Perce National Forest, Clearwater Ranger District, Idaho County, ID. Comment Period Ends: 11/05/2007. Contact: Darcy Pederson

(208)983-1950. *EIS No. 20070391, Draft EIS, NRC, OK,* Sequoyah Fuels Corporation Site, Proposed Reclamation Activities for the 243-hectare (600 acre) Site, (NUREG-1888) in Gore, OK, Comment Period Ends: 11/05/2007. Contact: Allen H. Fetter,

(301)415-8556. *EIS No. 20070392, Draft EIS, AFS, MT,* Bozeman Municipal Watershed Project, To Implement Fuel Reduction Activities, Bozeman Ranger District, Gallatin National Forest, City of Bozeman Municipal Watershed, Gallatin County, MT. Comment Period Ends: 11/05/2007. Contact: Jim Devitt,

(406)587-6749. *EIS No. 20070393, Draft Supplement, AFS, MT,* Fishtrap Project, Updated Information on Past Maintence/Restorative Treatments within Old Growth Stands, Timber Harvest, Prescribed Burning, Road Construction and Other Restoration Activities, Lolo National Forest, Plains/Thompson Falls Ranger District, Sanders County, MT. Comment Period Ends: 11/05/2007. Contact: Pat Partyka,

(406)826-4314. *EIS No. 20070394, Final EIS, COE, FL,* Central and Southern Florida Project, Comprehensive Everglades Restoration Plan, Caloosahatchee River (C-43) West Basin Storage Reservoir Project, Restoration of the Ecosystem in Caloosahatchee Estuary, Lake Okeechobee, FL, Wait Period Ends: 10/22/2007. Contact: Susan Conner,

(904)232-1782. *EIS No. 20070395, Final EIS, USA, MD,* Fort George G. Meade Base Realignment and Closure 2005 and Enhanced Use Lease

(EUL)Actions, Implementation, Anne Arundel, Howard, Montgomery, Prince George's Counties, MD. Wait Period Ends: 10/22/2007. Contact: Bob Ross,

(703)602-2878. Dated: September 18, 2007. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E7-18720 Filed 9-20-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2007-0960; FRL-8150-5] Pesticide Worker Protection; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA's Office of Pesticide Programs will host two public meetings regarding pesticide worker protection issues in October. A Pesticide Worker Safety and Health Conference will be held on October 2-4, 2007, in Arlington, VA, at the Hilton Hotel in Crystal City. The conference will provide an informational forum for federal and state agencies and private sector organizations involved in pesticide worker safety and health programs, policies and research initiatives. The conference will also highlight the accomplishments of the Agency's worker protection initiatives in partnership with our grantees. On the afternoon of October 4, 2007, the Office of Pesticide Programs will host a Diagnostic Tools Workshop in Arlington, VA, at the Hilton Hotel in Crystal City. Because health care providers lack tests to identify specific chemicals and/or levels of exposure that may be linked to the reported illnesses, the goal of this Workshop is to gather information on critical diagnostic needs, the current state of the science, and research needs for and feasibility of developing diagnostic tools to identify exposure to a specific chemical/level. DATES: The Pesticide Worker Safety and Health Conference will be held on October 2, 3, and 4, 2007, as follows: on October 2 from 1 p.m. to 6 p.m.; on October 3 from 8:30 a.m. to 5:30 p.m.; and on October 4 from 8:30 a.m. to noon. The Diagnostic Tools Workshop will be held on October 4, 2007, from 1:30 p.m. to 5:30 p.m. To request accommodation of a disability, please contact the persons listed under FOR FURTHER INFORMATON CONTACT , preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. ADDRESSES: The conference and workshop will be held at the Hilton Crystal City, 2399 Jefferson Davis Highway, Arlington, VA 22202. FOR FURTHER INFORMATION CONTACT: Questions regarding the Pesticide Worker Safety and Health Conference should be referred to: Elizabeth Evans, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-7891; fax number:

(703)308-2962; e-mail address: *worker_safety_health_conference@epa.gov* . Questions regarding the Diagnostic Tools Workshop should be referred to: Elizabeth Mendez, Health Effects Division (7509P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number

(703)305-5453; fax number

(703)305-5147; e-mail address: *Mendez.elizabeth@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you represent federal or state agencies or organizations which are involved or interested in pesticide worker safety and health programs, policies and research initiatives. Potentially affected entities may include, but are not limited to: Federal and state agencies, organizations and other stakeholders interested in pesticide worker safety and health programs, policies and research initiatives, including, but not limited to: Environmental occupational health and safety specialists, health care providers, epidemiologists, state departments of health, poison control centers, migrant clinicians, federal agencies, state lead agencies, grower organizations, and farmworker organizations. B. How Can I Get Copies of this Document and Other Related Information? 1. *Docket* . EPA has established a docket for this action under docket ID number EPA-HQ-OPP-2007-0960. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs

(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of the Docket Facility are 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is

(703)305-5805. 2. *Electronic access* . You may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . II. Background & Agendas A. Pesticide Worker Safety and Health Conference This Conference will focus on measuring the impact of current worker protection initiatives and developing effective interventions where protective gaps exist. The conference will also highlight the accomplishments of the Agency's worker protection initiatives in partnership with our grantees. Breakout sessions are planned for Wednesday, October 3 with expert presentations and panel discussions on: Take-home pesticide exposure and families of farmworkers; advances in engineering controls; education and training of farmworkers and pesticide applicators; administrative and policy solutions to better protect the pesticide workforce; risk communication strategies and lessons learned; the role of surveillance of occupational pesticide-related illnesses and injuries; worker exposure assessment, strengths and weaknesses in data collection. B. Diagnostic Tools Workshop One of the major challenges faced by health care professionals in the diagnosis and treatment of ailments associated with pesticide exposure is the lack of tests to identify specific chemicals and/or levels of exposure that may be linked to the reported illnesses. As a result, there is increasing interest in the development of more sophisticated diagnostic tools to help clinicians diagnose and prescribe effective courses of treatment. The goal of the Diagnostic Tools Workshop is to gather information on critical diagnostic needs, the current state of the science, and the research needs for and feasibility of developing diagnostic tools to identify exposure to a specific chemical/level. Planned agendas for both the Pesticide Worker Safety and Health Conference and the Diagnostic Tools Workshop are posted on the website at: *www.epa.gov/pesticides* . III. How Can I Request to Participate in these Meetings? Both of these meetings are open to the public. Persons interested in attending the Pesticide Worker Safety and Health Conference should go to EPA's website to register (at no cost) at: *www.epa.gov/pesticides* . The Diagnostic Tools Workshop is open to the public and seating is available on a first-come basis. List of Subjects Environmental protection, Pesticide worker safety, Farmworker. Dated: September 17, 2007. William R. Diamond, Director, Field and External Affairs Division, Office of Pesticide Programs. [FR Doc. E7-18706 Filed 9-20-07 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2007-0949; FRL-8149-4] Pesticide Registration; Clarification for Ion-Generating Equipment AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: With this notice, the Agency clarifies its position on the distinction between devices and pesticides with regard to ion-generating equipment and explains why such equipment is regulated as a pesticide. The notice also invites all interested parties to collaborate with the Agency in identifying data and other information that would be needed to support registration of these products. Through this notice, the Agency is establishing a process and a timeline for any parties affected by this notice to come into compliance with the clarified requirements of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FOR FURTHER INFORMATION CONTACT: Melba S. Morrow, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-2716; fax number:

(703)308-8481; e-mail address: *morrow.melba@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you sell or distribute ion-generating equipment that uses electrodes to emit chemical substances for pesticidal purposes. Potentially affected equipment include but are not limited to, washing machines containing electrodes that emit silver, copper, or zinc ions and ion generators used in swimming pools to kill algae and as an adjunct to the chlorination process. This listing is not exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of technology not listed in this notice could also be affected. The Agency requests information on any other type of equipment that generates ions from electrodes for pesticidal purposes that could be covered under this notice. B. How Can I Get Copies of this Document and Other Related Information? 1. *Docket* . EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2007-0949. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs

(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is

(703)305-5805. 2. *Electronic access* . You may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www./epa.gov/fedrgstr* . II. Background A. What Action is the Agency Taking? In a **Federal Register** notice published on November 19, 1976 (41 FR 51065), EPA consolidated and clarified the requirements applicable to pest control devices and device producers. In that notice, the Agency listed the types of products that would be affected by the notice and further provided a distinction between devices and pesticides. The notice clearly stated that if an article uses physical or mechanical means to trap, destroy, repel, or mitigate any pest, it is considered to be a device. In contrast, if the article incorporates a substance or mixture of substances to prevent, destroy, repel, or mitigate any pest, it is considered to be a pesticide. In September 2005, Agency staff advised a manufacturer that washing machines utilizing silver electrodes to produce silver ions for the pesticidal purpose of killing germs are considered devices rather than pesticides, and do not require registration. However, the Agency has since determined that under the statutory interpretation set out in the 1976 policy statement, such ion-generating equipment would require registration as a pesticide under FIFRA. This notice provides additional clarification of the Agency’s longstanding position, and gives the regulated community time to come into compliance with the requirements of FIFRA. B. What is the Agency’s Authority for Taking this Action? Under FIFRA, it is unlawful to sell or distribute any “pesticide” unless it is registered by EPA pursuant to FIFRA section 3. EPA has authority to register pesticides under FIFRA section 3, and therefore to interpret the terms “pesticide” and “device” for purposes of determining what is and what is not subject to the registration requirements of FIFRA. C. EPA’s Interpretations of “Pesticide” and “Device” Under FIFRA In the 1976 **Federal Register** notice that consolidated and clarified requirements for pest control devices and device producers, EPA stated its interpretation of the statutory terms “pesticide” and “device” for the purpose of distinguishing between items that were subject to the registration requirements of FIFRA (i.e., pesticides) and those that were not (i.e., devices). Section 2(h) of FIFRA defines “device” as “any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling or mitigating any pest.” Section 2(u) of FIFRA defines “pesticide” as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” In the 1976 **Federal Register** notice, EPA stated its statutory interpretation that the primary distinction between pesticides and devices was the means by which they achieved their pesticidal purpose. “If an article uses physical or mechanical means to trap, destroy, repeal [sic], or mitigate any [pest], it is considered to be a device. If the article incorporates a substance or mixture of substances intended to prevent, destroy, repeal [sic], or mitigate any pest, it is considered to be a pesticide.” (41 FR 51065). Therefore, the key distinction between pesticides and devices is whether the pesticidal activity of the article is due to physical or mechanical actions or due to a substance or mixture of substances. Some of the types of products that were specifically identified as devices in the notice included, but were not limited to, ultra violet light systems, ozone generators, water and air filters (except those containing substances or mixtures of substances), and ultrasonic devices making claims to inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites. At the time of the 1976 **Federal Register** notice, EPA was not aware of equipment such as the ion generating washing machine that was presented to EPA in 2005. In addition to the washing machine, EPA is also aware of other ion-generating equipment that is subject to this clarification. The articles covered by this notice are ion generators that incorporate a substance (e.g., silver or copper) in the form of an electrode, and pass a current through the electrode to release ions of that substance for the purpose of preventing, destroying, repelling, or mitigating a pest (e.g., bacteria or algae). Because these items incorporate a substance or substances that accomplish their pesticidal function, such items are considered pesticides for purposes of FIFRA, and must be registered prior to sale or distribution. D. Implementation EPA is aware that there may be some confusion in the regulated community regarding EPA’s interpretation of the distinction between pesticides and devices. EPA will work with producers of ion generators to identify what data and other information are required to support an application for registration and to obtain registrations to bring such equipment into compliance for equipment being distributed or sold in the United States on the date of publication of this notice. Any person distributing or selling such equipment on or prior to the date of publication of this notice may continue the distribution or sale of such equipment for 6 months from the date of publication of this notice, March 21, 2008. Any producer or importer of such equipment distributing or selling the equipment on or prior to the date of publication of this notice who wishes to continue that distribution or sale after 6 months from the date of publication of this notice, March 21, 2008, may do so only if a prospective registrant has commenced the registration process for the equipment by submitting, at a minimum, an Application for Pesticide Registration Form (EPA Form No. 8570-1) for the equipment. This form should be submitted to EPA on or before March 21, 2008. On the form, only the following information must be provided: Section I, Item 4: Company and Product Name; Section I, Item 5: Name and Address of Applicant; Section II, check “other” and place in explanation “Ion Generator FR Notice;” and all of Section IV. Persons distributing or selling such equipment on or prior to the date of publication of this notice other than the producer or importer may continue to distribute or sell such equipment until their inventories are exhausted. An electronic version of this form is *available at http://www.epa.gov/opprd001/forms* . Further, any producer or importer of such equipment who is distributing or selling the equipment on or prior to the date of publication of this notice who wishes to continue that distribution or sale after 18 months from the date of publication of this notice, March 23, 2009, may do so only if a prospective registrant has submitted to EPA a completed registration package for the equipment on or before March 23, 2009. Producers or importers of such equipment may continue to distribute or sell such equipment pursuant to this paragraph only until such time as EPA acts upon the application or the application is withdrawn. Again, persons distributing or selling such equipment on or prior to the date of publication of this notice other than the producer or importer may continue to distribute or sell such equipment until their inventories are exhausted. The completed one page application, EPA Form No. 8570-1, may be submitted to EPA by mail or by courier: 1. *Mail* (U.S. Postal Service): Document Processing Desk (AD ION) Office of Pesticide Programs (7504P) Environmental Protection Agency 1200 Pennsylvania Ave., NW. Washington, DC 20460-0001. 2. *Courier* : Document Processing Desk (AD ION) Office of Pesticide Programs (7504P) Environmental Protection Agency Room S-4900, One Potomac Yard 2777 S. Crystal Dr. Arlington, VA 22202-4501. List of Subjects Environmental protection, Copper ions, Ion-generating equipment, Pesticide devices, Pesticides and pests, Silver ions, Zinc ions. Dated: September 13, 2007. Anne E. Lindsay, Acting Director, Office of Pesticide Programs. [FR Doc. E7-18591 Filed 9-20-07; 8:45 am] BILLING CODE 6560-50-S FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY: Board of Governors of the Federal Reserve System SUMMARY: Background On June 15, 1984, the Office of Management and Budget

(OMB)delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act, as per 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR 1320 Appendix A.1. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Request for comment on information collection proposals The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information collection, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following: a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility; b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; c. Ways to enhance the quality, utility, and clarity of the information to be collected; and d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology. DATES: Comments must be submitted on or before November 20, 2007. ADDRESSES: You may submit comments, identified by (FR 29a,b; OMB No. 7100-0290) by any of the following methods: • Agency Web Site: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm. • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. • E-mail: regs.comments@federalreserve.gov. Include docket number in the subject line of the message. • FAX: 202/452-3819 or 202/452-3102. • Mail: Jennifer J. Johnson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, N.W., Washington, DC 20551. All public comments are available from the Board's web site at www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper in Room MP-500 of the Board's Martin Building (20th and C Streets, N.W.) between 9:00 a.m. and 5:00 p.m. on weekdays. Additionally, commenters should send a copy of their comments to the OMB Desk Officer by mail to the Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street, NW., Washington, DC 20503 or by fax to 202-395-6974. FOR FURTHER INFORMATION CONTACT: A copy of the PRA OMB submission including, the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at: http:// www.federalreserve.gov/boarddocs/reportforms/review.cfm or may be requested from the agency clearance officer, whose name appears below. Michelle Shore, Federal Reserve Board Clearance Officer (202-452-3829), Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551. Telecommunications Device for the Deaf

(TDD)users may contact (202-263-4869), Board of Governors of the Federal Reserve System, Washington, DC 20551. Proposal to approve under OMB delegated authority the extension for three years, without revision, of the following reports: *Report title:* Compensation and Salary Surveys *Agency form number:* FR 29a,b *OMB control number:* 7100-0290 *Frequency:* FR 29a, annually; FR 29b, on occasion *Reporters:* Employers considered competitors for Federal Reserve employees *Annual reporting hours:* FR 29a, 210 hours; FR 29b, 50 hours *Estimated average hours per response:* FR 29a, 6 hours; FR 29b, 1 hour *Number of respondents:* 45 *General description of report:* This information collection is voluntary (sections 10(4) and 11(1) of the Federal Reserve Act (12 U.S.C. 244 and 248(1)) and is given confidential treatment (5 U.S.C 552 (b)(4) and (b)(6)). *Abstract:* These surveys collect information on salaries, employee compensation policies, and other employee programs from employers that are considered competitors for Federal Reserve Board employees. The data from the surveys primarily are used to determine the appropriate salary structure and salary adjustments for Federal Reserve Board employees. Board of Governors of the Federal Reserve System, September 17, 2007. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E7-18622 Filed 9-20-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-379, CMS-10102, and CMS-R-235] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human 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), 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:* Extension of a currently approved collection; *Title of Information Collection:* Financial Statement of Debtor and Supporting Regulations in 42 CFR, Section 405.376; *Use:* Section 42 CFR 405.376(g) requires that, “ * * * In determining whether a claim will be compromised, or collection action terminated, CMS will consider the following factors: * * * age and health of the debtor, present and potential income, inheritance prospects, possible concealment or fraudulent transfer of assets * * *” Sections 1842(a)(1)(B) and

(C)of the Social Security Act and 42 CFR 405.376(g), provide the authority for collection of this information. In some instances a physician/supplier who is notified of a debt may allege inability to immediately repay the debt in full and may request an extended repayment schedule. Alternatively, the debtor may request a compromise settlement for less than the full amount due. Before establishing an extended repayment schedule or compromise settlement, the CMS's Regional Offices and the carrier must evaluate the provider's capacity to pay the debt. Accordingly, the provider is requested to complete a “Financial Statement of Debtor” form, CMS-379. *Form Number:* CMS-379 (OMB#: 0938-0270); *Frequency:* Reporting: Yearly; *Affected Public:* Business or other for-profit; *Number of Respondents:* 500; *Total Annual Responses:* 500; *Total Annual Hours:* 1000. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* National Implementation of Hospital Consumer Assessment of Health Providers and Systems (HCAHPS); *Use:* The intent of the HCAHPS initiative is to provide a standardized survey instrument and data collection methodology for measuring patients' perspectives on hospital care. While many hospitals collect information on patient satisfaction, there is no national standard for collecting or publicly reporting this information that would enable valid comparisons to be made across all hospitals. In order to make “apples to apples” comparisons to support consumer choice, it is necessary to introduce a standard measurement approach. Hospital Consumer Assessment of Healthcare Providers and Systems, also known as the CAHPS Hospital Survey (HCAHPS) can be viewed as a core set of questions that hospitals can combine with their customized items. HCAHPS was developed and is being implemented under the auspices of the Hospital Quality Alliance, a private/public partnership that includes hospital associations, consumer groups, payors and government agencies that share a common interest in reporting on hospital quality. Beginning in July 2007, participation in HCAHPS can affect the annual payment update for the inpatient prospective payment system

(IPPS)hospitals participating in the Reporting Hospital Quality Data Annual Payment Update (RHQDAPU) program; *Form Number:* CMS-10102 (OMB#: 0938-0981); *Frequency:* Reporting: Monthly; *Affected Public:* Individuals or households; *Number of Respondents:* 2,820,000; *Total Annual Responses:* 2,820,000; *Total Annual Hours:* 285,200. 3. *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 Section 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. While the burden has not changed, we revised the DUA to The DUA was updated to include language to ensure the agreement is a binding agreement between CMS and the User, to ensure the data is being encrypted and appropriate protections are in place at all times, and to ensure appropriate actions are immediately taken if there is a data breach or incident. *Form Number:* CMS-R-0235 (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. 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: September 13, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-18468 Filed 9-20-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10251 and CMS-10232] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human 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:* New Collection; *Title of Information Collection:* State Plan Pre-print for Integrated Medicare and Medicaid Programs; *Use:* Information submitted via the State Plan Amendment

(SPA)pre-print will be used by CMS Central and Regional Offices to analyze a State's proposal to implement integrated Medicare and Medicaid programs. The pre-print is an optional document for use by States to highlight the arrangements between a State and Medicare Advantage Special Needs Plans that are also providing Medicaid services. State Medicaid Agencies will complete the SPA pre-print and submit it to CMS for a comprehensive analysis. The pre-print provides the opportunity for States to confirm that their integrated care model complies with both federal statutory and regulatory requirements. The pre-print contains assurances, check-off items, and areas for States to describe policies and procedures for subjects such as enrollment, marketing and quality assurance. *Form Numbers:* CMS-10251 (OMB#: 0938-NEW); *Frequency:* Reporting—Once; *Affected Public:* State, Local, or Tribal Governments; *Number of Respondents:* 56; *Total Annual Responses:* 30; *Total Annual Hours:* 600. 2. *Type of Information Collection Request:* New Collection; *Title of Information Collection:* State Plan Template to Implement Section 6062 of the Deficit Reduction Act

(DRA)of 2005; *Use:* The DRA provides States with numerous flexibilities in operating their State Medicaid Programs. Section 6062 of the DRA (Opportunity for families of Disabled Children to Purchase Medicaid Coverage for Such Children) allows States the opportunity to provide Medicaid benefits to disabled children who would otherwise be ineligible because of family income that is above the State's highest Medicaid eligibility standards for children. It specifically allows families with disabled children to “buy-in” to Medicaid, and prevents them from having to stay impoverished, become impoverished, place their children in out-of-home placements, or simply give up custody of their child in order to access needed health care for their disabled children. Under the DRA, States must submit a SPA to CMS to effectuate this change to their Medicaid programs. CMS will provide a State Medicaid Director letter providing guidance on this provision and the associated SPA template for use by States to modify their Medicaid State Plans if they choose to implement this provision. Providing the State with this SPA template will reduce State burden significantly. *Form Numbers:* CMS-10232 (OMB#: 0938-NEW); *Frequency:* Reporting—Once; *Affected Public:* State, Local, or Tribal Governments; *Number of Respondents:* 56; *Total Annual Responses:* 30; *Total Annual Hours:* 600. 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 November 20, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attention: Melissa Musotto, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: September 13, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-18494 Filed 9-20-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0353] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pharmaceutical Development Study AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Pharmaceutical Development Study” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4816. SUPPLEMENTARY INFORMATION: In the **Federal Register** of February 13, 2006 (71 FR 7556), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0604. The approval expires on August 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: September 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-18641 Filed 9-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0337] Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees 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 information collection contained in regulations governing the use of radioactive drugs for basic informational research. DATES: Submit written or electronic comments on the collection of information by November 20, 2007. 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: Karen L. Nelson Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 1061, Rockville, MD 20857, 301-827-4816. 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. Radioactive Drug Research Committees— 21 CFR 361.1 (OMB Control Number 0910-0053) Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. Section 361.1 (21 CFR 361.1) sets forth specific regulations regarding the establishment and composition of Radioactive Drug Research Committees and their role in approving and monitoring basic research studies utilizing radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA approved Radioactive Drug Research Committee (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulation, and include studies of metabolism, human physiology, pathophysiology, or biochemistry. Section 361.1(c)(2) requires that each Radioactive Drug Research Committee shall select a chairman, who shall sign all applications, minutes, and reports of the committee. Each committee shall meet at least once each quarter in which research activity has been authorized or conducted. Minutes shall be kept and shall include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each Radioactive Drug Research Committee shall submit an annual report to FDA. The annual report shall include the names and qualifications of the members of, and of any consultants used by, the Radioactive Drug Research Committee, using FDA Form 2914, and a summary of each study conducted during the proceeding year, using FDA Form 2915. Under § 361.1(d)(5), each investigator shall obtain the proper consent required under the regulations. Each female research subject of childbearing potential must state in writing that she is not pregnant, or on the basis of a pregnancy test be confirmed as not pregnant. Under § 361.1(d)(8), the investigator shall immediately report to the Radioactive Drug Research Committee all adverse effects associated with use of the drug, and the committee shall then report to FDA all adverse reactions probably attributed to the use of the radioactive drug. Section 361.1(f) sets forth labeling requirements for radioactive drugs. These requirements are not in the reporting burden estimate because they are information supplied by the Federal Government to the recipient for the purposes of disclosure to the public (5 CFR 1320.3(c)(2)). Types of research studies not permitted under this regulation are also specified, and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial for safety or efficacy). These studies require filing of an investigational new drug application

(IND)under 21 CFR part 312, and the associated information collections are covered in OMB control no. 0910-0014. The primary purpose of this collection of information is to determine if the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson(s) of each individual Radioactive Drug Research Committee, investigators, and participants in the studies. The burden estimates are based on FDA's experience with these reporting and recordkeeping requirements over the past few years and the number of submissions received by FDA under the regulations. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section Forms No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 361.1(c)(3) and (c)(4) FDA 2914 80 1 80 1 80 361.1(c)(3) FDA 2915 50 6.8 340 3.5 1,190 361.1(d)(8) 50 6.8 340 0.1 34 Total Reporting 1,304 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Hours per Record Total Hours 361.1(c)(2) 80 4 10 800 361.1(d)(5) 50 6.8 .75 38 Total Recordkeeping 838 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-18646 Filed 9-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0347] Information Technology Strategic Planning; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; Request for comments. SUMMARY: The Food and Drug Administration

(FDA)is announcing a public meeting to solicit views and information from interested persons on issues concerning how the agency can best plan and apply information technology

(IT)resources to support the process for the review of human drug applications. In particular, FDA is seeking views and information from interested persons to identify and prioritize IT solutions that will support the process for the review of human drug applications. To help solicit such information and views, FDA is seeking responses to specific questions (see section IV of this document). DATES: *Public Meeting* : The public meeting will be held on October 19, 2007, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the meeting may be extended or may end early. *Registration and Participation* : Registration on the day of the public meeting will be provided on a space available basis beginning at 7:30 a.m. Because seating is limited, we recommend arriving early. See section I of the SUPPLEMENTARY INFORMATION section of this document for information on how to participate in the meeting. If you need special accommodations due to a disability, please contact Carolyn Yancey (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting. *Comments* : Submit written or electronic notices of participation and comments by 2 weeks prior to the public meeting. The docket for this meeting will remain open to receive additional comments until 15 days after the meeting date. ADDRESSES: The public meeting will be held at the Advisors and Consultants Staff Conference Room, FDA, 5630 Fishers Lane, Rockville, MD 20857. Additional information on parking and public transportation may be accessed at *http://www.fda.gov/oc/pdufa/default.htm* . Submit written notices of participation and comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20857. Submit electronic notices of participation and comments to *http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm* . Identify all submissions to the docket with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Carolyn Yancey, Office of Chief Information Officer (HFA-80), Food and Drug Administration, 5600 Fishers Lane, Rm. 16B-45, Rockville, MD 20857, 301-827-4302, *carolyn.yancey@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. How to Participate in the Meeting If you wish to make an oral presentation during the meeting, you must submit a written notice of participation with the Division of Dockets Management (see ADDRESSES ) no later than 2 weeks prior to the public meeting (see DATES ). To ensure timely handling, any outer envelope should be clearly marked with the docket number found in brackets in the heading of this document, along with the statement “Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management.” In the written notice, submit presenter's name and title, address, telephone and fax number, e-mail address, affiliation (if any), the sponsor of the presentation (e.g., the organization paying travel expenses or fees) (if any), and a brief summary of the presentation (including the discussion topic(s) that will be addressed or other pertinent information related to the topic in your presentation). If there are multiple participants please include the names and addresses of all individuals that plan to participate, and the approximate time requested for your presentation. We encourage individuals and organizations with common interests to consolidate or coordinate their presentations to allow adequate time for each request for presentation. Participants should submit to the Division of Dockets Management two copies of each presentation. We will file the meeting schedule indicating the order of presentation and the time allotted to each person with the Division of Dockets Management (see ADDRESSES ). We will also mail or telephone the schedule to each participant before the meeting. In anticipation of the meeting presentations moving ahead of schedule, participants are encouraged to arrive early to ensure their designated order of presentation. Participants who are not present when called risk forfeiting their scheduled time. II. Background Over the years, FDA has agreed to several IT-related performance commitments, starting with computer assisted reviews in the Prescription Drug User Fee Act (PDUFA) I, and continuing with the PDUFA III Electronic Applications and Submission Goals in which FDA committed to implementing the electronic Common Technical Document

(eCTD)and a common solution for the secure exchange of content, including secure e-mail and electronic submissions. FDA met these commitments by implementing the Electronic Submissions Gateway at *http://www.fda.gov/esg/* and an electronic system for facilitating the receipt and review of submissions in the eCTD format ( *http://www.fda.gov/cder/regulatory/ersr/ectd.htm* ). In addition, FDA implemented the first phase of the electronic labeling rule in the Center for Drug Evaluation and Research at *http://www.fda.gov/oc/datacouncil/spl.html* . Simultaneously, the Federal Government has also been pursuing healthcare electronic standards. In 2004, the President issued Executive Order 13335 establishing the position of the National Coordinator for Health Information Technology within the Office of the Secretary of Health and Human Services (HHS). The primary purpose of this position is to aid the Secretary of HHS in achieving the President's goal for most Americans to have access to an interoperable electronic medical record by 2014. One of the key initiatives under the Office of the National Coordinator was the establishment of the Health Information Technology Standards Panel—a public-private partnership with broad participation across more than 300 health-related organizations—to identify and harmonize data and technical standards for healthcare. Adding to the complexity of the healthcare movement towards a standards-based approach is the impact this may have on the regulated entities, from the small startup companies and research organizations, to the large multinational companies who submit regulatory submissions globally and are requesting global coordination on healthcare standards. During this timeframe FDA published IT plans to communicate FDA's overall direction and strategy in meeting IT-related performance goals and to describe our efforts in moving towards an electronic submission and review environment. In producing the previous IT plans FDA developed the plans internally and published the plans on the web—for example at *http://www.fda.gov/oc/pdufa/default.htm* . As FDA moves towards an automated standards-based electronic review environment, the agency is seeking public input on the type of information to be included in future IT plans that will provide our external stakeholders the information needed to be in alignment with the program direction and goals. III. Purpose and Scope of the Meeting The purpose of this public meeting is to provide stakeholders the opportunity to address specific topics (see section IV of this document) and present their views, recommendations, and any other pertinent information related to the scope of this public meeting. The scope of this public meeting includes the following areas: 1. The content of IT plans that is most useful to external stakeholders, 2. The data standards and guidance that best support available IT capabilities and any implementation considerations, and 3. How agency architecture and IT solutions can best be applied to support public health mission needs. IV. Issues for Discussion We are specifically interested in hearing comments regarding the following questions and any other pertinent information related to the feasibility of the electronic submission of premarket applications and other regulatory information related to the review of human drug applications including postmarket data sources: 1. What would help improve the quality of electronic submissions to the agency? 2. What would help increase the quantity of electronic submissions to the agency? 3. How would you prioritize these quality and quantity improvements? 4. What data standards are needed to implement these improvements? 5. How should FDA engage stakeholders while developing, testing, and implementing these solutions? 6. What topics are most useful to include in IT plans? 7. What lead time is needed for stakeholders to respond to and be in alignment with FDA initiatives? 8. How should FDA coordinate with stakeholders on the adoption and implementation of data standards? 9. What data standards areas provide the greatest challenge? 10. What approaches will facilitate the most effective and efficient adoption and implementation of data standards? 11. What key areas require new or expanded electronic submissions guidance? 12. What lessons learned and best practices should FDA consider as we transition from program-specific to enterprise IT solutions using a reusable and modular model? 13. What specific concerns (i.e., security, confidentiality, etc.) exist for a third party entity or entities providing services related to electronic submissions and review and how can they be addressed? V. Notice of Public Meeting The Commissioner of Food and Drugs is announcing that the public meeting will be conducted by FDA senior management. Persons who wish to participate in the meeting must file a written or electronic notice of participation with the Division of Dockets Management (see ADDRESSES and DATES ). No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Under 21 CFR 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. VI. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic notices of participation and comments for consideration. To permit time for all interested persons to submit data, information, or views on this subject, the administrative record of the meeting will remain open until 2 weeks prior to the public meeting. Persons who wish to provide additional materials for consideration should file these materials with the Division of Dockets Management (see ADDRESSES ). You should annotate and organize your comments to identify the specific questions to which they refer (see section IV of this document). Two paper copies of any mailed comments are to be submitted, 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VII. Transcripts The meeting will be transcribed. Transcripts of the meeting will be available for review at the Division of Dockets Management (see ADDRESSES ) and on the Internet at *http://www.fda.gov/ohrms/dockets* approximately 21 days after the meeting. You may place orders for copies of the transcript through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rm. 6-30, Rockville, MD 20857, at a cost of 10 cents per page. Dated: September 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-4692 Filed 9-18-07; 12:12 pm]

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