Notices. Notice

9,757 words·~44 min read·/register/2008/02/15/08-687

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

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-08-0493] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

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

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

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

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

(YRBS)(OMB No. 0920-0493)—Reinstatement—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The purpose of this request is to obtain OMB approval to continue data collection for the National Youth Risk Behavior Survey (YRBS), a school-based survey that has been conducted biennially since 1991. OMB approval for the 2005 YRBS and 2007 YRBS expired November 30, 2007 (OMB No. 0920-0493). CDC seeks a three-year approval to conduct the YRBS in Spring 2009 and Spring 2011. Minor changes incorporated into this reinstatement request include: An updated title for the information collection, to accurately reflect the years in which the survey will be conducted; minor changes to the burden estimate; and minor changes to the data collection instrument. The YRBS assesses priority health risk behaviors related to the major preventable causes of mortality, morbidity, and social problems among both youth and young adults in the United States. Data on health risk behaviors of adolescents are the focus of approximately 40 national health objectives in Healthy People 2010, an initiative of the U.S. Department of Health and Human Services (HHS). The YRBS provides data to measure at least 10 of the health objectives and 3 of the 10 Leading Health Indicators established by Healthy People 2010. In addition, the YRBS can identify racial and ethnic disparities in health risk behaviors. No other national source of data measures as many of the Healthy People 2010 objectives addressing adolescent behaviors as the YRBS. The data also will have significant implications for policy and program development for school health programs nationwide. In Spring 2009 and Spring 2011, the YRBS will be conducted among nationally representative samples of students attending public and private schools in grades 9-12. Information supporting the YRBS also will be collected from school administrators and teachers. The table below reports the number of respondents annualized over the 3-year project period. There are no costs to respondents except their time. Estimated Annualized Burden Hours Type of respondents Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Administrators Recruitment Script for the Youth Risk Behavior Survey 230 1 30/60 115 Teachers Data Collection Checklist for the Youth Risk Behavior Survey 400 1 15/60 100 Students Youth Risk Behavior Survey 8,000 1 45/60 6,000 Total 6,215 Dated: February 7, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-2832 Filed 2-14-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-08-0337] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

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

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

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project National Blood Lead Surveillance System (OMB No. 0920-0337)—Revision—National Center for Environmental Health (NCEH), Coordinating Center for Environmental Health and Injury Prevention (CCEHIP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The National Blood Lead Surveillance System (NBLSS) would like to continue its effort to collect information related to lead exposure among children less than six years old. The overarching goal of this system is to establish Childhood Lead Surveillance Systems at the state and national levels. This is a revision request in addition to a 3-year revision with an increase in the burden hours and inclusion of the adult blood lead surveillance system. As part of this effort we would like to revise this application to include 3 additional State and local Childhood Lead Poisoning Prevention Programs (CLPPP) who report to the NBLSS. These three programs were added to help provide a more comprehensive picture of childhood lead poisoning in the United States. The objectives for developing this system are three-fold. First, we would like to use surveillance data to estimate the extent of elevated blood-lead levels

(BLLs)among children less than 6 years old. This is important because it will allow us to systematically track the management and follow-up of those children found to be poisoned with lead. Our next objective for the development of this system is to examine potential sources of lead exposure. Although we've been successful in eliminating atmospheric lead with the use of unleaded gasoline and have continued to make strides in the elimination of household sources of lead commonly found in paint and dust, recent events have highlighted other potentially hidden sources of lead. This system will allow us to track the burden of such hidden sources and will help us eliminate such threats with the establishment of laws aimed at preventing the importation of such goods into our nation. The establishment of such laws will of course be a joint effort between several federal agencies; however, this surveillance system will help facilitate our efforts. The final objective of this system is to facilitate the allocation of resources for lead poison prevention activities. The allocation of federal resources to State surveillance systems are based on reports of blood-lead tests from laboratories. Ideally, laboratories report results of all lead tests to the state health department. State health departments then send reports to CDC using de-identified data. It is from these reports that CDC is able to determine funding levels. In addition to reporting child blood lead levels, many laboratories also report adult blood lead levels. Thus, this OMB request would also like to include the Adult Blood Lead Epidemiology and Surveillance Program (ABLES). The ABLES Program is a state-based surveillance system under which participating States provide information to CDC's National Institute for Occupational Safety and Health (NIOSH) on laboratory reported blood lead levels among adults. For all adults (16 and older) the State will provide data on all laboratory reports when the adult's blood lead level is equal to or greater than 25 mcg/dl. These data are to be consolidated into a single data submission by task time periods. The ABLES program ultimately aims to collect the complete list of variables for all blood lead tests, including blood lead levels less than 25 mcg/dl, and urges all States to progressively supply this information as it becomes available. All data submissions must be delivered in the supplied format providing a field for 20 variables, even if some variables have no data available at the time. The use of both Childhood Lead Surveillance System and the ABLES Program will allow us to systematically track pockets of exposure to lead. It will also allow us to fully understand exposure potential and ways in which to prevent future sources of lead poisoning. Both systems are invaluable and will no doubt help us as we continue our stride in the elimination of lead poisoning in our nation. There is no cost to respondents other than their time. Estimated Annualized Burden Table Respondents Number of respondents Number of response per respondent Average burden per response (in hrs.) Total burden hours State and Local Health Departments for Child Surveillance 42 4 2 336 State and Local Health Departments for Adult Surveillance 40 4 2 320 Total 656 Dated: February 6, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-2836 Filed 2-14-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10242, CMS-10165, CMS-10251, CMS-R-218 and CMS-10252] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Revisions to Payment Policies Under the Physician Fee Schedule, Other Changes to Payment Under Part B, and Revisions to Payment Policies for Ambulance Services for CY 2008 (42 CFR 424.36—Signature Requirements); *Use:* Section 42 CFR 424.33(a)(3) states that all claims must be signed by the beneficiary or the beneficiary's representative (in accordance with 42 CFR 424.36(b)). Section 42 CFR 424.36(a) states that the beneficiary's signature is required on a claim unless the beneficiary has died or the provisions of 424.36(b), (c), or

(d)apply. The statutory authority requiring a beneficiary's signature on a claim submitted by a provider is located in section 1835(a) and in 1814(a) of the Social Security Act (the Act), for Part B and Part A services, respectively. The authority requiring a beneficiary's signature for supplier claims is implicit in sections 1842(b)(3)(B)(ii) and in 1848(g)(4) of the Act. Because it is very difficult to obtain a beneficiary's signature (or the signature of a person authorized to sign on behalf of the beneficiary) on a claim when the beneficiary is being transported by ambulance in emergency situations, CMS is proposing that, for emergency ambulance transport services, an ambulance provider or supplier may submit the claim without a beneficiary's signature, as long as certain documentation requirements are met. The information collected will be used by CMS contractors (both, fiscal intermediaries and carriers) that process and pay emergency ambulance transport claims. *Form Number:* CMS-10242 (OMB#: 0938-New); *Frequency:* Reporting: Hourly, Daily, Weekly, Monthly and Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 9,000; *Total Annual Responses:* 6,500,000; *Total Annual Hours:* 541,667. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Electronic Health Record; *Use:* The purpose of this demonstration project is to reward the delivery of high-quality care supported by the adoption and use of electronic health records in small to medium-sized primary care physician practices. While this is separate and distinct from the Medicare Care Management Performance

(MCMP)Demonstration, it expands upon the foundation created by the MCMP Demonstration, which was mandated by Section 649 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. The electronic health record demonstration will be operational for a 5-year period and will be operated under section 402 demonstration waiver authority. The information to be obtained as part of the application form is necessary to document basic information for physician practices that intend to participate in this demonstration initiative. *Form Number:* CMS-10165 (OMB#: 0938-0965); *Frequency:* *Once; Affected Public:* Private sector—Business or other for-profit; *Number of Respondents:* 2400; *Total Annual Responses:* 2400; *Total Annual Hours:* 520. 3. *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. Based on comments received during the 60-day comment period, both the instructions and pre-print have been revised. *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. 4. *Type of Information Collection Request:* Extension of currently approved collection; *Title of Information Collection:* Information Collection Requirements Contained in 45 CFR Part 162; HIPAA Standards for Electronic Transactions; *Use:* This submission contains information collection requirements in HCFA-0149-F, CMS-0003-P, CMS-0005-P, and CMS-003/005-F. This collection establishes standards for electronic transactions and for code sets to be used in those transactions. The collection standardizes the approximately 400 formats of electronic health care claims used in the United States. The use of these standards significantly reduces the administrative burden associated with paper documents, lowers operating costs, and improves data quality for health care providers and health plans; *Form Number:* CMS-R-218 (OMB# 0938-0866); * Frequency:* On occasion; *Affected Public:* Business or other for-profit; *Number of Respondents:* 3,400,000; *Total Annual Responses:* 3,400,000; *Total Annual Hours:* 1. 5. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Certificate of Destruction for Data Acquired from the Centers for Medicare and Medicaid Services; *Use:* The Certificate of Destruction will be used by recipients of CMS data to certify that they have destroyed the data they have received through a CMS Data Use Agreement (DUA). The DUA requires the destruction of the data at the completion of the project/expiration of the DUA. The DUA addresses the conditions under which CMS will disclose and the User will maintain CMS data that are protected by the Privacy Act of 1974, § 552a and the Health Insurance Portability Accountability Act of 1996. CMS has developed policies and procedures for such disclosures that are based on the Privacy Act and the Health Insurance Portability Act (HIPAA). The Certificate of Destruction is required to close out the DUA and to ensure the data are destroyed and not used for another purpose. *Form Number:* CMS-10252 (OMB# 0938-New); *Frequency:* On occasion; *Affected Public:* Business or other for-profit; *Number of Respondents:* 500; *Total Annual Responses:* 500; *Total Annual Hours:* 84. 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 *March 17, 2008* . OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: February 8, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8-2804 Filed 2-14-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-267] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Advantage Program Requirements Referenced in 42 CFR part 422; *Use:* The information collection requirements are mandated by 42 CFR part 422. Section 4001 of the Balanced Budget Act of 1997

(BBA)added sections 1851 through 1859 to the Social Security Act to establish this program. The Medicare, Medicaid, and SCHIP Benefits Improvement Act and Protection Act of 2000, also added new requirements in addition to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Medicare Advantage

(MA)organizations (formerly M+C organizations) and potential MA organizations (applicants) use the information discussed to comply with the eligibility requirements and the MA contract requirements. CMS will use this information to approve contract applications, monitor compliance with contract requirements, make proper payment to MA organizations, determine compliance with the new prescription drug benefit requirements established by the MMA, and to ensure that correct information is disclosed to Medicare beneficiaries, both potential enrollees and enrollees. *Form Number:* CMS-R-267 (OMB #0938-0753); *Frequency:* Yearly; *Affected Public:* Business or other for-profit, and individuals or households; *Number of Respondents:* 9,000,670; *Total Annual Responses:* 9,000,670; *Total Annual Hours:* 7,711,085. 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. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by *April 15, 2008* : 1. *Electronically.* You may submit your comments electronically to *http://www.regulations.gov* . Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) accepting comments. 2. *By regular mail.* You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: February 8, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8-2813 Filed 2-14-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0077] Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting 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 present MedWatch Forms 3500 and 3500A (also known as MedWatch reporting forms) having an OMB expiration date of October 31, 2008. These forms are presently used to report to the agency about adverse events, product problems, and medication/device use errors that occur with FDA regulated products, including drugs, biologicals, medical devices, special nutritional products, dietary supplements, and non-prescription (over-the-counter (OTC)) human drug products marketed without an approved application. DATES: Submit written or electronic comments on the collection of information by April 15, 2008. ADDRESSES: Submit electronic comments on the collection of information to *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: Elizabeth Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. 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. MedWatch: The FDA Medical Products Reporting Program, Form FDA 3500 and Form FDA 3500A—(OMB Control Number 0910-0291)—Extension Under sections 505, 512, 513, 515, and 903 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355, 360b, 360c, 360e, and 393), and section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has the responsibility to ensure the safety and effectiveness of drugs, biologics, and devices. Under section 502(a) of the act (21 U.S.C. 352(a)), a drug or device is misbranded if its labeling is false or misleading. Under section 502(f)(1) of the act it is misbranded if it fails to bear adequate warnings, and under section 502(j), it is misbranded if it is dangerous to health when used as directed in its labeling. Under section 4 of the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417), 21 U.S.C. 342 is amended so that FDA must bear the burden of proof to show a dietary supplement is unsafe. To carry out its responsibilities, the agency needs to be informed whenever an adverse event, product problem, or error with use of a medication or device occurs. Only if FDA is provided with such information will the agency be able to evaluate the risk, if any, associated with the product, and take whatever action is necessary to reduce or eliminate the public's exposure to the risk through regulatory action. To ensure the marketing of safe and effective products, certain adverse events must be reported. Requirements regarding mandatory reporting of adverse events or product problems have been codified in parts 310, 314, 600, and 803 (21 CFR 310, 314, 600, and 803), specifically §§ 310.305, 314.80, 314.98, 600.80, 803.30, 803.50, 803.53, and 803.56. Two forms are available from the agency in order to implement these provisions for reporting of adverse events, product problems, and medication/device use errors for FDA regulated products such as medications, devices, biologics, special nutritional products, cosmetics, dietary supplements, and non-prescription

(OTC)human drug products marketed without an approved application, as well as any other products that are regulated by FDA. Form FDA 3500 may be used by health care professionals and the public for voluntary (i.e., not mandated by law or regulation) reporting. Form FDA 3500A is used by industry for mandatory reporting (i.e., required by law or regulation). Respondents to this collection of information are health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.), consumers, manufacturers of biological and drug products or medical devices, and importers. I. Use of Form FDA 3500 (Voluntary Version) The voluntary version of the form is used to submit all reports not mandated by Federal law or regulation. Individual health professionals are not required by law or regulation to submit reports to the agency or the manufacturer, with the exception of certain adverse reactions following immunization with vaccines as mandated by the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660). Those mandatory reports are not submitted to FDA on the 3500 or 3500A forms, but are submitted to the joint FDA/Centers for Disease Control and Prevention Vaccines Adverse Event Reporting System (VAERS) on the VAERS-1 form (see: *http://www.vaers.hhs.gov/pdf/vaers_form.pdf* ). Hospitals are not required by Federal law or regulation to submit reports associated with drug products, biological products, or special nutritional products. However, hospitals and other user facilities are required by Federal law to report medical device-related deaths and serious injuries. II. Use of Form FDA 3500A (Mandatory Version) A. Drug and Biologic Products In sections 505(j) and 704 of the act (21 U.S.C. 374), Congress has required that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 and 314 (drugs) and 600 (biologics). Parts 310, 314, and 600 mandate the use of FDA Form 3500A for reporting to FDA on adverse events that occur with drugs and biologics. Manufacturers whose name (under section 403(e)(1) of the act (21 U.S.C. 343(e)(1)) appears on the label of a dietary supplement marketed in the United States are required to report adverse reactions associated with use of the dietary supplement to FDA (the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462)). B. Medical Device Products Section 519 of the act (21 U.S.C. 360i) requires manufacturers and importers of devices intended for human use to establish and maintain records, make reports, and provide information as the Secretary of Health and Human Services may by regulation reasonably require to assure that such devices are not adulterated or misbranded and to otherwise assure their safety and effectiveness. The Safe Medical Device Act of 1990 (Public Law 91-4243), signed into law on November 28, 1990, amends section 519 of the act. The amendment requires that user facilities such as hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities report deaths related to medical devices to FDA and to the manufacturer, if known. Serious illnesses and injuries are to be reported to the manufacturer or to FDA if the manufacturer is not known. These statutory requirements regarding mandatory reporting have been codified by FDA under part 803. Part 803 mandates the use of FDA Form 3500A for reporting to FDA on medical devices. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), signed into law October 26, 2002, amended section 519 of the act. The amendment (section 303 of MDUFMA) required FDA to revise the MedWatch forms “to facilitate the reporting of information * * *relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused.” Under section 303 of the FDA Amendments Act of 2007 (Public Law 110-85), FDA must share reports for Humanitarian Device Exemption

(HDE)devices. To facilitate sharing the appropriate reports, it would be helpful to obtain the HDE number in the present section G, box 5, on page 2 of FDA Form 3500A. III. Proposed Modifications to Forms The proposed extension to Form FDA 3500 and Form FDA 3500A will only have changes in the form instructions to reflect the range of reportable products and provide clarity of reporting. The previous forms changes (2005-2008) allow reporters to better utilize available space for data entry and offer voluntary reporters the opportunity to clearly describe the suspected adverse event, product problem or error, and provide better quality safety-related data for agency evaluation. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 FDA Center No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours CBER/CDER Form 3500 22,955 1 22,955 0.6 13,773 Form 3500A (§§ 310.305, 314.80, 314.98, and 600.80) 600 579.9 347,940 1.1 382,734 CDRH Form 3500 3,433 1 3,433 0.6 2,060 Form 3500A (Part 803) 1,935 33 63,855 1.0 63,855 CFSAN Form 3500 847 1 847 0.6 508 Form 3500A 0 0 0 1.0 0 Form 3500 16,341 Form 3500A 446,589 Total 462,930 1 CBER (Center for Biologics Evaluation and Research), CDER (Center for Drug Evaluation and Research), CDRH (Center for Devices and Radiological Health), and CFSAN (Center for Food Safety and Applied Nutrition). FDA Form 3500 is for voluntary reporting; FDA Form 3500A is for mandatory reporting. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: February 8, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2821 Filed 2-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0073] (formerly Docket No. 2002N-0418) Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(AER)for licensed biological products, and general records associated with the manufacture and distribution of biological products. DATES: Submit written or electronic comments on the collection of information by April 15, 2008. ADDRESSES: Submit electronic comments on the collection of information to *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: JonnaLynn P. Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(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. Adverse Experience Reporting for Licensed Biological Products; and General Records —21 CFR Part 600 (OMB Control Number 0910-0308)—Extension Under the Public Health Service Act (42 U.S.C. 262), FDA is required to ensure the marketing of only those biological products which are safe and effective. FDA must, therefore, be informed of all adverse experiences occasioned by the use of licensed biological products. FDA issued the AER requirements in part 600 (21 CFR part 600) to enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The primary purpose of FDA's AER system is to flag potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a biological product's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides the opportunity to collect information on rare, latent, and long-term effects. Reports are obtained from a variety of sources, including patients, physicians, foreign regulatory agencies, and clinical investigators. Information derived from the AER system contributes directly to increased public health protection because such information enables FDA to recommend important changes to the product's labeling (such as adding a new warning), to initiate removal of a biological product from the market when necessary, and to assure the manufacturer has taken adequate corrective action if necessary. The regulation in § 600.80(c)(1) requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the licensed manufacturer. These are known as postmarketing 15-day Alert reports. Section 600.80(c)(1) also requires licensed manufacturers to submit any followup reports within 15 calendar days of receipt of new information or as requested by FDA. Section 600.80(e) requires licensed manufacturers to submit a 15-day Alert report for an adverse experience obtained from a postmarketing clinical study only if there is a reasonable possibility that the product caused the adverse experience. Section 600.80(c)(2) requires licensed manufacturers to report each adverse experience not reported in a postmarketing 15-day Alert report at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The majority of these periodic reports will be submitted annually because a large percentage of currently licensed biological products have been licensed longer than 3 years. Section 600.80(i) requires licensed manufacturers to maintain for a period of 10 years records of all adverse experiences known to the licensed manufacturer, including raw data and any correspondence relating to the adverse experiences. Section 600.81 requires licensed manufacturers to submit, at an interval of every 6 months, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. These semiannual distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, number of dosage units, and date of release. Under § 600.90, a licensed manufacturer may submit a waiver request for any requirements that applies to the licensed manufacturer under § 600.80 and 600.81. A waiver request submitted under § 600.90 must include supporting documentation. Manufacturers of biological products for human use must keep records of each step in the manufacture and distribution of a product including any recalls. These recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also enable FDA to perform meaningful inspections. Section 600.12 requires, among other things, concurrently with the performance of each step that all records of each step in the manufacture and distribution of a product be made and retained for no less than 5 years after the records of manufacture have been completed or 6 months after the latest expiration date for the individual product, whichever represents a later date. In addition, manufacturers must maintain records of sterilization of equipment and supplies, animal necropsy records, and records in cases of divided manufacturing of a product. Section 600.12(b)(2) requires manufacturers to maintain complete records pertaining to the recall from distribution of any product. Respondents to this collection of information are manufacturers of biological products. Under table 1 of this document, the number of respondents is based on the estimated number of manufacturers that submitted the required information to the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, FDA, in fiscal year

(FY)2006. Based on information obtained from FDA's database system, there were 88 licensed biologics manufacturers. This number excludes those manufacturers who produce blood and blood components and in-vitro diagnostic licensed products, because § 600.80(k) specifically exempts manufacturers of these products from adverse experience reporting requirements. The total annual responses are based on the estimated number of submissions received annually by FDA in FY 2006. However, not all manufacturers have submissions in a given year and some may have multiple submissions. There were an estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179 lot distribution reports submitted to FDA. The number of 15-day Alert reports for postmarketing studies under § 600.80(e) is included in the total number of 15-day Alert reports. FDA received 6 requests for waiver under § 600.90, all of which were granted. The hours per response are based on FDA experience. The burden hours required to complete the MedWatch Form for § 600.80(c)(1), (e), and

(f)are reported under OMB control no. 0910-0291. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 600.80(c)(1) and 600.80(e) 88 270.85 23,835 1 23,835 600.80(c)(2) 88 248.55 21,872 28 612,416 600.81 88 2.03 179 1 179 600.90 6 1 6 1 6 Total 636,436 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Under table 2 of this document, the number of respondents is based on the number of manufacturers subject to those regulations. Based on information obtained from FDA's database system, there were 303 licensed manufacturers of biological products in FY 2006. However, the number of recordkeepers listed for § 600.12(a) through

(e)excluding (b)(2) is estimated to be 112. This number excludes manufacturers of blood and blood components because their burden hours for recordkeeping have been reported under 21 CFR 606.160 in OMB control no. 0910-0116. The total annual records is based on the annual average of lots released (5,291), number of recalls made (1,841), and total number of adverse experience reports received (45,707) in FY 2006. The hours per record are based on FDA experience. FDA estimates the burden of this recordkeeping as follows: **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 600.12 112 47.24 5,291 32 169,312 600.12(b)(2) 303 6.08 1,841 24 44,184 600.80(i) 88 519.40 45,707 1 45,707 Total 259,203 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 8, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2890 Filed 2-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0095] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the draft guidance entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses.” FDA is issuing this draft guidance to inform industry and agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of influenza viruses. 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 May 15, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “ Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses “ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this 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.regulations.gov* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Tamara Feldblyum Center for Devices and Radiological Health (HFZ-440) Food and Drug Administration 2098 Gaither Rd., Rockville, MD 20850 240-276-0715. SUPPLEMENTARY INFORMATION: I. Background This draft guidance document recommends studies that may be used to establish the analytical and clinical performance of in vitro diagnostic devices

(IVDs)for the detection or detection and differentiation of influenza viruses. The document addresses devices that detect either influenza viral antigens or influenza viral genome (protein or nucleic acid), including those for novel influenza viruses in either human specimens or culture isolate. The guidance does not address devices that detect serological response from the host to the viral antigen, nor does it address establishing performance of non-influenza components of multi-analyte or multiplex devices. This guidance document identifies the classification regulations and product codes for existing legally marketed influenza tests and supplements other FDA documents that discuss the specific contents of premarket submissions. II. Significance of Guidance 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 establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of influenza viruses. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1638 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets/default.htm* . IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations and guidance documents. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807 subpart E have been approved under OMB Control No. 0910-0120; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB Control No. 0910-0130; the collections of information in 21 CFR part 814 have been approved under OMB Control No. 0910-0231; the collections of information in 21 CFR part 812 have been approved under OMB Control No. 0910-0078; and the collections of information associated with CLIA waiver submissions and described in the draft guidance document for industry and FDA staff, “Recommendations for Clinical Laboratory Improvement Amendments of 1988

(CLIA)Waiver Applications” have been approved under OMB Control No. 0910-0598. V. 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. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: February 11, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2826 Filed 2-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0065 (formerly Docket No. 2005D-0203)] Guidance for Industry on Safety Testing of Drug Metabolites; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance for industry entitled “Safety Testing of Drug Metabolites.” This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. It also provides recommendations on the timing and type of nonclinical studies that should be conducted to investigate the potential for clinical toxicity of drug metabolites. This guidance applies to small molecule nonbiologic drug products under development. This guidance finalizes the draft guidance published on June 6, 2005. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 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.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Aisar Atrakchi, Center for Drug Evaluation and Research (HFD-130), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4384, Silver Spring, MD 20993-0002, 301-796-1036. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled “Safety Testing of Drug Metabolites.” This guidance addresses drug metabolites of small molecule nonbiologic drug products and does not apply to some cancer products. It applies to drug metabolites that are not adequately evaluated in standard toxicology testing with the parent drug. This can happen if the metabolite is present only in humans or if it is present at higher levels (referred to in the guidance as “disproportionate drug metabolite”) in humans than in any of the animal toxicology test species. The guidance provides recommendations on the timing and types of nonclinical safety studies that should be conducted for drug metabolites that are present at greater than 10 percent of the parent drug systemic exposure as measured in plasma. A draft version of this guidance was made available for public comment in 2005 (70 FR 32839, June 6, 2005). All of the public comments we received have been considered and the guidance was revised as appropriate. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the safety testing of drug metabolites. 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. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. 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: February 8, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2827 Filed 2-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anti-Infective Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an amendment to the notice of a meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the **Federal Register** of January 11, 2008 (73 FR 2055). The amendment is being made to reflect a change in the *Date and Time* and *Agenda* portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512530. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of January 11, 2008, FDA announced that a meeting of the Anti-Infective Drugs Advisory Committee would be held on February 27 and 28, 2008. On page 2056, in the first column, the *Date and Time* and *Agenda* portions are amended to read as follows: *Date and Time* : The meeting will be held on February 27, 2008, from 8 a.m. to 5 p.m. *Agenda* : On February 27, 2008, the committee will discuss new drug application

(NDA)022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection. This notice is issued under the Federal Advisory Committee Act (U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: February 11, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-2824 Filed 2-14-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Molecular and Cellular Sciences Special Emphasis Panel. *Date:* February 28, 2008. *Time:* 11 a.m. to 2 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Noni Byrnes, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5130, MSC 7840, Bethesda, MD 20892,

(301)435-1023, *byrnesn@csr.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Member Conflict: Stress. *Date:* February 29, 2008. *Time:* 12 p.m. to 2 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Christine L. Melchior, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD 20892,

(301)435-1713, *melchioc@csr.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Member Conflict: Innate Immunity and Inflammation. *Date:* March 7, 2008. *Time:* 10 a.m. to 12 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Betty Hayden, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4206, MSC 7812, Bethesda, MD 20892, 301-435-1223, *haydenb@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Red Cell Cytoskeleton. *Date:* March 10, 2008. *Time:* 3 p.m. to 4:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). *Contact Person:* Manjit Hanspal, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7804, Bethesda, MD 20892, 301-435-1195. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Neuroimmunology and Neurological Disorders. *Date:* March 12, 2008. *Time:* 3 p.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call). *Contact Person:* Vilen A. Movsesyan, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD 20892, 301-402-7278, *movsesyanv@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Parasites. *Date:* March 13, 2008. *Time:* 12:30 p.m. to 3:30 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). *Contact Person:* Marian Wachtel, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3208, MSC 7858, Bethesda, MD 20892, 301-435-1148, *wachtelm@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Fellowships. *Date:* March 20-21, 2008. *Time:* 9 a.m. to 10 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). *Contact Person:* Malgorzata Klosek, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4188, MSC 7849, Bethesda, MD 20892, 301-435-2211, *klosekm@csr.nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Member Conflict: Oral, Dental and Craniofacial Sciences. *Date:* March 20, 2008. *Time:* 2 p.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). *Contact Person:* J. Terrell Hoffeld, DDS, PhD, Dental Officer, USPHS, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7816, Bethesda, MD 20892, 301-435-1781, *th88q@nih.gov.* *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Small Business Grant Applications: Immunology. *Date:* March 21, 2008. *Time:* 8:30 a.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* State Plaza Hotel, 2117 E Street, NW., Washington, DC 20037. *Contact Person:* Stephen M. Nigida, PhD, Health Scientist Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4212, MSC 7812, Bethesda, MD 20892. 301-435-1222, *nigidas@csr.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: February 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08-687 Filed 2-14-08; 8:45 am]

Connectionstraces to 12

Traces to 12 documents

U.S. Code