Notices. Notice

7,092 words·~32 min read·/register/2008/06/12/08-1350

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

BILLING CODE 6760-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Pediatric Medical Device Stakeholders Workshop AGENCIES: Agency for Healthcare Research and Quality (AHRQ); U.S. Food and Drug Administration (FDA); and National Institutes of Health (NIH). ACTION: Notice. SUMMARY: The Interagency (AHRQ-FDA-NIH) Pediatric Devices Working Group is holding a workshop to gather information about the development of pediatric devices. DATES: The workshop will be held on July 23, 2008 from 8 a.m. until 5 p.m.

EDT. ADDRESSES: The workshop will be held in Natcher Auditorium, located in Building 45, NIH Main Campus, Bethesda, Maryland 20814. FOR FURTHER INFORMATION CONTACT: Steven Hirschfeld, MD, PhD, Associate Director for Clinical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 31 Center Drive, Room 2A03, Bethesda, Maryland 20814; Tel: 301-496-3454; Fax: 301-402-1104; E-mail: *hirschfs@mail.nih.gov.* SUPPLEMENTARY INFORMATION: In September 2007, the Congress passed Title III of the FDA Amendments Act, called the Pediatric Medical Device Safety and Improvement Act.

The legislation requires that the DHHS Secretary submit a plan to Congress for expanding pediatric medical device research and development. In developing the plan, the DHHS Secretary shall consult with individuals and organizations with appropriate expertise in pediatric medical devices. The plan shall include the current status of federally funded pediatric medical device research; any gaps in such research, which may include a survey of pediatric medical providers regarding unmet pediatric medical device needs, as needed; and a research agenda for improving pediatric medical device development and Food and Drug Administration clearance or approval of pediatric medical devices, and evaluating the short- and long-term safety and effectiveness of pediatric medical devices.

This meeting of the Interagency Pediatric Devices Working Group, which includes AHRQ, FDA, and NIH, seeks to elicit feedback about expanding pediatric device research and development from interested communities and the public to help inform the plan that the DHHS Secretary will submit in accordance with the legislation. The purpose of this workshop is to: • Inform the community of the current status of pediatric device development; • Describe available mechanisms for device product registration; • Describe available mechanisms for pediatric device project funding; • Understand what stakeholders see to be important areas of study; • Determine gaps in knowledge and where the needs for research are; and • Discuss ways to gather the information needed to move ahead, such as overcoming barriers, handling logistics, determining classes of devices to study, and identifying available databases, registries, surveillance systems.

You are not required to preregister for this meeting to attend. However, preregistering allows you to receive current information about the meeting, its agenda, and other details (such as how to prepare statements, participating in working lunch sessions, etc.). To register, please send an e-mail to *hirschfs@mail.nih.gov* with “Device Workshop Registration” in the subject line. Please also include the following information. (Note: Incomplete information may limit the organizers' ability to keep you informed about the workshop; please provide accurate and complete information): • First and Last Name • Degree (optional) • Professional Title (optional) • Organization and Department • Type of Organization (e.g., government agency, non-profit hospital, for-profit company, etc.) • Address • City, State, and ZIP Code • Country • Phone (Main contact number): • Fax: • E-mail:

The agenda; logistics; legislation; background material and information; and a link to the Request for Information

(RFI)issued for this topic can be found at *http://www.nichd.nih.gov/about/meetings/2008/devices.cfm.* Duane Alexander, Director, Eunice Kennedy Shriver Institute of Child Health and Human Development, National Institutes of Health. [FR Doc. E8-13278 Filed 6-11-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-07BJ] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Economic Analysis of the National Program of Cancer Registries—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The National Program of Cancer Registries

(NPCR)is a comprehensive, federally sponsored public health program involving cancer registries in 45 States and the District of Columbia. The NPCR was established to collect data on the occurrence of cancer; the type, extent, and location of the cancer; and the type of initial treatment. CDC proposes to conduct a systematic analysis of the economic costs incurred by the NPCR. Additional information will be collected on registry activities, activity-based costs, other sources of funding and in-kind contributions. Information will be submitted to CDC once per year for three years using a Web-based system. There is no overlap with information currently collected from NPCR awardees through the Annual Program Evaluation Instrument (OMB No. 0920-0706, exp. 12/31/2008). The proposed information collection will allow CDC to assess the true cost of registry operations in relation to the benefits of those operations, identify factors that impact cost, perform cost-effectiveness analysis, and improve the efficiency of resource allocation within the NPCR. There are no costs to respondents except their time. The total estimated annualized burden hours are 1,012. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) NPCR funded registries 46 1 22 Dated: June 5, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-13181 Filed 6-11-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-0621] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project 2009 and 2011 National Youth Tobacco Surveys (NYTS)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC requests OMB approval to conduct the National Youth Tobacco Survey

(NYTS)in 2009 and 2011 (OMB No. 0920-0621; exp. date December 31, 2008). The NYTS is a school-based survey that that has been conducted in 1999, 2000, 2002, 2004, and 2006. To improve the coordination and efficiency of school-based surveillance activities within CDC, the proposed revision will establish a routine data collection schedule to occur in the Spring of odd-numbered years. Minor changes to the survey instrument and the burden estimate also are proposed. The NYTS provides national estimates for middle and high school students of tobacco use behaviors, information about exposure to pro- and anti-tobacco influences, and information about racial and ethnic disparities in these tobacco-related behaviors and behavioral determinants. Information collected through the NYTS is used to identify trends over time, to inform the development of tobacco cessation programs for youth, and to evaluate the effectiveness of existing interventions and programs. The NYTS covers the following topics related to youth tobacco use: Use of cigarettes, smokeless tobacco, cigars, pipes, bidis, and kreteks; knowledge and attitudes; media and advertising; access to tobacco products and enforcement of restrictions on access; school curriculum; environmental tobacco smoke exposure; and cessation. The NYTS will be conducted among nationally representative samples of students in grades 6-12 attending public and private schools. Responding students will complete a self-administered optically scannable questionnaire that includes multiple-choice questions. Information supporting the NYTS also will be collected from state-, district-, and school-level administrators and teachers. The table below reports the combined total number of respondents for the 2009 and 2011 NYTS annualized over the requested three-year OMB approval period. There are no costs to respondents except their time. The estimated annualized burden hours are 10,213. Estimated Annualized Burden Hours Type of respondents Form name Number of respondents Number of responses per respondent Average burden per response (in hours) State Administrators State-level Recruitment Script for the NYTS 17 1 30/60 District Administrators District-level Recruitment Script for the NYTS 80 1 30/60 School Administrators School-level Recruitment Script for the NYTS 133 1 30/60 Teachers Data Collection Checklist for the NYTS 635 1 15/60 Students National Youth Tobacco Survey

(NYTS)13,251 1 45/60 Dated: June 5, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-13194 Filed 6-11-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): CDC Grants for Public Health Research Dissertation (Panel C), Program Announcement

(PAR)07-231 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting: *Time and Date:* 8:30 a.m.-5 p.m., July 8, 2008 (Closed). *Place:* Hyatt Regency Atlanta, 265 Peachtree Street, NE., Atlanta, GA 30303, Telephone

(404)577-1234. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “CDC Grants for Public Health Research Dissertation (Panel C), PAR07-231.” *Contact Person for More Information:* Juliana Cyril, PhD, M.P.H., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone

(404)639-4639. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-13175 Filed 6-11-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Elimination of Health Disparities Through Translation Research (R18), Request for Application

(RFA)CD08-001 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting: *Time and Date:* 9 a.m.-5 p.m., July 9, 2008 (Closed). *Place:* Atlanta Marriott-Century Center, 2000 Century Boulevard, Atlanta, GA 30345. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “Elimination of Health Disparities Through Translation Research (R18, RFA CD08-001).” *Contact Person for More Information:* M. Chris Langub, PhD, Scientific Review Administrator, Office of Extramural Programs, CDC, 1600 Clifton Road, NE., Mailstop E74, Atlanta, GA 30333, Telephone

(404)498-2543. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-13174 Filed 6-11-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): CDC Grants for Public Health Research Dissertation (Panel A-1), Program Announcement

(PAR)07-231 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting: *Time and Date:* 8:30 a.m.-4 p.m., July 14, 2008 (Closed). *Place:* CDC, Global Communications Center, Room 256, 1600 Clifton Road, NE., Atlanta, GA 30333. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “CDC Grants for Public Health Research Dissertation (Panel A-1), PAR07-231.” *Contact Person for More Information:* Sheree Marshall Williams, PhD, M.Sc., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone

(404)639-7495. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-13178 Filed 6-11-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): CDC Grants for Public Health Research Dissertation (Panel A-2), Program Announcement

(PAR)07-231 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting: *Time and Date:* 12 p.m.-4 p.m., July 16, 2008 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “CDC Grants for Public Health Research Dissertation (Panel A-2), PAR07-231.” *Contact Person for More Information:* Sheree Marshall Williams, PhD, M.Sc., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone

(404)498-1194. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-13183 Filed 6-11-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Monitoring Hospitalization and Outpatient Visits for Pneumonia and Other Non-Invasive Pneumonococcal Diseases by Using National Databases, Potential Extramural Project 2008-R-17 *Correction:* This notice was published in the **Federal Register** on April 18, 2008, Volume 73, Number 76, page 21136. The aforementioned meeting has been rescheduled to the following: *Time and Date:* 1 p.m.-3 p.m., June 17, 2008 (Closed). *Contact Person for More Information:* Linda Shelton, Program Specialist, Coordinating Center for Health and Information Service, Office of the Director, CDC, 1600 Clifton Road, NE., Mailstop E21, Atlanta, GA 30333. Telephone

(PAR)07-231 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the aforementioned meeting: *Time and Date:* 12 p.m.-4 p.m., July 17, 2008 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of “CDC Grants for Public Health Research Dissertation (Panel A-3), PAR07-231.” *Contact Person for More Information:* Sheree Marshall Williams, Ph.D., M.Sc., Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D72, Atlanta, GA 30333, Telephone

(404)639-4896. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 6, 2008. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-13185 Filed 6-11-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request *Title:* State Plan for Foster Care, Independent Living Services and Adoption Assistance under Title IV-E of the Social Security Act. *OMB No.:* 0980-0141. *Description:* A State plan is required by sections 471 and 477(b)(2), part IV-E of the Social Security Act (the Act) for each public child welfare agency requesting Federal funding for foster care, independent living services and adoption assistance under the Act. The State plan is a comprehensive narrative description of the nature and scope of a State's programs and provides assurances the programs will be administered in conformity with the specific requirements stipulated in title IV-E. The plan must include all applicable State statutory, regulatory, or policy references and citation for each requirement as well as supporting documentation. A State may use the pre-print format prepared by the Children's Bureau of the Administration for Children and Families or a different format on the condition that the format used includes all of the title IV-E State plan requirements of the Act. *Respondents:* State and Territorial Agencies (State Agencies) administering or supervising the administration of the title IV-E program. Annual Burden Estimates Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Title IV-E State Plan 13 1 15 195 *Estimated Total Annual Burden Hours:* 195. *Additional Information:* Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L'Enfant Promenade, SW., Washington, DC 20447, *Attn:* ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: *infocollection@acf.hhs.gov.* *OMB Comment:* OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the **Federal Register** . Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project. *Fax:* 202-395-6974, *Attn:* Desk Officer for the Administration for Children and Families. Dated: June 5, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8-13089 Filed 6-11-08; 8:45 am] BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2001-D-0067] (formerly Docket No. 2001D-0185) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports.” This draft guidance consolidates and revises information in two existing draft guidances pertaining to electronic submission of postmarketing individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments). The submission of ICSRs and ICSR attachments in an electronic format significantly improves the agency's efficiency in processing, archiving, and reviewing the reports. 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 comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance, including comments regarding proposed collection of information, by August 11, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by calling CBER at 1-800-835-4709 or 301-827-1800. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Roger Goetsch, Center for Drug Evaluation and Research (HFD-410), Food and Drug Administration, 12300 Twinbrook Pkwy., suite 240, Rockville, MD 20851, 301-770-9299; or Steven Ripley, Center for Biologics Evaluation and Research (HFM-17),Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852,301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Postmarketing Individual Case Safety Reports” (the electronic ICSR draft guidance). The electronic ICSR draft guidance will apply to drug products marketed for human use with approved new drug applications

(NDAs)and abbreviated new drug applications (ANDAs); prescription drug products marketed for human use without an approved NDA or ANDA; nonprescription drug products marketed without an approved application; biological products, including therapeutic vaccines, marketed for human use with approved biologic license applications

(BLAs)and submission tracking numbers (STNs); and human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated under section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264). The electronic ICSR draft guidance will not apply to prophylactic vaccines, whole blood, or components of whole blood. A. Consolidation of Earlier Guidance This electronic ICSR draft guidance consolidates and revises information pertaining to electronic submission of postmarketing ICSRs and ICSR attachments in the following guidances: • Draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports” issued in May 2001 (Expedited Reports draft guidance) (66 FR 22585, May 4, 2001), and • Draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports” issued in June 2003 (Periodic Reports draft guidance) (68 FR 37504, June 24, 2003). The electronic ICSR draft guidance replaces the Expedited Reports draft guidance in its entirety, and we have removed the Expedited Reports draft guidance from the Center for Drug Evaluation and Research

(CDER)and CBER's guidance pages. The electronic ICSR draft guidance also replaces the ICSR and ICSR attachment portion of the Periodic Reports draft guidance, but does not address the descriptive information portion. We have removed the Periodic Reports draft guidance from CDER and CBER's guidance pages. For information on electronic submission of the descriptive information portion of periodic adverse drug experience reports, see the section on periodic safety update reports in the guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” (see Revision 2, June 2008). B. International Standards for Electronic Transmission FDA has cooperated with industry associations, standards development organizations, and the regulatory authorities of certain other nations to promote international harmonization of regulatory requirements. Much of this effort has been coordinated through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Under the auspices of the ICH, standards for electronic submission of safety information for human drug and biological products have been developed. This draft guidance is intended to provide guidance to industry regarding submission of postmarketing ICSRs and ICSR attachments to FDA in electronic form using the standards established by the ICH. C. Updated Recommendations As a result of comments received on the Expedited Reports and Periodic Reports draft guidances, as well as evolving technology, a number of substantive changes have been made to the agency's recommendations for the electronic transmission of ICSRs and ICSR attachments. In addition to consolidating all the information pertaining to electronic submission of ICSRs and ICSR attachments into a single guidance, the electronic ICSR draft guidance also provides references to technical specifications for these submissions. Since the Expedited Reports and Periodic Reports draft guidances were issued, the agency has received ICSRs for HCT/Ps regulated under section 361 of the PHS Act. On December 22, 2006, the President signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), which amended the Federal Food, Drug, and Cosmetic Act to add safety reporting requirements for nonprescription drug products marketed without an approved application (21 U.S.C. 379aa). The recommendations in this electronic ICSR draft guidance will apply to these products as well as to products with approved NDAs, ANDAs, BLAs and STNs, and prescription drug products marketed without an approved NDA or ANDA. 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 providing postmarketing ICSRs and ICSR attachments in electronic format. 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 Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at *http://www.regulations/gov* . III. Paperwork Reduction Act of 1995 This electronic ICSR draft guidance refers to proposed collections of information required by Public Law 109-462 and subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As required by the PRA, FDA is now requesting public comment (see DATES ) on these proposed collections of information. The agency's analysis and estimates of the proposed collections of information in the electronic ICSR draft guidance that are required by Public Law 109-462 have been described previously in FDA's notice of availability for a draft guidance entitled “Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application” (72 FR 58316, October 15, 2007) (the October 2007 PRA analysis). For burden estimates for the proposed collections of information in the electronic ICSR draft guidance, see the October 2007 PRA analysis. This electronic ICSR draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 310.305, 314.80, 600.80, and 1271.350 have been approved under OMB control numbers 0910-0291, 0910-0230, 0910-0308, and 0910-0543 respectively. IV. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/cder/guidance/index.htm* , *http://www.fda.gov/cber/guidelines.htm* , or *http://www.regulations.gov* . Dated: June 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-13269 Filed 6-11-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0339] Draft Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.” The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This draft guidance informs industry of how FDA intends to comply with the FDAAA requirement. Specifically, the draft guidance describes procedures and responsibilities for updating information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use. This draft guidance also describes procedures for making corresponding changes to susceptibility test interpretive criteria for antimicrobial susceptibility testing

(AST)devices. 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 comments 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 August 11, 2008. Submit written comments on the proposed collection of information by August 11, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 or the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850-4307. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance, including comments regarding proposed collection of information, 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: *Regarding antibacterial drug products* : Edward Cox, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6414, Silver Spring, MD 20993-0002, 301-796-1300, or *Regarding AST devices* : Freddie Poole, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0712. SUPPLEMENTARY INFORMATION: I. Background Antibacterial susceptibility testing is used to determine if bacteria that are isolated from a patient with an infection are likely to be killed or inhibited by a particular antibacterial drug product at the concentrations of the drug that are attainable at the site of infection using the dosing regimen(s) indicated in the drug product's labeling. The results from antibacterial susceptibility testing generally categorize bacteria as “susceptible,” “intermediate,” or “resistant” to each of the antibacterial drugs that are tested. When available, culture and susceptibility testing results are one of the factors that physicians consider when selecting an antimicrobial drug product for treating a patient. The numerical values generated by susceptibility testing to determine whether a particular microorganism is susceptible to a particular antimicrobial drug—the antimicrobial susceptibility test interpretive criteria—are commonly referred to as breakpoints. These breakpoints are specified in the antimicrobial drug product's label. The antimicrobial susceptibility test interpretive criteria can be used to interpret results from either manual or automated AST devices. On September 27, 2007, the President signed FDAAA (Public Law 110-85) into law. Section 1111 of FDAAA requires FDA to identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and to make those findings publicly available. By enacting section 1111 of FDAAA, Congress recognized the importance of maintaining updated susceptibility test interpretive criteria. FDA is announcing the availability of a draft guidance for industry entitled “Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices” to inform industry of how FDA intends to comply with section 1111 of FDAAA. The draft guidance explains the importance of making available to health care providers the most current information regarding susceptibility test interpretive criteria for antibacterial drug products. The draft guidance describes procedures for FDA, drug application holders, and AST device manufacturers to ensure that updated susceptibility test information is available to health care providers for the following reasons:

(1)To address concerns about antibacterial drug product labeling with out-of-date information on susceptibility test interpretive criteria, quality control parameters, and susceptibility test methods and

(2)to comply with the new requirements of section 1111 of FDAAA. Where appropriate, FDA intends to identify susceptibility test interpretive criteria, quality control parameters, and susceptibility test methods by recognizing annually, in a **Federal Register** notice, standards developed by one or more nationally or internationally recognized standard development organizations. Drug application holders of approved antibacterial drug products will then have the option of relying on FDA recognized standards to update their product labeling. The draft guidance describes possible approaches that holders of new drug applications

(NDAs)and those abbreviated new drug applications (ANDAs) that are designated as a reference listed drug can use to meet their responsibilities to update their product labeling for systemic antibacterial drug products. Application holders can use the following approaches: • Submit a labeling supplement that relies upon a standard recognized by the agency. • Submit a labeling supplement that includes data supporting a proposed change to the microbiology information in the labeling that differs from the agency's recognized standard. Alternatively, in the event that application holders do not believe that any labeling changes are necessary, they should provide written justification in support of the current information in the *Microbiology* subsection of the product labeling. The agency will make the updated information available by publicly posting changes to the product labeling within 30 days of approval of a supplement that includes a change to the *Microbiology* subsection of the product labeling. The draft guidance also describes how manufacturers of in vitro diagnostic AST devices should update the susceptibility test information in their labeling to incorporate an FDA recognized standard or a change in labeling for a relevant antibacterial drug product. 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 this topic. 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 Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at *http://www.regulations.gov* . III. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (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 that 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** for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document. With respect to the collection of information associated with this draft guidance, FDA invites comments on the following 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 estimated burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Application holders can use one of the following approaches to meet their responsibilities to update their product labeling under the draft guidance and FDA regulations: Submit a labeling supplement that relies upon a standard recognized by FDA in a **Federal Register** notice, or submit a labeling supplement that includes data supporting a proposed change to the microbiology information in the labeling. In addition, application holders should include in their annual report an assessment of whether the information in the *Microbiology* subsection of their product labeling is current or changes are needed. This information collection is already approved by OMB under control number 0910-0572 (the requirement in 21 CFR 201.56(a)(2) to update labeling when new information becomes available that causes the labeling to become inaccurate, false, or misleading) and control number 0910-0001 (the requirement in 21 CFR 314.70(b)(2)(v) to submit labeling supplements for certain changes in the product's labeling, and the requirement in 21 CFR 314.81(b)(2)(i) to include in the annual report a brief summary of significant new information from the previous year that might affect the labeling of the drug product). In addition, under the draft guidance, if the information in the applicant's product labeling differs from the standards recognized by FDA in the **Federal Register** notice, and the applicant believes that changes to the labeling are not needed, the applicant should provide written justification to FDA. This justification should explain why the recognized standard does not apply to its drug product and why changes are not needed to the *Microbiology* subsection of the product's labeling. This justification should also be submitted as general correspondence to the product's application, and a statement indicating that no change is currently needed and the supporting justification should be included in the annual report. Based on our knowledge of the need to update information on susceptibility test interpretive criteria, susceptibility test methods, and quality control parameters in the labeling for systemic antibacterial drug products for human use, we estimate that, annually, only 2 applicants will submit the written justification described previously and in the draft guidance. We also estimate that each justification will take approximately 16 hours to prepare and submit to FDA as general correspondence and as part of the annual report. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents No. of Responses per Respondent Total Responses Hours Per Response Total Hours Justification submitted as general correspondence and in the annual report 2 1 2 16 32 1 There are no capital costs or operating and maintenance costs associated with this collection of information. IV. 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.regulations.gov* . Dated: June 9, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. 08-1350 Filed 6-10-08; 11:31 am]

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