National Center on Birth Defects and Developmental Disabilities, 30466-30467 [05-10541]

Download as PDF 30466 Federal Register / Vol. 70, No. 101 / Thursday, May 26, 2005 / Notices the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements. New applications for Level One chemical laboratory capacity will be evaluated by an objective review panel using the criteria listed in the ‘‘V.1. Criteria’’ section above. In addition, these applications will also be reviewed by senior federal staff taking into account the results of the independent review, program needs and relevance to national goals, geographic location, and budgetary considerations. VI. Award Administration Information VI.1. Award Notices Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application. Unsuccessful applicants will receive notification of the results of the application review by mail. VI.2. Administrative and National Policy Requirements 45 CFR Part 74 and Part 92 For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http:// www.access.gpo.gov/nara/cfr/cfr-tablesearch.html The following additional requirements apply to this project: • AR–7 Executive Order 12372 • AR–9 Paperwork Reduction Act Requirements • AR–10 Smoke-Free Workplace Requirements • AR–11 Healthy People 2010 • AR–12 Lobbying Restrictions • AR–16 Security Clearance Requirement • AR–21 Small, Minority, and Women-Owned Business • AR–24 Health Insurance Portability and Accountability Act Requirements • AR–25 Release and Sharing of Data Additional information on these requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/ funding/ARs.htm. VI.3. Technical Reporting Requirements Quarterly Progress Reports for Budget Period One—Progress reports for VerDate jul<14>2003 19:11 May 25, 2005 Jkt 205001 activities undertaken in budget period, as well as special topics related to the goals and objectives, are due on January 15, 2006 (for activities undertaken August 31–November 30, 2005), April 15, 2006 (for activities undertaken December 1, 2005–February 28, 2006), and July 15, 2006 (for activities undertaken March 1–May 30, 2006). These reports must be submitted through the DSLR MIS. CDC will provide templates for these reports to assess program outcomes related to activities undertaken in BY 01. In addition, awardees may be required to submit information upon request based on changing threat status or national security priorities. Financial Status Reports—A mid-year estimated financial status report is due May 30, 2006, for the period August 31, 2005–February 28, 2006. The final Financial Status Report (FSR) is due 90 days after the end of the budget period, ending on August 30, 2006. The due date for the FSR is November 30, 2006. Estimated FSRs (through August 30, 2005) are requested with your continuation application (See Unobligated Funds on page 3). Final Reports—This cooperative agreement will end on August 30, 2006. An original and two copies of the final FSR will be due to the Grants Management Officer named below by November 30, 2006. Final project reports (for activities from June 1– August 30, 2006) should be submitted through the DSLR MIS by November 30, 2006. Please submit the hard copy of your financial status reports to: Rebecca B. O’Kelley, Acting Chief, Attn: Sharon Robertson, Acquisition and Assistance, Branch VI, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, MS K–75, Atlanta, GA 30341–4146. Telephone: 770–488–2748. E-mail address: sqr2@cdc.gov. Please copy your Project Officer on any electronic submissions. VII. Agency Contacts We encourage inquiries concerning this announcement. Programmatic technical assistance for this request may be obtained from your Project Officer. For general questions, contact: Sharon Robertson, Grants Management Specialist—Regions 1, 2, 3, 4, 10, Acquisition and Assistance Branch VI, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Atlanta, Georgia 30341–4146. Telephone: 770–488–2748. E-mail address: sqr2@cdc.gov. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Angela Webb, Grants Management Specialist—Regions 5, 6, 7, 8, 9, Acquisition and Assistance Branch VI, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Atlanta, Georgia 30341–4146. Telephone: 770–488–2784. E-mail address: aqw6@cdc.gov. VIII. Other Information Attachments will be available from the Secure Data Network (https:// sdn.cdc.gov). Appendix 1: Requirements for Level One and Level Two Chemical Laboratories. Appendix 2: Early Warning Infectious Disease Surveillance (EWIDS) Guidance. Appendix 3: Cities Readiness Initiative (CRI) Guidance. Appendix 4: DRAFT Measurement Descriptions and Methods of Data Collection. Appendix 5: Funding Table. Dated: May 20, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–10537 Filed 5–25–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) National Center on Birth Defects and Developmental Disabilities Name: National Workshop on Mild and Unilateral Hearing Loss. Times and Dates: 1 p.m.–5 p.m., July 26, 2005. 8:30 a.m.–5 p.m., July 27, 2005. Place: Beaver Run Resort and Conference Center, 620 Village Road, P.O. Box 2115, Breckenridge, CO 80424, Telephone: (970) 453–6000. Status: Open to the public, limited only by the space available. Purpose: The meeting will review and evaluate the scientific research and other data related to mild and unilateral HL to establish recommendations related to identification and appropriate intervention(s) for infants/children. In addition, the meeting will identify potential areas for future research related to mild and unilateral HL. Matters to be Discussed: The agenda will include a review of the published and unpublished literature assessing the identification and outcomes of infants/ children with mild and unilateral HL; a review of screening procedures; diagnostic protocols; follow-up practice; E:\FR\FM\26MYN1.SGM 26MYN1 Federal Register / Vol. 70, No. 101 / Thursday, May 26, 2005 / Notices the role of amplification; models of early intervention; and the need for future research. Agenda items are subject to change as priorities dictate. FOR FURTHER INFORMATION CONTACT: Marcus Gaffney, M.P.H., National Center on Birth Defects and Developmental Disabilities, CDC, 1600 Clifton Road, NE., M/S E–88, Atlanta, Georgia 30333. Telephone: (404) 498– 3031. 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: May 20, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–10541 Filed 5–25–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES improvements in the delivery of occupational safety and health services, and the prevention of work-related injury and illness. It is anticipated that research funded will promote these program goals. Matters to be Discussed: The meeting will convene in open session from 8–8:15 a.m. on June 21, 2005, to address matters related to the conduct of Study Section business. The remainder of the meeting will proceed in closed session. The purpose of the closed sessions is for the study section to consider safety and occupational health-related grant applications. These portions of 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, Centers for Disease Control and Prevention, pursuant to Section 10(d) Pub. L. 92–463. Agenda items are subject to change as priorities dictate. For Further Information Contact: Price Connor, Ph.D., NIOSH Health Scientist, 1600 Clifton Road, NE., Mailstop E–74, Atlanta, Georgia 30333, telephone 404/498–2511, fax 404/498–2569. 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: May 20, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–10542 Filed 5–25–05; 8:45 am] Centers for Disease Control and Prevention National Institute for Occupational Safety and Health, Safety and Occupational Health Study Section 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 following committee meeting. BILLING CODE 4163–18–P Name: Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH). Times and Dates: 8 a.m.–5 p.m., June 21, 2005. 8 a.m.–5 p.m., June 22, 2005. Place: Embassy Suites Hotel, 1900 Diagonal Road, Alexandria, Virginia, 22314, telephone 703/684–5900, fax 703/684–1403. Status: Open 8 a.m.–8:15 a.m., June 21, 2005. Closed 8:15 a.m.–5 p.m., June 21, 2005. Closed 8 a.m.–5 p.m., June 22, 2005. Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate grant application(s) received in response to the Institute’s standard grants review and funding cycles pertaining to research issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broadbased research endeavors in keeping with the Institute’s program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to support more focused research projects, which will lead to [Docket No. 2005D–0169] VerDate jul<14>2003 19:11 May 25, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance on Useful Written Consumer Medication Information AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Useful Written Consumer Medication Information (CMI).’’ CMI is written information developed for consumers about prescription drugs that is distributed to consumers when they have prescriptions filled. The guidance discusses general issues and makes recommendations on the content of useful written CMI. DATES: Submit written or electronic comments on the draft guidance by July 25, 2005. General comments on agency PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 30467 guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Ellen Tabak, Center for Drug Evaluation and Research (HFD–410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 7843. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled ‘‘Useful Written Consumer Medication Information (CMI).’’ This draft guidance is intended to assist individuals or organizations (e.g., pharmacies, private vendors, healthcare associations) in developing useful written CMI. CMI is written information about prescription drugs developed by organizations or individuals, other than a drug’s manufacturer, that is intended for distribution to consumers at the time of dispensing. Since neither FDA nor the drug’s manufacturer reviews or approves CMI, FDA recommends that the developers of written medication information use the factors discussed in this guidance to ensure that their CMI is useful to consumers. Traditionally, FDA has believed that when people are well-informed about the medications they take, they are able to make better decisions about their healthcare and better use of the prescription medications available to them. Access to useful written information about prescription medications is important to ensuring appropriate use of these products. In 1996, a steering committee comprised of interested stakeholders (including healthcare professionals, consumer organizations, voluntary health agencies, pharmaceutical manufacturers, prescription drug wholesalers, drug information database companies, CMI developers, and E:\FR\FM\26MYN1.SGM 26MYN1

Agencies

[Federal Register Volume 70, Number 101 (Thursday, May 26, 2005)]
[Notices]
[Pages 30466-30467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)


National Center on Birth Defects and Developmental Disabilities

    Name: National Workshop on Mild and Unilateral Hearing Loss.
    Times and Dates: 1 p.m.-5 p.m., July 26, 2005. 8:30 a.m.-5 p.m., 
July 27, 2005.
    Place: Beaver Run Resort and Conference Center, 620 Village Road, 
P.O. Box 2115, Breckenridge, CO 80424, Telephone: (970) 453-6000.
    Status: Open to the public, limited only by the space available.
    Purpose: The meeting will review and evaluate the scientific 
research and other data related to mild and unilateral HL to establish 
recommendations related to identification and appropriate 
intervention(s) for infants/children. In addition, the meeting will 
identify potential areas for future research related to mild and 
unilateral HL.
    Matters to be Discussed: The agenda will include a review of the 
published and unpublished literature assessing the identification and 
outcomes of infants/children with mild and unilateral HL; a review of 
screening procedures; diagnostic protocols; follow-up practice;

[[Page 30467]]

the role of amplification; models of early intervention; and the need 
for future research.
    Agenda items are subject to change as priorities dictate.

FOR FURTHER INFORMATION CONTACT: Marcus Gaffney, M.P.H., National 
Center on Birth Defects and Developmental Disabilities, CDC, 1600 
Clifton Road, NE., M/S E-88, Atlanta, Georgia 30333. Telephone: (404) 
498-3031.
    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: May 20, 2005.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 05-10541 Filed 5-25-05; 8:45 am]
BILLING CODE 4163-18-P