Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 38662 [E9-18526]

Download as PDF 38662 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices II. Significance of Special Controls Guidance Document Guidance documents are also available at http://www.regulations.gov. The final rule designates the guidance document entitled ‘‘Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy’’ as the special control for mercury, amalgam alloy, and dental amalgam. FDA believes that adherence to the recommendations described in this guidance document, in addition to the general controls under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), will provide reasonable assurance of the safety and effectiveness of dental amalgam, mercury, and amalgam alloy. Following the effective date of the final rule, any firm submitting a 510(k) premarket notification for dental amalgam, mercury, or amalgam alloy, as well as any firm currently marketing the devices, must address the issues covered in the special controls guidance. The firm must show that its device addresses the issues of safety and effectiveness identified in the special controls guidance, either by following the recommendations in the guidance or by some other means that provides equivalent assurances of safety and effectiveness. IV. 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. mstockstill on DSKH9S0YB1PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy’’ 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 301– 847–8149 to receive a hard copy. Please use the document number (1192) 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. VerDate Nov<24>2008 16:07 Aug 03, 2009 Jkt 217001 Dated: July 28, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–18445 Filed 7–29–09; 4:15 pm] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92–463), notice is hereby given of the following meeting: Name: Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). Dates and Times: September 24, 2009, 8:30 a.m. to 5 p.m. September 25, 2009, 8:30 a.m. to 3 p.m. Place: Bethesda Marriott–Pooks Hill, 5151 Pooks Hill Road, Bethesda, MD 20814. Status: The meeting will be open to the public with attendance limited to space availability. Participants are asked to register for the meeting by going to the registration web site at http://events.SignUp4.com/ ACHDNC0909. The registration deadline is Wednesday, September 23, 2009. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should indicate their needs on the registration web site. The deadline for special accommodation requests is Friday, September 18, 2009. If there are technical problems gaining access to the web site, please contact Tamar R. Shealy, Meetings Manager, Conference and Meetings Management, Altarum Institute, by telephone (202) 828–5100 or via e-mail conferences@altarum.org. Purpose: The Secretary’s ACHDNC was established to advise and guide the Secretary regarding the most appropriate application of universal newborn screening tests, technologies, policies, guidelines and PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 programs for effectively reducing morbidity and mortality in newborns and children having or at risk for heritable disorders. The ACHDNC also provides advice and recommendations concerning the grants and projects authorized under the Public Health Service Act, 42 U.S.C. 300b-10, (Heritable Disorders Program) as amended in the Newborn Screening Saves Lives Act of 2008. Agenda: The meeting will include presentations and continued discussions on the nomination/evaluation process for newborn screening candidate conditions. The agenda will include presentations on the Newborn Screening Use Case, the National Health Information Network, and Newborn Screening Quality Measures, as well as presentations on the continued work and reports of the ACHDNC’s subcommittees on laboratory standards and procedures, followup and treatment, and education and training. Proposed agenda items are subject to change as priorities dictate. You can locate the Agenda, Committee Roster and Charter, presentations, and meeting materials at the home page of the Web site at http:// events.SignUp4.com/ACHDNC0909. Webcast: The meeting will be Webcast. Information on how to access the Webcast will be available on the day of the meeting by clicking on the meeting date link at http://events.SignUp4.com/ACHDNC0909. Public Comments: Members of the public can present oral comments during the public comment periods of the meeting, which are scheduled for both days of the meeting. Those individuals who want to make a comment are requested to register online by Wednesday, September 23, 2009, at http:// events.SignUp4.com/ACHDNC0909. Requests will contain the name, address, telephone number, and any professional or business affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The list of public comment participants will be posted on the web site. Written comments should be emailed no later than Wednesday, September 23, 2009, for consideration. Comments should be submitted to Tamar R. Shealy, Meetings Manager, Conference and Meetings Management, Altarum Institute, 1200 18th Street, NW., Suite 700, Washington, DC 20036, telephone: 202 828–5100; fax: 202 785–3083, or e-mail: conferences@altarum.org. Contact Person: Anyone interested in obtaining other relevant information should write or contact Alaina M. Harris, Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A–19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone (301) 443–0721, aharris@hrsa.gov. More information on the Advisory Committee is available at http://mchb.hrsa.gov/ heritabledisorderscommittee. Dated: July 28, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–18526 Filed 8–3–09; 8:45 am] BILLING CODE 4165–15–P E:\FR\FM\04AUN1.SGM 04AUN1

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[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Page 38662]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Committee on Heritable Disorders in Newborns and 
Children; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Public Law 92-463), notice is hereby given of the 
following meeting:

    Name: Secretary's Advisory Committee on Heritable Disorders in 
Newborns and Children (ACHDNC).
    Dates and Times: September 24, 2009, 8:30 a.m. to 5 p.m. 
September 25, 2009, 8:30 a.m. to 3 p.m.
    Place: Bethesda Marriott-Pooks Hill, 5151 Pooks Hill Road, 
Bethesda, MD 20814.
    Status: The meeting will be open to the public with attendance 
limited to space availability. Participants are asked to register 
for the meeting by going to the registration web site at http://events.SignUp4.com/ACHDNC0909. The registration deadline is 
Wednesday, September 23, 2009. Individuals who need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should indicate their needs on the registration web 
site. The deadline for special accommodation requests is Friday, 
September 18, 2009. If there are technical problems gaining access 
to the web site, please contact Tamar R. Shealy, Meetings Manager, 
Conference and Meetings Management, Altarum Institute, by telephone 
(202) 828-5100 or via e-mail conferences@altarum.org.
    Purpose: The Secretary's ACHDNC was established to advise and 
guide the Secretary regarding the most appropriate application of 
universal newborn screening tests, technologies, policies, 
guidelines and programs for effectively reducing morbidity and 
mortality in newborns and children having or at risk for heritable 
disorders. The ACHDNC also provides advice and recommendations 
concerning the grants and projects authorized under the Public 
Health Service Act, 42 U.S.C. 300b-10, (Heritable Disorders Program) 
as amended in the Newborn Screening Saves Lives Act of 2008.
    Agenda: The meeting will include presentations and continued 
discussions on the nomination/evaluation process for newborn 
screening candidate conditions. The agenda will include 
presentations on the Newborn Screening Use Case, the National Health 
Information Network, and Newborn Screening Quality Measures, as well 
as presentations on the continued work and reports of the ACHDNC's 
subcommittees on laboratory standards and procedures, follow-up and 
treatment, and education and training.
    Proposed agenda items are subject to change as priorities 
dictate. You can locate the Agenda, Committee Roster and Charter, 
presentations, and meeting materials at the home page of the Web 
site at http://events.SignUp4.com/ACHDNC0909.
    Webcast: The meeting will be Webcast. Information on how to 
access the Webcast will be available on the day of the meeting by 
clicking on the meeting date link at http://events.SignUp4.com/ACHDNC0909.
    Public Comments: Members of the public can present oral comments 
during the public comment periods of the meeting, which are 
scheduled for both days of the meeting. Those individuals who want 
to make a comment are requested to register online by Wednesday, 
September 23, 2009, at http://events.SignUp4.com/ACHDNC0909. 
Requests will contain the name, address, telephone number, and any 
professional or business affiliation of the person desiring to make 
an oral presentation. Groups having similar interests are requested 
to combine their comments and present them through a single 
representative. The list of public comment participants will be 
posted on the web site. Written comments should be emailed no later 
than Wednesday, September 23, 2009, for consideration. Comments 
should be submitted to Tamar R. Shealy, Meetings Manager, Conference 
and Meetings Management, Altarum Institute, 1200 18th Street, NW., 
Suite 700, Washington, DC 20036, telephone: 202 828-5100; fax: 202 
785-3083, or e-mail: conferences@altarum.org.
    Contact Person: Anyone interested in obtaining other relevant 
information should write or contact Alaina M. Harris, Maternal and 
Child Health Bureau, Health Resources and Services Administration, 
Room 18A-19, Parklawn Building, 5600 Fishers Lane, Rockville, 
Maryland 20857, Telephone (301) 443-0721, aharris@hrsa.gov. More 
information on the Advisory Committee is available at http://mchb.hrsa.gov/heritabledisorderscommittee.

    Dated: July 28, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-18526 Filed 8-3-09; 8:45 am]
BILLING CODE 4165-15-P