38662 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

II. Significance of Special Controls 

Guidance Document 

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. 

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. 

Guidance documents are also available 

at http://www.regulations.gov. 

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. 

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 

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 

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