Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38661 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

EOVIST is 3,818 days. Of this time, 

3,450 days occurred during the testing 

phase of the regulatory review period, 

while 368 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

subsection 505(i) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 355(i)) became effective: January 

21, 1998. The applicant claims January 

19, 1998, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

January 21, 1998, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: July 2, 2007. The 

applicant claims June 29, 2007, as the 

date the new drug application (NDA) for 

EOVIST (NDA 22–090) was initially 

submitted. However, FDA records 

indicate that NDA 22–090 was 

submitted on July 2, 2007. 

3. The date the application was 

approved: July 3, 2008. FDA has verified 

the applicant’s claim that NDA 22–090 

was approved on July 3, 2008. This 

determination of the regulatory review 

period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,699 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by October 5, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

February 1, 2010. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: June 8, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–18527 Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2001–D–0129 (formerly 

Docket No. 2001D–0064)] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Dental Amalgam, Mercury, and 

Amalgam Alloy; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Dental Amalgam, Mercury, 

and Amalgam Alloy.’’ This guidance 

document describes a means by which 

manufacturers of dental amalgam, 

mercury, and amalgam alloy may 

comply with special controls that apply 

to these class II devices. Elsewhere in 

this issue of the Federal Register, FDA 

is publishing a final rule to classify 

dental amalgam into class II (special 

controls), reclassify dental mercury from 

class I (general controls) to class II 

(special controls), and designate a 

special controls guidance document to 

support the class II classification of 

these two devices, as well as the current 

class II classification of amalgam alloy. 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Dental Amalgam, 

Mercury, and Amalgam Alloy’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this 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: 

Michael Adjodha, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 2606, Silver Spring, 

MD 20993–0002, 301–796–6276. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

20, 2002 (67 FR 7620), FDA issued a 

proposed rule to issue a separate 

regulation classifying encapsulated 

dental amalgam into class II (special 

controls); amending the class II 

classification of amalgam alloy by 

designating special controls; and 

reclassifying dental mercury from class 

I (general controls) to class II (special 

controls). Also, in the Federal Register 

of February 20, 2002 (67 FR 7703), FDA 

announced the availability of the draft 

guidance entitled ‘‘Special Control 

Guidance Document on Encapsulated 

Amalgam, Amalgam Alloy, and Dental 

Mercury Labeling,’’ which would serve 

as a special control for all three devices. 

The comment period on the proposed 

rule closed on May 21, 2002. FDA 

reopened the comment period in July 

2002 (67 FR 46991) and again in April 

2008 (73 FR 22877) to provide the 

public with additional opportunities to 

comment and to submit data and 

information that may have become 

available since publication of the 

proposed rule. The comment period 

closed on July 28, 2008. 

FDA received more than 1,400 

comments on the proposed rule and the 

draft special controls guidance 

document. Because of the intertwined 

nature of the proposed rule and the draft 

guidance, and because of the significant 

overlap in comments, FDA considered 

all comments in preparing both the final 

rule and the special controls guidance 

document. The analysis of comments is 

contained in the preamble to the final 

rule. 

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

mstockstill on DSKH9S0YB1PROD with NOTICES