Federal Register / Vol. 72, No. 50 / Thursday, March 15, 2007 / Notices 12179 

Dated: March 7, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4685 Filed 3–14–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. 2006M–0384, 2006M–0385, 

2006M–0386] 

Medical Devices Regulated by the 

Center for Biologics Evaluation and 

Research; Availability of Summaries of 

Safety and Effectiveness Data for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved by the 

Center for Biologics Evaluation and 

Research (CBER). This list is intended to 

inform the public of the availability 

through the Internet and the FDA’s 

Division of Dockets Management of 

summaries of safety and effectiveness 

data of approved PMAs. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please include the appropriate docket 

number as listed in tables 1 and 2 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness data. 

FOR FURTHER INFORMATION CONTACT: 

Nathaniel L. Geary, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d)) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register, 

providing instead to post this 

information on the Internet at http:// 

www.fda.gov. In addition, the 

regulations provide that FDA publish a 

quarterly list of available safety and 

effectiveness summaries of PMA 

approvals and denials that were 

announced during the quarter. FDA 

believes that this procedure expedites 

public notification of these actions 

because announcements can be placed 

on the Internet more quickly than they 

can be published in the Federal 

Register, and FDA believes that the 

Internet is accessible to more people 

than the Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

administrative reconsideration of an 

FDA action under § 10.33(b) (21 CFR 

10.33(b)) for notices announcing 

approval of a PMA begins on the day the 

notice is placed on the Internet. Section 

10.33(b) provides that FDA may, for 

good cause, extend this 30-day period. 

Reconsideration of a denial or 

withdrawal of approval of a PMA may 

be sought only by the applicant; in these 

cases, the 30-day period will begin 

when the applicant is notified by FDA 

in writing of its decision. 

The following is a list of PMAs 

approved by CBER for which summaries 

of safety and effectiveness data were 

placed on the Internet from March 1, 

2006, through June 30, 2006, and from 

July 1, 2006, through September 30, 

2006. There were no denial actions 

during either period. The list provides 

the manufacturer’s name, the product’s 

generic name or the trade name, and the 

approval date. 

TABLE 1.—LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE MARCH

1, 2006, THROUGH JUNE 30, 2006 

PMA No./Docket No. Applicant Trade Name Approval Date 

BP050009/0/2006M–0384 Chembio Diagnostic Systems, Inc. SURE CHECK HIV 1/2 ASSAY May 25, 2006 

BP050010/0/2006M–0385 Chembio Diagnostic Systems, Inc. HIV 1/2 STAT–PAKT ASSAY May 25, 2006 

TABLE 2.—LIST SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE JULY 1, 

2006, THROUGH SEPTEMBER 30, 2006 

PMA No./Docket No. Applicant Trade Name Approval Date 

BP050030/0/2006M–0386 Bayer Healthcare LLC ADVIA Centaur HIV 1/0/2 Enhanced Assay May 18, 2006 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cber/products.htm. 

Dated: March 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–4677 Filed 3–14–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

National Communications System 

[Docket No. NCS–2007–0001] 

National Security Telecommunications 

Advisory Committee 

AGENCY: National Communications 

System, DHS. 

ACTION: Notice of partially closed 

advisory committee meeting. 

SUMMARY: The President’s National 

Security Telecommunications Advisory 

Committee (NSTAC) will be meeting by 

teleconference: the meeting will be 

partially closed. 

DATES: Thursday, March 29, 2007, from 

2 p.m. until 3 p.m. 


rmajette on PROD1PC67 with NOTICES
12180 Federal Register / Vol. 72, No. 50 / Thursday, March 15, 2007 / Notices 

ADDRESSES: The meeting will take place 

by teleconference. For access to the 

conference bridge and meeting 

materials, contact Mr. Kelvin Coleman 

at (703) 235–5643 or by e-mail at 

kelvin.coleman@dhs.gov by 5 p.m. on 

Friday, March 23, 2007. If you desire to 

submit comments, they must be 

submitted by April 5, 2007. Comments 

must be identified by NCS–2007–0001 

and may be submitted by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: NSTAC1@dhs.gov. Include 

docket number in the subject line of the 

message. 

• Mail: Office of the Manager, 

National Communications System (N5), 

Department of Homeland Security, 

Washington, DC, 20529. 

• Fax: 1–866–466–5370. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security’’ and NCS–2007–

0001, the docket number for this action. 

Comments received will be posted 

without alteration at 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received by the NSTAC, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Kiesha Gebreyes, Chief, Industry 

Operations Branch at (703) 235–5525, email: Kiesha.Gebreyes@dhs.gov or write 

the Deputy Manager, National 

Communications System, Department of 

Homeland Security, IP/NCS/N5. 

SUPPLEMENTARY INFORMATION: The 

NSTAC advises the President on issues 

and problems related to implementing 

national security and emergency 

preparedness telecommunications 

policy. Notice of this meeting is given 

under the Federal Advisory Committee 

Act (FACA), Public Law 92–463, as 

amended (5 U.S.C. App.1 et seq.). 

At the upcoming meeting, between 2 

p.m. and 2:25 p.m., the members will 

receive comments from government 

stakeholders and receive an update from 

the NSTAC’s International Task Force 

(ITF). This portion of the meeting will 

be open to the public. 

Between 2:25 p.m. and 3 p.m., the 

committee will discuss Global 

Infrastructure Resiliency (GIR). This 

portion of the meeting will be closed to 

the public. 

Persons with disabilities who require 

special assistance should indicate this 

when arranging access to the 

teleconference and are encouraged to 

identify anticipated special needs as 

early as possible. 

Basis for Closure: The GIR discussion 

will likely involve sensitive 

infrastructure information concerning 

system threats and explicit physical/ 

cyber vulnerabilities of the undersea 

communications infrastructure. Public 

disclosure of such information would 

heighten awareness of potential 

vulnerabilities and increase the 

likelihood of exploitation by terrorists 

or other motivated adversaries. Pursuant 

to Section 10(d) of the Federal Advisory 

Committee Act, Public Law 92–463, as 

amended (5 U.S.C. App. 1 et seq.), the 

Department has determined that this 

discussion will concern matters which, 

if disclosed, would be likely to frustrate 

significantly the implementation of a 

proposed agency action. Accordingly, 

the relevant portion of this meeting will 

be closed to the public pursuant to the 

authority set forth in 5 U.S.C. 

552b(c)(9)(B). 

Sallie McDonald, 

Deputy Manager, National Communications 

System. 

[FR Doc. 07–1217 Filed 3–12–07; 2:43 pm] 

BILLING CODE 4410–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Proposed Collection; Comment 

Request Regulations Relating to 

Recordation and Enforcement of 

Trademarks and Copyrights 

ACTION: Notice and request for 

comments. 

SUMMARY: As part of its continuing effort 

to reduce paperwork and respondent 

burden, Bureau of Customs and Border 

Protection (CBP) invites the general 

public and other Federal agencies to 

comment on an information collection 

requirement concerning the Regulations 

Relating to Recordation and 

Enforcement of Trademarks and 

Copyrights (Part 133 of the CBP 

Regulations). This request for comment 

is being made pursuant to the 

Paperwork Reduction Act of 1995 (Pub. 

L. 104–13; 44 U.S.C. 3505(c)(2)). 

DATES: Written comments should be 

received on or before May 14, 2007, to 

be assured of consideration. 

ADDRESSES: Direct all written comments 

to Bureau of Customs and Border 

Protection, Information Services Group, 

Attn.: Tracey Denning, 1300 

Pennsylvania Avenue, NW., Room 

3.2.C, Washington, DC 20229. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Bureau of Customs 

and Border Protection, Attn.: Tracey 

Denning, 1300 Pennsylvania Avenue 

NW., Room 3.2C, Washington, DC 

20229, Tel. (202) 344–1429. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). The comments 

should address: (a) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimates of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden including 

the use of automated collection 

techniques or the use of other forms of 

information technology; and (e) 

estimates of capital or start-up costs and 

costs of operations, maintenance, and 

purchase of services to provide 

information. The comments that are 

submitted will be summarized and 

included in the CBP request for Office 

of Management and Budget (OMB) 

approval. All comments will become a 

matter of public record. In this 

document CBP is soliciting comments 

concerning the following information 

collection: 

Title: Regulations Relating to 

Recordation and Enforcement of 

Trademarks and Copyrights (Part 133 of 

the CBP Regulations). 

OMB Number: 1651–0123. 

Form Number: None. 

Abstract: Trademark and trade name 

owners and those claiming copyright 

protection must provide information 

sufficient to enable CBP officers to 

identify violative articles at the borders. 

Current Actions: This submission is 

being submitted to extend the expiration 

date. 

Type of Review: Extension (without 

change to the burden hours). 

Affected Public: Businesses, 

Individuals. 

Estimated Number of Respondents: 

2,000. 

Estimated Time per Respondent: 2 

hours. 

Estimated Total Annual Burden 

Hours: 4,000. 

Estimated Total Annualized Cost on 

the Public: $380,000. 


rmajette on PROD1PC67 with NOTICES