56158 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Please cite 

the appropriate docket number as listed 

in Table 1 of this document when 

submitting a written request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the summaries of 

safety and effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Thinh Nguyen, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2186, ext. 152. 

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. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. 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 

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 regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from April 1, 2006, through 

June 30, 2006. There were no denial 

actions during this 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 SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1, 

2006, THROUGH JUNE 30, 2006 

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

P050021/2006M–0161 QLT, Inc. CERALAS I LASER & CERALINK SLIT LAMP ADAPTER December 20, 2005 

P040052/2006M–0264 MonoGen, Inc. MONOPREP PAP TEST (MPPT) March 3, 2006 

P040028/2006M–0148 Medispectra, Inc. LUMA CERVICAL IMAGING SYSTEM March 16, 2006 

P050012/2006M–0200 Dexcom, Inc. DEXCOM (STS) CONTINUOUS GLUCOSE MONITORING SYSTEM March 24, 2006 

P050026/2006M–0162 QLT, Inc. QUALTEL ACTIVIS LASER & ZSL30 ACT, ZSL120 ACT, 

and HSBMBQ ACT SLIT LAMP ADAPTERS 

April 4, 2006 

P030008(S4)/2006M–0199 SurgiVision Refractive Consultants WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER 

SYSTEM 

April 19, 2006 

P040033/2006M–0193 Smith & Nephew 

Orthopaedics 

BIRMINGHAM HIP RESURFACING (BHR) SYSTEM May 9, 2006 

P050047/2006M–0235 Inamed Corp. JUVEDERM 24HV, JUVEDERM 30, and JUVEDERM 

30HV GEL IMPLANTS 

June 2, 2006 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: September 15, 2006. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E6–15755 Filed 9–25–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0107] 

Food and Drug AdministrationRegulated Products Containing 

Nanotechnology Materials; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: This is an update to previous 

notice that the Food and Drug 

Administration (FDA) will hold a public 

meeting October 10, 2006, on 

nanotechnology as it relates to FDAregulated products. The primary 

purpose of this update is to notify the 

public that preregistration to attend or 

speak at the public meeting will close 

on September 29, 2006. The purpose of 

the meeting is to help FDA further its 

understanding of developments in 


pwalker on PRODPC60 with NOTICES
Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices 56159 

nanotechnology materials that pertain to 

FDA-regulated products. FDA is 

interested in learning about the kinds of 

new nanotechnology material products 

under development in the areas of foods 

(including dietary supplements), food 

and color additives, animal feeds, 

cosmetics, drugs and biologics, and 

medical devices, whether there are new 

or emerging scientific issues that should 

be brought to FDA’s attention, and any 

other scientific issues about which the 

regulated industry, academia, and the 

interested public may wish to inform 

FDA concerning the use of 

nanotechnology materials in FDAregulated products. 

DATES AND TIMES: The public meeting 

will be held October 10, 2006, from 9 

a.m. to 5 p.m. 

REGISTRATION: You may preregister to 

attend or make a presentation at http:// 

www.fda.gov/nanotechnology/. 

Preregistration to make a presentation 

will close on September 29, 2006; 

however, there will be onsite 

registration to attend on a first-come, 

first-served basis until the room 

capacity is reached. Onsite registration 

will be open at the meeting site at 8:30 

a.m. on October 10. Once room capacity 

is reached, individuals will be offered 

the opportunity to observe the meeting 

from an overflow room located at the 

meeting site. 

If time permits, there will be an open 

public session. Individuals who have 

not preregistered to make a presentation 

can register onsite if they wish to 

present public comments. While every 

effort will be made to provide an open 

public session after all preregistered 

speakers have made presentations, it is 

recommended that you preregister if 

you would like to make a presentation. 

Onsite registration to make a 

presentation will be taken on a firstcome, first-served basis. Individuals 

who register at the meeting to speak 

may be allotted less time to speak than 

preregistered speakers, depending on 

the number of registrants. 

We will post the agenda at http:// 

www.fda.gov/nanotechnology/ prior to 

the meeting. 

ADDRESSES: The public meeting will be 

held at the Natcher Auditorium, 

National Institutes of Health Campus 

(NIH), 9000 Rockville Pike, bldg. 45, 

Bethesda, MD. We will also post the 

address for the meeting at http:// 

www.fda.gov/nanotechnology/. Note 

that parking is limited on the NIH 

Campus and that security procedures 

are in effect. For further information on 

parking and security see http:// 

www.nih.gov/about/visitorsecurity.htm. 

Written or electronic comments may 

be submitted by November 10, 2006. 

Submit written comments 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. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Poppy Kendall, Food and Drug 

Administration (HF–11), 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, FAX: 301–594–6777, e-mail: 

poppy.kendall@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Holding a Public 

Meeting? 

Previous Federal Register Notices (71 

FR 19523, April 14, 2006; 71 FR 46232, 

August 11, 2006) contain detailed 

supplemental information regarding the 

rationale and background for the 

meeting. 

For more information about FDA’s 

role regarding nanotechnology products, 

see our Web page at http://www.fda.gov/ 

nanotechnology/. 

II. How Can You Participate? 

You can participate through oral 

presentation at the meeting or through 

written or electronic material submitted 

to the docket. The length of the 

presentations will be determined by the 

number of speakers who preregister and 

the time available. Based on the requests 

received so far, the presentations are 

likely to be less than 8 minutes long. In 

order to maximize the number of people 

who have the opportunity to present 

their views at this public meeting, each 

individual or organization will be 

limited to one opportunity to present 

views at the meeting. However, written 

material of any length can be submitted 

to the docket. 

Individuals and organizations with 

common interests are encouraged to 

consolidate or coordinate their 

presentations. FDA will give the 

registered speakers an estimated 

timeframe for their presentations by 

October 4 through email to the address 

provided during preregistration. Persons 

should arrive early to make sure that 

they are present to make their 

presentation in case we are ahead of 

schedule. 

In a previous notice we indicated the 

possibility of holding concurrent 

sessions. However, based on the number 

of requests for presentation received so 

far it appears that all can be 

accommodated by one general session. 

A final decision on whether there will 

be concurrent sessions will be made 

following the cutoff date for registration 

and will be communicated through the 

posted agenda at http://www.fda.gov/ 

nanotechnology/ and e-mail to 

registered speakers. 

We ask that you preregister by 

September 29 (see REGISTRATION) if you 

intend to provide an oral presentation. 

If time permits, there will be an open 

public session at the meeting. However, 

individuals who register at the meeting 

to speak may be allotted less time to 

speak than preregistered speakers, 

depending on the number of registrants. 

The information provided during 

preregistration will help us determine 

further how to organize the day. 

III. Will Meeting Transcripts Be 

Available? 

Following the meeting, transcripts 

will be available for review at the 

Division of Dockets Management (see 

ADDRESSES). 

IV. How Should You Send Comments 

on the Issues? 

An open public docket has been 

established. Individuals may submit 

their comments either in writing or 

electronically to the docket. All 

comments should include the docket 

number found in brackets in the 

heading of this document (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals have the option of 

submitting 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: September 20, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8242 Filed 9–21–06; 1:22 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Listing of Grants for 

Research Projects 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 


pwalker on PRODPC60 with NOTICES