Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 17137 

(PMAs) 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 data 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: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993, 301–796–6570. 

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 FD&C 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 FD&C 

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 October 1, 2010, through 

December 31, 2010, and includes one 

denial action during this period. The list 

provides the manufacturer’s name, the 

product’s generic name or the trade 

name, and the date of action. 

TABLE 1—LIST OF PMA ACTIVITY FROM OCTOBER 1, 2010, THROUGH DECEMBER 31, 2010 

PMA No. Docket No. Applicant Trade name Date of action 

P100016 ................... FDA–2010–M–0556 Aaren Scientific, Inc EC–3 intraocular lens (IOL) and EC–3 

precision aspheric lens (PAL) IOL.

Approved October 19, 2010. 

P040005 (S005) ....... FDA–2010–M–0558 Dako Denmark A/S HER 2 FISH PharmDx kit ........................ Approved October 20, 2010. 

P980018 (S010) ....... FDA–2010–M–0557 Dako Denmark A/S HercepTest kit .......................................... Approved October 20, 2010. 

P080009 ................... ................................. Ethicon Endo-Surgery, Inc.SEDASYS computer-assisted personalized sedation system.Denied October 27, 2010. 

P080018 ................... FDA–2010–M–0591 Carestream Health, 

Inc.

Kodak DirectView CR mammography 

system.

Approved November 3, 2010. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

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

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7212 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Pregnancy and Prescription 

Medication Use Symposium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

meeting: Pregnancy and Prescription 

Medication Use Symposium. The topic 

to be discussed is ‘‘Prescription Drug 

Use in Pregnancy.’’ 

Date and Time: The meeting will be 

held on May 17, 2011, from 8 a.m. to 

4:30 p.m. 

Location: The meeting will be held at 

FDA White Oak Campus, 10903 New 

Hampshire Ave., Building 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Contact: Monica Yu, Office of 

Women’s Health (OWH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 2313, 301–796–9449, 

e-mail: monica.yu@fda.hhs.gov. 

Registration: There is no registration 

fee, but seating is limited to 100. Send 

registration information (including 

name, title, firm name, address, 

telephone number, and e-mail address), 

to the following registration link by May 

10, 2011: http:// 

www.accessdata.fda.gov/scripts/email/ 

oc/pregnancysymposium.cfm. 

If you need special accommodations 

due to a disability, please contact 

Monica Yu at least 7 days in advance. 

Visitor parking: Please see http:// 

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

SUPPLEMENTARY INFORMATION: 

Transcripts: There will not be any 

transcripts; however, the speakers’ 

Power Point presentations will be 

posted on the FDA/OWH Web site after 

the meeting at: http://www.fda.gov/ 

ForConsumers/byAudience/ForWomen/ 

default.htm. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7215 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 


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