54154 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Robert H. 

King, Sr., Center for Drug 

Evaluation and Research (HFD– 

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002, 

301–796–1242, or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–25), Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of December 

17, 2009 (74 FR 66981), FDA published 

a notice announcing the availability of 

a draft tripartite guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 11: Capillary 

Electrophoresis General Chapter.’’ The 

notice gave interested persons an 

opportunity to submit comments by 

February 16, 2010. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 11: Capillary 

Electrophoresis General Chapter’’ was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in June 

2010. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Capillary Electrophoresis 

General Chapter harmonization 

proposal originating from the threeparty PDG. This guidance is in the form 

of an annex to the core ICH Q4B 

guidance made available in the Federal 

Register of February 21, 2008 (73 FR 

9575). When implemented, the annex 

will provide guidance for industry and 

regulators on the use of the specific 

pharmacopoeial texts evaluated by the 

ICH Q4B process. Following receipt of 

comments on the draft, no substantive 

changes were made to the annex. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: August 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21991 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–M–0244, FDA– 

2010–M–0220, FDA–2010–M–0219, FDA– 

2010–M–0242, FDA–2010–M–0261, FDA– 

2010–M–0262, FDA–2010–M–0264, FDA– 

2010–M–0294, FDA–2010–M–0285] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries 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. 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 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 20993–0002, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 54155 

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, 2010, through 

June 30, 2010. 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, 

2010, THROUGH JUNE 30, 2010 

PMA No. Docket No. Applicant TRADE NAME Approval Date 

P090018 

FDA–2010–M–0244 

Envoy Medical Corp. ESTEEM TOTALLY IMPLANTABLE HEARING 

SYSTEM 

March 17, 2010 

P080029 

FDA–2010–M–0220 

Interventional Therapies, 

LLC 

QUICK CLOSE VASCULAR SUTURING SYSTEM April 8, 2010 

P090022 

FDA–2010–M–0219 

Lenstec, Inc. SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) April 12, 2010 

P080032 

FDA–2010–0242 

Asthmatix, Inc. ALAIR BRONCHIAL THERMOPLASTY April 27, 2010 

P090007 

FDA–2010–M–0261 

Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND 

ELECSYS PRECICONTROL ANTI-HCV FOR 

USE ON THE COBAS E411 IMMUNOASSAY 

ANALYZER 

April 29, 2010 

P090008 

FDA–2010–M–0262 

Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND 

ELECSYS PRECICONTROL ANTI-HCV FOR 

USE ON THE COBAS E601 IMMUNOASSAY 

ANALYZER 

April 29, 2010 

P090009 

FDA–2010–M–0264 

Roche Diagnostics Corp. ELECSYS ANTI-HCV IMMUNOASSAY AND 

ELECSYS PRECICONTROL ANTI-HCV FOR 

USE ON THE MODULAR ANALYTICS E170 

ANALYZER 

April 29, 2010 

P050027 

FDA–2010–M–0294 

Karl Storz endoscopy— 

America, Inc. 

PHOTODYNAMIC DIAGNOSTIC D-LIGHT C May 28, 2010 

P060029 

FDA–2010–M–0285 

Ethicon, Inc. OMNEX SURGICAL SEALANT June 3, 2010 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

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

Dated: August 31, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–22085 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 


srobinson on DSKHWCL6B1PROD with NOTICES