Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15779 

TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference 

Number and date 

M. Tissue Engineering 

15–32 ........................... Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton 

Nuclear Magnetic Resonance (1 H NMR) Spectroscopy.

ASTM F2260–03 (Reapproved 2008). 

15–33 ........................... Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by 

Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC–MALS).

ASTM F2602–08 1. 

15–34 ........................... Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion 

Chromatography with Multi-angle Light Scattering Detection (SEC–MALS).

ASTM F2605–08 1. 

15–35 ........................... Standard Guide for Characterization of Hydrogels used in Regenerative Medicine .................. ASTM F2900–11. 

15–36 ........................... Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs).ASTM F2383–11. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

IV. List of Recognized Standards 

FDA maintains the Agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

minor revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will announce additional 

modifications and minor revisions to 

the list of recognized consensus 

standards, as needed, in the Federal 

Register once a year, or more often, if 

necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the FD&C Act by 

submitting such recommendations, with 

reasons for the recommendation, to the 

contact person (see FOR FURTHER

INFORMATION CONTACT). To be properly 

considered, such recommendations 

should contain, at a minimum, the 

following information: (1) Title of the 

standard; (2) any reference number and 

date; (3) name and address of the 

national or international standards 

development organization; (4) a 

proposed list of devices for which a 

declaration of conformity to this 

standard should routinely apply; and (5) 

a brief identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

You may obtain a copy of ‘‘Guidance 

on the Recognition and Use of 

Consensus Standards’’ by using the 

Internet. CDRH maintains a site on the 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards-related 

documents. After publication in the 

Federal Register, this notice 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 028’’ will be available on the 

CDRH home page. You may access the 

CDRH home page at http://www.fda.gov/ 

MedicalDevices. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ at http://www.fda.gov/ 

MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) either electronic 

or written comments regarding this 

document. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

028. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: March 12, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6389 Filed 3–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–M–0735, FDA– 

2011–M–0736, FDA–2011–M–0737, FDA– 

2011–M–0746, FDA–2011–M–0786, FDA– 

2011–M–0791, FDA–2011–M–0792, FDA– 

2011–M–0796, FDA–2011–M–0832, FDA– 

2011–M–0837, FDA–2011–M–0848, FDA– 

2011–M–0865, FDA–2011–M–0866, FDA– 

2011–M–0910, and FDA–2011–M–0917] 

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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15780 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

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: 

I. Background 

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, 2011, through 

December 31, 2011. 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 OCTOBER 1, 

2011, THROUGH DECEMBER 31, 2011 

PMA No., Docket No. Applicant Trade name Approval date 

P110003, FDA–2011–M–0746 ............. Pluromed, Inc ...................................... LEGOO ................................................ September 28, 2011. 

P090024, FDA–2011–M–0737 ............. Siemens Healthcare Diagnostics ........ ADVIA CENTAUR HBEAG assay and 

quality control material.

October 11, 2011. 

P040024 (S51), FDA–2011–M–0735 ... Medicis Aesthetics, Inc ........................ RESTYLANE injectable gel ................. October 11, 2011. 

P010029 (S8), FDA–2011–M–0736 ..... Ferring Pharmaceuticals, Inc .............. EUFLEXXA (1% sodium hyaluronate) October 11, 2011. 

P110022, FDA–2011–M–0786 ............. Roche Diagnostics Corp ..................... ELECSYS anti-HBC IGM 

immunoassay and ELECSYS 

PRECICONTROL anti-HBC IGM.

October 26, 2011. 

P110011, FDA–2011–M–0791 ............. Medtronic Ireland ................................. ASSURANT COBALT iliac balloon-expandable stent system.October 26, 2011. 

P100042, FDA–2011–M–0792 ............. Gen-Probe Incorporated ...................... APTIMA HPV assay ............................ October 28, 2011. 

P110019, FDA–2011–M–0796 ............. Abbott Vascular ................................... XIENCE PRIME and XIENCE PRIME 

LL EVEROLIMUS-eluting coronary 

stent system.

November 1, 2011. 

P100041, FDA–2011–M–0837 ............. Edwards Lifesciences, LLC ................. EDWARDS SAPIEN transcatheter 

heart valve and RETROFLEX 3 delivery system, RETROFLEX balloon 

catheter and crimper.

November 2, 2011. 

P090016, FDA–2011–M–0832 ............. Merz Aesthetics, Inc ............................ BELOTERO balance ........................... November 14, 2011. 

H090002, FDA–2011–M–0848 ............. BSD Medical Corp ............................... BSD–2000 hyperthermia system ........ November 18, 2011. 

P110010, FDA–2011–M–0865 ............. Boston Scientific Corp ......................... PROMUS ELEMENT PLUS 

EVEROLIMUS-eluting platinum 

chromium coronary stent system.

November 22, 2011. 

P100024, FDA–2011–M–0866 ............. Dako Denmark A/S ............................. HER2 CISH PHARMDX kit ................. November 30, 2011. 

P110025, FDA–2011–M–0917 ............. Roche Diagnostics Corp ..................... ELECSYS anti-HBC IGM 

immunoassay and ELECSYS 

PRECICONTROL anti-HBC IGM for 

use on the MODULAR ANALYTICS 

E170 immunoassay analyze.

December 14, 2011. 

P100046, FDA–2011–M–0910 ............. AtriCure Inc ......................................... ATRICURE SYNERGY ablation system.December 14, 2011. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at: 

http://www.fda.gov/MedicalDevices/

ProductsandMedicalProcedures/

DeviceApprovalsandClearances/

PMAApprovals/default.htm; and 

http://www.fda.gov/MedicalDevices/

ProductsandMedicalProcedures/

DeviceApprovalsandClearances/

HDEApprovals/ucm161827.htm. 

Dated: March 12, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6390 Filed 3–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

New Proposed Collection; Comment 

Request: Child Health Disparities 

Measurement for the National 

Children’s Study 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Child Health and 

Human Development (NICHD), the 

mstockstill on DSK4VPTVN1PROD with NOTICES