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

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15781 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Child 

Health Disparities Substudy for the 

National Children’s Study (NCS). Type 

of Information Collection Request: 

NEW. Need and Use of Information 

Collection: The Children’s Health Act of 

2000 (Pub. L. 106–310) states: 

(a) PURPOSE.—It is the purpose of this 

section to authorize the National Institute of 

Child Health and Human Development* to 

conduct a national longitudinal study of 

environmental influences (including 

physical, chemical, biological, and 

psychosocial) on children’s health and 

development. 

(b) IN GENERAL.—The Director of the 

National Institute of Child Health and 

Human Development* shall establish a 

consortium of representatives from 

appropriate Federal agencies (including the 

Centers for Disease Control and Prevention, 

the Environmental Protection Agency) to— 

(1) Plan, develop, and implement a 

prospective cohort study, from birth to 

adulthood, to evaluate the effects of both 

chronic and intermittent exposures on child 

health and human development; and 

(2) Investigate basic mechanisms of 

developmental disorders and environmental 

factors, both risk and protective, that 

influence health and developmental 

processes. 

(c) REQUIREMENT.—The study under 

subsection (b) shall— 

(1) Incorporate behavioral, emotional, 

educational, and contextual consequences to 

enable a complete assessment of the physical, 

chemical, biological, and psychosocial 

environmental influences on children’s wellbeing; 

(2) Gather data on environmental 

influences and outcomes on diverse 

populations of children, which may include 

the consideration of prenatal exposures; and 

(3) Consider health disparities among 

children, which may include the 

consideration of prenatal exposures. 

To fulfill the requirements of the 

Children’s Health Act, the Child Health 

Disparities Substudy will validate 

measures needed for studying health 

disparities and selected biomarkers. 

Utilizing cognitive interview techniques 

and components of standardized 

questionnaires, responses will be used 

to assess and validate measures of 

health literacy, discrimination, 

parenting self-efficacy, and health care 

accessibility. 

Acceptability and feasibility of saliva 

collection from a subsample of women 

and young children will also be 

evaluated. The incorporation of saliva 

measurements will increase 

understanding of biological responses to 

environmental factors and how these 

may be correlated with health 

disparities within this population. 

Background: The National Children’s 

Study is a prospective, national 

longitudinal study of the interaction 

between environment, genetics on child 

health and development. The Study 

defines ‘‘environment’’ broadly, taking a 

number of natural and man-made 

environmental, biological, genetic, and 

psychosocial factors into account. By 

studying children through their 

different phases of growth and 

development, researchers will be better 

able to understand the role these factors 

have on health and disease. Findings 

from the Study will be made available 

as the research progresses, making 

potential benefits known to the public 

as soon as possible. The National 

Children’s Study is led by a consortium 

of federal partners: the U.S. Department 

of Health and Human Services 

(including the Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development and the National 

Institute of Environmental Health 

Sciences of the National Institutes of 

Health and the Centers for Disease 

Control and Prevention), and the U.S. 

Environmental Protection Agency. 

To conduct the detailed preparation 

needed for a study of this size and 

complexity, the NCS was designed to 

include a preliminary pilot study 

known as the Vanguard Study. The 

purpose of the Vanguard Study is to 

assess the feasibility, acceptability, and 

cost of the recruitment strategy, study 

procedures, and outcome assessments 

that are to be used in the NCS Main 

Study. The Vanguard Study begins prior 

to the NCS Main Study and will run in 

parallel with the Main Study. At every 

phase of the NCS, the multiple 

methodological studies conducted 

during the Vanguard phase will inform 

the implementation and analysis plan 

for the Main Study. 

In this information collection request, 

the NCS requests approval from OMB to 

perform a multi-center substudy called 

the Child Health Disparity Substudy. 

This substudy aims to validate measures 

needed for studying health disparities 

and selected biomarkers. Developing 

optimum measures for studying health 

disparities is of particular interest to the 

NCS because studies have shown that 

health literacy, discrimination, 

parenting self-efficacy, health care 

(access, utilization, and quality) 

contribute to health disparities. 

Additionally, aspects of the social 

environment such as social isolation, 

lack of control and contingency and 

social support, violence, discrimination, 

challenging and changing social 

relationships, and restricted access to 

health care are thought to interact with 

biological processes. Variation in these 

processes has been associated with 

negative emotional states, cognitive 

deficits, problem behavior, and a variety 

of metabolic and immune-related 

processes. Alone, or particularly in 

combination with other commonly 

collected measures of social forces and 

family relationships, salivary analytes 

have the potential to advance our 

understanding of maternal and child 

health and development. This project 

will make its contribution to the NCS 

Main Study and to the health disparities 

field as a whole by constructing a 

validated set of questionnaire measures 

and biomarker analyses that can be used 

among pregnant women and mothers of 

young children for the purpose of 

investigating disparities. 

Frequency of Response: One-time data 

collection conducted in multiple 

phases. 

Affected Public: Pregnant women, 

mothers with young children, and their 

children. 

Type of Respondents: Pregnant 

women, mothers with young children, 

and their children who are not 

geographically eligible to enroll in the 

NCS Vanguard Study. 

Annual Reporting Burden: See Table 

1. The annualized cost to respondents is 

estimated at $24,600 (based on $10 per 

hour). There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15782 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, CHILD HEALTH DISPARITIES SUBSTUDY

Data collection activity Type of 

respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

Consent ........................ Pregnant Women/ 

Mothers of children 

ages 0–5.

Members of NCS target population (not 

NCS participants).

1,260 1 0.08 105 

Cognitive Interview ....... Mothers of children 

ages 0–5.

Members of NCS target population (not 

NCS participants).

60 1 1.33 80 

Primary Data Collection Pregnant Women/ 

Mothers of children 

ages 0–5.

Mothers of children 

ages 0–5.

Members of NCS target population (not 

NCS participants).

600 

600 

2 

1 

1.08 

1.08 

1,300 

650 

Saliva Collection ........... Pregnant Women/ 

Mothers of children 

ages 0–5.

Additional mothers of 

children ages 0–5.

Children ages 0–5 .......

Members of NCS target population (not 

NCS participants).

260 

260 

520 

2 

1 

1 

0.25 

0.25 

0.25 

130 

65 

130 

Total ...................... ..................................... ..................................... 1,780 ........................ ........................ 2,460 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to minimize 

the burden of the collection of 

information on those who are to 

respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Sarah L. 

Glavin, Deputy Director, Office of 

Science Policy, Analysis and 

Communication, National Institute of 

Child Health and Human Development, 

31 Center Drive, Room 2A18, Bethesda, 

Maryland 20892, or call non-toll free 

number (301) 496–1877 or email your 

request, including your address to 

glavins@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: March 12, 2012. 

Sarah L. Glavin, 

Deputy Director, Office of Science Policy, 

Analysis and Communications, National 

Institute of Child Health and Human 

Development. 

[FR Doc. 2012–6354 Filed 3–15–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute Amended; 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Institute Special Emphasis Panel, April 

18, 2012, 1 p.m. to April 18, 2012, 5 

p.m., National Institutes of Health, 6116 

Executive Boulevard, 8055B, Rockville, 

MD 20852 which was published in the 

Federal Register on March 1, 2012, 77 

FR 12600. 

This notice is being amended to 

change the times of the meeting from 1 

p.m.–5 p.m. to 12 p.m.–3 p.m. The 

meeting is closed to the public. 

Dated: March 9, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–6352 Filed 3–15–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2) 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 purpose of this 

meeting is to evaluate requests for 

preclinical development resources for 

potential new therapeutics for the 

treatment of cancer. The outcome of the 

evaluation will provide information to 

internal NCI committees that will 

decide whether NCI should support 

requests and make available contract 

resources for development of the 

potential therapeutic to improve the 

treatment of various forms of cancer. 

The research proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material and 

personal information concerning 

individuals associated with the 

proposed research projects, the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal privacy. 

mstockstill on DSK4VPTVN1PROD with NOTICES