9256 Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 

Medicare—Supplementary Medical 

Insurance Program) 

Section 1833(t)(9)(A) of the Act (42 U.S.C. 

1395l(t)(9)(A)). The Panel is governed by the 

provisions of the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2). 

Dated: February 8, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–3643 Filed 2–15–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0123] 

Design and Methodology for 

Postmarket Surveillance Studies Under 

Section 522 of the Federal Food, Drug, 

and Cosmetic Act; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘Design and 

Methodology for Postmarket 

Surveillance Studies under Section 522 

of the Federal Food, Drug and Cosmetic 

Act’’. The purpose of the public 

workshop is to provide a forum for 

discussion among FDA, industry, 

governmental agencies, academia, 

clinicians and various stakeholders with 

experience in epidemiology, statistics, 

and biomedical research to advance the 

design and methodologies for medical 

device surveillance studies in the 

‘‘postmarket’’ setting, i.e., after FDA 

premarket approval or clearance of the 

device and marketing of the device has 

begun. 

DATES: The meeting will be held on 

March 7, 2012, from 8 a.m. to 5:30 p.m. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31, Rm 

1503 (the Great Room), Silver Spring, 

MD 20993. For parking and security 

information, please visit the following 

Web site: http://www.fda.gov/ 

AboutFDA/WorkingatFDA/ 

BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. The public workshop 

will also be available to be viewed 

online via webcast. 

FOR FURTHER INFORMATION CONTACT: 

Samantha Jacobs, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4201C, Silver 

Spring, MD 20993, 301–796–6897, 

email: samantha.jacobs@fda.hhs.gov; or 

Mary Beth Ritchey, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4118, Silver Spring, 

MD 20993, 301–796–6638, email: 

maryelizabeth.ritchey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Registration: To register for the public 

workshop, please visit the following 

Web site: http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/ucm289465.htm 

(or go to http://www.fda.gov and select 

the FDA Medical Devices News & 

Events—Workshops & Conferences 

calendar and select this public 

workshop from the posted events list). 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone number. For persons 

interested in attending this workshop 

and without Internet access, please call 

one of the people listed in the FOR

FURTHER INFORMATION CONTACT section 

in this document in order to register. 

Registrants will receive confirmation 

once they have been accepted. You will 

be notified if you are on a waitlist. 

There is no fee to attend the public 

workshop, but attendees must register in 

advance. Registration will be on a firstcome, first-served basis. Persons 

interesting in attending this workshop 

must register online by February 29, 

2012. Registration is mandatory as space 

is limited and onsite registration will 

not be available. FDA may limit the 

number of participants from each 

organization. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan at 

susan.monahan@fda.hhs.gov no later 

than March 1, 2012. 

Security: Non-U.S. citizens are subject 

to additional security screening, and 

they should register as soon as possible. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please visit the Web site 

address in the ADDRESSES section of this 

document. 

Streaming Webcast of the Public 

Workshop: This workshop will also be 

webcast. Persons interested in viewing 

the webcast must register online by 5 

p.m. on February 29, 2012. Early 

registration is recommended because 

webcast connections are limited. 

Organizations are requested to register 

all participants, but view using one 

connection per location. Webcast 

participants will be sent technical 

system requirements after registration, 

and will be sent connection access 

information after March 1, 2012. If you 

have never attended a Connect Pro 

meeting before, test your connection at: 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit: http://www.adobe.com/ 

go/connectpro_overview. (FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Background: Under section 522(a) of 

the Federal Food, Drug and Cosmetic 

Act (FD&C Act), enacted by the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA) (Pub. L. 105–115, 

§ 212, 111 Stat. 2346), codified at 21 

U.S.C. 360l(a), FDA may order a 

manufacturer to conduct postmarket 

surveillance for any Class II or Class III 

device (i) Intended to be implanted in 

the human body for more than 1 year or 

to be used to sustain or support life 

outside a device user facility, or (ii) 

whose failure would be reasonably 

likely to have serious adverse health 

consequences. The Food and Drug 

Administration Amendments of 2007 

(FDAAA) (Pub. L. 110–85, § 307, 121 

Stat. 865) expanded the scope of section 

522 to include devices intended for 

pediatric use. 

Agenda for the Public Workshop 

1. Why are we holding this public 

workshop? 

The purpose of the proposed 

workshop is to facilitate discussion 

among the FDA, industry, governmental 

agencies, academia, clinicians, and key 

stakeholders with experience in 

epidemiology, statistics, and biomedical 

research in the scientific community to 

advance the design and methodologies 

for medical device surveillance studies 

in the postmarket setting. 

2. Who is the target audience for this 

public workshop? Who should attend 

this public workshop? 

This workshop is open to all 

interested parties. The target audience is 

professionals in the scientific 

community interested in advancing the 

infrastructure and methodology for 

postmarket surveillance studies. 

3. What are the topics we intend to 

address at the public workshop? 

We intend to discuss a large number 

of issues at the workshop, including, but 

not limited to the following: 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 9257 

• Regulations for postmarket 

surveillance studies, 

• Challenges and opportunities for 

collaborative efforts, 

• Innovative methodologies and 

scientific infrastructure to promote 

innovation, 

• Role of networks, registries and 

observational studies, 

4. Where can I find out more about this 

public workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, and 

other relevant information will be 

posted, as it becomes available, on the 

Internet at http://www.fda.gov/cdrh/ 

meetings.html. 

Comments: Regardless of attendance 

at the public workshop, interested 

persons may submit electronic 

comments, or written comments by 

April 6, 2012. Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comment to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration 5630 Fishers Lane, rm, 

1061, Rockville, MD 20852. Comments 

are to be identified with the docket 

number found in brackets in the 

heading of this document. In addition, 

when responding to specific topics 

listed in paragraph 3 of the ‘‘Agenda for 

the Public Workshop’’ section of this 

document, please identify the topic you 

are addressing. Received comments may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Any 

written request for a transcript is to be 

sent to the Division of Freedom of 

Information. Written requests are to be 

sent to Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857. A link to the transcripts will also 

be available on the Internet at http:// 

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (select this public workshop 

from the posted events list), 

approximately 45 days after the public 

workshop. 

Dated February 10, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–3606 Filed 2–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1984. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the Agency; (b) the accuracy of the 

Agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Maternal, Infant, and 

Early Childhood Home Visiting 

Program Information System (OMB No. 

0915–xxxx)—[New] 

On March 23, 2010, the President 

signed into law the Patient Protection 

and Affordable Care Act of 2010 (Pub. 

L. 111–148), historic and transformative 

legislation designed to make quality, 

affordable health care available to all 

Americans, reduce costs, improve 

health care quality, enhance disease 

prevention, and strengthen the health 

care workforce. Through a provision 

authorizing the creation of the Maternal, 

Infant, and Early Childhood Home 

Visiting (MIECHV) Program, the Act 

responds to the diverse needs of 

children and families in communities at 

risk and provides an unprecedented 

opportunity for collaboration and 

partnership at the Federal, State and 

community levels to improve health and 

development outcomes for at-risk 

children through evidence-based home 

visiting programs. The MIECHV 

Program is designed: (1) To strengthen 

and improve the programs and activities 

carried out under Title V; (2) to improve 

coordination of services for at-risk 

communities; and (3) to identify and 

provide comprehensive services to 

improve outcomes for families who 

reside in at-risk communities. 

The Social Security Act, Title V, 

Section 511 (42 U.S.C. 711), as amended 

by the Patient Protection and Affordable 

Care Act of 2010, requires that MIECHV 

grantees collect data to measure 

improvements for eligible families in six 

specified areas (referred to as 

‘‘benchmark areas’’) that encompass the 

major goals for the program. The 

Supplemental Information Request for 

the Submission of the Updated State 

Plan for a State Home Visiting Program 

(SIR), published on February 8, 2011, 

further listed a variety of constructs 

under each benchmark area for which 

grantees were to select and submit 

relevant performance measures. Per 

Section 511(d)(1)(B)(i) of the legislation, 

no later than 30 days after the end of the 

third year of the program, grantees are 

required to demonstrate improvement in 

at least four of the six benchmark areas. 

The SIR and subsequent MIECHV 

guidance documents for both 

competitive and formula grants also 

require that grantees report annually on 

the constructs under each benchmark 

area, as well as on demographic, service 

utilization, budgetary and other 

administrative data related to program 

implementation. 

The proposed data collection and 

reporting forms were developed by an 

internal MIECHV workgroup in 

consultation with Home Visiting Model 

Developers and selected grantees. The 

data collected from the proposed forms 

will be used to track the grantees’ 

progress in demonstrating improvement 

under each benchmark area and to 

provide an overall picture of the 

population being served. The proposed 

data collection forms are as follows: 

Form 1—Demographic and Service 

Utilization Data for Enrollees and 

Children: This form will request data to 

determine the unduplicated number of 

participants and of participant groups 

by primary insurance coverage. This 

form will also request data on the 

demographic characteristics of program 

participants. For example, data will be 


srobinson on DSK4SPTVN1PROD with NOTICES