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
9258 Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 

collected on the race/ethnicity of 

program participants and household 

demographics including income data. 

Form 2—State Performance Measures 

Template: Grantees have already 

selected relevant performance measures 

for the legislatively identified 

benchmark areas. This form provides a 

template for grantees to report aggregate 

data on their State-selected performance 

measures. 

While there will be variation in the 

data collection and reporting burden to 

the grantees based on the number of 

families served and state data system 

capacity, the estimated average annual 

burden is as follows: 

Reporting document Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Burden hours 

per response 

Total burden 

hours 

Form 1: Demographic and Service Utilization Data for Enrollees and Children ......................................................... 56 1 56 731 40,936 

Form 2: State Performance Measures Template ................ 56 1 56 313 17,528 

Total .............................................................................. 56 ........................ 56 ........................ 58,464 

Email comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Reports Clearance Officer, Room 

10–29, Parklawn Building, 5600 Fishers 

Lane, Rockville, MD 20857. Written 

comments should be received within 60 

days of this notice. 

Dated: February 10, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–3710 Filed 2–15–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Extension of an Existing 

Information Collection Request; 

Comment Request 

ACTION: 60-Day Notice of Information 

Collection Under Review: Form N–25, 

Request for Verification of 

Naturalization. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) will be 

submitting the following information 

collection request for review and 

clearance in accordance with the 

Paperwork Reduction Act of 1995. The 

information collection notice, OMB 

Control Number 1615–0049, is 

published in the Federal Register to 

obtain comments from the public and 

affected agencies. Comments are 

encouraged and will be accepted for 

sixty days until April 16, 2012. 

During this 60-day period USCIS will 

be evaluating whether to revise the 

Form N–25. Should USCIS decide to 

revise this form it will advise the public 

when it publishes the 30-day notice in 

the Federal Register in accordance with 

the Paperwork Reduction Act. The 

public will then have 30-days to 

comment on any revisions to this form. 

Written comments and suggestions 

regarding items contained in this notice 

and especially with regard to the 

estimated public burden and associated 

response time should be directed to the 

Department of Homeland Security 

(DHS), USCIS, Chief, Regulatory 

Products Division, Clearance Office, 20 

Massachusetts Avenue NW., 

Washington, DC 20529. Comments may 

also be submitted to DHS via facsimile 

to 202–272–0997, or via email at 

uscisfrcomment@dhs.gov. When 

submitting comments by email, please 

add the OMB Control Number 1615– 

0049 in the subject box. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points: 

(1) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques, or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of an existing information 

collection. 

(2) Title of the Form/Collection: 

Request for Verification of 

Naturalization. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form N–25. 

U.S. Citizenship and Immigration 

Services. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Not for Profit 

Institutions. This form will allow U.S. 

Citizenship and Immigration Services 

(USCIS) to obtain verification from the 

courts that a person claiming to be a 

naturalized citizen has, in fact, been 

naturalized. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 1,000 responses at 15 minutes 

(.25) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 250 annual burden hours. 

If you have additional comments, 

suggestions, or need a copy of the 

information collection instrument, 

please visit: http://www.regulations.gov/ 

search/index.jsp. 

We may also be contacted at: USCIS, 

Regulatory Management Division, 20 

Massachusetts Avenue NW., 

Washington, DC 20529, telephone 

number 202–272–8377. 

Dated: February 10, 2012. 

William Bacon, 

Deputy Chief, Office of the Executive 

Secretariat, U.S. Citizenship and Immigration 

Services, Department of Homeland Security. 

[FR Doc. 2012–3665 Filed 2–15–12; 8:45 am] 

BILLING CODE 9111–97–P 


srobinson on DSK4SPTVN1PROD with NOTICES