23266 Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices 

Information Collection: Post Clinical 

Laboratory Survey Questionnaire and 

Supporting Regulations in 42 CFR 

493.1771, 493.1773, and 493.1777. Use: 

Form CMS–668B is used by a Clinical 

Laboratory Improvement Amendments 

(CLIA) laboratory to express its 

satisfaction with the survey process and 

to make recommendations for 

improvement. Surveyors furnish this 

form to all laboratories that receive 

either an onsite survey or the Alternate 

Quality Assessment Survey (i.e., paper 

survey of quality indicators). CMS 

Central Office performs an overview 

evaluation of the completed forms. Each 

calendar year, a summary of the 

information collected is sent to the State 

and CMS Regional Office. Form 

Number: CMS–668B (OCN 0938–0653). 

Frequency: Biennially; Affected Public: 

Business or other for-profits and not-forprofit institutions. State, Local, or Tribal 

Government, Federal Government. 

Number of Respondents: 21,000. Total 

Annual Responses: 10,500. Total 

Annual Hours: 2,625. (For policy 

questions regarding this collection 

contact Kathleen Todd at 410–786– 

3385. For all other issues call 410–786– 

1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection. Title of 

Information Collection: Survey Report 

Form for Clinical Laboratory 

Improvement Amendments (CLIA) and 

Supporting Regulations in 42 CFR 

493.1–493.2001. Use: CMS 1557 is used 

to report surveyor findings during a 

CLIA survey. For each type of survey 

conducted (i.e., initial certification, 

recertification, validation, complaint, 

addition/deletion of specialty/ 

subspecialty, transfusion fatality 

investigation, or revisit inspections) the 

Survey Report Form incorporates the 

requirements specified in the CLIA 

regulations. Form Number: CMS–1557 

(OCN 0938–0544). Frequency: 

Biennially. Affected Public: Business or 

other for-profit, Not-for-profit 

institutions, State, Local or Tribal 

Governments and Federal Government. 

Number of Respondents: 21,000. Total 

Annual Responses: 10,500. Total 

Annual Hours: 5,248. (For policy 

questions regarding this collection 

contact Kathleen Todd at 410–786– 

3385. For all other issues call 410–786– 

1326.) 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Analysis of 

Transportation Barriers to Utilization of 

Medicare Services by American Indian 

and Alaska Native Medicare 

Beneficiaries; Use: The purpose of the 

proposed study is to identify and 

analyze transportation barriers 

associated with the utilization of 

Medicare services by American Indian 

and Alaska Native (AI/AN) 

beneficiaries, to identify and analyze the 

health outcomes resulting from those 

barriers, and ultimately to identify 

potential solutions that could help 

mitigate the problem and produce 

meaningful improvements in health care 

use and health outcomes for this 

population. Specifically, the 

information that will be collected 

through the use of instruments and the 

study developed under the Analysis of 

Transportation Barriers to Utilization of 

Medicare Services by American Indian 

and Alaska Native Medicare 

Beneficiaries Project has not been 

collected or evaluated previously by any 

agency or individual, so data on the 

extent of transportation barriers for rural 

AI/AN beneficiaries to Medicare 

services by AI/AN Medicare 

beneficiaries are not available except 

from the proposed data collection 

activity. 

The information gathered as part of 

the project—through the use of survey, 

interview, and focus group 

instruments—will be used by CMS to 

identify transportation barriers to 

Medicare services for AI/AN Medicare 

beneficiaries. It will provide the first 

ever complete evaluation of 

transportation barriers to health care for 

this population. 

The information collection request 

has been revised since the publication 

of the 60-day Federal Register notice. 

Several questions were added in 

response to public comments. In 

addition to new questions, several 

clarifying edits were made as well. Form 

Number: CMS–10399 (OMB # 0938– 

NEW); Frequency: Occasionally; 

Affected Public: Individuals and 

Households, Private Sector; Number of 

Respondents: 3,418; Total Annual 

Responses: 3,418; Total Annual Hours: 

2,544. (For policy questions regarding 

this collection contact Roger Goodacre 

at 410–786–3209. For all other issues 

call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on May 18, 2012. 

OMB, Office of Information and 

Regulatory Affairs, 

Attention: CMS Desk Officer, 

Fax Number: (202) 395–6974, 

Email: OIRA_submission@omb.eop.gov. 

Dated: April 12, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division-B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–9259 Filed 4–17–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: National Youth in Transition 

Database and Youth Outcome Survey. 

OMB No.: 0970–0340. 

Description: The Foster Care 

Independence Act of 1999 (42 U.S.C. 

1305 et seq.) as amended by Public Law 

106–169 requires State child welfare 

agencies to collect and report to the 

Administration on Children and 

Families (ACF) data on the 

characteristics of youth receiving 

independent living services and 

information regarding their outcomes. 

The regulation implementing the 

National Youth in Transition Database, 

listed in 45 CFR 1356.80, contains 

standard data collection and reporting 

requirements for States to meet the law’s 

requirements. ACF will use the 

information collected under the 

regulation to track independent living 

services, assess the collective outcomes 

of youth, and potentially to evaluate 

State performance with regard to those 

outcomes consistent with the law’s 

mandate. 

Respondents: State agencies that 

administer the John H. Chafee Foster 

Care Independence Program. 

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Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices 23267 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden 

hours 

Youth Outcome Survey ................................................................... 15,334 1 0.50 7,667 

Data File .......................................................................................... 52 2 1,201 124,904 

Estimated Total Annual Burden 

Hours: 132,571. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: ACF Reports Clearance 

Officer. Email address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden 

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. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–9337 Filed 4–17–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0324] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry, FDA Staff, and Foreign 

Governments: Fiscal Year 2012 

Medical Device User Fee Small 

Business Qualification and 

Certification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

Form FDA 3602 and Form FDA 3602A, 

which will allow domestic and foreign 

applicants to certify that they qualify as 

a ‘‘small business’’ and pay certain 

medical device user fees at reduced 

rates. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 18, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.regulations.

gov. Submit written comments on the 

collection of information to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry, FDA Staff, and 

Foreign Governments: Fiscal Year 2012 

Medical Device User Fee Small 

Business Qualification and 

Certification—(OMB Control Number 

0910–0508)—Extension 

Section 101 of the Medical Device 

User Fee and Modernization Act 

(MDUFMA) amends the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

to provide for user fees for certain 

medical device applications. FDA 

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