Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices 21563 

ESTIMATED ANNUALIZED BURDEN TABLE—Continued 

Data collection task Instrument/form name Number of 

respondents 

Number 

responses/ 

respondent 

Average 

burden/ 

response 

(in hours) 

Total response 

burden 

(in hours) 

In person focus groups (public health professionals).Screener ............................... 140 1 10/60 23.3 

Focus Group ......................... 70 1 1.5 105 

Confidentiality Agreement .... 70 1 5/60 6 

Remote focus groups (consumers with limited health literacy and/or Spanish speakers).Screener ............................... 168 1 10/60 28 

Focus Group ......................... 42 1 1.5 63 

Confidentiality Agreement .... 42 1 5/60 3.5 

Remote focus groups (health intermediaries).Screener ............................... 126 1 10/60 21 

Focus Group ......................... 42 1 1.5 63 

Confidentiality Agreement .... 42 1 5/60 3.5 

Remote focus groups (public health professionals).Screener ............................... 84 1 10/60 14 

Focus Group ......................... 42 1 1.5 63 

Confidentiality Agreement .... 42 1 5/60 3.5 

In person usability and prototype testing of 

materials (print and Web).

Screener ............................... 160 1 10/60 27 

Usability Test ........................ 40 1 1.5 60 

Confidentiality Agreement .... 40 1 5/60 3.3 

Remote usability, prototype and concept 

testing.

Screener ............................... 200 1 10/60 33.3 

Web-test ............................... 50 1 1 50 

Confidentiality Agreement .... 50 1 5/60 4.2 

In person card sorting ................................... Screener ............................... 120 1 10/60 20 

Card Sort .............................. 30 1 1.5 45 

Confidentiality Agreement .... 30 1 5/60 2.5 

Web-based card sorting ............................... Screener ............................... 400 1 10/60 67 

Card Sort .............................. 100 1 .5 50 

Confidentiality Agreement .... 100 1 5/60 8.3 

Web-based message testing ........................ Screener ............................... 0 0 0 0 

Web-test ............................... 115 1 1 115 

Confidentiality Agreement .... 115 1 5/60 9.6 

TOTAL ................................................... ............................................... ........................ ........................ ........................ 1329.1 

Keith A. Tucker, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2012–8518 Filed 4–9–12; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Annual Survey of Refugees 

(Form ORR–9). 

OMB No.: 0970–0033. 

Description: The Annual Survey of 

Refugees collects information on the 

social and economic circumstances of a 

random sample of refugees, Amerasians, 

and entrants who arrived in the United 

States in the five years prior to the date 

of the survey. The survey focuses on the 

refugees training, labor force 

participation, and welfare utilization 

rates. Dates are segmented by region of 

origin, State of resettlement, and 

number of months since arrival. From 

the responses, the Office of Refugee 

Resettlement reports on the economic 

adjustment of refugees to the American 

economy. These data are used by 

Congress in its annual deliberations for 

refugee admissions and funding and by 

program managers in formulating 

policies for the future direction of the 

Refugee Resettlement Program. 

Respondents: Refugees, entrants, 

Amerasians, and Havana parolees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per respondent 

Average burden 

hours 

per response 

Total burden 

hours 

ORR–9 Annual Survey of Refugees ............................................... 2,000 1 0.63 1,253.20 

Request for Participation Letter ....................................................... 2,000 1 0.04 80 


srobinson on DSK4SPTVN1PROD with NOTICES
21564 Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices 

Estimated Total Annual Burden 

Hours: 1,333.20. 

Additional Information 

Copies of the proposed collection may 

be obtained 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. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–8512 Filed 4–9–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0306] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Detention and Banned Medical Devices 

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 

information collection for 

administrative detention and banned 

medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 11, 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. 

Administrative Detention and Banned 

Medical Devices—(OMB Control 

Number 0910–0114)—Extension 

FDA has the statutory authority under 

section 304(g) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 334(g)) to detain during 

established inspections devices that are 

believed to be adulterated or 

misbranded. Section 800.55 (21 CFR 

800.55), on administrative detention, 

includes among other things, certain 

reporting requirements and 

recordkeeping requirements. Under 

§ 800.55(g), an applicant of a detention 

order must show documentation of 

ownership if devices are detained at a 

place other than that of the appellant. 

Under § 800.55(k), the owner or other 

responsible person must supply records 

about how the devices may have 

become adulterated or misbranded, in 

addition to records of distribution of the 

detained devices. These recordkeeping 

requirements for administrative 

detentions permit FDA to trace devices 

for which the detention period expired 

before a seizure is accomplished or 

injunctive relief is obtained. 

FDA also has the statutory authority 

under section 516 of the FD&C Act (21 

U.S.C. 360f) to ban devices that present 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury. Section 895.21 (21 CFR 

895.21), on banned devices, contains 

certain reporting requirements. Section 

895.21(d) describes the procedures for 

banning a device when the 

Commissioner of Food and Drugs (the 

Commissioner) decides to initiate such 

a proceeding. Under 21 CFR 895.22, a 

manufacturer, distributor, or importer of 

a device may be required to submit to 

FDA all relevant and available data and 

information to enable the Commissioner 

to determine whether the device 

presents substantial deception, 

unreasonable and substantial risk of 

illness or injury, or unreasonable, direct, 

and substantial danger to the health of 

individuals. 

During the past several years, there 

has been an average of less than one 

new administrative detention action per 

year. Each administrative detention will 

have varying amounts of data and 

information that must be maintained. 

FDA’s estimate of the burden under the 

administrative detention provision is 

based on FDA’s discussion with one of 

three firms whose devices had been 

detained. 

FDA estimates the burden of this 

collection of information as follows: 


srobinson on DSK4SPTVN1PROD with NOTICES