52332 Federal Register / Vol. 76, No. 162 / Monday, August 22, 2011 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

Title Amendments ............................................................................ 18 1 3 54 

State TANF plan .............................................................................. 18 1 30 540 

Estimated Total Annual Burden 

Hours: 594. 

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. E-mail 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. Fax: 202– 

395–7285. E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–21316 Filed 8–19–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0591] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Data To Support 

Communications Usability Testing, as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

21, 2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–New and 

title: ‘‘Data to Support Communications 

Usability Testing, as Used by the Food 

and Drug Administration.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Data To Support Communications 

Usability Testing, as Used by the Food 

and Drug Administration—(OMB 

Control Number 0910–New) 

FDA plans to use the data collected 

under this generic clearance to inform 

its communications campaigns on a 

variety of topics related to products that 

FDA regulates. FDA expects the data to 

help staff message developers achieve 

FDA communication objectives. FDA 

also plans to use the data to help tailor 

print, broadcast, and electronic media 

communications in order for them to 

have powerful and desired impacts on 

target audiences. The data will not be 

used for the purposes of making policy 

or regulatory decisions. 

The information collected will serve 

two major purposes. First, as formative 

research it will provide the critical 

knowledge needed about target 

audiences. FDA must explore 

audiences’ beliefs, perceptions, and 

decisionmaking processes on specific 

topics in order to meet the basic 

objectives of its risk communication 

campaigns. Such knowledge will 

provide the needed target audience 

understanding to design effective 

communication strategies, messages, 

and product labels. These 

communications will aim to improve 

public understanding of the risks and 

benefits of using various FDA-regulated 

products by providing users with a 

better context in which to place risk 

information more completely. 

Second, as pretesting, it will give FDA 

some information about the potential 

effectiveness of messages and materials 

in reaching and successfully 

communicating with their intended 

audiences. Testing messages with a 

sample of the target audience will allow 

FDA to refine messages while still in the 

developmental stage. Respondents may 

be asked to give their reaction to the 

messages in person or on-line. 

FDA’s Centers and Offices will use 

this mechanism to test the usability of 

messages about FDA-regulated products 

for consumers, patients, industry 

representatives, or health care 

professionals. The data will not be used 

for the purposes of making policy or 

regulatory decisions. 

In the Federal Register of June 10, 

2011 (76 FR 34083), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 


jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 162 / Monday, August 22, 2011 / Notices 52333 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Survey type Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

In-Person Surveys ............................................................... 7,500 1 7,500 1 7,500 

Remote Online Surveys ....................................................... 67,000 1 67,000 30/60 33,500 

Screener Only 2 .................................................................... 500 1 500 5/60 42 

Total .............................................................................. ........................ ........................ ........................ ........................ 41,042 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2These participants take the screener (which will be comprised of Demographic and/or Introductory Questions, attachments 5 and 6) but are 

not selected for the full survey. 

There will be two lengths of surveys 

conducted, depending on whether the 

survey is in-person or remote and 

online. An in-person survey will last an 

average of 60 minutes and take place at 

an FDA computer or at a 

nongovernmental location; a remote 

survey will last approximately 30 

minutes and take place at the 

participant’s computer. These estimates 

were determined through analysis of 

times from previous usability surveys 

using similar questions, a survey of 

usability professionals to ascertain 

average times for users to perform tasks, 

and a pilot survey of 10 internal users 

comprised of staff from the Centers for 

Disease Control and Prevention (CDC) 

and CDC contractors. Some remote 

surveys will take much less time. The 

majority of usability surveys conducted 

at CDC were done remotely; thus FDA 

estimates that in the future more 

surveys will be done remotely rather 

than in person. 

Estimate of survey respondents was 

based on an estimate of the ideal 

number of usability surveys that FDA 

would conduct over a 3-year period. 

Factored in were initial surveys and 

subsequent followup surveys utilizing a 

satisfactory level of participants. 

Because FDA has not conducted these 

types of surveys at the level needed 

previously, it is anticipated that most of 

FDA’s communications will require 

some sort of usability survey. 

Additionally, FDA anticipates 

conducting a number of important 

baseline surveys for its home Web page 

and other highly trafficked subsites in 

order to redesign these pages as part of 

FDA’s priority to more effectively utilize 

its Web site. 

Annually, FDA projects about 125 

studies using the variety of test methods 

listed previously. FDA is requesting this 

burden so as not to restrict the Agency’s 

ability to gather information on public 

sentiment for its proposals in its 

regulatory and communications 

programs. 

Dated: August 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–21379 Filed 8–19–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0553] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Tobacco Product 

Reporting Violation Form 

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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information contained 

in FDA’s Tobacco Product Reporting 

Violation Form. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 21, 2011. 

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 

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. 


jlentini on DSK4TPTVN1PROD with NOTICES