62160 Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 

regulations and ORR policies and 

procedures. 

Melody Wayland, 

Senior Grants Policy Specialist, Office of 

Administration, Office of Financial Services, 

Division of Grants Policy. 

[FR Doc. 2014–24555 Filed 10–15–14; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1533] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Establishment of a 

Tobacco User Panel 

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 establishment of a probability-based 

panel of tobacco users. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 15, 2014. 

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: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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 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. 

Establishment of a Tobacco User 

Panel—(OMB Control Number 0910– 

NEW) 

The Food and Drug Administration’s 

Center for Tobacco Products (CTP) 

proposes to establish a high quality, 

probability-based, primarily Web-based 

panel of 4,000 tobacco users. The panel 

will include individuals who can 

participate in up to 8 studies over a 3- 

year period to assess consumers’ 

responses to tobacco marketing, warning 

statements, product labels, and other 

communications about tobacco 

products. CTP proposed the 

establishment of the panel of consumers 

because currently existing Web-based 

panels have a number of significant 

limitations. First, most existing 

consumer panels are drawn from 

convenience samples that limit the 

generalizability of study findings (Baker 

et al., 2010). Second, although at least 

two probability-based panels of 

consumers exist in the United States, 

there is a concern that responses to the 

studies using tobacco users in these 

panels may be biased due to panel 

conditioning effects (e.g., Coen, Lorch 

and Piekarski, 2005; Nancarrow and 

Catwright, 2007). That is, consumers in 

these panels complete surveys so 

frequently that their responses may not 

adequately represent the population as 

a whole. Panel conditioning has been 

associated with repeated measurement 

on the same topic (e.g., Kruse et al., 

2009), panel tenure (e.g., Coen, Lorch 

and Piekarski, 2005), and frequency of 

the survey request (e.g., Nancarrow and 

Catwright, 2007). This issue is of 

particular concern for tobacco users 

who represent a minority of the 

members in the panels, and so may be 

more likely to be selected for 

participation in experiments and/or 

surveys related to tobacco products. 

Third, a key benefit of the Web panel 

approach is that the surveys can include 

multimedia, such as images of tobacco 

product packages, tobacco advertising, 

new and existing warning statements 

and labels, and potential reduced harm 

claims in the form of labels and print 

advertisements. Establishing a primarily 

Web-based panel of tobacco users 

through in-person probability-based 

recruitment of eligible adults and 

limiting the number of times 

individuals participate in tobaccorelated studies will result in nationally 

representative and unbiased data 

collection on matters of importance for 

FDA. 

With this submission, the FDA seeks 

approval from OMB to establish the 

Tobacco User Panel, a nationally 

representative, primarily web-based 

panel of 4,000 current tobacco users. 

Data collection activities will involve 

pilot testing of panel recruitment and 

management procedures and systems, 

mail and in-person household 

screening, in-person recruitment of 

tobacco users, enrollment of selected 

household members, administration of a 

baseline survey, and panel maintenance 

surveys, following all required informed 

consent procedures for panel members. 

Once the panel is established, panel 

members will be asked to participate in 

up to eight experimental and 

observational studies over the 3-year 

panel commitment period. The first of 

these studies (Study 1) is included in 

this information collection request; 

approval for the remainder of the 

studies will be appear in future 

requests. The current request also seeks 

approval to conduct up to two rounds 

of cognitive testing of new survey items 

and up to two focus groups to further 

refine study protocols, as needed. With 

this clearance, study investigators will 

be able to use the OMB approved data 

collection methods where appropriate to 

plan and implement the national panel. 

The overall purpose of the proposed 

data collection is to collect information 

from a representative sample of tobacco 

users to provide data that may be used 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 62161 

to develop and support FDA’s policies 

related to tobacco products, including 

their labels, labeling, and advertising. 

Data will be collected from the panel 

primarily through the use of 

randomized experimental designs, 

however, there may be data collected 

through the use of other methods, such 

as surveys, interviews, or online group 

discussions. Given the limitations on 

the existing Web-based panels, it is 

important to develop a new panel of 

tobacco users that balances the need to 

conduct experiments while limiting the 

number of tobacco-related studies per 

year so as to not bias study results. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity or type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Household Screening Respondent .............................. 29,385 0.33 9,697 0.16 (10 minutes) ... 1,552 

Panel Member Enrollment Survey .............................. 4,000 0.33 1,320 0.25 (15 minutes) .. 330 

Panel Member Baseline Survey .................................. ........................ 0.33 1,320 0.25 (15 minutes) ... 330 

Panel Maintenance/Bi-annual Update Surveys ........... ........................ 3.0 12,000 0.08 (5 minutes) ..... 960 

Experimental/Observational Studies * ......................... ........................ 2.7 10,800 0.33 (20 minutes) ... 3,564 

Panel Replenishment Screening Respondent ............ 10,285 0.50 5,143 0.16 (10 minutes) ... 823 

Panel Replenishment Enrollment Survey ** ................ 2,800 0.33 924 0.25 (15 minutes) ... 231 

Panel Replenishment Baseline Survey ** .................... 2,800 0.33 924 0.25 (15 minutes) .. 231 

Cognitive Interview Subjects ....................................... 20 0.33 7 1.0 .......................... 7 

Focus Group Subjects ................................................. 20 0.33 7 1.5 .......................... 10 

Total ...................................................................... 49,310 ........................ ........................ ................................ 8,038 

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

* Includes a total of 8 experimental or observational studies over a 3-year period for each of the 4,000 panel members who are active at the 

time of each study. The first study (Study 1) is included in this clearance request; the remaining studies will be funded under separate task orders but are included in this table to present an overall estimate of the burden for each participating panel member. **Assumes 1,400 additional panel members will be recruited annually (2,800 total) as part of the panel replenishment effort. 

The burden above was estimated 

using data from timed-readings of each 

instrument, including the mail and field 

screeners, enrollment survey, baseline 

survey, panel maintenance 

questionnaires, and Study 1 

questionnaire. 

Dated: October 9, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24538 Filed 10–15–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0555] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Device Tracking 

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 November 

17, 2014. 

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 emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0442. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

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. 

Medical Devices; Device Tracking—21 

CFR part 821 (OMB Control Number 

0910–0442)—Extension 

Section 211 of the Food and Drug 

Administration Modernization Act 

(FDAMA) (Pub. L. 105–115) became 

effective on February 19, 1998. FDAMA 

amended the previous medical device 

tracking provisions under section 

519(e)(1) and (e)(2) of the Federal Food, 

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

(21 U.S.C. 360i(e)(1) and (e)(2)) that 

were added by the Safe Medical Devices 

Act of 1990 (SMDA) (Pub. L. 101–629). 

Unlike the tracking provisions under 

SMDA, which required tracking of any 

medical device meeting certain criteria, 

FDAMA allows FDA discretion in 

applying tracking provisions to medical 

devices meeting certain criteria and 

provides that tracking requirements for 

medical devices can be imposed only 

after FDA issues an order. In the Federal 

Register of February 8, 2002 (67 FR 

5943), FDA issued a final rule that 

conformed existing tracking regulations 

to changes in tracking provisions 

effected by FDAMA under part 821 (21 

CFR part 821). 

Section 519(e)(1) of the FD&C Act, as 

amended by FDAMA, provides that 

FDA may require by order that a 

manufacturer adopt a method for 

tracking a class II or III medical device, 

if the device meets one of the three 

following criteria: (1) The failure of the 

device would be reasonably likely to 

have serious adverse health 

consequences, (2) the device is intended 

to be implanted in the human body for 

more than 1 year (referred to as a 

‘‘tracked implant’’), or (3) the device is 

life-sustaining or life-supporting 

(referred to as a ‘‘tracked l/s-l/s device’’) 

and is used outside a device user 

facility. 

Tracked device information is 

collected to facilitate identifying the 

current location of medical devices and 


asabaliauskas on DSK5VPTVN1PROD with NOTICES