14018 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Information Collections .................................................................................... 2,700 1 2 5,400 

Estimated Total Annual Burden 

Hours: 5,400. 

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. Fax: 202–395–7285, 

Email: OIRA_SUBMISSION@OMB.EOP.

GOV. Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–5600 Filed 3–7–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0553] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Potential Tobacco 

Product Violations Reporting Form 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by April 9, 

2012. 

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–NEW and 

title ‘‘Potential Tobacco Product 

Violations Reporting Form.’’ Also 

include the FDA 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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Potential Tobacco Product Violations 

Reporting Form—(OMB Control 

Number 0910–NEW) 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 321 et. seq.) 

by adding a new chapter granting FDA 

important new authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

FDA is requesting OMB approval for 

a new collection of information to 

accept consumer and other stakeholder 

feedback and notification of potential 

tobacco violations of the FD&C Act, as 

amended by the Tobacco Control Act. 

As part of its enforcement strategy, 

FDA created a Tobacco Call Center 

(with a toll-free number: 1–877–CTP– 

1373) to accept information from the 

public about violations of the Tobacco 

Control Act. Callers are able to report 

potential violations of the Tobacco 

Control Act, and FDA may conduct 

targeted followup investigation based on 

information received. When callers 

report a violation, the caller will be 

asked to provide as much information as 

they can recall, including: The date the 

potential violation happened, the 

product type (e.g., cigarette, smokeless, 

roll-your-own, etc.), tobacco brand, type 

of potentially violative promotional 

materials, potential violation type, who 

potentially violated, and the name, 

address, phone number, and email 

address of the potential violator. The 

caller will also be asked to list the 

potential violator’s Web site (if 

available), describe the potential 

violation, and provide any additional 

files or information pertinent to the 

potential violation. FDA has developed 

a form that will be used to solicit this 

information from the caller (Form FDA 

3779, Potential Tobacco Product 

Violations Reporting), which is 

expected to eventually replace current 

Form FDA 3734 for Cigarette Flavor Ban 

Violations. This new form will be 

posted on FDA’s Web site, and 

information may be submitted by filling 

out the form online (or the public can 

request a copy of Form FDA 3779 by 

contacting the Center for Tobacco 

Products (CTP)). In addition, FDA has 

developed a smartphone application for 

use with mobile devices (i.e., iPhones, 

Android) to allow consumers to report 

potential violations to FDA via their 

smartphone. Others may simply choose 

to send a letter to FDA with their 

information. In summary, the public 

and interested stakeholders will be able 

to report information regarding possible 

violations of the Tobacco Control Act 

through the following methods: Calling 

the Tobacco Call Center using CTP’s 

toll-free number, using a fill-able form 

found on FDA’s Web site, using FDA’s 

tobacco violation reporting smartphone 

application, and sending a letter to 

FDA’s Center for Tobacco Products. 

In the Federal Register of August 22, 

2011 (76 FR 52333), FDA published a 

60-day notice requesting public 

comment on this proposed collection of 

information. FDA received 24 comment 

submissions, which included over 60 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 14019 

comments embedded. The comments 

have been summarized into four PRArelated areas as follows. 

(Comment 1) FDA received several 

comments that said the Tobacco Control 

Act does not include a provision 

directing FDA to request or accept 

information on potential tobacco 

product violations from the public and 

other stakeholder groups. The 

comments stated that the public and 

other stakeholder groups have not been 

trained to inspect retail tobacco 

operations, have not been trained to 

recognize or report tobacco product 

violations, and are not able to verify 

what does or does not constitute 

compliance with the Tobacco Control 

Act. Commenters also stated that a 

retailer of tobacco products could be 

targeted by overzealous stakeholders 

and unfairly earmarked by FDA for 

future inspections. 

(Response) FDA disagrees with this 

comment. The Tobacco Control Act 

amended the FD&C Act by adding a new 

chapter granting FDA important new 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect public health 

generally and to reduce tobacco use by 

minors. This includes broad authority to 

enforce the provisions of the Tobacco 

Control Act. 

FDA is requesting OMB approval for 

a new collection of information to 

accept consumer and other stakeholder 

feedback and notification of potential 

violations of the FD&C Act, as amended 

by the Tobacco Control Act (TCA). This 

collection of information falls under 

FDA’s responsibilities to monitor 

compliance with and enforce the TCA. 

In addition, the proposed tobacco 

violation form does not require 

respondents to verify compliance with 

or violations of the TCA. Instead, the 

submitted information will be one 

source of information to help FDA 

identify potential areas for further 

Agency inquiry. 

(Comment 2) FDA received several 

comments that stated that the form is 

contrary to and may violate Executive 

Order 13563, ‘‘Improving Regulation 

and Regulatory Review,’’ the intent of 

which is to eliminate unnecessary and 

wasteful government regulations. 

(Response) FDA disagrees with this 

comment. Executive Order 13563 

pertains to unnecessary and wasteful 

regulations. This form is not a 

regulation but an extension of the means 

that the public and stakeholders have to 

voluntarily report potential tobacco 

violations and events to FDA. Current 

methods of reporting are FDA’s toll-free 

hotline number (1–877–CTP–1373), 

email (AskCTP@fda.hhs.gov), and Form 

FDA 3734. This form is not an 

inspection reporting form but is another, 

perhaps easier, way for the public and 

stakeholders to report information to 

FDA. No information received from the 

form will be forwarded to inspectors 

unless the information is deemed 

credible by FDA. 

(Comment 3) Several comments 

questioned the burden to complete the 

form and the methodology used to 

compute total responses expected 

through the use of this form. 

Commenters also stated that the form is 

overly broad and includes some 

categories of tobacco products currently 

not regulated by FDA under the Tobacco 

Control Act. Commenters also stated 

that the form was redundant in places, 

while one commenter liked the form 

and encouraged FDA to make the public 

aware that the form exists. 

(Response) FDA generally agrees with 

these comments, except with regard to 

the redundancy of the form. The time to 

gather information and complete the 

form has been tested internally to take 

no longer than 10 minutes. However, 

due to the comments received, FDA is 

revising the burden estimate upward to 

indicate that the form or mobile 

application will take 15 minutes to 

complete. 

With regard to the form being overly 

broad, the Potential Tobacco Product 

Violations Reporting Form has been 

revised to ensure that it only lists 

currently regulated tobacco products 

and possible violations under the TCA 

for those products. Most notably, the 

word ‘‘other’’ has been removed from 

some of the questions on the form to 

reduce confusion about which tobacco 

products are regulated by FDA. The 

layout of the form has also been 

adjusted to make it easier for the public 

to voluntarily submit information to 

FDA. The intent of the form is not to 

gather establishment inspection 

information like that collected by 

Federal, State, or local inspectors of 

tobacco facilities but to offer another 

means of contacting FDA about tobaccorelated events and potential violations, 

such as that offered by the 1–877–CTP– 

1373 toll-free hotline and the AskCTP@

fda.hhs.gov email address. The use of 

the form is voluntary and is not 

designed to target specific 

establishments or deputize the public as 

inspectors for identifying specific 

violations of the TCA. 

With regard to the comments 

addressing the methodology for 

computing the burden, FDA has based 

this estimate on information received 

from several flavored cigarette reports, 

reports currently received from FDA’s 

toll-free hotline and email address, and 

FDA experience. If the number of actual 

reports received is either too high or 

low, FDA will either correct the 

collection via a revision of the 

information collection or during its next 

renewal submission to OMB. Upon 

receiving OMB approval for the form 

and the collection of information, FDA 

will place the form on its complaint 

Web site and will advertise its location 

to the public. 

With regard to the redundancy of 

fields of information on the form, FDA 

has reviewed all aspects of the form and 

mobile application carefully and has 

eliminated any redundant fields on the 

form. 

(Comment 4) Several comments 

indicated that they thought the form is 

being used by the public and 

stakeholders as an inspection report to 

police or target tobacco retailers and the 

public, and that stakeholders have not 

been thoroughly or extensively trained 

with the training provided to FDA’s 

Federal, State, and local inspectors. In 

addition to the lack of training, 

commenters also wondered what type of 

corrective action would or could be 

taken against a person or entity who 

files a false or inaccurate report against 

a retailer. 

(Response) FDA’s intent in creating 

this form and mobile application is not 

to target retailers but to provide the 

public and stakeholders with another 

means to report tobacco-related events, 

concerns, or potential violations, much 

like the information that is currently 

collected using the existing Center for 

Tobacco Products toll-free hotline 

telephone number, email address, and 

Form FDA 3774. The Web-based, paper, 

and mobile application form may allow 

the Agency to become better informed 

about certain tobacco-related topics and 

will provide the public and other 

stakeholders with an easier and possibly 

more efficient way to submit potential 

violation and event information to FDA. 

Information received by FDA from this 

form will not be forwarded to an 

inspector unless FDA deems the 

information is credible and worth 

further investigation. The information 

provided by this form will also help 

FDA more efficiently use its inspection 

resources, based on credible information 

provided by the public and stakeholders 

on potential events. 

With regard to the type of corrective 

action taken against persons falsifying 

information submitted on these forms, 

FDA will scrutinize each submission 

carefully. Only forms containing 

information which are determined to be 

worthy of further investigation will be 

submitted to investigators for further 

review. Because this form is voluntary, 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
14020 Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices 

submission of the information by the 

public and stakeholders does not 

guarantee that an investigation against a 

retailer will be triggered, and FDA will 

work to ensure that no specific retailer 

or supplier is unfairly targeted. 

To clarify that Form FDA 3779 is not 

an inspection report, FDA is amending 

the title of Form FDA 3779 to ‘‘Potential 

Tobacco Product Violations Reporting.’’ 

FDA is making this change to reflect 

that the form is voluntary, that the form 

is intended to be a means for the public 

to submit information to FDA regarding 

possible violations of the laws that it 

enforces, and that a Form FDA 3779 

submission is not, by itself, enough to 

warrant further FDA action. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity and Form FDA 3779 Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Reporting potential violations of the FD&C Act, as amended by the Tobacco Control Act, by telephone, Internet or 

paper form, smartphone application or email .................. 1,000 1 1,000 0.25 250 

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

FDA estimates that submitting the 

information (by phone, Internet form, 

paper form by mail, smartphone 

application, or email) will take 15 

minutes per response. Since a similar 

type of reporting went into effect for the 

cigarette flavor ban, FDA has received 

several reports via the Internet or email. 

Based on the rate of reporting for the 

cigarette flavor ban, reports received 

from FDA’s toll-free telephone number 

and email address, and FDA experience, 

FDA estimates the number of annual 

respondents to this collection of 

information will be 1,000, who will 

each submit 1 report by phone, Internet 

form, paper form, smartphone 

application, or email. Each report is 

expected to take 15 minutes to complete 

and submit, therefore, total burden 

hours for this collection of information 

is estimated to be 250 hours (1,000 

responses × 0.25 hours per response). 

Because of the variety of products 

regulated by FDA under the authority of 

the FD&C Act, as amended by the 

Tobacco Control Act, FDA expects the 

rate of calls and reports received to 

remain constant over the next 3 years. 

Dated: March 5, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5634 Filed 3–7–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0197] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Emergency 

Shortages Data Collection System 

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 

the Emergency Shortages Data 

Collection System. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 7, 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. 

Emergency Shortages Data Collection 

System—Section 903(d)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(OMB Control Number 0910–0491)— 

Extension 

Under section 903(d)(2) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 393(d)(2)), the 

Commissioner of Food and Drugs is 

authorized to implement general powers 

(including conducting research) to carry 

out effectively the mission of FDA. 

Subsequent to the events of September 

11, 2001, and as part of broader 


wreier-aviles on DSK5TPTVN1PROD with NOTICES