65490 Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of 

respondent Form name Number of respondents 

Responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Selected women for exploratory focus groups Exploratory Focus Group Guide .................... 72 1 2 

Selected women for message testing focus 

groups.

Message Testing Focus Group Guide ........... 54 1 2 

Dated: October 19, 2010. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–26878 Filed 10–22–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0542] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Information 

Request Regarding Dissolvable 

Tobacco Products 

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 

an information request regarding the use 

of dissolvable tobacco products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 27, 2010. 

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: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr. PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.Capezzuto@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. 

Information Request Regarding 

Dissolvable Tobacco Products 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

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

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(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 the public health generally and 

to reduce tobacco use by minors. 

Section 917 of the Tobacco Control 

Act required the Secretary of Health and 

Human Services (the Secretary) to 

establish a Tobacco Products Scientific 

Advisory Committee (TPSAC). Section 

907(f) of the Tobacco Control Act 

requires the TPSAC to submit a report 

and recommendations to the Secretary 

on the impact of the use of dissolvable 

tobacco products on the public health, 

including such use among children. To 

ensure a comprehensive review of this 

issue, FDA is requesting tobacco 

industry documents and information to 

support the work of TPSAC. Under 

section 907(f), TPSAC must submit its 

report and recommendations to the 

Secretary within 2 years of its 

formation, or March 23, 2012. 

In order to provide TPSAC with the 

information it needs to carry out its 

statutory obligation, FDA is requesting 

that tobacco companies submit 

information under section 904(b) of the 

Tobacco Control Act pertaining to 

documents and underlying scientific 

and financial information relating to 

research, and research findings, 

conducted, supported, or possessed by 

the manufacturer (or agents thereof) on 

a specified set of topics. For the 

purposes of this request, ‘‘research’’ may 

include, but is not limited to, focus 

groups, surveys, experimental clinical 

studies, post-marketing surveillance, 

toxicological and biochemical assays, 

taste panels, and assessments of the 

effectiveness of product marketing 

practices. Topics for which information 

relating to dissolvable tobacco products 

is requested are marketing research; 

marketing practices; effectiveness of 

marketing practices; and health, 

toxicological, behavioral, and 

physiological effects. FDA’s request for 

documents related to dissolvable 

tobacco products includes, but is not 

limited to products for research, 

investigational use, developmental 

studies, test marketing, and/or 

commercial marketing, and also to the 

components, parts, or accessories of 

such products. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 65491 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1—ESTIMATE OF ONE-TIME REPORTING BURDEN1

Activity Number of 

respondents 

Annual 

frequency 

per response 

Total 

average 

annual 

responses 

Hours per response Total hours 

Providing negative response to request for dissolvable 

tobacco product documents ........................................... 110 1 110 0 .50 55 

Submission of dissolvable tobacco products ..................... 10 1 10 230 2,300 

Total ............................................................................ 120 ........................ 120 .......................... 2,355 

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

These burden estimates were derived 

by taking into consideration FDA’s 

experience with document production, 

experience with submissions pertaining 

to other tobacco product-related 

information collections, and comments 

received in response to other tobacco 

product-related information collections. 

FDA is limiting the burden on 

respondents by only requesting 

documents on specific topics that will 

have utility for FDA. FDA is requesting 

the final version of documents or the 

most recent draft in the absence of a 

final document. Also, publically 

available published abstracts, editorials, 

letters, and manuscripts are not being 

requested, although FDA would 

appreciate a list of such publications. 

Information responsive to this section 

904(b) information request that has been 

previously provided to FDA under the 

FD&C Act or other letter requests does 

not have to be resubmitted as long as the 

document is fully referenced. FDA 

believes that the number of documents 

being requested in this information 

collection will be limited due to the 

estimated small number of respondents 

and the relatively shorter amount of 

time these tobacco products have been 

in existence compared to other tobacco 

products. 

FDA estimates that there are 

approximately 120 tobacco product 

manufacturers who may be affected by 

this collection of information. Of the 

total number of manufacturers, FDA 

estimates that most manufacturers (110) 

will not have documents which will be 

responsive to this section 904(b) request 

and that they will only need to send a 

letter notifying the FDA’s Center for 

Tobacco Products that they have no 

documents to report. FDA anticipates it 

should take no longer than 30 minutes 

to draft such a response and send to 

FDA. The total one-time hourly burden 

to submit this letter to FDA is estimated 

to be 55 hours (30 minutes × 110 

manufacturers). 

FDA estimates that there are 

approximately 10 tobacco product 

manufacturers who may have 

documents meeting the criteria of this 

information collection request. Because 

the volume of responsive documents 

each of these respondents may have will 

likely vary, the corresponding time 

burden for each respondent to satisfy 

this information collection request will 

also vary. Therefore, FDA estimates that 

these 10 respondents will average 

approximately 230 hours each to satisfy 

the requirements of this section 904(b) 

request. The total one-time hourly 

burden to locate and send documents 

meeting the requirements of this request 

is estimated to be 2,300 hours (230 

hours × 10 manufacturers). The total 

one-time hourly burden for this 

collection of information is 2,355 hours 

(55 hours + 2,300 hours). 

Dated: October 19, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26830 Filed 10–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0411] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guide To Minimize 

Microbial Food Safety Hazards of 

Fresh-Cut Fruits and Vegetables 

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 

24, 2010. 

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 0910–0609. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Guide To Minimize Microbial Food 

Safety Hazards of Fresh-Cut Fruits and 

Vegetables—(OMB Control Number 

0910–0609)—Extension 

Fresh-cut fruits and vegetables are 

fruits and vegetables that have been 

processed by peeling, slicing, chopping, 

shredding, coring, trimming, or 

mashing, with or without washing or 

other treatment, prior to being packaged 

for consumption. The methods by 

which produce is grown, harvested, and 

processed may contribute to its 

contamination with pathogens and, 

consequently, the role of the produce in 

transmitting foodborne illness. Factors 

such as the high degree of handling and 

mixing of the product, the release of 

cellular fluids during cutting or 

mashing, the high moisture content of 

the product, the absence of a step lethal 


emcdonald on DSK2BSOYB1PROD with NOTICES