Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46007 

2 In 2007, the Commission issued information 

requests to five cigarette companies and five 

smokeless tobacco companies. Given changing 

growth conditions in the industry since then, the 

Commission anticipates that it will issue requests 

to six cigarette companies in 2009. 

3 70 FR 24415 (May 9, 2005); 70 FR 62313 

(October 31, 2005). 

January 31, 2009, under OMB Control 

No. 3084-0134. 

The FTC plans to continue sending 

information requests annually to the 

ultimate parent company of several of 

the largest cigarette companies and 

smokeless tobacco companies in the 

United States (‘‘industry members’’). 

The information requests will seek data 

regarding, inter alia: (1) the tobacco 

sales of industry members; (2) how 

much industry members spend 

advertising and promoting their tobacco 

products, and the specific amounts 

spent in each of a number of specified 

expenditure categories; (3) whether 

industry members are involved in the 

appearance of their tobacco products in 

television shows or movies; (4) how 

much industry members spend on 

advertising intended to reduce youth 

tobacco usage; (5) the events, if any, 

during which industry members’

tobacco brands are televised; and (6) for 

the cigarette industry, the tar, nicotine, 

and carbon monoxide ratings of their 

cigarettes, to the extent they possess 

such data. The information will again be 

sought using compulsory process under 

Section 6(b) of the FTC Act. 

Under the PRA, 44 U.S.C. 3501-3521, 

federal agencies must obtain approval 

from OMB for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ means 

agency requests or requirements that 

members of the public submit reports, 

keep records, or provide information to 

a third party. 44 U.S.C. 3502(3), 5 CFR 

1320.3(c). As required by section 

3506(c)(2)(A) of the PRA, the FTC is 

providing this opportunity for public 

comment before requesting that OMB 

extend the existing paperwork clearance 

for the instant collection of information. 

The FTC invites comments on: (1) 

whether the proposed collection of 

information required by the Rule is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (2) the accuracy of the 

agency’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 those who are to respond, including 

through the use of appropriate 

automated, electronic, mechanical, or 

other technological collection 

techniques or other forms of information 

technology, e.g., permitting electronic 

submission of responses. 

Estimated hours burden: The FTC 

staff’s estimate of the hours burden is 

based on the time required to respond 

to each information request. Although 

the FTC currently anticipates sending in 

2009 information requests to the six 

largest cigarette companies and the five 

largest smokeless tobacco companies,2

the burden estimate is based on up to 15 

information requests being issued per 

year to take into account any future 

changes in these industries. These 

companies vary greatly in size, in the 

number of products that they sell, and 

in the extent and variety of their 

advertising and promotion. Prior input 

received from the industries, combined 

with staff’s knowledge of them, suggests 

that the time most companies would 

require to gather, organize, format, and 

produce their responses would range 

from 30 to 80 hours per information 

request for the smaller companies, to as 

much as hundreds of hours for the very 

largest companies. As an 

approximation, staff continues to 

assume a per company average of 180 

hours for the ten largest recipients of the 

Commission’s information request to 

comply with it; cumulatively, 1,800 

hours per year.3 Staff further estimates 

that for the eleventh anticipated 

recipient of the information request to 

be issued in 2009 and the four possible 

additional recipients, all of which 

would be smaller companies, the 

burden should not exceed 60 hours per 

company or 300 hours, cumulatively. 

Thus, overall estimated burden for a 

maximum of 15 recipients of the 

information request is 2,100 hours. 

These estimates include any time spent 

by separately incorporated subsidiaries 

and other entities affiliated with the 

ultimate parent company that has 

received the information request. 

Estimated cost burden: It is not 

possible to calculate with precision the 

labor costs associated with this data 

production, as they entail varying 

compensation levels of management 

and/or support staff among companies 

of different sizes. Financial, legal, 

marketing, and clerical personnel may 

be involved in the information 

collection process. Commission staff 

assumes that professional personnel 

will handle most of the tasks involved 

in gathering and producing responsive 

information, and have applied an 

average hourly wage of $150/hour for 

their combined labor. Staff’s best 

estimate for the total labor costs for up 

to 15 information requests is $315,000. 

Staff believes that the capital or other 

non-labor costs associated with the 

information requests are minimal. 

Although the information requests may 

necessitate that industry members 

maintain the requested information 

provided to the Commission, they 

should already have in place the means 

to compile and maintain business 

records. 

William Blumenthal 

General Counsel 

[FR Doc. E8–18098 Filed 8–6–08: 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0063] (formerly 

Docket No. 2008N–0016) 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Exports: Notification and 

Recordkeeping Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Exports: Notification and 

Recordkeeping Requirements’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers 

Lane,Rockville, MD 20857, 301–796–

3794. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 8, 2008 (73 FR 

26119), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0482. The 

approval expires on July 31, 2011. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 


sroberts on PROD1PC70 with NOTICES
46008 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Dated: July 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18128 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0056] (formerly 

Docket No. 2004N–0234) 

Annual Guidance Agenda 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing its 

annual guidance document agenda. This 

list is being published under FDA’s 

good guidance practices (GGPs) 

regulations. It is intended to seek public 

comment on possible topics for future 

guidance document development or 

revisions of existing ones. 

DATES: Submit comments on this list 

and on any agency guidance documents 

at any time. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2004–N–

0056, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: For 

general information regarding FDA’s 

GGP policy contact: Lisa Helmanis, 

Office of Policy (HF–26), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3480. 

For information regarding specific 

topics or guidances: Please see contact 

persons listed in the table in the 

SUPPLEMENTARY INFORMATION section. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

19, 2000 (65 FR 56468), FDA issued its 

final rule on GGPs (21 CFR 10.115). 

GGPs are intended to ensure 

involvement of the public in the 

development of guidance documents 

and to enhance understanding of the 

availability, nature, and legal effect of 

such guidance documents. 

As part of FDA’s effort to ensure 

meaningful interaction with the public 

regarding guidance documents, the 

agency committed to publishing an 

annual guidance document agenda of 

possible guidance topics or documents 

for development or revision during the 

coming year. The agency also 

committed to soliciting public input 

regarding these and additional ideas for 

new topics or revisions to existing 

guidance documents (65 FR 56468 at 

56477; 21 CFR 10.115(f)(5)). 

The agency is neither bound by this 

list of possible topics nor required to 

issue every guidance document on this 

list or precluded from issuing guidance 

documents not on the list set forth in 

this document. 

The following list of guidance topics 

or documents represents possible new 

topics or revisions to existing guidance 

documents that the agency is 

considering. The agency solicits 

comments on the topics listed in this 

document and also seeks additional 

ideas from the public. 

The guidance documents are 

organized by the issuing Center or 

Office within FDA, and are further 

grouped by topic categories. The 

agency’s contact persons for each 

specific area are listed in the tables that 

follow. 

II. Center for Biologics Evaluation and 

Research (CBER) 

Title/Topic of Guidance Contact 

CATEGORY—BLOOD AND BLOOD COMPONENTS Stephen Ripley, Center for Biologics Evaluation and Research 

(HFM–17), Food and Drug Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448, 301–

827–6210 

Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Same as above (Do) 

Assessment of Donors of Blood and Blood Components for Transfusion Transmitted Malaria Risk Do 

Use of Serological of Tests on Samples from Donors of Whole Blood and Blood Components for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to Reduce the Risk of Transmission of Trypanosoma cruzi Infection Do 

CATEGORY—VACCINES AND ALLERGENICS 

Considerations for the Development of Vaccines to Protect Against Global Infectious Diseases Do 


sroberts on PROD1PC70 with NOTICES