Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Notices 27313 

would be minor or applied only to one 

brand or brand variety. 

Commission staff also estimates that 

over the requested three-year clearance 

period up to four smokeless tobacco 

manufacturers, packagers, or importers 

will file an initial plan that includes 

rotational schemes for both packaging 

and advertising, for an additional 

burden of no more than 240 hours. This 

estimate is conservative because over 

the past five years, only four initial 

plans with both packaging and 

advertising schemes have been filed 

with the FTC. When the regulations 

were first proposed in 1986, 

representatives of the Smokeless 

Tobacco Council, Inc. indicated that the 

six companies it represented would 

require approximately 700 to 800 hours 

in total (133 hours each) to complete the 

initial required plans, involving 

multiple brands, multiple brand 

varieties, and multiple forms of both 

packaging and advertising. The four 

initial plans submitted over the past five 

years are considerably less complex. 

Each of these plans involves only one or 

two brands or brand varieties, with 

more limited types of advertising and 

packaging. In addition, three of the four 

companies submitting plans had prior 

familiarity with the preparation of 

rotational warning plans. Further, 

increased computerization and 

improvements in electronic 

communication over the past 20 years 

have decreased the time needed for the 

preparation and drafting of rotational 

warning plans. Staff estimates that it 

would require no more than 60 hours to 

prepare such an initial plan, and that 

four initial plans will be submitted. 

Staff anticipates that over the next 

three years, up to four smokeless 

tobacco manufacturers, packagers, or 

importers may submit initial plans 

covering packaging alone, for an 

additional burden of no more than 160 

hours. Over the past five years, the 

Commission has received four such 

plans. Because each of the plans 

involved only a single brand, a single 

form of packaging, and no advertising, 

the estimated time to prepare the plans 

is very modest. Staff anticipates that the 

companies that submit initial plans 

covering packaging alone will spend no 

more than 40 hours each to prepare the 

plans, and possibly considerably less. 

This estimate is conservative. Like other 

estimates stated herein, this is based on 

the total number of plans submitted to 

the FTC over the past five years, rather 

than annually. 

Finally, staff estimates that over the 

next three years, up to four amendments 

will be filed by companies other than 

the five largest smokeless tobacco 

manufacturers. Over the past five years, 

the Commission has received four such 

plans. Each of the amendments involved 

very modest changes to the existing 

plans. Staff estimates that four 

companies submitting similar amended 

plans will spend no more than 20 to 40 

hours each to prepare the amendments, 

for an additional burden estimate of no 

more than 160 hours. As above, this is 

conservatively based on the total 

number of plans submitted to the FTC 

over the past five years, rather than 

annually. 

Estimated total annual hours burden: 

1,000 hours. 

Based on these assumptions, the total 

annual hours should not exceed 1,000 

hours. [(5 companies × 40 hours each) 

+ (4 companies × 60 hours each) + (4 

companies × 40 hours each) + (4 

companies × 40 hours each) = 760 total 

hours, rounded to one thousand hours] 

Estimated labor costs: $203,000. 

The total annualized labor cost to 

these companies should not exceed 

$203,000. This is based on the 

assumption that management or 

attorneys will account for 80% of the 

estimated 1,000 hours required to draft 

initial or amended plans, at an hourly 

rate of $250 per hour, and that clerical 

support will account for the remaining 

time (20%) at an hourly rate of $15. 

[Management and attorneys’ time (1,000 

hours × 0.80 × $250 = $200,000) + 

clerical time (1,000 hours × 0.20 × $15 

= $3,000) = $203,000] 

Estimated annual non-labor cost 

burden: $0 or minimal. 

The applicable requirements impose 

minimal start-up costs. The companies 

may keep copies of their plans to ensure 

that labeling and advertising complies 

with the requirements of the Smokeless 

Tobacco Act. Such recordkeeping would 

require the use of office supplies, e.g., 

file folders and paper, all of which the 

companies should have on hand in the 

ordinary course of their business. 

While companies submitting initial 

plans may incur one-time capital 

expenditures for equipment used to 

print package labels in order to include 

the statutory health warnings or to 

prepare acetates for advertising, the 

warnings themselves disclose 

information completely supplied by the 

federal government. As such, the 

disclosure does not constitute a 

‘‘collection of information’’ as it is 

defined in the regulations implementing 

the PRA, nor, by extension, do the 

financial resources expended in relation 

to it constitute paperwork ‘‘burden.’’

See 5 CFR 1320.3(c)(2). Moreover, any 

expenditures relating to the statutory 

health warning requirements would 

likely be minimal in any event. For 

companies that have already submitted 

approved plans, there are no capital 

expenditures. After the Commission 

approves a plan for the rotation and 

display of the warnings required by the 

Smokeless Tobacco Act, the companies 

are required to make additional 

submissions to the Commission only if 

they choose to change the way they 

display the warnings. Once companies 

have prepared the artwork for printing 

the required warnings on package 

labels, there are no additional start-up 

costs associated with the display of the 

warnings on packaging. Similarly, once 

companies have prepared artwork and 

possibly acetates for the display of the 

warnings in advertising, there are no 

additional start-up costs associated with 

printing the warnings in those materials. 

William Blumenthal, 

General Counsel. 

[FR Doc. E7–9304 Filed 5–14–07; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Vaccine 

Advisory Committee 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (DHHS) is hereby giving notice 

that the National Vaccine Advisory 

Committee (NVAC) will hold a meeting. 

The meeting is open to the public. 

DATES: The meeting will be held on June 

7, 2007, from 9 a.m. to 5:30 p.m., and 

on June 8, 2007, from 9 a.m. to 4 p.m. 

ADDRESSES: Department of Health and 

Human Services; Hubert H. Humphrey 

Building, Room 800; 200 Independence 

Avenue, SW., Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Emma English, Program Analyst, 

National Vaccine Program Office, 

Department of Health and Human 

Services, Room 443–H Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201; 

(202) 690–5566, nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Service 

Act (42 U.S.C. 300aa–1), the Secretary of 

Health and Human Services was 

mandated to establish the National 

Vaccine Program to achieve optimal 

prevention of human infectious diseases 

through immunization and to achieve 

optimal prevention against adverse 

reactions to vaccines. The National 


cprice-sewell on PROD1PC62 with NOTICES
27314 Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Notices 

Vaccine Advisory Committee was 

established to provide advice and make 

recommendations to the Assistant 

Secretary for Health, as the Director of 

the National Vaccine Program, on 

matters related to the program’s 

responsibilities. 

Topics to be discussed at the meeting 

include seasonal influenza, pandemic 

vaccine prioritization, vaccine 

financing, and other Departmental 

vaccine priorities. Subcommittees 

meetings will be held on the afternoon 

of June 7, 2007. A tentative agenda is 

currently available on the NVAC Web 

site: www.hhs.gov/nvpo/nvac. 

Public attendance at the meeting is 

limited to space available. Individuals 

must provide a photo ID for entry into 

the Humphrey Building. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

designated contact person. Members of 

the public will have the opportunity to 

provide comments at the meeting. 

Public comment will be limited to five 

minutes per speaker. Any members of 

the public who wish to have printed 

material distributed to NVAC members 

should submit materials to the 

Executive Secretary, NVAC, through the 

contact person listed above prior to 

close of business June 1, 2007. Preregistration is required for both public 

attendance and comment. Any 

individual who wishes to attend the 

meeting and/or participate in the public 

comment session should e-mail 

nvpo@hhs.gov or call 202–690–5566. 

Dated: May 9, 2007. 

Bruce Gellin, 

Director, National Vaccine Program Office. 

[FR Doc. E7–9346 Filed 5–14–07; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day–07–0650] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 371–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Prevention Research Center 

Information System—Extension—

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

In spring 2003, CDC published RFA 

#04003 (FY 2003–2009) for the 

Prevention Research Centers Program. 

The RFA introduced a set of 

performance indicators developed 

collaboratively with the PRCs and other 

stakeholders and are consistent with 

federal requirements that all agencies, in 

response to the Government 

Performance and Results Act of 1993, 

prepare performance plans and collect 

program-specific performance measures. 

Currently, CDC provides funding to 33 

PRCs selected through competitive peer 

review process and managed as CDC 

cooperative agreements. Awards are 

made for five (5) years and may be 

renewed through a competitive RFA 

process. PRCs are housed in a school of 

public health, medicine, or osteopathy 

and conduct health promotion and 

disease prevention research using a 

community-based participatory 

approach. 

The Centers for Disease Control and 

Prevention (CDC) is seeking a 3 year 

Office of Management and Budget 

(OMB) approval for an extension of a 

reporting system for the Prevention 

Research Centers Program Information 

System. In accordance with the original 

OMB approval (0920–0650), the 

modification approved September 2005 

(to add work plans and progress reports 

and to increase burden from 28 PRCs to 

33 PRCs), and the modification 

approved November 2006 (to delete, 

modify, and add questions related to the 

performance indicators with no change 

in burden), this requested 3 year 

extension will continue the data 

collection as approved. The Information 

System (IS) is a web-based, password 

protected technical reporting system 

that allows the accurate, uniform, and 

complete collection of PRC information 

using the Internet. The IS allows CDC to 

monitor and report on PRC activities 

efficiently and effectively. Data reported 

to CDC through the PRC IS are used to 

identify training and technical 

assistance needs, monitor compliance 

with cooperative agreement 

requirements, evaluate the progress 

made in achieving center-specific goals 

and objectives, and obtain information 

needed to describe the impact and 

effectiveness of the overall program as 

needed to respond to Congressional and 

other inquiries regarding the PRC 

Program. The annual report and record 

keeping burden is the same as the 

modification approved September 2005. 

There are no costs to respondents 

except their time to participate in the 

survey. The total estimated annualized 

burden hours are 279. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hrs.) 

Clerical ......................................................................................................................................... 33 2 2.73 

Directors ....................................................................................................................................... 33 2 1.5 


cprice-sewell on PROD1PC62 with NOTICES