Meeting of the National Vaccine Advisory Committee, 27313-27314 [E7-9346]

Download as PDF cprice-sewell on PROD1PC62 with NOTICES Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Notices 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 VerDate Aug<31>2005 13:50 May 14, 2007 Jkt 211001 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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 27313 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 Department of Health and Human Services, Office of the Secretary. ACTION: Notice. AGENCY: 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 E:\FR\FM\15MYN1.SGM 15MYN1 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 Number of respondents Respondents cprice-sewell on PROD1PC62 with NOTICES Clerical ......................................................................................................................................... Directors ....................................................................................................................................... VerDate Aug<31>2005 13:50 May 14, 2007 Jkt 211001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\15MYN1.SGM Number of responses per respondent 33 33 15MYN1 2 2 Average burden per response (in hrs.) 2.73 1.5

Agencies

[Federal Register Volume 72, Number 93 (Tuesday, May 15, 2007)]
[Notices]
[Pages 27313-27314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9346]


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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

[[Page 27314]]

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. Pre-registration 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
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