2076 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 

Audio conferencing will be available for 

the second day of the meeting. 

DATES: The meeting will be held on 

February 5, 2009, from 8:30 a.m. to 6:30 

p.m. and on February 6, 2009, from 8 

a.m. to 3:30 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. 

Andrea Krull, National Vaccine Program 

Office, Department of Health and 

Human Services, Room 443-H, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. Phone: (202) 

690–5566; Fax: (202) 260–1165; e-mail: 

nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Health 

Service Act (42 U.S.C. Section 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 Vaccine Advisory Committee 

was established to provide advice and 

make recommendations to the Director 

of the National Vaccine Program, on 

matters related to the Program’s 

responsibilities. The Assistant Secretary 

for Health serves as Director of the 

National Vaccine Program. 

Topics to be discussed at the meeting 

on Thursday, February 5, 2009 include 

vaccine financing, vaccine safety, 

vaccine stockpile, seasonal influenza 

and related issues, vaccine 

development, and the National Vaccine 

Plan. Updates will be given by the 

NVAC Financing, Adult Immunization, 

and Safety working groups. The meeting 

on Friday, February 6, 2009 is a full day 

stakeholders’ meeting to discuss the 

draft strategic National Vaccine Plan. 

The draft plan can be viewed at the 

following Web site: http://www.hhs.gov/ 

nvpo/vacc_plan/. The meeting will 

begin with a plenary session to provide 

an overview of the day’s agenda 

followed by break-out sessions for each 

of the five draft strategic National 

Vaccine Plan goals. Audio-conferencing 

will be available for the stakeholders’ 

meeting on February 6, 2009 for the 

plenary as well as break-out sessions. 

Call-in numbers for the meeting are as 

follows: plenary sessions on February 6: 

(888) 390–3413 (passcode: 60302); goal 

1: research (888) 469–1340 (passcode 

27271); goal 2: safety (888) 989–4406 

(passcode 41520); goal 3: 

communication (800) 779–6844 

(passcode 19562); goal 4: supply (888) 

994–8791 (passcode 37886); and goal 5: 

global health (888) 989–4717 (passcode 

12377). Agendas for each day of the 

meeting will be posted on the NVAC 

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

January 21, 2009. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

designated contact person at least one 

week prior to the meeting. Members of 

the public will have the opportunity to 

provide comments at the meeting. 

Public comment will be limited to five 

minutes per speaker. Individuals who 

would like to submit written statements 

should e-mail or fax their comments to 

the National Vaccine Program Office at 

least five business days prior to the 

meeting. A separate Federal Register 

Notice will be issued with detailed 

instructions for submitting comments 

about the draft strategic National 

Vaccine Plan. 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 January 30, 2009. 

Dated: January 5, 2009. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office. 

[FR Doc. E9–498 Filed 1–13–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health; Decision To 

Evaluate a Petition To Designate a 

Class of Employees for the Piqua 

Organic Moderated Reactor Site, 

Piqua, Ohio, To Be Included in the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice as required 

by 42 CFR 83.12(e) of a decision to 

evaluate a petition to designate a class 

of employees for the Piqua Organic 

Moderated Reactor site, Piqua, Ohio, to 

be included in the Special Exposure 

Cohort under the Energy Employees 

Occupational Illness Compensation 

Program Act of 2000. The initial 

proposed definition for the class being 

evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Piqua Organic Moderated 

Reactor site. 

Location: Piqua, Ohio. 

Job Titles and/or Job Duties: All 

employees associated with reactor 

activities who worked within and 

around the Reactor Dome. 

Period of Employment: January 1, 

1963 through December 31, 1966. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 4676 Columbia 

Parkway, MS C–46, Cincinnati, OH 

45226, Telephone 513–533–6800 (this is 

not a toll-free number). Information 

requests can also be submitted by e-mail 

to OCAS@CDC.GOV. 

Dated: January 6, 2009. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E9–571 Filed 1–13–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Written Comments on 

Draft Strategic National Vaccine Plan 

AGENCY: Department of Health and 

Human Services, Office of the Secretary. 

ACTION: Notice. 

SUMMARY: On behalf of the National 

Vaccine Advisory Committee (NVAC), 

the National Vaccine Program Office 

(NVPO) is soliciting public comment on 

the draft strategic National Vaccine 

Plan. 

DATES: All comments on the draft 

strategic National Vaccine Plan should 

be received no later than 5 p.m. on 

January 30, 2009. 

ADDRESSES: Electronic responses are 

preferred and may be addressed to 

NVPComments@hhs.gov. Written 

responses should be addressed to 

National Vaccine Program Office, 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Room 443–H, Washington, DC 

20201, Attention: National Vaccine Plan 

RFI. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Raymond A. Strikas, M.D., 

National Vaccine Program Office, 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Room 443–H, Washington, DC 

20201; (202) 690–5566; fax 202–260– 

1165; e-mail nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: 


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Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 2077 

I. Background 

The National Vaccine Program was 

established in 1986 to achieve optimal 

prevention of infectious diseases 

through immunization and optimal 

prevention of adverse reactions to 

vaccines. NVPO is located within the 

Office of Public Health and Science 

within the Office of the Secretary, HHS, 

and has responsibility for coordinating 

and ensuring collaboration among the 

many Federal agencies involved in 

vaccine and immunization activities as 

part of the National Vaccine Program. 

NVAC is a statutory Federal advisory 

committee that provides advice and 

makes recommendations to the Director 

of the National Vaccine Program on 

matters related to the Program. The 

purpose of the National Vaccine Plan is 

to promote achievement of the National 

Vaccine Program mission by providing 

strategic direction and promoting 

coordinated action by vaccine and 

immunization enterprise stakeholders. 

Federal involvement in civilian and 

military vaccination programs is 

longstanding, including in research and 

development, regulation, vaccine 

delivery and the evaluation of the 

impacts of immunizations. This draft 

strategic National Vaccine Plan builds 

on the many achievements of the 

vaccine and immunization enterprise 

prior to and since the establishment of 

the National Vaccine Program in 1986 

and the completion of the first National 

Vaccine Plan in 1994. Both the draft 

strategic National Vaccine Plan and the 

1994 National Vaccine Plan are 

available at http://www.hhs.gov/nvpo/ 

vacc_plan/. New vaccines have been 

developed and licensed; many of these 

new vaccines are now recommended for 

children, adolescents and adults. These 

new vaccines have expanded the 

number of infections that can be 

prevented, and more effectively and 

safely prevent some diseases for which 

earlier generation vaccines already 

existed. Opportunities exist to improve 

protection against vaccine-preventable 

diseases by (1) developing improved 

vaccines based on new adjuvants and 

better understanding of the immune 

system, and (2) developing a variety of 

delivery systems for vaccines, such as 

intradermal, oral, and immunostimulant 

patches. In addition, federal 

immunization financing programs have 

reduced or eliminated many financial 

barriers to immunizations, particularly 

for children. The number of infections 

prevented by vaccination has decreased 

significantly while coverage for many 

vaccines has reached record levels. 

More robust systems have been 

developed to identify adverse events 

following immunization and to assess 

potential associations of those events 

with vaccination. Globally, the United 

States has worked with multilateral and 

bilateral partners and non-governmental 

organizations in contributing to 

improvements in child health status and 

the prevention of hundreds of 

thousands of child deaths each year 

through improved vaccine coverage and 

introduction of new vaccines. Of the 

fourteen anticipated outcomes included 

in the 1994 National Vaccine Plan, most 

were substantially or fully realized. 

Despite these successes, however, 

many of the challenges that stimulated 

establishment of the National Vaccine 

Program and the development of the 

1994 National Vaccine Plan remain 

relevant today. Vaccine shortages have 

frequently been experienced for many 

routinely recommended vaccines. 

Despite improved vaccination coverage 

among children, the occurrence of 

several recent vaccine preventable 

disease outbreaks serves as a reminder 

that these diseases still occur. Among 

older adults both vaccination coverage 

and the effectiveness of some routinely 

recommended vaccines remain suboptimal. As the number of vaccines has 

increased and vaccine preventable 

diseases have declined, vaccine safety 

concerns are expressed more 

prominently today and may be more 

widely shared. Enhancing the current 

vaccine safety system is important to 

keep pace with several factors 

influencing it: an increasing number of 

vaccines and vaccine combinations, 

expanding target populations, and a 

better understanding of human biology, 

especially the human immune system. 

As the cost of vaccination has increased, 

financial barriers to vaccination have 

emerged for health departments, health 

care providers, and the public. 

Significant scientific challenges remain 

in the development of safe and effective 

vaccines against existing global health 

threats, such as HIV, TB, malaria, and 

influenza (developing vaccines with 

broader protection). Vaccines that have 

been developed and are in use in 

industrialized countries have the 

potential to make major contributions to 

health in developing countries, but are 

underutilized. Additionally, emerging 

and pandemic infections and 

bioterrorist threats pose new challenges 

for vaccine development and 

manufacturing, vaccine delivery, 

regulation, and access in the U.S. and 

abroad. 

The Plan is built around the 

achievement of five broad goals: 

Goal 1: Develop new and improved 

vaccines. 

Goal 2: Enhance the safety of vaccines 

and vaccination practices. 

Goal 3: Support informed vaccine 

decision-making by the public, 

providers, and policy-makers. 

Goal 4: Ensure a stable supply of 

recommended vaccines and achieve 

better use of existing vaccines to prevent 

disease, disability and death in the 

United States. 

Goal 5: Increase global prevention of 

death and disease through safe and 

effective vaccination. 

These goals will be achieved by 

pursuing objectives and strategies that 

address each of the key determinants of 

those outcomes. Success in achieving 

these goals will be assessed by tracking 

progress in achieving measurable 

outcomes (‘‘indicators’’) associated with 

each goal. Final definition of the 

indicators and the development of 

specific numeric targets will occur 

through further consultation with 

stakeholders and the IOM Committee. 

The current draft strategic National 

Vaccine Plan is based largely on input 

received from Federal Departments and 

agencies. Recognizing that success can 

best be achieved through a national plan 

that includes coordinated action by 

public and private sector stakeholders 

in pursuit of the Plan’s goals, extensive 

outreach and consultation will be 

implemented as the Plan is finalized. A 

committee empanelled by the National 

Academy of Sciences’ Institute of 

Medicine (IOM) reviewed the 1994 

National Vaccine Plan and provided 

guidance on the development of the 

updated Plan (see http://www.iom.edu/ 

CMS/3793/55143.aspx). The IOM 

committee is also holding a series of 

national meetings focused around each 

of the goals in which perspectives from 

many of the stakeholders will be 

obtained. Following these meetings, the 

IOM committee will prepare a report 

that includes conclusions and 

recommendations about priority actions 

within major components of the Plan. 

The National Vaccine Advisory 

Committee (NVAC), a Federal advisory 

committee that includes representatives 

from many of the key vaccine and 

immunization enterprise stakeholders, 

is also implementing a process to obtain 

input from a wide range of stakeholder 

groups. This input will include 

comments on this draft Plan and 

additional strategies that they can 

contribute to achieve Plan goals. The 

NVAC will devote its meeting on 

February 6, 2009 to stakeholder and 

public comments on the draft Plan. In 

addition, input from the public will also 

be solicited to identify priority areas 

from their perspective in a series of 

meetings planned for later in 2009, 


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2078 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 

locations to be determined. This draft 

Plan will serve as the basis for the 

development of the updated National 

Vaccine Plan and based on this range of 

input, indicators of measurable 

outcomes will be determined and 

priorities will be presented. In addition, 

an implementation plan will be drafted 

that identifies specific actions that will 

be undertaken by government and other 

vaccine and immunization enterprise 

stakeholders to achieve the objectives 

and strategies in the plan and 

milestones will be established that will 

allow progress to be measured. The draft 

Plan has a ten-year horizon, and thereby 

balances a strategic vision, which 

requires development and 

implementation of new initiatives, with 

the recognition that changing 

circumstances and new opportunities 

and challenges will occur over the next 

decade. The ten-year horizon also 

allows incorporation of the 

HealthyPeople 2020 objectives once 

those are established by the Department 

of Health and Human Services (see 

http://www.healthypeople.gov). Annual 

monitoring of progress and a mid-course 

review will promote both accountability 

and flexibility. The updated National 

Vaccine Plan is expected to be 

completed by early 2010. 

Through this Request for Information, 

HHS is seeking broad comment from 

stakeholders and the general public. 

Comments received will be available for 

public viewing and will be summarized 

in an open meeting on February 6, 2009, 

to the NVAC in Washington, DC. If you 

wish to attend the meeting in person or 

by audioconference, please reply to 

nvpo@hhs.gov, or to 202–690–5566. 

II. Information Request 

NVPO, on behalf of the NVAC 

requests information in four broad areas. 

Responders may address one or more of 

the areas below. 

(1) Comments on priorities for the 

National Vaccine Plan for a ten-year 

period: What do you recommend be the 

top priorities for vaccines and the 

immunization enterprise in the United 

States and globally? Why are those 

priorities most important to you? 

[Provide up to 3 pages for an answer to 

these questions]. 

(2) Comments on the goals, objectives, 

and strategies for the National Vaccine 

Plan for a ten-year period: Please 

comment on the existing goals, 

objectives, and strategies in the draft 

Plan, and suggest specific goals, 

objectives, or strategies to be added to 

it, if the existing ones do not address 

your concerns. Are there any goals, 

objectives or strategies in the draft 

strategic Plan that should be discarded 

or revised? Which ones, and why? 

[Provide up to 3 pages for an answer to 

these questions]. 

(3) Comments on the indicators for 

the National Vaccine Plan for a ten-year 

period: Please comment on the existing 

indicators in the draft Plan, and suggest 

target estimates for them. Please suggest 

new indicators to be added to it, if the 

existing ones do not address your 

concerns. Are there any indicators in 

the draft strategic Plan that should be 

discarded or revised? Which ones, and 

why? [Provide up to 3 pages for an 

answer to these questions]. 

(4) Comments on stakeholders’ roles 

in the National Vaccine Plan: Please 

identify which stakeholders you believe 

should have responsibility for enacting 

the objectives and strategies listed in the 

draft Plan, as well as for any new 

objectives and strategies you suggest. 

Specifically identify roles your 

organization can play in the Plan. 

[Provide up to 3 pages for an answer to 

these questions]. 

III. Potential Responders 

HHS invites input from a broad range 

of individuals and organizations that 

have interests in vaccines and the 

immunization enterprise. Some 

examples of these organizations include, 

but are not limited to, the following: 

• General public. 

• Advocacy groups and public 

interest organizations. 

• State, local, and tribal governments 

and public health agencies. 

• State and local public health 

departments. 

• Vaccine manufacturing industry, 

distributors, investors, and other 

businesses. 

• Health care professional societies 

and organizations. 

• Academic researchers and groups. 

• Health care payers and plans. 

• International organizations. 

• Non-governmental organizations. 

• Philanthropic organizations. 

• Travel industry. 

The submission of written materials 

in response to the RFI should not 

exceed 12 pages (3 pages for each of the 

four broad topics), not including 

appendices and supplemental 

documents. Responders may submit 

other forms of electronic materials to 

demonstrate or exhibit concepts of their 

written responses. Any information you 

submit will be made public. 

Consequently, do not send proprietary, 

commercial, financial, business 

confidential, trade secret, or personal 

information that you do not wish to be 

made public. Information and 

comments will not be considered nor 

made publicly available, if it is not 

signed by, or attributed to, an 

individual, or an individual 

representing an organization. 

Public Access: Responses to this RFI 

will be available to the public on the 

NVPO Web site at http://www.hhs.gov/ 

nvpo/vacc_plan/. You may access 

public comments received from this RFI 

by going to the above Web site. 

Dated: January 7, 2009. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office, 

U.S. Department of Health and Human 

Services. 

[FR Doc. E9–495 Filed 1–13–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10161, CMS– 

1882, CMS–437A and B, CMS–1557 and 

CMS–10036] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: New Freedom 

Initiative—Web-based Reporting System 

for Grantees; Use: CMS currently awards 

competitive grants to States and other 

eligible entities for the purpose of 

designing and implementing effective 

and enduring improvements in 

community-based long-term services 


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