2013-18479. Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and Draft Recommendations for Enhancing the Work of the HHS National Vaccine Program in Global Immunizations for Consideration by the National ...

AGENCY:

National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (§ 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program.

The ASH charged the NVAC with reviewing the role of HHS in global vaccination, the effects of global vaccination on global populations, the effects of global vaccination on U.S. populations, and recommending how HHS can best continue to contribute, consistent with its newly established Global Health Strategy and Goal 5 of the National Vaccine Plan. The NVAC was also asked to make recommendations on how to best communicate this information to decision makers and the general public to ensure continued sufficient resources for the global vaccination efforts. The NVAC established the Global Immunizations Working Group to assist in addressing these charges.

A draft report and draft recommendations have been developed by the working group for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in September 2013 at the quarterly NVAC meeting.

DATES:

Comments for consideration by the NVAC should be received no later than 5:00 p.m. EDT on August 16, 2013.

ADDRESSES:

(1) The draft report and draft recommendations are available on the web at http://www.hhs.gov/​nvpo/​nvac/​index.html.

(2) Electronic responses are preferred and may be addressed to: [e-mail].

(3) Written responses should be addressed to: National Vaccine Program Office, U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 733G, Washington, DC 20201. Attn: HHS Global Immunizations c/o Dr. Jennifer Gordon.

FOR FURTHER INFORMATION CONTACT:

Jennifer Gordon, Ph.D., National Vaccine Program Office, Office of the Assistant Secretary for Health, Department of Health and Human Services; telephone [phone]; fax [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various Federal agencies involved in vaccine and immunization activities. These coordinated efforts are aimed to achieve the strategic goals outlined in the National Vaccine Plan. The National Vaccine Plan provides a framework, including goals, objectives, and strategies, for pursuing the prevention of infectious diseases through immunizations. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the Assistant Secretary for Health in his capacity as the Director of National Vaccine Program on matters related to vaccine program responsibilities.

Global immunization efforts save millions of lives every year and are deemed one of the most cost-effective strategies in public health. The global health community has the potential to substantially reduce childhood mortality and alleviate the economic and societal burdens vaccine preventable diseases impose on nations through immunization. However, continued efforts are needed to strengthen and optimize routine immunization systems to ensure the full benefits of immunization are extended to all people, regardless of where they are born, who they are, or where they live.

Global immunization efforts are also important to protecting the health and economic investments of the U.S. Globalization, frequent travel, and the ongoing threat of disease outbreaks due to importations of infectious diseases bring global health to the forefront of HHS efforts to protect the health and well-being of Americans as well as populations across the globe. This is reflected in the Secretary's 2010-2015 HHS Strategy, the HHS Global Health Strategy, the 2010 National Vaccine Plan, and a number of strategic plans specific to the individual HHS agencies and offices.

Through a series of teleconferences and electronic communications, the NVAC Global Immunizations working group identified a number of draft recommendations that fell into six priority areas, which represent both opportunities for improving global immunizations, as well as areas that will benefit the most from continued and enhanced HHS participation. These priority areas include:

1. Tackling time-limited opportunities to complete polio eradication and to advance measles mortality reduction and regional measles/rubella elimination goals

2. Strengthening Global Immunization Systems

3. Enhancing Global Capacity for Vaccine Safety Monitoring and Post-Marketing Surveillance

4. Building Global Immunization Research and Development Capacity

5. Strengthening Capacity for Vaccine Policy and Decision Making

6. HHS Leadership and Coordination.

The NVAC draft report details the background and rationale for each of the recommendations, how HHS is currently contributing to these global efforts, and how the ASH can support and further HHS activities in these areas. The NVAC intends for the recommendations to serve as a potential roadmap for better coordination and tracking of HHS global immunization efforts. The continued participation of HHS in the six priority areas identified by NVAC will make certain that global immunizations remain at the forefront of HHS global health priorities.

II. Request for Comment

NVPO, on behalf of the NVAC Global Immunizations Working Group, requests input on the draft report and draft recommendations. In addition to general comments on the draft report and draft recommendations, NVPO is seeking input on activities not represented in the report where HHS efforts can offer a comparative advantage or where HHS efforts could enhance other USG efforts in alignment with the HHS Global Health Strategy and the National Vaccine Plan. Please limit your comments to six (6) pages.

III. Potential Responders

HHS invites input from a broad range of stakeholders including individuals and organizations that have interests in global immunization efforts and the role of HHS in enhancing those efforts.

Examples of potential responders include, but are not limited to, the following:

—General public;

—Advocacy groups and public interest organizations;

—Academics and professional societies;

—Global organizations, governmental, and non-governmental organizations;

—Development partners, foundations, and philanthropic organizations;

—Representatives from the private sector.

When responding, please self-identify with any of the above or other categories (include all that apply) and your name. Anonymous submissions will not be considered. Written submissions should not exceed six pages. Please do not send proprietary, commercial, financial, business, confidential, trade secret, or personal information.

Dated: July 24, 2013.

Bruce Gellin,

Deputy Assistant Secretary for Health, Director, National Vaccine Program Office.