[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 34994-34995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14722]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Vaccine To Protect Children From Anthrax--Public Engagement 
Workshop

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice.

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SUMMARY: The National Biodefense Science Board's (NBSB) Anthrax Vaccine 
(AV) Working Group (WG) will hold a public engagement workshop on July 
7, 2011, to discuss vaccine to protect children from anthrax. This 
meeting is open to the public and prior registration is required. The 
public may attend in-person or by teleconference.

DATES: The NBSB's AV WG will hold a public engagement workshop on July 
7, 2011, to discuss vaccine to protect children from anthrax. The 
meeting will be from 9 a.m. to 4 p.m. ET.

ADDRESSES: Washington Plaza Hotel, 10 Thomas Circle Northwest, 
Washington, DC. The call-in details will be posted as they become 
available on the Workshop's July meeting Web page at http://www.phe.gov/PREPAREDNESS/LEGAL/BOARDS/NBSB/Pages/default.aspx.

FOR FURTHER INFORMATION CONTACT: E-mail: [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to section 319M of the Public 
Health Service Act (42 U.S.C. 247d-7f) and section 222 of the Public 
Health Service Act (42 U.S.C. 217a), the Department of Health and Human 
Services established the NBSB. The Board shall provide expert advice 
and guidance to the Secretary on scientific, technical, and other 
matters of special interest to the Department of Health and Human 
Services regarding current and future chemical, biological, nuclear, 
and radiological agents, whether naturally occurring, accidental, or 
deliberate. The Board may also provide advice and guidance to the 
Secretary and/or the Assistant Secretary for Preparedness and Response 
on other matters related to public health emergency preparedness and 
response.
    Background: In a letter dated 27 April 2011, the Assistant 
Secretary for Preparedness and Response (ASPR), Dr. Nicole Lurie asked 
the NBSB to consider issues related to the use of anthrax vaccine 
adsorbed (AVA), BioThrax[supreg], for children. AVA is currently in the 
Strategic National Stockpile and licensed for use only by healthy 
persons 18 to 65 years of age for traditional pre-exposure vaccination. 
It may be used in a declared emergency under an Emergency Use 
Authorization (EUA) for this same population as post-exposure 
prophylaxis in combination with licensed antibiotics for prevention of 
anthrax disease. However, the pediatric population is not covered by 
the EUA due to lack of safety and immunological data related to the 
vaccine. If there was known exposure of a population of individuals to 
anthrax there would be subsequent decisions about, for example, 
deployment of medical countermeasures (MCMs), evacuation versus 
sheltering-in-place, and the airborne spread of anthrax outside the 
city.
    Questions about the need for a vaccine program for populations that 
may continue to live in impacted areas may be raised. Because studies 
have been done to show safety and effectiveness of anthrax vaccine only 
for adults, if such an anthrax attack were to occur in the near future, 
the only way to use the existing vaccine to protect children would be 
to use an investigational new drug (IND) clinical protocol. These 
factors complicate operational response and public messaging.
    The NBSB has previously identified the need to look at other MCMs 
for pediatric populations. This Public Engagement Workshop provides an 
opportunity to include the public in the discussion about vaccines to 
protect children from anthrax or treat children exposed to anthrax. The 
forum includes discussion of the types of data and types of studies 
that may be needed to show whether existing FDA-approved vaccines, 
could also be used for children. No decisions or recommendations will 
be made at the Workshop.
    Availability of Materials: The meeting agenda and materials will be 
posted prior to the meeting on the Workshop's July meeting Web page at 
http://www.phe.gov/PREPAREDNESS/LEGAL/BOARDS/NBSB/Pages/default.aspx.
    Procedures for Providing Public Input: Any member of the public 
planning to attend in-person must register in advance by e-mailing 
[email protected]

[[Page 34995]]

with ``Vaccine to Protect Children from Anthrax--Public Engagement 
Workshop'' as the subject line and provide name, address, and 
affiliation. If you need special assistance, such as sign language 
interpretation or other reasonable accommodations, please include that 
in your registration e-mail. A ``listen-only'' teleconference number 
will be provided on the Web site. Written comments and/or questions may 
be submitted in advance or during the Workshop and will be provided to 
the Workshop hosts. There will be two scheduled public comment periods 
during the Workshop. Public comments will be limited to 2 minutes per 
person.

    Dated: June 8, 2011.
Nicole Lurie,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2011-14722 Filed 6-14-11; 8:45 am]
BILLING CODE 4150-37-P