[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Notices]
[Pages 41872-41873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Commission on Childhood Vaccines; Notice of Meeting

SUMMARY: In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), as amended, the Department of Health 
and Human Services is hereby giving notice that the Advisory Commission 
on Childhood Vaccines (ACCV) will hold a special meeting, to be held by 
teleconference. This meeting will be equivalent to an in-person meeting 
and will be open to the public.
    Date and Time: The ACCV will meet on Thursday, July 29 from 1 p.m. 
to 2 p.m. (ET). The public can join the meeting via audio conference 
call by dialing 1-888-606-5950 on July 29 at 1 pm and providing the 
following information:
    Leader's Name: Dr. Geoffrey Evans.
    Password: ACCV.
    Agenda: This is a special meeting of the ACCV. Discussions will 
surround the draft interim influenza vaccine information materials 
developed by the Centers for Disease Control and Prevention (CDC) for 
distribution during the 2010-2011 season by health care providers in 
the United States to all seasonal influenza vaccine recipients (or to 
parents or legal representatives in certain cases). For this special 
meeting, members of the public are invited to attend by teleconference 
via a toll-free call-in phone number.

SUPPLEMENTARY INFORMATION: Section 2126 of the Public Health Service 
Act, as amended, codified at 42 U.S.C. 300aa-26, requires the Secretary 
of Health and Human Services to develop and disseminate vaccine 
information materials for distribution by all health care providers in 
the United States to any person (or to parents or legal representatives 
in certain cases) receiving vaccines covered under the VICP.
    Development and revision of vaccine information materials, also 
known as Vaccine Information Statements (VIS), have been delegated by 
the Secretary to the CDC. Section 2126 requires that the

[[Page 41873]]

materials be developed, or revised, after notice to the public, with a 
60-day comment period, and in consultation with the ACCV, appropriate 
health care provider and parent organizations, and the Food and Drug 
Administration. The law also requires that the information contained in 
the materials be based on available data and information, be presented 
in understandable terms, and include:
    (1) A concise description of the benefits of the vaccine,
    (2) A concise description of the risks associated with the vaccine,
    (3) A statement of the availability of the National Vaccine Injury 
Compensation Program, and
    (4) Such other relevant information as may be determined by the 
Secretary.
    Instructions for use of the vaccine information materials and 
copies of the materials can be found on the CDC Web site at: http://www.cdc.gov/vaccines/pubs/VIS/. In addition, single camera-ready copies 
may be available from State health departments.
    The meeting described in this notice fulfills the legal 
requirements that the ACCV be consulted concerning the development or 
revision of vaccine information materials with respect to vaccines 
covered under the National Vaccine Injury Compensation Program.
    Public Comments: Persons interested in providing an oral 
presentation should submit a written request, along with a copy of 
their presentation to: Annie Herzog, DVIC, Healthcare Systems Bureau 
(HSB), Health Resources and Services Administration (HRSA), Room 11C-
26, 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail: 
[email protected]. Requests should contain the name, address, telephone 
number, e-mail address, and any business or professional affiliation of 
the person desiring to make an oral presentation. Groups having similar 
interests are requested to combine their comments and present them 
through a single representative. The allocation of time may be adjusted 
to accommodate the level of expressed interest. DVIC will notify each 
presenter by e-mail, mail or telephone of their assigned presentation 
time. Persons who do not file an advance request for a presentation, 
but desire to make an oral statement, may announce it at the time of 
the public comment period. Public participation and ability to comment 
will be limited to space and time as it permits.
    This meeting notice is being published less than the normally 
required 15-day timeframe due to the public health urgency of this 
agency business and in order to assure that completed vaccine 
information materials will be available for distribution prior to the 
beginning of vaccination for the upcoming influenza season (41 CFR 102-
3.150(b)).

FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding 
the ACCV should contact Annie Herzog, DVIC, HSB, HRSA, Room 11C-26, 
5600 Fishers Lane, Rockville, MD 20857; telephone (301) 443-6593 or e-
mail: [email protected].

    Dated: July 12, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-17437 Filed 7-14-10; 4:15 pm]
BILLING CODE 4165-15-P