2010-17437. 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 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: [e-mail]. 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 [phone] or e-mail: [e-mail].

Dated: July 12, 2010.

Sahira Rafiullah,

Director, Division of Policy and Information Coordination.