Updated Vaccine Information Statements for Influenza Vaccines; Revised Instructions for Use of Vaccine Information Statements, 50065-50066 [E6-14030]

Download as PDF Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices participate, dial 877/315–6535 and enter conference code 383520. Purpose: Under the charge of the BSC, NCEH/ATSDR, the PPRS will provide the BSC, NCEH/ATSDR with advice and recommendations on NCEH/ATSDR program peer review. They will serve the function of organizing, facilitating, and providing a longterm perspective to the conduct of NCEH/ ATSDR program peer review. Matters to be Discussed: A review of the minutes from the previous meeting; a discussion to finalize members of the Peer Review Workgroup for the site specific activities’ peer review, external partners and customers, and chairperson(s); a discussion on the revised schedule for program peer reviews; a discussion of Terrorism Preparedness and Emergency Response Peer Review in February 2007. Agenda items are subject to change as priorities dictate. Supplementary Information: Public comment period is scheduled for 11:20–11:30 a.m. For Further Information Contact: Sandra Malcom, Committee Management Specialist, Office of Science, NCEH/ATSDR, M/S E–28, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone 404/498–0622. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and NCEH/ATSDR. Dated: August 18, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–14032 Filed 8–23–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention rmajette on PROD1PC67 with NOTICES1 Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772–76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 71 FR 44298–44300, dated August 4, 2006) is amended to reflect the transfer of functions and name change to Office of Equal Employment Opportunity, Office of the Director, Centers for Disease Control and Prevention. Section C–B, Organization and Functions, is hereby amended as follows: VerDate Aug<31>2005 15:15 Aug 23, 2006 Jkt 208001 Under item (7) of the functional statement for the Office of the Chief Operating Officer (CAJ), delete the following: alternative dispute resolution activities. Delete in its entirety the title and functional statement for the Office of Equal Employment Opportunity (CAV), and insert the following: Office of Dispute Resolution and Equal Employment Opportunity (CAV). The Office of Dispute Resolution and Equal Employment Opportunity (ODREEO) is located in the Office of the Director, Centers for Disease Control and Prevention (CDC). The Director, ODREEO, serves as the principal advisor to the Director, CDC, on all equal employment opportunity matters. The ODREEO: (1) Develops and recommends for adoption CDC-wide equal employment opportunity policies, goals, and priorities to carry out the directives of the U.S. Office of Personnel Management, U.S. Equal Employment Opportunity Commission, and Department of Health and Human Services (DHHS) equal employment opportunity policies and requirements that are mandated by Title VII, Civil Rights Act of 1964; Age Discrimination in Employment Act (ADEA); Rehabilitation Act of 1973; Civil Service Reform Act; 29 CFR 1614, Federal Sector Equal Employment Opportunity; Executive Order 11478, Equal Employment Opportunity in the Federal Government; (2) provides leadership, direction, and technical guidance to CDC managers and staff for the development of comprehensive programs and plans; (3) coordinates and evaluates agency equal employment opportunity operations and plans, including affirmative action; (4) develops plans, programs, and procedures to assure the prompt receipt, investigation, and resolution of complaints of alleged discrimination by reason of race, sex, age, religion, national origin, handicap, or by reason of reprisal or retaliation; (5) coordinates the development of comprehensive special emphasis programs to assure full recognition of the needs of women, Hispanics, other minorities and the handicapped in hiring and employment; (6) identifies needs for ODREEO functions within CDC and assures the development of a training curriculum for all CDC supervisory personnel; (7) prepares or coordinates the preparation of, reports and analyses designed to reflect the status of employment of women and minorities at CDC and maintains liaison with DHHS and other organizations concerned with equal employment opportunity; (8) ensures effective coordination of ODREEO PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 50065 activities with CDC personnel and training programs, and with CDC national centers manpower planning and support programs in the health professions; (9) develops a system of structured reviews and evaluations of CDC ODREEO activities to assure effective operations and accountability; (10) assists in assuring the adequate allocation of resources for ODREEO including the establishment of guidelines for recruiting, selection, and training of agency personnel; (11) develops and directs research and evaluation studies to focus on, and improve the effectiveness of, ODREEO program activities; (12) provides direction for the agency’s alternative dispute resolution activities, and (13) provides direct support for ODREEO program activities in CDC. Dated: August 14, 2006. William H. Gimson, Chief Operating Officer, Centers for Disease Control and Prevention (CDC). [FR Doc. 06–7117 Filed 8–23–06; 8:45 am] BILLING CODE 4160–18–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Updated Vaccine Information Statements for Influenza Vaccines; Revised Instructions for Use of Vaccine Information Statements Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa–26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. Since January 1, 2006, use of trivalent influenza vaccine information materials has been required. This notice announces availability of updated influenza vaccine information materials for use in the upcoming 2006–07 influenza season. DATES: Each health care provider who administers any trivalent influenza vaccine to any child or adult in the United States during the 2006–07 influenza season shall provide copies of the relevant influenza vaccine information materials referenced in this notice, dated June 30, 2006, to the patient/parent/legal representative in conformance with the June 30, 2006 E:\FR\FM\24AUN1.SGM 24AUN1 50066 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices CDC Instructions for the Use of Vaccine Information Statements. FOR FURTHER INFORMATION CONTACT: Anne Schuchat, M.D., Director, National Immunization Program, Centers for Disease Control and Prevention, Mailstop E–05, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone (404) 639–8200. SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 1986 (Pub. L. 99–660), as amended by section 708 of Public Law 103–183, added section 2126 to the Public Health Service Act. Section 2126, 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, whether public or private, to any patient (or to the parent or legal representative in the case of a child) receiving vaccines covered under the National Vaccine Injury Compensation Program. Development and revision of the vaccine information materials, also known as Vaccine Information Statements (VIS), have been delegated by the Secretary to the Centers for Disease Control and Prevention (CDC). The vaccines initially covered under the National Vaccine Injury Compensation Program were diphtheria, tetanus, pertussis, measles, mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any health care provider in the United States who intends to administer one of these covered vaccines is required to provide copies of the relevant vaccine information materials prior to administration of any of these vaccines. Since June 1, 1999, health care providers are also required to provide copies of vaccine information materials for the following vaccines that were added to the National Vaccine Injury Compensation Program: hepatitis B, haemophilus influenzae type b (Hib), and varicella (chickenpox) vaccines. In addition, use of vaccine information materials for pneumococcal conjugate vaccine has been required since December 15, 2002, materials for trivalent influenza vaccines since January 1, 2006 and materials for hepatitis A vaccine since July 1, 2006. rmajette on PROD1PC67 with NOTICES1 Updated Influenza Vaccine Information Materials Inactivated Influenza Vaccine Information Statement Initial vaccine information materials developed under 42 U.S.C. 300aa–26 for 15:15 Aug 23, 2006 Jkt 208001 Instructions for the Use of Vaccine Information Statements The CDC Instructions for the Use of Vaccine Information Statements have been updated to note the new edition dates of the influenza vaccine information materials. Those updated instructions, dated June 30, 2006, can be downloaded at the CDC Web site at: https://www.cdc.gov/nip/publications/ VIS. In addition, copies of the updated influenza materials can be downloaded in PDF format at the same Web site. Alternatively, single camera-ready copies are available from State health departments. A list of State health department contacts for obtaining copies of these materials is included in a December 17, 1999 Federal Register notice (64 FR 70914). Dated: August 16, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E6–14030 Filed 8–23–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families President’s Committee for People With Intellectual Disabilities; Notice of Meeting ACTION: PO 00000 Thursday, September 14, 2006, from 9 a.m. to 5:30 p.m., and Friday, September 15, 2006, from 9 a.m. to 5 p.m. The entire meeting of PCPID will be open to the public. DATES: The meeting will be held in Room 800 of the Hubert H. Humphrey building, 200 Independence Ave., SW., Washington, DC 20201. Individuals who will need accommodations for a disability in order to attend the meeting (e.g., interpreting services, assistive listening devices, materials in alternative format such as large print or Braille) should notify Sally Atwater at 202–619–0634 no later than September 7, 2006. We will attempt to meet requests made after that date, but cannot guarantee availability. All meeting sites are barrier free. Agenda: Day One—The new Committee members will take the oath of office, be sworn in as members of the President’s Committee for People with Intellectual Disabilities and receive guidance on ethics regulations and the Federal Advisory Committee Act (FACA). Committee members will also hear from the various ex officio members regarding the programs and services provided by their respective Federal agencies. Agenda: Day Two—The Committee will receive a briefing on the New Freedom Initiative and then begin discussion to set Committee priorities for the coming year. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Sally D. Atwater, Executive Director, President’s Committee for People with Intellectual Disabilities, The Aerospace Center, Suite 701, 370 L’Enfant Promenade, SW., Washington, DC 20447. Telephone: 202–619–0634, fax: 202–205–9591. E-mail: satwater@acf.hhs.gov. PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and supports for persons with intellectual disabilities. The Committee, by Executive Order, is responsible for evaluating the adequacy of current practices in programs, services and supports for persons with intellectual disabilities, and for reviewing legislative proposals that impact the quality of life experienced by citizens with intellectual disabilities and their families. SUPPLEMENTARY INFORMATION: BILLING CODE 4163–18–P AGENCY: President’s Committee for People with Intellectual Disabilities (PCPID), Department of Health And Human Services. Live, Intranasal Influenza Vaccine Information Statement VerDate Aug<31>2005 trivalent inactivated influenza vaccine and for trivalent live, intranasal influenza vaccine were published in the Federal Register on November 10, 2005 (70 FR 68461). The edition date of those materials was October 20, 2005. This notice announces availability of the 2006–07 editions of these influenza vaccine information materials. The only substantive revisions that appear in these updated materials are the addition of the influenza season date of 2006–07, the VIS edition date of 6/30/2006 and an update to note the expanded recommended schedule for administration of inactivated influenza vaccine to all children 6–59 months of age and to the household contacts and out-of-home caregivers of such children (with either inactivated or live, intranasal influenza vaccine as applicable). Notice of quarterly meeting. Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50065-50066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Updated Vaccine Information Statements for Influenza Vaccines; 
Revised Instructions for Use of Vaccine Information Statements

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 
U.S.C. 300aa-26), the CDC must develop vaccine information materials 
that all health care providers are required to give to patients/parents 
prior to administration of specific vaccines. Since January 1, 2006, 
use of trivalent influenza vaccine information materials has been 
required. This notice announces availability of updated influenza 
vaccine information materials for use in the upcoming 2006-07 influenza 
season.

DATES: Each health care provider who administers any trivalent 
influenza vaccine to any child or adult in the United States during the 
2006-07 influenza season shall provide copies of the relevant influenza 
vaccine information materials referenced in this notice, dated June 30, 
2006, to the patient/parent/legal representative in conformance with 
the June 30, 2006

[[Page 50066]]

CDC Instructions for the Use of Vaccine Information Statements.

FOR FURTHER INFORMATION CONTACT: Anne Schuchat, M.D., Director, 
National Immunization Program, Centers for Disease Control and 
Prevention, Mailstop E-05, 1600 Clifton Road, NE., Atlanta, Georgia 
30333, telephone (404) 639-8200.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986 (Pub. L. 99-660), as amended by section 708 of Public Law 103-183, 
added section 2126 to the Public Health Service Act. Section 2126, 
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, 
whether public or private, to any patient (or to the parent or legal 
representative in the case of a child) receiving vaccines covered under 
the National Vaccine Injury Compensation Program. Development and 
revision of the vaccine information materials, also known as Vaccine 
Information Statements (VIS), have been delegated by the Secretary to 
the Centers for Disease Control and Prevention (CDC).
    The vaccines initially covered under the National Vaccine Injury 
Compensation Program were diphtheria, tetanus, pertussis, measles, 
mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any 
health care provider in the United States who intends to administer one 
of these covered vaccines is required to provide copies of the relevant 
vaccine information materials prior to administration of any of these 
vaccines. Since June 1, 1999, health care providers are also required 
to provide copies of vaccine information materials for the following 
vaccines that were added to the National Vaccine Injury Compensation 
Program: hepatitis B, haemophilus influenzae type b (Hib), and 
varicella (chickenpox) vaccines. In addition, use of vaccine 
information materials for pneumococcal conjugate vaccine has been 
required since December 15, 2002, materials for trivalent influenza 
vaccines since January 1, 2006 and materials for hepatitis A vaccine 
since July 1, 2006.

Updated Influenza Vaccine Information Materials

Inactivated Influenza Vaccine Information Statement

Live, Intranasal Influenza Vaccine Information Statement

    Initial vaccine information materials developed under 42 U.S.C. 
300aa-26 for trivalent inactivated influenza vaccine and for trivalent 
live, intranasal influenza vaccine were published in the Federal 
Register on November 10, 2005 (70 FR 68461). The edition date of those 
materials was October 20, 2005. This notice announces availability of 
the 2006-07 editions of these influenza vaccine information materials. 
The only substantive revisions that appear in these updated materials 
are the addition of the influenza season date of 2006-07, the VIS 
edition date of 6/30/2006 and an update to note the expanded 
recommended schedule for administration of inactivated influenza 
vaccine to all children 6-59 months of age and to the household 
contacts and out-of-home caregivers of such children (with either 
inactivated or live, intranasal influenza vaccine as applicable).

Instructions for the Use of Vaccine Information Statements

    The CDC Instructions for the Use of Vaccine Information Statements 
have been updated to note the new edition dates of the influenza 
vaccine information materials. Those updated instructions, dated June 
30, 2006, can be downloaded at the CDC Web site at: https://www.cdc.gov/
nip/publications/VIS.
    In addition, copies of the updated influenza materials can be 
downloaded in PDF format at the same Web site. Alternatively, single 
camera-ready copies are available from State health departments. A list 
of State health department contacts for obtaining copies of these 
materials is included in a December 17, 1999 Federal Register notice 
(64 FR 70914).

    Dated: August 16, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E6-14030 Filed 8-23-06; 8:45 am]
BILLING CODE 4163-18-P

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