81 FR 23301 - Final Revised Vaccine Information Materials for Meningococcal ACWY Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 76 (April 20, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23301-23301 | |
| FR Document | 2016-09166 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Page 23301] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09166] [[Page 23301]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2015-0059] Final Revised Vaccine Information Materials for Meningococcal ACWY Vaccines 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), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 14, 2015, CDC published a notice in the Federal Register (80 FR 61819) seeking public comments on proposed updated vaccine information materials for Meningococcal ACWY and Serogroup B Meningococcal vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for Meningococcal ACWY vaccines. Copies of the final vaccine information materials for Meningococcal ACWY vaccines are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0059). CDC will publish the final vaccine information materials for Serogroup B Meningococcal vaccines when they are completed. DATES: Beginning no later than July 1, 2016, each health care provider who administers Meningococcal ACWY vaccine to any child or adult in the United States shall provide copies of the relevant vaccine information materials referenced in this notice, in conformance with the March 31, 2016 CDC Instructions for the Use of Vaccine Information Statements prior to providing such vaccinations. FOR FURTHER INFORMATION CONTACT: Suzanne Johnson-DeLeon ([email protected]), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia 30329. 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 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 (VICP). 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). 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 Advisory Commission on Childhood Vaccines, 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. 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 then, the following vaccines have been added to the National Vaccine Injury Compensation Program, requiring use of vaccine information materials for them as well: Hepatitis B, Haemophilus influenzae type b (Hib), varicella (chickenpox), pneumococcal conjugate, rotavirus, hepatitis A, meningococcal, human papillomavirus (HPV), and seasonal influenza vaccines. Instructions for use of the vaccine information materials are found on the CDC Web site at: http://www.cdc.gov/vaccines/hcp/vis/index.html. Revised Vaccine Information Materials The Meningococcal ACWY vaccine information materials referenced in this notice were developed in consultation with the Advisory Commission on Childhood Vaccines, the Food and Drug Administration, and parent and healthcare provider organizations. Following consultation and review of comments submitted, the vaccine information materials covering meningococcal ACWY vaccines have been finalized and are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0059). The Vaccine Information Statement (VIS) is ``Meningococcal ACWY Vaccines (MenACWY and MPSV4): What You Need to Know,'' publication date March 31, 2016. With publication of this notice, as of July 1, 2016, all health care providers will be required to provide copies of these updated meningococcal ACWY vaccine information materials prior to immunization in conformance with CDC's March 31, 2016 Instructions for the Use of Vaccine Information Statements. Dated: April 15, 2016. Veronica Kennedy, Acting Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2016-09166 Filed 4-19-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23301
DEPARTMENT OF HEALTH AND Service Act. Section 2126, codified at 42 notice were developed in consultation
HUMAN SERVICES U.S.C. 300aa–26, requires the Secretary with the Advisory Commission on
of Health and Human Services to Childhood Vaccines, the Food and Drug
Centers for Disease Control and develop and disseminate vaccine Administration, and parent and
Prevention information materials for distribution by healthcare provider organizations.
[Docket No. CDC–2015–0059] all health care providers in the United Following consultation and review of
States to any patient (or to the parent or comments submitted, the vaccine
Final Revised Vaccine Information legal representative in the case of a information materials covering
Materials for Meningococcal ACWY child) receiving vaccines covered under meningococcal ACWY vaccines have
Vaccines the National Vaccine Injury been finalized and are available to
Compensation Program (VICP). download from http://www.cdc.gov/
AGENCY: Centers for Disease Control and Development and revision of the vaccines/hcp/vis/index.html or http://
Prevention (CDC), Department of Health vaccine information materials, also www.regulations.gov (see Docket
and Human Services (HHS). known as Vaccine Information Number CDC–2015–0059). The Vaccine
ACTION: Notice. Statements (VIS), have been delegated Information Statement (VIS) is
by the Secretary to the Centers for ‘‘Meningococcal ACWY Vaccines
SUMMARY: Under the National Disease Control and Prevention (CDC). (MenACWY and MPSV4): What You
Childhood Vaccine Injury Act (NCVIA) Section 2126 requires that the materials Need to Know,’’ publication date March
(42 U.S.C. 300aa–26), CDC must develop be developed, or revised, after notice to 31, 2016.
vaccine information materials that all the public, with a 60-day comment With publication of this notice, as of
health care providers are required to period, and in consultation with the July 1, 2016, all health care providers
give to patients/parents prior to Advisory Commission on Childhood will be required to provide copies of
administration of specific vaccines. On Vaccines, appropriate health care these updated meningococcal ACWY
October 14, 2015, CDC published a provider and parent organizations, and vaccine information materials prior to
notice in the Federal Register (80 FR the Food and Drug Administration. The immunization in conformance with
61819) seeking public comments on law also requires that the information CDC’s March 31, 2016 Instructions for
proposed updated vaccine information contained in the materials be based on the Use of Vaccine Information
materials for Meningococcal ACWY and available data and information, be Statements.
Serogroup B Meningococcal vaccines. presented in understandable terms, and Dated: April 15, 2016.
Following review of comments include: Veronica Kennedy,
submitted and consultation as required (1) A concise description of the Acting Executive Secretary, Centers for
under the law, CDC has finalized the benefits of the vaccine, Disease Control and Prevention.
materials for Meningococcal ACWY (2) A concise description of the risks
[FR Doc. 2016–09166 Filed 4–19–16; 8:45 am]
vaccines. Copies of the final vaccine associated with the vaccine,
BILLING CODE 4163–18–P
information materials for (3) A statement of the availability of
Meningococcal ACWY vaccines are the National Vaccine Injury
available to download from http:// Compensation Program, and DEPARTMENT OF HEALTH AND
www.cdc.gov/vaccines/hcp/vis/ (4) Such other relevant information as
HUMAN SERVICES
index.html or http:// may be determined by the Secretary.
www.regulations.gov (see Docket The vaccines initially covered under Administration for Children and
Number CDC–2015–0059). CDC will the National Vaccine Injury Families
publish the final vaccine information Compensation Program were diphtheria,
materials for Serogroup B tetanus, pertussis, measles, mumps, Proposed Information Collection
Meningococcal vaccines when they are rubella, and poliomyelitis vaccines. Activity; Comment Request
completed. Since April 15, 1992, any health care
provider in the United States who Proposed Projects
DATES: Beginning no later than July 1,
2016, each health care provider who intends to administer one of these Title: The Tribal TANF Financial
administers Meningococcal ACWY covered vaccines is required to provide Report (ACF–196T).
copies of the relevant vaccine OMB No.: 0970–0345.
vaccine to any child or adult in the Description: Tribes use Form ACF–
United States shall provide copies of the information materials prior to
administration of any of these vaccines. 196T to report expenditures for the
relevant vaccine information materials Tribal TANF grant. Authority to collect
referenced in this notice, in Since then, the following vaccines have
been added to the National Vaccine and report this information is found in
conformance with the March 31, 2016 the Personal Responsibility and Work
CDC Instructions for the Use of Vaccine Injury Compensation Program, requiring
use of vaccine information materials for Opportunity Reconciliation Act of 1996
Information Statements prior to (PRWORA), Public Law 104–193. Tribal
providing such vaccinations. them as well: Hepatitis B, Haemophilus
influenzae type b (Hib), varicella entities with approved Tribal plans for
FOR FURTHER INFORMATION CONTACT: implementation of the TANF program
(chickenpox), pneumococcal conjugate,
Suzanne Johnson-DeLeon (msj1@ rotavirus, hepatitis A, meningococcal, are required by Section 412(h) of the
cdc.gov), National Center for human papillomavirus (HPV), and Social Security Act to report financial
Immunization and Respiratory Diseases, seasonal influenza vaccines. data. Form ACF–196T provides for the
Centers for Disease Control and Instructions for use of the vaccine collection of data regarding Federal
Lhorne on DSK5TPTVN1PROD with NOTICES
Prevention, Mailstop A–19, 1600 Clifton information materials are found on the expenditures. Failure to collect this data
Road NE., Atlanta, Georgia 30329. CDC Web site at: http://www.cdc.gov/ would seriously compromise the
SUPPLEMENTARY INFORMATION: The vaccines/hcp/vis/index.html. Administration for Children and
National Childhood Vaccine Injury Act Families’ (ACF) ability to monitor
of 1986 (Pub. L. 99–660), as amended by Revised Vaccine Information Materials expenditures. This information is also
section 708 of Public Law 103–183, The Meningococcal ACWY vaccine used to estimate outlays and may be
added section 2126 to the Public Health information materials referenced in this used to prepare ACF budget
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Document Created: 2016-04-20 01:51:15
Document Modified: 2016-04-20 01:51:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Beginning no later than July 1, 2016, each health care provider who administers Meningococcal ACWY vaccine to any child or adult in the United States shall provide copies of the relevant vaccine information materials referenced in this notice, in conformance with the March 31, 2016 CDC Instructions for the Use of Vaccine Information Statements prior to providing such vaccinations. | |
| Contact | Suzanne Johnson-DeLeon ([email protected]), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia 30329. | |
| FR Citation | 81 FR 23301 |
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