80 FR 61819 - Proposed Revised Vaccine Information Materials for Meningococcal ACWY and Serogroup B Meningococcal Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 198 (October 14, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 198 (October 14, 2015)
| Page Range | 61819-61819 | |
| FR Document | 2015-26076 |
[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)] [Notices] [Page 61819] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26076] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2015-0059] Proposed Revised Vaccine Information Materials for Meningococcal ACWY and Serogroup B Meningococcal Vaccines AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for meningococcal ACWY and serogroup B meningococcal vaccines. DATES: Written comments must be received on or before December 14, 2015. ADDRESSES: You may submit comments, identified by Docket No. CDC-2015- 0059, by any of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Mail: Written comments should be addressed to Suzanne Johnson-DeLeon, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and docket number. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Skip Wolfe ([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. HHS/CDC is proposing updated versions of the meningococcal ACWY and serogroup B meningococcal vaccine information statements. The vaccine information materials referenced in this notice are being developed in consultation with the Advisory Commission on Childhood Vaccines, the Food and Drug Administration, and parent and health care provider groups. We invite written comment on the proposed vaccine information materials entitled ``Meningococcal ACWY Vaccines (MenACWY and MPSV4): What You Need to Know'' and ``Serogroup B Meningococcal Vaccine (MenB): What You Need to Know.'' Copies of the proposed vaccine information materials are available at http://www.regulations.gov (see Docket Number CDC-2015-0059).Comments submitted will be considered in finalizing these materials. When the final materials are published in the Federal Register, the notice will include an effective date for their mandatory use. Dated: October 7, 2015. Sandra Cashman, Acting Director, Division of the Executive Secretariat, Office of the Chief of Staff, Centers for Disease Control and Prevention. [FR Doc. 2015-26076 Filed 10-13-15; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices 61819
techniques or other forms of information Mailstop A–19, 1600 Clifton Road NE., provider in the United States who
technology. Atlanta, Georgia 30329. intends to administer one of these
Obtaining Copies of Proposals: Instructions: All submissions received covered vaccines is required to provide
Requesters may obtain a copy of the must include the agency name and copies of the relevant vaccine
information collection documents from docket number. All relevant comments information materials prior to
the General Services Administration, received will be posted without change administration of any of these vaccines.
Regulatory Secretariat Division (MVCB), to http://regulations.gov, including any Since then, the following vaccines have
1800 F Street NW., Washington, DC personal information provided. For been added to the National Vaccine
20405, telephone 202–501–4755. Please access to the docket to read background Injury Compensation Program, requiring
cite OMB Control No. 9000–0076, documents or comments received, go to use of vaccine information materials for
Novation/Change of Name http://www.regulations.gov. them as well: Hepatitis B, Haemophilus
Requirements, in all correspondence. FOR FURTHER INFORMATION CONTACT: Skip influenzae type b (Hib), varicella
Wolfe (crw4@cdc.gov), National Center (chickenpox), pneumococcal conjugate,
Edward Loeb,
for Immunization and Respiratory rotavirus, hepatitis A, meningococcal,
Acting Director, Federal Acquisition Policy human papillomavirus (HPV), and
Division, Office of Governmentwide
Diseases, Centers for Disease Control
Acquisition Policy, Office of Acquisition and Prevention, Mailstop A–19, 1600 seasonal influenza vaccines.
Policy, Office of Governmentwide Policy. Clifton Road, NE., Atlanta, Georgia Instructions for use of the vaccine
[FR Doc. 2015–26012 Filed 10–13–15; 8:45 am] 30329. information materials are found on the
CDC Web site at: http://www.cdc.gov/
BILLING CODE 6820–EP–P SUPPLEMENTARY INFORMATION: The
vaccines/hcp/vis/index.html.
National Childhood Vaccine Injury Act
HHS/CDC is proposing updated
of 1986 (Pub. L. 99–660), as amended by
versions of the meningococcal ACWY
DEPARTMENT OF HEALTH AND section 708 of Public Law 103–183,
and serogroup B meningococcal vaccine
HUMAN SERVICES added section 2126 to the Public Health
information statements.
Service Act. Section 2126, codified at 42 The vaccine information materials
Centers for Disease Control and U.S.C. 300aa–26, requires the Secretary referenced in this notice are being
Prevention of Health and Human Services to developed in consultation with the
develop and disseminate vaccine Advisory Commission on Childhood
[Docket No. CDC–2015–0059] information materials for distribution by Vaccines, the Food and Drug
Proposed Revised Vaccine Information all health care providers in the United Administration, and parent and health
Materials for Meningococcal ACWY States to any patient (or to the parent or care provider groups.
and Serogroup B Meningococcal legal representative in the case of a We invite written comment on the
Vaccines child) receiving vaccines covered under proposed vaccine information materials
the National Vaccine Injury entitled ‘‘Meningococcal ACWY
AGENCY: Centers for Disease Control and Compensation Program (VICP). Vaccines (MenACWY and MPSV4):
Prevention (CDC), Department of Health Development and revision of the What You Need to Know’’ and
and Human Services (HHS). vaccine information materials, also ‘‘Serogroup B Meningococcal Vaccine
ACTION: Notice with comment period. known as Vaccine Information (MenB): What You Need to Know.’’
Statements (VIS), have been delegated Copies of the proposed vaccine
SUMMARY: Under the National by the Secretary to the Centers for information materials are available at
Childhood Vaccine Injury Act (NCVIA) Disease Control and Prevention (CDC). http://www.regulations.gov (see Docket
(42 U.S.C. 300aa–26), the Centers for Section 2126 requires that the materials Number CDC–2015–0059).Comments
Disease Control and Prevention (CDC) be developed, or revised, after notice to submitted will be considered in
within the Department of Health and the public, with a 60-day comment finalizing these materials. When the
Human Services (HHS) develops period, and in consultation with the final materials are published in the
vaccine information materials that all Advisory Commission on Childhood Federal Register, the notice will include
health care providers are required to Vaccines, appropriate health care an effective date for their mandatory
give to patients/parents prior to provider and parent organizations, and use.
administration of specific vaccines. the Food and Drug Administration. The
HHS/CDC seeks written comment on the law also requires that the information Dated: October 7, 2015.
proposed updated vaccine information contained in the materials be based on Sandra Cashman,
statements for meningococcal ACWY available data and information, be Acting Director, Division of the Executive
and serogroup B meningococcal presented in understandable terms, and Secretariat, Office of the Chief of Staff,
vaccines. include: Centers for Disease Control and Prevention.
(1) A concise description of the [FR Doc. 2015–26076 Filed 10–13–15; 8:45 am]
DATES: Written comments must be
received on or before December 14, benefits of the vaccine, BILLING CODE 4163–18–P
(2) A concise description of the risks
2015.
associated with the vaccine,
ADDRESSES: You may submit comments, (3) A statement of the availability of DEPARTMENT OF HEALTH AND
identified by Docket No. CDC–2015– the National Vaccine Injury HUMAN SERVICES
0059, by any of the following methods: Compensation Program, and
• Federal eRulemaking Portal: http:// (4) Such other relevant information as Administration for Children and
Families
tkelley on DSK3SPTVN1PROD with NOTICES
www.regulations.gov. Follow the may be determined by the Secretary.
instructions for submitting comments. The vaccines initially covered under
Proposed Information Collection
• Mail: Written comments should be the National Vaccine Injury
Activity; Comment Request
addressed to Suzanne Johnson-DeLeon, Compensation Program were diphtheria,
National Center for Immunization and tetanus, pertussis, measles, mumps, Proposed Projects:
Respiratory Diseases, Centers for rubella and poliomyelitis vaccines. Title: Annual Survey of Refugees
Disease Control and Prevention, Since April 15, 1992, any health care (Form ORR–9)
VerDate Sep<11>2014 16:39 Oct 13, 2015 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\14OCN1.SGM 14OCN1](https://thefederalregister.org/doc/80_FR_62017/page/1.svg)
Document Created: 2018-02-27 08:50:13
Document Modified: 2018-02-27 08:50:13
| 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 with comment period. | |
| Dates | Written comments must be received on or before December 14, 2015. | |
| Contact | Skip Wolfe ([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 | 80 FR 61819 |
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