81 FR 13794 - Proposed Revised Vaccine Information Materials for Polio and Varicella Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 50 (March 15, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 50 (March 15, 2016)
| Page Range | 13794-13794 | |
| FR Document | 2016-05776 |
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)] [Notices] [Page 13794] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05776] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2016-0029] Proposed Revised Vaccine Information Materials for Polio and Varicella 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 polio and varicella vaccines. DATES: Written comments must be received on or before May 16, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0029, 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 polio and varicella 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 ``Polio Vaccine: What You Need to Know'' and ``Varicella Vaccine: What You Need to Know.'' Copies of the proposed vaccine information materials are available at http://www.regulations.gov (see Docket Number CDC-2016-0029). 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: March 9, 2016. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2016-05776 Filed 3-14-16; 8:45 am] BILLING CODE 4163-18-P
![13794 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
Board of Governors of the Federal Reserve Clifton Road NE., Atlanta, Georgia Instructions for use of the vaccine
System, March 10, 2016. 30329. information materials are found on the
Michael J. Lewandowski, CDC Web site at: http://www.cdc.gov/
SUPPLEMENTARY INFORMATION: The
Associate Secretary of the Board. National Childhood Vaccine Injury Act vaccines/hcp/vis/index.html.
[FR Doc. 2016–05777 Filed 3–14–16; 8:45 am] HHS/CDC is proposing updated
of 1986 (Pub. L. 99–660), as amended by
versions of the polio and varicella
BILLING CODE 6210–01–P section 708 of Public Law 103–183,
vaccine information statements.
added section 2126 to the Public Health The vaccine information materials
Service Act. Section 2126, codified at 42 referenced in this notice are being
DEPARTMENT OF HEALTH AND U.S.C. 300aa–26, requires the Secretary developed in consultation with the
HUMAN SERVICES of Health and Human Services to Advisory Commission on Childhood
develop and disseminate vaccine Vaccines, the Food and Drug
Centers for Disease Control and information materials for distribution by Administration, and parent and health
Prevention all health care providers in the United care provider groups.
States to any patient (or to the parent or We invite written comment on the
[Docket No. CDC–2016–0029] legal representative in the case of a proposed vaccine information materials
child) receiving vaccines covered under entitled ‘‘Polio Vaccine: What You Need
Proposed Revised Vaccine Information
the National Vaccine Injury to Know’’ and ‘‘Varicella Vaccine: What
Materials for Polio and Varicella
Compensation Program (VICP). You Need to Know.’’ Copies of the
Vaccines
Development and revision of the proposed vaccine information materials
AGENCY: Centers for Disease Control and vaccine information materials, also are available at http://
Prevention (CDC), Department of Health known as Vaccine Information www.regulations.gov (see Docket
and Human Services (HHS). Statements (VIS), have been delegated Number CDC–2016–0029). Comments
ACTION: Notice with comment period. by the Secretary to the Centers for submitted will be considered in
Disease Control and Prevention (CDC). finalizing these materials. When the
SUMMARY: Under the National Section 2126 requires that the materials final materials are published in the
Childhood Vaccine Injury Act (NCVIA) be developed, or revised, after notice to Federal Register, the notice will include
(42 U.S.C. 300aa–26), the Centers for the public, with a 60-day comment an effective date for their mandatory
Disease Control and Prevention (CDC) period, and in consultation with the use.
within the Department of Health and Advisory Commission on Childhood
Dated: March 9, 2016.
Human Services (HHS) develops Vaccines, appropriate health care
provider and parent organizations, and Sandra Cashman,
vaccine information materials that all
health care providers are required to the Food and Drug Administration. The Executive Secretary, Centers for Disease
law also requires that the information Control and Prevention.
give to patients/parents prior to
contained in the materials be based on [FR Doc. 2016–05776 Filed 3–14–16; 8:45 am]
administration of specific vaccines.
HHS/CDC seeks written comment on the available data and information, be BILLING CODE 4163–18–P
proposed updated vaccine information presented in understandable terms, and
statements for polio and varicella include:
(1) A concise description of the DEPARTMENT OF HEALTH AND
vaccines.
benefits of the vaccine, HUMAN SERVICES
DATES: Written comments must be
(2) A concise description of the risks Food and Drug Administration
received on or before May 16, 2016.
associated with the vaccine,
ADDRESSES: You may submit comments, (3) A statement of the availability of [Docket No. FDA–2016–N–0736]
identified by Docket No. CDC–2016– the National Vaccine Injury
0029, by any of the following methods: Compensation Program, and Agency Information Collection
• Federal eRulemaking Portal: http:// (4) Such other relevant information as Activities; Proposed Collection;
www.regulations.gov. Follow the may be determined by the Secretary. Comment Request; Tracking Network
instructions for submitting comments. The vaccines initially covered under for PETNet, LivestockNet, and
• Mail: Written comments should be the National Vaccine Injury SampleNet
addressed to Suzanne Johnson-DeLeon, Compensation Program were diphtheria, AGENCY: Food and Drug Administration,
National Center for Immunization and tetanus, pertussis, measles, mumps, HHS.
Respiratory Diseases, Centers for rubella and poliomyelitis vaccines.
Disease Control and Prevention, ACTION: Notice.
Since April 15, 1992, any health care
Mailstop A–19, 1600 Clifton Road NE., provider in the United States who SUMMARY: The Food and Drug
Atlanta, Georgia 30329. intends to administer one of these Administration (FDA, we) is
Instructions: All submissions received covered vaccines is required to provide announcing an opportunity for public
must include the agency name and copies of the relevant vaccine comment on the proposed collection of
docket number. All relevant comments information materials prior to certain information by the Agency.
received will be posted without change administration of any of these vaccines. Under the Paperwork Reduction Act of
to http://regulations.gov, including any Since then, the following vaccines have 1995 (the PRA), Federal Agencies are
personal information provided. For been added to the National Vaccine required to publish notice in the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
access to the docket to read background Injury Compensation Program, requiring Federal Register concerning each
documents or comments received, go to use of vaccine information materials for proposed collection of information,
http://www.regulations.gov. them as well: hepatitis B, Haemophilus including each proposed extension of an
FOR FURTHER INFORMATION CONTACT: Skip influenzae type b (Hib), varicella existing collection of information, and
Wolfe (crw4@cdc.gov), National Center (chickenpox), pneumococcal conjugate, to allow 60 days for public comment in
for Immunization and Respiratory rotavirus, hepatitis A, meningococcal, response to the notice. This notice
Diseases, Centers for Disease Control human papillomavirus (HPV), and solicits comments on our use of a
and Prevention, Mailstop A–19, 1600 seasonal influenza vaccines. tracking network to collect and share
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Document Created: 2016-03-15 04:07:05
Document Modified: 2016-03-15 04:07:05
| 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 May 16, 2016. | |
| 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 | 81 FR 13794 |
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