81 FR 62137 - Final Revised Vaccine Information Materials for Polio Vaccine
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 174 (September 8, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 174 (September 8, 2016)
| Page Range | 62137-62138 | |
| FR Document | 2016-21575 |
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)] [Notices] [Pages 62137-62138] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21575] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2015-0029] Final Revised Vaccine Information Materials for Polio Vaccine 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 March 15, 2016, CDC published a notice in the Federal Register (81 FR 13794) seeking public comments on proposed updated vaccine information materials for polio vaccine and varicella vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for polio vaccine. Copies of the final vaccine information materials for polio vaccine are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0029). CDC will publish the final vaccine information materials for varicella vaccine when they are completed. DATES: Beginning no later than November 1, 2016, each health care provider who administers polio 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 August 9, 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 polio 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. [[Page 62138]] Following consultation and review of comments submitted, the vaccine information materials covering polio vaccine 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- 0029). The Vaccine Information Statement (VIS) is ``Polio Vaccine: What You Need to Know,'' publication date July 20, 2016. With publication of this notice, by November 1, 2016, all health care providers must discontinue use of the previous edition and provide copies of these updated polio vaccine information materials prior to immunization in conformance with CDC's August 9, 2016 Instructions for the Use of Vaccine Information Statements. Dated: September 1, 2016. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2016-21575 Filed 9-7-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 62137
provider in the United States who DEPARTMENT OF HEALTH AND all health care providers in the United
intends to administer one of these HUMAN SERVICES States to any patient (or to the parent or
covered vaccines is required to provide legal representative in the case of a
copies of the relevant vaccine Centers for Disease Control and child) receiving vaccines covered under
information materials prior to Prevention the National Vaccine Injury
administration of any of these vaccines. [Docket No. CDC–2015–0029] Compensation Program (VICP).
Since then, the following vaccines have Development and revision of the
been added to the National Vaccine Final Revised Vaccine Information vaccine information materials, also
Materials for Polio Vaccine known as Vaccine Information
Injury Compensation Program, requiring
Statements (VIS), have been delegated
use of vaccine information materials for AGENCY: Centers for Disease Control and by the Secretary to the Centers for
them as well: Hepatitis B, Haemophilus Prevention (CDC), Department of Health Disease Control and Prevention (CDC).
influenzae type b (Hib), varicella and Human Services (HHS). Section 2126 requires that the materials
(chickenpox), pneumococcal conjugate, ACTION: Notice. be developed, or revised, after notice to
rotavirus, hepatitis A, meningococcal, the public, with a 60-day comment
human papillomavirus (HPV), and SUMMARY: Under the National period, and in consultation with the
seasonal influenza vaccines. Childhood Vaccine Injury Act (NCVIA) Advisory Commission on Childhood
Instructions for use of the vaccine (42 U.S.C. 300aa–26), CDC must develop Vaccines, appropriate health care
information materials are found on the vaccine information materials that all provider and parent organizations, and
CDC Web site at: http://www.cdc.gov/ health care providers are required to the Food and Drug Administration. The
vaccines/hcp/vis/index.html. give to patients/parents prior to law also requires that the information
administration of specific vaccines. On contained in the materials be based on
Revised Vaccine Information Materials March 15, 2016, CDC published a notice available data and information, be
The serogroup B meningococcal in the Federal Register (81 FR 13794) presented in understandable terms, and
seeking public comments on proposed include:
vaccine information materials
updated vaccine information materials (1) A concise description of the
referenced in this notice were
for polio vaccine and varicella vaccine. benefits of the vaccine,
developed in consultation with the Following review of comments (2) A concise description of the risks
Advisory Commission on Childhood submitted and consultation as required associated with the vaccine,
Vaccines, the Food and Drug under the law, CDC has finalized the (3) A statement of the availability of
Administration, and parent and materials for polio vaccine. Copies of the National Vaccine Injury
healthcare provider organizations. the final vaccine information materials Compensation Program, and
Following consultation and review of for polio vaccine are available to (4) Such other relevant information as
comments submitted, the vaccine download from http://www.cdc.gov/ may be determined by the Secretary.
information materials covering vaccines/hcp/vis/index.html or http:// The vaccines initially covered under
serogroup B meningococcal vaccine www.regulations.gov (see Docket the National Vaccine Injury
have been finalized and are available to Number CDC–2015–0029). CDC will Compensation Program were diphtheria,
download from http://www.cdc.gov/ publish the final vaccine information tetanus, pertussis, measles, mumps,
vaccines/hcp/vis/index.html or http:// materials for varicella vaccine when rubella, and poliomyelitis vaccines.
www.regulations.gov (see Docket they are completed. Since April 15, 1992, any health care
Number CDC–2015–0059). The Vaccine DATES: Beginning no later than
provider in the United States who
Information Statement (VIS) is November 1, 2016, each health care intends to administer one of these
‘‘Serogroup B Meningococcal (MenB) provider who administers polio vaccine covered vaccines is required to provide
Vaccine: What You Need to Know,’’ to any child or adult in the United copies of the relevant vaccine
States shall provide copies of the information materials prior to
publication date August 9, 2016.
relevant vaccine information materials administration of any of these vaccines.
With publication of this notice, as of Since then, the following vaccines have
December 1, 2016, all health care referenced in this notice, in
conformance with the August 9, 2016 been added to the National Vaccine
providers will be required to provide Injury Compensation Program, requiring
CDC Instructions for the Use of Vaccine
copies of these updated serogroup B use of vaccine information materials for
Information Statements prior to
meningococcal vaccine information them as well: Hepatitis B, Haemophilus
providing such vaccinations.
materials prior to immunization in influenzae type b (Hib), varicella
FOR FURTHER INFORMATION CONTACT:
conformance with CDC’s August 9, 2016 (chickenpox), pneumococcal conjugate,
Suzanne Johnson-DeLeon (msj1@ rotavirus, hepatitis A, meningococcal,
Instructions for the Use of Vaccine
cdc.gov), National Center for human papillomavirus (HPV), and
Information Statements.
Immunization and Respiratory Diseases, seasonal influenza vaccines.
Dated: September 1, 2016. Centers for Disease Control and Instructions for use of the vaccine
Sandra Cashman, Prevention, Mailstop A–19, 1600 Clifton information materials are found on the
Executive Secretary, Centers for Disease Road NE., Atlanta, Georgia 30329. CDC Web site at: http://www.cdc.gov/
Control and Prevention. SUPPLEMENTARY INFORMATION: The vaccines/hcp/vis/index.html.
[FR Doc. 2016–21574 Filed 9–7–16; 8:45 am] National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by Revised Vaccine Information Materials
mstockstill on DSK3G9T082PROD with NOTICES
BILLING CODE 4163–18–P
section 708 of Public Law 103–183, The polio vaccine information
added section 2126 to the Public Health materials referenced in this notice were
Service Act. Section 2126, codified at 42 developed in consultation with the
U.S.C. 300aa–26, requires the Secretary Advisory Commission on Childhood
of Health and Human Services to Vaccines, the Food and Drug
develop and disseminate vaccine Administration, and parent and
information materials for distribution by healthcare provider organizations.
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![62138 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
Following consultation and review of • Mail: Leroy A. Richardson, personnel and to be able to respond to
comments submitted, the vaccine Information Collection Review Office, a collection of information, to search
information materials covering polio Centers for Disease Control and data sources, to complete and review
vaccine have been finalized and are Prevention, 1600 Clifton Road NE., MS– the collection of information; and to
available to download from http:// D74, Atlanta, Georgia 30329. transmit or otherwise disclose the
www.cdc.gov/vaccines/hcp/vis/ Instructions: All submissions received information.
index.html or http:// must include the agency name and
Proposed Project
www.regulations.gov (see Docket Docket Number. All relevant comments
Number CDC–2015–0029). The Vaccine received will be posted without change Early Hearing Detection and
Information Statement (VIS) is ‘‘Polio to Regulation.gov, including any Intervention—Pediatric Audiology
Vaccine: What You Need to Know,’’ personal information provided. For Links to Service (EHDI–PALS) Survey
publication date July 20, 2016. access to the docket to read the (OMB No. 0920–0955, Expiration 03/31/
With publication of this notice, by background documents or comments 2017)—Extension—National Center on
November 1, 2016, all health care received, go to Regulations.gov. Birth Defects and Developmental
providers must discontinue use of the FOR FURTHER INFORMATION CONTACT:
Disabilities (NCBDDD), Centers for
previous edition and provide copies of Leroy A. Richardson, Information Disease Control and Prevention (CDC).
these updated polio vaccine information Collection Review Office, Centers for Background and Brief Description
materials prior to immunization in Disease Control and Prevention, 1600 The Division of Human Development
conformance with CDC’s August 9, 2016 Clifton Road NE., MS–D74, Atlanta, and Disability, located within NCBDDD,
Instructions for the Use of Vaccine Georgia 30329. promotes the health of babies, children,
Information Statements. SUPPLEMENTARY INFORMATION: Under the and adults, with a focus on preventing
Dated: September 1, 2016. Paperwork Reduction Act of 1995 (PRA) birth defects and developmental
Sandra Cashman, (44 U.S.C. 3501–3520), Federal agencies disabilities and optimizing the health
Executive Secretary, Centers for Disease must obtain approval from the Office of outcomes of those with disabilities.
Control and Prevention. Management and Budget (OMB) for each Since the passage of the Early Hearing
[FR Doc. 2016–21575 Filed 9–7–16; 8:45 am] collection of information they conduct Detection and Intervention (EHDI) Act,
BILLING CODE 4163–18–P
or sponsor. In addition, the PRA also 98% of newborn infants are now
requires Federal agencies to provide a screened for hearing loss prior to
60-day notice in the Federal Register hospital discharge. However, many of
DEPARTMENT OF HEALTH AND concerning each proposed collection of these infants have not received needed
HUMAN SERVICES information, and each reinstatement of hearing tests and follow up services
previously approved information after their hospital discharges. The 2013
Centers for Disease Control and collection before submitting the collect national average loss to follow-up/loss
Prevention to OMB for approval. To comply with to documentation rate is at 32%. This
[60Day–16–0955; Docket No. CDC–2016–
this requirement, we are publishing this rate remains an area of critical concern
0089] notice of a proposed data collection as for state EHDI programs and CDC–EHDI
described below. team’s goal of timely diagnosis by 3
Proposed Data Collections Submitted Comments are invited on: (a) Whether months of age and intervention by 6
for Public Comment and the proposed collection of information months of age. Many states cite the lack
Recommendations is necessary for the proper performance of audiology resources as the main
of the functions of the agency, including factor behind the high loss to follow-up.
AGENCY: Centers for Disease Control and whether the information shall have To compound the problem, many
Prevention (CDC), Department of Health practical utility; (b) the accuracy of the pediatric audiologists may be proficient
and Human Services (HHS). agency’s estimate of the burden of the evaluating children age 5 and older but
ACTION: Notice with comment period. proposed collection of information; (c) are not proficient with diagnosing
ways to enhance the quality, utility, and infants or younger children because
SUMMARY: The Centers for Disease clarity of the information to be children age 5 and younger require a
Control and Prevention (CDC), as part of collected; and (d) ways to minimize the different skill set. There is still no
its continuing efforts to reduce public burden of the collection of information existing literature or database available
burden and maximize the utility of on respondents, including through the to help states verify and quantify their
government information, invites the use of automated collection techniques states’ true follow up capacity until this
general public and other Federal or other forms of information project went live in 2013.
agencies to take this opportunity to technology; and (e) estimates of capital Meeting since April 2010, the EHDI–
comment on proposed and/or or start-up costs and costs of operation, PALS workgroup has sought consensus
continuing information collections, as maintenance, and purchase of services on the loss to follow-up/loss to
requires by the Paperwork Reduction to provide information. Burden means documentation issue facing the EHDI
Act of 1995. This notice invites the total time, effort, or financial programs. A survey based on standard
comments on Early Hearing Detection resources expended by persons to of care practice was developed for state
and Intervention Pediatric Audiology generate, maintain, retain, disclose or EHDI programs to quantify the pediatric
Links to Services (EDHI–PALS) provide information to or for a Federal audiology resource distribution within
DATES: Written comments must be agency. This includes the time needed their state, particularly audiology
mstockstill on DSK3G9T082PROD with NOTICES
received on or before November 7, 2016. to review instructions; to develop, facilities that are equipped to provide
ADDRESSES: You may submit comments, acquire, install and utilize technology follow up services for children age five
identified by Docket No. CDC–2016– and systems for the purpose of and younger. After three years of data
0089 by any of the following methods: collecting, validating and verifying collection, data suggested that children
• Federal eRulemaking Portal: information, processing and residing in certain regions of the US
Regulations.gov. Follow the instruction maintaining information, and disclosing who were loss to follow up were due to
for submitting comments. and providing information; to train the distance parents had to travel to
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Document Created: 2018-02-09 13:12:40
Document Modified: 2018-02-09 13:12:40
| 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 November 1, 2016, each health care provider who administers polio 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 August 9, 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 62137 |
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