81 FR 62139 - Final Revised Vaccine Information Materials for Hepatitis A and Hepatitis B Vaccines
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 | 62139-62140 | |
| FR Document | 2016-21573 |
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)] [Notices] [Pages 62139-62140] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21573] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2016-0015] Final Revised Vaccine Information Materials for Hepatitis A and Hepatitis B 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 February 8, 2016, CDC published a notice in the Federal Register (81 FR 6520) seeking public comments on proposed updated vaccine information materials for hepatitis A and hepatitis B vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for hepatitis A and hepatitis B vaccines. Copies of the final vaccine information materials for hepatitis A and hepatitis B vaccines are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2016-0015). DATES: Beginning no later than November 1, 2016, each health care provider who administers hepatitis A or hepatitis B 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 [[Page 62140]] 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 hepatitis A and hepatitis B 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 hepatitis A and hepatitis B 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-2016-0015). The Vaccine Information Statements (VIS) are ``Hepatitis A Vaccine: What You Need to Know'' and ``Hepatitis B 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 of each and provide copies of these updated hepatitis A and hepatitis B 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. 2016-21573 Filed 9-7-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 62139
reach a pediatric audiology facility. For There will be no revision done to the answers. Both the American Speech-
example, parents who reside in western survey because the data collected in the Language-Hearing Association and the
region of Nebraska and Iowa on average past three years has proven to be American Academy of Audiology are
have to drive over 100 miles and in valuable and appropriate as evidenced members of the EHDI–PALS workgroup
Montana over 200 miles to reach a by the high usage rate. Consumers have and will continue to disseminate a
pediatric audiology facility. accessed the facility information over request through association e-
140,000 times as of April 2016. To newsletters and e-announcements to all
CDC is requesting an Office of
minimize burden and improve audiologists who provide services to
Management and Budget (OMB)
convenience, the survey will continue children younger than five years of age
approval to continue collecting to be available via a secure password
audiology facility information from to complete the EHDI–PALS survey. It is
protected Web site. Placing the survey estimated that potentially an additional
audiologists or facility managers so both on the internet ensures convenient, on-
parents, physicians and state EHDI 400 new audiologists will read through
demand access by the audiologists. the purpose statement located on page
programs will have a tool to find where Financial cost is minimized because no
the pediatric audiology facilities are one of the survey to decide whether or
mailing fee will be associated with not to complete the survey. This will
located. This survey will continue to sending or responding to this survey.
allow the CDC–EHDI team and state take one minute per person. It is
EHDI–PALS currently has 1,005
EHDI programs to compile a systematic, facilities in the database since the estimated that 200 audiologists will
quantifiable distribution of audiology beginning of the data collection. All complete the survey which will average
facilities and the capacity of each 1,005 facilities’ contact will receive a nine minutes per respondent. The nine
facility to provide services for children brief email from the University of Maine minutes calculation is based on a
age five and younger. The data collected to remind them to review their survey previous timed pre-test with six
will also allow the CDC–EHDI team to answers. It is estimated that volunteer audiologists. There are no
analyze facility distribution data to approximately 800 audiologists will do costs to respondents other than their
improve technical assistance to state so. It takes approximately two minutes time.
EHDI programs. per person to review the survey The total burden hours are 64.
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response (in hours)
respondent (in hours)
Annual Survey Review .................................................................................... 800 1 2/60 27
Survey Introduction .......................................................................................... 400 1 1/60 7
Survey .............................................................................................................. 200 1 9/60 30
Total .......................................................................................................... 1,400 ........................ ........................ 64
Leroy A. Richardson, give to patients/parents prior to FOR FURTHER INFORMATION CONTACT:
Chief, Information Collection Review Office, administration of specific vaccines. On Suzanne Johnson-DeLeon (msj1@
Office of Scientific Integrity, Office of the February 8, 2016, CDC published a cdc.gov), National Center for
Associate Director for Science, Office of the notice in the Federal Register (81 FR Immunization and Respiratory Diseases,
Director, Centers for Disease Control and 6520) seeking public comments on Centers for Disease Control and
Prevention. Prevention, Mailstop A–19, 1600 Clifton
proposed updated vaccine information
[FR Doc. 2016–21609 Filed 9–7–16; 8:45 am] Road NE., Atlanta, Georgia 30329.
materials for hepatitis A and hepatitis B
BILLING CODE 4163–18–P vaccines. Following review of SUPPLEMENTARY INFORMATION: The
comments submitted and consultation National Childhood Vaccine Injury Act
as required under the law, CDC has of 1986 (Pub. L. 99–660), as amended by
DEPARTMENT OF HEALTH AND finalized the materials for hepatitis A
HUMAN SERVICES section 708 of Public Law 103–183,
and hepatitis B vaccines. Copies of the added section 2126 to the Public Health
Centers for Disease Control and final vaccine information materials for Service Act. Section 2126, codified at 42
Prevention hepatitis A and hepatitis B vaccines are U.S.C. 300aa–26, requires the Secretary
available to download from http:// of Health and Human Services to
[Docket No. CDC–2016–0015] www.cdc.gov/vaccines/hcp/vis/ develop and disseminate vaccine
index.html or http:// information materials for distribution by
Final Revised Vaccine Information www.regulations.gov (see Docket all health care providers in the United
Materials for Hepatitis A and Hepatitis Number CDC–2016–0015). States to any patient (or to the parent or
B Vaccines legal representative in the case of a
DATES: Beginning no later than
AGENCY: Centers for Disease Control and November 1, 2016, each health care child) receiving vaccines covered under
Prevention (CDC), Department of Health provider who administers hepatitis A or the National Vaccine Injury
and Human Services (HHS). hepatitis B vaccine to any child or adult Compensation Program (VICP).
mstockstill on DSK3G9T082PROD with NOTICES
ACTION: Notice. in the United States shall provide copies Development and revision of the
of the relevant vaccine information vaccine information materials, also
SUMMARY: Under the National materials referenced in this notice, in known as Vaccine Information
Childhood Vaccine Injury Act (NCVIA) conformance with the August 9, 2016 Statements (VIS), have been delegated
(42 U.S.C. 300aa–26), CDC must develop CDC Instructions for the Use of Vaccine by the Secretary to the Centers for
vaccine information materials that all Information Statements prior to Disease Control and Prevention (CDC).
health care providers are required to providing such vaccinations. Section 2126 requires that the materials
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![62140 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
be developed, or revised, after notice to What You Need to Know,’’ publication consideration, comments and
the public, with a 60-day comment date July 20, 2016. recommendations must be submitted in
period, and in consultation with the With publication of this notice, by any one of the following ways:
Advisory Commission on Childhood November 1, 2016, all health care 1. Electronically. You may send your
Vaccines, appropriate health care providers must discontinue use of the comments electronically to http://
provider and parent organizations, and previous edition of each and provide www.regulations.gov. Follow the
the Food and Drug Administration. The copies of these updated hepatitis A and instructions for ‘‘Comment or
law also requires that the information hepatitis B vaccine information Submission’’ or ‘‘More Search Options’’
contained in the materials be based on materials prior to immunization in to find the information collection
available data and information, be conformance with CDC’s August 9, 2016 document(s) that are accepting
presented in understandable terms, and Instructions for the Use of Vaccine comments.
include: Information Statements. 2. By regular mail. You may mail
(1) A concise description of the written comments to the following
Dated: September 1, 2016.
benefits of the vaccine, address: CMS, Office of Strategic
(2) A concise description of the risks Sandra Cashman,
Operations and Regulatory Affairs,
associated with the vaccine, Executive Secretary, Centers for Disease
Control and Prevention.
Division of Regulations Development,
(3) A statement of the availability of Attention: Document Identifier/OMB
the National Vaccine Injury [FR Doc. 2016–21573 Filed 9–7–16; 8:45 am]
Control Number _________, Room C4–
Compensation Program, and BILLING CODE 4163–18–P
26–05, 7500 Security Boulevard,
(4) Such other relevant information as Baltimore, Maryland 21244–1850.
may be determined by the Secretary. To obtain copies of a supporting
The vaccines initially covered under DEPARTMENT OF HEALTH AND
statement and any related forms for the
the National Vaccine Injury HUMAN SERVICES
proposed collection(s) summarized in
Compensation Program were diphtheria,
Centers for Medicare & Medicaid this notice, you may make your request
tetanus, pertussis, measles, mumps,
Services using one of following:
rubella, and poliomyelitis vaccines.
1. Access CMS’ Web site address at
Since April 15, 1992, any health care [Document Identifier: CMS–10287] http://www.cms.hhs.gov/
provider in the United States who
PaperworkReductionActof1995.
intends to administer one of these Agency Information Collection
2. Email your request, including your
covered vaccines is required to provide Activities: Proposed Collection;
address, phone number, OMB number,
copies of the relevant vaccine Comment Request
and CMS document identifier, to
information materials prior to
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov.
administration of any of these vaccines.
Medicaid Services, HHS. 3. Call the Reports Clearance Office at
Since then, the following vaccines have
ACTION: Notice. (410) 786–1326.
been added to the National Vaccine
Injury Compensation Program, requiring FOR FURTHER INFORMATION CONTACT:
SUMMARY: The Centers for Medicare & Reports Clearance Office at (410) 786–
use of vaccine information materials for
Medicaid Services (CMS) is announcing 1326.
them as well: Hepatitis B, Haemophilus
an opportunity for the public to
influenzae type b (Hib), varicella SUPPLEMENTARY INFORMATION:
comment on CMS’ intention to collect
(chickenpox), pneumococcal conjugate,
information from the public. Under the Contents
rotavirus, hepatitis A, meningococcal,
Paperwork Reduction Act of 1995 (the
human papillomavirus (HPV), and This notice sets out a summary of the
PRA), federal agencies are required to
seasonal influenza vaccines. use and burden associated with the
publish notice in the Federal Register
Instructions for use of the vaccine following information collections. More
concerning each proposed collection of
information materials are found on the detailed information can be found in
information (including each proposed
CDC Web site at: http://www.cdc.gov/ each collection’s supporting statement
extension or reinstatement of an existing
vaccines/hcp/vis/index.html. and associated materials (see
collection of information) and to allow
ADDRESSES).
Revised Vaccine Information Materials 60 days for public comment on the
The hepatitis A and hepatitis B proposed action. Interested persons are CMS–10287 Medicare Quality of Care
vaccine information materials invited to send comments regarding our Complaint Form
referenced in this notice were burden estimates or any other aspect of Under the PRA (44 U.S.C. 3501–
developed in consultation with the this collection of information, including 3520), federal agencies must obtain
Advisory Commission on Childhood any of the following subjects: The approval from the Office of Management
Vaccines, the Food and Drug necessity and utility of the proposed and Budget (OMB) for each collection of
Administration, and parent and information collection for the proper information they conduct or sponsor.
healthcare provider organizations. performance of the agency’s functions; The term ‘‘collection of information’’ is
Following consultation and review of the accuracy of the estimated burden; defined in 44 U.S.C. 3502(3) and 5 CFR
comments submitted, the vaccine ways to enhance the quality, utility, and 1320.3(c) and includes agency requests
information materials covering hepatitis clarity of the information to be or requirements that members of the
A and hepatitis B vaccines have been collected; and the use of automated public submit reports, keep records, or
finalized and are available to download collection techniques or other forms of provide information to a third party.
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from http://www.cdc.gov/vaccines/hcp/ information technology to minimize the Section 3506(c)(2)(A) of the PRA
vis/index.html or http:// information collection burden. requires federal agencies to publish a
www.regulations.gov (see Docket DATES: Comments must be received by 60-day notice in the Federal Register
Number CDC–2016–0015). The Vaccine November 7, 2016. concerning each proposed collection of
Information Statements (VIS) are ADDRESSES: When commenting, please information, including each proposed
‘‘Hepatitis A Vaccine: What You Need reference the document identifier or extension or reinstatement of an existing
to Know’’ and ‘‘Hepatitis B Vaccine: OMB control number. To be assured collection of information, before
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Document Created: 2018-02-09 13:12:38
Document Modified: 2018-02-09 13:12:38
| 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 hepatitis A or hepatitis B 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 62139 |
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