81 FR 6520 - Proposed 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 25 (February 8, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 25 (February 8, 2016)
| Page Range | 6520-6521 | |
| FR Document | 2016-02395 |
[Federal Register Volume 81, Number 25 (Monday, February 8, 2016)] [Notices] [Pages 6520-6521] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02395] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2016-0015] Proposed 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 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 hepatitis A and hepatitis B vaccines. DATES: Written comments must be received on or before April 8, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0015, 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 hepatitis A and hepatitis B 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 revised vaccine information materials entitled ``Hepatitis A Vaccine: What You Need to Know'' and ``Hepatitis B Vaccine: What You Need to Know.'' Copies of the proposed vaccine information materials are available at http://www.regulations.gov (see Docket Number CDC-2016-0015). Comments submitted will be considered in finalizing these materials. When the final materials are published in the Federal Register, the notice will include [[Page 6521]] an effective date for their mandatory use. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2016-02395 Filed 2-5-16; 8:45 am] BILLING CODE 4163-18-P
![6520 Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Notices
collects information regarding the (42 U.S.C. 300aa–26), the Centers for period, and in consultation with the
vendor’s preference for delivery ports. Disease Control and Prevention (CDC) Advisory Commission on Childhood
The information is used to evaluate within the Department of Health and Vaccines, appropriate health care
offers [on the basis of shipment through Human Services (HHS) develops provider and parent organizations, and
the port resulting in the lowest cost to vaccine information materials that all the Food and Drug Administration. The
the Government. health care providers are required to law also requires that the information
give to patients/parents prior to contained in the materials be based on
B. Annual Reporting Burden administration of specific vaccines. available data and information, be
Respondents: 100. HHS/CDC seeks written comment on the presented in understandable terms, and
Responses per Respondent: 4. proposed updated vaccine information include:
Annual Responses: 400. statements for hepatitis A and hepatitis (1) A concise description of the
Hours per Response: 0.25. B vaccines. benefits of the vaccine,
Total Burden Hours: 100.
DATES: Written comments must be (2) A concise description of the risks
C. Public Comments received on or before April 8, 2016. associated with the vaccine,
Public comments are particularly ADDRESSES: You may submit comments, (3) A statement of the availability of
invited on: Whether this collection of identified by Docket No. CDC–2016– the National Vaccine Injury
information is necessary; whether it will 0015, by any of the following methods: Compensation Program, and
have practical utility; whether our • Federal eRulemaking Portal: http:// (4) Such other relevant information as
estimate of the public burden of this www.regulations.gov. Follow the may be determined by the Secretary.
collection of information is accurate, instructions for submitting comments. The vaccines initially covered under
• Mail: Written comments should be the National Vaccine Injury
and based on valid assumptions and
addressed to Suzanne Johnson-DeLeon, Compensation Program were diphtheria,
methodology; ways to enhance the
National Center for Immunization and tetanus, pertussis, measles, mumps,
quality, utility, and clarity of the
Respiratory Diseases, Centers for rubella and poliomyelitis vaccines.
information to be collected; and ways in
Disease Control and Prevention, Since April 15, 1992, any health care
which we can minimize the burden of
Mailstop A–19, 1600 Clifton Road NE., provider in the United States who
the collection of information on those
Atlanta, Georgia 30329. intends to administer one of these
who are to respond, through the use of
Instructions: All submissions received covered vaccines is required to provide
appropriate technological collection
must include the agency name and copies of the relevant vaccine
techniques or other forms of information
docket number. All relevant comments information materials prior to
technology.
received will be posted without change administration of any of these vaccines.
Obtaining Copies of Proposals:
to http://regulations.gov, including any Since then, the following vaccines have
Requesters may obtain a copy of the
personal information provided. For been added to the National Vaccine
information collection documents from
access to the docket to read background Injury Compensation Program, requiring
the General Services Administration,
documents or comments received, go to use of vaccine information materials for
Regulatory Secretariat Division (MVCB),
http://www.regulations.gov. them as well: Hepatitis B, Haemophilus
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please FOR FURTHER INFORMATION CONTACT: Skip influenzae type b (Hib), varicella
cite OMB Control Number ‘‘9000–0057, Wolfe (crw4@cdc.gov), National Center (chickenpox), pneumococcal conjugate,
Evaluation of Export Offers’’ in all for Immunization and Respiratory rotavirus, hepatitis A, meningococcal,
correspondence. Diseases, Centers for Disease Control human papillomavirus (HPV), and
and Prevention, Mailstop A–19, 1600 seasonal influenza vaccines.
Dated: February 3, 2016. Clifton Road NE., Atlanta, Georgia Instructions for use of the vaccine
Lorin S. Curit, 30329. information materials are found on the
Director, Federal Acquisition Policy Division, CDC Web site at: http://www.cdc.gov/
SUPPLEMENTARY INFORMATION: The
Office of Governmentwide Acquisition Policy,
National Childhood Vaccine Injury Act vaccines/hcp/vis/index.html.
Office of Acquisition Policy, Office of
Governmentwide Policy. of 1986 (Pub. L. 99–660), as amended by HHS/CDC is proposing updated
section 708 of Public Law 103–183, versions of the hepatitis A and hepatitis
[FR Doc. 2016–02448 Filed 2–5–16; 8:45 am]
added section 2126 to the Public Health B vaccine information statements.
BILLING CODE 6820–EP–P
Service Act. Section 2126, codified at 42 The vaccine information materials
U.S.C. 300aa–26, requires the Secretary referenced in this notice are being
of Health and Human Services to developed in consultation with the
DEPARTMENT OF HEALTH AND Advisory Commission on Childhood
develop and disseminate vaccine
HUMAN SERVICES Vaccines, the Food and Drug
information materials for distribution by
Centers for Disease Control and all health care providers in the United Administration, and parent and health
Prevention States to any patient (or to the parent or care provider groups.
legal representative in the case of a We invite written comment on the
[Docket No. CDC–2016–0015] child) receiving vaccines covered under proposed revised vaccine information
the National Vaccine Injury materials entitled ‘‘Hepatitis A Vaccine:
Proposed Revised Vaccine Information Compensation Program (VICP). What You Need to Know’’ and
Materials for Hepatitis A and Hepatitis Development and revision of the ‘‘Hepatitis B Vaccine: What You Need to
asabaliauskas on DSK5VPTVN1PROD with NOTICES
B Vaccines vaccine information materials, also Know.’’ Copies of the proposed vaccine
AGENCY: Centers for Disease Control and known as Vaccine Information information materials are available at
Prevention (CDC), Department of Health Statements (VIS), have been delegated http://www.regulations.gov (see Docket
and Human Services (HHS). by the Secretary to the Centers for Number CDC–2016–0015). Comments
ACTION: Notice with comment period. Disease Control and Prevention (CDC). submitted will be considered in
Section 2126 requires that the materials finalizing these materials. When the
SUMMARY: Under the National be developed, or revised, after notice to final materials are published in the
Childhood Vaccine Injury Act (NCVIA) the public, with a 60-day comment Federal Register, the notice will include
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![Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Notices 6521
an effective date for their mandatory DEPARTMENT OF HEALTH AND populations, that is, lesbian, gay, and
use. HUMAN SERVICES bisexual populations. ACF expects to
collect and analyze data from a range of
Sandra Cashman, Administration for Children and information collection efforts—
Executive Secretary, Centers for Disease Families including interviews with program
Control and Prevention.
Submission for OMB Review; administrators, program managers,
[FR Doc. 2016–02395 Filed 2–5–16; 8:45 am]
Comment Request healthy marriage and relationship
BILLING CODE 4163–18–P programming experts, and focus groups
Title: Same-sex relationships: Updates with program applicants and program
to Healthy Marriage and Relationship attendees—to propose methods and
Education. practices for serving such couples/
OMB No.: New Collection. individuals/youth.
Description: The Administration for
Children and Families (ACF) will Respondents: Current program
examine how healthy marriage applicants and participants, program
programs currently approach, and could managers and facilitators, and experts in
approach, serving sexual minority the field.
ANNUAL BURDEN ESTIMATES
Total/ Number of Average
Instrument annual Annual burden
responses per burden hours
(and appendix No.) number of hours
respondent per response
respondents
Focus Group Guide for Adult Applicants (Instrument #1) ............................... 18 1 1.5 27
Focus Group Guide for Adult Attendees (Instrument #2) ............................... 36 1 1.5 54
Focus Group Guide for Youth (Instrument #3) ................................................ 36 1 1.5 54
Interview Guide with Experts (Instrument #4) ................................................. 12 1 1 12
Interview Guide with Program Managers (Instrument #5) .............................. 10 1 1 10
Interview Guide with Facilitators (Instrument #6) ............................................ 10 1 1 10
Staff Recruitment Script ................................................................................... 90 1 .25 23
Estimated Annual Burden Hours: 190. DEPARTMENT OF HEALTH AND (OHS) and Office of Child Care (OCC)
Additional Information: Copies of the HUMAN SERVICES National Centers, regional training and
proposed collection may be obtained by technical assistance (T/TA) specialists,
Administration for Children and and implementation planners and fiscal
writing to the Administration for
Families consultants). State and federal agencies
Children and Families, Office of
(including OHS and OCC federal staff,
Planning, Research and Evaluation, 330 Submission for OMB Review; Child Care and Development Fund
C Street SW., Washington, DC 20201, Comment Request (CCDF) administrators, Head Start state
Attn: OPRE Reports Clearance Officer. and national collaboration office
Title: National Center on Early Head
All requests should be identified by the directors), as well as EHS–CCP grantees
Start-Child Care Partnerships (NCEHS–
title of the information collection. Email will also find helpful information on
CCP) Evaluation.
address: OPREinfocollection@ OMB No.: New Collection. partnerships through NCEHS–CCP’s
acf.hhs.gov. Description: The Administration for resources.
OMB Comment: OMB is required to Children and Families (ACF) in the NCEHS–CCP at ZERO TO THREE is
make a decision concerning the Department of Health and Human proposing to conduct a descriptive
collection of information between 30 Services (HHS) has awarded 275 Early study of NCEHS–CCP that will provide
and 60 days after publication of this Head Start expansion and Early Head information that will document the
document in the Federal Register. Start–child care partnership grants activities and progress of NCEHS–CCP
Therefore, a comment is best assured of (EHS–CCP) in 50 states; Washington, toward its goals and objectives. Findings
DC; Puerto Rico; and the Northern from the evaluation will be translated
having its full effect if OMB receives it
Mariana Islands. These grants will allow into action steps to inform continuous
within 30 days of publication. Written
new or existing Early Head Start quality improvement of NCEHS–CCP.
comments and recommendations for the The proposed data collection
programs to partner with local child
proposed information collection should activities for the descriptive study of
care centers and family child care
be sent directly to the following: Office providers to expand high-quality early NCEHS–CCP will include the following
of Management and Budget, Paperwork learning opportunities for infants and components:
Reduction Project, Email: OIRA_ toddlers from low-income families. • Stakeholder survey. Web-based
SUBMISSION@OMB.EOP.GOV, Attn: NCEHS–CCP will support the surveys will be conducted in the spring
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Desk Officer for the Administration for effective implementation of new EHS– of 2016 and 2018 with key stakeholders
Children and Families. CCP grants by disseminating (including regional T/TA specialists,
information through training and CCDF administrators, Head Start state
Robert Sargis,
technical assistance (T/TA) and and national collaboration office
ACF Certifying Officer. resources and materials. NCEHS–CCP is directors, and implementation planners
[FR Doc. 2016–02358 Filed 2–5–16; 8:45 am] primarily targeted to T/TA providers and fiscal consultants). The stakeholder
BILLING CODE 4184–73–P working directly with the EHS–CCP survey will collect information about
grantees (including Office of Head Start the types of support they received from
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Document Created: 2016-02-06 00:24:39
Document Modified: 2016-02-06 00:24:39
| 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 April 8, 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 6520 |
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