Proposed Revised Vaccine Information Materials for Hepatitis A and Hepatitis B Vaccines, 6520-6521 [2016-02395]

Download as PDF 6520 Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Notices collects information regarding the vendor’s preference for delivery ports. The information is used to evaluate offers [on the basis of shipment through the port resulting in the lowest cost to the Government. B. Annual Reporting Burden Respondents: 100. Responses per Respondent: 4. Annual Responses: 400. Hours per Response: 0.25. Total Burden Hours: 100. C. Public Comments Public comments are particularly invited on: Whether this collection of information is necessary; whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control Number ‘‘9000–0057, Evaluation of Export Offers’’ in all correspondence. Dated: February 3, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2016–02448 Filed 2–5–16; 8:45 am] BILLING CODE 6820–EP–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention asabaliauskas on DSK5VPTVN1PROD with NOTICES [Docket No. CDC–2016–0015] Proposed Revised Vaccine Information Materials for Hepatitis A and Hepatitis B Vaccines Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: Under the National Childhood Vaccine Injury Act (NCVIA) SUMMARY: VerDate Sep<11>2014 17:51 Feb 05, 2016 Jkt 238001 (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 (crw4@cdc.gov), 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 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 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 E:\FR\FM\08FEN1.SGM 08FEN1 6521 Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Notices an effective date for their mandatory use. DEPARTMENT OF HEALTH AND HUMAN SERVICES Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. Administration for Children and Families [FR Doc. 2016–02395 Filed 2–5–16; 8:45 am] Submission for OMB Review; Comment Request BILLING CODE 4163–18–P Title: Same-sex relationships: Updates to Healthy Marriage and Relationship Education. OMB No.: New Collection. Description: The Administration for Children and Families (ACF) will examine how healthy marriage programs currently approach, and could approach, serving sexual minority populations, that is, lesbian, gay, and bisexual populations. ACF expects to collect and analyze data from a range of information collection efforts— including interviews with program administrators, program managers, healthy marriage and relationship programming experts, and focus groups with program applicants and program attendees—to propose methods and practices for serving such couples/ individuals/youth. Respondents: Current program applicants and participants, program managers and facilitators, and experts in the field. ANNUAL BURDEN ESTIMATES Total/ annual number of respondents Instrument (and appendix No.) asabaliauskas on DSK5VPTVN1PROD with NOTICES Focus Group Guide for Adult Applicants (Instrument #1) ............................... Focus Group Guide for Adult Attendees (Instrument #2) ............................... Focus Group Guide for Youth (Instrument #3) ................................................ Interview Guide with Experts (Instrument #4) ................................................. Interview Guide with Program Managers (Instrument #5) .............................. Interview Guide with Facilitators (Instrument #6) ............................................ Staff Recruitment Script ................................................................................... Estimated Annual Burden Hours: 190. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@ acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, ACF Certifying Officer. [FR Doc. 2016–02358 Filed 2–5–16; 8:45 am] BILLING CODE 4184–73–P VerDate Sep<11>2014 17:51 Feb 05, 2016 Jkt 238001 18 36 36 12 10 10 90 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: National Center on Early Head Start-Child Care Partnerships (NCEHS– CCP) Evaluation. OMB No.: New Collection. Description: The Administration for Children and Families (ACF) in the Department of Health and Human Services (HHS) has awarded 275 Early Head Start expansion and Early Head Start–child care partnership grants (EHS–CCP) in 50 states; Washington, DC; Puerto Rico; and the Northern Mariana Islands. These grants will allow new or existing Early Head Start programs to partner with local child care centers and family child care providers to expand high-quality early learning opportunities for infants and toddlers from low-income families. NCEHS–CCP will support the effective implementation of new EHS– CCP grants by disseminating information through training and technical assistance (T/TA) and resources and materials. NCEHS–CCP is primarily targeted to T/TA providers working directly with the EHS–CCP grantees (including Office of Head Start PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 1 1 1 1 1 Average burden hours per response 1.5 1.5 1.5 1 1 1 .25 Annual burden hours 27 54 54 12 10 10 23 (OHS) and Office of Child Care (OCC) National Centers, regional training and technical assistance (T/TA) specialists, and implementation planners and fiscal consultants). State and federal agencies (including OHS and OCC federal staff, Child Care and Development Fund (CCDF) administrators, Head Start state and national collaboration office directors), as well as EHS–CCP grantees will also find helpful information on partnerships through NCEHS–CCP’s resources. NCEHS–CCP at ZERO TO THREE is proposing to conduct a descriptive study of NCEHS–CCP that will provide information that will document the activities and progress of NCEHS–CCP toward its goals and objectives. Findings from the evaluation will be translated into action steps to inform continuous quality improvement of NCEHS–CCP. The proposed data collection activities for the descriptive study of NCEHS–CCP will include the following components: • Stakeholder survey. Web-based surveys will be conducted in the spring of 2016 and 2018 with key stakeholders (including regional T/TA specialists, CCDF administrators, Head Start state and national collaboration office directors, and implementation planners and fiscal consultants). The stakeholder survey will collect information about the types of support they received from E:\FR\FM\08FEN1.SGM 08FEN1

Agencies

[Federal Register Volume 81, Number 25 (Monday, February 8, 2016)]
[Notices]
[Pages 6520-6521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02395]


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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 (crw4@cdc.gov), 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