80 FR 79340 - Final Revised Vaccine Information Materials for Pneumococcal Conjugate Vaccine (PCV13)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 244 (December 21, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 244 (December 21, 2015)
| Page Range | 79340-79341 | |
| FR Document | 2015-31989 |
[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)] [Notices] [Pages 79340-79341] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31989] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2015-0014] Final Revised Vaccine Information Materials for Pneumococcal Conjugate Vaccine (PCV13) 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), the 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 May 20, 2015, CDC published a notice in the Federal Register (80 FR 29009) seeking public comments on proposed updated vaccine information materials for pneumococcal conjugate vaccine (PCV13). Following review of comments submitted and consultation as required under the law, CDC has finalized the materials. Copies of the final vaccine information materials for pneumococcal conjugate vaccine (PCV13) are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0014). DATES: Beginning no later than March 1, 2016, each health care provider who administers pneumococcal conjugate vaccine (PCV13) to any child or adult in the United States shall provide copies of the relevant vaccine information materials contained in this notice, in conformance with the November 5, 2015 CDC Instructions for the Use of Vaccine Information Statements prior to providing such vaccinations. FOR FURTHER INFORMATION CONTACT: Suzanne Johnson-DeLeon (msj1@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 [[Page 79341]] 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 pneumococcal conjugate vaccine (PCV13) 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 pneumococcal conjugate vaccine (PCV13) 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-2015-0014). The Vaccine Information Statement (VIS) is ``Pneumococcal Conjugate Vaccine (PCV13): What You Need to Know,'' publication date November 5, 2015. With publication of this notice, as of March 1, 2016, all health care providers will be required to provide copies of these updated pneumococcal conjugate vaccine (PCV13) information materials prior to immunization in conformance with CDC's November 5, 2015 Instructions for the Use of Vaccine Information Statements. Dated: December 16, 2015. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2015-31989 Filed 12-18-15; 8:45 am] BILLING CODE 4163-18-P
![79340 Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
President) 600 Atlantic Avenue, Boston, the offices of the Board of Governors. DATES: Beginning no later than March 1,
Massachusetts 02210–2204: Interested persons may express their 2016, each health care provider who
1. Pentucket Bank Holdings, MHC, views in writing to the Reserve Bank administers pneumococcal conjugate
and Pentucket Bancorp, Inc., both in indicated for that notice or to the offices vaccine (PCV13) to any child or adult in
Haverhill, Massachusetts; to become of the Board of Governors. Comments the United States shall provide copies of
bank holding companies by acquiring must be received not later than January the relevant vaccine information
100 percent of the voting shares of 4, 2016. materials contained in this notice, in
Pentucket Bank, Haverhill, A. Federal Reserve Bank of Kansas conformance with the November 5, 2015
Massachusetts. City (Dennis Denney, Assistant Vice CDC Instructions for the Use of Vaccine
B. Federal Reserve Bank of Chicago President) 1 Memorial Drive, Kansas Information Statements prior to
(Colette A. Fried, Assistant Vice City, Missouri 64198–0001: providing such vaccinations.
President) 230 South LaSalle Street, 1. Janet McCauslin, Chillicothe, FOR FURTHER INFORMATION CONTACT:
Chicago, Illinois 60690–1414: Missouri; John Littrell, Brookfield, Suzanne Johnson-DeLeon (msj1@
1. Eastern Michigan Financial Missouri, as a group acting in concert, cdc.gov), National Center for
Corporation, Croswell, Michigan; to and Allen D. Powell Bank Share Trust, Immunization and Respiratory Diseases,
merge with Ruth Bank Corporation, and and Allen Powell, as trustee, both of Centers for Disease Control and
thereby indirectly acquire voting shares Linneus, Missouri; to acquire voting Prevention, Mailstop A–19, 1600 Clifton
of Ruth State Bank, both in Ruth, shares of Capital Bancshares, Inc., and Road NE., Atlanta, Georgia 30329.
Michigan. thereby indirectly acquire voting shares SUPPLEMENTARY INFORMATION: The
C. Federal Reserve Bank of of Bank of Brookfield-Purdin, N.A., both
Minneapolis (Jacquelyn K. Brunmeier, National Childhood Vaccine Injury Act
in Brookfield, Missouri. of 1986 (Pub. L. 99–660), as amended by
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota Board of Governors of the Federal Reserve section 708 of Public Law 103–183,
System, December 15, 2015. added section 2126 to the Public Health
55480–0291:
1. First Bancshares Corporation, Michael J. Lewandowski, Service Act. Section 2126, codified at 42
Gladstone, Michigan; to acquire 100 Associate Secretary of the Board. U.S.C. 300aa-26, requires the Secretary
percent of the voting shares of Northern [FR Doc. 2015–31888 Filed 12–18–15; 8:45 am] of Health and Human Services to
Michigan Bank & Trust, Escanaba, BILLING CODE 6210–01–P develop and disseminate vaccine
Michigan. information materials for distribution by
D. Federal Reserve Bank of Kansas all health care providers in the United
City (Dennis Denney, Assistant Vice DEPARTMENT OF HEALTH AND States to any patient (or to the parent or
President) 1 Memorial Drive, Kansas HUMAN SERVICES legal representative in the case of a
City, Missouri 64198–0001: child) receiving vaccines covered under
1. CSBO Holdings, Inc., Employee Centers for Disease Control and the National Vaccine Injury
Stock Ownership Plan, Ridgway, Prevention Compensation Program (VICP).
Colorado; to become a bank holding Development and revision of the
[Docket No. CDC–2015–0014]
company by acquiring 51 percent of the vaccine information materials, also
voting shares of CSBO Holdings, Inc., Final Revised Vaccine Information known as Vaccine Information
Ridgway, Colorado, and thereby Materials for Pneumococcal Conjugate Statements (VIS), have been delegated
indirectly acquire voting shares of Vaccine (PCV13) by the Secretary to the Centers for
Citizens State Bank of Ouray, Ouray, Disease Control and Prevention (CDC).
Colorado. AGENCY: Centers for Disease Control and Section 2126 requires that the materials
Prevention (CDC), Department of Health be developed, or revised, after notice to
Board of Governors of the Federal Reserve
System, December 15, 2015.
and Human Services (HHS). the public, with a 60-day comment
ACTION: Notice. period, and in consultation with the
Michael J. Lewandowski,
Advisory Commission on Childhood
Associate Secretary of the Board. SUMMARY: Under the National Vaccines, appropriate health care
[FR Doc. 2015–31889 Filed 12–18–15; 8:45 am] Childhood Vaccine Injury Act provider and parent organizations, and
BILLING CODE 6210–01–P (NCVIA)(42 U.S.C. 300aa–26), the CDC the Food and Drug Administration. The
must develop vaccine information law also requires that the information
materials that all health care providers contained in the materials be based on
FEDERAL RESERVE SYSTEM are required to give to patients/parents available data and information, be
prior to administration of specific presented in understandable terms, and
Change in Bank Control Notices;
vaccines. On May 20, 2015, CDC include:
Acquisitions of Shares of a Bank or
published a notice in the Federal (1) A concise description of the
Bank Holding Company
Register (80 FR 29009) seeking public benefits of the vaccine,
The notificants listed below have comments on proposed updated vaccine (2) A concise description of the risks
applied under the Change in Bank information materials for pneumococcal associated with the vaccine,
Control Act (12 U.S.C. 1817(j)) and conjugate vaccine (PCV13). Following (3) A statement of the availability of
§ 225.41 of the Board’s Regulation Y (12 review of comments submitted and the National Vaccine Injury
CFR 225.41) to acquire shares of a bank consultation as required under the law, Compensation Program, and
mstockstill on DSK4VPTVN1PROD with NOTICES
or bank holding company. The factors CDC has finalized the materials. Copies (4) Such other relevant information as
that are considered in acting on the of the final vaccine information may be determined by the Secretary.
notices are set forth in paragraph 7 of materials for pneumococcal conjugate The vaccines initially covered under
the Act (12 U.S.C. 1817(j)(7)). vaccine (PCV13) are available to the National Vaccine Injury
The notices are available for download from http://www.cdc.gov/ Compensation Program were diphtheria,
immediate inspection at the Federal vaccines/hcp/vis/index.html or http:// tetanus, pertussis, measles, mumps,
Reserve Bank indicated. The notices www.regulations.gov (see Docket rubella, and poliomyelitis vaccines.
also will be available for inspection at Number CDC–2015–0014). Since April 15, 1992, any health care
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![Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices 79341
provider in the United States who DEPARTMENT OF HEALTH AND Disease Control and Prevention, 1600
intends to administer one of these HUMAN SERVICES Clifton Road NE., MS–D74, Atlanta,
covered vaccines is required to provide Georgia 30329; phone: 404–639–7570;
copies of the relevant vaccine Centers for Disease Control and Email: omb@cdc.gov.
information materials prior to Prevention SUPPLEMENTARY INFORMATION: Under the
administration of any of these vaccines. [60Day–16–0841; Docket No. CDC–2015– Paperwork Reduction Act of 1995 (PRA)
Since then, the following vaccines have 0115] (44 U.S.C. 3501–3520), Federal agencies
been added to the National Vaccine must obtain approval from the Office of
Injury Compensation Program, requiring Proposed Data Collection Submitted Management and Budget (OMB) for each
use of vaccine information materials for for Public Comment and collection of information they conduct
them as well: Hepatitis B, Haemophilus Recommendations or sponsor. In addition, the PRA also
influenzae type b (Hib), varicella AGENCY: Centers for Disease Control and requires Federal agencies to provide a
(chickenpox), pneumococcal conjugate, Prevention (CDC), Department of Health 60-day notice in the Federal Register
rotavirus, hepatitis A, meningococcal, and Human Services (HHS). concerning each proposed collection of
human papillomavirus (HPV), and information, including each new
ACTION: Notice with comment period.
seasonal influenza vaccines. proposed collection, each proposed
Instructions for use of the vaccine SUMMARY: The Centers for Disease extension of existing collection of
information materials are found on the Control and Prevention (CDC), as part of information, and each reinstatement of
its continuing efforts to reduce public previously approved information
CDC Web site at: http://www.cdc.gov/
burden and maximize the utility of collection before submitting the
vaccines/hcp/vis/index.html.
government information, invites the collection to OMB for approval. To
Revised Vaccine Information Materials general public and other Federal comply with this requirement, we are
agencies to take this opportunity to publishing this notice of a proposed
The pneumococcal conjugate vaccine comment on proposed and/or data collection as described below.
(PCV13) information materials continuing information collections, as Comments are invited on: (a) Whether
referenced in this notice were required by the Paperwork Reduction the proposed collection of information
developed in consultation with the Act of 1995. This notice invites is necessary for the proper performance
Advisory Commission on Childhood comment on the Management of the functions of the agency, including
Vaccines, the Food and Drug Information System for Comprehensive whether the information shall have
Administration, and parent and Cancer Control Programs data practical utility; (b) the accuracy of the
healthcare provider organizations. collection. CDC uses the electronic MIS agency’s estimate of the burden of the
Following consultation and review of to collect information about cancer proposed collection of information; (c)
comments submitted, the vaccine prevention and control activities ways to enhance the quality, utility, and
information materials covering conducted by states, territories, and clarity of the information to be
pneumococcal conjugate vaccine tribal organizations. collected; (d) ways to minimize the
(PCV13) have been finalized and are DATES: Written comments must be burden of the collection of information
available to download from http://www. received on or before February 19, 2016. on respondents, including through the
cdc.gov/vaccines/hcp/vis/index.html or use of automated collection techniques
ADDRESSES: You may submit comments,
http://www.regulations.gov (see Docket or other forms of information
identified by Docket No. CDC–2015–
Number CDC–2015–0014). The Vaccine technology; and (e) estimates of capital
0115 by any of the following methods:
or start-up costs and costs of operation,
Information Statement (VIS) is Federal eRulemaking Portal:
maintenance, and purchase of services
‘‘Pneumococcal Conjugate Vaccine Regulation.gov. Follow the instructions
to provide information. Burden means
(PCV13): What You Need to Know,’’ for submitting comments.
Mail: Leroy A. Richardson, the total time, effort, or financial
publication date November 5, 2015. resources expended by persons to
Information Collection Review Office,
With publication of this notice, as of generate, maintain, retain, disclose or
Centers for Disease Control and
March 1, 2016, all health care providers Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal
will be required to provide copies of D74, Atlanta, Georgia 30329. agency. This includes the time needed
these updated pneumococcal conjugate Instructions: All submissions received to review instructions; to develop,
vaccine (PCV13) information materials must include the agency name and acquire, install and utilize technology
prior to immunization in conformance Docket Number. All relevant comments and systems for the purpose of
with CDC’s November 5, 2015 received will be posted without change collecting, validating and verifying
Instructions for the Use of Vaccine to Regulations.gov, including any information, processing and
Information Statements. personal information provided. For maintaining information, and disclosing
access to the docket to read background and providing information; to train
Dated: December 16, 2015. personnel and to be able to respond to
Sandra Cashman,
documents or comments received, go to
Regulations.gov. a collection of information, to search
Executive Secretary, Centers for Disease data sources, to complete and review
Control and Prevention. Please note: All public comment should be the collection of information; and to
submitted through the Federal eRulemaking
[FR Doc. 2015–31989 Filed 12–18–15; 8:45 am] transmit or otherwise disclose the
portal (Regulations.gov) or by U.S. mail to the
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4163–18–P address listed above. information.
FOR FURTHER INFORMATION CONTACT: To Proposed Project
request more information on the Management Information System for
proposed project or to obtain a copy of Comprehensive Cancer Control
the information collection plan and Programs (OMB No. 0920–0841, exp. 3/
instruments, contact the Information 31/2016)—Revision—National Center
Collection Review Office, Centers for for Chronic Disease Prevention and
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Document Created: 2015-12-19 02:56:58
Document Modified: 2015-12-19 02:56:58
| 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 March 1, 2016, each health care provider who administers pneumococcal conjugate vaccine (PCV13) to any child or adult in the United States shall provide copies of the relevant vaccine information materials contained in this notice, in conformance with the November 5, 2015 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 | 80 FR 79340 |
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