81 FR 23299 - Final Revised Vaccine Information Materials for 9-valent HPV (Human Papillomavirus) Vaccine
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 76 (April 20, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23299-23300 | |
| FR Document | 2016-09167 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23299-23300] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09167] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2015-0089] Final Revised Vaccine Information Materials for 9-valent HPV (Human Papillomavirus) 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 October 22, 2015, CDC published a notice in the Federal Register (80 FR 64002) seeking public comments on proposed updated vaccine information materials for 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 vaccine. 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 9-valent HPV Gardasil[supreg]-9 vaccine are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0089). DATES: Beginning no later than July 1, 2016, each health care provider who administers 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 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 March 31, 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 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 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 9-valent [[Page 23300]] HPV Gardasil[supreg]-9 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-2015-0089). The Vaccine Information Statement (VIS) is ``HPV (Human Papillomavirus) Vaccine: What You Need to Know [Gardasil[supreg]-9],'' publication date March 31, 2016. With publication of this notice, as of July 1, 2016, all health care providers will be required to provide copies of these updated 9- valent HPVGardasil[supreg]-9 vaccine information materials prior to immunization in conformance with CDC's March 31, 2016 Instructions for the Use of Vaccine Information Statements. Dated: April 15, 2016. Veronica Kennedy, Acting Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2016-09167 Filed 4-19-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23299
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Form name Type of respondent responses per
respondents response
respondent (in hours)
Pathology Chairs ............................................ 33
Laboratory Directors ....................................... 33
Laboratory Managers ..................................... 34
Laboratory Supervisors .................................. 33
Histotechnologists .......................................... 33
IHC focus group .............................................. Pathologists .................................................... 4 1 1
Pathology Chairs ............................................ 4
Laboratory Directors ....................................... 4
Laboratory Managers ..................................... 4
Laboratory Supervisors .................................. 4
Histotechnologists .......................................... 4
LeRoy A. Richardson, administers 9-valent HPV (Human presented in understandable terms, and
Chief, Information Collection Review Office, Papillomavirus) Gardasil®-9 vaccine to include:
Office of Scientific Integrity, Office of the any child or adult in the United States (1) A concise description of the
Associate Director for Science, Office of the shall provide copies of the relevant benefits of the vaccine,
Director, Centers for Disease Control and vaccine information materials (2) A concise description of the risks
Prevention.
referenced in this notice, in associated with the vaccine,
[FR Doc. 2016–09190 Filed 4–19–16; 8:45 am] conformance with the March 31, 2016 (3) A statement of the availability of
BILLING CODE 4163–18–P CDC Instructions for the Use of Vaccine the National Vaccine Injury
Information Statements prior to Compensation Program, and
providing such vaccinations. (4) Such other relevant information as
DEPARTMENT OF HEALTH AND may be determined by the Secretary.
FOR FURTHER INFORMATION CONTACT:
HUMAN SERVICES The vaccines initially covered under
Suzanne Johnson-DeLeon (msj1@
Centers for Disease Control and cdc.gov), National Center for the National Vaccine Injury
Prevention Immunization and Respiratory Diseases, Compensation Program were diphtheria,
Centers for Disease Control and tetanus, pertussis, measles, mumps,
[Docket No. CDC–2015–0089] Prevention, Mailstop A–19, 1600 Clifton rubella, and poliomyelitis vaccines.
Road NE., Atlanta, Georgia 30329. Since April 15, 1992, any health care
Final Revised Vaccine Information provider in the United States who
SUPPLEMENTARY INFORMATION: The
Materials for 9-valent HPV (Human intends to administer one of these
Papillomavirus) Vaccine National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by covered vaccines is required to provide
AGENCY: Centers for Disease Control and section 708 of Public Law 103–183, copies of the relevant vaccine
Prevention (CDC), Department of Health added section 2126 to the Public Health information materials prior to
and Human Services (HHS). Service Act. Section 2126, codified at 42 administration of any of these vaccines.
ACTION: Notice. U.S.C. 300aa–26, requires the Secretary Since then, the following vaccines have
of Health and Human Services to been added to the National Vaccine
SUMMARY: Under the National develop and disseminate vaccine Injury Compensation Program, requiring
Childhood Vaccine Injury Act information materials for distribution by use of vaccine information materials for
(NCVIA)(42 U.S.C. 300aa–26), CDC must all health care providers in the United them as well: Hepatitis B, Haemophilus
develop vaccine information materials States to any patient (or to the parent or influenzae type b (Hib), varicella
that all health care providers are legal representative in the case of a (chickenpox), pneumococcal conjugate,
required to give to patients/parents prior child) receiving vaccines covered under rotavirus, hepatitis A, meningococcal,
to administration of specific vaccines. the National Vaccine Injury human papillomavirus (HPV), and
On October 22, 2015, CDC published a Compensation Program (VICP). seasonal influenza vaccines.
notice in the Federal Register (80 FR Development and revision of the Instructions for use of the vaccine
64002) seeking public comments on vaccine information materials, also information materials are found on the
proposed updated vaccine information known as Vaccine Information CDC Web site at: http://www.cdc.gov/
materials for 9-valent HPV (Human Statements (VIS), have been delegated vaccines/hcp/vis/index.html.
Papillomavirus) Gardasil®-9 vaccine. by the Secretary to the Centers for
Following review of comments Disease Control and Prevention (CDC). Revised Vaccine Information Materials
submitted and consultation as required Section 2126 requires that the materials The 9-valent HPV (Human
under the law, CDC has finalized the be developed, or revised, after notice to Papillomavirus) Gardasil®-9 vaccine
materials. Copies of the final vaccine the public, with a 60-day comment information materials referenced in this
information materials for 9-valent HPV period, and in consultation with the notice were developed in consultation
Lhorne on DSK5TPTVN1PROD with NOTICES
Gardasil®-9 vaccine are available to Advisory Commission on Childhood with the Advisory Commission on
download from http://www.cdc.gov/ Vaccines, appropriate health care Childhood Vaccines, the Food and Drug
vaccines/hcp/vis/index.html or http:// provider and parent organizations, and Administration, and parent and
www.regulations.gov (see Docket the Food and Drug Administration. The healthcare provider organizations.
Number CDC–2015–0089). law also requires that the information Following consultation and review of
DATES: Beginning no later than July 1, contained in the materials be based on comments submitted, the vaccine
2016, each health care provider who available data and information, be information materials covering 9-valent
VerDate Sep<11>2014 14:53 Apr 19, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1](https://thefederalregister.org/doc/81_FR_23375/page/1.svg)
![23300 Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
HPV Gardasil®-9 vaccine have been provide information about evidence- Purpose: The purpose of the meeting
finalized and are available to download based options that decision makers and is for the Task Force to consider the
from http://www.cdc.gov/vaccines/hcp/ stakeholders can consider when findings of systematic reviews and issue
vis/index.html or http:// determining what best meets the findings and recommendations. Task
www.regulations.gov (see Docket specific needs, preferences, available Force recommendations provide
Number CDC–2015–0089). The Vaccine resources, and constraints of their information about evidence-based
Information Statement (VIS) is ‘‘HPV jurisdictions and constituents. The Task options that decision makers and
(Human Papillomavirus) Vaccine: What Force’s recommendations, along with stakeholders can consider when
You Need to Know [Gardasil®-9],’’ the systematic reviews of the scientific determining what best meets the
publication date March 31, 2016. evidence on which they are based, are specific needs, preferences, available
With publication of this notice, as of compiled in the Guide to Community resources, and constraints of their
July 1, 2016, all health care providers Preventive Services (Community Guide). jurisdictions and constituents.
will be required to provide copies of DATES: The meeting will be held on
these updated 9-valent HPVGardasil®-9 Matters to be discussed: Cancer
Wednesday, June 22, 2016 from 8:30
vaccine information materials prior to prevention and control, cardiovascular
a.m. to 6:00 p.m. EDT and Thursday,
immunization in conformance with June 23, 2016 from 8:30 a.m. to 1:00 disease prevention and control, diabetes
CDC’s March 31, 2016 Instructions for p.m. EDT. prevention and control, and increasing
the Use of Vaccine Information physical activity.
Statements. ADDRESSES: The Task Force Meeting
will be held at CDC Edward R. Roybal Roybal Campus Security Guidelines:
Dated: April 15, 2016. Campus, Tom Harkin Global The Edward R. Roybal Campus is the
Veronica Kennedy, Communications Center (Building 19), headquarters of the U.S. Centers for
Acting Executive Secretary, Centers for and 1600 Clifton Road NE., Atlanta, GA Disease Control and Prevention and is
Disease Control and Prevention. 30329. You should be aware that the located at 1600 Clifton Road NE.,
[FR Doc. 2016–09167 Filed 4–19–16; 8:45 am] meeting location is in a Federal Atlanta, Georgia. The meeting is being
BILLING CODE 4163–18–P government building; therefore, Federal held in a Federal government building;
security measures are applicable. For therefore, Federal security measures are
additional information, please see applicable.
DEPARTMENT OF HEALTH AND Roybal Campus Security Guidelines
HUMAN SERVICES All meeting attendees must RSVP by
under SUPPLEMENTARY INFORMATION. the dates outlined under Meeting
Information regarding meeting logistics Accessability. In planning your arrival
Centers for Disease Control and will be available on the Community
Prevention time, please take into account the need
Guide Web site
to park and clear security. All visitors
Meeting of the Community Preventive (www.thecommunityguide.org).
must enter the Edward R. Roybal
Services Task Force Meeting Accessability: This meeting is
Campus through the front entrance on
open to the public, limited only by
AGENCY: Centers for Disease Control and Clifton Road. Your car may be searched,
space availability. All meeting attendees
Prevention (CDC), Department of Health must RSVP to ensure the required and the guard force will then direct
and Human Services (HHS). security procedures are completed to visitors to the designated parking area.
ACTION: Notice of meeting. gain access to the CDC’s Global Upon arrival at the facility, visitors must
Communications Center. present government issued photo
SUMMARY: The Centers for Disease identification (e.g., a valid federal
U.S. citizens must RSVP by June 20,
Control and Prevention (CDC) identification badge, state driver’s
2016.
announces the next meeting of the license, state non-driver’s identification
Community Preventive Services Task Non U.S. citizens must RSVP by May
23, 2016 due to additional security steps card, or passport). Non-United States
Force (Task Force). The Task Force is an citizens must complete the required
independent, nonpartisan, nonfederal, that must be completed. Failure to RSVP
by the dates identified could result in security paperwork prior to the meeting
and unpaid panel. Its members date and must present a valid passport,
represent a broad range of research, the inability to attend the Task Force
meeting due to the strict security visa, Permanent Resident Card, or other
practice, and policy expertise in
regulations on federal facilities. type of work authorization document
prevention, wellness, health promotion,
Meeting Accessibility: This meeting is upon arrival at the facility. All persons
and public health, and are appointed by
the CDC Director. The Task Force was available to the public via Webcast. The entering the building must pass through
convened in 1996 by the Department of Webcast URL will be sent to you upon a metal detector. Visitors will be issued
Health and Human Services (HHS) to receipt of your RSVP. All meeting a visitor’s ID badge at the entrance to
identify community preventive attendees must RSVP to receive the Building 19 and may be escorted to the
programs, services, and policies that webcast information which will be meeting room. All items brought to
increase healthy longevity, save lives emailed to you upon receipt of HHS/CDC are subject to inspection.
and dollars and improve Americans’ registration to the CPSTF@cdc.gov
Dated: April 16, 2016.
quality of life. CDC is mandated to mailbox.
Veronica Kennedy,
provide ongoing administrative, For Further Information and to RSVP
Contact: Onslow Smith, Center for Acting Executive Secretary, Centers for
research, and technical support for the Disease Control and Prevention.
Lhorne on DSK5TPTVN1PROD with NOTICES
operations of the Task Force. During its Surveillance, Epidemiology and
Laboratory Services, Centers for Disease [FR Doc. 2016–09164 Filed 4–19–16; 8:45 am]
meetings, the Task Force considers the
findings of systematic reviews on Control and Prevention, 1600 Clifton BILLING CODE 4163–18–P
existing research and issues Road NE., MS–E–69, Atlanta, GA 30329,
recommendations. Task Force phone: (404) 498–6778, email: CPSTF@
recommendations are not mandates for cdc.gov.
compliance or spending. Instead, they SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 14:53 Apr 19, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 9990 E:\FR\FM\20APN1.SGM 20APN1](https://thefederalregister.org/doc/81_FR_23375/page/2.svg)
Document Created: 2016-04-20 01:51:57
Document Modified: 2016-04-20 01:51:57
| 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 July 1, 2016, each health care provider who administers 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 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 March 31, 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 23299 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR