81 FR 71735 - Proposed Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 201 (October 18, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 201 (October 18, 2016)
| Page Range | 71735-71736 | |
| FR Document | 2016-25144 |
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)] [Notices] [Pages 71735-71736] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25144] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2016-0094] Proposed Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella and MMRV (Measles, Mumps, Rubella, and Varicella) 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 MMR (measles, mumps, and rubella) and MMRV (measles, mumps, rubella, and varicella) vaccines. DATES: Written comments must be received on or before December 19, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0094, 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 ([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. 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, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia 30329, email: [email protected]. 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 [[Page 71736]] 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 MMR (measles, mumps, and rubella) and MMRV (measles, mumps, rubella, and varicella) 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 ``MMR Vaccine (Measles, Mumps, and Rubella): What You Need to Know'' and ``MMRV Vaccine (Measles, Mumps, Rubella, and Varicella): What You Need to Know.'' Copies of the proposed vaccine information materials are available at http://www.regulations.gov (see Docket Number CDC-2016-0094). Comments submitted will be considered in finalizing these materials. When the final materials are published in the Federal Register, the notice will include an effective date for their mandatory use. Dated: October 13, 2016. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2016-25144 Filed 10-17-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices 71735
‘‘Information Regarding Responsibility Total Annual Recordkeeping Hours: administration of specific vaccines.
Matters’’ under 52.209–7 violates 508,000. HHS/CDC seeks written comment on the
Executive Order 13610, Identifying and proposed updated vaccine information
Public Comments
Reducing Regulatory Burdens, in that it statements for MMR (measles, mumps,
is a redundant collection of information Public comments are particularly and rubella) and MMRV (measles,
and fails to maximize the re-use of data invited on: Whether this collection of mumps, rubella, and varicella) vaccines.
that are already collected. The information is necessary; whether it will DATES: Written comments must be
commenter states that FAR clauses have practical utility; whether our received on or before December 19,
52.209–5 and 52.209–7 request for estimate of the public burden of this 2016.
information overlaps and yet is different collection of information is accurate,
ADDRESSES: You may submit comments,
enough to create substantial additional and based on valid assumptions and
identified by Docket No. CDC–2016–
burden and confusion for offerors methodology; ways to enhance the
0094, by any of the following methods:
evaluating instance of litigation under quality, utility, and clarity of the • Federal eRulemaking Portal: http://
both standards. information to be collected; and ways in www.regulations.gov. Follow the
Response: FAR 52.209–7 is a statutory which we can minimize the burden of instructions for submitting comments.
clause that requires the Government to the collection of information on those • Mail: Written comments should be
collect information that is loaded into who are to respond, through the use of addressed to Suzanne Johnson-DeLeon
FAPIIS. The clause must be appropriate technological collection (VIScomments@cdc.gov), National
implemented as intended. Some of the techniques or other forms of information Center for Immunization and
information being collected may seem technology. Respiratory Diseases, Centers for
redundant but it has different criteria. It Obtaining Copies of Proposals: Disease Control and Prevention,
is not identical information and used Requesters may obtain a copy of the Mailstop A–19, 1600 Clifton Road NE.,
differently. Furthermore, the thresholds information collection documents from Atlanta, Georgia 30329.
are different. the General Services Administration, Instructions: All submissions received
FAR 52.209–5 implements policy Regulatory Secretariat Division (MVCB), must include the agency name and
guidance on debarment, suspension and 1800 F Street NW., Washington, DC docket number. All relevant comments
ineligibility. FAR 52.209–5 is a 20405, telephone 202–501–4755. Please received will be posted without change
certification that is placed in all cite OMB Control No. 9000–0094, to http://regulations.gov, including any
solicitations when the contract value is Debarment and Suspension and Other personal information provided. For
expected to exceed the simplified Responsibility Matters, in all access to the docket to read background
acquisition threshold and covers 3 correspondence. documents or comments received, go to
years. FAR 52.209–7 goes in Dated: October 13, 2016. http://www.regulations.gov.
solicitations expected to exceed Lorin S. Curit, FOR FURTHER INFORMATION CONTACT: Skip
$550,000 and covers 5 years and Director, Federal Acquisition Policy Division, Wolfe, National Center for
requires that the information be placed Office of Governmentwide Acquisition Policy, Immunization and Respiratory Diseases,
into FAPIIS (as required by statute). Office of Acquisition Policy, Office of Centers for Disease Control and
Comment: The existence of FAR Governmentwide Policy. Prevention, Mailstop A–19, 1600 Clifton
52.209–5 and 52.209–11 obviate the [FR Doc. 2016–25123 Filed 10–17–16; 8:45 am] Road NE., Atlanta, Georgia 30329,
need for FAR 52.209–7 because all three BILLING CODE 6820–EP–P email: VIScomments@cdc.gov.
clauses use offeror’s litigation history as SUPPLEMENTARY INFORMATION: The
an indicator of it present responsibility. National Childhood Vaccine Injury Act
Response: These data requirements of 1986 (Pub. L. 99–660), as amended by
are different. One major difference DEPARTMENT OF HEALTH AND
HUMAN SERVICES section 708 of Public Law 103–183,
between these clauses is that FAR added section 2126 to the Public Health
52.209–7 collects data to be added into Centers for Disease Control and Service Act. Section 2126, codified at 42
FAPIIS. The others do not. Therefore, Prevention U.S.C. 300aa–26, requires the Secretary
FAR 52.209–7 has a different of Health and Human Services to
requirement intent and needed. [Docket No. CDC–2016–0094]
develop and disseminate vaccine
Comment: FAR 52.209–7 requires information materials for distribution by
offerors to report information on matters Proposed Revised Vaccine Information
Materials for MMR (Measles, Mumps, all health care providers in the United
so old they are no longer relevant to States to any patient (or to the parent or
present responsibility. and Rubella and MMRV (Measles,
Mumps, Rubella, and Varicella) legal representative in the case of a
Response: The statute that this clause child) receiving vaccines covered under
is based requires that it collects 5 years Vaccines
the National Vaccine Injury
of data. AGENCY: Centers for Disease Control and Compensation Program (VICP).
C. Annual Reporting and Prevention (CDC), Department of Health Development and revision of the
Recordkeeping Burden and Human Services (HHS). vaccine information materials, also
ACTION: Notice with comment period. known as Vaccine Information
Annual Reporting Burden Statements (VIS), have been delegated
Respondents: 486,000. SUMMARY: Under the National by the Secretary to the Centers for
Responses per Respondent: 2.55. Childhood Vaccine Injury Act (NCVIA) Disease Control and Prevention (CDC).
Lhorne on DSK30JT082PROD with NOTICES
Total Annual Responses: 1,239,602. (42 U.S.C. 300aa–26), the Centers for Section 2126 requires that the materials
Hours per Response: 0.34. Disease Control and Prevention (CDC) be developed, or revised, after notice to
Total Burden Hours: 415,687. within the Department of Health and the public, with a 60-day comment
Human Services (HHS) develops period, and in consultation with the
Annual Recordkeeping Burden vaccine information materials that all Advisory Commission on Childhood
Recordkeepers: 5,080. health care providers are required to Vaccines, appropriate health care
Hours per Recordkeeper: 100. give to patients/parents prior to provider and parent organizations, and
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![71736 Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices
the Food and Drug Administration. The Administration, and parent and health Reauthorization Act) of October 27,
law also requires that the information care provider groups. 1998, Public Law 105–285, section
contained in the materials be based on We invite written comment on the 680(b) as amended. The reporting
available data and information, be proposed revised vaccine information format, Performance Progress Report
presented in understandable terms, and materials entitled ‘‘MMR Vaccine (PPR), collects information concerning
include: (Measles, Mumps, and Rubella): What the outcomes and management of CED
(1) A concise description of the You Need to Know’’ and ‘‘MMRV projects. OCS will use the data to
benefits of the vaccine, Vaccine (Measles, Mumps, Rubella, and critically review the overall design and
(2) A concise description of the risks Varicella): What You Need to Know.’’ effectiveness of the program.
associated with the vaccine, Copies of the proposed vaccine The PPR will continue to be
(3) A statement of the availability of information materials are available at administered to all active grantees of the
the National Vaccine Injury http://www.regulations.gov (see Docket CED program. Grantees will be required
Compensation Program, and Number CDC–2016–0094). Comments to use this reporting tool for their semi-
(4) Such other relevant information as submitted will be considered in annual reports to be submitted twice a
may be determined by the Secretary. finalizing these materials. When the year. The current PPR replaced both the
The vaccines initially covered under final materials are published in the annual questionnaire and other semi-
the National Vaccine Injury Federal Register, the notice will include annual reporting formats, which
Compensation Program were diphtheria, an effective date for their mandatory resulted in an overall reduction in
tetanus, pertussis, measles, mumps, use. burden for the grantees while
rubella and poliomyelitis vaccines. Dated: October 13, 2016. significantly improving the quality of
Since April 15, 1992, any health care Sandra Cashman, the data collected by OCS. OCS seeks to
provider in the United States who Executive Secretary, Centers for Disease
renew this PPR to continue to collect
intends to administer one of these Control and Prevention. quality data from grantees. To ensure
covered vaccines is required to provide [FR Doc. 2016–25144 Filed 10–17–16; 8:45 am]
the burden on grantees is not increased,
copies of the relevant vaccine but that the information collected
BILLING CODE 4163–18–P
information materials prior to demonstrates the full impact of the
administration of any of these vaccines. program, OCS has conducted an in-
Since then, the following vaccines have DEPARTMENT OF HEALTH AND depth review to remove indicators that
been added to the National Vaccine HUMAN SERVICES are not being used; add indicators that
Injury Compensation Program, requiring will allow OCS to better demonstrate
use of vaccine information materials for Administration for Children and the impact of the program; and clarify
them as well: Hepatitis B, Haemophilus Families language of some indicators to reduce
influenzae type b (Hib), varicella grantee confusion. Based on this review,
(chickenpox), pneumococcal conjugate, Proposed Information Collection proposed changes to the CED PPR are
rotavirus, hepatitis A, meningococcal, Activity; Comment Request minimal and focused on clarifying
human papillomavirus (HPV), and language, removing outdated indicators,
Proposed Projects:
seasonal influenza vaccines. Title: Renewal of Office of and gathering minimal additional data
Instructions for use of the vaccine Community Services (OCS) Community that will not increase the burden on
information materials are found on the Economic Development (CED) Standard grantees. These measures will result in
CDC Web site at: http://www.cdc.gov/ Reporting Format. a stronger and streamlined CED PPR
vaccines/hcp/vis/index.html. OMB No.: 0970–0386. that will allow for the following:
HHS/CDC is proposing updated Description: The Office of Community —More clarity for grantees and ability to
versions of the MMR (measles, mumps, Services (OCS) will continue collecting avoid confusion around what data
and rubella) and MMRV (measles, key information about projects funded should be provided.
mumps, rubella, and varicella) vaccine through the Community Economic —Increased consistency across data.
information statements. Development (CED) program. The —Ability for OCS and grantees to better
The vaccine information materials legislative requirement for this program demonstrate the impact of these
referenced in this notice are being is in Title IV of the Community projects.
developed in consultation with the Opportunities, Accountability and A summary of all proposed changes
Advisory Commission on Childhood Training and Educational Services Act can be provided upon request.
Vaccines, the Food and Drug (COATS Human Services Respondents: Active CED Grantees
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
PPR for Current OCS–CED Grantees ............................................................. 170 2 1.5 510
Estimated Total Annual Burden on the specific aspects of the and Evaluation, 330 C Street SW.,
Lhorne on DSK30JT082PROD with NOTICES
Hours: information collection described above. Washington DC 20201. Attn: ACF
In compliance with the requirements Copies of the proposed collection of Reports Clearance Officer. Email
of the Paperwork Reduction Act of 1995 information can be obtained and address: infocollection@acf.hhs.gov. All
(Pub. L. 104–13, 44 U.S.C. Chap 35), the comments may be forwarded by writing requests should be identified by the title
Administration for Children and to the Administration for Children and of the information collection.
Families is soliciting public comment Families, Office of Planning, Research
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Document Created: 2016-10-17 23:52:48
Document Modified: 2016-10-17 23:52:48
| 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 December 19, 2016. | |
| Contact | Skip Wolfe, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia 30329, email: [email protected] | |
| FR Citation | 81 FR 71735 |
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