Proposed Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines, 71735-71736 [2016-25144]

Download as PDF Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices ‘‘Information Regarding Responsibility Matters’’ under 52.209–7 violates Executive Order 13610, Identifying and Reducing Regulatory Burdens, in that it is a redundant collection of information and fails to maximize the re-use of data that are already collected. The commenter states that FAR clauses 52.209–5 and 52.209–7 request for information overlaps and yet is different enough to create substantial additional burden and confusion for offerors evaluating instance of litigation under both standards. Response: FAR 52.209–7 is a statutory clause that requires the Government to collect information that is loaded into FAPIIS. The clause must be implemented as intended. Some of the information being collected may seem redundant but it has different criteria. It is not identical information and used differently. Furthermore, the thresholds are different. FAR 52.209–5 implements policy guidance on debarment, suspension and ineligibility. FAR 52.209–5 is a certification that is placed in all solicitations when the contract value is expected to exceed the simplified acquisition threshold and covers 3 years. FAR 52.209–7 goes in solicitations expected to exceed $550,000 and covers 5 years and requires that the information be placed into FAPIIS (as required by statute). Comment: The existence of FAR 52.209–5 and 52.209–11 obviate the need for FAR 52.209–7 because all three clauses use offeror’s litigation history as an indicator of it present responsibility. Response: These data requirements are different. One major difference between these clauses is that FAR 52.209–7 collects data to be added into FAPIIS. The others do not. Therefore, FAR 52.209–7 has a different requirement intent and needed. Comment: FAR 52.209–7 requires offerors to report information on matters so old they are no longer relevant to present responsibility. Response: The statute that this clause is based requires that it collects 5 years of data. C. Annual Reporting and Recordkeeping Burden Lhorne on DSK30JT082PROD with NOTICES Annual Reporting Burden Respondents: 486,000. Responses per Respondent: 2.55. Total Annual Responses: 1,239,602. Hours per Response: 0.34. Total Burden Hours: 415,687. Annual Recordkeeping Burden Recordkeepers: 5,080. Hours per Recordkeeper: 100. VerDate Sep<11>2014 13:19 Oct 17, 2016 Jkt 241001 Total Annual Recordkeeping Hours: 508,000. 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 No. 9000–0094, Debarment and Suspension and Other Responsibility Matters, in all correspondence. Dated: October 13, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2016–25123 Filed 10–17–16; 8:45 am] BILLING CODE 6820–EP–P 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 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) (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 SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 71735 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 (VIScomments@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. 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: VIScomments@cdc.gov. 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 E:\FR\FM\18OCN1.SGM 18OCN1 71736 Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Title: Renewal of Office of Community Services (OCS) Community Economic Development (CED) Standard Reporting Format. OMB No.: 0970–0386. Description: The Office of Community Services (OCS) will continue collecting key information about projects funded through the Community Economic Development (CED) program. The legislative requirement for this program is in Title IV of the Community Opportunities, Accountability and Training and Educational Services Act (COATS Human Services Reauthorization Act) of October 27, 1998, Public Law 105–285, section 680(b) as amended. The reporting format, Performance Progress Report (PPR), collects information concerning the outcomes and management of CED projects. OCS will use the data to critically review the overall design and effectiveness of the program. The PPR will continue to be administered to all active grantees of the CED program. Grantees will be required to use this reporting tool for their semiannual reports to be submitted twice a year. The current PPR replaced both the annual questionnaire and other semiannual reporting formats, which resulted in an overall reduction in burden for the grantees while significantly improving the quality of the data collected by OCS. OCS seeks to renew this PPR to continue to collect quality data from grantees. To ensure the burden on grantees is not increased, but that the information collected demonstrates the full impact of the program, OCS has conducted an indepth review to remove indicators that are not being used; add indicators that will allow OCS to better demonstrate the impact of the program; and clarify language of some indicators to reduce grantee confusion. Based on this review, proposed changes to the CED PPR are minimal and focused on clarifying language, removing outdated indicators, and gathering minimal additional data that will not increase the burden on grantees. These measures will result in a stronger and streamlined CED PPR that will allow for the following: —More clarity for grantees and ability to avoid confusion around what data should be provided. —Increased consistency across data. —Ability for OCS and grantees to better demonstrate the impact of these projects. A summary of all proposed changes can be provided upon request. Respondents: Active CED Grantees ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours PPR for Current OCS–CED Grantees ............................................................. Lhorne on DSK30JT082PROD with NOTICES Instrument 170 2 1.5 510 Estimated Total Annual Burden Hours: In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment VerDate Sep<11>2014 13:19 Oct 17, 2016 Jkt 241001 on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. E:\FR\FM\18OCN1.SGM 18OCN1

Agencies

[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Notices]
[Pages 71735-71736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25144]


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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 (VIScomments@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.
    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: VIScomments@cdc.gov.

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