Proposed Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines, 71735-71736 [2016-25144]
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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: https://
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 https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://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: https://www.cdc.gov/
vaccines/hcp/vis/.
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
https://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
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]]>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]
=======================================================================
-----------------------------------------------------------------------
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: https://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 https://regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://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: https://www.cdc.gov/vaccines/hcp/vis/.
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 https://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
