60 Day FRN

Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2014–0007]

Final Revised Vaccine Information
Materials for Td, Tdap, Hib, and
Rotavirus Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS)
ACTION: Notice.
AGENCY:

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 June 25, 2014, CDC published a
notice in the Federal Register (79 FR
36068) seeking public comments on
proposed new vaccine information
materials for Td, Tdap, Haemophilus
influenzae type b (Hib), and rotavirus
vaccines. 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
Td, Tdap, Hib, and rotavirus are
available to download from http://
www.cdc.gov/vaccines/hcp/vis/
index.html or http://
www.regulations.gov (see Docket
Number CDC–2014–0007).
DATES: Beginning no later than
November 1, 2015, each health care
provider who administers any Td, Tdap,
Hib, or rotavirus vaccine 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 April
15, 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

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SUMMARY:

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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.
New Vaccine Information Materials
The Td, Tdap, Hib, and rotavirus
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

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32127

healthcare provider organizations.
Following consultation and review of
comments submitted, the vaccine
information materials covering Td,
Tdap, Hib, and rotavirus 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–2014–0007). The Vaccine
Information Statements (VIS), are: ‘‘Td
Vaccine: What You Need to Know’’
(publication date February 24, 2015),
‘‘Tdap Vaccine: What You Need to
Know’’ (publication date February 24,
2015), ‘‘Haemophilus influenzae type b
Vaccine: What You need to Know’’
(publication date April 2, 2015), and
‘‘Rotavirus Vaccine: What You Need to
Know’’ (publication date April 15,
2015).
With publication of this notice, as of
November 1, 2015, all health care
providers will be required to provide
copies of these updated Td, Tdap, Hib,
and rotavirus vaccine information
materials prior to immunization in
conformance with CDC’s April 15, 2015
Instructions for the Use of Vaccine
Information Statements.
Dated: June 1, 2015.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2015–13694 Filed 6–4–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0042; 60Day–15–
0981]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on Assessing and Evaluating
Human Systems Integration needs in
mining. CDC objective is to conduct

SUMMARY:

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32128

Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices

research to improve working conditions
to prevent accidents and occupational
disease in underground coal and metal/
nonmetal mines in the U.S.
DATES: Written comments must be
received on or before August 4, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0042 by any of the following methods:
Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE.,
MS–D74, 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 Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have

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FOR FURTHER INFORMATION CONTACT:

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practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Assessing and Evaluating Human
Systems Integration Needs in Mining
(OMB No. 0920–0981, expires 08/31/
2015)—Extension—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
NIOSH, under Public Law 91–173 as
amended by Public Law 95–164
(Federal Mine Safety and Health Act of
1977), and Public Law 109–236 (Mine
Improvement and New Emergency
Response Act of 2006) has the
responsibility to conduct research to
improve working conditions and to
prevent accidents and occupational
diseases in underground coal and metal/
nonmetal mines in the United States of
America. NIOSH proposes to request
additional time through an extension of
the approved OMB control number in
order to collect assessment and
evaluation data.
The project is aimed at determining
the following information with regards
to the necessary inclusion of Human
Systems Integration into research
related to underground coal mining: (1)
What information is critical for a miner
to safely perform his job, (2) what
processes (e.g., expertise, decision

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making, attention, etc.) are necessary for
a miner to effectively perform his job,
and (3) how do the miner and the
machine interact. In order to accomplish
these goals, the following data
collection instruments are being used:
The General Preference Questionnaire
was designed to determine how and
when miners working in an
underground coal mine prefer to have
information about their work
environment, the location of
themselves, others, and equipment
communicated to them while they are
working. This questionnaire will be
administered to 75 miners working in
an underground coal mine.
The Subject Matter Expert (SME)
Questionnaire was designed to
determine how subject matter experts
(e.g., experienced continuous miner
operators) prefer to have information
about their work environment, the
location of themselves, others and
equipment communicated to them
while they are working. The
questionnaire will be administered to 50
miners working in an underground coal
mine in one of two positions:
Continuous miner operator or fire boss.
The Safety Director Questionnaire
was designed to determine what
machinery and equipment is currently
being used within the underground coal
mining environment. This questionnaire
will be administered to up to 50 Safety
Directors working at an underground
mining operation.
Vest Usability Testing was designed
to examine the effectiveness and
viability of physically integrating
equipment. This will be done by asking
a group of miners to wear mining vests
during their normal work hours and
complete a questionnaire before and
after the vest wearing period.
Approximately 60 underground coal
miners will be asked to take part in Vest
Usability Testing.
The Roof Bolter Questionnaire will be
used to assess the functional lighting
needs and problems around roof bolting
machines and the usability of a lighting
feedback system for specific controls.
Approximately 30 Roof Bolter Operators
will be asked to complete the Roof
Bolter Questionnaire (half before the
intervention and half after).
There are no costs to the miners as
study participation will take place
during their normal working hours.
Thus, any cost associated with the
experiment will be incurred by the
mining company. The total estimated
annual burden hours are 442.

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Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Mine
Mine
Mine
Mine

Employee
Employee
Employee
Employee

.................................
.................................
.................................
.................................

Average
burden
per response
(in hours)

Total burden
(in hours)

285
285
285
10

1
1
1
1

5/60
2/60
2/60
2

24
10
10
20

10

1

2

20

10

1

4

40

.................................
.................................
.................................
.................................
.................................
.................................
.................................
.................................

Informed Consent .............................
Talent Waiver ...................................
Demographic Questionnaire ............
Task and Cognitive Task Analyses:
Continuous Miner Operator.
Task and Cognitive Task Analyses:
Fire Boss.
Direct
Observation:
Continuous
Miner Operator.
Direct Observation: Fire Boss ..........
General Preference Questionnaire ..
Subject Matter Expert Questionnaire
Safety Director Questionnaire ..........
Roof Bolter Questionnaire ................
Vest Usability Testing ......................
Focus Groups ...................................
Lab Experiments ..............................

10
75
50
50
30
60
30
30

1
1
1
1
2
2
1
1

4
30/60
1
30/60
15/60
45/60
1
1

40
38
50
25
15
90
30
30

Total ...........................................

...........................................................

........................

........................

........................

442

Mine Employee .................................
Mine Employee .................................
Mine
Mine
Mine
Mine
Mine
Mine
Mine
Mine

Employee
Employee
Employee
Employee
Employee
Employee
Employee
Employee

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–13799 Filed 6–4–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15AME; Docket No. CDC–2015–
0043]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a Monitoring and
Reporting System for the National
Tobacco Control Program. CDC will use
the information collected to monitor
cooperative agreement awardees and to

SUMMARY:

asabaliauskas on DSK5VPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Form name

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18:31 Jun 04, 2015

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identify facilitators and challenges to
program implementation and
achievement of outcomes.
DATES: Written comments must be
received on or before August 4, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0043 by any of the following methods:
Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, 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 Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
FOR FURTHER INFORMATION CONTACT:

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Sfmt 4703

must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology

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05JNN1