60 Day FRN

11532

Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices

The purpose of this analysis is to
facilitate public comment on the
proposed Consent agreement, and the
Commission does not intend this
analysis to constitute an official
interpretation of the proposed Consent
Agreement or to modify its terms in any
way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–05252 Filed 3–14–18; 8:45 am]
BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2016–0094]

Final 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.
AGENCY:

Under the National
Childhood Vaccine Injury Act (NCVIA),
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 18, 2016, CDC
published a notice in the Federal
Register seeking public comments on
proposed updated vaccine information
materials for MMR vaccine and MMRV
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 MMR and
MMRV vaccine are available to
download from http://www.cdc.gov/
vaccines/hcp/vis/index.html or http://
www.regulations.gov (see Docket
Number CDC–2016–0094).
DATES: Beginning no later than June 1,
2018, each health care provider who
administers MMR or MMRV vaccine to
any child or adult in the United States
shall provide copies of the relevant
vaccine information materials
referenced in this notice, dated February
12, 2018, in conformance with the
February 23, 2018 CDC Instructions for
the Use of Vaccine Information
Statements prior to providing such
vaccinations.
FOR FURTHER INFORMATION CONTACT:
Suzanne Johnson-DeLeon (msj1@

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SUMMARY:

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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
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,

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rotavirus, hepatitis A, meningococcal,
human papillomavirus (HPV), and
seasonal influenza vaccines.
Instructions for use of the vaccine
information materials are found on the
CDC website at: http://www.cdc.gov/
vaccines/hcp/vis/index.html.
Revised Vaccine Information Materials
The 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 MMR
and MMRV vaccines 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–2016–0094). The Vaccine
Information Statements (VISs) are
‘‘MMR Vaccine (Measles, Mumps, and
Rubella): What You Need to Know’’ and
‘‘MMRV Vaccine (Measles, Mumps,
Rubella, and Varicella): What You Need
to Know,’’ publication date February 12,
2018.
With publication of this notice, by
June 1, 2018, all health care providers
must discontinue use of the previous
editions and provide copies of these
updated vaccine information materials
prior to immunization in conformance
with CDC’s February 23, 2018
Instructions for the Use of Vaccine
Information Statements.
Dated: March 12, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2018–05299 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–FY–1072; Docket No. CDC–2018–
0020]

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 effort to reduce public

SUMMARY:

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Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comments on the
proposed revision of the information
collection titled ‘‘The Enhanced STD
surveillance Network (SSuN),’’ which is
the only source for enhanced and
sentinel sexually transmitted disease
(STD) surveillance data in the United
States that: (1) Serves to strengthen
national and local surveillance capacity;
(2) collects information on populations
at risk for STDs attending healthcare
facilities; and (3) provides more
accurate estimates of the burden of
disease, incidence of disease, trends and
impact of STDs at the population level.
DATES: CDC must receive written
comments on or before May 14, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0020 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments 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 Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
omb@cdc.gov.
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

sradovich on DSK3GMQ082PROD with NOTICES

FOR FURTHER INFORMATION CONTACT:

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extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
The Enhanced STD surveillance
Network (SSuN)—Revision—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention
seeks to request a three-year revision
approval of the information collection
project entitled, The Enhanced STD
surveillance Network (SSuN). Revisions
to this submission include, removal of
facility-based surveillance in family
planning clinics, the addition of seven
interview questions to the gonorrhea
population component and eight new
data elements to the facility component,
and the addition of an enhanced
surveillance activity to monitor adverse
health outcomes of early syphilis cases
with neurologic and/or ocular syphilis
manifestations. The estimate of
annualized burden hours will increase
from 3,052 hours to 3,479 hours as a
result of the revision.
The purpose of this project is to: (1)
Provide supplemental information on
case reports of notifiable STDs that
enhances the ability of public health
authorities to interpret trends in

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11533

reported case incidence, assess
inequalities in the burden of disease by
population characteristics and to
monitor STD treatment and selected
adverse health outcomes of STDs; and
(2) monitor STD screening, incidence,
prevalence, epidemiologic and health
care access trends in at-risk populations
seeking STD services in specific clinical
settings.
While routine STD surveillance
activities are ongoing in all U.S. states
and jurisdictions, through the National
Notifiable Disease Surveillance System,
these data are often missing critical
patient demographics and are of limited
scope with respect to risk behavior,
provider and clinical information,
treatment and partner characteristics
needed to direct disease control
activities. Enhanced SSuN is the only
infrastructure providing information
about diagnosed and reported STD cases
with respect to patient and partner
characteristics, clinical presentation,
screening and uptake of HIV testing,
treatment patterns or provider
compliance with treatment
recommendations for patients receiving
STD-related care.
The precursor to Enhanced SSuN was
the STD Surveillance Network (SSuN),
established in 2005 as a network of
collaborating state and local public
health agencies to provide more
comprehensive STD case-level and
clinical facility information. In 2008,
SSuN was expanded to 12 awardees to
add important geographic diversity and
to include visit-level data on a full
census of patients being seen in
categorical STD clinics. Activities of the
previously funded SSuN were
subsumed under the network’s scope in
establishing enhanced SSuN in 2013.
The current project comprises 10 US
local/state health departments. These
facilities include Baltimore City Health
Department, California Department of
Public Health, Florida Department of
Health, Massachusetts Department of
Public Health, Minnesota Department of
Health, Multnomah County Health
Department, New York City Department
of Health & Mental Hygiene,
Philadelphia Department of Public
Health, San Francisco Department of
Public Health, and Washington State
Department of Health.
Since the initial OMB approval in
2015, Enhanced SSuN has provided
ongoing data addressing CDC/Division
of Sexually Transmitted Disease and
Prevention priorities (DSTDP),
including contributing to CDC’s annual
STD surveillance report, CDC’s
quarterly progress indicators, and
informed policy discussions on
expedited partner therapy, pre-exposure

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Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices

prophylaxis to prevent HIV infection
(PrEP), documentation of critical
clinical services provided by categorical
STD clinics, and on the proportion of
cases treated with appropriate
antimicrobial regimens, which is an
essential indicator of compliance with
CDC treatment recommendations.
The two major data collection
components of the Enhanced SSuN
project are grouped into two primary
categories, reflecting sentinel and
enhanced population-based surveillance
activities. The first component includes
sentinel surveillance in participating
STD clinics, which monitors patient
care, screening and diagnostic practices,
treatment and STD-related services
delivered. Participating local/state
health departments have implemented
common protocols to collect
demographic, clinical, risk behaviors on
patients presenting for care in selected
facilities. Data for this activity is
abstracted from existing electronic
medical records at participating STD
clinics, leveraging information routinely
collected in the provision of clinical
care. All records are fully de-identified
by collaborating health departments and
transmitted to CDC through secure file
transport mechanisms six times
annually (every 2 months). The
estimated time for the clinic data
managers to abstract data is 3 hours
every 2 months.
The second population-focused
component is comprised of two
activities, including enhanced
surveillance on a random sample of
persons diagnosed with gonorrhea, and
enhanced surveillance on person
diagnosed and reported with early
syphilis with ocular/neurologic
manifestations. For the first activity a
random sample of all gonorrhea cases
diagnosed and reported to health

departments among persons residing
within the participating jurisdictions are
selected for enhanced interview. The
second population of interest are
persons diagnosed with primary,
secondary, and early latent syphilis.
Cases determined to have neurologic/
ocular manifestations will be selected
for enhanced interview/investigation. In
both these activities, jurisdictions
follow consensus protocols to collect
uniform data on demographic
characteristics, behavioral risk factors,
and health care seeking behaviors.
In 2016, there were 129,434 persons
diagnosed and reported with gonorrhea
across the 10 participating Enhanced
SSuN jurisdictions. Approximately
10%, or 12,943 cases were randomly
sampled for enhanced investigation.
Many cases were lost to follow-up
because of limited contact information.
Hence, the response rate for gonorrhea
patient interviews in the first three years
of Enhanced SSuN data collection was
39.3%, with approximately 5,086
respondents interviewed.
In 2016, there were 25,253 early
syphilis cases reported across the 10
participating SSuN jurisdictions.
Studies estimate that 2% of all early
syphilis cases will report neurologic
and/or ocular manifestations,
corresponding to 507 cases requiring
additional investigation. CDC expects to
interview 80% of 507 patients or 406
respondents. The 5,492 patient
interviews for both the gonorrhea and
early syphilis are estimated to take 10
minutes to complete for an estimated
annualized burden hours of 934.
CDC will conduct an early syphilis
case follow-up evaluation with
diagnosing or reporting providers to
ascertain additional information about
physical exam findings, laboratory tests
results, including cerebrospinal fluid

(CSF) results, and prescribed (type and
duration) treatment not present in the
original case or laboratory report. CDC
will collect clinical information from
the diagnosing healthcare facilities for
those diagnosed with early syphilis who
reported neurologic/ocular symptoms
(406 early syphilis cases). These
evaluations can be either by direct
contact with providers (phone) or
through other methods such as secure
fax-back, mail or other means as long as
privacy of patient information can be
strictly maintained.
Collection of this information is
estimated to take approximately 10
minutes to complete, for 69 burden
hours.
For the syphilis cases with neurologic
and/or ocular manifestations only, there
will be a three-month follow up
interview to document resolution of
symptoms. Data collection for this threemonth follow-up is expected to take
about five minutes per person and will
be conducted through either telephoneadministered or in-person interviews.
With an estimated 50% follow-up
success rate, the total burden hours is
estimated at 16 hours.
Data managers at each of the 10 local/
state health departments will be
responsible for transmitting validated
datasets to CDC every month,
alternating between the facility and
population-based activities in Enhanced
SSuN. This reflects 2,280 burden hours
for data management (10 respondents ×
12 data transmissions × 19 hours).
The total estimated annual burden
hours are 3,479 for Enhanced SSuN.
Respondents from local/state health
departments receive federal funds to
participate in this project. Participation
of patients and of facility staff are
voluntary. There are no additional costs
to respondents other than their time.

sradovich on DSK3GMQ082PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average burden per
response
(in hours)

Total
burden
(in hours)

Type of respondents

Form name

Data manager at Sentinel STD clinics ...........
General Public—Adults (persons diagnosed
with gonorrhea or early syphilis.
Diagnosing Provider ........................................
General Public—Adults (persons with early
syphilis who have neurologic/ocular manifestations.
Data Managers: 10 local/state health department.

Record Abstraction .................
Interview .................................

10
5,492

6
1

3
10/60

180
934

Data for early syphilis cases ..
Follow up Interview ................

406
203

1
1

10/60
5/60

69
16

Data cleaning/validation .........

10

12

19

2,280

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

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

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

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

3,479

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

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Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
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. 2018–05243 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–18PR; Docket No. CDC–2018–
0021]

Proposed Data Collection Submitted
for Public Comment and
Recommendations

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

Decision To Evaluate a Petition To
Designate a Class of Employees From
the De Soto Avenue Facility in Los
Angeles County, California, To Be
Included in the Special Exposure
Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.

AGENCY:

ACTION:

Notice.

NIOSH gives notice of a
decision to evaluate a petition to
designate a class of employees from the
De Soto Avenue Facility in Los Angeles
County, California, to be included in the
Special Exposure Cohort under the
Energy Employees Occupational Illness
Compensation Program Act of 2000.

SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 1090 Tusculum
Avenue, MS C–46, Cincinnati, OH
45226–1938, Telephone 877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:

sradovich on DSK3GMQ082PROD with NOTICES

Authority: 42 CFR 83.9–83.12.

Pursuant to 42 CFR 83.12, the initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: De Soto Avenue Facility.
Location: Los Angeles County,
California.
Job Titles and/or Job Duties: All
employees of the Department of Energy,
its predecessor agencies, and their
contractors and subcontractors who
worked at the De Soto Avenue Facility.
Period of Employment: January 1,
1965 through December 31, 1995.
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health.
[FR Doc. 2018–05277 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–19–P

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Jkt 244001

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled The World Trade Center Health
Program (WTCHP): Impact Assessment
and Strategic Planning for Translational
Research—Focus Group Protocol. This
project includes a series of focus groups
with different stakeholder groups to
explore their perspectives on the
decisions that each of them makes in the
context of the WTCHP.
DATES: CDC must receive written
comments on or before May 14, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0021 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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. CDC will post, without
change, all relevant comments to
Regulations.gov.
SUMMARY:

Please note: Submit all comments 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 Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton

FOR FURTHER INFORMATION CONTACT:

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11535

Road, NE MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
omb@cdc.gov.
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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
The World Trade Center Health
Program: Impact Assessment and
Strategic Planning for Translational
Research (Focus Group Protocol)—
New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The James Zadroga 9/11 Health and
Compensation Act of 2010, Public Law
111–347 (hereafter referred to as ‘‘the
Zadroga Act’’), established the World
Trade Center Health Program (WTCHP).
Under subtitle C, the Zadroga Act
requires the establishment of a research
program on health conditions resulting

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