60 Day FRN

Att 2 60 Day Published 9-30-2020.pdf

Strengthening US Response to Resistant Gonorrhea (SURRG)

60 Day FRN

OMB: 0920-1242

Document [pdf]
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61750

Federal Register / Vol. 85, No. 190 / Wednesday, September 30, 2020 / Notices

disclosure. Comments will be posted on
https://www.regulations.gov. Therefore,
do not include any information in your
comment or supporting materials that
you consider confidential or
inappropriate for public disclosure. If
you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be on
public display. ATSDR will review all
submissions and may choose to redact,
or withhold, submissions containing
private or proprietary information such
as Social Security numbers, medical
information, inappropriate language, or
duplicate/near duplicate examples of a
mass-mail campaign. ATSDR will
carefully consider all comments
submitted in preparation of the final
Toxicological Profile and may revise the
profile as appropriate.

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Legislative Background
The Superfund Amendments and
Reauthorization Act of 1986 (SARA) [42
U.S.C. 9601 et seq.] amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) [42
U.S.C. 9601 et seq.] by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(EPA) regarding the hazardous
substances most commonly found at
facilities on the CERCLA National
Priorities List (NPL). Among these
statutory requirements is a mandate for
the Administrator of ATSDR to prepare
toxicological profiles for each substance
included on the priority list of
hazardous substances [also called the
Substance Priority List (SPL)]. This list
identifies 275 hazardous substances that
ATSDR and EPA have determined pose
the most significant potential threat to
human health. The SPL is available
online at www.atsdr.cdc.gov/spl.
In addition, CERCLA provides ATSDR
with the authority to prepare
toxicological profiles for substances not
found on the SPL. CERCLA authorizes
ATSDR to establish and maintain an
inventory of literature, research, and
studies on the health effects of toxic
substances (CERCLA Section
104(i)(1)(B); 42 U.S.C. 9604(i)(1)(B)); to
respond to requests for health
consultations (CERCLA Section
104(i)(4); 42 U.S.C. 9604(i)(4)); and to
support the site-specific response
actions conducted by the agency.
Availability
The Draft Toxicological Profile for
Ethylene Oxide will be available online
at http://www.atsdr.cdc.gov/ToxProfiles

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and at www.regulations.gov, Docket No.
ATSDR–2016–0004.
Donata Green,
Acting Director, Office of Policy, Planning,
and Partnerships, Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2020–21619 Filed 9–29–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–1242; Docket No. CDC–2020–
0099]

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
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 Strengthening U.S. Response to
Resistant Gonorrhea, which is to
intended to enhance U.S. state and local
public health surveillance and program
infrastructure, build capacity to support
rapid detection and public health
response to antibiotic-resistant
gonorrhea (an urgent public health
threat), and advance the understanding
of epidemiological factors contributing
to antibiotic-resistant gonorrhea. CDC is
requesting a three-year approval.
DATES: CDC must receive written
comments on or before November 30,
2020.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2020–
0099 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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

ADDRESSES:

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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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
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 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
Strengthening U.S. Response to
Resistant Gonorrhea (SURRG) (OMB
Control No. 0920–1242, Exp. 9/30/

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Federal Register / Vol. 85, No. 190 / Wednesday, September 30, 2020 / Notices
2021)—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 purposes of this Revision request
for Strengthening U.S. Response to
Resistant Gonorrhea (SURRG) are to: (1)
Improve national, state, and local
capacity to rapidly detect, monitor, and
respond to emerging antibiotic-resistant
gonorrhea (and get actionable
information to local health
departments), (2) understand trends in
and factors contributing to antibioticresistant gonorrhea, and (3) build a
robust evidence base for public health
action. This information collection is
important because: (1) Effective
treatment of gonorrhea is critical to
gonorrhea control and prevention, (2)
untreated or inadequately treated
gonorrhea can cause serious
reproductive health complications, such
as infertility, (3) Neisseria gonorrhoeae
(the bacterium that causes gonorrhea)
has consistently demonstrated the
ability to develop antibiotic resistance
and may be developing resistance to the
last remaining treatment option
recommended by the Centers for Disease
Control and Prevention (CDC), and (4)
antibiotic-resistant gonorrhea is
extremely difficult to detect without
enhanced surveillance and public
health activities, such as SURRG,
because healthcare providers rarely
perform or have access to culture and
resistance testing for individual
patients.
Jurisdictions participating in SURRG
applied as part of a competitive process
and will participate voluntarily. As an
overview of SURRG, healthcare
providers at participating clinics collect
specimens for N. gonorrhoeae culture

(approximately three hours every two
months). Microbiologists at public
health laboratories from each funded
jurisdiction conduct resistance testing
on ∼700 N. gonorrhoeae isolates each
year (600 clinical isolates and 100
control strains; each test ∼10 minutes).
Laboratory data managers take about
one hour every two months to abstract,
clean, and transmit data.
Health department staff will
interview: Any person diagnosed with
antibiotic-resistant gonorrhea or have a
case of gonorrhea of public health
significance index case, and their sexual
contacts. On average, each jurisdiction
will identify four drug-resistant isolates
each month; these isolates will spur
field investigations and six additional
interviews monthly. We estimate a total
of 120 interviews annually at each site,
for a total across the eight sites of 960
interviews each year. Each interview
will take ∼20 minutes.
The total estimated annual burden
hours are 2,665. This burden represents
a decrease from the burden of the initial
submission. The number of jurisdictions
decreased from nine to eight. So the
number of local data managers
decreased from nine to eight (and the
burden hours decreased from 1008 to
896), the number of public health
microbiologists decreased from nine to
eight (burden hours decreased from
1050 to 933), the number of lab data
managers decreased from nine to eight
(burden hours decreased from 54 to 48),
and the number of gonorrhea and
contacts decreased from 1080 to 960
(burden hours decreased from 540 to
480). The number of clinic sites will
increase from 18 to 26. Respondents
receive federal funds to participate in
this project. There are no additional
costs to respondents other than their
time.

testing. Specimens that demonstrate N.
gonorrhoeae (called ‘‘isolates’’) rapidly
undergo antibiotic resistance testing at
the local public health laboratory.
Detection of resistance is rapidly
communicated by laboratory staff to the
healthcare provider and health
department. The patient (from whom
the resistant specimen was collected) is
interviewed by local health department
staff about risk factors and recent
contacts, and will be re-tested to ensure
that they were cured. Recent contacts
are interviewed by the health
department (contact tracing) and tested
for gonorrhea. The participating health
departments collect and transmit to CDC
demographic and clinical data about
persons tested for and diagnosed with
gonorrhea in the participating clinics,
results of local antibiotic resistance
testing, and information about field
investigations. None of the data
transmitted to CDC contains any
personally identifiable information.
These data are used by CDC to monitor
and better understand resistance and
identify effective approaches to prevent
resistance spread. Data are transmitted
to CDC through a secure encrypted file
transfer application and stored in a
secure CDC server with strictly
controlled and restricted access rights.
In processes that take approximately
16 hours every two months (plus an
annual cumulative datafile), local
SURRG data managers abstract STD
clinic data for patients tested for
gonorrhea and field investigation data,
receive gonorrhea data from non-STD
clinic healthcare sites and resistance
testing results from local public health
laboratories, and clean and transmit
data to CDC.
Other data managers at each
participating non-STD clinic health
center abstract, clean, and transmit data

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Average
burden per
response
(hours)

Total burden
hours

Type of respondent

Form name

Local SURRG data manager ............
Data manager at non-STD clinic
health centers.
Public Health Laboratory Microbiologist.
Public Health Laboratory Data Manager.
Gonorrhea Patients, Social and Sexual Contacts.

STD Clinic Facility Data Elements ...
Non-STD Clinic Facility Data Elements.
Laboratory Data Elements ...............

8
26

7
6

16
3

896
468

8

700

10/60

933

Laboratory Testing Data Elements ..

8

6

1

48

Investigation Data Elements ............

960

1

0.33

320

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

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

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

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

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

2,665

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61752

Federal Register / Vol. 85, No. 190 / Wednesday, September 30, 2020 / Notices

Jeffery M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–21621 Filed 9–29–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
DD21–001, Study to Explore Early
Development (SEED) Follow up Studies.
Date: January 12–13, 2021.
Time: 10:00 a.m.–6:00 p.m., EST.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Jaya
Raman Ph.D., Scientific Review Officer,
CDC, 4770 Buford Highway, Mailstop
S107–8, Atlanta, Georgia 30341,

Telephone: (770) 488–6511, JRaman@
cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–21604 Filed 9–29–20; 8:45 am]

decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.

ADDRESSES:

SUPPLEMENTARY INFORMATION:

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; National
Advisory Committee on the Sex
Trafficking of Children and Youth in
the United States (NAC)
Recommendations and State SelfAssessment Survey (NEW)
Office on Trafficking in
Persons, Administration for Children
and Families, HHS.
ACTION: Request for public comment.
AGENCY:

The Office on Trafficking in
Persons (OTIP), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to collect
data for a new survey, the National
Advisory Committee on the Sex
Trafficking of Children and Youth in the
United States (NAC) Recommendations
and State Self-Assessment Survey.
DATES: Comments due within 30 days of
publication. OMB is required to make a
SUMMARY:

Description: The Preventing Sex
Trafficking and Strengthening Families
Act of 2014 mandated the NAC to
develop a report describing how each
state and territory has implemented its
recommendations to address sex
trafficking in children and youth. The
NAC proposes to administer a survey
allowing states to assess their progress
in implementing NAC
recommendations. Submissions will
allow states to document their efforts in
the following sections:
Multidisciplinary Response, Screening
and Identification, Child Welfare,
Service Provision, Housing, Law
Enforcement and Prosecution, Judiciary,
Demand Reduction, Prevention,
Legislation and Regulation, Research
and Data, and Funding. Each state will
have the opportunity to provide a selfassessed tier ranking for each
recommendation, a justification of their
assessment, sources for their
assessment, and the public or private
nature of those sources.
Respondents: State Governors, Child
Welfare Agencies, Local Law
Enforcement, and Other Local Agencies.
Annual Burden Estimates:

ESTIMATED OPPORTUNITY COSTS FOR RESPONDENTS
Instrument

Total number
of respondents
contributing for
50 states

Total number of
responses per
respondent

250

1

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NAC Recommendations and State Self-Assessment Survey .......................

Estimated Total Annual Burden
Hours: 1,713.

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Average
burden hours
per response
6.85

Total/annual
burden hours
1,713


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