Federal Register Notice

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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices

work is cryptosporidiosis, an acute
diarrheal disease caused by infection
with Cryptosporidium parasites.
The Case Surveillance node is a subunit within the Domestic WASH
Epidemiology Team which focuses on
the data collection and management
activities of six waterborne diseases,
including cryptosporidiosis, in the
United States. The Case Surveillance
node’s current scope of work includes
modernizing data collection and
management, enabling data connections,
and improving public data access to aid
public health action.
CryptoNet is the first molecular
tracking system for Cryptosporidium in
the United States. To meet the needs of

order to systematically assess core
exposure elements and risk factors
among cases of cryptosporidiosis.
Collected data will be used by CDC staff
to inform cryptosporidiosis sporadic
case and cluster and outbreak
prevention and control strategies. CRF
data elements and the CRF form were
designed for administration via
telephone interviews with individuals
ill with cryptosporidiosis, or their
designated proxy.
CDC requests OMB approval for an
estimated 125 annual burden hours.
Providing information is voluntary, and
there are no costs to respondents other
than their time.

the CryptoNet, the Case Surveillance
node, and the needs of local officials,
the CryptoNet case report form (CRF)
was developed. The CRF includes a set
of data elements that can be used to
identify exposure trends in outbreakand non-outbreak-associated
Cryptosporidium cases, to generate
hypotheses about the source(s) of
infection in clusters or outbreaks, and to
identify strategies to prevent and control
Cryptosporidium cases, clusters, or
outbreaks.
Data from the CRF will be used by
federal, state, and local public health
officials responsible for conducting
interviews with reported cases of
cryptosporidiosis in their jurisdiction in

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Individuals ill with cryptosporidiosis, or their designated proxy.

CryptoNet Case Report
Form.

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–04669 Filed 3–5–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–0307 Docket No. CDC–2021–
0017]

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 ‘‘Gonococcal Isolate Surveillance

SUMMARY:

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Number of
respondents

Type of respondents

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

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Total burden
(in hours)

500

1

15/60

125

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

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

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

125

Project (GISP)’’. The purpose of GISP is
to monitor trends in antimicrobial
resistance in N. gonorrhoeae strains in
the United States in order to establish a
scientific basis for the selection of
gonococcal therapies and to allow
proactive changes to treatment
guidelines before widespread resistance
and failures of treatment occur.
DATES: CDC must receive written
comments on or before May 7, 2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2021–
0017 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
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,

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Average
burden per
response
(in hours)

Number of
responses per
respondent

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Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7118; 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 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;

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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices
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.

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Proposed Project
Gonococcal Isolate Surveillance
Project (OMB Control No. 0920–0307,
Exp. 8/31/2021)—Revision—National
Center for HIV/AIDS, Viral Hepatitis,
STD, TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Gonococcal Isolate Surveillance
Project (GISP) was created in 1986 to
monitor trends in antimicrobial
susceptibilities of Neisseria gonorrhoeae
strains in the United States. GISP
continues to be a collaboration between
different branches of the CDC’s Division
of STD Prevention, selected regional
laboratories and selected state/local
public health departments and their
associated STD specialty care clinics in
the United States. National
organizations, local jurisdictions and
individuals use data collected in GISP
to understand, monitor, and prevent
further transmission of antibiotic
resistant strains of N. gonorrhoeae. Data
from GISP are used to establish a
scientific basis for the selection of
gonococcal therapies and to allow proactive changes to treatment guidelines
before widespread resistance and
failures of treatment occur. To increase
capacity to detect and monitor resistant
gonorrhea and to improve the specificity
of GISP, this revision is being submitted
to include collection of remnant nucleic
acid amplification test (NAAT)
specimens and updated data element
options for treatment received based on
the 2020 updated gonorrhea treatment
recommendations.
GISP core surveillance activities
sample <4% of reported male gonorrhea
cases in the United States and are
limited to urethral infections only. In
2018, enhanced GISP (eGISP) began
sampling female genital (endocervical
and vaginal) and male and female
extragenital (pharyngeal and rectal)
anatomic sites, in addition to the male
genital site already sampled in GISP
core surveillance. Including isolates
from the pharynx and other anatomic
sites, as well as from women, expands

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on GISP’s public health efforts to detect
and respond to resistance more quickly.
GISP surveillance was also strengthened
with the addition of eGISP by
identifying isolates that are culture
positive for N. gonorrhoeae, but
negative by NAAT, which is a more
specific diagnostic test. This helped to
ensure that non-gonococcal bacteria are
excluded from gonococcal data,
strengthening the accuracy and
usefulness of GISP data, especially
when clinical syndromes with other
Neisseria species are indistinguishable
from gonorrhea.
To further improve and strengthen
GISP surveillance, an additional
enhanced surveillance activity in the
form of molecular surveillance has been
added to this revision. Participating
sites already locally performing NAATs
would retain the leftover gonorrheapositive samples (remnant) after
diagnostic results have been determined
and reported as part of standard care.
The gonorrhea-positive remnant NAAT
sample would be frozen, stored and
then shipped directly to CDC on a
monthly basis for molecular
characterization of known resistanceconferring gene mutations. Remnant
NAAT specimens from any anatomic
site (including from the urethra,
pharynx, rectum, vagina and cervix) of
gonorrhea positive persons will be
accepted. We anticipate that 10 sites
will participate in this molecular
surveillance activity and we anticipate
up to ∼70 positive remnant NAAT
specimens per month will be sent by
each of these 10 sites to CDC for testing.
To maintain accurate collection of
GISP data elements, this revision also
includes the updated weight-based
dosing of ceftriaxone and cefixime. In
December 2020, CDC released the
Update to CDC’s Treatment Guidelines
for Gonococcal Infection. These new
treatment recommendations increased
the dose of the recommended regimen
and the dose for an alternative regimen
(ceftriaxone and cefixime, respectively).
These values, collected and recorded
under the received treatment data
element, are being added to allow for
the collection of treatment data
consistent with these updated
recommendations.
Under this revision, the data
collection and processes for all GISP
activities are unchanged. The increased
dosages for ceftriaxone and cefixime
treatments allow for new data element
options, but not a change in the number
of data elements or the current work
demand to collect them. All
demographic/clinical data from the
sentinel sites will be submitted

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13395

electronically directly from the sentinel
sites to the GISP data manager at CDC
through; (1) a secure data portal, or (2)
through the CDC Secure Access
Management Services partner portal. To
minimize burden, comma-separated
values (csv) files that provide
standardized structure of the electronic
data are provided to sentinel sites and
laboratories. Additionally, to further
minimize burden, the regional
laboratories will be able to extract
electronic data directly from electronic
laboratory information systems instead
of hand entering data. Laboratories are
not required to report control strain
testing results.
This project will not collect name,
social security number, or date of birth.
A Patient ID, a unique patient identifier
assigned by the site that allows for
linking of multiple isolates from a single
person at a single clinic visit and across
multiple clinic visits, is requested and
will be provided to CDC for purposes of
enhanced surveillance. Sensitive
information such as sex of sex partners,
HIV status, sex work exposure, and
injection drug use are collected. Patient
data are obtained through review of
medical records by the clinic staff and
included in collection reporting of
demographic/clinical information. All
personally identifiable information (PII)
is retained by the STD clinics that
treated the patient and is not recorded
with data sent to CDC or regional
laboratories. The electronic GISP
database is stored on the CDC
mainframe computer and only approved
Division of STD Prevention (DSTDP)
staff have access rights to the data. As
part of the revision, we will continue to
systematically identify the risks and
potential effects of collecting,
maintaining, and disseminating PII and
to examine and evaluate alternative
processes for handling that information
to mitigate potential privacy risks and
risks to confidentiality.
The CDC has designated N.
gonorrhoeae as one of five ‘‘urgent’’
antibiotic resistance threats in the
United States. The CDC is requesting a
three-year OMB approval for this
revision, which directly responds to the
National Strategy for Combating
Antibiotic Resistant Bacteria by
improving and strengthening
surveillance of antimicrobial resistance
through GISP. GISP data can help
monitor and evaluate the effectiveness
of public health interventions
conducted to support the National
Strategy for Combating Antibiotic
Resistant Bacteria. There are no costs to
respondents other than their time.

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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Sentinel site conducting culturebased core surveillance.
Sentinel site conducting culturebased enhanced surveillance.
Sentinel site conducting molecular
enhanced surveillance.
Regional laboratory ...........................

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

Demographic/Clinical Data
ment 3a1).
Demographic/Clinical Data
ment 3a2).
Demographic/Clinical Data
ment 3a2).
Antimicrobial Susceptibility
Results (Attachment 3b).
Control Strain Susceptibility

[FR Doc. 2021–04671 Filed 3–5–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Family
Violence Prevention and Services
Program (OMB #0970–0280)
Family and Youth Services
Bureau; Administration on Children,
Youth and Families; Administration for
Children and Families (ACF); HHS.
ACTION: Request for public comment.
AGENCY:

The Administration on
Children, Youth and Families, Family
and Youth Services Bureau plans to

SUMMARY:

Total burden
hours

(Attach-

20

240

11/60

880

(Attach-

10

840

12/60

1,680

(Attach-

10

840

12/60

1,680

Testing

4

3,300

40/60

8,800

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

48

5/60

16

44

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

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

13,056

Testing

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Form name

extend data collection for the Family
Violence Prevention and Services
Program (OMB #0970–0280; Expiration
Date: March 31, 2021). No changes are
proposed to the existing information
collection.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about 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.
ADDRESSES: 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.

SUPPLEMENTARY INFORMATION:
Description: The Family Violence
Prevention and Services Act (FVPSA)
Program has a legislative requirement
for grantees to report on activities
carried out throughout their grant
period and provide an evaluation on the
effectiveness of the activities in
achieving the purposes of the grant.
Grantees must collect unduplicated data
and only share non-personally
identifying information, in the
aggregate, regarding services to their
clients in order to comply with federal,
state, or tribal reporting, evaluation, or
data collection requirements, 42 U.S.C.
10406(c)(5)(D). Client-level data shall
not be shared with a third party,
regardless of encryption, hashing, or
other data security measures, without a
written, time-limited release as
described in 42 U.S.C. 10406(c)(5).
Respondents: FVPSA-funded
grantees.

ANNUAL BURDEN ESTIMATES

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FVPSA State Grants Funding Opportunity Announcement
FVPSA Tribes/Tribal Organizations Grants Funding Opportunity Announcement ................................................
FVPSA State Domestic Violence Coalitions Grants Funding Opportunity Announcement ......................................
State FVPSA Grant Performance Progress Report ..........
Tribal FVPSA Grant Performance Progress Report ..........
State Domestic Violence Coalition Performance Progress
Report .............................................................................

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Total number
of responses
per respondent

Number of
respondents

Instrument

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Average
burden hours
per response

Total burden
hours

Annual burden
hours

52

1

10

520

173

150

1

10

1,500

500

56
52
150

1
3
3

10
10
10

560
1,560
4,500

187
520
1,500

56

3

10

1,680

560

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