Agency Forms Undergoing Paperwork Reduction Act Review, 35292-35294 [2021-14226]
Download as PDF
lotter on DSK11XQN23PROD with NOTICES1
35292
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
facilities covered by the EEOICPA
programs; or familiarity, experience, or
history of participation with the
EEOICPA program. Any interested
person or organization may nominate
one or more individuals for
membership. Interested persons are also
invited and encouraged to submit
statements in support of nominees.
The ABRWH consists of not more
than 20 members appointed by the
President of the United States. As
required by 42 U.S.C. 7384o(a)(2), the
President makes appointments to the
ABRWH in consultation with
organizations with expertise on worker
health issues in order to ensure that the
membership of the ABRWH reflects a
balance of scientific, medical, and
worker perspectives. As required by 42
U.S.C. 7384o(a)(3), the President
designates a Chair for the ABRWH from
among its members. The authorizing
statutory provision under 42 U.S.C.
7384o and Section 4 of Executive Order
13179 do not include a limit for terms
of appointment for ABRWH members.
Nomination Process: Any interested
person or organization may nominate
one or more qualified individuals for
membership. If you would like to
nominate an individual or yourself for
appointment to the ABRWH, please
submit the following information:
• The nominee’s contact information
(name, title, business address, business
phone, fax number, and/or business
email address) and current employment
or position.
• A copy of the nominee’s resume or
curriculum vitae; category of
membership (e.g., scientific, medical,
and/or worker perspective) that the
nominee represents; a summary of the
background, experience, and
qualifications that addresses the
nominee’s suitability for the nominated
membership category identified above.
• Articles or other documents the
nominee has authored that indicate the
nominee’s knowledge, experience, and
expertise in the fields of health physics,
industrial hygiene, toxicology,
epidemiology, occupational medicine,
or the worker perspective in the nuclear
facilities covered by the EEOICPA
program; or familiarity, experience, or
history of participation with the
EEOICPA program. Nominations may be
submitted by the candidate him or
herself, or by the person/organization
recommending the candidate.
• At least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services. Candidates
may submit letter(s) from current HHS
employees if they wish, but at least one
letter must be submitted by a person not
VerDate Sep<11>2014
17:12 Jul 01, 2021
Jkt 253001
employed by an HHS agency (e.g., CDC,
NIH, FDA, etc.).
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. 2021–14204 Filed 7–1–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–0307]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Gonococcal
Isolate Surveillance Project (GISP)’’ to
the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on March 8, 2021 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
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. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Gonococcal Isolate Surveillance
Project—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)
E:\FR\FM\02JYN1.SGM
02JYN1
35293
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
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
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
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. The
estimated annual burden is 13,056
hours.
lotter on DSK11XQN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Type of respondent
Form name
Sentinel site conducting culture-based core
surveillance.
Sentinel site conducting culture-based enhanced surveillance.
Sentinel site conducting molecular enhanced
surveillance.
Regional laboratory .........................................
Demographic/Clinical Data .............................
20
240
11/60
Demographic/Clinical Data .............................
10
840
12/60
Demographic/Clinical Data .............................
10
840
12/60
Antimicrobial Susceptibility Testing Results ..
Control Strain Susceptibility Testing ..............
4
3,300
48
40/60
5/60
VerDate Sep<11>2014
17:12 Jul 01, 2021
Jkt 253001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
E:\FR\FM\02JYN1.SGM
02JYN1
35294
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–14226 Filed 7–1–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–21GA Docket No. CDC–2021–
0061]
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
proposal to allow CDC’s National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention (NCHHSTP), Division of
Adolescent and School Health (DASH)
to conduct a research information
collection project titled ‘‘Teen and
Parents Surveys of Health (TAPS)’’. This
project serves to inform the CDC’s
Division of Adolescent and School
Health’s (DASH) key school-based
programmatic strategies of improving
family- and school-level protective
factors, bolstering health education, and
increasing adolescent access to quality
health services.
DATES: CDC must receive written
comments on or before August 31, 2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2021–
0061 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:12 Jul 01, 2021
Jkt 253001
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:
404–639–7118; 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;
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; and
5. Assess information collection costs.
Proposed Project
Teen and Parents Surveys of Health
(TAPS)—New—National Center for
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Division of
Adolescent and School Health (DASH)
requests approval for ‘‘Teen and Parent
Surveys of Health (TAPS)’’ through an
existing online panel using NORC at the
University of Chicago’s AmeriSpeaks
panel. Documenting health-related risk
behaviors and experiences and health
outcomes of young people through
routine surveillance is a critical
component of DASH’s prevention
efforts. Another component of DASH’s
efforts to improve adolescent health is
observational research to inform its
school-based programmatic strategies.
This type of research serves to inform
priority settings and sub-populations for
intervention as well as specific
intervention strategies. TAPS data will
allow DASH to refine existing strategies
for funded school district partners to
improve the quality of their programs
and services to prevent HIV, other STDs,
and pregnancy among adolescents, as
well as improve mental health, sexual
health and other adolescent health
outcomes (e.g., substance use, violence
victimization). Data will be used to
inform DASH’s key school-based
programmatic strategies of improving
family- and school-level protective
factors, bolstering health education, and
increasing adolescent access to quality
health services. This observational
research complements and extends
DASH’s ongoing surveillance efforts
through the Youth Risk Behavioral
Surveillances System (YRBSS) (OMB
Control No. 0920–0493, Exp. 11/30/
2023), which provides key national
estimates of adolescent health risk
behaviors and health outcomes, by
providing a deeper dive into individual,
family, and school factors that
positively associate with adolescent
behaviors and health outcomes.
Collecting this observational data
provides the opportunity to examine
untested associations of protective
factors, health education experiences,
and health service use (immediate
outcomes of DASH strategies) with
mental health, sexual health, and
substance use outcomes.
CDC requests approval for an
estimated 1,378 annual burden hours.
There are no costs to respondents other
than their time to participate.
E:\FR\FM\02JYN1.SGM
02JYN1
Agencies
[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35292-35294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-0307]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Gonococcal Isolate Surveillance Project
(GISP)'' to the Office of Management and Budget (OMB) for review and
approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and Recommendations'' notice on March 8,
2021 to obtain comments from the public and affected agencies. CDC did
not receive comments related to the previous notice. This notice serves
to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. 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. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Gonococcal Isolate Surveillance Project--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
pro-active 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)
[[Page 35293]]
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 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 gonorrhea-positive 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 resistance-conferring 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 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. The estimated annual
burden is 13,056 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Sentinel site conducting culture-based Demographic/Clinical 20 240 11/60
core surveillance. Data.
Sentinel site conducting culture-based Demographic/Clinical 10 840 12/60
enhanced surveillance. Data.
Sentinel site conducting molecular Demographic/Clinical 10 840 12/60
enhanced surveillance. Data.
Regional laboratory................... Antimicrobial 4 3,300 40/60
Susceptibility Testing
Results.
Control Strain 48 5/60
Susceptibility Testing.
----------------------------------------------------------------------------------------------------------------
[[Page 35294]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-14226 Filed 7-1-21; 8:45 am]
BILLING CODE 4163-18-P