60d FRN - published

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Federal Register / Vol. 88, No. 146 / Tuesday, August 1, 2023 / Notices
clinical data from diagnosing providers,
matching cases with existing health
department disease registries and brief
patient demographic and behavioral
interviews (10 minutes per response).
The population of interest includes all
persons diagnosed and reported with
gonorrhea and syphilis; existing case
records are matched to other health
department disease registries to
determine co-infections and to
document laboratory and treatment
information known by the health
department through routine case
investigations and local laboratory
reporting. In the proposed Revision,
syphilis cases will also be selected for
enhanced provider and patient
investigations utilizing the same
consensus protocols used for enhanced
gonorrhea case investigations.
Considering recent increases in syphilis
cases in the U.S., especially congenital
syphilis, these data are critical to
informing local and national syphilis

prevention and control activities. SSuN
recipients implement protocols
providing uniformly coded data on
demographic characteristics, behavioral
risk factors, clinical care, laboratory data
and health care seeking behaviors that
are combined into a national dataset
following data quality assurance at CDC.
In 2021, there were 211,791 cases of
gonorrhea diagnosed and reported
across the 11 current recipients of
SSuN. Approximately 7.4%, or 15,715
cases were randomly sampled for
enhanced investigation; full enhanced
investigations were completed for 6,186
(39.4%). During the COVID–19 public
health emergency, a slightly larger
proportion of cases were lost to followup than in prior years due to local
staffing shortages, issues with timely
laboratory and case reporting, and
higher than average patient refusals. No
additional burden is anticipated from
the future inclusion of early syphilis
cases in Strategy B because of the

decrease in gonorrhea case
investigations.
Data managers at each of the local/
state health departments or clinical
facilities receiving funding are
responsible for transmitting validated
datasets for these activities to CDC every
other month. This reflects 5,280 burden
hours for Strategy A and B data
management (11 respondents x 12 data
transmissions x 40 hours per data
transmission), which includes
automated HIV registry matching which
was previously included as a separate
activity; burden for this previously
approved component as a separate
activity is reduced to zero.
The total estimated annual burden
hours are 7,487 for SSuN. Respondents
from local/state health departments
and/or clinical facilities receive federal
funds to participate in this project.
There are no costs to patients or
respondents other than their time and
no risk or penalty for non-participation.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Data managers at sentinel STD clinics ..........
General Public—Adults (persons diagnosed
with gonorrhea).
Data Managers: local/state health departments (strategy A).

Electronic Clinical Record Abstraction ...........
Patient interviews for a random sample of
gonorrhea and syphilis cases.
Data cleaning/validation, HIV registry matching and data transmissions for all activity
components.
Data cleaning/validation, HIV registry matching and data transmissions for all activity
components.
Clinic waiting room surveys ...........................

Data Managers: local/state health departments (strategy B).
General Public—Adults (persons presenting
for care in STD Clinics).

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–16220 Filed 7–31–23; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

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[60Day–23–0260; Docket No. CDC–2023–
0065]

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:

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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 continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Health Hazard
Evaluations/Technical Assistance and
Emerging Problems. This data collection
is designed to assist the National
Institute for Occupational Safety and
Health (NIOSH) in responding to
requests for Health Hazard Evaluations
(HHEs) to identify chemical, biological
or physical hazards in workplaces
throughout the United States.

SUMMARY:

CDC must receive written
comments on or before October 2, 2023.

DATES:

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Number of
responses per
respondent

Average hours
per response

40
7,000

6
1

4
10/60

11

6

40

11

6

40

1000

1

5/60

Number of
respondents

Type of respondent

You may submit comments,
identified by Docket No. CDC–2023–
0065 by either of the following methods:
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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,
ADDRESSES:

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Federal Register / Vol. 88, No. 146 / Tuesday, August 1, 2023 / Notices

Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 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;
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.

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Proposed Project
Health Hazard Evaluations/Technical
Assistance and Emerging Problems
(OMB Control No. 0920–0260, Exp. 3/
31/2024)—Revision—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In accordance with its mandates
under the Occupational Safety and
Health Act of 1970 and the Federal
Mine Safety and Health Act of 1977,
NIOSH responds to requests for Health
Hazard Evaluations (HHE) to identify

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chemical, biological or physical hazards
in workplaces throughout the United
States. Each year, NIOSH receives
approximately 250 such requests
although that number has been lower in
the most recent years presumably due to
the COVID–19 pandemic. Most HHE
requests come from workplaces in the
following industrial sectors: services,
manufacturing, health and social
services, transportation, and
construction.
A printed HHE request form is
available in English and in Spanish. The
form is also available on the internet
and differs from the printed version
only in format and in the fact that it can
be submitted directly from the website.
The request form takes an estimated 12
minutes to complete. The form provides
the mechanism for employees,
employers, and other authorized
representatives to supply the
information required by the regulations
governing the NIOSH HHE program (42
CFR 85.3–1). NIOSH then reviews the
HHE request to determine if an on-site
evaluation is needed. The primary
purpose of an on-site evaluation is to
help employers and employees identify
and eliminate occupational health
hazards. For approximately 25% of the
requests received NIOSH determines an
on-site evaluation is needed. In
approximately 70% of these on-site
evaluations, employees are interviewed
in an informal manner to help further
define concerns. Interviews may take
approximately 15 minutes per
respondent. The interview questions are
specific to each workplace and its
suspected diseases and hazards.
However, interviews are based on
standard medical practices. In
approximately 30% of on-site
evaluations, questionnaires are
distributed or administered by NIOSH
staff to employees. Questionnaires may
require approximately 30 minutes to
complete. The survey questions are
specific to each workplace, and its
suspected diseases and hazards;
however, items in the questionnaires are
derived from standardized or widely
used medical and epidemiologic data
collection instruments.
Approximately two (less than 1%) of
the onsite evaluations involve medical
tests or the collection of biological
samples that would require informed
consent. The estimated time to complete
the informed consent process is 30
minutes. If 30 employees are monitored
at each of the two work sites, the burden
from this activity is 30 hours. Roughly
70% of the on-site evaluations involve
employee exposure monitoring in the
workplace. Employees participating in
on-site evaluations by wearing a

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sampling or monitoring device to
measure personal workplace exposures
are offered the opportunity to receive
notification of their exposure results. To
indicate their preference and, if
interested, provide contact information,
employees complete a contact
information post card or form.
Completing the contact card or form
may take five minutes or less. The
number of employees monitored for
workplace exposures per on-site
evaluation is estimated to be 25 per site.
NIOSH distributes interim and final
reports of health hazard evaluations,
excluding personal identifiers, to the
following: requesters, employers,
employee representatives; the
Department of Labor (Occupational
Safety and Health Administration or
Mine Safety and Health Administration,
as appropriate); state health
departments; and, as needed, other state
and federal agencies. NIOSH also
administers a followback program to
assess the effectiveness of its HHE
program in reducing workplace hazards.
This program entails the distribution of
followback surveys to employer and
employee representatives at all the
workplaces where NIOSH conducted an
on-site evaluation. In a small number of
instances, a followback on-site
evaluation may be completed. The first
followback survey is sent shortly after
the first visit for an on-site evaluation
and takes about 10 minutes to complete.
A second followback survey is sent after
the final report is completed and
requires about 20 minutes to complete.
At 12 months, a third followback survey
is sent, which takes about 15 minutes to
complete.
For requests where NIOSH does not
conduct an on-site evaluation, the
requestor receives the first followback
survey after our response letter is sent
and a second one 12 months after our
response. The first survey takes about 10
minutes to complete, and the second
survey takes about 15 minutes to
complete. Because of the number of
investigations conducted each year, the
need to respond quickly to requests for
assistance, the diverse and
unpredictable nature of these
investigations, and its followback
program to assess evaluation
effectiveness, NIOSH requests a
consolidated clearance for data
collections performed within the
domain of its HHE program. In
consideration of this planned
continuation, the program is submitting
this Revision to include the next three
years from the approval date. The total
estimated burden hours are 1745 hours.
There is no cost to respondents other
than their time.

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Federal Register / Vol. 88, No. 146 / Tuesday, August 1, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Employees and Representatives ..........

Health Hazard Evaluation Request
Form.
Health Hazard Evaluation Request
Form.
Health Hazard Evaluation specific
interview example.
Health Hazard Evaluation specific
questionnaire example.
HHE specific informed consent form ...
Contact information post card ..............
First Followback Survey .......................

Employers .............................................
Employees ............................................
Employees ............................................
Employees ............................................
Employees ............................................
Employees and Representatives; Employers—Year 1 (on-site evaluation).
Employees and Representatives; Employers—Year 1 (on-site evaluation).
Employees and Representatives; Employers—Year 2 (on-site evaluation).
Employees and Representatives; Employers—Year 1 (without on-site
evaluation).
Employees and Representatives; Employers—Year 2 (without on-site
evaluation).
Total ...............................................

35

75

1

12/60

15

1,470

1

15/60

368

2,100

1

30/60

1,050

60
1,225
140

1
1
1

30/60
5/60
10/60

30
102
23

Second Followback Survey ..................

140

1

20/60

47

Third Followback Survey ......................

140

1

15/60

35

First Followback Survey .......................

94

1

10/60

16

Second Followback Survey ..................

94

1

15/60

24

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

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

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

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

1,745

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10241]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are

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Total
burden
(in hours)

12/60

BILLING CODE 4163–18–P

VerDate Sep<11>2014

Average
burden per
response
(in hours)

1

[FR Doc. 2023–16221 Filed 7–31–23; 8:45 am]

SUMMARY:

Number of
responses per
respondent

175

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.

lotter on DSK11XQN23PROD with NOTICES1

Number of
respondents

Type of respondents

invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
October 2, 2023.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.

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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10241 Survey of Retail Prices
Under the 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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires Federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of

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