60 day FRN

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monitoring. This information includes
an Environmental Public Health
Tracking Workplan Template, a
Performance Measure Report, a
Communication Plan, a Partnership
Plan, and a website Analytics Template.
Each of these forms are collected
annually as documents emailed to the
Tracking Program. A public health
action (PHA) report is submitted at least
once and up to four times a year via
email to the Tracking Program as funded
SLHD have PHA to report.
Over the past three years, these data
were used to identify funded SLHD in

some cases, the data at the source are
centralized and easily extracted. In
other cases, like for radon data, the data
are not. In those cases, the number of
hours for extracting and standardizing
the data is much greater. Four
respondents have been added to the 26
SLHDs the program currently funds to
account for the data voluntarily received
from unfunded SLHDs and to allow for
potential program growth over the next
three years.

need of additional technical assistance,
identify common challenges and
successes, improve communication
between funded SLHD and CDC, and to
monitor funded SLHD compliance with
funding requirements.
There are no costs for the respondents
other than their time. The total
estimated time burden is 21,860 hours.
This estimate includes the time it takes
to extract the data from the original data
source(s), standardize and format the
data to match the corresponding
Tracking Network data form, and submit
the data to the Tracking Network. In

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Avg. burden
per response
(in hrs.)

Total burden
(in hrs.)

Form name

State and local health departments ..

Birth defects prevalence ..................
Childhood lead blood levels .............
Community drinking water monitoring.
Emergency department visits ...........
Hospitalizations ................................
Radon testing ...................................
Metadata records .............................
EPHT Work Plan ..............................
Public Health Action Report .............
Performance Measure Report ..........
Communications plan .......................
Partnership plan ...............................
Website analytics .............................

22
18
30

1
1
1

80
80
100

1760
1440
3000

30
30
18
30
30
30
30
30
30
30

1
1
1
6
1
4
1
1
1
2

80
80
100
20
40
20
20
20
20
1

2400
2400
1800
3600
1200
2400
600
600
600
60

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

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

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

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

21,860

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–02542 Filed 2–7–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–0260; Docket No. CDC–2020–
0008]

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:

jbell on DSKJLSW7X2PROD with NOTICES

Number of
respondents

Type of respondent

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

SUMMARY:

VerDate Sep<11>2014

16:58 Feb 07, 2020

Jkt 250001

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 Health Hazard Evaluations/
Technical Assistance and Emerging
Problems. This proposed collection, in
accordance with mandates under the
Occupational Safety and Health Act of
1970 and the Federal Mine Safety and
Health Act of 1977, allows the National
Institute for Occupational Safety and
Health (NIOSH) to respond to requests
for HHEs to identify chemical,
biological or physical hazards in
workplaces throughout the United
States.
CDC must receive written
comments on or before April 10, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0008 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
DATES:

PO 00000

Frm 00035

Fmt 4703

Sfmt 4703

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,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; 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

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Federal Register / Vol. 85, No. 27 / Monday, February 10, 2020 / Notices
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
Health Hazard Evaluations/Technical
Assistance and Emerging Problems
(OMB Control No. 0920–0260, Exp. 10/
31/2020)—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 Evaluation (HHE) to identify
chemical, biological or physical hazards
in workplaces throughout the United
States. Each year, NIOSH receives
approximately 250 such requests. Most
HHE requests come from workplaces in
the following industrial sectors:

contact card 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:
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 administers a follow-back
program to assess the effectiveness of its
HHE program in reducing workplace
hazards. This program entails the
mailing of follow-back questionnaires 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 follow-back
questionnaire is sent shortly after the
first visit for an on-site evaluation and
takes about 10 minutes to complete. A
second follow-back questionnaire is sent
after the final report is completed and
requires about 20 minutes to complete.
At 12 months, a third follow-back
questionnaire 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 follow-back
questionnaire after our response letter is
sent and a second one 12 months after
our response. The first questionnaire
takes about 10 minutes to complete and
the second questionnaire 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 follow-back
program to assess evaluation
effectiveness, NIOSH requests a
consolidated clearance for data
collections performed within the
domain of its HHE program. The total
estimated burden hours is 1715. There
is no cost to respondents other than
their time.

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 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 25% of the requests
received, NIOSH determines an on-site
evaluation is needed.
In about 70% of 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 to the employees (averaging
about 100 employees per site).
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.
About 70% of the on-site evaluations
involve employee exposure monitoring
in the workplace. Employees
participating in on-site evaluations by
wearing a sampler or monitoring device
to measure personal workplace
exposures are offered the opportunity to
get notification of their exposure results.
To indicate their preference and, if
interested, provide contact information,
employees complete a contact
information post card. Completing the

jbell on DSKJLSW7X2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Employees and Representatives ......

VerDate Sep<11>2014

16:58 Feb 07, 2020

Number of
respondents

Form name

Health Hazard Evaluation Request
Form.

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Fmt 4703

Number of
responses per
respondent

175

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1

10FEN1

Average
burden per
response
(in hrs.)
12/60

Total burden
(in hrs.)
35

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Federal Register / Vol. 85, No. 27 / Monday, February 10, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name

Employers * .......................................

Health Hazard Evaluation Request
Form.
Health Hazard Evaluation specific
interview example.
Health Hazard Evaluation specific
questionnaire example.
Contact information post card ..........
First follow-back questionnaire ........

Employees ........................................
Employees ........................................
Employees ........................................
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 onsite evaluation).
Employees and Representatives;
Employers—Year 2 (without onsite evaluation).
Total ...........................................

12/60

15

1,470

1

15/60

368

2,100

1

30/60

1,050

1,225
140

1
1

5/60
10/60

102
23

Second follow-back questionnaire ...
Third follow-back questionnaire .......

140
140

1
1

20/60
15/60

47
35

First follow-back questionnaire ........

94

1

10/60

16

Second follow-back questionnaire ...

94

1

15/60

24

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

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

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

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

1,715

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1095]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Submission Process for Voluntary
Allegations to the Center for Devices
and Radiological Health
Food and Drug Administration,

HHS.
Notice.

The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
voluntarily submitted to the Center for

jbell on DSKJLSW7X2PROD with NOTICES

SUMMARY:

VerDate Sep<11>2014

16:58 Feb 07, 2020

Total burden
(in hrs.)

1

[FR Doc. 2020–02541 Filed 2–7–20; 8:45 am]

ACTION:

Average
burden per
response
(in hrs.)

75

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

AGENCY:

Number of
responses per
respondent

Number of
respondents

Type of respondents

Jkt 250001

Devices and Radiological Health (CDRH)
on actual or potential health risk
concerns about a medical device or
radiological product or its use.
DATES: Submit either electronic or
written comments on the collection of
information by April 10, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 10,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 10, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or

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Sfmt 4703

confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–1095 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Electronic Submission Process for
Voluntary Allegations to the Center for
Devices and Radiological Health.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be

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