Proposed Data Collection Submitted for Public Comment and Recommendations, 47424-47425 [2022-16561]
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47424
Federal Register / Vol. 87, No. 148 / Wednesday, August 3, 2022 / Notices
reconstruction cannot be completed and
encourage them to submit the petition.
NIOSH expects most petitioners for
whom Form B would be appropriate
will also use the form, since it provides
a simple, organized format for
addressing the informational
requirements of a petition.
NIOSH will use the information
obtained through the petition for the
following purposes: (a) identify the
petitioner(s), obtain their contact
information, and establish that the
petitioner(s) is qualified and intends to
petition HHS; (b) establish an initial
definition of the class of employees
being proposed to be considered for
addition to the Cohort; (c) determine
whether there is justification to require
decision relies on a record of either
factual or procedural errors in the
implementation of these procedures.
NIOSH estimates that the average time
to prepare and submit such a challenge
is five hours. Because of the uniqueness
of this submission, NIOSH is not
providing a form. The submission will
typically be in the form of a letter to the
Secretary.
CDC requests OMB approval for an
estimated 43 annual burden hours.
There are no costs to respondents other
than their time to participate, unless a
respondent/petitioner chooses to
purchase the services of an expert in
dose reconstruction, an option provided
for under the rule.
HHS to evaluate whether or not to
designate the proposed class as an
addition to the Cohort (such an
evaluation involves potentially
extensive data collection, analysis, and
related deliberations by NIOSH, the
Board, and HHS); and (d) target an
evaluation by HHS to examine relevant
potential limitations of radiation
monitoring and/or dosimetry-relevant
records and to examine the potential for
related radiation exposures that might
have endangered the health of members
of the class.
Finally, under the rule, petitioners
may contest the proposed decision of
the Secretary to add or deny adding
classes of employees to the cohort by
submitting evidence that the proposed
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hrs.)
Total burden
(in hrs.)
Form name
Petitioners .........................................
Form A: 42 CFR 83.9 ......................
Form B: 42 CFR 83.9 ......................
42 CFR 83.9 .....................................
2
5
1
1
1
1
3/60
5
6
1
25
6
42 CFR 83.18 ...................................
2
1
5
10
Authorization Form: 42 CFR 83.7 ....
3
1
3/60
1
...........................................................
........................
........................
........................
43
Petitioners using a submission format other than Form B (as permitted by rule).
Petitioners Appealing final HHS decision (no specific form is required).
Claimant authorizing a party to submit petition on his/her behalf.
Total ...........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–16563 Filed 8–2–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
agencies the opportunity to comment on
a proposed information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Assessing
Fatigue and Fatigue Management in U.S.
Onshore Oil and Gas Extraction. This
project is designed to evaluate oil and
gas extraction workers’ sleep, fatigue,
and other related factors, and their
relationship to risks associated with the
industry.
[60Day–22–22HO; Docket No. CDC–2022–
0091]
DATES:
Proposed Data Collection Submitted
for Public Comment and
Recommendations
ADDRESSES:
CDC must receive written
comments on or before October 3, 2022.
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondents
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
18:39 Aug 02, 2022
Jkt 256001
You may submit comments,
identified by Docket No. CDC–2022–
0091 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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,
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
E:\FR\FM\03AUN1.SGM
03AUN1
47425
Federal Register / Vol. 87, No. 148 / Wednesday, August 3, 2022 / Notices
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,
between sleep, fatigue, fatigue
management, and related factors, within
the onshore OGE industry.
Primary data will be collected using
three approaches. First, researchers will
collect direct measurements of sleep
and alertness among OGE workers.
Second, researchers will use
questionnaires to collect information on
OGE worker demographics, occupation,
general heath, normal working hours,
commute times, home life, physical
sleeping environment, and typical sleep
quality. Third, researchers will collect
qualitative information through
interviews with workers, front-line
supervisors, health and safety leaders,
as well as subject matter experts, to
understand challenges and
opportunities related to fatigue
management in the OGE industry.
CDC requests OMB approval for an
estimated 305 annual burden hours.
There is no cost to respondents other
than their time to participate.
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
Assessing Fatigue and Fatigue
Management in U.S. Onshore Oil and
Gas Extraction Industry—New—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Oil and gas extraction (OGE) workers
play an important role in supporting the
United States economy and help fulfill
the energy needs of Americans and
American businesses. OGE workers
have significant risks for a variety of
exposures at oil and gas well sites.
There has been no significant fatigue
research in the United States onshore
upstream OGE sector. This proposed
project will characterize relationships
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)
Total burden
(in hours)
Form name
Land-based OGE workers ................
Land-based OGE workers ................
Land-based OGE workers ................
Land-based OGE workers ................
Land-based OGE workers ................
Field-level Supervisors ......................
Health and Safety Leaders ...............
Subject Matter Experts .....................
Baseline Questionnaire ....................
Daily Pre-Shift Questionnaires .........
Daily Post-Shift Questionnaires .......
Psychomotor Vigilance Test (PVT) ..
Worker Interview Guide ...................
Manager Interview Guide .................
HSE Interview Guide ........................
SME Interview Guide .......................
80
80
80
80
30
10
7
3
1
14
14
28
1
1
1
1
12/60
3/60
3/60
3/60
90/60
1
1
1
16
56
56
112
45
10
7
3
Total ...........................................
...........................................................
........................
........................
........................
305
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–16561 Filed 8–2–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondents
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
18:39 Aug 02, 2022
Jkt 256001
announcing the availability of
additional draft and revised draft
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs). In the
Federal Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website. The guidances
identified in this notice were developed
using the process described in that
guidance.
Submit either electronic or
written comments on the draft guidance
by October 3, 2022 to ensure that the
Agency considers your comment on this
DATES:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
draft guidance before it begins work on
the final version of the guidance.
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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
confidential business information, such
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47424-47425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16561]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-22HO; Docket No. CDC-2022-0091]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: 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 information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Assessing Fatigue and Fatigue Management in U.S. Onshore Oil and
Gas Extraction. This project is designed to evaluate oil and gas
extraction workers' sleep, fatigue, and other related factors, and
their relationship to risks associated with the industry.
DATES: CDC must receive written comments on or before October 3, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0091 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, 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: [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
[[Page 47425]]
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
Assessing Fatigue and Fatigue Management in U.S. Onshore Oil and
Gas Extraction Industry--New--National Institute for Occupational
Safety and Health (NIOSH), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Oil and gas extraction (OGE) workers play an important role in
supporting the United States economy and help fulfill the energy needs
of Americans and American businesses. OGE workers have significant
risks for a variety of exposures at oil and gas well sites. There has
been no significant fatigue research in the United States onshore
upstream OGE sector. This proposed project will characterize
relationships between sleep, fatigue, fatigue management, and related
factors, within the onshore OGE industry.
Primary data will be collected using three approaches. First,
researchers will collect direct measurements of sleep and alertness
among OGE workers. Second, researchers will use questionnaires to
collect information on OGE worker demographics, occupation, general
heath, normal working hours, commute times, home life, physical
sleeping environment, and typical sleep quality. Third, researchers
will collect qualitative information through interviews with workers,
front-line supervisors, health and safety leaders, as well as subject
matter experts, to understand challenges and opportunities related to
fatigue management in the OGE industry.
CDC requests OMB approval for an estimated 305 annual burden hours.
There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Land-based OGE workers........ Baseline 80 1 12/60 16
Questionnaire.
Land-based OGE workers........ Daily Pre-Shift 80 14 3/60 56
Questionnaires.
Land-based OGE workers........ Daily Post-Shift 80 14 3/60 56
Questionnaires.
Land-based OGE workers........ Psychomotor 80 28 3/60 112
Vigilance Test
(PVT).
Land-based OGE workers........ Worker Interview 30 1 90/60 45
Guide.
Field-level Supervisors....... Manager 10 1 1 10
Interview Guide.
Health and Safety Leaders..... HSE Interview 7 1 1 7
Guide.
Subject Matter Experts........ SME Interview 3 1 1 3
Guide.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 305
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-16561 Filed 8-2-22; 8:45 am]
BILLING CODE 4163-18-P
