60 Day FRN

4894

Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices

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
Research Data Center Proposal for
Access to Confidential Data for the
National Center for Health Statistics—
Existing Collection in use without an
OMB Control Number—National Center
for Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).

Background and Brief Description
Section 306(b)(4) of the Public Health
Service (PHS) Act (42 U.S.C. 242k(b)(4)),
as amended, authorizes that the
Secretary of Health and Human Services
(DHHS), acting through NCHS, receive
requests for providing data and statistics
to the public. NCHS receives requests
for confidential data from the public
through the Research Data Center
Proposal for Access to Confidential
Data. This is a request for approval from
OMB to collect information via the
Researcher Data Center proposal.
As part of a comprehensive data
dissemination program, the Research
Data Center (RDC), National Center for
Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC),
requires prospective researchers who
need access to confidential data to
complete a research proposal.
Researchers self-select whether they

need access to confidential data to
answer their research questions. The
RDC requires the researcher to complete
a research proposal so NCHS
understands the research proposed,
whether confidential data are available
to address the research questions, how
the confidential data will be used, and
what data outputs the researcher needs
to satisfy their project. The completed
proposal is sent to NCHS for
adjudication on whether the proposed
research is possible. NCHS estimates
receipt of an average of 110 proposals
per year. All information collection is
conducted electronically.
OMB approval is requested for three
years. The estimated burden per
response is three hours and there are no
costs to respondents other than their
time to complete the proposal. The total
estimated annualized burden is 330
hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Researcher ......................................................

Research Data Center proposal ....................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–01824 Filed 1–28–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–22CA; Docket No. CDC–2022–
0013]

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

SUMMARY:

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Number of
respondents

Type of respondents

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proposed information collection project
titled Fire Fighter Fatality Investigation
and Prevention Program Survey which
will evaluate fire department
implementation of the National Institute
for Occupational Safety and Health
(NIOSH) Fire Fighter Fatality
Investigation and Prevention Program
(FFFIPP) recommendations. The
evaluation will assess whether NIOSH
FFFIPP recommendations are utilized
by fire departments, identify barriers to
implementation of recommendations,
and identify areas for potential
intervention projects.
DATES: CDC must receive written
comments on or before April 1, 2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0013 by either 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 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
regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal

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110

Number of
responses per
respondent

Avg. burden
per response
(in hours)

1

3

(regulations.gov) or by U.S. mail to the
address listed above.
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, H21–
8, Atlanta, Georgia 30329; phone: 404–
639–7570; Email: [email protected].

FOR FURTHER INFORMATION CONTACT:

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:

SUPPLEMENTARY INFORMATION:

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4895

Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices
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
Fire Fighter Fatality Investigation and
Prevention Program (FFFIPP) Survey—
New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The FFFIPP conducts independent
investigations of fire fighter (FF) line-ofduty deaths and recommends ways to
prevent deaths and injuries. In 2003, an
evaluation was conducted to determine

This data collection will assess FD
implementation of the NIOSH FFFIPP
recommendations and identify barriers
to implementation of recommendations.
Results will provide an understanding
of current FD operational procedures,
insight into motor vehicle-related
activities and related policies and
identify whether FFFIPP
recommendations are being utilized by
FDs. Findings will inform strategies for
communication of future
recommendations and identify areas for
potential intervention projects in order
to improve the delivery of services and
help ensure an effective and efficient
stakeholder experience with the FFFIPP.
The estimate for burden hours is
based on a pilot test of the survey
instrument by eight FD personnel. In the
pilot test, the average time to complete
the survey including time for reviewing
instructions, gathering needed
information, and completing the survey
was 10–25 minutes. For the purposes of
estimating burden hours, the upper
limit of this range is used. There are
screening questions at the beginning of
the survey so all respondents may not
actually participate.
The respondent universe is based on:
(1) 4,500 FDs, (2) eight strata (region,
department type), and (3) position (FF,
chief, company officer). An estimated
13,500 respondents are anticipated to
participate in the survey. The annual
respondent burden is estimated to be
4,050 hours.

the extent to which recommendations
from NIOSH investigations of FF
fatalities are being implemented by fire
departments (FDs). Since then, there
have been changes to the FFFIPP
recommendations and methods of
disseminating FFFIPP reports. For
example, there have been changes to: (1)
The details and types of
recommendations for preventing FF
fatalities, and (2) the method to
disseminate the FFFIPP reports to FDs
(driven in large part by cost).
Dissemination methods have evolved
from hardcopy mailings to FDs to
internet-based, with notifications of new
FFFIPP reports by the fire service media
and if FDs sign-up at the NIOSH website
for notifications of new reports.
Understanding how or if NIOSH
recommendations are used by various
types of FDs will allow a better
understanding of barriers to the use of
proven prevention recommendations
and help identify approaches to
improve the delivery of services to FDs.
Additionally, we will gain insight into
whether changes to the communication
and dissemination have impacted the
reach of these recommendations.
Knowing if different types of FDs are
aware of and willing to access FFFIPP
reports and recommendations in nonprint formats is critical, as these
recommendations cannot have the
intended impact of saving FF lives if
large numbers of FDs do not know
where to find NIOSH reports or have the
resources to access them.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Fire Fighters ......................................
Fire Chiefs .........................................
Company Officers .............................

Survey ..............................................
Survey ..............................................
Survey ..............................................

4,500
4,500
4,500

1
1
1

18/60
18/60
18/60

1,350
1,350
1,350

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

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

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

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

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

4,050

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration

[FR Doc. 2022–01825 Filed 1–28–22; 8:45 am]

[Docket No. FDA–2019–D–0078]

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Principles of Premarket Pathways for
Combination Products; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

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Notice of availability.

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The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry and FDA staff
entitled ‘‘Principles of Premarket
Pathways for Combination Products.’’
This guidance presents FDA’s current
thinking on principles for premarket
review of combination products. This
guidance includes general, high-level
information regarding what combination
products are, coordination within FDA
and interaction between FDA and
sponsors regarding combination product
regulation, and how combination
products are reviewed by FDA before

SUMMARY:

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