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Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices
requested for one year. The total

estimated annualized burden hours are
512.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Quantitative:
Healthcare Professionals (POC)
IT Staff .......................................
Qualitative:
Healthcare Professionals ...........
Total ....................................

50
50

1
1

20/60
7.5

17
375

Key Informant Interview ...................
Focus Groups ...................................

12
72

1
1

1
1.5

12
108

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

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

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

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

512

[FR Doc. 2019–04011 Filed 3–5–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–0980; Docket No. CDC–2019–
0011]

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
proposed information collection project
titled National Environmental
Assessment Reporting System (NEARS)
to collect data from foodborne illness
outbreak environmental assessments
routinely conducted by local, state,
territorial, or tribal food safety programs
during outbreak investigations.
DATES: CDC must receive written
comments on or before May 6, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0011 by any of the following methods:
SUMMARY:

18:35 Mar 05, 2019

Total
burden
(in hrs.)

Survey ..............................................
EMR data .........................................

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

VerDate Sep<11>2014

Average
burden per
response
(in hrs.)

Number of
responses per
respondent

Number of
respondents

Form name

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• 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
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
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:

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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
National Environmental Assessment
Reporting System (NEARS) (OMB
Control No. 0920–0980, Exp. 8/31/
2019)—Revision—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC is requesting OMB approval for
the National Environmental Assessment
Reporting System (NEARS) (0920–0980)
to collect data from foodborne illness
outbreak environmental assessments
routinely conducted by local, state,
territorial, or tribal food safety programs
during outbreak investigations. Prior to
the development of NEARS,
environmental assessment data were not
collected at the national level. The data
reported through this surveillance
system provides timely information on
the causes of outbreaks, including
environmental factors associated with

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Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices

outbreaks, and are essential to
environmental public health regulators’
efforts to respond more effectively to
outbreaks and prevent future, similar
outbreaks. This surveillance system was
specifically designed to link to CDC’s
National Outbreak Reporting System
(NORS), a disease (e.g. enteric diseases
transmitted by food) outbreak
surveillance system. NEARS was
developed by the Environmental Health
Specialists Network (EHS–Net), a
collaborative network of CDC, the U.S.
Food and Drug Administration (FDA),
the U.S. Department of Agriculture
(USDA), and nine state food safety
programs (California, Connecticut,
Georgia, Iowa, New York, Minnesota,
Oregon, Rhode Island, and Tennessee).
The network consists of environmental
health specialists (EHSs),
epidemiologists, and laboratorians.
EHS-Net developed a standardized
protocol for identifying, reporting, and
analyzing data relevant to foodborne
illness outbreak environmental
assessments.
While conducting environmental
assessments during outbreak
investigations is routine for food safety
program officials, reporting information
from the environmental assessments to
CDC is not routine. Local, state, federal,
territorial, and tribal food safety
programs are the primary respondents
for this data collection. One official
from each participating program will
report environmental assessment data
on outbreaks. These programs are
typically located in public health or
agriculture agencies. In the U.S., there
are approximately 3,000 such agencies.
Currently, 31 state and local health
departments are registered to report data
on outbreaks to NEARS. Based on our
experience over the past five years, we
expect up to 10 additional local and
state public health departments to

estimate the burden of this training to be
a maximum of 10 hours. Respondents
will only have to take this training one
time. Assuming a maximum
participation of up to 10 programs and
approximately five staff being trained at
each program, the estimated burden
associated with this training is 500
hours.
Data reporting activities for NEARS
will be done once for each
establishment involved in the outbreak.
Information collection activities for
NEARS consist of the following: NEARS
data reporting and NEARS manager
interview. For each outbreak, the
respondent (one official from each
participating program) will spend
around 30 minutes recording
environmental assessment data on pen
and paper. Assuming a maximum of 300
outbreaks, the estimated annual burden
is 150 hours for recording observations.
The manager interview will be
conducted at each establishment
associated with an outbreak and data is
initially recorded using pen and paper.
The respondents for this activity are the
retail food managers of the outbreak
establishments. Most outbreaks are
associated with only one establishment;
however, some are associated with
multiple establishments. We estimate
that a maximum of four manager
interviews will be conducted per
outbreak. Each interview and data
reporting will take about 20 minutes.
Assuming a maximum of 300 outbreaks,
the estimated annual burden is 400
hours. Web-based data entry for both
data recording and the manager
interview will be combined. Data entry
into the NEARS system is expected to
take approximately 40 minutes for the
combined activities, for a total of 200
burden hours. The total estimated
annual burden for this information
collection is 1,350 hours.

register to report outbreak data to
NEARS over the next three years. It is
not possible to determine exactly how
many outbreaks will occur in the future,
nor where they will occur. Based on
past trends, it is likely that up to 300
foodborne illness outbreaks may be
reported annually to NEARS from up to
41 entities for the duration of the next
PRA clearance. Only programs in the
jurisdictions in which these outbreaks
occur would report to NEARS. Thus, not
every program of the approximate 3,000
programs will respond every year.
Assuming each outbreak occurs in a
different jurisdiction, there will be one
respondent per outbreak.
The activities associated with NEARS
that require a burden estimate consist of
training, observing, data recording, and
data reporting events. The first activity
is the training for the food safety
program personnel participating in
NEARS. These staff will be encouraged
to attend a Skype Meeting (i.e., webinar)
training session conducted by CDC staff.
Training burden is based on the
maximum expected participation from
the reporting entities which could be up
to 10 additional local and state health
departments. We estimate the burden of
this training to be a maximum of two
hours. Respondents will only be
required to take this training one time.
Assuming a maximum participation of
up to 10 programs and about five staff
being trained at each participating
program, the total estimated burden
associated with this training is 100
hours.
Food safety program personnel
participating in NEARS will also be
encouraged to complete CDC’s
Environmental Assessment Training
Series (EATS). This eCourse provides
training to staff on how to use a systems
approach in foodborne illness outbreak
environmental assessments. We

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

Food safety program personnel ........

Retail food personnel ........................

NEARS Food Safety Program Training.
NEARS e-Learning (screenshots) ....
NEARS Data Recording (paper
form).
NEARS Data reporting and manager’s interview (web entry).
NEARS Manager Interview ..............

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

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

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Fmt 4703

Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

50

1

2

100

50
300

1
1

10
30/60

500
150

300

1

40/60

200

1200

1

20/60

400

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

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

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

1,350

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Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–04012 Filed 3–5–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1398]

Mitigation Strategies To Protect Food
Against Intentional Adulteration; Draft
Guidance for Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Mitigation Strategies to Protect Food
Against Intentional Adulteration:
Guidance for Industry.’’ The revised
draft guidance supersedes the version of
the intentional adulteration draft
guidance that we announced on June 20,
2018. This draft guidance document,
when finalized, will help food facilities
that manufacture, process, pack, or hold
food, and that are required to register
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) comply with
the requirements of our regulation
entitled ‘‘Mitigation Strategies to Protect
Food Against Intentional Adulteration.’’
DATES: Submit either electronic or
written comments on the draft guidance
by July 5, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:

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
as a manufacturing process. Please note

VerDate Sep<11>2014

18:35 Mar 05, 2019

Jkt 247001

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–
2018–D–1398 for ‘‘Mitigation Strategies
to Protect Food Against Intentional
Adulteration: Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed

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8103

except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Center for
Food Safety and Applied Nutrition,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Ryan Newkirk, Center for Food Safety
and Applied Nutrition (HFS–005), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
3712, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
helping to ensure the safety and security
of the food supply. FSMA enables FDA
to focus more on preventing food safety
problems rather than relying primarily
on reacting to problems after they occur.
FSMA added to the FD&C Act several
new sections that reference intentional
adulteration. For example, section 418
of the FD&C Act (21 U.S.C. 350g)
addresses intentional adulteration in the
context of facilities that manufacture,
process, pack, or hold food, and that are
required to register under section 415
(21 U.S.C. 350d). Section 420 of the
FD&C Act (21 U.S.C. 350i) addresses
intentional adulteration in the context
of high-risk foods and exempts farms
except for farms that produce milk.
We are announcing the availability of
a revised draft guidance for industry
entitled ‘‘Mitigation Strategies to Protect
Food Against Intentional Adulteration:
Guidance for Industry.’’ This revised
draft guidance supersedes the version of

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