Published 60-day FRn

Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–00230 Filed 1–9–15; 8:45 am]
BILLING CODE 4163–18–P

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

Proposed Project

[60Day–15–0792]

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Proposed Data Collections Submitted
for Public Comment and
Recommendations
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 to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. To request more
information on the below proposed
project or to obtain a copy of the
information collection plan and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology

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and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Environmental Health Specialists
Network (EHS-NET) Program (OMB No.
0920–0792, expires 2/28/2015)—
Revision—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The CDC is requesting OMB approval
for three additional years to use this
generic clearance for a research program
focused on identifying the
environmental causes of foodborne
illness.
To date, EHS-Net has conducted four
studies under this generic clearance.
The first study collected data on
improper cooling of hot foods, a food
handling practice associated with
foodborne illness and outbreaks. The
second study collected data on the
relationship between kitchen manager
food safety certification and foodborne
illness risk factors in restaurants. Public
health agencies are increasingly
encouraging or requiring certification as
a foodborne illness prevention measure,
yet little is known about its
effectiveness. The third study collected
data on the environmental factors
associated with contamination of the
retail deli environment with Listeria, a
foodborne illness pathogen ranked 3rd
in terms of the number of deaths it
causes. The fourth study collected data
on restaurant managers’ and workers’
food allergen knowledge, attitudes, and
practices. Food allergens are an
important food safety issue for
restaurants.
The data from the first two studies
have been disseminated to
environmental public health/food safety
regulatory programs and the food
industry in the form of presentations at
conferences and meetings, scientific
journal publications, and Web site
postings. We will continue to analyze
and present the data from all four
studies, and expect that they will
continue to provide valuable and useful
data about environmental factors

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associated with foodborne illness
outbreaks and food safety issues.
This revision will provide OMB
clearance for EHS-Net data collections
conducted in 2015 through 2018
(approximately one per year). The
program is revising the generic
information collection request (ICR) in
the following ways:
(1) Because of the re-announcement
and re-competition of the EHS-Net
cooperative agreement in 2015, it is
likely that the sites in which data will
be collected will differ from the sites in
which data were collected previously.
(2) We revised the estimated study
sample size and burden downward.
Thus, the estimated burden has been
reduced.
(3) We have eliminated proposed
sample weighting analyses.
Reducing foodborne illness first
requires identification and
understanding of the environmental
factors that cause these illnesses. We
need to know how and why food
becomes contaminated with foodborne
illness pathogens. This information can
then be used to determine effective food
safety prevention methods. Ultimately,
these actions can lead to increased
regulatory program effectiveness and
decreased foodborne illness. The
purpose of this food safety research
program is to identify and understand
environmental factors associated with
foodborne illness and outbreaks. This
program is conducted by the
Environmental Health Specialists
Network (EHS-Net), a collaborative
project of CDC, FDA, USDA, and local
and state sites.
Environmental factors associated with
foodborne illness include both food
safety practices (e.g., inadequate
cleaning practices) and the factors in the
environment associated with those
practices (e.g., worker and retail food
establishment characteristics). To
understand these factors, we need to
continue to collect data from those who
prepare food (i.e., food workers) and on
the environments in which the food is
prepared (i.e., retail food establishment
kitchens). Thus, data collection methods
for this generic package include: (1)
Manager and worker interviews/
surveys, and (2) observation of kitchen
environments. Both methods allow data
collection on food safety practices and
environmental factors associated with
those practices.
For each data collection, we will
collect data in approximately 47 retail
food establishments per site. Thus, there
will be approximately 376
establishments per data collection (an
estimated 8 sites × 47 establishments).
We expect a manager/establishment

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Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices

response rate of approximately 60
percent; thus, we will need to attempt
to recruit 627 managers/establishments
via telephone in order to meet our goal
of 376 establishments. Each manager
will respond to the recruiting script
only once for approximately 3 minutes.
Thus, the maximum burden for the
manager recruiting attempts will be
31.35 hours (627 managers × 3 minutes).
We will collect interview/survey data
from a manager in each establishment.
Each manager will respond only once
for approximately 30 minutes. Thus, the
maximum burden for the manager

worker response rate of 90 percent (339
workers). Each worker will respond
only once for approximately 10 minutes.
Thus, the maximum burden for the
worker interview/survey will be 56.5
hours (339 workers × 10 minutes). In
total, the average burden per worker
response will be 75.3 hours (18.8 hours
for recruiting + 56.5 hours for the
interview/survey).
There is no cost to respondents other
than their time. The total estimated
annual burden for the data collection
will be 295 hours.

interview/survey will be 188 hours (376
managers × 30 minutes). In total, the
average burden for managers will be
219.35 hours (31.35 hours for recruiting
plus 188 hours for the interview/
survey).
For each data collection, we will
recruit a worker from each participating
establishment to provide interview/
survey data. Each worker will respond
to the recruiting script only once for
approximately 3 minutes. Thus, the
maximum burden for the worker
recruiting attempts will be 18.8 hours
(376 workers × 3 minutes). We expect a

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Retail
Retail
Retail
Retail

managers ............
managers ............
food workers ........
food workers ........

Manager Telephone Recruiting Script .................
Manager Interview/survey ...................................
Worker Recruiting Script .....................................
Worker Interview/survey ......................................

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

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

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–00241 Filed 1–9–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0543]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Waiver of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. 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 of an existing collection of
information, and to allow 60 days for

SUMMARY:

tkelley on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Form name

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627
376
376
339

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1
1
1
1

Average
burden per
response
(in hours)
3/60
30/60
3/60
10/60

Total burden
hours
31
188
19
57
295

public comment in response to the
notice. This notice solicits comments on
the current burden hours on regulated
industry of complying with the
guidance underlying this collection of
information.
DATES: Submit electronic or written
comments on the collection of
information by March 13, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to http://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
‘‘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

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Number of
responses per
respondent

provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.

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