Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities-Survey, 37465-37466 [E8-14888]
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Federal Register / Vol. 73, No. 127 / Tuesday, July 1, 2008 / Notices
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed 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.
Mental Models Study of Farmers’
Understanding and Implementation of
Good Agricultural Practices
The proposed information collection
will help FDA protect the public from
foodborne illness by increasing the
agency’s understanding of how farmers
and growers use Good Agricultural
Practices (GAPs) to address common
risk factors in their operations and
thereby minimize food safety hazards
potentially associated with fresh
produce. Fresh fruits and vegetables are
those that are likely to be sold to
consumers in an unprocessed or
minimally processed (i.e., raw) form and
that are reasonably likely to be
consumed raw. Under section 903(b)(2)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393 (b)(2)), FDA is
authorized to conduct research relating
to foods and to conduct educational and
public information programs relating to
the safety of the Nation’s food supply.
Under Title 42 of the Public Health
Service Act (1944), FDA has authority to
act to protect the public health.
In 1998, FDA issued a guidance
document entitled ‘‘Guide to Minimize
Microbial Food Safety Hazards for Fresh
Fruits and Vegetables,’’ available at
https://www.cfsan.fda.gov/~dms/
prodguid.html. The guidance addresses
microbial food safety hazards and good
agricultural and good management
practices common to the growing,
harvesting, washing, sorting, packing,
and transporting of most fruits and
vegetables sold to consumers in an
unprocessed or minimally processed
(raw) form.
There is evidence that growers have
not fully implemented the GAPs to
reduce production risks, despite
intensive GAPS training programs. FDA
is planning to conduct a study to
determine growers’ decision-making
processes with regard to understanding
and implementing GAPs on the farm, to
more fully understand the barriers and
constraints associated with GAPs
implementation.
The project will use ‘‘mental
modeling,’’ a qualitative research
method wherein the decision-making
processes of a group of respondents
(described below) concerning the
implementation of GAPs on the farm are
modeled and compared to a model
based on expert knowledge and
experience in the implementation of
GAPs. The information will be collected
via a telephone interview concerning
the factors that influence the
perceptions and motivations related to
the implementation of GAPs. A
comparison between expert and
consumer models based on the collected
information may identify
‘‘consequential knowledge gaps’’ that
can be redressed through information
campaigns designed by FDA.
Description of respondents:
Respondents will be farmers or growers,
GAPs trainers, and retail buyer and/or
grower association representatives.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Pre-tests/ Cognitive Interviews
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
9
9
.75
6.75
60
Study
1
1
60
.75
45
Total
sroberts on PROD1PC70 with NOTICES
1There
51.75
are no capital costs or operating and maintenance costs associated with this collection of information.
The study will involve approximately
60 respondents, including 24 farmers or
growers of fruits and vegetables, 24
GAPs trainers, and 12 retail buyer or
grower association representatives. FDA
will also conduct a pretest using 9
respondents. FDA estimates that each
respondent will take 45 minutes (0.75
hours) to complete the interview for the
study (60 respondents x 0.75 hours = 45
hours). Thus, the total annual burden
for this one-time collection of
information is 51.75 hours (6.75 hours
+ 45 hours = 51.75 hours). These
estimates are based on FDA’s experience
with consumer research.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
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21:01 Jun 30, 2008
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the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14887 Filed 6–30–08; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0146]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements for
Collection of Data Relating to the
Prevention of Medical Gas Mix-ups at
Health Care Facilities-Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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E:\FR\FM\01JYN1.SGM
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37466
Federal Register / Vol. 73, No. 127 / Tuesday, July 1, 2008 / Notices
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Fax written comments on the
collection of information by July 31,
2008
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0548. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Requirements for Collection of Data
Relating to the Prevention of Medical
Gas Mix-ups at Health Care FacilitiesSurvey—(OMB Control Number 0910–
0548)—Extension
FDA has received four reports of
medical gas mix-ups occurring during
the past 9 years. These reports were
received from hospitals and nursing
homes and involved 7 deaths and 15
injuries to patients who were thought to
be receiving medical grade oxygen, but
who were actually receiving a different
gas (e.g., nitrogen, argon) that had been
mistakenly connected to the facility’s
oxygen supply system. In 2001, FDA
published guidance making
recommendations to help hospitals,
nursing homes, and other health care
facilities avoid the tragedies that result
from medical gas mix-ups and alerting
these facilities to the hazards. This
survey is intended to assess the degree
of facilities’ compliance with safety
measures to prevent mix-ups, to
determine if further steps are warranted
to ensure the safety of patients.
In the Federal Register of March 7,
2008 (73 FR 12452), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
210 and 211
285
1
285
.25
71.25
Total
285
1
285
.25
71.25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–14888 Filed 6–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Innovative Food Defense Projects;
New Limited Competition Cooperative
Agreement U13; Request for
Application Number: RFA–FDA–08–010
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Division of
Federal-State Relations (DFSR) is
announcing the availability of grant
funds for the support of innovative food
defense projects. These grants are
available to State, local, and tribal levels
and must have national implication or
application that can enhance Federal,
State, and local food regulatory
programs and are likely to impact
preparedness, response and/or recovery.
FDA anticipates providing
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21:01 Jun 30, 2008
Jkt 214001
approximately $240,000 in direct plus
indirect costs in support of this program
in fiscal year 2008. It is anticipated that
6 awards will be made for up to $40,000
per award/per year for up to 1 year.
DATES: The application receipt date is
July 30, 2008.
I. Background/Funding Opportunity
Description
Food defense is a term used to
describe activities associated with
protecting the nation’s food supply from
intentional contamination. FDA
(agency) has adopted 3 broad strategies
that encompass its food defense
activities:
(1) Awareness: Prevention/
Preparedness: Increase awareness
among Federal, state, local, and tribal
governments and the private sector to
better understand where the greatest
vulnerabilities lie and develop effective
protection/mitigation strategies to shield
the food supply from intentional
contamination; (2) Response: Develop
the capacity for a rapid coordinated
response to a foodborne terrorist attack;
and (3) Recovery: Develop the capacity
for a rapid coordinated recovery from a
foodborne terrorist attack.
In the aftermath of 9/11, the agency
utilized an approach known as
Operational Risk Management (ORM).
ORM involves a determination of which
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combinations of foods and agents, and
where on the farm-to-table continuum,
constitute the highest risks of being
targeted for attack that may result in a
large number of causalities. It is
recognized that any food could
potentially be contaminated and thus
zero-risk foods do not exist. However,
based on ORM analysis it was
discovered that higher-risk foods do
share several common vulnerability
factors: Large batch size, which implies
a large number of servings; short shelf
life, which implies rapid turnaround at
retail and rapid consumption; uniform
mixing, which would maximize the
potential number of contaminated units;
and accessibility of a so-called critical
node, defined as a process or activity in
the farm-to-table chain during which the
agent could be added and go
undetected.
Currently, there is a joint program led
by FDA, U.S. Department of Agriculture,
Federal Bureau of Investigations, and
the Department of Homeland Security,
in collaboration with private industry
and the states known as the Strategic
Partnership Program Agroterrorism
(SPPA) Initiative. The SPPA was
launched in July 2005 and through
industry and state volunteers
vulnerability assessments are conducted
locally in different states on a variety of
food commodities in coordination with
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]]>Agencies
[Federal Register Volume 73, Number 127 (Tuesday, July 1, 2008)]
[Notices]
[Pages 37465-37466]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14888]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0146]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements for
Collection of Data Relating to the Prevention of Medical Gas Mix-ups at
Health Care Facilities-Survey
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing
[[Page 37466]]
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
31, 2008
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0548. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Requirements for Collection of Data Relating to the Prevention of
Medical Gas Mix-ups at Health Care Facilities-Survey--(OMB Control
Number 0910-0548)--Extension
FDA has received four reports of medical gas mix-ups occurring
during the past 9 years. These reports were received from hospitals and
nursing homes and involved 7 deaths and 15 injuries to patients who
were thought to be receiving medical grade oxygen, but who were
actually receiving a different gas (e.g., nitrogen, argon) that had
been mistakenly connected to the facility's oxygen supply system. In
2001, FDA published guidance making recommendations to help hospitals,
nursing homes, and other health care facilities avoid the tragedies
that result from medical gas mix-ups and alerting these facilities to
the hazards. This survey is intended to assess the degree of
facilities' compliance with safety measures to prevent mix-ups, to
determine if further steps are warranted to ensure the safety of
patients.
In the Federal Register of March 7, 2008 (73 FR 12452), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
210 and 211 285 1 285 .25 71.25
----------------------------------------------------------------------------------------------------------------
Total 285 1 285 .25 71.25
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14888 Filed 6-30-08; 8:45 am]
BILLING CODE 4160-01-S
