Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Food Bioterrorism Risk Awareness, 15140-15141 [07-1577]
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15140
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0105]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mental Models
Study of Food Bioterrorism Risk
Awareness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: 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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the mental models study of food
bioterrorism risk awareness.
DATES: Submit written or electronic
comments on the collection of
information by May 29, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
Under the
PRA (44 U.S.C. 3501–3520), Federal
SUPPLEMENTARY INFORMATION:
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
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
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 Food
Bioterrorism Risk Awareness
The proposed information collection
will help FDA protect the public from
food bioterrorism by preparing the
agency to take appropriate action in the
event of a crisis. Under the Federal
Food, Drug, and Cosmetic Act of 1938,
as amended, FDA has authority to act to
protect 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 addition, title III of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(Public Law 107–188), FDA has
authority to act to improve the ability of
the United States to prevent, prepare
for, and respond to bioterrorism and
other public health emergencies.
FDA has crafted and disseminated
messages intended to raise the
awareness of state and local government
agency and industry representatives
regarding food defense issues and
preparedness, but FDA does not
currently have similar initiatives for
consumers. Extensive research exists in
disaster preparedness and in effective
communication to the public of risk or
crisis information by government or
non-government entities. However,
additional research is needed to help
FDA design communications that will
increase consumer awareness of the
potential for food bioterrorism and help
consumers to make good decisions in
the event of a food bioterrorism
emergency.
The project will use ‘‘mental
modeling,’’ a qualitative research
method wherein the decision-making
processes of a group of consumer
respondents (described in the next
paragraph) concerning food bioterrorism
are modeled and compared to a model
based on expert knowledge and
experience in food bioterrorism. The
information will be collected via a
telephone interview concerning the
factors that influence the perceptions
and motivations related to the threat of
food bioterrorism. A comparison
between expert and consumer models
based on the collected information may
identify ‘‘consequential knowledge
gaps’’ that can be redressed through
messages or information campaigns
designed by FDA.
Description of Respondents:
Respondents will be adult parents over
the age of 18 who have at least one child
age 4 to 13 residing in the home at least
half-time. The sample will be divided
by gender.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Respondents
Annual Frequency
per Response
cprice-sewell on PROD1PC66 with NOTICES
45
1There
Total Annual
Responses
1
Hours per
Response
1
.75
are no capital costs or operating and maintenance costs associated with this collection of information.
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33.75
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Notices
Food and Drug Administration
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Jeanne M. Delasko, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6474,
Silver Spring, MD 20993–0002, 301–
796–0900.
SUPPLEMENTARY INFORMATION:
[Docket No. 2007D–0089]
I. Background
Draft Guidance for Industry and
Review Staff on Target Product
Profile—A Strategic Development
Process Tool; Availability
FDA is announcing the availability of
a draft guidance for industry and review
staff entitled ‘‘Target Product Profile—A
Strategic Development Process Tool.’’ In
1997, a Clinical Development Working
Group composed of representatives from
FDA and pharmaceutical sponsors
began discussions on ways to improve
sponsor and FDA interactions in the
drug development process. The working
group recommended use of a template
that provides a summary of drug
labeling concepts to focus discussions
and aid in the understanding between
sponsors and FDA. The resulting TPP is
a format for a summary of a drug
development program described in
terms of labeling concepts.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on target product profiles. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
The study will involve 45
respondents and take approximately 45
minutes each to complete. These
estimates are based on FDA’s experience
with consumer research.
Dated: March 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–1577 Filed 3–29–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry and review staff entitled
‘‘Target Product Profile—A Strategic
Development Process Tool.’’ The
purpose of this guidance is to inform
sponsors and the review staff in the
Center for Drug Evaluation and Research
(CDER) of the availability and potential
usefulness of a target product profile
(TPP). A TPP can be prepared by a
sponsor and then shared voluntarily
with the appropriate FDA review staff to
facilitate communication regarding a
particular drug development program.
This draft guidance describes the
purposes of a TPP, provides guidance
on how to complete a TPP, makes
suggestions on how to best use a TPP,
and relates case studies that
demonstrate the potential usefulness of
a TPP.
DATES: Submit written or electronic
comments on the draft guidance and/or
on the collection of information by May
29, 2007. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance and/or on the collection of
information to the Division of Dockets
VerDate Aug<31>2005
15:49 Mar 29, 2007
Jkt 211001
II. The Paperwork Reduction Act of
1995
Under the Paperwork Reduction Act
(44 U.S.C. 3501–3520) (the PRA),
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
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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
15141
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 below.
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 on respondents, including
through the use of automated collection
techniques, when appropriate, and other
forms of information technology.
Title: Draft Guidance for Industry and
Review Staff: Target Product Profile—A
Strategic Development Process Tool.
Description: The draft guidance is
intended to provide sponsors and FDA
review staff with information regarding
TPPs. A TPP can be prepared by a
sponsor and then shared voluntarily
with the appropriate FDA review staff to
facilitate communication regarding a
particular drug development program. A
Clinical Development Working Group
recommended use of a template that
provides a summary of drug labeling
concepts to focus discussions and aid in
the understanding between sponsors
and FDA. The resulting TPP is a format
for a summary of a drug development
program described in terms of labeling
concepts. With the TPP, a sponsor
specifies the labeling concepts that are
the goals of the drug development
program, documents the specific studies
that are intended to support the labeling
concepts, and then uses the TPP to
assist in a constructive dialogue with
FDA. The draft guidance describes the
purpose of a TPP, its advantages, and its
optimal use. It also provides
information on how to complete a TPP
and relates case studies that
demonstrate a TPP’s usefulness.
Sponsors are not required to submit a
TPP. The TPP does not represent an
implicit or explicit obligation on the
sponsor’s part to pursue all stated goals.
Submission of a TPP summary does not
constrain the sponsor to submit draft
labeling in a new drug application
(NDA) or biologics license application
(BLA) that is identical to the TPP. The
TPP is part of the proprietary
investigational new drug application
(IND) file.
E:\FR\FM\30MRN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Notices]
[Pages 15140-15141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1577]
[[Page 15140]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0105]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Mental Models Study of Food Bioterrorism Risk
Awareness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the mental models study of food bioterrorism risk awareness.
DATES: Submit written or electronic comments on the collection of
information by May 29, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 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 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 Food Bioterrorism Risk Awareness
The proposed information collection will help FDA protect the
public from food bioterrorism by preparing the agency to take
appropriate action in the event of a crisis. Under the Federal Food,
Drug, and Cosmetic Act of 1938, as amended, FDA has authority to act to
protect 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 addition, title III of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-
188), FDA has authority to act to improve the ability of the United
States to prevent, prepare for, and respond to bioterrorism and other
public health emergencies.
FDA has crafted and disseminated messages intended to raise the
awareness of state and local government agency and industry
representatives regarding food defense issues and preparedness, but FDA
does not currently have similar initiatives for consumers. Extensive
research exists in disaster preparedness and in effective communication
to the public of risk or crisis information by government or non-
government entities. However, additional research is needed to help FDA
design communications that will increase consumer awareness of the
potential for food bioterrorism and help consumers to make good
decisions in the event of a food bioterrorism emergency.
The project will use ``mental modeling,'' a qualitative research
method wherein the decision-making processes of a group of consumer
respondents (described in the next paragraph) concerning food
bioterrorism are modeled and compared to a model based on expert
knowledge and experience in food bioterrorism. The information will be
collected via a telephone interview concerning the factors that
influence the perceptions and motivations related to the threat of food
bioterrorism. A comparison between expert and consumer models based on
the collected information may identify ``consequential knowledge gaps''
that can be redressed through messages or information campaigns
designed by FDA.
Description of Respondents: Respondents will be adult parents over
the age of 18 who have at least one child age 4 to 13 residing in the
home at least half-time. The sample will be divided by gender.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per
No. of Respondents Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
45 1 1 .75 33.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 15141]]
The study will involve 45 respondents and take approximately 45
minutes each to complete. These estimates are based on FDA's experience
with consumer research.
Dated: March 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1577 Filed 3-29-07; 8:45 am]
BILLING CODE 4160-01-S
