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Federal Register / Vol. 77, No. 241 / Friday, December 14, 2012 / Notices

Dated: December 10, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director.

and Control (NCIPC), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description

[FR Doc. 2012–30180 Filed 12–13–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–0604]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Ron Otten, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to [email protected].
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; and (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. Written comments should
be received within 60 days of this
notice.
Proposed Project
School Associated Violent Death
Surveillance System (0920–0604,
Expiration 1/31/2013)—Revision—
National Center for Injury Prevention

The Division of Violence Prevention
(DVP), National Center for Injury
Prevention and Control (NCIPC)
proposes to maintain a system for the
surveillance of school-associated
homicides and suicides. The system
relies on existing public records and
interviews with law enforcement
officials and school officials. The
purpose of the system is to (1) estimate
the rate of school-associated violent
death in the United States and (2)
identify common features of schoolassociated violent deaths. The system
will contribute to the understanding of
fatal violence associated with schools,
guide further research in the area, and
help direct ongoing and future
prevention programs.
Violence is the leading cause of death
among young people, and increasingly
recognized as an important public
health and social issue. In 2006, over
3,200 school-aged children (5 to 18
years old) in the United States died
violent deaths due to suicide, homicide,
and unintentional firearm injuries. The
vast majority of these fatal injuries were
not school associated. However,
whenever a homicide or suicide occurs
in or around school, it becomes a matter
of particularly intense public interest
and concern. NCIPC conducted the first
scientific study of school-associated
violent deaths (SAVD) during the 1992–
99 academic years to establish the true
extent of this highly visible problem.
Despite the important role of schools as
a setting for violence research and
prevention interventions, relatively
little scientific or systematic work has
been done to describe the nature and
level of fatal violence associated with
schools. Until NCIPC conducted the first
nationwide investigation of violent
deaths associated with schools, public
health and education officials had to
rely on limited local studies and
estimated numbers to describe the
extent of school-associated violent
death.
SAVD is an ongoing surveillance
system that draws cases from the entire
United States in attempting to capture
all cases of school-associated violent

deaths that have occurred. Investigators
review public records and published
press reports concerning each schoolassociated violent death. For each
identified case, investigators also
interview an investigating law
enforcement official (defined as a police
officer, police chief, or district attorney),
and a school official (defined as a school
principal, school superintendent, school
counselor, school teacher, or school
support staff) who are knowledgeable
about the case in question. Respondents
will only be interviewed once.
Researchers request information on both
the victim and alleged offender(s)—
including demographic data, their
academic and criminal records, and
their relationship to one another. Data
are also collected on the time and
location of the death; the circumstances,
motive, and method of the fatal injury;
and the security and violence
prevention activities in the school and
community where the death occurred,
before and after the fatal injury event.
The data collection process has been
revised to update items included in the
surveys administered to law
enforcement and school staff and to
incorporate use of Computer Assisted
Telephone Interviewing software to
further reduce respondent burden. To
obtain as much detailed information as
possible concerning each identified
case, investigators seek to obtain the
initial law enforcement investigative
report.
All data are secured through the use
of technical, physical, and
administrative controls. Hard copies of
data are to be kept under lock and key
in secured offices, located in a secured
facility that can be accessed only by
presenting the appropriate credentials.
Digital data are password protected and
then stored (and backed up routinely)
onto a secure Local Area Network that
can only be accessed by individuals
who have been appropriately
authorized. Study data are reported in
the aggregate, such that no individual
case can be identified from the reports.
Data collection will be discontinued for
the early part of 2013 as we wait for the
30-day notice to post and approval of
our revision package.
There are no costs to the respondents
other than their time.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

School Officials .................................

School Interview ...............................

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burden per
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74485

Federal Register / Vol. 77, No. 241 / Friday, December 14, 2012 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Police Officials ..................................

Law Enforcement Interview ..............

35

1

1

35

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

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

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

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70

Dated: December 10, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director.
[FR Doc. 2012–30183 Filed 12–13–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0711]

Request for Comments and
Information on Initiating a Risk
Assessment for Establishing Food
Allergen Thresholds; Establishment of
Docket
AGENCY:

Food and Drug Administration,

HHS.
Notice; establishment of docket;
request for comments.

ACTION:

SUMMARY: The Food and Drug
Administration (FDA or we) is
establishing a docket to obtain
comments relevant to conducting a risk
assessment to establish regulatory
thresholds for major food allergens as
defined in the Food Allergen Labeling
and Consumer Protection Act of 2004.
DATES: Submit either electronic or
written comments by February 12, 2013.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2012–N–
0711, by any of the following methods:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions

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Submit written submissions in the
following ways:
• Fax: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

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Instructions: All submissions received
must include the Agency name and
Docket No. FDA–2012–N–0711. All
comments received may be posted
without change to http://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to http://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS–
200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 240–402–1056.
SUPPLEMENTARY INFORMATION:
I. Background
Food allergy is an immune-mediated
sensitivity to foods that can lead to lifethreatening adverse reactions. Because
there is no cure for food allergy, allergic
consumers must use avoidance to
prevent allergic reactions. Successful
avoidance requires, among other things,
that allergic consumers and their
caregivers be able to read and
understand the ingredient lists on
packaged foods.
To help consumers more easily
identify ingredients in foods that may
cause an allergic reaction, the President
signed the Food Allergen Labeling and
Consumer Protection Act of 2004
(FALCPA) (Title II of Pub. L. 108–282),
which amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) by
defining the term ‘‘major food allergen’’
and stating that foods regulated under
the FD&C Act are misbranded unless
they declare the presence of major food
allergens on the product label using the
common or usual name of that major
food allergen. Section 201(qq) of the
FD&C Act (21 U.S.C. 321(qq)) now

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defines a major food allergen as ‘‘[m]ilk,
egg, fish (e.g., bass, flounder, or cod),
Crustacean shellfish (e.g., crab, lobster,
or shrimp), tree nuts (e.g., almonds,
pecans, or walnuts), wheat, peanuts,
and soybeans’’ and also as a food
ingredient that contains protein derived
from such foods. The definition
excludes any highly refined oil derived
from a major food allergen and any
ingredient derived from such highly
refined oil.
FALCPA provides two mechanisms
through which ingredients may become
exempt from the major food allergen
labeling requirement. An individual
may petition for an exemption by
providing scientific evidence, including
the analytical method used, that an
ingredient ‘‘does not cause an allergic
response that poses a risk to human
health.’’ (21 U.S.C. 403(w)(6)(C)).
Alternatively, an individual may submit
a notification that contains either
scientific evidence showing that an
ingredient ‘‘does not contain allergenic
protein’’ or that a determination has
previously been made through a
premarket approval process that the
ingredient ‘‘does not cause an allergic
response that poses a risk to human
health.’’ (21 U.S.C. 403(w)(7)(A)).
In addition to their intended use as
ingredients, the unintended presence of
major food allergens in foods may occur
through cross-contact. Cross-contact
describes the inadvertent introduction
of an allergen into a product that would
not intentionally contain that allergen as
an ingredient. Most cross-contact can be
avoided by controlling the production
environment. These controls can
include a wide range of activities, such
as establishing personnel and traffic
patterns that minimize the potential to
transfer an allergen from one product to
another.
FDA has used several risk
management strategies to reduce the risk
from unlabeled major food allergens,
such as targeted inspections or
discussions with industry organizations.
However, we have not established
regulatory thresholds or action levels for
major food allergens. The establishment
of regulatory thresholds or action levels
for major food allergens would help us

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