Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability, 67186-67187 [E8-26869]
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Federal Register / Vol. 73, No. 220 / Thursday, November 13, 2008 / Notices
about the product, a description of the
details for the anticipated meeting, and
data and information that generally
would already have been compiled for
submission to the agency.
As stated earlier, the guidance
provides information on how the agency
will interpret and apply section 119(a)
of the Modernization Act, specific
PDUFA goals for the management of
meetings associated with the review of
human drug applications for PDUFA
products, and provisions of existing
regulations describing certain meetings
(§§ 312.47 and 312.82). The information
collection provisions in § 312.47
concerning End-of-Phase 2 meetings and
Pre-NDA meetings have been approved
by OMB (OMB Control No. 0910–0014).
However, the guidance provides
additional recommendations for
submitting information to FDA in
support of a meeting request. As a
result, FDA is submitting these
additional estimates for OMB approval.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Meeting Requests and Information
Packages
No. of
Respondents
No. of responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
Meeting Requests
CDER
907
2.44
2,210
10
22,100
CBER
144
1.99
287
10
2,870
Total
24,970
Information Packages
CDER
774
2.20
1,705
18
30,690
CBER
120
1.65
198
18
3,564
Total
34,254
Grand Total
59,224
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
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: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–27008 Filed 11–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2008–N–0574]
Interim Safety and Risk Assessment of
Melamine and Its Analogues in Food
for Humans; Availability
mstockstill on PROD1PC66 with NOTICES
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Melamine and Its Analogues in Food for
Humans.’’ The interim safety/risk
assessment evaluated exposure to
melamine and its analogues (cyanuric
acid, ammelide and ammeline) in infant
formula and other foods to identify,
where possible, a level of exposure that
would not raise public health concerns.
FDA is seeking public comment on the
interim safety/risk assessment.
DATES: Comments on the interim safety/
risk assessment must be submitted by
January 12, 2009.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
Annette McCarthy, Center for Food
Safety and Applied Nutrition (HFS–
205), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1057, FAX: 301–
436–2973, or e-mail:
Annette.McCarthy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Notice.
I. Background
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Interim Safety and Risk Assessment of
VerDate Aug<31>2005
17:13 Nov 12, 2008
Jkt 217001
The purpose of the interim safety/risk
assessment is to identify the level of
melamine and melamine-related
compounds in food which would not
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
raise public health concerns. On
September 11, 2008, FDA learned that
melamine may be contained in an infant
formula manufactured by a firm in
China. As of September 21, 2008, FDA
learned that a total of 52,857 cases of
nephrolithiasis (and, in some instances,
renal failure) had been reported in
China linked to consumption of this
contaminated powdered formula. There
have been approximately 13,000
hospitalizations, and at least 3 deaths
have been confirmed to date. The results
of an investigation conducted in China
indicated that Chinese-produced
powdered infant formula was linked to
these illnesses; no cases were associated
with liquid infant formula. Test results
conducted in China on samples of the
powdered infant formula showed that
they contained a wide range of
concentrations (0.1 parts per million
(ppm) to greater than 2,500 ppm
melamine). In addition, other countries
have reported detection of melamine in
other product categories, such as
confections and beverages.
The interim safety/risk assessment
concludes that, based on currently
available data and information, there is
too much uncertainty for FDA to
establish a level of melamine and its
analogues in infant formula that does
not raise public health concerns. In
foods other than infant formula, FDA
concludes that levels of melamine and
E:\FR\FM\13NON1.SGM
13NON1
Federal Register / Vol. 73, No. 220 / Thursday, November 13, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
melamine-related compounds below 2.5
ppm do not raise public health
concerns. This interim safety/risk
assessment was developed rapidly due
to the extremely time-sensitive need to
understand the nature of the potential
risk. We are seeking public comment on
this interim safety/risk assessment. In
addition, it will undergo expert peer
review.
II. Safety/Risk Assessment
A human health safety/risk
assessment is a scientifically-based
methodology used to estimate risk to
human health from exposure to specific
compounds such as contaminant(s) in
food. The interim safety/risk assessment
of melamine and its analogues builds
upon the 2007 Melamine Safety/Risk
Assessment and considers the
toxicological profile of melamine and its
analogues, including the observed
results from controlled animal studies
conducted with melamine.
For infant formula, there are gaps in
our scientific knowledge about the
toxicity of melamine and its analogues
in infants, including:
1. The consequences of the
continuous use of infant formulas as the
sole source of nutrition;
2. The uncertainties associated with
the possible presence and co-ingestion
of more than one melamine analogue;
and
3. For premature infants with
immature kidney function, the
possibility that they may be fed these
formulas as the sole source of nutrition
and thus on a body weight basis
experience greater levels of intake for a
longer time than is experienced by term
infants. For these reasons, there is too
much uncertainty for FDA to establish
a level of melamine and its analogues in
infant formula that does not raise public
health concerns. However, it is
important to understand that this does
not mean that any exposure to any
detectable level of melamine and
melamine-related compounds in
formula will result in harm to infants.
In food products other than infant
formula, to estimate the level of
melamine that does not raise public
health concerns, FDA used a worst case
exposure scenario in which one-half of
a person’s total daily dietary intake
(Tolerable Daily Intake (TDI), an
estimate of the maximum amount of an
agent to which an individual could be
exposed on a daily basis over the course
of a lifetime without appreciable health
risk) is contaminated with melamine
and its analogues. The TDI used, 0.63
milligrams/kilogram (mg/kg) body
weight/day (bw/d), was developed in
2007 in collaboration with the Food
VerDate Aug<31>2005
17:13 Nov 12, 2008
Jkt 217001
Safety and Inspection Service of the
Department of Agriculture and in
consultation with the Centers for
Disease Control and Prevention, the
Environmental Protection Agency, and
the Department of Homeland Security.1
In the present interim safety/risk
assessment, we estimated that if 50
percent of the diet were contaminated at
a level of 2.5 ppm of melamine and its
analogues, a person’s daily intake would
equal 0.063 mg/kg bw/d —a level 10fold below the TDI. Therefore, FDA
concludes that levels of melamine and
melamine-related compounds below 2.5
ppm do not raise public health concerns
in food other than infant formula.
Recognizing the time-sensitive need
for the safety/risk assessment, FDA
invites comments concerning:
1. The assessment approach used;
2. The assumptions made;
3. The data used; and
4. The transparency and clarity of the
report.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
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.
IV. Electronic Access
The interim safety/risk assessment is
available electronically at https://
www.cfsan.fda.gov/~dms/
melamra3.html.
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–26869 Filed 11–12–08; 8:45 am]
BILLING CODE 4160–01–S
1Interim Melamine and Analogues Safety/Risk
Assessment, May 25, 2007 (https://
www.cfsan.fda.gov/~dms/melamra.html).
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
67187
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Anesthesiology and Respiratory
Therapy Devices Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anesthesiology
and Respiratory Therapy Devices Panel
of the Medical Devices Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 5, 2008, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Neel J. Patel, Center
for Devices and Radiological Health
(HFZ–480), Food and Drug
Administration, 9200 Corporate Blvd.,
240–276–3700, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512624. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss,
make recommendations and vote on a
premarket approval application,
sponsored by Emphasys Medical, Inc.,
for the Emphasys Zephyr Endobronchial
Valve System, which is intended to
improve forced expiratory volume in the
first second (FEV1) and 6-minute walk
test distance in patients with severe
heterogeneous emphysema who have
received optimal medical management.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
E:\FR\FM\13NON1.SGM
13NON1
]]>Agencies
[Federal Register Volume 73, Number 220 (Thursday, November 13, 2008)]
[Notices]
[Pages 67186-67187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26869]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0574]
Interim Safety and Risk Assessment of Melamine and Its Analogues
in Food for Humans; Availability
AGENCY: Food and Drug Administration, HHS
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Interim Safety and Risk
Assessment of Melamine and Its Analogues in Food for Humans.'' The
interim safety/risk assessment evaluated exposure to melamine and its
analogues (cyanuric acid, ammelide and ammeline) in infant formula and
other foods to identify, where possible, a level of exposure that would
not raise public health concerns. FDA is seeking public comment on the
interim safety/risk assessment.
DATES: Comments on the interim safety/risk assessment must be submitted
by January 12, 2009.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Annette McCarthy, Center for Food
Safety and Applied Nutrition (HFS-205), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1057, FAX:
301-436-2973, or e-mail: Annette.McCarthy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the interim safety/risk assessment is to identify
the level of melamine and melamine-related compounds in food which
would not raise public health concerns. On September 11, 2008, FDA
learned that melamine may be contained in an infant formula
manufactured by a firm in China. As of September 21, 2008, FDA learned
that a total of 52,857 cases of nephrolithiasis (and, in some
instances, renal failure) had been reported in China linked to
consumption of this contaminated powdered formula. There have been
approximately 13,000 hospitalizations, and at least 3 deaths have been
confirmed to date. The results of an investigation conducted in China
indicated that Chinese-produced powdered infant formula was linked to
these illnesses; no cases were associated with liquid infant formula.
Test results conducted in China on samples of the powdered infant
formula showed that they contained a wide range of concentrations (0.1
parts per million (ppm) to greater than 2,500 ppm melamine). In
addition, other countries have reported detection of melamine in other
product categories, such as confections and beverages.
The interim safety/risk assessment concludes that, based on
currently available data and information, there is too much uncertainty
for FDA to establish a level of melamine and its analogues in infant
formula that does not raise public health concerns. In foods other than
infant formula, FDA concludes that levels of melamine and
[[Page 67187]]
melamine-related compounds below 2.5 ppm do not raise public health
concerns. This interim safety/risk assessment was developed rapidly due
to the extremely time-sensitive need to understand the nature of the
potential risk. We are seeking public comment on this interim safety/
risk assessment. In addition, it will undergo expert peer review.
II. Safety/Risk Assessment
A human health safety/risk assessment is a scientifically-based
methodology used to estimate risk to human health from exposure to
specific compounds such as contaminant(s) in food. The interim safety/
risk assessment of melamine and its analogues builds upon the 2007
Melamine Safety/Risk Assessment and considers the toxicological profile
of melamine and its analogues, including the observed results from
controlled animal studies conducted with melamine.
For infant formula, there are gaps in our scientific knowledge
about the toxicity of melamine and its analogues in infants, including:
1. The consequences of the continuous use of infant formulas as the
sole source of nutrition;
2. The uncertainties associated with the possible presence and co-
ingestion of more than one melamine analogue; and
3. For premature infants with immature kidney function, the
possibility that they may be fed these formulas as the sole source of
nutrition and thus on a body weight basis experience greater levels of
intake for a longer time than is experienced by term infants. For these
reasons, there is too much uncertainty for FDA to establish a level of
melamine and its analogues in infant formula that does not raise public
health concerns. However, it is important to understand that this does
not mean that any exposure to any detectable level of melamine and
melamine-related compounds in formula will result in harm to infants.
In food products other than infant formula, to estimate the level
of melamine that does not raise public health concerns, FDA used a
worst case exposure scenario in which one-half of a person's total
daily dietary intake (Tolerable Daily Intake (TDI), an estimate of the
maximum amount of an agent to which an individual could be exposed on a
daily basis over the course of a lifetime without appreciable health
risk) is contaminated with melamine and its analogues. The TDI used,
0.63 milligrams/kilogram (mg/kg) body weight/day (bw/d), was developed
in 2007 in collaboration with the Food Safety and Inspection Service of
the Department of Agriculture and in consultation with the Centers for
Disease Control and Prevention, the Environmental Protection Agency,
and the Department of Homeland Security.\1\ In the present interim
safety/risk assessment, we estimated that if 50 percent of the diet
were contaminated at a level of 2.5 ppm of melamine and its analogues,
a person's daily intake would equal 0.063 mg/kg bw/d --a level 10-fold
below the TDI. Therefore, FDA concludes that levels of melamine and
melamine-related compounds below 2.5 ppm do not raise public health
concerns in food other than infant formula.
---------------------------------------------------------------------------
\1\Interim Melamine and Analogues Safety/Risk Assessment, May
25, 2007 (https://www.cfsan.fda.gov/~dms/melamra.html).
---------------------------------------------------------------------------
Recognizing the time-sensitive need for the safety/risk assessment,
FDA invites comments concerning:
1. The assessment approach used;
2. The assumptions made;
3. The data used; and
4. The transparency and clarity of the report.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to 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.
IV. Electronic Access
The interim safety/risk assessment is available electronically at
https://www.cfsan.fda.gov/~dms/melamra3.html.
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26869 Filed 11-12-08; 8:45 am]
BILLING CODE 4160-01-S
