Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability, 30014-30015 [07-2679]
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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
information provided in these optional
fields is not required. For example, the
data contained in the ‘‘Other Names’’
and ‘‘Other Provider Identifiers’’ data
fields are optional. Further, a primary
‘‘Healthcare Provider Taxonomy Code’’
is required to be furnished when
applying for an NPI; however, the
reporting of additional ‘‘Healthcare
Provider Taxonomy Codes’’ (a total of
15 may be reported) is optional.
The HHS NPPES data dissemination
policy is as follows:
1. NPPES health care provider data
that are required to be disclosed under
the FOIA will be available as a
downloadable file on a Web site.
Section 552(a)(2)(D) of the FOIA
requires agencies to make available by
electronic means copies of records
which have been released to any person
under the FOIA and which, because of
the nature of their subject matter, the
agency determines have become or are
likely to become the subject of
subsequent requests for substantially the
same records. We believe that the
demand for NPPES health care provider
data will be such that it will justify our
making NPPES health care provider data
that are required to be disclosed under
the FOIA available for download by the
public from an Internet Web site. The
location of the downloadable file will be
announced on the CMS NPI Web page
(https://www.cms.hhs.gov/
NationalProvIdentStand/) prior to its
availability. Each month, an update file
will also be available for download from
the same Web site. The update file will
not replace the initial file: The update
file will contain only (1) data that are
required to be disclosed under FOIA for
health care providers who obtained
NPIs within the prior month, and (2)
updates and changes to the data that are
required to be disclosed under the FOIA
for enumerated health care providers
that were made within the prior month.
The first update file will be available for
downloading 30 days after the
availability of the initial file, and a new
update file will be available for
downloading each month thereafter.
There will be no charge to download
the files.
We may decide to discontinue making
these files available if we determine that
the query-only database described in (2)
below is an adequate replacement.
The NPPES data elements that HHS
has determined are required to be
disclosed under FOIA and will be
contained in the downloadable files are
listed in the table above.
2. NPPES health care provider data
that HHS has determined are required
to be disclosed under FOIA will be
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
available in a query-only database on an Paperwork Reduction Act of 1995 (44
Internet Web site.
U.S.C. 3501 et seq.).
Section 552(a)(2)(D) of the FOIA
Authority: Sections 1171 through 1179 of
requires agencies to make available by
the Social Security Act (42 U.S.C. 1320d–
electronic means copies of records
1320d–8), as added by section 262 of Pub. L.
which have been released to any person 104–191. 42 CFR 162, Subpart D. (Catalog of
Federal Domestic Assistance Program, No.
under the FOIA and which, because of
93.773, Medicare—Hospital Insurance
the nature of their subject matter, the
Program; and No. 93.774, Medicare—
agency determines have become or are
Supplementary Medical Insurance Program)
likely to become the subject of
Dated: August 30, 2005.
subsequent requests for substantially the
same records.
Mark B. McClellan,
We believe that the demand for
Administrator, Centers for Medicare &
NPPES health care provider data will be Medicaid Services.
such that it will justify our making a
Dated: February 22, 2007.
query-only database containing NPPES
Michael O. Leavitt
health care provider data that are
required to be disclosed under the FOIA Secretary, Department of Health and Human
Services.
available to the public on an Internet
[FR Doc. 07–2651 Filed 5–23–07; 4:12 pm]
Web site. Users will be able to run
BILLING CODE 4120–01–P
simple queries online, such as queries
by NPI and by name of health care
provider.
DEPARTMENT OF HEALTH AND
There will be no charge to use the
HUMAN SERVICES
query-only database.
The NPPES data elements that HHS
Food and Drug Administration
has determined are required to be
disclosed under FOIA and will be
[Docket No. 2007N–0208]
available from the query-only database
Interim Melamine and Melamine
are listed in the table above.
Analogues Safety/Risk Assessment;
3. Other requests for NPPES health
Availability
care provider data that HHS has
determined are required to be disclosed AGENCY: Food and Drug Administration,
under the FOIA.
HHS
Requests for FOIA-disclosable data in
ACTION: Notice.
formats or in media that are not
described above, or any other custom
SUMMARY: The Food and Drug
requests, will be considered in
Administration (FDA) is announcing the
accordance with the FOIA and CMS
availability of a document entitled,
FOIA procedures and charges (see
‘‘Interim Melamine and Melamine
https://www.cms.hhs.gov/AboutWebsite/ Analogues Safety/Risk Assessment.’’
04_FOIA.asp). For example, these could The interim safety/risk assessment
be requests for FOIA-disclosable data for describes the risk to human health
specific health care providers, or for
associated with eating pork, chicken,
health care providers in certain States or fish, and eggs from animals that were
with certain Healthcare Provider
inadvertently fed animal feed that
Taxonomy Codes, or requests for FOIAcontained melamine and its analogues
disclosable data on CD, diskette, or
(cyanuric acid, ammelide and
paper. These requests must be described ammeline). FDA is seeking public
in detail and be submitted to the
comment on the interim safety/risk
following address: Centers for Medicare assessment to assist the agency and the
& Medicaid Services, Office of Strategic
Food Safety and Inspection Service
Operations and Regulatory Affairs,
(FSIS) at the U. S. Department of
Freedom of Information Group, Room
Agriculture (USDA) in the ongoing
N2–20–16, 7500 Security Boulevard,
investigation of contaminated vegetable
Baltimore, Maryland 21244–1850.
protein products imported from China
Requests may be sent by fax to (410)
that were mislabeled as ‘‘wheat gluten’’
786–0474. We will not acknowledge,
and ‘‘rice protein concentrate,’’ and
respond to, or honor requests that are
ensuring the safety of the U.S. food
made by telephone.
supply.
III. Collection of Information
DATES: Comments on the interim safety/
Requirements
risk assessment must be submitted by
June 29, 2007.
This document does not impose
information collection and
ADDRESSES: Submit written comments
recordkeeping requirements.
to the Division of Dockets Management
Consequently, it need not be reviewed
(HFA–305), Food and Drug
by the Office of Management and
Administration, 5630 Fishers Lane, rm.
Budget under the authority of the
1061, Rockville, MD 20852. Submit
PO 00000
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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
electronic comments to https://
www.fda.gov/dockets/ecomments.
P.
Michael Bolger, Chief, Risk Assessment
Staff, Center for Food Safety and
Applied Nutrition (HFS–308), 5100
Paint Branch Pkwy., College Park, MD
20740–3835, 301–436–1941, FAX 301–
436–2632, or e-mail:
Mike.Bolger@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
The interim safety/risk assessment
was prepared by FDA in collaboration
with FSIS and in consultation with the
Centers for Disease Control and
Prevention, the Environmental
Protection Agency, and the Department
of Homeland Security. The purpose of
the safety/risk assessment is to assist
FDA and FSIS in the ongoing
investigation of contaminated vegetable
protein products imported from China
that were mislabeled as ‘‘wheat gluten’’
and ‘‘rice protein concentrate,’’ and
ensuring the safety of the U.S. food
supply. The interim safety/risk
assessment concludes that, based on
currently available data and
information, the consumption of even
large amounts of pork, chicken, fish,
and/or eggs from animals that had been
inadvertently fed animal feed
contaminated with melamine and its
analogues is very unlikely to pose a
human health risk. This safety/risk
assessment was developed rapidly due
to the extremely time-sensitive need to
understand the nature of the potential
risk. However, we are seeking public
comment on this interim safety/risk
assessment, and in addition it will
undergo expert peer review.
sroberts on PROD1PC70 with NOTICES
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 melamine and its
analogues safety/risk assessment
addresses:
(1) The chemical characteristics of
melamine and its analogues;
(2) The toxicological profile of
melamine and its analogues, including
the observed results from controlled
animal studies conducted with
melamine; and
(3) The likelihood that consumption
of pork, chicken, fish and eggs from
animals fed feed contaminated with
melamine and its analogues poses a
health risk to humans.
FDA used the following methodology
to develop the safety/risk assessment.
VerDate Aug<31>2005
19:13 May 29, 2007
Jkt 211001
The safety/risk assessment was based on
the currently available scientific data
and information. FDA estimated human
exposure to melamine and its analogues
based on the estimated levels in specific
foods and the estimated consumption of
those foods. The agency compared the
exposure estimate to a ‘‘Tolerable Daily
Intake’’ level, which was derived using
available toxicity data on the level of
melamine that did not cause adverse
renal effects in a laboratory-animal (13week rat) bioassay study. FDA adjusted
this level, ‘‘the No Observed Adverse
Effect Level’’ for uncertainty in the data
by dividing by a safety/uncertainty
factor of 100 to account for differences
in sensitivity within and across species.
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.
IV. Electronic Access
The interim safety/risk assessment is
available electronically at https://
www.cfsan.fda.gov/~dms/
melamra.html.
Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–2679 Filed 5–25–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
PO 00000
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30015
that the following committee will
convene its fifty-sixth meeting.
Name: National Advisory Committee on
Rural Health and Human Services.
Dates and Times: June 10, 2007, 1 p.m.–
5:45 p.m., June 11, 2007, 8:45 a.m.–5 p.m.,
June 12, 2007, 8:50 a.m.–10:45 a.m.
Place: Fort Collins Hilton, 425 Prospect
Road, Fort Collins, CO 80526, Phone: 970–
482–2626.
Status: The meeting will be open to the
public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations to the Secretary with
respect to the delivery, research,
development and administration of health
and human services in rural areas.
Agenda: Sunday afternoon, June 10, at
1 p.m., the meeting will be called to order by
the Chairperson of the Committee, the
Honorable David Beasley. Jim Wescott,
Senior Demographer with Colorado State will
be give an overview of Rural Colorado.
Following this presentation will be two
panels on health and human services issues.
The first will be an health panel. The
speakers will be Mark Wallace, President of
Northern Colorado Health Alliance, and Dr.
Jack Westfall, Associate Dean for Rural
Health at the Colorado University School of
Medicine. The second will be a human
services panel. The speakers will be Patricia
Brewster-Willeke, a Public Health Nurse, and
Kindra Mulch, Administrator of Kit Carson
County Health and Human Services.
Following the panel discussions will be an
overview of Monday’s site visits by Lou Ann
Wilroy with the Colorado State Office of
Rural Health. The Sunday meeting will close
at 5:45 p.m.
Monday morning, June 11, at 8:30 a.m., the
Committee will break into Subcommittee
format for the site visits. At 8:45 a.m., both
Subcommittees will depart for site visits. The
Health Subcommittee will depart to East
Morgan County Hospital in Brush, Colorado.
The Human Services Subcommittee will
depart to the Area Agency on Aging in Fort
Morgan, Colorado. Transportation to these
sites will not be provided. Both
Subcommittees will return to Fort Collins
Hilton and resume meeting in Subcommittee
format at 4 p.m. The Monday meeting will
close at 5 p.m.
The final session will be convened
Tuesday morning, June 12, at 8:50 a.m. A
Committee member, Mayor Larry Otis, will
present a case study titled Employee Health
Care in Rural Mississippi. Following this
presentation will be a review of the site
visits, discussion on the letter to the
Secretary, and discussion of the upcoming
September meeting. The meeting will be
adjourned at 10:45 a.m.
For Further Information Contact: Anyone
requiring information regarding the
Committee should contact Tom Morris,
M.P.A., Executive Secretary, National
Advisory Committee on Rural Health and
Human Services, Health Resources and
Services Administration, Parklawn Building,
Room 9A–55, 5600 Fishers Lane, Rockville,
MD 20857, Telephone (301) 443–0835, Fax
(301) 443–2803.
E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 30014-30015]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2679]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0208]
Interim Melamine and Melamine Analogues Safety/Risk Assessment;
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 Melamine and Melamine
Analogues Safety/Risk Assessment.'' The interim safety/risk assessment
describes the risk to human health associated with eating pork,
chicken, fish, and eggs from animals that were inadvertently fed animal
feed that contained melamine and its analogues (cyanuric acid, ammelide
and ammeline). FDA is seeking public comment on the interim safety/risk
assessment to assist the agency and the Food Safety and Inspection
Service (FSIS) at the U. S. Department of Agriculture (USDA) in the
ongoing investigation of contaminated vegetable protein products
imported from China that were mislabeled as ``wheat gluten'' and ``rice
protein concentrate,'' and ensuring the safety of the U.S. food supply.
DATES: Comments on the interim safety/risk assessment must be submitted
by June 29, 2007.
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
[[Page 30015]]
electronic comments to https://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: P. Michael Bolger, Chief, Risk
Assessment Staff, Center for Food Safety and Applied Nutrition (HFS-
308), 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-
1941, FAX 301-436-2632, or e-mail: Mike.Bolger@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The interim safety/risk assessment was prepared by FDA in
collaboration with FSIS and in consultation with the Centers for
Disease Control and Prevention, the Environmental Protection Agency,
and the Department of Homeland Security. The purpose of the safety/risk
assessment is to assist FDA and FSIS in the ongoing investigation of
contaminated vegetable protein products imported from China that were
mislabeled as ``wheat gluten'' and ``rice protein concentrate,'' and
ensuring the safety of the U.S. food supply. The interim safety/risk
assessment concludes that, based on currently available data and
information, the consumption of even large amounts of pork, chicken,
fish, and/or eggs from animals that had been inadvertently fed animal
feed contaminated with melamine and its analogues is very unlikely to
pose a human health risk. This safety/risk assessment was developed
rapidly due to the extremely time-sensitive need to understand the
nature of the potential risk. However, we are seeking public comment on
this interim safety/risk assessment, and 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 melamine
and its analogues safety/risk assessment addresses:
(1) The chemical characteristics of melamine and its analogues;
(2) The toxicological profile of melamine and its analogues,
including the observed results from controlled animal studies conducted
with melamine; and
(3) The likelihood that consumption of pork, chicken, fish and eggs
from animals fed feed contaminated with melamine and its analogues
poses a health risk to humans.
FDA used the following methodology to develop the safety/risk
assessment. The safety/risk assessment was based on the currently
available scientific data and information. FDA estimated human exposure
to melamine and its analogues based on the estimated levels in specific
foods and the estimated consumption of those foods. The agency compared
the exposure estimate to a ``Tolerable Daily Intake'' level, which was
derived using available toxicity data on the level of melamine that did
not cause adverse renal effects in a laboratory-animal (13-week rat)
bioassay study. FDA adjusted this level, ``the No Observed Adverse
Effect Level'' for uncertainty in the data by dividing by a safety/
uncertainty factor of 100 to account for differences in sensitivity
within and across species.
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.
IV. Electronic Access
The interim safety/risk assessment is available electronically at
https://www.cfsan.fda.gov/~dms/melamra.html.
Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-2679 Filed 5-25-07; 8:45 am]
BILLING CODE 4160-01-S
