National Advisory Committee on Rural Health and Human Services; Notice of Meeting, 30015-30016 [07-2683]
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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.
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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.
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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices
Persons interested in attending any portion
of the meeting should contact Michele PrayGibson, Office of Rural Health Policy
(ORHP), Telephone (301) 443–0835. The
Committee meeting agenda will be posted on
ORHP’s Web site https://
www.ruralhealth.hrsa.gov.
Due to scheduling difficulties, this notice
will publish in the Federal Register less than
15 days before the date of the meeting.
Dated: May 24, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. 07–2683 Filed 5–25–07; 10:55 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Proposed
Collection; Comment Requested;
Study to Improve Thyroid Doses from
Fallout Exposure in Kazakhstan
SUMMARY: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
January 18, 2007, pages 2286–2287 and
allowed 60-days for public comment.
No public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Proposed Collection
Title: Study to improve thyroid doses
from fallout exposure in Kazakhstan,
Radiation Epidemiology Branch,
Division of Cancer Epidemiology and
Genetics, National Cancer Institute
(NCI). This is a dose reconstruction
effort. Additional data will be acquired
to improve on published estimates of
individual internal and external
radiation dose and better characterize
the underlying dose uncertainties for
individuals exposed as children to
radioactive fallout from nuclear tests
conducted at the Semipalatinsk Nuclear
Test Site (SNTS) in Kazakhstan during
the 1950s. Village residents near the test
site received high doses of internal and
external radiation to the thyroid gland
(up to 10 Gy for internal and 0.6 Gy for
external radiation) as a result of
multiple nuclear tests. Internal radiation
exposure occurred primarily through
consumption of milk and other dairy
products from animals grazing on
pastures contaminated with radioactive
iodine. The external dose received by
individuals was a function of the
exposure rate when the fallout was
deposited, shielding provided by
buildings and the number of hours
spent outdoors on a daily basis.
Collection from small focus groups of
persons who were young adults at the
time of the nuclear tests of specific
information about children’s milk
consumption and time spent indoors
and outdoors, shielding, and pasturing
and feeding of dairy animals for the
months following the nuclear tests will
allow dosimetrists to evaluate and
change, as appropriate, the current
assumptions and input values for the
parameters of the dose estimation
model. The new data will allow more
objective model assumptions and result
in a more informed characterization of
uncertainty.
Type of information collection
request: NEW. The Kazakhstan
population was exposed to high levels
of radiation from external as well as
internal sources, unlike the vast
majority of persons living downwind
from the Chernobyl accident who were
exposed only to radioactive isotopes of
ingested and inhaled iodine.
Availability of accurate dose estimates
will allow evaluation of the relative
biological effectiveness (RBE) of internal
vs. external radiation exposures in terms
of thyroid disease risk within a single
population. The conditions of fallout
exposure in Kazakhstan are directly
relevant to conditions following a
hypothetical nuclear accident or a
terrorist attack involving high levels of
local fallout.
Need and Use of Information
Collection: NCI proposes a small-scale
field study to acquire new data to
improve published estimates of internal
and external radiation doses to
individuals exposed to fallout from
nuclear tests conducted at the SNTS
during 1949–1962. Retrospective
information about factors influencing
radiation dose to the thyroid gland in
children of two distinct ethnic groups
(Kazakh and Russian) will be collected
using focus group interviews. New data
to be collected on milk and milk
product consumption, time typically
spent outdoors, radiation shielding
provided by dwellings and other
buildings, and seasonal practices of
pasturing and supplemental feeding of
dairy animals at the time of the nuclear
tests will enable dosimetrists to address
key weaknesses in the current dosimetry
models. Since the objective is to
estimate group-specific mean values
(and ranges) and not to collect
individual data, focus groups are better
suited than conventional in-depth
individual interviews. Focus group
members will be recruited from among
women and men who speak Russian or
Kazakh and have a verified history of
residence in the village at the time of
the nuclear tests. In each village, three
groups of 8 women, age 70 or older, who
had children or provided care to other
children (e.g., younger siblings, nieces
and nephews) who were under age 21
at the time of the nuclear tests will be
enrolled. In each village, 8 men, age 70
or older, who were engaged in farming
and the care of dairy animals at the time
of the nuclear tests will be enrolled.
Frequency of Response: Once.
Affected Public: Individual and
household. Type of Respondent: Women
and men, age 70 or older. Estimated
Number of Respondents: 128. Estimated
Number of Responses per Respondent:
1. Average Burden Hours per Response:
2.0. Annual Burden Hours Requested:
85.3.
TABLE 1.—ESTIMATES OF ANNUALIZED HOUR BURDEN TO RESPONDENTS
Number of
respondents
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Type of respondent
Frequency of
response
Average hours
per response
Total hours
(3 yr)
Annual hour
burden
Focus group
Kazakhstan villagers (adults) ≥70 yrs old) ..........................
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]]>Agencies
[Federal Register Volume 72, Number 103 (Wednesday, May 30, 2007)]
[Notices]
[Pages 30015-30016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2683]
-----------------------------------------------------------------------
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 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.
[[Page 30016]]
Persons interested in attending any portion of the meeting
should contact Michele Pray-Gibson, Office of Rural Health Policy
(ORHP), Telephone (301) 443-0835. The Committee meeting agenda will
be posted on ORHP's Web site https://www.ruralhealth.hrsa.gov.
Due to scheduling difficulties, this notice will publish in the
Federal Register less than 15 days before the date of the meeting.
Dated: May 24, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. 07-2683 Filed 5-25-07; 10:55 am]
BILLING CODE 4165-15-P
