Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices 30015 

electronic comments to http:// 

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 http:// 

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 

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. 


sroberts on PROD1PC70 with NOTICES
30016 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 http:// 

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

Type of respondent Number of 

respondents 

Frequency of 

response 

Average hours 

per response 

Total hours 

(3 yr) 

Annual hour 

burden 

Focus group 

Kazakhstan villagers (adults) ≥70 yrs old) .......................... 128 1 1.9 243 81.1 


sroberts on PROD1PC70 with NOTICES