Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 51489 

the data are released in the public 

domain, so such requests will receive a 

lower priority for the specimens. 

Restricting a research proposal to 

demographic categories that are design 

variables for the survey is encouraged if 

laboratory testing must be restricted. 

(4) Clinical Significance or results: 

Since the consent document for 

specimen storage and continuing 

studies states that individual results 

will not be provided, the clinical 

significance of the proposed laboratory 

test should be addressed. 

The proposal should include a 

discussion of the potential clinical 

significance of the results and whether 

there is definitive evidence that results 

of the test would provide grounds for 

medical intervention even if many years 

have passed since the examination of 

the participant and collection of the 

sample. Any test with results that 

should be reported to a participant 

should be considered for inclusion in 

the concurrent survey, and is not 

appropriate for testing on the stored 

samples. 

(5) Qualification: Provide a brief 

description of the Principal 

Investigator’s expertise in the proposed 

area should be provided, including 

publications in this area within the last 

three years. A representative sample of 

earlier publications may be listed as 

long as this section does not exceed two 

pages. 

(6) Period of performance: Specify the 

project period. Substantial progress 

must be made in the first year, and the 

project should be completed in two 

years. If additional time is needed for 

the research project a detailed 

justification with a timeline should be 

included. The investigator should 

address his/her ability to comply with 

this timeline or request and justify 

additional time for the project. Return of 

the specimens will be requested if 

progress is not made in the project at the 

end of the second year. Refund of 

payment for the specimens will not be 

returned in this situation. At the end of 

the project period, any unused samples 

must be returned to the NHANES 

Specimen Bank or discarded. The NCHS 

Project Officer must be consulted about 

the disposition of the samples. 

(7) Funding: Include the source and 

status of the funding to perform the 

requested laboratory analysis should be 

included. Investigators will be 

responsible for the cost of processing 

and shipping the samples. The cost per 

specimen is $6.50. The basis for the cost 

structure is in the last section of this 

document. Reimbursement for the 

samples will be collected before the 

samples are released. 

Submission of Proposals 

Proposals can be submitted in MS 

Word format by E-mail to: Dr. Geraldine 

McQuillan, Division of Health and 

Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, Room 

4204, Hyattsville, MD 20782, Phone: 

301–458–4371 Fax: 301–458–4028, Email gmm2@cdc.gov. 

Approved Proposals 

Approved projects will be provided 

specimens on receipt of a signed 

Materials Transfer Agreement (MTA) 

and a check (written to The Centers for 

Disease Control and Prevention) for the 

cost of the specimens. All laboratory 

results obtained from the samples will 

be sent back to NCHS to be linked to the 

sequence number that is the linking 

identifier on the public use files. All 

files will undergo disclosure review at 

NCHS. Within 90 days of the return of 

the data to NCHS these data may be 

released to the public. 

Agency Agreement 

A formal signed agreement in the 

form of a Materials Transfer Agreement 

(MTA) with individuals who have 

projects approved will be completed 

before the release of the samples. This 

agreement will contain the conditions 

for use of the samples as stated in this 

document and as agreed upon by the 

investigators and CDC. 

Progress Reports 

Brief progress report will be 

submitted annually. This will be the 

basis for the NHANES ERB continuation 

reports that are required annually. 

Disposition of Results and Samples 

No samples provided can be used for 

any purpose other than those 

specifically requested in the proposal 

and approved by the Technical Panel 

and the NHANES ERB. No sample can 

be shared with others, including other 

investigators, unless specified in the 

proposal and so approved. Any unused 

samples must be returned to the 

NHANES Specimen Bank or disposed of 

upon completion of the approved 

project. These results, once returned to 

NCHS, will be part of the public 

domain. The proposer will have 90 days 

for quality control review of the data 

before public release. 

Proposed Cost Schedule for Providing 

NHANES Specimens: 

A nominal processing fee of $6.50 is 

proposed for each sample received from 

the NHANES Specimen Bank. The costs 

include both the collection, storage and 

processing of the specimens along with 

the review of proposals and the 

preparation of the data files. These costs 

were based on an assumption that 

NCHS will receive and process eight 

proposals in a year, each requesting 

5,000 samples as shown in the table 

below. 

The materials listed are for the 

recurring laboratory costs to dispense 

and prepare the samples during 

collection and for shipping; the 

computer software needed for the 

preparation of the data files and for the 

release of the data along with 

documentation on the NHANES Web 

page. Labor costs are based on a 

proposal administrator and computer 

programmers at NCHS to prepare the 

data files. The storage and pulling fees 

include the costs for the NHANES 

repository. 

Total costs Cost 

Labor ............................................. $0.70 

Collection Storage ........................ 2.96 

Pulling specimens ......................... 1.04 

Shipping ........................................ 0.31 

Subtotal ......................................... 5.01 

CDC/FMO support (10%) ............. 0.50 

Subtotal ......................................... 5.51 

NCHS support (18%) .................... 0.99 

Total ....................................... 6.50 

Comments are solicited on the 

proposed cost schedule. Comments are 

due by: October 3, 2008. 

Send Comments and Requests for 

Information to: Dr. Geraldine 

McQuillan, Division of Health and 

Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, Room 

4204, Hyattsville, MD 20782, Phone: 

301–458–4371; Fax: 301–458–4028, 

e-mail gmm2@cdc.gov. 

Dated: August 26, 2008. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E8–20335 Filed 9–2–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notification of the Establishment of the 

National Commission on Children and 

Disasters 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 


sroberts on PROD1PC70 with NOTICES
51490 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 

ACTION: Notification of the 

establishment of the National 

Commission on Children and Disasters. 

SUMMARY: This notice announces the 

establishment of the National 

Commission on Children and Disasters, 

a Secretary’s Advisory Committee. The 

Consolidated Appropriations Act, 2008 

(Pub. L. 110–161), Division G, Title VI, 

directs the establishment of the National 

Commission on Children and Disasters. 

The Commission shall conduct a 

comprehensive study to examine and 

assess the needs of children as they 

relate to preparation for, response to, 

and recovery from all hazards, building 

upon the evaluation of other entities 

and avoiding unnecessary duplication 

by reviewing the findings, conclusions, 

and recommendations of these entities, 

and shall then submit a report to the 

President and Congress on the 

Commission’s specific findings, 

conclusions, and recommendations to 

address the needs of children as they 

relate to major disasters and 

emergencies. 

FOR FURTHER INFORMATION CONTACT: 

Roberta Lavin, Office of Human Services 

Emergency Preparedness and Response, 

e-mail Roberta.lavin@acf.hhs.gov or 

202–401–9306. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Commission and its staff are 

governed by the provisions of the 

Federal Advisory Committee Act (5 

U.S.C. Appendix 2), which sets forth the 

standards for the formation and use of 

advisory committees. The Secretary’s 

establishment of this Commission is 

authorized pursuant to Section 1114 of 

the Social Security Act (42 U.S.C. 1314). 

The Commission shall determine a 

schedule of meetings following an 

election of a Chairperson and Vice 

Chairperson from among its members. 

An initial meeting of the Commission 

shall take place not later than 120 days 

after all members of the Commission 

have been appointed. 

II. Criteria for Members 

The Commission shall be composed 

of ten members, of whom one shall be 

the Chairperson and one shall be the 

Vice Chairperson, as determined by an 

election among the total membership, 

and shall be appointed by the Secretary 

in a manner designed to assure 

bipartisan representation on the 

Commission, in accordance with the 

intent of Congress as follows: 

• No members of the Commission 

may be officials or employees of the 

Federal Government; 

• At least one member appointed to 

the Commission must be a 

representative from a private nonprofit 

entity with demonstrated experience in 

addressing the needs of children as they 

relate to preparation for, response to, 

and recovery from all hazards, including 

major disasters and emergencies; and 

• At least one member appointed to 

the Commission must be a State 

emergency manager or local emergency 

manager. 

III. Copies of the Charter 

To obtain a copy of the Commission’s 

Charter, submit a written request to the 

above contact. 

Dated: August 27, 2008. 

Daniel C. Schneider, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. E8–20378 Filed 9–2–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–F–0462] 

Zentox Corp.; Filing of Food Additive 

Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Zentox Corp. has filed a petition 

proposing that the food additive 

regulations be amended to provide for 

the safe use of monochloramine as an 

antimicrobial agent in poultry process 

chiller water. 

DATES: Submit written or electronic 

comments on the petitioner’s 

environmental assessment by October 3, 

2008. 

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 http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Judith Kidwell, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 301–436–1071. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))), 

notice is given that a food additive 

petition (FAP 8A4775) has been filed by 

Zentox Corp., c/o Burdock Group, 801 

North Orange Ave., suite 710, Orlando, 

FL 32801. The petition proposes to 

amend the food additive regulations in 

part 173—Secondary Direct Food 

Additives Permitted in Food for Human 

Consumption (21 CFR part 173) to 

provide for the safe use of 

monochloramine as an antimicrobial 

agent in poultry process chiller water. 

The potential environmental impact 

of this petition is being reviewed. To 

encourage public participation 

consistent with regulation issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see DATES and ADDRESSES) for public 

review and comment. 

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. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the agency finds 

that an environmental impact statement 

is not required, and this petition results 

in a regulation, the notice of availability 

of the agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 

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 

http://www.regulations.gov. 

Dated: August 27, 2008. 

Laura M. Tarantino, 

Director, Office of Food Additive Safety, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. E8–20293 Filed 9–2–08; 8:45 am] 

BILLING CODE 4160–01–S 


sroberts on PROD1PC70 with NOTICES