Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 51487 

to oversee the project; see Exhibit 3. The 

annualized cost for this two year project 

is $422,000. 

EXHIBIT 3—PROJECT COST

COMPONENTS

Cost components Cost 

estimate 

Experimental design ................... $168,900 

Development of simulated Webbased reports .......................... 157,900 

Pilot testing ................................. 56,000 

Usability testing of Web-based 

reports ..................................... 56,300 

Data collection via Knowledge 

Networks ................................. 126,000 

Data analysis .............................. 56,300 

Preparation of reports and journal papers ............................... 112,600 

AHRQ project management 110,000 

Total ..................................... 844,000 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 26, 2008. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E8–20315 Filed 9–2–08; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Health and Nutrition 

Examination Survey (NHANES) Stored 

Biologic Specimens: Guidelines for 

Proposals To Use Samples and 

Proposed Cost Schedule 

AGENCY: Centers for Disease Control and 

Prevention, Department of Health and 

Human Services. 

ACTION: Notice and request for 

comments. 

SUMMARY: The National Health and 

Nutrition Examination Survey 

(NHANES) is a program of periodic 

surveys conducted by the National 

Center for Health Statistics (NCHS) of 

the Centers for Disease Control and 

Prevention (CDC). Examination surveys 

conducted since 1960 by NCHS, have 

provided national estimates of health 

and nutritional status of the United 

States civilian non-institutionalized 

population. To add to the large amount 

of information collected for the purpose 

of describing the health of the 

population in the most recent survey, 

serum, urine and limited plasma 

samples were collected and stored for 

future research projects. Specimens are 

currently available from NHANES III 

(conducted from 1988–1994) and from 

NHANES 1999+. In 1999, NHANES 

became a continuous survey with data 

release every two years. Specimens are 

available from two year survey cycles 

after the demographic file has been 

released to the public. Participants in 

the survey that began in 1999 signed a 

separate consent document agreeing to 

specimen storage allowing their biologic 

specimens to be used for approved 

research projects. 

Specimens are stored in two 

Specimen Banks. Surplus samples that 

were initially used for laboratory assays 

included in the surveys, have since been 

stored at ¥70°C and have been through 

at least two freeze-thaw cycles. They are 

stored at a commercial repository under 

contract to NCHS. In addition, on 

average, six vials of sera were also 

stored in vapor-phase liquid nitrogen at 

the CDC and ATSTR Specimen 

Packaging, Inventory and Repository 

(CASPIR) Repository in Lawrenceville, 

GA. These specimens have not 

undergone a freeze-thaw cycle. The 

CASPIR Repository is considered a longterm repository for the NHANES 

specimens. NCHS is making both of 

these collections available for research 

proposals. The research proposals that 

can use the surplused specimens will 

receive higher priority. Proposals that 

request the specimens in CASPIR need 

to justify the use of the unthawed 

specimens. 

The purpose of this notice is to 

request comments on this program and 

the proposed cost schedule. After 

consideration of comments submitted, 

CDC will finalize and publish the cost 

schedule and accept proposals for use of 

the NHANES stored biologic samples. 

Please go to http://www.cdc.gov/nchs/ 

about/major/nhanes/serum1b.htm for 

final proposal guidelines. 

All interested researchers are 

encouraged to submit proposals. No 

funding is provided as part of this 

solicitation. Samples will not be 

provided to those projects requiring 

funding until the project has received 

funds. Approved projects that do not 

obtain funding will be canceled. A more 

complete description of this program 

follows. 

DATES:

• Comment Receipt Date: October 3, 

2008. 

• Invitation to Submit Proposals: Can 

be submitted on an ongoing basis. 

• Scientific Review Date: Within two 

months of proposal submission. 

• Institutional Review Date: Within 

one month of final proposal acceptance. 

• Anticipated distribution of samples: 

One month after IRB approval. 

ADDRESSES: To send comments and to 

request information, contact: 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. Internet: http:// 

www.cdc.gov/nchs/about/major/ 

nhanes/serum1b.htm. 

Authority: Sections 301, 306 and 308 of the 

Public Health Service Act (42 U.S.C. 241, 

242k and 242M). 

SUPPLEMENTARY INFORMATION: The goals 

of NHANES are: (1) To estimate the 

number and percent of persons in the 

U.S. population and designated 

subgroups with selected diseases and 

risk factors; (2) to monitor trends in the 

prevalence, awareness, treatment and 

control of selected diseases; (3) to 

monitor trends in risk behaviors and 

environmental exposures; (4) to analyze 

risk factors for selected diseases; (5) to 

study the relationship between diet, 

nutrition and health; (6) to explore 

emerging public health issues and new 

technologies; and, (7) to establish and 

maintain a national probability sample 


sroberts on PROD1PC70 with NOTICES
51488 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 

of baseline information on health and 

nutrition status. 

Specimens are available from the 

third National Health and Nutrition 

Examination Survey (NHANES III) and 

the continuous NHANES that started in 

1999. Approximately 30,000 individuals 

were examined in NHANES III which 

began in the fall of 1988, and ended in 

the fall of 1994. This survey can be 

analyzed in two phases. Phase 1 was 

conducted from October 1988 to 

October 1991 and Phase 2 began 

October 1991 and ended October 1994. 

Though participants consented to 

storing samples of their blood for future 

testing only research projects that 

include results that are judged not to 

have clinical significance for 

participants will be accepted. See: 

http://www.cdc.gov/nchs/about/major/ 

nhanes/nh3data.htm for more 

information on NHANES III. 

Beginning in 1999, NHANES became 

a continuous, annual survey with 

examination of approximately 5,000 

individuals a year and data release 

every two years. Proposed research 

projects and samples requested must 

come from this two-year design (i.e. 

request must be for 1999–2000 samples 

or 2001–2002, etc.). Samples from a 

single year of the survey will not be 

provided for research projects, but 

multiple two-year cycles may be 

requested. For details of the sampling 

design see the Analytic Guidelines at: 

http://www.cdc.gov/nchs/about/major/ 

nhanes/nhanes2003-2004/ 

analytical_guidelines.htm. 

Starting in 1999 to 2008 survey 

participants were informed in the 

consent document for future laboratory 

analysis that they would not receive the 

results from these studies. Therefore, 

only research projects that propose 

laboratory results that do not have 

clinical relevance to an individual will 

be accepted by NCHS. Clinical 

significance of a laboratory test will be 

judged by the NHANES Medical Officer, 

but the researcher should address this in 

the research proposal. See http:// 

www.cdc.gov/nchs/about/major/ 

nhanes/nhanes2007-2008/ 

current_nhanes_07_08.htm for a copy of 

the current consent document. 

All proposals for use of NHANES 

samples will be evaluated by a technical 

panel for scientific merit and by the 

NHANES Ethics Review Board (ERB) for 

any potential human subjects concerns. 

The NHANES ERB will review the 

proposal even if the investigator has 

received approval by their institutional 

review panel. 

To determine if this limited resource 

should be used in the proposed projects, 

a Technical Panel will evaluate the 

public health significance and scientific 

merit of the proposed research. 

Scientific merit will be judged as to the 

scientific, technical or medical 

significance of the research, the 

appropriateness and adequacy of the 

experimental approach, and the 

methodology proposed to reach the 

research goals. See ‘Criteria for 

Technical Evaluation of Proposals’ 

below. The proposal should outline how 

the results from the laboratory analysis 

will be used. Because NHANES is a 

complex, multistage probability sample 

of the national population, the 

appropriateness of the NHANES sample 

to address the goals of the proposal will 

be an important aspect of scientific 

merit. The survey oversamples the two 

largest race/ethnic minority groups, 

non-Hispanic blacks and Mexican 

Americans along with other subgroups 

of the population. Sampling weights are 

therefore used to make national 

estimates of frequencies. The use of 

weights, sampling frame and methods of 

assessment of variables included in the 

data are likely to affect the proposed 

research. The Technical Panel will 

review the analysis plan and evaluate 

whether the proposal is an appropriate 

use of the NHANES population. The 

Technical Panel will also assure that the 

proposed project does not go beyond 

either the general purpose for collecting 

the samples in the survey, or of the 

specific stated goals of the proposal. 

Investigators are encouraged to review 

the NHANES data, survey documents, 

manuals and questionnaires at: http:// 

www.cdc.gov/nchs/about/major/ 

nhanes/nhanes99-02.htm or for 

NHANES III: http://www.cdc.gov/nchs/ 

about/major/nhanes/nh3data.htm. 

Procedures for Proposals 

All investigators (including CDC 

investigators) must submit a proposal 

for use of NHANES specimens. 

Proposals are limited to a maximum 

of 10 single-spaced typed pages, 

excluding figures and tables, using 10 

cpi type density. The cover of the 

proposal should include the name, 

address, and phone number and E-mail 

address of the principal investigator (PI) 

and the name of the institution where 

the laboratory analysis will be done. All 

proposals should be E-mailed to 

gmm2@cdc.gov. Proposals must include 

a cover page with the title of the 

proposal and the name, address, phone 

number and E-mail address of all 

investigators. Proposals from CDC 

investigators must also include 

investigators scientific ethic verification 

number. 

The following criteria will be used for 

technical evaluation of proposals: 

Proposals should include the 

following information: 

(1) Specific Aims: List the broad 

objectives; describe concisely and 

realistically what the research is 

intended to accomplish, and state the 

specific hypotheses to be tested. 

NHANES is designed to provide 

prevalence estimates of diseases or 

conditions that are expected to affect 

between 5–10 percent of the population. 

Research proposals that expect much 

lower prevalence estimates need to 

provide more detail on why specimens 

from NHANES are needed for the 

project and provide details on how 

these data will be analyzed. 

(2) Background and Public Health 

Significance: Describe the public health 

significance, scientific merit and 

practical utility of the assay. Briefly 

describe in 1–2 pages the background of 

the proposal, identifying gaps in 

knowledge that the project is intended 

to fill. State concisely the importance of 

the research in terms of the broad, longterm objectives and public health 

relevance including a discussion of how 

the results will affect public health 

policy or further scientific knowledge. 

The proposal should justify the need for 

specimens that are representative of the 

U.S. population. The proposer should 

convey how the results will be used and 

the relationship of the results to the data 

already collected in NHANES. The 

proposer should include an analysis 

plan. The analyses ought to be 

consistent with the NHANES mission 

and the health status variables. 

(3) Research Design and Methods: 

Describe the research design and the 

procedures to be used. A detailed 

description of laboratory methods 

including validity and reliability must 

be included with references. The 

volume of specimen and number of 

samples requested must be specified. 

Adequate methods for handling and 

storage of samples must also be 

addressed. The laboratory must 

demonstrate expertise in the proposed 

laboratory test including the capability 

for handling the workload requested in 

the proposal. The proposal should also 

include a justification for determination 

of sample size or a power calculation. If 

the researcher is requesting a subsample of specimens, a detailed 

description and justification, must be 

given. The researcher must describe 

how this sub-sample will be re-weighted 

to provide national estimates. The 

program will evaluate the study design 

and analysis plan in the proposal to 

determine whether the project is 

consistent with the design of the 

NHANES survey. Sub-samples are less 

useful to the research community when 


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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