9666 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact 

Nathaniel Rothman, Senior Investigator 

for the Occupational and Environmental 

Epidemiology Branch, Division of 

Epidemiology and Genetics, National 

Cancer Institute, 6120 Executive 

Boulevard, Room 8118, Rockville, MD 

20892 or call non-toll-free number 301– 

496–9093 or email your request, 

including your address to: 

rothmann @mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 15 days of the date of 

this publication. 

Dated: February 13, 2012. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2012–3830 Filed 2–16–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; New Proposed 

Collection; Comment Request Stress 

and Cortisol Measurement for the 

National Children’s Study 

Summary: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Child Health and 

Human Development (NICHD), 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. 

Proposed Collection 

Title: Stress and Cortisol 

Measurement Substudy for the National 

Children’s Study (NCS). Type of 

Information Collection Request: NEW. 

Need and Use of Information Collection: 

The Children’s Health Act of 2000 (Pub. 

L. 106–310) states: 

(a) PURPOSE.—It is the purpose of this 

section to authorize the National Institute of 

Child Health and Human Development to 

conduct a national longitudinal study of 

environmental influences (including 

physical, chemical, biological, and 

psychosocial) on children’s health and 

development. 

(b) IN GENERAL.—The Director of the 

National Institute of Child Health and 

Human Development shall establish a 

consortium of representatives from 

appropriate Federal agencies (including the 

Centers for Disease Control and Prevention, 

the Environmental Protection Agency) to— 

(1) Plan, develop, and implement a 

prospective cohort study, from birth to 

adulthood, to evaluate the effects of both 

chronic and intermittent exposures on child 

health and human development; and 

(2) Investigate basic mechanisms of 

developmental disorders and environmental 

factors, both risk and protective, that 

influence health and developmental 

processes. 

(c) REQUIREMENT.—The study under 

subsection (b) shall— 

(1) Incorporate behavioral, emotional, 

educational, and contextual consequences to 

enable a complete assessment of the physical, 

chemical, biological, and psychosocial 

environmental influences on children’s wellbeing; 

(2) Gather data on environmental 

influences and outcomes on diverse 

populations of children, which may include 

the consideration of prenatal exposures; and 

(3) Consider health disparities among 

children, which may include the 

consideration of prenatal exposures. 

To fulfill the requirements of the 

Children’s Health Act, the Stress and 

Cortisol Measurement Substudy will 

develop an optimized, item-reduced 

measure of self-reported stress that is 

supported empirically through 

convergent validity analysis of stress 

biomarkers. Specifically, key 

moderators of stress biomarkers will be 

evaluated to inform the efficiency and 

quality of measurements during 

pregnancy. Development of a 

scientifically robust maternal stress 

measure would measure chronic stress 

more efficiently, would not require 

biospecimen collection and biomarker 

analyses, and would thereby reduce 

participant burden and NCS Vanguard 

(Pilot) and NCS Main Study costs. With 

this information collection request, the 

NCS seeks to obtain OMB’s clearance to 

conduct a substudy aimed at developing 

a validated questionnaire that will 

reflect specific biological and 

physiological measures of maternal 

stress. 

Background 

The National Children’s Study is a 

prospective, national longitudinal study 

of the interaction between environment, 

genetics on child health and 

development. The Study defines 

‘‘environment’’ broadly, taking a 

number of natural and man-made 

environmental, biological, genetic, and 

psychosocial factors into account. By 

studying children through their 

different phases of growth and 

development, researchers will be better 

able to understand the role these factors 

have on health and disease. Findings 

from the Study will be made available 

as the research progresses, making 

potential benefits known to the public 

as soon as possible. The National 

Children’s Study is led by a consortium 

of federal partners: the U.S. Department 

of Health and Human Services (http:// 

www.hhs.gov/) (including the Eunice 

Kennedy Shriver National Institute of 

Child Health and Human Development 

(http://www.nichd.nih.gov/) and the 

National Institute of Environmental 

Health Sciences (http:// 

www.niehs.nih.gov/) of the National 

Institutes of Health (http:// 

www.nih.gov/) and the Centers for 

Disease Control and Prevention (http:// 

www.cdc.gov/)), and the U.S. 

Environmental Protection Agency 

(http://www.epa.gov/). 

To conduct the detailed preparation 

needed for a study of this size and 

complexity, the NCS was designed to 

include a preliminary pilot study 

known as the Vanguard Study. The 

purpose of the Vanguard Study is to 

assess the feasibility, acceptability, and 

cost of the recruitment strategy, study 

procedures, and outcome assessments 

that are to be used in the NCS Main 

Study. The Vanguard Study begins prior 

to the NCS Main Study and will run in 

parallel with the Main Study. At every 

phase of the NCS, the multiple 

methodological studies conducted 

during the Vanguard phase will inform 

the implementation and analysis plan 

for the Main Study. 

In this information collection request, 

the NCS requests approval from OMB to 

perform a multi-center substudy, called 

the Stress and Cortisol Measurement 

Substudy. This substudy aims to 

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Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 9667 

determine the most reliable, acceptable, 

and cost-efficient approach for assessing 

maternal stress. Maternal stress is of 

particular interest to the NCS due to 

studies that have shown an association 

between maternal stress and negative 

health outcomes, including preterm 

birth which is one of the most important 

problems in maternal-child health in the 

US. Stress factors are also more 

prevalent in the population of sociodemographically disadvantaged women 

who are at an increased risk for preterm 

birth. Maternal stress is associated with 

additional health outcomes, such as 

still-birth, low birth weight, problems in 

offspring brain function and behavior 

(including lower IQ and impaired 

executive function), immune-related 

problems such as allergies and asthma, 

congenital malformations, infections, 

and numerous disorders of organ 

systems. 

Development of a scientifically robust 

and validated questionnaire to reflect 

specific physiological measures of stress 

would allow us to measure chronic 

stress more efficiently, would not 

require biospecimen collection and 

biomarker analyses, and would thereby 

reduce participant burden and Study 

costs. To develop this instrument, the 

NCS will collect several types of 

information from substudy participants 

through medical record abstraction, 

questionnaires (a series of validated 

stress measures), physiological 

measures (heart rate and self-reported 

stress), and several types of 

biospecimens. 

Frequency of Response: Annual [As 

needed]. 

Affected Public: Pregnant women and 

their children. 

Type of Respondents: Pregnant 

women who are not geographically 

eligible to enroll in the NCS Vanguard 

Study. 

Annual Reporting Burden: See Table 

1. The annualized cost to respondents is 

estimated at: $74,677 (based on $10 per 

hour). There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, STRESS AND CORTISOL MEASUREMENTS

Data collection activity Type of respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

Screening .......................................... Members of NCS target population 

(not NCS participants).

2,100 1 0.08 175 

Consent ............................................. Members of NCS target population 

(not NCS participants).

700 1 0.17 117 

Saliva Self-Collection Demonstration Members of NCS target population 

(not NCS participants).

700 1 0.25 175 

Urine Self-Collection Instructions ...... Members of NCS target population 

(not NCS participants).

700 1 0.08 58 

Ecological Momentary Assessment 

Training.

Members of NCS target population 

(not NCS participants).

700 1 0.50 350 

Visit 1 Stress Questionnaire ............. Members of NCS target population 

(not NCS participants).

700 1 1.00 700 

Adult Blood ........................................ Members of NCS target population 

(not NCS participants).

700 2 0.50 700 

Adult Urine ........................................ Members of NCS target population 

(not NCS participants).

700 1 0.25 175 

Adult Hair .......................................... Members of NCS target population 

(not NCS participants).

700 2 0.25 350 

Adult Saliva ....................................... Members of NCS target population 

(not NCS participants).

700 28 0.05 980 

Demographic and Health Interview .. Members of NCS target population 

(not NCS participants).

700 1 1.00 700 

Participant Contact Information 

Sheet.

Members of NCS target population 

(not NCS participants).

700 1 0.08 58 

Take-Home Questionnaire ................ Members of NCS target population 

(not NCS participants).

700 1 0.50 350 

Time Diary ......................................... Members of NCS target population 

(not NCS participants).

700 72 0.03 1,680 

Heart Monitoring ............................... Members of NCS target population 

(not NCS participants).

700 1 0.03 23 

Visit 2 Stress Questionnaire ............. Members of NCS target population 

(not NCS participants).

700 1 0.75 525 

Stressful Life Events Schedule 

Checklist.

Members of NCS target population 

(not NCS participants).

700 1 0.50 350 

Total ........................................... ........................................................... 700 ........................ ........................ 7,467 

Request for Comments 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

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9668 Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices 

For Further Information 

To request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Sarah L. 

Glavin, Deputy Director, Office of 

Science Policy, Analysis and 

Communication, National Institute of 

Child Health and Human Development, 

31 Center Drive Room 2A18, Bethesda, 

Maryland, 20892, or call non-toll free 

number (301) 496–1877 or Email your 

request, including your address to 

glavins@mail.nih.gov. 

Comments Due Date 

Comments regarding this information 

collection are best assured of having 

their full effect if received within 60 

days of the date of this publication. 

Dated: February 10, 2012. 

Sarah L. Glavin, 

Deputy Director, Office of Science Policy, 

Analysis and Communications, National 

Institute of Child Health and Human 

Development. 

[FR Doc. 2012–3809 Filed 2–16–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301– 

496–7057; fax: 301–402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Selective Inhibitors of Polo-Like Kinase 

1 (PLK1) Polo-Box Domains as Potential 

Anticancer Agents 

Description of Technology: PLK1 is a 

regulator of cell growth that represents 

a new target for anticancer therapeutic 

development. High expression of PLK1 

has been associated with several types 

of cancer (e.g., breast cancer, prostate 

cancer, ovarian cancer, non-small cell 

lung carcinoma). Inhibiting PLK1 could 

be an effective treatment for cancer 

patients without significant side-effects. 

Available for licensing are synthetic 

peptides with the ability to bind to pololike kinase 1 (PLK1) polo-box domains 

(PBDs) with selectivity and nanomolar 

affinity and induce apoptosis in cancer 

cells. By inhibiting the functions of 

PLK1, these peptides could serve as 

potential anti-cancer therapies. This 

technology is related to and an 

extension of HHS technology reference 

E–181–2009. 

Potential Commercial Applications: 

• New anticancer therapies that 

specifically target PLK1. 

• Platform for the development of 

further improved PLK1 inhibitors. 

Competitive Advantages: 

• High PBD binding affinity. 

• High binding selectivity. 

Development Stage: Early-stage. 

Inventors: Terrence R. Burke, Jr. (NCI), 

et al. 

Publications: 

1. Liu F, et al. Serendipitous 

alkylation of a Plk1 ligand uncovers a 

new binding channel. Nat Chem Biol. 

2011 Jul 17;7(9):595–601. [PMID 

21765407] 

2. Qian W, et al. Investigation of 

unanticipated alkylation at the N(pi) 

position of a histidyl residue under 

Mitsunobu conditions and synthesis of 

orthogonally protected histidine 

analogues. J Org Chem. 2011 Nov 

4;76(21):8885–8890. [PMID 21950469] 

Intellectual Property: HHS Reference 

No. E–053–2012/0—U.S. Provisional 

Application No. 61/588,470 filed 19 Jan 

2012. 

Related Technology: HHS Reference 

No. E–181–2009/3—U.S. Provisional 

Application No. 61/474,621 filed 12 Apr 

2011. 

Licensing Contact: Patrick McCue, 

Ph.D.; 301–435–5560; 

mccuepat@mail.nih.gov. 

Influenza Vaccine 

Description of Technology: It has been 

shown that the fusion peptide, a 

sequence comprised of fourteen amino 

acids at the N-terminal of the influenza 

hemagglutinin 2 protein is conserved 

among A and B influenza viruses. 

Monoclonal antibodies against this 

peptide are capable of binding all 

influenza virus HA proteins and inhibit 

viral growth by impeding the fusion 

process between the virus and the target 

cell. This application claims 

immunogenic conjugates comprising the 

fusion peptide region linked to a carrier 

protein. In preclinical studies, these 

conjugates were immunogenic and 

induced booster responses. The induced 

antibodies bound to the recombinant 

HA protein. This methodology of 

linking the highly conserved fusion 

peptide region to a carrier protein can 

broaden the protective immune 

response to include influenza A and B 

virus strains. This would eliminate the 

need for annual influenza vaccination. 

Potential Commercial Applications: 

• Influenza vaccines 

• Influenza diagnostics 

• Research tools 

Competitive Advantages: 

• Universal influenza vaccine 

• Efficient manufacturing process 

• May eliminate need for yearly 

influenza vaccination 

Development Stage: 

• Pre-clinical 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Joanna Kubler-Kielb, Jerry 

M. Keith, Rachel Schneerson (NICHD). 

Intellectual Property: HHS Reference 

No. E–271–2011/0—U.S. Provisional 

Application No. 61/541,942 filed 30 Sep 

2011. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; ps193c@nih.gov. 

Collaborative Research Opportunity: 

The NICHD is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize conjugate influenza 

vaccines comprising fusion peptide 

region. For collaboration opportunities, 

please contact Joseph Conrad, Ph.D., J.D. 

at 301–435–3107 or 

jmconrad@mail.nih.gov. 

ACSF3-Based Diagnostics and 

Therapeutics for Combined Malonic 

and Methylmalonic Aciduria 

(CMAMMA) and Other Metabolic 

Disorders 

Description of Technology: Combined 

malonic and methylmalonic aciduria 

(CMAMMA) is a metabolic disorder in 

which malonic acid and methylmalonic 

acid, key intermediates in fatty acid 

metabolism, accumulate in the blood 

and urine. This disorder is often 

undetected until symptoms manifest, 

which can include developmental 

delays and a failure to thrive in 

children, and psychiatric and 

neurological disorders in adults. Once 

thought to be a very rare disease, 

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