19022 Federal Register / Vol. 77, No. 61 / Thursday, March 29, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development Submission for 

OMB Review; Comment Request; New 

Proposed Collection, 

Neuropsychosocial Formative 

Research Methodological Studies for 

the National Children’s Study 

SUMMARY: Under the provisions of 

Section (3507(a)(1)(D)) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health has submitted to the 

Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on May 2, 2011, pages 24497– 

24498, and allowed 60 days for public 

comment. Two written comments and 

two verbal comments were received. 

The verbal comments expressed support 

for the broad scope of the study. The 

written comments were identical and 

questioned the cost and utility of the 

study. 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: 

Neuropsychosocial Formative Research 

Methodological Studies for the National 

Children’s Study (NCS). Type of 

Information 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 of 2000, the 

results of formative research will be 

used to maximize the efficiency 

(measured by scientific robustness, 

participant and infrastructure burden, 

and cost) of tools to assess language, 

behavior, and neurodevelopment, 

psychosocial stress, and health literacy 

and thereby inform data collection 

methodologies for the National 

Children’s Study (NCS) Vanguard (Pilot) 

and Main Studies. With this information 

collection request, the NCS seeks to 

obtain OMB’s generic clearance to 

conduct formative research featuring 

neuropsychosocial measures. 

The results from these formative 

research projects will inform the 

feasibility (scientific robustness), 

acceptability (burden to participants 

and study logistics), and cost of NCS 

Vanguard (Pilot) Study and Main Study 

neuropsychosocial measures in a 

manner that minimizes public 

information collection burden compared 

to burden anticipated if these projects 

were incorporated directly into either 

the NCS Vanguard or Main Study. 

Frequency of Response: Annual [As 

needed on an on-going and concurrent 

basis]. Affected Public: Members of the 

public, researchers, practitioners, and 

other health professionals. 

Type of Respondents: Women of 

child-bearing age/potential NCS 

participants, infants, children, fathers, 

legal guardians, health care facilities 

and professionals, hospital 

administrators and staff, pediatric 

professional organizations and 

practitioners, educational professionals, 

public health organizations, community 

leaders, members, and organizations, 

and cultural and faith-based centers. 

These include both persons enrolled in 

the NCS Vanguard Study and their peers 

who are not participating in the NCS 

Vanguard Study. 

Annual reporting burden: See Table 1. 

The annualized cost to respondents is 

estimated at: $742,000 (based on 

approximately $10 per hour for NCS 

participants and members of the NCS 

target population (non-NCS 

participants), $101 per hour for health 

providers (OB/GYNs), and $20 per hour 

for social service providers). There are 

no capital costs to report. There are no 

operating or maintenance costs to 

report. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, NEUROPSYCHOSOCIAL MEASURES

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 

requested 

Physical measurement and examinations.NCS participants ..............................

Members of NCS target population 

(not NCS participants).

4,000 

4,000 

1 

1 

1 

1 

4,000 

4,000 

Child Developmental Measures (cognitive).NCS participants ..............................

Members of NCS target population 

(not NCS participants).

4,000 

4,000 

1 

1 

1 

1 

4,000 

4,000 

Computer-based reaction time testing.NCS participants ..............................

Members of NCS target population 

(not NCS participants).

4,000 

4,000 

1 

1 

1 

1 

4,000 

4,000 

Small, focused survey and instrument design and administration.NCS participants ..............................

Members of NCS target population 

(not NCS participants).

4,000 

4,000 

2 

2 

1 

1 

8,000 

8,000 

Health Care Providers ...................... 1,000 1 1 1,000 

Social Service Providers .................. 1,000 1 1 1,000 

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Federal Register / Vol. 77, No. 61 / Thursday, March 29, 2012 / Notices 19023 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, NEUROPSYCHOSOCIAL MEASURES—Continued 

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 

requested 

Community Stakeholders ................. 2,000 1 1 2,000 

Focus groups .................................... NCS participants ..............................

Members of NCS target population 

(not NCS participants).

2,000 

2,000 

1 

1 

1 

1 

2,000 

2,000 

Health Care Providers ...................... 1,000 1 1 1,000 

Social Service Providers .................. 1,000 1 1 1,000 

Community Stakeholders ................. 2,000 1 1 2,000 

Cognitive interviews .......................... NCS participants .............................. 500 1 2 1,000 

Members of NCS target population 

(not NCS participants).

500 1 2 1,000 

Total ........................................... ........................................................... 45,000 ........................ ........................ 54,000 

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 enhance 

the quality, utility, and clarity of the 

information collected; and (4) 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. 

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 Office of 

Management and Budget, Office of 

Information and Regulatory Affairs, 

Attn: NIH Desk Officer, by Email to 

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 Ms. 

Jamelle E. Banks, Public Health Analyst, 

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 a non-toll free 

number (301) 496–1877 or Email your 

request, including your address to 

banksj@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: March 21, 2012. 

Jamelle E. Banks, 

Public Health Analyst, Office of Science 

Policy, Analysis and Communications, 

National Institute of Child Health and Human 

Development. 

[FR Doc. 2012–7589 Filed 3–28–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Channels— 

Physiology and Signaling. 

Date: April 11, 2012. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Geoffrey G Schofield, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040–A, 

MSC 7850, Bethesda, MD 20892, 301–435– 

1235, geoffreys@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 20, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–7579 Filed 3–28–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Neurodegeneration. 

Date: April 13, 2012. 

Time: 12 p.m. to 2 p.m. 

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