New Proposed Collection; Comment Request; Environmental Science Formative Research Methodology Studies for the National Children's Study

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

New Proposed Collection; Comment Request; Environmental Science Formative Research Methodology Studies 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. This proposed information collection was previously published in the

Federal Register

on April 27, 2011, pages 23603-23605, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study specifically and of federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment.

Proposed Collection

Title:

Environmental Science Formative Research Methodology Studies for the National Children's Study (NCS).

Type of Information Collection Request:

Generic Clearance.

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 well-being;

(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 results of formative research will be used to maximize the efficiency (measured by scientific robustness, participant and infrastructure burden, and cost) of environmental sample collection procedures and technology, storage procedures, accompanying questionnaires, and assays, and thereby inform data collection methodologies for the National Children's Study (NCS) Vanguard and Main Studies. With this submission, the NCS seeks to obtain OMB's generic clearance to collect environmental samples from homes and child care settings, and conduct accompanying short surveys related to the physical and chemical environment.

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 and Main Study environmental sample and information collection 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, fathers, public health and environmental science professional organizations and practitioners, and schools and child care organizations. 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: $780,000 (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, Environmental Science

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

Home Air

NCS participants

4,000

1

1

4,000

Members of NCS target population (not NCS participants)

4,000

1

1

4,000

Home Water

NCS participants

4,000

1

1

4,000

Members of NCS target population (not NCS participants)

4,000

1

1

4,000

Home Dust

NCS participants

4,000

1

1

4,000

Members of NCS target population (not NCS participants)

4,000

1

1

4,000

School and Child Care Facility Air

NCS participants

4,000

1

1

4,000

Members of NCS target population (not NCS participants)

4,000

1

1

4,000

School and Child Care Facility Water

NCS participants

4,000

1

1

4,000

Members of NCS target population (not NCS participants)

4,000

1

1

4,000

School and Child Care Facility Dust

NCS participants

4,000

1

1

4,000

Members of NCS target population (not NCS participants)

4,000

1

1

4,000

Small, focused survey and instrument design and administration

NCS participants

4,000

2

1

8,000

Members of NCS target population (not NCS participants)

4,000

2

1

8,000

Health and Social Service Providers

2,000

1

1

2,000

Community Stakeholders

2,000

1

1

2,000

Focus groups

NCS participants

2,000

1

1

2,000

Members of NCS target population (not NCS participants)

2,000

1

1

2,000

Health and Social Service Providers

2,000

1

1

2,000

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

69,000

78,000

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 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.

FOR FURTHER INFORMATION CONTACT:

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 E-mail your request, including your address to

glavins@mail.nih.gov.

DATES:

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: June 21, 2011.

Sarah L. Glavin,

Deputy Director, Office of Science Policy, Analysis and Communications, National Institute of Child Health and Human Development.

[FR Doc. 2011-16300 Filed 6-28-11; 8:45 am]

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