Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)

Notices

Pages 54474-54476

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

FR Doc No: 2011-22456

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; Comment Request New proposed collection, Biospecimen and Physical Measures Formative Research

Methodology 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 April 27, 2011, pages 23609-23611, 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: Biospecimen and Physical Measures

Formative Research Methodology 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 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 tests will be used to maximize the efficiency (measured by scientific robustness, participant and infrastructure burden, and cost) of biospecimen and physical measurement collection procedures, accompanying questionnaires, storage and information management processes, and assay procedures, thereby informing 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 conduct formative research featuring biospecimen and physical measurement collections.

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 biospecimen collection procedures and physical measurements 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, infants, children, fathers, health care facilities and professionals, public health professional organizations and practitioners, and hospital administrators. 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: $600,000 (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, Biological and Physical Measures

Estimated

Estimated

Type of

Estimated

number of

Average burden total annual

Data collection activity

respondent

number of

responses per

hours per

burden hours respondents

respondent

response

requested

Blood:

Adult..................... NCS participants

4,000

1

0.5

2,000

Page 54475

Members of NCS

4,000

1

0.5

2,000 target population (not

NCS participants).

Infant/Child.............. NCS participants

2,000

1

0.5

1,000

Members of NCS

2,000

1

0.5

1,000 target population (not

NCS participants).

Urine:

Adult..................... NCS participants

4,000

1

0.25

1,000

Members of NCS

4,000

1

0.25

1,000 target population (not

NCS participants).

Infant/Child.............. NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Hair:

Adult..................... NCS participants

4,000

1

0.25

1,000

Members of NCS

4,000

1

0.25

1,000 target population (not

NCS participants).

Nails:

Adult..................... NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Cervical Fluid:

Women..................... NCS participants

4,000

1

0.5

2,000

Members of NCS

4,000

1

0.5

2,000 target population (not

NCS participants).

Breast Milk:

Women..................... NCS participants

4,000

1

0.5

2,000

Members of NCS

4,000

1

0.5

2,000 target population (not

NCS participants).

Cord Blood:

Infant/ Child............. NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Meconium:

Infant/Child.............. NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Placenta:

Infant.................... NCS participants

4,000

1

0.25

1000

Members of NCS

4,000

1

0.25

1000 target population (not

NCS participants).

Length:

Infant.................... NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Height:

Child..................... NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Weight:

Infant/Child.............. NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Head Circumference:

Infant/Child.............. NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Middle Upper Arm

Circumference:

Infant/Child.............. NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Ulnar Length:

Infant/Child.............. NCS participants

2,000

1

0.25

500

Members of NCS

2,000

1

0.25

500 target population (not

NCS participants).

Small, focused survey and

NCS participants

4,000

2

1

8,000 instrument design and administration.

Members of NCS

4,000

2

1

8,000 target population (not

NCS participants).

Health and

2,000

1

1

2,000

Social Service

Providers.

Page 54476

Community

2,000

1

1

2,000

Stakeholders.

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

2,000

1

1

2,000

Members of NCS

2,000

1

1

2,000 target population (not

NCS participants).

Health and

2,000

1

1

2,000

Social Service

Providers.

Community

2,000

1

1

2,000

Stakeholders.

Cognitive interviews.......... NCS participants

500

1

2

1,000

Members of NCS

500

1

2

1,000 target population (not

NCS participants).

Total..................... ................

113,000 .............. ..............

60,000

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 E-mail 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 E-mail 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: August 25, 2011.

Jamelle E. Banks,

Public Health Analyst, Office of Science Policy, Analysis and

Communications, National Institute of Child Health and Human

Development.

FR Doc. 2011-22456 Filed 8-31-11; 8:45 am

BILLING CODE 4140-01-P

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