National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; Formative Research Methodology Studies for the National Children's Study, 38401-38403 [2011-16528]

Download as PDF 38401 Federal Register / Vol. 76, No. 126 / Thursday, June 30, 2011 / Notices document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration, for Children and Families. Dated: June 22, 2011. Steven M. Hanmer, OPRE Reports Clearance Officer. [FR Doc. 2011–16212 Filed 6–29–11; 8:45 am] BILLING CODE 4184–09–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request Health Resources and Services Administration, HHS. AGENCY: ACTION: amended. ‘‘FQHC Look-Alikes’’ are health centers that have been determined by HRSA to meet the requirements of the Health Center Program but which do not receive a grant. The UDS includes reporting requirements for grantees of the following primary care programs: Community Health Centers, Migrant Health Centers, Health Care for the Homeless, and Public Housing Primary Care. On page 35900, second column, second paragraph, correct the fifth sentence to read as follows: These new measures are included in the UDS data collection request in order to allow advance time for health centers and FQHC Look-Alikes to change data collection systems. On page 35900, please correct the burden table as follows: Correction. The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of June 20, 2011 (FR Doc. 2011–15194), on page 35900, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915–0193). FOR FURTHER INFORMATION CONTACT: Charles Daly, Public Health Analyst at 301–594–5110. SUMMARY: Correction In the Federal Register issue of June 20, 2011, FR Doc. 2011–15194), on page 35900, second column, under the section Proposed Project: Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915–0193– Revision), correct the first paragraph to read as follows: The Uniform Data System (UDS) contains the annual reporting requirements for the cluster of primary care grantees funded by the Health Resources and Services Administration (HRSA) under the Health Center Program as authorized under section 330 of the Public Health Service Act, as Responses per respondent Number of respondents Type of report Hours per response Total burden hours Universal report ............................................................................................... Grant report ..................................................................................................... 1,287 328 1 1 82 18 105,534 5,904 Total .......................................................................................................... 1,615 ........................ ........................ 111,438 Dated: June 23, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–16478 Filed 6–29–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health srobinson on DSK4SPTVN1PROD with NOTICES National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; Formative Research Methodology Studies for the National Children’s Study 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 SUMMARY: VerDate Mar<15>2010 16:24 Jun 29, 2011 Jkt 223001 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 23608–23609, 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 specifically and of federally funded biomedical research overall. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Formative Research Studies for the National Children’s Study (NCS) Type of Information Collection Request: RENEWAL of OMB Clearance 0925–0590, Expiration June 30, 2011 Need and Use of Information Collection: The Children’s Health Act of 2000 (Pub. L. 106–310) states: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 (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 E:\FR\FM\30JNN1.SGM 30JNN1 38402 Federal Register / Vol. 76, No. 126 / Thursday, June 30, 2011 / Notices 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 results of formative research and pilot tests will be used to maximize the efficiency of NCS procedures, materials, and methods for outreach, engagement of stakeholders, recruitment and retention of Study subjects, and to ensure scientifically robust 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 approval to conduct survey and instrument design and administration, focus groups, cognitive interviews, and health and social service provider information collection surrounding outreach, engagement, recruitment, consent and questionnaire design, and retention activities. The results from formative research and pilot tests proposed will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of NCS Vanguard and Main Study recruitment, retention, study visit measures and study logistics. 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, community leaders, members, and organizations, health care facilities and professionals, public health, environmental, social and cognitive science professional organizations and practitioners, hospital administrators, cultural and faith-based centers, 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: $300,000 (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 Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Data collection activity Type of respondent 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 NCS participants .............................. 2,000 1 2 2,000 Members of NCS target population (not NCS participants). 2,000 1 2 2,000 Health and Social Service Providers 2,000 1 2 2,000 Community Stakeholders ................. 2,000 1 2 2,000 NCS participants .............................. 500 1 2 1,000 Members of NCS target population (not NCS participants). 500 1 2 1,000 ..................................................... 21,000 30,000 hrs are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Maryland 20892, or call non-toll free number (301) 496–1877 or E-mail 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 30 days of the date of this publication. Focus groups ..................................... Cognitive interviews .......................... srobinson on DSK4SPTVN1PROD with NOTICES Total ........................................... 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 VerDate Mar<15>2010 16:24 Jun 29, 2011 Jkt 223001 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, FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1 Federal Register / Vol. 76, No. 126 / Thursday, June 30, 2011 / Notices This notice is being published less than 15 days prior to the meeting due to the urgent need to discuss issues related to seclusion and restraint and autism spectrum disorder (ASD) prior to the next IACC full committee meeting, which will take place on July 19, 2011. Schedule subject to change. Information about the IACC is available on the Web site: https://www.iacc.hhs.gov. Dated: June 27, 2011. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communications, National Institute of Child Health and Human Development. [FR Doc. 2011–16528 Filed 6–29–11; 8:45 am] BILLING CODE 4140–01–P Dated: June 23, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2011–16460 Filed 6–29–11; 8:45 am] BILLING CODE 4140–01–P Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a joint conference call of the Interagency Autism Coordinating Committee (IACC) Subcommittee on Safety and the IACC Services Subcommittee. The IACC Subcommittee on Safety and Services Subcommittee will be having a joint conference call on Monday, July 11, 2011. The two subcommittees plan to discuss issues related to seclusion and restraint and autism spectrum disorder (ASD). srobinson on DSK4SPTVN1PROD with NOTICES National Institute of Mental Health; Notice of Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: Interagency Autism Coordinating Committee (IACC). Type of Meeting: Subcommittee on Safety and Services Subcommittee Joint, Conference Call. Date: July 11, 2011. Time: 2 p.m. to 4 p.m. Eastern Time. Agenda: The Services and Safety Subcommittees of the IACC will meet jointly to discuss issues related to seclusion and restraint and autism spectrum disorder (ASD). Place: No in-person meeting; conference call only. Conference Call: Dial: 888–391–6569. Access code: 3061094, Contact Person: Ms. Lina Perez, Office of Autism Research Coordination, National Institute of Mental Health, NIH, 6001 Executive Boulevard, NSC, Room 8185a, Rockville, MD 20852, Phone: 301–443–6040, E-mail: IACCPublicInquiries@mail.nih.gov. Please Note: The conference call will be accessible to the public through a conference call-in number and access code. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the conference call or webcast, please email IACCTechSupport@acclaroresearch.com or call the IACC Technical Support Help Line at 443–680–0098. Individuals who participate by using this electronic service and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the Contact Person listed on this notice at least 7 days prior to the meeting. VerDate Mar<15>2010 16:24 Jun 29, 2011 Jkt 223001 National Institutes of Health National Institute of Mental Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of an Interagency Autism Coordinating Committee (IACC) meeting. The meeting will feature invited speakers and discussion of committee business items including the 2011 IACC Summary of Advances, subcommittee activities related to seclusion and restraint, and the Fall 2011 IACC Services Workshop. The meeting will be open to the public and accessible by live webcast and conference call. Name of Committee: Interagency Autism Coordinating Committee (IACC) . Type of Meeting: Open meeting. Date: July 19, 2011. Time: 10 a.m. to 5 p.m. *Eastern Time*— Approximate end time. Agenda: The meeting will feature invited speakers and discussion of committee business items including the 2011 IACC Summary of Advances, subcommittee activities related to seclusion and restraint, and the Fall 2011 IACC Services Workshop. Place: The Bethesda Marriott Pooks Hill, 5151 Pooks Hill Road, Bethesda, MD 20814. Conference Call: Dial: 800–369–1814. Access code: 7791752. Cost: The meeting is free and open to the public. Webcast Live: https://videocast.nih.gov/. Registration: https:// www.acclaroresearch.com/oarc/7–19–11/. Pre-registration is recommended to expedite check-in. Seating in the meeting room is limited to room capacity and on a first come, first served basis. Deadlines: Notification of intent to present oral comments: Friday, July 8, 2011 by 5 p.m. E.T. Submission of written/electronic statement for oral comments: Tuesday, July 12, 2011 by 5 p.m. E.T. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 38403 Submission of written comments: Thursday, July 14, 2011 by 5 p.m. E.T. Access: Medical Center Metro (Red Line)— 11⁄2 miles from the hotel. On-site parking with parking validation available. Contact Person: Ms. Lina Perez, Office of Autism Research Coordination, National Institute of Mental Health, NIH, 6001 Executive Boulevard, NSC, Room 8185a, Rockville, MD 20852, Phone: (301) 443–6040, E-mail: IACCPublicInquiries@mail.nih.gov. Please Note: Any member of the public interested in presenting oral comments to the Committee must notify the Contact Person listed on this notice by 5 p.m. E.T. on Friday, July 8, 2011, with their request to present oral comments at the meeting. Interested individuals and representatives of organizations must submit a written/ electronic copy of the oral statement/ comments including a brief description of the organization represented by 5 p.m. E.T. on Tuesday, July 12, 2011. Statements submitted will become a part of the public record. Only one representative of an organization will be allowed to present oral comments on behalf of that organization, and presentations will be limited to three to five minutes per speaker, depending on number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in the order of the date and time when their request to speak is received, along with the required submission of the written/electronic statement by the specified deadline. If special accommodations are needed, please e-mail the Contact Person listed above. In addition, any interested person may submit written comments to the IACC prior to the meeting by sending the comments to the Contact Person listed on this notice by 5 p.m. E.T., Thursday, July 14, 2011. The comments should include the name and, when applicable, the business or professional affiliation of the interested person. All written comments received by the deadlines for both oral and written public comments will be provided to the IACC for their consideration and will become part of the public record. The meeting will be open to the public through a conference call phone number and webcast live on the Internet. Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. If you experience any technical problems with the conference call or webcast, please e-mail IACCTechSupport@acclaroresearch.com or call the IACC Technical Support Help Line at 443–680–0098. To access the webcast live on the Internet the following computer capabilities are required: (A) Internet Explorer 5.0 or later, Netscape Navigator 6.0 or later or Mozilla Firefox 1.0 or later; (B) Windows® 2000, XP Home, XP Pro, 2003 Server or Vista; (C) Stable 56k, cable modem, ISDN, DSL or better Internet connection; (D) Minimum of Pentium 400 with 256 MB of RAM (Recommended); (E) Java Virtual Machine enabled (Recommended). Individuals who participate in person or by using these electronic services and who need E:\FR\FM\30JNN1.SGM 30JNN1

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[Federal Register Volume 76, Number 126 (Thursday, June 30, 2011)]
[Notices]
[Pages 38401-38403]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16528]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; 
Revision to Proposed Collection; Comment Request; 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 23608-23609, 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 specifically and of 
federally funded biomedical research overall. The purpose of this 
notice is to allow an additional 30 days for public comment.
    Proposed Collection:
    Title: Formative Research Studies for the National Children's Study 
(NCS)
    Type of Information Collection Request: RENEWAL of OMB Clearance 
0925-0590, Expiration June 30, 2011
    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

[[Page 38402]]

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 and pilot tests will be used to maximize 
the efficiency of NCS procedures, materials, and methods for outreach, 
engagement of stakeholders, recruitment and retention of Study 
subjects, and to ensure scientifically robust 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 
approval to conduct survey and instrument design and administration, 
focus groups, cognitive interviews, and health and social service 
provider information collection surrounding outreach, engagement, 
recruitment, consent and questionnaire design, and retention 
activities.
    The results from formative research and pilot tests proposed will 
inform the feasibility (scientific robustness), acceptability (burden 
to participants and study logistics) and cost of NCS Vanguard and Main 
Study recruitment, retention, study visit measures and study logistics.
    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, community 
leaders, members, and organizations, health care facilities and 
professionals, public health, environmental, social and cognitive 
science professional organizations and practitioners, hospital 
administrators, cultural and faith-based centers, 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: $300,000 (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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Estimated                       Estimated
                                                                                             Estimated       number of        Average      total annual
            Data collection activity                        Type of respondent               number of     responses per   burden  hours   burden hours
                                                                                            respondents     respondent     per  response     requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small, focused survey and instrument design and  NCS participants.......................           4,000               2               1           8,000
 administration.
                                                --------------------------------------------------------------------------------------------------------
                                                 Members of NCS target population (not             4,000               2               1           8,000
                                                  NCS participants).
                                                --------------------------------------------------------------------------------------------------------
                                                 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               2           2,000
                                                --------------------------------------------------------------------------------------------------------
                                                 Members of NCS target population (not             2,000               1               2           2,000
                                                  NCS participants).
                                                --------------------------------------------------------------------------------------------------------
                                                 Health and Social Service Providers....           2,000               1               2           2,000
                                                --------------------------------------------------------------------------------------------------------
                                                 Community Stakeholders.................           2,000               1               2           2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interviews...........................  NCS participants.......................             500               1               2           1,000
                                                --------------------------------------------------------------------------------------------------------
                                                 Members of NCS target population (not               500               1               2           1,000
                                                  NCS participants).
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Total......................................  .......................................          21,000  ..............  ..............      30,000 hrs
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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.
    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.


[[Page 38403]]


    Dated: June 27, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications, 
National Institute of Child Health and Human Development.
[FR Doc. 2011-16528 Filed 6-29-11; 8:45 am]
BILLING CODE 4140-01-P
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