National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; the National Children's Study (NCS), Vanguard (Pilot) Study, Recruitment Substudy Phase 1, 32474-32476 [2010-13705]

Download as PDF 32474 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices displays a currently valid OMB control number. Proposed Collection: Title: STAR METRICS. Science and Technology for America’s Reinvestment: Measuring the Effects of Research on Innovation, Competitiveness and Science. Type of Information Collection Request: NEW. Need and Use of Information Collection: The aim of STAR METRICS is twofold. The initial goal of STAR METRICS is to provide mechanisms that will allow participating universities and Federal agencies with a reliable and consistent Estimated Number of Respondents: 100. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: Reduced by 156; and Estimated Total Annual Burden Hours Requested: Reduced by 15,600. The annualized cost to respondents is estimated to be reduced by $780,000. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. means to account for the number of scientists and staff that are on research institution payrolls, supported by Federal funds. In subsequent generations of the program, it is hoped that STAR METRICS will allow for measurement of science impact on economic outcomes (such as job creation), on knowledge generation (such as citations and patents) as well as on social and health outcomes. Frequency of Response: Quarterly. Affected Public: Universities. Type of Respondents: University administrators. A.12—1 ESTIMATES OF NET HOUR BURDEN REDUCTION Number of respondents Type of respondents Average time per response (in hours) Frequency of response Annual hour burden 100 1 72 +7200 100 4 40 ¥16000 Net reduction in burden .......................................................................... 100 4 .......................... ¥8800 Stage 1: Future .............................................................................................. Stage 2: Expected Reduction in Current burden (assuming 100 universities and at median) .................................................................................. 100 4 1.0 +400 100 4 Net reduction in burden .......................................................................... emcdonald on DSK2BSOYB1PROD with NOTICES Stage 1: Immediate ....................................................................................... Stage 1: Expected Reduction in Current burden (assuming 100 universities and at median) .................................................................................. 100 4 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 to be 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 the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. To request more information on the proposed project or VerDate Mar<15>2010 16:31 Jun 07, 2010 Jkt 220001 to obtain a copy of the data collection plans and instruments, contact: Dr. Stefano Bertuzzi, MSC 0166, Building 1 Room 218, 9000 Rockville Pike, Bethesda, MD 20892, or call non-tollfree number 301–496–9286 or E-mail your request, including your address to: Stefano.bertuzzi@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: June 2, 2010. Laverne Stringfield, Executive Officer, Office of the Director, National Institutes of Health. [FR Doc. 2010–13736 Filed 6–7–10; 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; Revision to Proposed Collection; Comment Request; the National Children’s Study (NCS), Vanguard (Pilot) Study, Recruitment Substudy Phase 1 SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 40 .......................... ¥16000 ¥15600 Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 22, 2010, pages 14165–14168, and allowed 60 days for public comment. One comment was received. The comment questioned the value and utility of the proposed data collection, stating that this type of research is not needed. 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: Pilot Study for the National Children’s Study, Type of Information Collection Request: Revision, Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 18–49 years of age, their husbands or partners, and their children who live in selected areas within National Children’s Study sites. Health care E:\FR\FM\08JNN1.SGM 08JNN1 32475 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices professionals, community leaders, and child care personnel are also potentially affected. Frequency of Response: On occasion. See burden table for estimated number of annual responses for each respondent. Need and use of information collection: The purpose of the proposed methodological study is to evaluate the feasibility, acceptability, and cost of three separate recruitment strategies for enrollment of women into a prospective, national longitudinal study of child health and development. This Recruitment Substudy is a component of the Vanguard Phase of the National Children’s Study (NCS). In combination, the studies in the Vanguard Phase will be used to inform the design of the Main Study of the National Children’s Study. This data collection will evaluate the feasibility, acceptability and cost of three separate recruitment strategies for enrollment of women into the NCS. Up to 30 additional sites will be added to the NCS Vanguard Cohort, as reflected in the burden table, in order to ensure an adequate cohort size. These additional sites will be chosen from among those already identified for the Main Study of the NCS. Across these additional sites, three alternate recruitment strategies will be assessed: • An enhanced household enumeration strategy that builds on the lessons learned in the existing Vanguard Study by enhancing enumeration techniques and employing a more streamlined recruitment process; • A provider based recruitment strategy that relies on health care providers for assistance in participant identification and recruitment; and • A two-tiered recruitment strategy that relies on larger secondary sampling units to increase the number of geographically-eligible women in a given area, and allows for both higherintensity and lower-intensity forms of data collection. The feasibility (technical performance), acceptability (respondent tolerance and impact on study infrastructure), and cost (operations, time, and effort) of each of these three strategies will be evaluated using predetermined measures. The findings will be assessed and used to inform the strategies, or combinations of strategies, that might be used in the Main Study of the NCS. Further details pertaining to the NCS background and planning can be found at: https:// www.nationalchildrensstudy.gov. Burden statement: The public burden for this study will vary depending on the eligibility and pregnancy status of potential participants at the time of household screening and the method of recruitment. The table below provides an annualized average burden per person for each stage of the Recruitment Substudy. TABLE 1—ESTIMATED HOUR BURDEN AND COST FOR RECRUITMENT SUBSTUDY RESPONDENTS—STAGE 1 [July 2010 to December 2010] Recruitment strategy/activity Number of respondents Type of respondent Responses per respondent Hours per response Annual hour burden Provider-based: 10 Study Locations—Projected for Stage 1 (July 2010–December 2010) Screening Activities Address Look-Up .................................. Pregnancy Screening ........................... Preconception Activities Pre-Pregnancy Interview ...................... PPG Follow Up Script .......................... Pregnancy Activities Women’s Informed Consent Form ....... First Pregnancy Interview ..................... Second Pregnancy Interview ............... Birth-Related Activities Birth Visit Interview ............................... Total—Stage 1 .............................. Age-Eligible Women ............ Age-Eligible Women ............ 7,500 1,500 1 1 0.1 0.42 750 630 Age-Eligible Women ............ Age-Eligible Women ............ 123 123 1 6 0.75 0.1 92 74 Pregnant Women ................. Pregnant Women ................. Pregnant Women ................. 1,500 572 572 1 1 1 0.67 1 0.75 1,005 572 429 Mother/Baby ........................ 299 1 0.4 .............................................. 12,188 ........................ .......................... 120 3,671 emcdonald on DSK2BSOYB1PROD with NOTICES Enhanced Household: 10 Study Locations—Projected for Stage 1 (July 2010–December 2010) Screening Activities Household Enumeration Script ............ Pregnancy Screening ........................... Neighbor Report ................................... Preconception Activities Pre-Pregnancy Interview ...................... PPG Follow Up Script .......................... Pregnancy Activities Women’s Informed Consent Form ....... First Pregnancy Interview ..................... Second Pregnancy Interview ............... Birth-Related Activities Birth Visit Interview ............................... Total—Stage 1 .............................. HH reporters ........................ Age-Eligible Women ............ Neighbors ............................ 120,000 51,198 12,000 1 1 1 0.33 0.42 0.05 39,600 21,503 600 Age-Eligible Women ............ Age-Eligible Women ............ 211 211 1 6 0.75 0.1 158 127 Pregnant Women ................. Pregnant Women ................. Pregnant Women ................. 2,586 986 986 1 1 1 0.67 1 0.75 1,733 986 740 Mother/Baby ........................ 516 1 0.4 .............................................. 188,695 ........................ .......................... 206 65,653 Two Tier (Low): 10 Study Locations Across Both Tiers—Projected for Stage 1 (July 2010–December 2010) Screening Activities Low-intensity CATI Preg. Screener ...... Low Intensity Consent Script ............... Preconception Activities VerDate Mar<15>2010 16:31 Jun 07, 2010 Jkt 220001 Age-Eligible Women ............ Age-Eligible Women ............ PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 48,000 28,800 E:\FR\FM\08JNN1.SGM 1 1 08JNN1 0.35 0.33 16,800 9,504 32476 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices TABLE 1—ESTIMATED HOUR BURDEN AND COST FOR RECRUITMENT SUBSTUDY RESPONDENTS—STAGE 1—Continued [July 2010 to December 2010] Number of respondents Responses per respondent Hours per response Annual hour burden Recruitment strategy/activity Type of respondent Low-intensity CATI Questionnaire ........ PPG Follow Up Script .......................... Pregnancy Activities Low-intensity CATI Questionnaire ........ Birth-Related Activities Low-intensity CATI Questionnaire ........ Age-Eligible Women ............ Age-Eligible Women ............ 10,057 10,057 1 6 0.5 0.1 5,028 6,034 Pregnant Women ................. 518 1 0.5 259 Mother/Baby ........................ 166 1 0.5 83 Total—Stage 1 .............................. .............................................. 97,598 ........................ .......................... 37,709 Two Tier (High): 10 Study Locations Across Both Tiers—Projected for Stage 1 (July 2010–December 2010) Screening Activities Pregnancy Screening ........................... Preconception Activities Pre-Pregnancy Interview ...................... PPG Follow Up Script .......................... Pregnancy Activities Women’s Informed Consent Form ....... First Pregnancy Interview ..................... Second Pregnancy Interview ............... Birth-Related Activities Birth Visit Interview ............................... Total—Stage 1 .............................. emcdonald on DSK2BSOYB1PROD with NOTICES Grand Total, Substudy. Recruitment Age-Eligible Women ............ 15,840 1 0.42 6,653 Age-Eligible Women ............ Age-Eligible Women ............ 761 761 1 6 0.75 0.1 571 456 Pregnant Women ................. Pregnant Women ................. Pregnant Women ................. 9,504 3,552 3,552 1 1 1 0.67 1 0.75 6,368 3,552 2,664 Mother/Baby ........................ 1,857 1 0.4 .............................................. 35,826 ........................ .......................... 21,006 .............................................. 334,308 ........................ .......................... 176,876 The estimated annualized cost to respondents is $1,782,053 based on the differential hourly rate estimates in the above table. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. 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 to be 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. FOR FURTHER INFORMATION CONTACT: 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: VerDate Mar<15>2010 16:31 Jun 07, 2010 Jkt 220001 Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Sarah L. Glavin, Ph.D., 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. Dated: June 2, 2010. Sarah L. Glavin, NICHD Project Clearance Liaison, National Institutes of Health. [FR Doc. 2010–13705 Filed 6–7–10; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 743 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0250] Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for premarket approval of medical devices. DATES: Submit either electronic or written comments on the collection of information by August 9, 2010. E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32474-32476]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13705]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and Human Development;

Revision to Proposed Collection; Comment Request; the National

Children's Study (NCS), Vanguard (Pilot) Study, Recruitment Substudy

Phase 1

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork

Reduction Act of 1995, the National Institute of Child Health and Human

Development (NICHD), the National Institutes of Health (NIH) has

submitted to the Office of Management and Budget (OMB) a request for

review and approval of the information collection listed below. This

proposed information collection was previously published in the Federal

public comment. One comment was received. The comment questioned the

value and utility of the proposed data collection, stating that this

type of research is not needed. 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: Pilot Study for the National Children's

Study, Type of Information Collection Request: Revision, Affected

entities: Households and individuals. Types of respondents: People

potentially affected by this action are pregnant women, women age 18-49

years of age, their husbands or partners, and their children who live

in selected areas within National Children's Study sites. Health care

[[Page 32475]]

professionals, community leaders, and child care personnel are also

potentially affected. Frequency of Response: On occasion. See burden

table for estimated number of annual responses for each respondent.

Need and use of information collection: The purpose of the proposed

methodological study is to evaluate the feasibility, acceptability, and

cost of three separate recruitment strategies for enrollment of women

into a prospective, national longitudinal study of child health and

development. This Recruitment Substudy is a component of the Vanguard

Phase of the National Children's Study (NCS). In combination, the

studies in the Vanguard Phase will be used to inform the design of the

Main Study of the National Children's Study.

This data collection will evaluate the feasibility, acceptability

and cost of three separate recruitment strategies for enrollment of

women into the NCS. Up to 30 additional sites will be added to the NCS

Vanguard Cohort, as reflected in the burden table, in order to ensure

an adequate cohort size. These additional sites will be chosen from

among those already identified for the Main Study of the NCS. Across

these additional sites, three alternate recruitment strategies will be

assessed:

An enhanced household enumeration strategy that builds on

the lessons learned in the existing Vanguard Study by enhancing

enumeration techniques and employing a more streamlined recruitment

process;

A provider based recruitment strategy that relies on

health care providers for assistance in participant identification and

recruitment; and

A two-tiered recruitment strategy that relies on larger

secondary sampling units to increase the number of geographically-

eligible women in a given area, and allows for both higher-intensity

and lower-intensity forms of data collection.

The feasibility (technical performance), acceptability (respondent

tolerance and impact on study infrastructure), and cost (operations,

time, and effort) of each of these three strategies will be evaluated

using pre-determined measures. The findings will be assessed and used

to inform the strategies, or combinations of strategies, that might be

used in the Main Study of the NCS. Further details pertaining to the

NCS background and planning can be found at: https://www.nationalchildrensstudy.gov.

Burden statement: The public burden for this study will vary

depending on the eligibility and pregnancy status of potential

participants at the time of household screening and the method of

recruitment. The table below provides an annualized average burden per

person for each stage of the Recruitment Substudy.

Table 1--Estimated Hour Burden and Cost for Recruitment Substudy Respondents--Stage 1

[July 2010 to December 2010]

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

Type of Number of Responses per Hours per Annual hour

Recruitment strategy/activity respondent respondents respondent response burden

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

Provider-based: 10 Study Locations--Projected for Stage 1 (July 2010-December 2010)

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

Screening Activities

Address Look-Up........... Age-Eligible 7,500 1 0.1 750

Women.

Pregnancy Screening....... Age-Eligible 1,500 1 0.42 630

Women.

Preconception Activities

Pre-Pregnancy Interview... Age-Eligible 123 1 0.75 92

Women.

PPG Follow Up Script...... Age-Eligible 123 6 0.1 74

Women.

Pregnancy Activities

Women's Informed Consent Pregnant Women.. 1,500 1 0.67 1,005

Form.

First Pregnancy Interview. Pregnant Women.. 572 1 1 572

Second Pregnancy Interview Pregnant Women.. 572 1 0.75 429

Birth-Related Activities

Birth Visit Interview..... Mother/Baby..... 299 1 0.4 120

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

Total--Stage 1........ ................ 12,188 .............. .............. 3,671

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

Enhanced Household: 10 Study Locations--Projected for Stage 1 (July 2010-December 2010)

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

Screening Activities

Household Enumeration HH reporters.... 120,000 1 0.33 39,600

Script.

Pregnancy Screening....... Age-Eligible 51,198 1 0.42 21,503

Women.

Neighbor Report........... Neighbors....... 12,000 1 0.05 600

Preconception Activities

Pre-Pregnancy Interview... Age-Eligible 211 1 0.75 158

Women.

PPG Follow Up Script...... Age-Eligible 211 6 0.1 127

Women.

Pregnancy Activities

Women's Informed Consent Pregnant Women.. 2,586 1 0.67 1,733

Form.

First Pregnancy Interview. Pregnant Women.. 986 1 1 986

Second Pregnancy Interview Pregnant Women.. 986 1 0.75 740

Birth-Related Activities

Birth Visit Interview..... Mother/Baby..... 516 1 0.4 206

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

Total--Stage 1........ ................ 188,695 .............. .............. 65,653

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

Two Tier (Low): 10 Study Locations Across Both Tiers--Projected for Stage 1 (July 2010-December 2010)

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

Screening Activities

Low-intensity CATI Preg. Age-Eligible 48,000 1 0.35 16,800

Screener. Women.

Low Intensity Consent Age-Eligible 28,800 1 0.33 9,504

Script. Women.

Preconception Activities

[[Page 32476]]

Low-intensity CATI Age-Eligible 10,057 1 0.5 5,028

Questionnaire. Women.

PPG Follow Up Script...... Age-Eligible 10,057 6 0.1 6,034

Women.

Pregnancy Activities

Low-intensity CATI Pregnant Women.. 518 1 0.5 259

Questionnaire.

Birth-Related Activities

Low-intensity CATI Mother/Baby..... 166 1 0.5 83

Questionnaire.

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

Total--Stage 1........ ................ 97,598 .............. .............. 37,709

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

Two Tier (High): 10 Study Locations Across Both Tiers--Projected for Stage 1 (July 2010-December 2010)

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

Screening Activities

Pregnancy Screening....... Age-Eligible 15,840 1 0.42 6,653

Women.

Preconception Activities

Pre-Pregnancy Interview... Age-Eligible 761 1 0.75 571

Women.

PPG Follow Up Script...... Age-Eligible 761 6 0.1 456

Women.

Pregnancy Activities

Women's Informed Consent Pregnant Women.. 9,504 1 0.67 6,368

Form.

First Pregnancy Interview. Pregnant Women.. 3,552 1 1 3,552

Second Pregnancy Interview Pregnant Women.. 3,552 1 0.75 2,664

Birth-Related Activities

Birth Visit Interview..... Mother/Baby..... 1,857 1 0.4 743

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

Total--Stage 1........ ................ 35,826 .............. .............. 21,006

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

Grand Total, ................ 334,308 .............. .............. 176,876

Recruitment

Substudy.

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

The estimated annualized cost to respondents is $1,782,053 based on

the differential hourly rate estimates in the above table. There are no

Capital Costs to report. There are no Operating or Maintenance Costs to

report.

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 to be 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.

FOR FURTHER INFORMATION CONTACT: 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: Office of Management and Budget, Office of Regulatory

Affairs, New Executive Office Building, Room 10235, Washington, DC

20503, Attention: Desk Officer for NIH. To request more information on

the proposed project or to obtain a copy of the data collection plans

and instruments, contact: Sarah L. Glavin, Ph.D., 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.

Dated: June 2, 2010.

Sarah L. Glavin,

NICHD Project Clearance Liaison, National Institutes of Health.

[FR Doc. 2010-13705 Filed 6-7-10; 8:45 am]

BILLING CODE 4140-01-P

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