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 

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. 

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. 

A.12—1 ESTIMATES OF NET HOUR BURDEN REDUCTION

Type of respondents Number of 

respondents 

Frequency of 

response 

Average time 

per response 

(in hours) 

Annual hour 

burden 

Stage 1: Immediate ....................................................................................... 100 1 72 +7200 

Stage 1: Expected Reduction in Current burden (assuming 100 universities and at median) .................................................................................. 100 4 40 ¥16000 

Net reduction in burden .......................................................................... 100 4 .......................... ¥8800 

Stage 1: Future .............................................................................................. 100 4 1 .0 +400 

Stage 2: Expected Reduction in Current burden (assuming 100 universities and at median) .................................................................................. 100 4 40 ¥16000 

Net reduction in burden .......................................................................... 100 4 .......................... ¥15600 

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 

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 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 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 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: http:// 

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 Type of respondent Number of 

respondents 

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 .................................. Age-Eligible Women ............ 7,500 1 0 .1 750 

Pregnancy Screening ........................... Age-Eligible Women ............ 1,500 1 0 .42 630 

Preconception Activities 

Pre-Pregnancy Interview ...................... Age-Eligible Women ............ 123 1 0 .75 92 

PPG Follow Up Script .......................... Age-Eligible Women ............ 123 6 0 .1 74 

Pregnancy Activities 

Women’s Informed Consent Form ....... Pregnant Women ................. 1,500 1 0 .67 1,005 

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 Script ............ HH reporters ........................ 120,000 1 0 .33 39,600 

Pregnancy Screening ........................... Age-Eligible Women ............ 51,198 1 0 .42 21,503 

Neighbor Report ................................... Neighbors ............................ 12,000 1 0 .05 600 

Preconception Activities 

Pre-Pregnancy Interview ...................... Age-Eligible Women ............ 211 1 0 .75 158 

PPG Follow Up Script .......................... Age-Eligible Women ............ 211 6 0 .1 127 

Pregnancy Activities 

Women’s Informed Consent Form ....... Pregnant Women ................. 2,586 1 0 .67 1,733 

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. Screener ...... Age-Eligible Women ............ 48,000 1 0 .35 16,800 

Low Intensity Consent Script ............... Age-Eligible Women ............ 28,800 1 0 .33 9,504 

Preconception Activities 


emcdonald on DSK2BSOYB1PROD with NOTICES
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] 

Recruitment strategy/activity Type of respondent Number of 

respondents 

Responses 

per respondent 

Hours per 

response 

Annual hour 

burden 

Low-intensity CATI Questionnaire ........ Age-Eligible Women ............ 10,057 1 0 .5 5,028 

PPG Follow Up Script .......................... Age-Eligible Women ............ 10,057 6 0 .1 6,034 

Pregnancy Activities 

Low-intensity CATI Questionnaire ........ Pregnant Women ................. 518 1 0 .5 259 

Birth-Related Activities 

Low-intensity CATI Questionnaire ........ 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 ........................... Age-Eligible Women ............ 15,840 1 0 .42 6,653 

Preconception Activities 

Pre-Pregnancy Interview ...................... Age-Eligible Women ............ 761 1 0 .75 571 

PPG Follow Up Script .......................... Age-Eligible Women ............ 761 6 0 .1 456 

Pregnancy Activities 

Women’s Informed Consent Form ....... Pregnant Women ................. 9,504 1 0 .67 6,368 

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, Recruitment 

Substudy.

.............................................. 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: 

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 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES