24964 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

Recordkeeping Number of record 

keepers Hours per year Total burden hours 

Recordkeeping 

Non-alternative Facilities (124.510(a)) ...................................................................... 33 50 1,650.00 

Unrestricted Availability (124.510(b)) ........................................................................ 30 50 1,500.00 

Subtotal Recordkeeping Burden ........................................................................ .............................. .............................. 3,150.00 

Email comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–29, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: April 20, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–10031 Filed 4–25–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development Submission for 

OMB Review; Comment Request; 

Provider-Based Sampling Feasibility 

Study for the Vanguard (Pilot) Study 

and Data Collection Updates for the 

National Children’s Study (NICHD) 

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 January 30, 

2012, pages 4569–4571, and allowed 60 

days for public comment. No written 

comments were received. 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: Provider-Based Sampling 

Feasibility Study for the Vanguard 

(Pilot) Study and Data Collection 

Updates for the National Children’s 

Study (NICHD). 

The National Children’s Study, 

Vanguard (Pilot) Study. 

Type of Information Collection 

Request: Revision. 

Need and Use of Information Collection 

The purpose of the proposed 

methodological study is to continue the 

Vanguard phase of the National 

Children’s Study with updated 

instruments and additional biospecimen 

collections and physical measures and 

to evaluate the feasibility, acceptability, 

and cost of a different sampling strategy 

for enrollment of pregnant women. This 

study is one component of a larger 

group of studies being conducted during 

the Vanguard Phase of the National 

Children’s Study (NCS), a prospective, 

national longitudinal study of child 

health and development. In 

combination, these studies will be used 

to inform the design of the Main Study 

of the National Children’s Study. 

Background 

The National Children’s Study is a 

prospective, national longitudinal study 

of the interaction between environment, 

genetics on child health and 

development. The Study defines 

‘‘environment’’ broadly, taking a 

number of natural and man-made 

environmental, biological, genetic, and 

psychosocial factors into account. 

Findings from the Study will be made 

available as the research progresses, 

making potential benefits known to the 

public as soon as possible. 

The National Children’s Study (NCS) 

has several components, including a 

pilot or Vanguard Study, and a Main 

Study to collect exposure and outcome 

data. The sample frame for the NCS 

Vanguard and Main Study was initially 

based on a national probability sample 

using geography as the basis and 

selecting about 100 of the about 3,000 

counties in the United States as the 

basis for Primary Sampling Units. 

Within the Primary Sampling Units, 

smaller geographic segments were 

selected as Secondary Sampling Units 

in an attempt to normalize live birth 

rates per area sampled. Women who 

resided at the time of enrollment within 

a designated Secondary Sampling Unit 

and were either pregnant or between 18 

and 49 were eligible for enrollment. The 

initial recruitment technique within the 

selected geographic areas was 

household contact by field workers 

going door to door. 

The Vanguard Study was launched in 

January 2009 and, by the summer of 

2009, field experience suggested that the 

household contact recruitment strategy 

was not feasible with available 

resources. Thus, in 2010, new 

recruitment strategies were launched to 

evaluate options. By late 2011, the NCS 

had sufficient data to evaluate 

operational aspects of various 

recruitment strategies. Preliminary 

analyses suggested that a ProviderBased Recruitment strategy was the 

most efficient, but due to constrictions 

of the geographic sampling frame, the 

potential of the strategy was limited. 

Specifically, many women had to be 

screened at a particular provider to 

locate the relatively few who resided in 

a designated segment. Anticipating this 

limitation, the NCS Program Office 

developed and discussed with the NCS 

Federal Advisory Committee a different 

sampling frame using provider location. 

This new sampling strategy is termed 

Provider-Based Sampling (PBS). 

Information from this data collection is 

critical to determine the plausibility of 

a provider-based sampling frame as an 

option for some parts of the NCS Main 

Study. 

Research Questions 

Two research goals will be 

accomplished by this information 

collection. One goal is to test the 

feasibility of Provider-Based Sampling 

using three study locations. Another 

goal is to systematically pilot additional 

study visit measures and collections to 

assess the scientific robustness, burden 

to participants and study infrastructure, 

and cost for use in the Vanguard (Pilot) 

Study and to inform the design of the 

Main Study. 

Methods 

Provider Based Sampling 

We will compile a list of prenatal 

providers serving women who reside 

within the Primary Sampling Unit at 

three study locations. Providers will be 

asked to complete a brief questionnaire 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24965 

about their practice and their patient 

demographics. For this pilot, a woman 

will be eligible for recruitment if she 

resides in the Primary Sampling Unit 

and is seeing a provider for her first 

prenatal visit. 

Recruitment of participants at the 

selected provider offices will largely 

follow the protocol and procedures 

developed for the Provider-Based 

Recruitment Substudy, as previously 

approved by the Office of Information 

and Regulatory Affairs within the Office 

of Management and Budget. Potential 

participants will be screened on age 

eligibility, residence in the sampled 

Primary Sampling Unit, and pregnancy 

status at the initial prenatal visit. In 

some locations, medical records may be 

pre-screened to identify participants 

meeting these eligibility criteria. 

Supplemental Information and 

Biospecimen Collections 

We will continue data collection with 

pregnancy and birth periods, as well as 

postnatal data collection points at 3, 6, 

9, 12, 18, and 24 months of age. We 

propose to add or modify the selected 

measures below to address analytic 

goals of assessing feasibility, 

acceptability and cost of specific study 

visit measures. 

Core Questionnaire: We propose to 

pilot a Core Questionnaire containing 

key variables and designed to collect 

core data at every study visit contact 

from the time that the enrolled child is 

6 months of age to the time the child is 

5 years of age. 

30-Month Data Collection Module: 

We propose piloting an age-specific 

module alongside of the Core 

Questionnaire with the 30-Month 

Interview. 

Validation Questions for 18, 24 and 

30 Month: We propose addition of brief, 

telephone-based questions that would 

be fielded to a random sample of each 

interviewer’s cases after completion of 

the 18-Month, 24-Month, and 30-Month 

interviews to monitor interviewer 

performance and identify occurrences of 

data falsification. 

Nonrespondent Questionnaire: We 

will collect information on why a 

participant chose to not enroll or 

withdraw from the NCS. This 

information may be used to revise our 

approaches to recruitment and will help 

the Study frame other systematic 

analyses of nonresponse bias. 

Physical Measures: The addition of 6 

month, 12, and 24-Month infant 

measures of child anthropometry and/or 

blood pressure may provide critical 

pieces of information for future research 

on the causes of obesity, diabetes, 

premature puberty and a host of other 

health outcomes. 

Revised Father Questionnaire: We 

seek to incorporate behavioral, 

emotional, educational and contextual 

consequences to enable a complete 

assessment of psychosocial influences 

on children’s well-being. The revised 

Father Questionnaire now includes 

measures addressing key social/personal 

resources and fathers’ capacity, desire 

and attitudes towards engaging with 

mothers and children. 

Additional Instrument at the 24- 

Month Interview: The Modified 

Checklist for Autism in toddlers (M– 

CHATTM) is a validated brief screening 

measure for identification of Autism 

and will be added to the 24-Month 

Interview. 

Breast Milk Collection 1 and 3 

Months: Additional collections are 

needed to determine the feasibility, 

acceptability and cost of collection. 

Infant Urine Collection at 6- and 12- 

Month Visits: Additional collections are 

needed to determine the feasibility, 

acceptability and cost of collection. 

Infant Blood and Saliva Collection at 

the 12-Month Visit: Additional 

collections are needed to determine the 

feasibility, acceptability and cost of 

collection. 

Frequency of Response: See above 

descriptions. 

Affected Public: Healthcare providers, 

pregnant women, fathers, and their 

children. The additional annualized 

cost to respondents over the three-year 

data collection period is estimated at 

annualized cost of $229,804. This is 

calculated as estimating 31,082 

respondent contacts at an estimated 

average of 0.73 hours per contact, for a 

total estimated annual respondent 

burden as 22,791 hours. There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Data collection activity Type of 

respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Estimated total 

annual burden 

hours 

Estimated total 

annual 

respondent 

cost 

Screening Activities 

Provider Based Sampling Eligibility 

Screener (PBS) 

Pregnant Women 3,125 1 20/60 1,042 $10,417 

Provider Based Sampling Frame 

Questionnaire (PBS) 

Healthcare Providers 50 1 25/60 21 2,104 

Continuous Activities 

Nonrespondent Questionnaire (PB, 

EH, TT–HI, TT–LI, PBS) 

Pregnant Women, 

Mothers or Fathers 

480 1 5/60 40 400 

Validation Interview—up to 30 

Months (PB, EH, TT–HI, TT–LI, 

PBS).

Respondents ....... 1,268 1 5/60 106 $1,057 

Participant Verification (PB, EH, TT– 

HI, TT–LI, PBS).

Pregnant Women, 

Mothers or Fathers.

2,320 1 5/60 193 1,933 

Tracing Interview (PB, EH, TT–HI, 

TT–LI, PBS).

Respondents ....... 1,167 13 10/60 2,528 25,281 

Pregnancy Activities 

Low-intensity Questionnaire (Found 

Pregnant) (TT–LI).

Pregnant Women 173 1 15/60 43 432 


tkelley on DSK3SPTVN1PROD with NOTICES
24966 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

Data collection activity Type of 

respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Estimated total 

annual burden 

hours 

Estimated total 

annual 

respondent 

cost 

Pregnancy Visit 1 Interview (PB, EH, 

TT–HI, PBS).

Pregnant Women 2,018 1 35/60 1,177 11,774 

Pregnancy Visit 2 Interview (PB, EH, 

TT–HI, PBS).

Pregnant Women 1,817 1 25/60 757 7,569 

Biological and Environmental Sample 

Collection—Prenatal (PB, EH, TT– 

HI).

Pregnant Women 1,456 2 60/60 2,913 29,127 

Pregnancy Health Care Log (PB, EH, 

TT–HI, PBS).

Pregnant Women 1,615 1 20/60 538 5,382 

Father Interview (PB, EH, TT–HI) ..... Alternate Caregiver.818 1 35/60 477 4,770 

Birth-Related Activities 

Birth Visit Interview (PB, EH, TT–HI, 

PBS).

Mother/Baby ........ 1,141 1 20/60 380 3,802 

Low-intensity Questionnaire (Birthfocus) (TT–LI).Mother/Baby ........ 432 1 15/60 108 1,080 

Postnatal Activities 

Infant Feeding Log (PB, EH, TT–HI, 

PBS).

Mother/Baby ........ 1,106 1 20/60 369 3,688 

Biological Sample Collection—Mother/Baby (PB, EH, TT–HI).Mother/Baby ........ 761 4 22.5/60 1,141 11,411 

3-Month Interview (PB, EH, TT–HI, 

TT–LI, PBS).

Mother/Baby ........ 1,518 1 20/60 506 5,061 

6-Month Interview (PB, EH, TT–HI, 

PBS).

Mother/Baby ........ 1,066 1 30/60 533 5,331 

Physical Measures—Child Anthropometry (6-,12-, 24-Month) (PB, 

EH, TT–HI).

Baby/Child ........... 701 3 20/60 701 7,014 

Physical Measures—Child Blood 

Pressure (12-, 24-Month) (PB, EH, 

TT–HI).

Baby/Child ........... 675 2 10/60 225 2,250 

9-Month Interview (PB, EH, TT–HI, 

TT–LI, PBS).

Mother/Baby ........ 1,428 1 10/60 238 2,381 

12-Month Interview (PB, EH, TT–HI, 

PBS).

Mother/Baby ........ 1,003 1 50/60 836 8,360 

18-Month Interview (PB, EH, TT–HI, 

TT–LI, PBS).

Mother/Child ........ 1,316 1 30/60 658 6,582 

24-Month Interview (PB, EH, TT–HI, 

TT–LI, PBS).

Mother/Child ........ 1,251 1 35/60 729 7,295 

Core Questionnaire (PB, EH, TT–HI, 

TT–LI, PBS).

Mother/Child ........ 1,188 1 30/60 594 5,940 

30-Month Visit Interview (PB, EH, 

TT–HI, TT–LI, PBS).

Mother/Child ........ 1,188 1 55/60 1,089 10,890 

Total, Vanguard (Pilot) Study ..... .............................. 31,082 ........................ ........................ 17,943 181,331 

Total, Formative Research ......... .............................. ........................ ........................ ........................ 4,847 48,473 

Grand Total ......................... .............................. 31,082 ........................ ........................ 22,791 229,804 

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 Email 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, 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24967 

Maryland 20892, or call a non-toll free 

number (301) 496–1877 or Email 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: April 16, 2012. 

Jamelle E. Banks, 

Project Clearance Liaison, Office of Science 

Policy, Analysis and Communications, 

National Institute of Child Health and Human 

Development. 

[FR Doc. 2012–10113 Filed 4–25–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications. 

Date: May 16, 2012. 

Time: 12 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817, 

(Telephone Conference Call). 

Contact Person: Maja Maric, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

DHHS/NIH/NIAID, 6700B Rockledge Drive, 

Room 3266, Bethesda, MD 20892–7616, 301– 

451–2634, maja.maric@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: April 19, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–10089 Filed 4–25–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel RFA–RM– 

11–016 Regional Comprehensive 

Metabolomics Resource Cores. 

Date: May 15–16, 2012. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: James J Li, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 5148, MSC 7849, Bethesda, MD 

20892, 301–806–8065, lijames@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel PAR12–010 

Smoking and Tobacco Revision Applications: 

Social Sciences and Population Studies. 

Date: May 21–22, 2012. 

Time: 8:30 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco Alexandria, 480 King 

Street, Alexandria, VA 22314. 

Contact Person: Suzanne Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Room 3139, MSC 7770, 

Bethesda, MD 20892, (301) 435–1712, 

ryansj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Social 

Sciences and Population Studies: Second 

Panel. 

Date: May 21–22, 2012. 

Time: 8:30 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco Alexandria, 480 King 

Street, Alexandria, VA 22314. 

Contact Person: Suzanne Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892, (301) 435– 

1712, ryansj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Member 

Conflict: Myocardial Metabolism, Ischemia 

and Heart Failure. 

Date: May 22, 2012. 

Time: 2 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Yuanna Cheng, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

1195, Chengy5@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: April 19, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–10088 Filed 4–25–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Risk, Prevention and Health 

Behavior. 

Date: May 9–10, 2012. 

Time: 9 a.m. to 5 p.m. 


tkelley on DSK3SPTVN1PROD with NOTICES