National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; The National Children's Study (NCS), Vanguard (Pilot) Study, 35042-35044 [2010-14969]
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35042
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Recruitment screener ......................................................................................
Exploratory Focus Groups ...............................................................................
Message Testing Focus Groups ......................................................................
252
72
54
1
1
1
5/60
2
2
21
144
108
Total ..........................................................................................................
........................
........................
........................
273
Dated: June 3, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–14873 Filed 6–18–10; 8:45 am]
BILLING CODE 4163–18–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
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
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 A.2—ESTIMATED HOUR BURDEN AND COST FOR RECRUITMENT SUBSTUDY RESPONDENTS—STAGE 1
sroberts on DSKD5P82C1PROD with NOTICES
[July 2010 to December 2010]
Recruitment
strategy
Activity
Type of respondent
Number of
respondents
Provider-based: 10 Study Locations
Screening Activities
Address Look-Up ................
VerDate Mar<15>2010
15:46 Jun 18, 2010
Jkt 220001
PO 00000
Hours per response
Annual hour
burden
Projected for Stage 1 (July 2010–December 2010)
Age-Eligible
Women.
Frm 00073
Responses
per
respondent
Fmt 4703
7,500
Sfmt 4703
E:\FR\FM\21JNN1.SGM
1
21JNN1
0.1
750
35043
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
TABLE A.2—ESTIMATED HOUR BURDEN AND COST FOR RECRUITMENT SUBSTUDY RESPONDENTS—STAGE 1—Continued
[July 2010 to December 2010]
Recruitment
strategy
Activity
Type of respondent
Pregnancy Screening ..........
Preconception Activities
Pre-Pregnancy Interview .....
Pregnancy
Probability
Group Follow Up Script.
Pregnancy Activities
Women’s Informed Consent
Form.
Pregnancy Visit 1 Interview
Pregnancy Visit 2 Interview
Birth-Related Activities
Birth Visit Interview .............
Total—Stage 1 .............
Number of
respondents
Neighbor Report ..................
Preconception Activities
Pre-Pregnancy Interview .....
Pregnancy
Probability
Group Follow Up Script.
Pregnancy Activities
Women’s Informed Consent
Form.
Pregnancy Visit 1 Interview
Pregnancy Visit 2 Interview
Birth-Related Activities
Birth Visit Interview .............
Total—Stage 1 .............
sroberts on DSKD5P82C1PROD with NOTICES
Total—Stage 1 .............
1
0.42
630
Age-Eligible
Women.
Age-Eligible
Women.
123
1
0.75
92
123
6
0.1
74
Pregnant Women ..
1,500
1
0.67
1,005
Pregnant Women ..
Pregnant Women ..
572
572
1
1
1
0.75
572
429
Mother/Baby ..........
299
1
0.4
120
................................
12,188
........................
Preconception Activities
Pre-Pregnancy Interview .....
VerDate Mar<15>2010
15:46 Jun 18, 2010
Jkt 220001
PO 00000
..........................
3,671
Projected for Stage 1 (July 2010–December 2010)
HH reporters ..........
120,000
1
0.33
39,600
Age-Eligible
Women.
Neighbors ..............
51,198
1
0.42
21,503
12,000
1
0.05
600
211
1
0.75
158
211
6
0.1
127
Pregnant Women ..
2,586
1
0.67
1,733
Pregnant Women ..
Pregnant Women ..
986
986
1
1
1
0.75
986
740
Mother/Baby ..........
516
1
0.4
206
................................
188,695
........................
Age-Eligible
Women.
Age-Eligible
Women.
..........................
65,653
Projected for Stage 1 (July 2010–December 2010)
Age-Eligible
Women.
Age-Eligible
Women.
48,000
1
0.35
16,800
28,800
1
0.33
9,504
10,057
1
0.5
5,028
10,057
6
0.1
6,034
Pregnant Women ..
518
1
0.5
259
Mother/Baby ..........
166
1
0.5
83
................................
97,598
........................
Age-Eligible
Women.
Age-Eligible
Women.
Two Tier (High): 10 Study Locations Across Both Tiers
Screening Activities
Pregnancy Screening ..........
Annual hour
burden
1,500
Two Tier (Low): 10 Study Locations Across Both Tiers
Screening Activities
Low-intensity CATI Preg.
Screener.
Low-Intensity
Consent
Script.
Preconception Activities
Low-intensity CATI Questionnaire.
Pregnancy
Probability
Group Follow Up Script.
Pregnancy Activities
Low-intensity CATI Questionnaire.
Birth-Related Activities
Low-intensity CATI Questionnaire.
Hours per response
Age-Eligible
Women.
Enhanced Household: 10 Study Locations
Screening Activities
Household
Enumeration
Script.
Pregnancy Screening ..........
Responses
per
respondent
..........................
37,709
Projected for Stage 1 (July 2010–December 2010)
Age-Eligible
Women.
15,840
1
0.42
6,653
Age-Eligible
Women.
761
1
0.75
571
Frm 00074
Fmt 4703
Sfmt 4703
E:\FR\FM\21JNN1.SGM
21JNN1
35044
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Notices
TABLE A.2—ESTIMATED HOUR BURDEN AND COST FOR RECRUITMENT SUBSTUDY RESPONDENTS—STAGE 1—Continued
[July 2010 to December 2010]
Recruitment
strategy
Activity
Type of respondent
Annual hour
burden
761
6
0.1
Pregnant Women ..
9,504
1
0.67
6,368
Pregnant Women ..
Pregnant Women ..
3,552
3,552
1
1
1
0.75
3,552
2,664
Mother/Baby ..........
1,857
1
0.4
................................
35,826
........................
..........................
21,006
Grand Total, Recruitment Substudy ..........................
................................
334,308
........................
..........................
128,039
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: Jamelle
E. Banks, M.P.H., National Institute of
Child Health and Human Development,
31 Center Drive, Room 2A18, Bethesda,
Maryland, 20892, or call non-toll free
number (301) 443–7210, or e-mail your
VerDate Mar<15>2010
15:46 Jun 18, 2010
Jkt 220001
Age-Eligible
Women.
Hours per response
Total—Stage 1 .............
sroberts on DSKD5P82C1PROD with NOTICES
Pregnancy
Probability
Group Follow Up Script.
Pregnancy Activities
Women’s Informed Consent
Form.
Pregnancy Visit 1 Interview
Pregnancy Visit 2 Interview
Birth-Related Activities
Birth Visit Interview .............
Responses
per
respondent
Number of
respondents
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: June 15, 2010.
Jamelle E. Banks,
NICHD Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–14969 Filed 6–18–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0002]
Notice of Approval of a Supplemental
New Animal Drug Application;
Penicillin G Procaine Suspension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice that it has approved a
supplemental new animal drug
application (NADA) filed by Norbrook
Laboratories, Ltd. The supplemental
NADA provides for a revised
formulation of penicillin G procaine
injectable suspension that includes
lecithin as a surfactant.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
456
743
Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
a supplement to NADA 065–010 for use
of NOROCILLIN (penicillin G procaine)
Injectable Suspension by intramuscular
injection in cattle, sheep, swine, and
horses. The supplement provides for a
revised formulation that includes
lecithin as a surfactant. In accordance
with section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360b(i)) and part 514 (21 CFR
514), in §§ 514.105(a) and 514.106(a),
the Center for Veterinary Medicine is
providing notice that this supplemental
NADA is approved as of April 23, 2010.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(iii) of the
act (21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval.
FDA has determined under 21 CFR
25.33 that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Notices]
[Pages 35042-35044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14969]
-----------------------------------------------------------------------
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
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
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 A.2--Estimated Hour Burden and Cost for Recruitment Substudy Respondents--Stage 1
[July 2010 to December 2010]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Annual hour
Recruitment strategy Activity Type of respondent respondents respondent response burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provider-based: 10 Study LocProjected for Stage 1 (July 2010-December 2010)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening Activities
Address Look-Up......... Age-Eligible Women.... 7,500 1 0.1 750
[[Page 35043]]
Pregnancy Screening..... Age-Eligible Women.... 1,500 1 0.42 630
Preconception Activities
Pre-Pregnancy Interview. Age-Eligible Women.... 123 1 0.75 92
Pregnancy Probability Age-Eligible Women.... 123 6 0.1 74
Group Follow Up Script.
Pregnancy Activities
Women's Informed Consent Pregnant Women........ 1,500 1 0.67 1,005
Form.
Pregnancy Visit 1 Pregnant Women........ 572 1 1 572
Interview.
Pregnancy Visit 2 Pregnant Women........ 572 1 0.75 429
Interview.
Birth-Related Activities
Birth Visit Interview... Mother/Baby........... 299 1 0.4 120
---------------------------------------------------------------
Total--Stage 1........ ...................... 12,188 .............. .............. 3,671
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enhanced Household: 10 Study LProjected 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 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
Pregnancy Probability Age-Eligible Women.... 211 6 0.1 127
Group Follow Up Script.
Pregnancy Activities
Women's Informed Consent Pregnant Women........ 2,586 1 0.67 1,733
Form.
Pregnancy Visit 1 Pregnant Women........ 986 1 1 986
Interview.
Pregnancy Visit 2 Pregnant Women........ 986 1 0.75 740
Interview.
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 AcProjected for Stage 1 (July 2010-December 2010)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening Activities
Low-intensity CATI Preg. Age-Eligible Women.... 48,000 1 0.35 16,800
Screener.
Low-Intensity Consent Age-Eligible Women.... 28,800 1 0.33 9,504
Script.
Preconception Activities
Low-intensity CATI Age-Eligible Women.... 10,057 1 0.5 5,028
Questionnaire.
Pregnancy Probability Age-Eligible Women.... 10,057 6 0.1 6,034
Group Follow Up Script.
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 AProjected 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
[[Page 35044]]
Pregnancy Probability Age-Eligible Women.... 761 6 0.1 456
Group Follow Up Script.
Pregnancy Activities
Women's Informed Consent Pregnant Women........ 9,504 1 0.67 6,368
Form.
Pregnancy Visit 1 Pregnant Women........ 3,552 1 1 3,552
Interview.
Pregnancy Visit 2 Pregnant Women........ 3,552 1 0.75 2,664
Interview.
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 .............. .............. 128,039
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: Jamelle E. Banks, M.P.H., National Institute
of Child Health and Human Development, 31 Center Drive, Room 2A18,
Bethesda, Maryland, 20892, or call non-toll free number (301) 443-7210,
or e-mail your request, including your address to banksj@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: June 15, 2010.
Jamelle E. Banks,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-14969 Filed 6-18-10; 8:45 am]
BILLING CODE 4140-01-P
