New Proposed Collection; Comment Request: Child Health Disparities Measurement for the National Children's Study, 15780-15782 [2012-6354]
Download as PDF
<![CDATA[
15780
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from October 1, 2011, through
December 31, 2011. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2011, THROUGH DECEMBER 31, 2011
PMA No., Docket No.
Applicant
Trade name
Approval date
P110003, FDA–2011–M–0746 .............
P090024, FDA–2011–M–0737 .............
Pluromed, Inc ......................................
Siemens Healthcare Diagnostics ........
September 28, 2011.
October 11, 2011.
P040024 (S51), FDA–2011–M–0735 ...
P010029 (S8), FDA–2011–M–0736 .....
P110022, FDA–2011–M–0786 .............
Medicis Aesthetics, Inc ........................
Ferring Pharmaceuticals, Inc ..............
Roche Diagnostics Corp .....................
P110011, FDA–2011–M–0791 .............
Medtronic Ireland .................................
P100042, FDA–2011–M–0792 .............
P110019, FDA–2011–M–0796 .............
Gen-Probe Incorporated ......................
Abbott Vascular ...................................
P100041, FDA–2011–M–0837 .............
Edwards Lifesciences, LLC .................
P090016, FDA–2011–M–0832 .............
H090002, FDA–2011–M–0848 .............
P110010, FDA–2011–M–0865 .............
Merz Aesthetics, Inc ............................
BSD Medical Corp ...............................
Boston Scientific Corp .........................
P100024, FDA–2011–M–0866 .............
P110025, FDA–2011–M–0917 .............
Dako Denmark A/S .............................
Roche Diagnostics Corp .....................
P100046, FDA–2011–M–0910 .............
AtriCure Inc .........................................
LEGOO ................................................
ADVIA CENTAUR HBEAG assay and
quality control material.
RESTYLANE injectable gel .................
EUFLEXXA (1% sodium hyaluronate)
ELECSYS
anti-HBC
IGM
immunoassay
and
ELECSYS
PRECICONTROL anti-HBC IGM.
ASSURANT COBALT iliac balloon-expandable stent system.
APTIMA HPV assay ............................
XIENCE PRIME and XIENCE PRIME
LL EVEROLIMUS-eluting coronary
stent system.
EDWARDS SAPIEN transcatheter
heart valve and RETROFLEX 3 delivery system, RETROFLEX balloon
catheter and crimper.
BELOTERO balance ...........................
BSD–2000 hyperthermia system ........
PROMUS
ELEMENT
PLUS
EVEROLIMUS-eluting
platinum
chromium coronary stent system.
HER2 CISH PHARMDX kit .................
ELECSYS
anti-HBC
IGM
immunoassay
and
ELECSYS
PRECICONTROL anti-HBC IGM for
use on the MODULAR ANALYTICS
E170 immunoassay analyze.
ATRICURE SYNERGY ablation system.
mstockstill on DSK4VPTVN1PROD with NOTICES
II. Electronic Access
Persons with access to the Internet
may obtain the documents at:
https://www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm; and
https://www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
HDEApprovals/ucm161827.htm.
VerDate Mar<15>2010
17:10 Mar 15, 2012
Jkt 226001
Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–6390 Filed 3–15–12; 8:45 am]
October 11, 2011.
October 11, 2011.
October 26, 2011.
October 26, 2011.
October 28, 2011.
November 1, 2011.
November 2, 2011.
November 14, 2011.
November 18, 2011.
November 22, 2011.
November 30, 2011.
December 14, 2011.
December 14, 2011.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request: Child Health Disparities
Measurement for the National
Children’s Study
BILLING CODE 4160–01–P
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
E:\FR\FM\16MRN1.SGM
16MRN1
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Child
Health Disparities Substudy for the
National Children’s Study (NCS). Type
of Information Collection Request:
NEW. Need and Use of Information
Collection: The Children’s Health Act of
2000 (Pub. L. 106–310) states:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) Plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) Investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) REQUIREMENT.—The study under
subsection (b) shall—
(1) Incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) Gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) Consider health disparities among
children, which may include the
consideration of prenatal exposures.
mstockstill on DSK4VPTVN1PROD with NOTICES
To fulfill the requirements of the
Children’s Health Act, the Child Health
Disparities Substudy will validate
measures needed for studying health
disparities and selected biomarkers.
Utilizing cognitive interview techniques
and components of standardized
questionnaires, responses will be used
to assess and validate measures of
health literacy, discrimination,
VerDate Mar<15>2010
17:10 Mar 15, 2012
Jkt 226001
parenting self-efficacy, and health care
accessibility.
Acceptability and feasibility of saliva
collection from a subsample of women
and young children will also be
evaluated. The incorporation of saliva
measurements will increase
understanding of biological responses to
environmental factors and how these
may be correlated with health
disparities within this population.
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. By
studying children through their
different phases of growth and
development, researchers will be better
able to understand the role these factors
have on health and disease. 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 is led by a consortium
of federal partners: the U.S. Department
of Health and Human Services
(including the Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
Institute of Environmental Health
Sciences of the National Institutes of
Health and the Centers for Disease
Control and Prevention), and the U.S.
Environmental Protection Agency.
To conduct the detailed preparation
needed for a study of this size and
complexity, the NCS was designed to
include a preliminary pilot study
known as the Vanguard Study. The
purpose of the Vanguard Study is to
assess the feasibility, acceptability, and
cost of the recruitment strategy, study
procedures, and outcome assessments
that are to be used in the NCS Main
Study. The Vanguard Study begins prior
to the NCS Main Study and will run in
parallel with the Main Study. At every
phase of the NCS, the multiple
methodological studies conducted
during the Vanguard phase will inform
the implementation and analysis plan
for the Main Study.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
15781
In this information collection request,
the NCS requests approval from OMB to
perform a multi-center substudy called
the Child Health Disparity Substudy.
This substudy aims to validate measures
needed for studying health disparities
and selected biomarkers. Developing
optimum measures for studying health
disparities is of particular interest to the
NCS because studies have shown that
health literacy, discrimination,
parenting self-efficacy, health care
(access, utilization, and quality)
contribute to health disparities.
Additionally, aspects of the social
environment such as social isolation,
lack of control and contingency and
social support, violence, discrimination,
challenging and changing social
relationships, and restricted access to
health care are thought to interact with
biological processes. Variation in these
processes has been associated with
negative emotional states, cognitive
deficits, problem behavior, and a variety
of metabolic and immune-related
processes. Alone, or particularly in
combination with other commonly
collected measures of social forces and
family relationships, salivary analytes
have the potential to advance our
understanding of maternal and child
health and development. This project
will make its contribution to the NCS
Main Study and to the health disparities
field as a whole by constructing a
validated set of questionnaire measures
and biomarker analyses that can be used
among pregnant women and mothers of
young children for the purpose of
investigating disparities.
Frequency of Response: One-time data
collection conducted in multiple
phases.
Affected Public: Pregnant women,
mothers with young children, and their
children.
Type of Respondents: Pregnant
women, mothers with young children,
and their children who are not
geographically eligible to enroll in the
NCS Vanguard Study.
Annual Reporting Burden: See Table
1. The annualized cost to respondents is
estimated at $24,600 (based on $10 per
hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
E:\FR\FM\16MRN1.SGM
16MRN1
15782
Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, CHILD HEALTH DISPARITIES SUBSTUDY
Estimated
number of
respondents
Type of
respondent
Data collection activity
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated
total annual
burden hours
Pregnant Women/
Mothers of children
ages 0–5.
Members of NCS target population (not
NCS participants).
1,260
1
0.08
105
Cognitive Interview .......
Mothers of children
ages 0–5.
Members of NCS target population (not
NCS participants).
60
1
1.33
80
Primary Data Collection
Pregnant Women/
Mothers of children
ages 0–5.
Mothers of children
ages 0–5.
Members of NCS target population (not
NCS participants).
600
600
2
1
1.08
1.08
1,300
650
Saliva Collection ...........
Pregnant Women/
Mothers of children
ages 0–5.
Additional mothers of
children ages 0–5.
Children ages 0–5 .......
Members of NCS target population (not
NCS participants).
260
260
520
2
1
1
0.25
0.25
0.25
130
65
130
Total ......................
mstockstill on DSK4VPTVN1PROD with NOTICES
Consent ........................
.....................................
.....................................
1,780
........................
........................
2,460
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to minimize
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Sarah L.
Glavin, Deputy Director, Office of
Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive, Room 2A18, Bethesda,
Maryland 20892, or call non-toll free
number (301) 496–1877 or email 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 60 days of the date of
this publication.
VerDate Mar<15>2010
17:10 Mar 15, 2012
Jkt 226001
Dated: March 12, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development.
[FR Doc. 2012–6354 Filed 3–15–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Amended;
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel, April
18, 2012, 1 p.m. to April 18, 2012, 5
p.m., National Institutes of Health, 6116
Executive Boulevard, 8055B, Rockville,
MD 20852 which was published in the
Federal Register on March 1, 2012, 77
FR 12600.
This notice is being amended to
change the times of the meeting from 1
p.m.–5 p.m. to 12 p.m.–3 p.m. The
meeting is closed to the public.
Dated: March 9, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–6352 Filed 3–15–12; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2) 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 purpose of this
meeting is to evaluate requests for
preclinical development resources for
potential new therapeutics for the
treatment of cancer. The outcome of the
evaluation will provide information to
internal NCI committees that will
decide whether NCI should support
requests and make available contract
resources for development of the
potential therapeutic to improve the
treatment of various forms of cancer.
The research proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material and
personal information concerning
individuals associated with the
proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15780-15782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6354]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request: Child Health
Disparities Measurement for the National Children's Study
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Child
Health and Human Development (NICHD), the
[[Page 15781]]
National Institutes of Health (NIH) will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Proposed Collection: Title: Child Health Disparities Substudy for
the National Children's Study (NCS). Type of Information Collection
Request: NEW. Need and Use of Information Collection: The Children's
Health Act of 2000 (Pub. L. 106-310) states:
(a) PURPOSE.--It is the purpose of this section to authorize the
National Institute of Child Health and Human Development* to conduct
a national longitudinal study of environmental influences (including
physical, chemical, biological, and psychosocial) on children's
health and development.
(b) IN GENERAL.--The Director of the National Institute of Child
Health and Human Development* shall establish a consortium of
representatives from appropriate Federal agencies (including the
Centers for Disease Control and Prevention, the Environmental
Protection Agency) to--
(1) Plan, develop, and implement a prospective cohort study,
from birth to adulthood, to evaluate the effects of both chronic and
intermittent exposures on child health and human development; and
(2) Investigate basic mechanisms of developmental disorders and
environmental factors, both risk and protective, that influence
health and developmental processes.
(c) REQUIREMENT.--The study under subsection (b) shall--
(1) Incorporate behavioral, emotional, educational, and
contextual consequences to enable a complete assessment of the
physical, chemical, biological, and psychosocial environmental
influences on children's well-being;
(2) Gather data on environmental influences and outcomes on
diverse populations of children, which may include the consideration
of prenatal exposures; and
(3) Consider health disparities among children, which may
include the consideration of prenatal exposures.
To fulfill the requirements of the Children's Health Act, the Child
Health Disparities Substudy will validate measures needed for studying
health disparities and selected biomarkers. Utilizing cognitive
interview techniques and components of standardized questionnaires,
responses will be used to assess and validate measures of health
literacy, discrimination, parenting self-efficacy, and health care
accessibility.
Acceptability and feasibility of saliva collection from a subsample
of women and young children will also be evaluated. The incorporation
of saliva measurements will increase understanding of biological
responses to environmental factors and how these may be correlated with
health disparities within this population.
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. By studying children through their different phases of growth
and development, researchers will be better able to understand the role
these factors have on health and disease. 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
is led by a consortium of federal partners: the U.S. Department of
Health and Human Services (including the Eunice Kennedy Shriver
National Institute of Child Health and Human Development and the
National Institute of Environmental Health Sciences of the National
Institutes of Health and the Centers for Disease Control and
Prevention), and the U.S. Environmental Protection Agency.
To conduct the detailed preparation needed for a study of this size
and complexity, the NCS was designed to include a preliminary pilot
study known as the Vanguard Study. The purpose of the Vanguard Study is
to assess the feasibility, acceptability, and cost of the recruitment
strategy, study procedures, and outcome assessments that are to be used
in the NCS Main Study. The Vanguard Study begins prior to the NCS Main
Study and will run in parallel with the Main Study. At every phase of
the NCS, the multiple methodological studies conducted during the
Vanguard phase will inform the implementation and analysis plan for the
Main Study.
In this information collection request, the NCS requests approval
from OMB to perform a multi-center substudy called the Child Health
Disparity Substudy. This substudy aims to validate measures needed for
studying health disparities and selected biomarkers. Developing optimum
measures for studying health disparities is of particular interest to
the NCS because studies have shown that health literacy,
discrimination, parenting self-efficacy, health care (access,
utilization, and quality) contribute to health disparities.
Additionally, aspects of the social environment such as social
isolation, lack of control and contingency and social support,
violence, discrimination, challenging and changing social
relationships, and restricted access to health care are thought to
interact with biological processes. Variation in these processes has
been associated with negative emotional states, cognitive deficits,
problem behavior, and a variety of metabolic and immune-related
processes. Alone, or particularly in combination with other commonly
collected measures of social forces and family relationships, salivary
analytes have the potential to advance our understanding of maternal
and child health and development. This project will make its
contribution to the NCS Main Study and to the health disparities field
as a whole by constructing a validated set of questionnaire measures
and biomarker analyses that can be used among pregnant women and
mothers of young children for the purpose of investigating disparities.
Frequency of Response: One-time data collection conducted in
multiple phases.
Affected Public: Pregnant women, mothers with young children, and
their children.
Type of Respondents: Pregnant women, mothers with young children,
and their children who are not geographically eligible to enroll in the
NCS Vanguard Study.
Annual Reporting Burden: See Table 1. The annualized cost to
respondents is estimated at $24,600 (based on $10 per hour). There are
no Capital Costs to report. There are no Operating or Maintenance Costs
to report.
[[Page 15782]]
Table 1--Estimated Annual Reporting Burden Summary, Child Health Disparities Substudy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated
Data collection activity Type of respondent number of responses per hours per total annual
respondents respondent response burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consent.............................. Pregnant Women/Mothers Members of NCS target 1,260 1 0.08 105
of children ages 0-5. population (not NCS
participants).
---------------------------------------------------------------
Cognitive Interview.................. Mothers of children ages Members of NCS target 60 1 1.33 80
0-5. population (not NCS
participants).
---------------------------------------------------------------
Primary Data Collection.............. Pregnant Women/Mothers Members of NCS target 600 2 1.08 1,300
of children ages 0-5. population (not NCS 600 1 1.08 650
Mothers of children ages participants).
0-5.
---------------------------------------------------------------
Saliva Collection.................... Pregnant Women/Mothers Members of NCS target 260 2 0.25 130
of children ages 0-5. population (not NCS 260 1 0.25 65
Additional mothers of participants). 520 1 0.25 130
children ages 0-5.
Children ages 0-5.......
------------------------------------------------------------------------------------------------------------------
Total............................ ........................ ....................... 1,780 .............. .............. 2,460
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to minimize the burden of the collection
of information on those who are to respond, including the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Dr. Sarah L. Glavin, Deputy Director, Office of
Science Policy, Analysis and Communication, National Institute of Child
Health and Human Development, 31 Center Drive, Room 2A18, Bethesda,
Maryland 20892, or call non-toll free number (301) 496-1877 or email
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 60 days
of the date of this publication.
Dated: March 12, 2012.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2012-6354 Filed 3-15-12; 8:45 am]
BILLING CODE 4140-01-P
