New Proposed Collection; Comment Request; Study Logistic Formative Research Methodology Studies for the National Children's Study, 40379-40381 [2011-17201]
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40379
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
information. FDA received one
comment which was related to the
Paperwork Reduction Act burden
associated with this collection of
information.
The comment indicated that table 2 in
the 60-day notice was not clear if it
represented burden for all respondents,
or just one respondent. In addition, the
commenter noted that if table 2
represented the estimated burden for all
respondents, that they did not agree
with the accuracy of FDA’s estimate, as
the table appears to assume that each
respondent creates one SOP per each
21 CFR section listed. The commenter
felt that this assumption is not correct
for large companies, who could possibly
have several thousand systems, each
requiring their own SOPs. If this were
burden adequately represents the
average burden a firm might expend to
complete the recordkeeping
requirements for this collection.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of standard
operating procedures, validation, and
certification. The Agency anticipates the
use of electronic media will
substantially reduce the paperwork
burden associated with maintaining
FDA required records. The respondents
will be businesses and other for-profit
organizations, State or local
governments, Federal Agencies, and
nonprofit institutions.
FDA estimates the burden of this
collection of information as follows:
the case, the recordkeeping burden in
Table 2 would be severely understated.
FDA’s response is to note that the
recordkeeping burden in table 2 is an
estimate of both large and small firms,
and the burden represented in the table
is an average of the burden for all forms.
In addition, the recordkeeping
requirements ask each respondent to
this collection maintain a set of SOPs
which could help the company and
FDA in the future determine the
methodology the company employed in
its systems to ensure that the electronic
signatures for its employees on
documents submitted to the FDA were
valid, if needed. Over the years, FDA
developed this recordkeeping burden by
listening to feedback from its staff and
external stakeholders, and feels that the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
11,100 ..................................................................................
4,500
1
4,500
1
4,500
Total ..............................................................................
........................
........................
........................
........................
4,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
11.10 ....................................................................................
11.30 ....................................................................................
11.50 ....................................................................................
11.300 ..................................................................................
2,500
2,500
4,500
4,500
1
1
1
1
2,500
2,500
4,500
4,500
20
20
20
20
50,000
50,000
90,000
90,000
Total ..............................................................................
........................
........................
........................
........................
280,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17155 Filed 7–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institutes of Health
New Proposed Collection; Comment
Request; Study Logistic Formative
Research Methodology Studies for the
National Children’s Study
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
SUMMARY:
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17:52 Jul 07, 2011
Jkt 223001
National Institute of Child Health and
Human Development (NIHCD), the
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. This proposed
information collection was previously
published in the Federal Register on
April 27, 2011, pages 23605–23606, and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
Proposed Collection
Title: Study Logistics Formative
Research Methodology Studies for the
National Children’s Study (NCS).
Type of Information Collection
Request: Generic Clearance.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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
E:\FR\FM\08JYN1.SGM
08JYN1
40380
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
(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.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of new
and existing study measures, participant
communication techniques, and
technologies being utilized, and thereby
inform data collection methodologies
for the National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain
OMB’s generic clearance to conduct
formative research relating to
instrument design and modality with a
view to reduce item and unit nonresponse to Study instruments while
preserving scientific quality.
The results from these formative
research projects will inform the
feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study instrument
design and modality in a manner that
minimizes public information collection
burden compared to burden anticipated
if these projects were incorporated
directly into either the NCS Vanguard or
Main Study.
Frequency of Response: Annual [As
needed on an on-going and concurrent
basis].
Affected Public: Members of the
public, researchers, practitioners, and
other health professionals.
Type of Respondents: Women of
child-bearing age, fathers, health care
facilities and professionals, public
health professional organizations and
practitioners, and schools and child care
organizations. These include both
persons enrolled in the NCS Vanguard
Study and their peers who are not
participating in the NCS Vanguard
Study.
Annual reporting burden: See Table 1.
The annualized cost to respondents is
estimated at: $300,000 (based on $10 per
hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, STUDY OPERATIONS
Estimated number
of respondents
Estimated number
of responses per
respondent
NCS participants ...................
4,000
2
1
8,000
Members of NCS target population (not NCS participants).
Health and Social Service
Providers.
Community Stakeholders .....
NCS participants ...................
Members of NCS target population (not NCS participants).
Health and Social Service
Providers.
Community Stakeholders .....
NCS participants ...................
Members of NCS target population (not NCS participants).
4,000
2
1
8,000
2,000
1
1
2,000
2,000
2,000
2,000
1
1
1
1
1
1
2,000
2,000
2,000
2,000
1
1
2,000
2,000
500
500
1
1
1
1
2
2
2,000
1,000
1,000
...............................................
21,000
..............................
..............................
30,000
Data collection activity
Type of respondent
Small, focused survey and
instrument design and administration.
Focus groups ........................
Cognitive interviews ..............
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Total ...............................
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
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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
PO 00000
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Average burden
hours per
response
Estimated total
annual burden
hours requested
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.
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Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
Dated: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development.
reactivity and mediate an immune
response that promotes robust tumor
cell elimination.
Advantages
[FR Doc. 2011–17201 Filed 7–7–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Breakthrough Immunotherapy for
Brain Cancer: Epidermal Growth
Factor Receptor Variant III Chimeric
Antigen Receptors
Description of Technology: Scientists
at the National Institutes of Health (NIH)
have developed chimeric antigen
receptors (CARs) with high affinity for
the epidermal growth factor receptor
variant III (EGFRvIII) to use as a
promising immunotherapy for
aggressive brain cancer (glioblastoma) as
well as several other malignancies.
CARs are hybrid proteins consisting of
the portion of an antibody that
recognizes a cancer antigen, in this case
human monoclonal antibody 139 which
recognizes EGFRvIII, fused to protein
signaling domains that serve to activate
the CAR-expressing cell. Human cells
that express CARs, most notably T cells,
can recognize specific tumor antigens in
an MHC-unrestricted manner with high
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• EGFRvIII CAR immunotherapy is a
breakthrough treatment for
glioblastomas, a cancer with no other
effective treatment option.
• EGFRvIII CARs can cross the bloodbrain barrier, are expected to target only
tumor cells, and thus, generate fewer
side effects than other brain cancer
treatment approaches.
• With the advent of Provenge®,
personalized immunotherapy is
becoming more widely accepted as a
viable cancer treatment option.
Applications
• Immunotherapeutics to treat and/or
prevent the recurrence of a variety of
cancers that overexpress human
EGFRvIII, primarily glioblastoma
multiforme (GBM). About half of GBM
tumor cells express the EGFRvIII
antigen. Other cancers that overexpress
EGFRvIII include breast, ovarian,
prostate, bladder, colorectal, non-small
cell lung carcinomas, and head and
neck squamous cell carcinomas.
• A personalized cancer treatment
strategy for patients whose tumor cells
express EGFRvIII whereby the patient’s
own T cells are isolated, engineered to
express the EGFRvIII specific CAR, and
re-infused into the patient to attack the
tumor.
EGFRvIII is a rare antigen in that is
highly expressed by tumor cells, but not
expressed by other cells in the body.
This cancer antigen is expressed on
nearly 50% of GBM tumor cells and also
in other tumor types, such as other
nervous system cancers and head and
neck cancers. There exist very few, if
any, effective treatments for GBM, so the
expected clinical benefit of an antiEGFRvIII CAR to patients is expected to
be a therapeutic breakthrough for
treatment of this cancer. These CARs are
expected to combine high affinity
recognition of EGFRvIII provided by the
antibody portion with the target cell
killing activity of cytotoxic T cells.
Infusion of these EGFRvIII-specific
CARs into patients could prove to be a
powerful new immunotherapeutic tool
for treating brain cancers, a type of
cancer with a long-felt need for
breakthrough therapeutics.
Development Status: This technology
could soon be ready for clinical
development. A clinical protocol to
utilize an EGFRvIII CAR to treat GBM is
currently under review at NIH.
Inventors: Richard A. Morgan and
Steven A. Rosenberg (NCI).
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40381
Patent Status: U.S. Provisional
Application No. 61/473,409 filed April
8, 2011 (HHS Reference No. E–148–
2011/0–US–01).
Related Technologies
• E–269–2010/0—U.S. Provisional
Application No. 61/384,931 filed
September 21, 2010.
• E–236–2010/0—U.S. Provisional
Application No. 61/405,931 filed
October 22, 2010.
• E–205–2009/0—PCT Application
No. PCT/US2010/048701 filed
September 14, 2010, which published as
WO2011/041093 on April 7, 2011.
Relevant Publications
1. Weber R, et al. U.S. Patent No.
7,628,986 issued December 8, 2009
entitled ‘‘Antibodies Directed to the
Deletion Mutants of Epidermal Growth
Factor Receptor and Uses Thereof’’.
2. Carter B.S., et al. U.S. Patent
Application No. 12/444,090 filed April
2, 2009 entitled ‘‘Chimeric T–Cell
Receptors and T–Cells Targeting
EGFRvIII on Tumors’’.
3. Bullian SS, et al. Genetically
engineered T cells to target EGFRvIII
expressing glioblastoma. J Neurooncol.
2009 Sept;94(3):373–382. [PMID:
19387557].
4. Ohno M, et al. Retrovirally
engineered T-cell based immunotherapy
targeting type III variant epidermal
growth factor receptor, a gliomaassociated antigen. Cancer Sci. 2010
Dec;101(12):2518–2524. [PMID:
20880333].
Licensing Status: Available for
licensing.
Licensing Contact: Samuel E. Bish,
PhD; 301–435–5282;
bishse@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute, Surgery
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize cell-based
immunotherapies targeting EGFRvIII
expressing cancers. Please contact John
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
An Improved Anti-Mesothelin
Immunotoxin for Treatment of
Mesothelioma, Lung Cancer, Ovarian
Cancer and Pancreatic Cancer
Description of Technology:
Mesothelin is a cell surface glycoprotein
that is highly expressed in many cancers
(e.g., malignant mesothelioma, lung
cancer, ovarian cancer, and pancreatic
cancer). Because of its differential
expression, mesothelin is an excellent
E:\FR\FM\08JYN1.SGM
08JYN1
]]>Agencies
[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40379-40381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17201]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request; Study Logistic
Formative Research Methodology Studies 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 (NIHCD), the 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. This proposed information collection was previously published
in the Federal Register on April 27, 2011, pages 23605-23606, and
allowed 60 days for public comment. No comments were received. The
purpose of this notice is to allow an additional 30 days for public
comment.
Proposed Collection
Title: Study Logistics Formative Research Methodology Studies for
the National Children's Study (NCS).
Type of Information Collection Request: Generic Clearance.
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
[[Page 40380]]
(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
results of formative research will be used to maximize the efficiency
(measured by scientific robustness, participant and infrastructure
burden, and cost) of new and existing study measures, participant
communication techniques, and technologies being utilized, and thereby
inform data collection methodologies for the National Children's Study
(NCS) Vanguard and Main Studies. With this submission, the NCS seeks to
obtain OMB's generic clearance to conduct formative research relating
to instrument design and modality with a view to reduce item and unit
non-response to Study instruments while preserving scientific quality.
The results from these formative research projects will inform the
feasibility (scientific robustness), acceptability (burden to
participants and study logistics) and cost of NCS Vanguard and Main
Study instrument design and modality in a manner that minimizes public
information collection burden compared to burden anticipated if these
projects were incorporated directly into either the NCS Vanguard or
Main Study.
Frequency of Response: Annual [As needed on an on-going and
concurrent basis].
Affected Public: Members of the public, researchers, practitioners,
and other health professionals.
Type of Respondents: Women of child-bearing age, fathers, health
care facilities and professionals, public health professional
organizations and practitioners, and schools and child care
organizations. These include both persons enrolled in the NCS Vanguard
Study and their peers who are not participating in the NCS Vanguard
Study.
Annual reporting burden: See Table 1. The annualized cost to
respondents is estimated at: $300,000 (based on $10 per hour). There
are no Capital Costs to report. There are no Operating or Maintenance
Costs to report.
Table 1--Estimated Annual Reporting Burden Summary, Study Operations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated number Average burden Estimated total
Data collection activity Type of respondent Estimated number of responses per hours per annual burden
of respondents respondent response hours requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small, focused survey and instrument design NCS participants.............. 4,000 2 1 8,000
and administration.
Members of NCS target 4,000 2 1 8,000
population (not NCS
participants).
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders........ 2,000 1 1 2,000
Focus groups................................ NCS participants.............. 2,000 1 1 2,000
Members of NCS target 2,000 1 1 2,000
population (not NCS
participants).
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders........ 2,000 1 1 2,000
Cognitive interviews........................ NCS participants.............. 500 1 2 1,000
Members of NCS target 500 1 2 1,000
population (not NCS
participants).
-----------------------------------------------------------------------------------------------------------
Total................................... .............................. 21,000 ................. ................. 30,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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.
[[Page 40381]]
Dated: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2011-17201 Filed 7-7-11; 8:45 am]
BILLING CODE 4140-01-P
