National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Formative Research and Pilot Studies for the National Children's Study, 65047-65048 [E7-22592]
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Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
rwilkins on PROD1PC63 with NOTICES
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for FDA advisory
committee members and FDA staff
entitled, ‘‘Voting Procedures for
Advisory Committee Meetings,’’ dated
November 2007.
FDA’s advisory committees provide
independent, expert advice to the
agency on a range of complex scientific,
technical, and policy issues, including
questions related to the development
and evaluation of products regulated by
FDA. Advisory committees are a
valuable resource to FDA, and they
make an important contribution to the
agency’s decision-making processes.
Although advisory committees provide
recommendations to FDA, FDA makes
the final decisions.
Advisory committees typically
communicate advice or
recommendations to the agency in two
ways. First, committee members
routinely share their individual
thoughts and recommendations during
the discussion of a particular matter at
an advisory committee meeting. Second,
advisory committees often vote on a
question or series of questions posed to
the committee during a committee
meeting.
Votes can be an effective means of
communicating with FDA because they
provide feedback on discrete questions.
These questions are generally scientific
in nature and can involve a range of
subjects, including evaluation of postmarket safety data or pre-market
assessment of a product’s risk/benefit
profile. Since all members vote on the
same question, the results help FDA
gauge a committee’s collective view on
complex, multi-faceted issues. This
view helps inform the agency’s own
deliberations on scientific and
regulatory matters.
This draft guidance recommends
adopting uniform voting procedures to
help maximize the integrity and
meaning of voting results. In developing
these recommendations, FDA is mindful
of the legal requirements of the Federal
Advisory Committee Act, other relevant
statutes (e.g., the Federal Food, Drug,
and Cosmetic Act), regulations (e.g., 21
CFR Part 14) , guidance, and policies,
and the goals of FDA’s of advisory
committee program.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance represents the
agency’s current thinking on
recommended uniform procedures that
can be used for the voting process when
votes are taken during advisory
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20:17 Nov 16, 2007
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committee meetings. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
Dated: November 14, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07–5751 Filed 11–15–07; 9:06 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Proposed
Collection; Comment Request;
Formative Research and Pilot 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 (NICHD), 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.
Proposed Collection: Title: Formative
Research and Pilot Studies for the
National Children’s Study. Type of
Information Collection Request: NEW.
PO 00000
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65047
Need and use of information collection:
The NICHD seeks to obtain OMB’s
generic approval to conduct pilot and
formative research to be used in the
development of instruments, materials,
and procedures for the National
Children’s Study (NCS). The NCS is a
long-term cohort study of environmental
influences on child health and
development authorized under the
Children’s Health Act of 2000. The Act
specifies a broad definition of
environment, including biologic,
chemical, physical, and psycho-social
factors and authorizes the NICHD to
plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of
those exposures on child health and
human development. Further details
pertaining to the NCS background and
planning, including the NCS Research
Plan, can be found at: https://
nationalchildrensstudy.gov. The
proposed data collection program will
include community outreach materials,
medical provider and participant
materials, questionnaires and measures,
use of technology such as Interactive
Voice Recognition (IVR), and other
aspects related to data collection.
Activities will include small focused
studies to test data collection items and
methods on a specific or targeted
population, validation of questionnaires
for targeted populations, focus groups
within the NCS communities to test
forms and procedures, cognitive
interviews to test data items, and the
use of materials on targeted populations
such as medical providers and
hospitals, and materials translated into
other languages. These activities will be
conducted over the life of the study to
develop procedures and materials for
each stage of data collection. The results
of these pilot tests will be used to
maximize the efficiency of study
procedures, materials, and methods for
community outreach, engagement of the
medical community, for recruiting and
retaining study subjects prospectively
across study visits and to ensure that
data collection methodologies are
efficient and valid for all potential
participants. Without this information,
NCS will be hampered in its efforts to
effectively publicize the NCS, gain
public and professional support, and
effectively recruit and retain
respondents and collect data over the
life of the Study. Affected entities:
Individuals. Types of respondents:
People potentially affected by this
action are pregnant women or women of
childbearing age, their husbands or
partners, health care professionals, and
community leaders. The annual
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65048
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
reporting burden is as follows:
Estimated Number of Respondents:
3,150. Frequency of Response: On
occasion (see Burden table). The
Estimated Number of Responses per
Respondent: 1. Average Burden Hours
Per Response: Varies with study type.
Estimated Total Annual Burden Hours
Requested: 5,825. The estimated
annualized cost to respondents is
Estimated
number of
respondents
Type of respondents
(estimated hourly rate)
$114,250 (based on rates listed in the
burden table). There are no Capital
Costs to report. There are no Operating
or Maintenance Costs to report.
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
Small focused studies ($10) ............................................................................
Focus groups with potential participants ($10) ................................................
Focus groups with health care professionals ($50) ........................................
Focus groups with community leaders ($10) ..................................................
Medical provider feedback on materials through informal in-person contacts
($50) .............................................................................................................
Cognitive interviews ($10) ...............................................................................
1,250
350
350
350
1
1
1
1
1.5
3.0
3.0
3.0
1,875
1,050
1,050
1,050
700
150
1
1
0.5
3.0
350
450
Total ..........................................................................................................
3,150
........................
........................
5,825
Requests 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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Ruth A. Brenner,
MD, MPH, National Institute of Child
Health and Human Development,
Building 6100, 5C01, 6100 Executive
Blvd, Bethesda, Maryland 20892, or call
non-toll free number (301) 594–9147, or
e-mail your request, including your
address to ncsinfo@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.
rwilkins on PROD1PC63 with NOTICES
FOR FURTHER INFORMATION CONTACT:
Paul Johnson,
NICHD Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E7–22592 Filed 11–16–07; 8:45 am]
BILLING CODE 4140–01–P
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Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Division of
Extramural Research and Training;
Submission for OMB Review;
Comment Request; Program
Assessment and Evaluations for
NIEHS—Asthma Research
Summary: Under the provision of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Environmental Health
Sciences (NIEHS), 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 May 9, 2007,
page 26399 and allowed 60 days for
public comment. No public 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: Program
Assessment and Evaluations for
NIEHS—Asthma Research. Type of
Information Collection Request: NEW.
New and Use of Information Collection:
National Institute of Environmental
Health Sciences, Division of Extramural
Research and Training (DERT). DERT,
with contract support from Battelle
Centers for Public Health Research and
Evaluation, is examining the impact of
PO 00000
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its research portfolio. Focusing
specifically on one portion of the
research portfolio—asthma research—
DERT proposes to supplement extant
data sources with a primary data
collection activity. The purpose of the
proposed primary data collection is to
obtain information from grantees
regarding the impact of their funded
asthma research in the short-,
intermediate-, and long-term. This will
be done through a survey of grantees
that includes questions about the impact
of funding on career development, the
field of asthma research, public
attitudes, commercial product
development, clinical practice, business
and industry practices, and long-term
human and environmental health.
Frequency of Response: One time.
Affected Public: Individuals. Type of
Respondents: Individuals receiving
asthma funding. A 15-minute, closeended, multi-mode (web and paper)
survey will be administered to the
universe of NIEHS-funded asthma
researchers (N=179) and comparison
agency asthma researchers (N=1371).
Comparison agencies include other NIH
institutes (NICHD, NIAID, NIA, NHLBI),
the CDC, AHRQ, and the EPA. The
survey development process included
formative interviews with a small
sample of NIEHS asthma researchers.
The annual reporting burden is as
follows: Estimated Number of
Respondents: 1550; Estimated Number
of Responses per Respondent: 1;
Average Burden Hours per Response: 15
minutes; and Estimated Total Annual
Burden Hours Requested: 387.5. The
annualized cost to respondents is
estimated at $13,039.38. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
E:\FR\FM\19NON1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65047-65048]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22592]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development;
Proposed Collection; Comment Request; Formative Research and Pilot
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 (NICHD), 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.
Proposed Collection: Title: Formative Research and Pilot Studies
for the National Children's Study. Type of Information Collection
Request: NEW. Need and use of information collection: The NICHD seeks
to obtain OMB's generic approval to conduct pilot and formative
research to be used in the development of instruments, materials, and
procedures for the National Children's Study (NCS). The NCS is a long-
term cohort study of environmental influences on child health and
development authorized under the Children's Health Act of 2000. The Act
specifies a broad definition of environment, including biologic,
chemical, physical, and psycho-social factors and authorizes the NICHD
to plan, develop, and implement a prospective cohort study, from birth
to adulthood, to evaluate the effects of those exposures on child
health and human development. Further details pertaining to the NCS
background and planning, including the NCS Research Plan, can be found
at: https://nationalchildrensstudy.gov. The proposed data collection
program will include community outreach materials, medical provider and
participant materials, questionnaires and measures, use of technology
such as Interactive Voice Recognition (IVR), and other aspects related
to data collection. Activities will include small focused studies to
test data collection items and methods on a specific or targeted
population, validation of questionnaires for targeted populations,
focus groups within the NCS communities to test forms and procedures,
cognitive interviews to test data items, and the use of materials on
targeted populations such as medical providers and hospitals, and
materials translated into other languages. These activities will be
conducted over the life of the study to develop procedures and
materials for each stage of data collection. The results of these pilot
tests will be used to maximize the efficiency of study procedures,
materials, and methods for community outreach, engagement of the
medical community, for recruiting and retaining study subjects
prospectively across study visits and to ensure that data collection
methodologies are efficient and valid for all potential participants.
Without this information, NCS will be hampered in its efforts to
effectively publicize the NCS, gain public and professional support,
and effectively recruit and retain respondents and collect data over
the life of the Study. Affected entities: Individuals. Types of
respondents: People potentially affected by this action are pregnant
women or women of childbearing age, their husbands or partners, health
care professionals, and community leaders. The annual
[[Page 65048]]
reporting burden is as follows: Estimated Number of Respondents: 3,150.
Frequency of Response: On occasion (see Burden table). The Estimated
Number of Responses per Respondent: 1. Average Burden Hours Per
Response: Varies with study type. Estimated Total Annual Burden Hours
Requested: 5,825. The estimated annualized cost to respondents is
$114,250 (based on rates listed in the burden table). There are no
Capital Costs to report. There are no Operating or Maintenance Costs to
report.
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average Estimated
Type of respondents (estimated hourly rate) number of responses per burden hours total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Small focused studies ($10)..................... 1,250 1 1.5 1,875
Focus groups with potential participants ($10).. 350 1 3.0 1,050
Focus groups with health care professionals 350 1 3.0 1,050
($50)..........................................
Focus groups with community leaders ($10)....... 350 1 3.0 1,050
Medical provider feedback on materials through 700 1 0.5 350
informal in-person contacts ($50)..............
Cognitive interviews ($10)...................... 150 1 3.0 450
---------------------------------------------------------------
Total....................................... 3,150 .............. .............. 5,825
----------------------------------------------------------------------------------------------------------------
Requests 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: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Ruth A. Brenner, MD, MPH, National Institute of
Child Health and Human Development, Building 6100, 5C01, 6100 Executive
Blvd, Bethesda, Maryland 20892, or call non-toll free number (301) 594-
9147, or e-mail your request, including your address to
ncsinfo@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.
Paul Johnson,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-22592 Filed 11-16-07; 8:45 am]
BILLING CODE 4140-01-P
