Agency Information Collection Activities; Proposed Collection; Comment Request; Followup Study for Infant Feeding Practices Study II, 11251-11252 [2011-4459]
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Federal Register / Vol. 76, No. 40 / Tuesday, March 1, 2011 / Notices
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–4418 Filed 2–28–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0099]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Followup Study for
Infant Feeding Practices Study II
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a study entitled ‘‘Followup Study for
Infant Feeding Practices Study II.’’
DATES: Submit either electronic or
written comments on the collection of
information by May 2, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:42 Feb 28, 2011
Jkt 223001
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Followup Study for Infant Feeding
Practices Study II (OMB Control
Number 0910–NEW)
I. Background
FDA is planning to conduct a survey
of the mothers who participated in the
Infant Feeding Practices Study II (IFPS
II) (Ref. 1). The IFPS II sample was
drawn from a commercial consumer
opinion panel, and so participants are
expected to be easier to re-contact than
would be the case for a random sample
of the population. Some participants
will still be panel members. The
purpose of the study is to enhance
FDA’s understanding of the associations
between infant feeding practices and
diet quality, food allergy, overweight
and obesity, and other health and
development outcomes in young
children.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
11251
The study results will be used to help
the Agency to understand the possible
role of infant feeding practices in the
development and progression of food
allergy and childhood overweight and
obesity, in addition to resistance to
infection and other health and
development outcomes. The results of
the study will not be used to develop
population estimates.
The data will be collected by a mailed
questionnaire from most respondents
and by telephone from those who do not
respond to the mailed questionnaire.
The study will focus on the following
types of information: The child’s
consumption of various food groups; the
child’s other consumption practices
(such as how often the child eats dinner
with a parent and how often the child
eats from fast food restaurants); the
mother’s control over the child’s eating
patterns; the child’s physical activity
and time spent watching a screen (TV or
computer); the child’s sleep patterns;
extent of the child’s cognitive
stimulation at home; the child’s height,
weight, and waist circumference; the
child’s visits to a dentist and number of
cavities; number of the child’s recent
physician visits; number of various
types of infections the child had in the
past year; whether the child has various
health conditions including digestive
problems, eczema, food allergy,
respiratory allergy, attention deficit
disorder, developmental delay, anxiety
problems, depression, or asthma; the
child’s social development; the child’s
family medical history; the mother’s
height and weight, physical activity,
depression, pregnancies subsequent to
the sample child and whether
subsequent children were breastfed, and
employment conditions; the mother or
child’s participation in certain
government programs; and the child’s
potential exposure to certain
environmental contaminants including
cigarette smoke and pesticides. A
demographic questionnaire will also be
mailed to respondents for whom current
information is not available through the
consumer opinion panel. Participation
in the study is voluntary.
To refine the questionnaire used in
the study, a pretest will be conducted
with 100 participants, 91 by mailed
questionnaire and 9 by telephone
interview. We estimate that it will take
a respondent 20 minutes (0.33 hours) to
complete the survey and 5 minutes (0.08
hours) to complete debriefing questions
for the pretest, for a total of 25 minutes
(0.42 hours) per respondent and a total
of 38 hours for the mailed and 4 hours
for the interview pretest. The sample for
the pretest will be panel members who
are mothers of children 5 to 7 years old
E:\FR\FM\01MRN1.SGM
01MRN1
11252
Federal Register / Vol. 76, No. 40 / Tuesday, March 1, 2011 / Notices
who did not participate in the IFPS II.
All IFPS II participants who completed
at least two surveys after their infants
were born and for whom current contact
information can be found will be sent
the mailed questionnaire. This is
expected to be about 2,562 participants.
We estimate that 1,538 respondents will
return it and that it will take a
respondent 20 minutes (0.33 hours) to
complete the questionnaire, for a total of
513 hours. An additional 522 mothers
are expected to complete the telephone
interview of 20 minutes (0.33 hours) for
a total of 174 hours. An estimated 1,380
participants will return the
demographic questionnaire, which will
require 5 minutes (0.08 hours) to
complete for a total of 110 hours. Thus,
the total estimated burden is 839 hours.
FDA’s burden estimate is based on prior
experience with consumer surveys that
are similar to this proposed data
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
Portion of study
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
Pretest mailed questionnaire ...............................................
Pretest telephone interview .................................................
Main study mailed questionnaire .........................................
Main study telephone interview ...........................................
Demographic questionnaire .................................................
91
9
1,538
522
1,380
1
1
1
1
1
91
9
1,538
522
1,380
0.42
0.42
0.33
0.33
0.08
38
4
513
174
110
Total ..............................................................................
........................
........................
........................
........................
839
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Fein, Sara B., Judith Labiner-Wolfe,
Katherine Shealy, et al., ‘‘Infant Feeding
Practices Study II: Study Methods,’’
Pediatrics 2008; 122(suppl 2): S28–S35.
Dated: February 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–4459 Filed 2–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on DSKJ8SOYB1PROD with NOTICES
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 USC,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
VerDate Mar<15>2010
18:42 Feb 28, 2011
Jkt 223001
Name of Committee: National Institute on
Drug Abuse Initial Review Group; Training
and Career Development Subcommittee.
Date: March 9–10, 2011.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel at Pentagon City,
1250 South Hayes Street, Arlington, VA
22202.
Contact Person: Eliane Lazar-Wesley,
Ph.D., Health Scientist Administrator, Office
of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 4245, MSC
9550, 6001 Executive Blvd., Bethesda, MD
20892–9550, 301–451–4530, el6r@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; NIDA–
K Conflicts.
Date: March 9, 2011.
Time: 5 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel at Pentagon City,
1250 South Hayes Street, Arlington, VA
22202.
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 4238, MSC
9550, 6001 Executive Blvd., Bethesda, MD
20892–9550, 301–402–6626,
gml45a@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Pharmacological Development of Treatment
Agents and Formulations or Tobacco
Dependence.
Date: March 18, 2011.
Time: 1 p.m. to 5 p.m.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Jose F. Ruiz, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, Room 4228, MSC 9550,
6001 Executive Blvd., Bethesda, MD 20892–
9550, (301) 451–3086, ruizjf@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; High
Throughput Screening for Nicotinic Receptor
Subunits.
Date: March 24, 2011.
Time: 2:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 4238, MSC
9550, 6001 Executive Blvd., Bethesda, MD
20892–9550, 301–402–6626,
gm145a@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Training in Computational Neuroscience
(T90/R90).
Date: March 30, 2011.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Minna Liang, Ph.D.,
Scientific Review Officer, Grants Review
Branch, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH, Room
4226, MSC 9550, 6001 Executive Blvd.,
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Notices]
[Pages 11251-11252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4459]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0099]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Followup Study for Infant Feeding Practices Study II
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a study entitled ``Followup Study for
Infant Feeding Practices Study II.''
DATES: Submit either electronic or written comments on the collection
of information by May 2, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA'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 respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Followup Study for Infant Feeding Practices Study II (OMB Control
Number 0910-NEW)
I. Background
FDA is planning to conduct a survey of the mothers who participated
in the Infant Feeding Practices Study II (IFPS II) (Ref. 1). The IFPS
II sample was drawn from a commercial consumer opinion panel, and so
participants are expected to be easier to re-contact than would be the
case for a random sample of the population. Some participants will
still be panel members. The purpose of the study is to enhance FDA's
understanding of the associations between infant feeding practices and
diet quality, food allergy, overweight and obesity, and other health
and development outcomes in young children.
The study results will be used to help the Agency to understand the
possible role of infant feeding practices in the development and
progression of food allergy and childhood overweight and obesity, in
addition to resistance to infection and other health and development
outcomes. The results of the study will not be used to develop
population estimates.
The data will be collected by a mailed questionnaire from most
respondents and by telephone from those who do not respond to the
mailed questionnaire. The study will focus on the following types of
information: The child's consumption of various food groups; the
child's other consumption practices (such as how often the child eats
dinner with a parent and how often the child eats from fast food
restaurants); the mother's control over the child's eating patterns;
the child's physical activity and time spent watching a screen (TV or
computer); the child's sleep patterns; extent of the child's cognitive
stimulation at home; the child's height, weight, and waist
circumference; the child's visits to a dentist and number of cavities;
number of the child's recent physician visits; number of various types
of infections the child had in the past year; whether the child has
various health conditions including digestive problems, eczema, food
allergy, respiratory allergy, attention deficit disorder, developmental
delay, anxiety problems, depression, or asthma; the child's social
development; the child's family medical history; the mother's height
and weight, physical activity, depression, pregnancies subsequent to
the sample child and whether subsequent children were breastfed, and
employment conditions; the mother or child's participation in certain
government programs; and the child's potential exposure to certain
environmental contaminants including cigarette smoke and pesticides. A
demographic questionnaire will also be mailed to respondents for whom
current information is not available through the consumer opinion
panel. Participation in the study is voluntary.
To refine the questionnaire used in the study, a pretest will be
conducted with 100 participants, 91 by mailed questionnaire and 9 by
telephone interview. We estimate that it will take a respondent 20
minutes (0.33 hours) to complete the survey and 5 minutes (0.08 hours)
to complete debriefing questions for the pretest, for a total of 25
minutes (0.42 hours) per respondent and a total of 38 hours for the
mailed and 4 hours for the interview pretest. The sample for the
pretest will be panel members who are mothers of children 5 to 7 years
old
[[Page 11252]]
who did not participate in the IFPS II. All IFPS II participants who
completed at least two surveys after their infants were born and for
whom current contact information can be found will be sent the mailed
questionnaire. This is expected to be about 2,562 participants. We
estimate that 1,538 respondents will return it and that it will take a
respondent 20 minutes (0.33 hours) to complete the questionnaire, for a
total of 513 hours. An additional 522 mothers are expected to complete
the telephone interview of 20 minutes (0.33 hours) for a total of 174
hours. An estimated 1,380 participants will return the demographic
questionnaire, which will require 5 minutes (0.08 hours) to complete
for a total of 110 hours. Thus, the total estimated burden is 839
hours. FDA's burden estimate is based on prior experience with consumer
surveys that are similar to this proposed data collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Portion of study No. of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Pretest mailed questionnaire.... 91 1 91 0.42 38
Pretest telephone interview..... 9 1 9 0.42 4
Main study mailed questionnaire. 1,538 1 1,538 0.33 513
Main study telephone interview.. 522 1 522 0.33 174
Demographic questionnaire....... 1,380 1 1,380 0.08 110
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 839
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Fein, Sara B., Judith Labiner-Wolfe, Katherine Shealy, et al.,
``Infant Feeding Practices Study II: Study Methods,'' Pediatrics 2008;
122(suppl 2): S28-S35.
Dated: February 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4459 Filed 2-28-11; 8:45 am]
BILLING CODE 4160-01-P
