Agency Information Collection Activities; Proposed Collection; Comment Request; Followup Study for Infant Feeding Practices Study II, 11251-11252 [2011-4459]

Download as PDF 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]


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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
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