Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Followup Study for Infant Feeding Practices Study II, 41501-41502 [2011-17676]

Download as PDF Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Intent To Award Affordable Care Act (ACA) Funding, EH09–907 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: This notice provides public announcement of CDC’s intent to award Affordable Care Act (ACA) appropriations to the following 7 grantees: Colorado, Iowa, Kansas, Louisiana, Minnesota, South Carolina, and Vermont to develop and implement their Tracking Networks. These activities are proposed by the abovementioned grantees in their FY 2011 applications submitted under funding opportunity EH09–907, ‘‘National Environmental Public Health Tracking Program—Network Implementation (EPHT),’’ Catalogue of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $4,920,000 in ACA funding will be awarded to the grantees for network expansion and enhancement. Funding is appropriated under the Affordable Care Act (Pub. L. 111–148), Section 4002 [42 U.S.C. 300u–11]; (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH09–907: —Authority: Sections 311 and 317(k)(2) of the Public Health Service Act, [42 U.S.C. Sections 243 and 247b(k)(2)] as amended, and the Patient Protection and Affordable Care Act (ACA), Section 4002 [42 U.S.C. 300u–11]. —CFDA #: 93.538 Affordable Care Act— National Environmental Public Health Tracking Program—Network Implementation. wreier-aviles on DSKGBLS3C1PROD with NOTICES SUMMARY: Award Information: Type of Award: Non-Competing Continuation Cooperative Agreement. Approximate Total Current Fiscal Year ACA Funding: $4,920,000. Anticipated Number of Awards: 7. Fiscal Year Funds: 2011. Anticipated Award Date: August 1, 2011. Application Selection Process: Funding will be awarded to applicants based on results from successful past performance review. Funding Authority: CDC will add the ACA Authority to that which is reflected in the published Funding Opportunity CDC–RFA–EH09– VerDate Mar<15>2010 14:55 Jul 13, 2011 Jkt 223001 907. The revised funding authority language will read: —This program is authorized under Sections 311 and 317(k)(2) of the Public Health Service Act, [42 U.S.C. Sections 243 and 247b(k)(2)], as amended, and the Patient Protection and Affordable Care Act (ACA), Section 4002 [42 U.S.C. 300u–11]. DATES: The effective date for this action is the date of publication of this Notice and remains in effect until the expiration of the project period of the ACA funded applications. FOR FURTHER INFORMATION CONTACT: Elmira Benson, Acting Deputy Director, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341, telephone (770) 488–2802, e-mail Elmira.Benson@cdc.gov. SUPPLEMENTARY INFORMATION: On March 23, 2010, the President signed into law the Affordable Care Act (ACA), Public Law 111–148. The ACA is designed to improve and expand the scope of health care coverage for Americans. Cost savings through disease prevention is an important element of this legislation and the ACA has established a Prevention and Public Health Fund (PPHF) for this purpose. Specifically, the legislation states in Section 4002 that the PPHF is to ‘‘provide for expanded and sustained national investment in prevention and public health programs to improve health and help restrain the rate of growth in private and public sector health care costs.’’ The ACA and the Prevention and Public Health Fund make improving public health a priority with investments to improve public health. The PPHF states that the Secretary shall transfer amounts in the Fund to accounts within the Department of Health and Human Services to increase funding, over the fiscal year 2008 level, for programs authorized by the Public Health Service Act, for prevention, wellness and public health activities including prevention research and health screenings, such as the Community Transformation Grant Program, the Education and Outreach Campaign for Preventative Benefits, and Immunization Programs. The ACA legislation affords an important opportunity to advance public health across the lifespan and to improve public health by supporting the Tracking Network. This network builds on ongoing efforts within the public health and environmental sectors to improve health tracking, hazard monitoring and response capacity. Therefore, increasing funding available to applicants under this FOA using the PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 41501 PPHF will allow them to expand and sustain their existing tracking networks, utilize tracking data available on networks for potential public health assessments which is consistent with the purpose of the PPHF, as stated above, and to provide for an expanded and sustained national investment in prevention and public health programs. Further, the Secretary allocated funds to CDC, pursuant to the PPHF, for the types of activities this FOA is designed to carry out. Dated: June 30, 2011. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2011–17661 Filed 7–13–11; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0099] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by August 15, 2011. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–New and title ‘‘Followup Study for Infant Feeding Practices Study II.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUMMARY: E:\FR\FM\14JYN1.SGM 14JYN1 41502 Federal Register / Vol. 76, No. 135 / Thursday, July 14, 2011 / Notices In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 he or she 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 and weight; 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’s or child’s participation in certain government programs; and the child’s potential exposure to certain environmental contaminants including cigarette smoke and pesticides. Although all sample members were consumer opinion panel members when the IFPS II was conducted, many will no longer participate on the panel. Therefore, a demographic questionnaire will be mailed to respondents who are no longer a panel member to update current demographic information. Participation in the study is voluntary. In the Federal Register of March 1, 2011 (76 FR 11251), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Portion of study Total annual responses Pilot study mailed questionnaire .............................. Pilot study 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 Total .................................................................. ........................ ........................ ........................ wreier-aviles on DSKGBLS3C1PROD with NOTICES 1 There Average burden per response 0.42 0.42 0.33 0.33 0.08 Total hours (25 minutes) ...... (25 minutes) ...... (20 minutes) ...... (20 minutes) ...... (5 minutes) ........ 38 4 508 172 110 .................................... 832 are no capital costs or operating and maintenance costs associated with this collection of information. To refine the questionnaire used in the study, a pilot study will be conducted with 100 participants, 91 by mailed questionnaire and 9 by telephone interview. We estimate that it will take a respondent 25 minutes (0.42 hours) to complete the survey and debriefing questions by either method for a total of 38 hours for the mailed and 4 hours for the interview pretest. The sample for the pilot study will be panel members who are mothers of 6-year-old children and 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 VerDate Mar<15>2010 14:55 Jul 13, 2011 Jkt 223001 that 1,538 respondents will return it and that it will take an average of 20 minutes (0.33 hours) to complete the questionnaire, for a total of 508 hours. An additional 522 mothers are expected to complete the telephone interview of 20 minutes (0.33 hours) for a total of 172 hours. Sample members who are no longer a panel member will be asked to complete a questionnaire to update their demographic information. 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 832 hours. FDA’s burden estimate is based on prior experience with consumer surveys that are similar to this proposed data collection. PO 00000 Frm 00055 Fmt 4703 Sfmt 9990 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: July 7, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–17676 Filed 7–13–11; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\14JYN1.SGM 14JYN1

Agencies

[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41501-41502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17676]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0099]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
15, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Followup Study for Infant Feeding Practices Study II.'' Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

[[Page 41502]]


SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 he or she 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 and weight; 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's or child's participation in certain government 
programs; and the child's potential exposure to certain environmental 
contaminants including cigarette smoke and pesticides. Although all 
sample members were consumer opinion panel members when the IFPS II was 
conducted, many will no longer participate on the panel. Therefore, a 
demographic questionnaire will be mailed to respondents who are no 
longer a panel member to update current demographic information. 
Participation in the study is voluntary.
    In the Federal Register of March 1, 2011 (76 FR 11251), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              Portion of study                   Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study mailed questionnaire............              91               1              91  0.42 (25 minutes).........................              38
Pilot study telephone interview.............               9               1               9  0.42 (25 minutes).........................               4
Main study mailed questionnaire.............           1,538               1           1,538  0.33 (20 minutes).........................             508
Main study telephone interview..............             522               1             522  0.33 (20 minutes).........................             172
Demographic questionnaire...................           1,380               1           1,380  0.08 (5 minutes)..........................             110
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             832
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    To refine the questionnaire used in the study, a pilot study will 
be conducted with 100 participants, 91 by mailed questionnaire and 9 by 
telephone interview. We estimate that it will take a respondent 25 
minutes (0.42 hours) to complete the survey and debriefing questions by 
either method for a total of 38 hours for the mailed and 4 hours for 
the interview pretest. The sample for the pilot study will be panel 
members who are mothers of 6-year-old children and 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 an average of 20 minutes (0.33 hours) 
to complete the questionnaire, for a total of 508 hours. An additional 
522 mothers are expected to complete the telephone interview of 20 
minutes (0.33 hours) for a total of 172 hours. Sample members who are 
no longer a panel member will be asked to complete a questionnaire to 
update their demographic information. 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 832 hours. FDA's burden estimate is based on prior 
experience with consumer surveys that are similar to this proposed data 
collection.

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: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17676 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P
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