Proposed Data Collections Submitted for Public Comment and Recommendations, 26404-26406 [E9-12746]

Download as PDF 26404 Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices FEDERAL RESERVE SYSTEM Sunshine Act Meeting AGENCY HOLDING THE MEETING: Board of Governors of the Federal Reserve System. TIME AND DATE: 11:30 a.m., Monday, June 8, 2009. PLACE: Marriner S. Eccles Federal Reserve Board Building, 20th and C Streets, N.W., Washington, D.C. 20551. STATUS: Closed. MATTERS TO BE CONSIDERED: 1. Personnel actions (appointments, promotions, assignments, reassignments, and salary actions) involving individual Federal Reserve System employees. 2. Any items carried forward from a previously announced meeting. FOR FURTHER INFORMATION CONTACT: Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202–452–2955. SUPPLEMENTARY INFORMATION: You may call 202–452–3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board’s Web site at https:// www.federalreserve.gov for an electronic announcement that not only lists applications, but also indicates procedural and other information about the meeting. Board of Governors of the Federal Reserve System, May 29, 2009. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E9–12940 Filed 5–29–09; 4:15 am] BILLING CODE 6210–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Performance Measurement Online Tool (PMOTOOL). OMB No.: New Collection. Description: The Performance Measurement On-line Tool was designed by the Children’s Bureau to collect data, in an automated format, from specified discretionary grants funded by the Children’s Bureau. The data collected by this instrument will be submitted by individual discretionary grantees funded under the following programs: Abandoned Infants Assistance Program, Infant Adoption Awareness Training Program, Adoption Opportunities Program, Child Abuse and Neglect Program and the Child Welfare Training Program. Grantees will submit this information on a semiannual basis in conjunction with their semi-annual program progress report. The purpose of this data collection is to assist the Children’s Bureau in responding to the Program Assessment Rating Tool (PART), an OMB-mandated reporting system that focuses on quantifiable outcome measures, directly related to the expected social impact or public benefit of each federal program. The Children’s Bureau will use the aggregated data collected under each federal program. These measurable outcomes will serve as evidence that the federally funded programs are making progress toward achieving broad, legislated program goals. Respondents: All competitive discretionary grant programs funded by the Children’s Bureau. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response 36 2 1 72 6 55 32 55 2 2 2 2 1 1 1 1 12 110 64 110 Performance Measurement On-line Tool/Abandoned Infants Assistance Program ............................................................................................................. Performance Measurement On-line Tool/Infant Adoption Awareness Program ............................................................................................................. Performance Measurement On-Line/Adoption Opportunities Program ........... Performance Measurement Online Tool/Child Abuse and Neglect Program Performance Measurement On Line Tool/Child Welfare Training Program ... Estimated Total Annual Burden Hours: 368 In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. VerDate Nov<24>2008 16:43 Jun 01, 2009 Jkt 217001 The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Total burden hours Dated: May 27, 2009. Janean Chambers, Reports Clearance Officer. [FR Doc. E9–12670 Filed 6–1–09; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-09–0920–09BQ] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for E:\FR\FM\02JNN1.SGM 02JNN1 26405 Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Examining In-vehicle Exposures to Air Pollutants and Corresponding Health Outcomes of Commuters— New—National Center for Environmental Health, (NCEH) and Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention, (CDC). with severe asthma, ever suffering a myocardial infarction, smoking tobacco products, or ever being diagnosed with a pulmonary disease such as emphysema, COPD, or any type of lung cancer. Approximately one week prior to their scheduled commute, participants will complete a one-time baseline questionnaire to assess medical history and general exposures. Additionally, a short symptom diary recording any respiratory symptoms will be completed by the participant each day for the seven days prior to the commute and on the day of the commute. On the day of the planned commute, health measurements for lung function, lung inflammatory markers, heart rate, and biomarkers of systemic inflammation will also be conducted by a trained field technician. In-vehicle exposures to particulate matter and other air pollutants will then be measured for all participants during their commute. After the commute, the symptom diary and health measurements will be conducted again to assess any potential changes in respiratory and cardiovascular health effects. The information learned from the health measurements and diary entries before and after the commute will be important in better understanding the potential acute health impacts associated with exposures to invehicle traffic pollutants and respiratory and cardiovascular health, and whether urban commuters—especially those with asthma—should be viewed as a susceptible sub-population given their enhanced exposures to PM2.5 and gasphased pollutants. There is no cost to participants other than their time. Background and Brief Description Numerous studies have found associations between ambient fine particulate matter (PM2.5) and adverse cardiovascular outcomes. Several recent epidemiologic studies suggest that vehicle-related emissions, in particular, may be linked to many of the these adverse effects and that specific subpopulations may be more susceptible to health risks due to their enhanced exposures to vehicle-related PM2.5 sources. Commuters are a potentially susceptible, yet poorly characterized, sub-population. Importantly, recent epidemiologic studies indicate that specific sub-groups, including those with asthma, may be at risk to cardiorespiratory health effects due to their pre-existing health condition. A more complete understanding of invehicle exposures for the commuter population, especially those with asthma, is therefore becoming increasingly necessary as commuting durations and roadway congestion have steadily increased throughout the U.S. during the last 20 years. The National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC) will conduct this study to characterize in-vehicle exposures to traffic-related air pollutants among commuters, with and without asthma, and any health impacts that these exposures may have on the commuter. A total of 40 participants (20 adults with physician-diagnosed asthma and 20 healthy adults) living in the Atlanta metro area will be recruited for participation in this study. Participants will be excluded if they meet specific criteria including: ever being diagnosed ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Instrument type Respondents Baseline questionnaire ......................................... Eligible participants with and without asthma. Eligible participants with and without asthma. ....................................... Symptom diary ...................................................... Total ............................................................... VerDate Nov<24>2008 16:43 Jun 01, 2009 Jkt 217001 PO 00000 Frm 00045 Fmt 4703 Number of responses per respondent Average burden per response (in hours) Total burden (in hours) 40 1 30/60 20 40 8 5/60 27 ........................ ........................ ........................ 47 Sfmt 4703 E:\FR\FM\02JNN1.SGM 02JNN1 26406 Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices Dated: May 26, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–12746 Filed 6–1–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0221] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the act). DATES: Submit written or electronic comments on the collection of information by August 3, 2009. 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: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. 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, including each proposed extension of an existing 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. Food Labeling; Notification Procedures for Statements on Dietary Supplements—21 CFR 101.93 (OMB Control Number 0910–0331)—Extension Section 403(r)(6) of the act (21 U.S.C. 343(r)(6)) requires that the agency be notified by manufacturers, packers, and distributors of dietary supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in section 403(r)(6). Section 403(r)(6) of the act requires that the agency be notified, with a submission about such statements, no later than 30 days after the first marketing of the dietary supplement. Information that is required in the submission includes the following items: (1) The name and address of the manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is being made; (3) the name of the dietary ingredient or supplement that is the subject of the statement; (4) the name of the dietary supplement (including the brand name); and (5) a signature of a responsible individual who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading. The agency established § 101.93 (21 CFR 101.93) as the procedural regulation for this program. Section 101.93 provides details of the procedures associated with the submission and identifies the information that must be included in order to meet the requirements of section 403 of the act. Description of Respondents: Respondents to this collection of information include manufacturers, packers, or distributors of dietary supplements that bear section 403(r)(6) of the act statements on their labels or labeling. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 101.93 1 There Annual Frequency per Response 2,200 Total Annual Responses 1 Hours per Response 2,200 Total Hours 0.75 1,650 are no capital costs or operating and maintenance costs associated with this collection of information. The agency believes that there will be minimal burden on the industry to generate information to meet the VerDate Nov<24>2008 16:43 Jun 01, 2009 Jkt 217001 requirements of section 403 of the act in submitting information regarding section 403(r)(6) statements on labels or PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 in labeling of dietary supplements. The agency is requesting only information that is immediately available to the E:\FR\FM\02JNN1.SGM 02JNN1

Agencies

[Federal Register Volume 74, Number 104 (Tuesday, June 2, 2009)]
[Notices]
[Pages 26404-26406]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-09-0920-09BQ]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for

[[Page 26405]]

opportunity for public comment on proposed data collection projects, 
the Centers for Disease Control and Prevention (CDC) will publish 
periodic summaries of proposed projects. To request more information on 
the proposed projects or to obtain a copy of the data collection plans 
and instruments, call 404-639-5960 and send comments to Maryam I. 
Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-
D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Examining In-vehicle Exposures to Air Pollutants and Corresponding 
Health Outcomes of Commuters--New--National Center for Environmental 
Health, (NCEH) and Agency for Toxic Substances and Disease Registry 
(ATSDR), Centers for Disease Control and Prevention, (CDC).

Background and Brief Description

    Numerous studies have found associations between ambient fine 
particulate matter (PM2.5) and adverse cardiovascular 
outcomes. Several recent epidemiologic studies suggest that vehicle-
related emissions, in particular, may be linked to many of the these 
adverse effects and that specific sub-populations may be more 
susceptible to health risks due to their enhanced exposures to vehicle-
related PM2.5 sources. Commuters are a potentially 
susceptible, yet poorly characterized, sub-population. Importantly, 
recent epidemiologic studies indicate that specific sub-groups, 
including those with asthma, may be at risk to cardiorespiratory health 
effects due to their pre-existing health condition. A more complete 
understanding of in-vehicle exposures for the commuter population, 
especially those with asthma, is therefore becoming increasingly 
necessary as commuting durations and roadway congestion have steadily 
increased throughout the U.S. during the last 20 years. The National 
Center for Environmental Health (NCEH), Centers for Disease Control and 
Prevention (CDC) will conduct this study to characterize in-vehicle 
exposures to traffic-related air pollutants among commuters, with and 
without asthma, and any health impacts that these exposures may have on 
the commuter.
    A total of 40 participants (20 adults with physician-diagnosed 
asthma and 20 healthy adults) living in the Atlanta metro area will be 
recruited for participation in this study. Participants will be 
excluded if they meet specific criteria including: ever being diagnosed 
with severe asthma, ever suffering a myocardial infarction, smoking 
tobacco products, or ever being diagnosed with a pulmonary disease such 
as emphysema, COPD, or any type of lung cancer.
    Approximately one week prior to their scheduled commute, 
participants will complete a one-time baseline questionnaire to assess 
medical history and general exposures. Additionally, a short symptom 
diary recording any respiratory symptoms will be completed by the 
participant each day for the seven days prior to the commute and on the 
day of the commute. On the day of the planned commute, health 
measurements for lung function, lung inflammatory markers, heart rate, 
and biomarkers of systemic inflammation will also be conducted by a 
trained field technician. In-vehicle exposures to particulate matter 
and other air pollutants will then be measured for all participants 
during their commute. After the commute, the symptom diary and health 
measurements will be conducted again to assess any potential changes in 
respiratory and cardiovascular health effects. The information learned 
from the health measurements and diary entries before and after the 
commute will be important in better understanding the potential acute 
health impacts associated with exposures to in-vehicle traffic 
pollutants and respiratory and cardiovascular health, and whether urban 
commuters--especially those with asthma--should be viewed as a 
susceptible sub-population given their enhanced exposures to 
PM2.5 and gas-phased pollutants.
    There is no cost to participants other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
        Instrument type            Respondents      respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Baseline questionnaire........  Eligible                      40               1           30/60              20
                                 participants
                                 with and
                                 without asthma.
Symptom diary.................  Eligible                      40               8            5/60              27
                                 participants
                                 with and
                                 without asthma.
    Total.....................  ................  ..............  ..............  ..............              47
----------------------------------------------------------------------------------------------------------------



[[Page 26406]]

    Dated: May 26, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E9-12746 Filed 6-1-09; 8:45 am]
BILLING CODE 4163-18-P
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