Attachment 2 - 60 day FRN

26404

Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices

FEDERAL RESERVE SYSTEM
Sunshine Act 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
AGENCY HOLDING THE MEETING:

contact the Board’s Web site at http://
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
Instrument

Number of respondents

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:
[email protected]. All requests
should be identified by the title of the
information collection.

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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.

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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

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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
[email protected].
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 ...............................................................

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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

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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 http://
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

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requirements of section 403 of the act in
submitting information regarding
section 403(r)(6) statements on labels or

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in labeling of dietary supplements. The
agency is requesting only information
that is immediately available to the

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