Agency Information Collection Activities; Proposed Collection; Comment Request; Service; Provider Study, 9903-9904 [2010-4602]
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Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices
continue and complete updating the
occupational and environmental
exposure information as well as medical
history information for respondents
enrolled in the Agriculture Health
Study. This represents a request to
continue and complete phase III (2005–
2010) of the study. The primary
objectives of the study are to determine
the health effects resulting from
occupational and environmental
exposures in the agricultural
environment. Secondary objectives
include evaluating biological markers
that may be associated with agricultural
exposures and risk of certain types of
cancer. Questionnaire data will be
collected by using computer assisted
telephone interview (CATI) and inperson interview (CAPI) systems for
telephone screeners and home visit
interviews, respectively. Some
respondents will also be asked to
participate in the collection of
biospecimens including blood, urine,
and buccal cells (loose cells from the
respondent’s mouth). The findings will
provide valuable information
concerning the potential link between
agricultural exposures and cancer and
other chronic diseases among
agricultural Health Study cohort
members, and this information may be
generalized to the entire agricultural
community. Frequency of Response:
One or Three. Affected Public: Private
Sector, Farms. Type of Respondents:
Licensed pesticide applicators and their
spouses. The annual reporting burden is
as follows:
ESTIMATES OF HOUR BURDEN
Estimated
annual
number of respondents
Instrument
Private Applicators ............................
CATI Screener .................................
960
1
Private Applicators ............................
Home Visit CAPI and Biospecimens
× 1.
Home Visit CAPI and Biospecimens
× 3.
Introductory Telephone Contact and
Buccal Cell.
310
1
10
3
150
1
1430
........................
Private Applicators ............................
Private Applicators, Spouses, Commercial Applicators.
Total ...........................................
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Average time
per response
minutes/hour
Frequency of
response
Type of respondent
The annualized cost to respondents is
estimated at $16,153 each year for a
three-year period.
There are no capital costs, operating
costs, and/or maintenance costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’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 those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Michael Alavanja,
Dr.P.H, Occupational and
Environmental Epidemiology Branch,
VerDate Nov<24>2008
16:39 Mar 03, 2010
Jkt 220001
Division of Cancer Epidemiology and
Genetics, National Cancer Institute,
NIH, Executive Plaza South, Room 8000,
6120 Executive Blvd., Rockville, MD
20892, or call 301–496–9093, or e-mail
your request, including your address to:
alavanjm@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: February 26, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–4567 Filed 3–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Aging
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Service; Provider
Study
Administration on Aging, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: The Administration on Aging
(AoA) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
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5/60
(0.083)
95/60
(1.5)
95/60
(1.5)
5/60
(0.083)
........................
Annual burden
hours
80
465
45
13
603
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 requirements relating to Area
Agency on Aging and Local Service
Provider Study.
DATES: Submit written or electronic
comments on the collection of
information by May 3, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to:
jennifer.klocinski@aoa.hhs.gov.
Submit written comments on the
collection of information to
Administration on Aging, Office of
Evaluation, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Jennifer Klocinski at 202–357–0146.
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 request or
requirements that members of the public
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9904
Federal Register / Vol. 75, No. 42 / Thursday, March 4, 2010 / Notices
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, AoA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, AoA invites comments
on: (1) Whether the proposed collection
of information is necessary for the
proper performance of AoA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
AoA’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.
The Administration on Aging collects
annual program data at the state level
and has sponsored studies to collect
information regarding the Area Agencies
on Aging. The third component of the
Aging Network that administers and
implements OAA programs, the Local
Service Providers are poorly understood
and characterized. The purpose of this
data collection is to better understand
the relationship between the Area
Agencies on Aging and the Local
Service Providers with whom they work
to provide OAA programs to seniors.
This data collection focuses on two
areas: an investigation of the feasibility
of compiling a national inventory of
aging services providers; and an
investigation of how Area Agencies on
Aging utilize their providers to achieve
program goals. This information will be
used by AoA to determine the capacity
of the provider network to meet the
needs of the expected increase in the
percentage of persons 60 years and
older. The proposed data collection
tools may be found on the AoA Web site
at https://www.aoa.gov/AoARoot/
Program_Results/
Program_Evaluation.aspx.
AoA estimates the burden of this
collection of information as follows: 200
hours
VerDate Nov<24>2008
16:39 Mar 03, 2010
Jkt 220001
Dated: March 1, 2010.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2010–4602 Filed 3–3–10; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0205]
James A. Holland; Denial of Hearing;
Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is denying James
A. Holland’s request for a hearing and
is issuing an order under the Federal
Food, Drug, and Cosmetic Act (the act)
debarring Holland for 5 years from
providing services in any capacity to a
person who has an approved or pending
drug product application. FDA bases
this order on a finding that Holland was
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval of a drug
product or otherwise relating to the
regulation of a drug product under the
act and that the type of conduct
underlying the conviction undermines
the process for the regulation of drugs.
In determining the appropriateness and
length of Holland’s debarment period,
FDA has considered the relevant factors
listed in the act. Holland has failed to
file with the agency information and
analysis sufficient to create a basis for
a hearing concerning this action.
DATES: The order is effective March 4,
2010.
Submit applications for
termination of debarment to the Dockets
Management Branch (HFA–305), Food
and Drug Administration, 12420
Parklawn Dr., rm. 1–23, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: G.
Matthew Warren, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–4613.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
On April 24, 2007, Holland, formerly
the head of the oncology program at the
Stratton Veterans Affairs Medical
Center, pled guilty to failing to establish
and maintain a required record under
section 505(i) of the act (21 U.S.C.
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Frm 00038
Fmt 4703
Sfmt 4703
355(i)) in violation of sections 301(e) of
the act (21 U.S.C. 331(e)). On March 31,
2009, the United States District Court
for the Northern District of New York
sentenced Holland to 5 years of
probation for his resulting Federal
misdemeanor conviction under section
303(a)(1) of the act (21 U.S.C. 333(a)(1)).
The basis for this conviction was
Holland’s failure to establish and
maintain adequate and accurate case
histories for the subjects of clinical trials
he oversaw.
Holland is subject to debarment based
on a finding, under section 306(b) of the
act, (1) that he was convicted of a
misdemeanor under Federal law for
conduct relating to the development or
approval of a drug product or otherwise
relating to the regulation of a drug
product under the act and (2) that the
type of conduct underlying the
conviction undermines the process for
the regulation of drugs. Holland’s
conduct related to the development or
approval of a drug product in that it
involved clinical trials designed to
study the effectiveness of drug products
for possible approval by FDA.
By letter dated June 1, 2009, FDA
served Holland a notice proposing to
debar him for 5 years from providing
services in any capacity to a person
having an approved or pending drug
product application. By letter dated July
1, 2009, Holland, through counsel,
requested a hearing on the proposal. In
his request for a hearing, Holland does
not dispute his misdemeanor conviction
under Federal law, as alleged by FDA.
However, he asserts that he has
appealed the conviction to the United
States Court of Appeals for the Second
Circuit.
We reviewed Holland’s request for a
hearing and find that Holland has not
created a basis for a hearing because
hearings will be granted only if there is
a genuine and substantial issue of fact.
Hearings will not be granted on issues
of policy or law, on mere allegations,
denials, or general descriptions of
positions and contentions, or on data
and information insufficient to justify
the factual determination urged or the
action requested (see 21 CFR 12.24(b)).
The Acting Chief Scientist and
Deputy Commissionerhas considered
Holland’s arguments and concludes that
they are unpersuasive and fail to raise
a genuine and substantial issue of fact
requiring a hearing.
II. Arguments
In support of his hearing request,
Holland argues that the conviction on
which FDA bases his proposed
debarment is currently on appeal.
However, under 306(b)(2)(B)(i), Holland
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]]>Agencies
[Federal Register Volume 75, Number 42 (Thursday, March 4, 2010)]
[Notices]
[Pages 9903-9904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4602]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration on Aging
Agency Information Collection Activities; Proposed Collection;
Comment Request; Service; Provider Study
AGENCY: Administration on Aging, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration on Aging (AoA) 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 requirements relating
to Area Agency on Aging and Local Service Provider Study.
DATES: Submit written or electronic comments on the collection of
information by May 3, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to: jennifer.klocinski@aoa.hhs.gov.
Submit written comments on the collection of information to
Administration on Aging, Office of Evaluation, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Jennifer Klocinski at 202-357-0146.
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 request or requirements that members of
the public
[[Page 9904]]
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, AoA is publishing notice of the proposed collection of
information set forth in this document. With respect to the following
collection of information, AoA invites comments on: (1) Whether the
proposed collection of information is necessary for the proper
performance of AoA's functions, including whether the information will
have practical utility; (2) the accuracy of AoA'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.
The Administration on Aging collects annual program data at the
state level and has sponsored studies to collect information regarding
the Area Agencies on Aging. The third component of the Aging Network
that administers and implements OAA programs, the Local Service
Providers are poorly understood and characterized. The purpose of this
data collection is to better understand the relationship between the
Area Agencies on Aging and the Local Service Providers with whom they
work to provide OAA programs to seniors. This data collection focuses
on two areas: an investigation of the feasibility of compiling a
national inventory of aging services providers; and an investigation of
how Area Agencies on Aging utilize their providers to achieve program
goals. This information will be used by AoA to determine the capacity
of the provider network to meet the needs of the expected increase in
the percentage of persons 60 years and older. The proposed data
collection tools may be found on the AoA Web site at https://www.aoa.gov/AoARoot/Program_Results/Program_Evaluation.aspx.
AoA estimates the burden of this collection of information as
follows: 200 hours
Dated: March 1, 2010.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2010-4602 Filed 3-3-10; 8:45 am]
BILLING CODE 4154-01-P
