Award of Three Single-Source Expansion Supplements to The University of Colorado Health Sciences Center in Aurora, CO, The University of Massachusetts (Institute for Community Inclusion) in Boston, MA, and The University of Minnesota (The Research and Training Center) in Minneapolis, MN, 65494-65495 [2010-26933]
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65494
Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices
emcdonald on DSK2BSOYB1PROD with NOTICES
a recall plan, as provided in 21 CFR
7.59, have been approved under OMB
control number 0910–0249. Therefore,
FDA is not calculating a new paperwork
burden for recall plans.
Preventative Control Program
When properly designed and
maintained by the establishment’s
personnel, a preventive control program
is a valuable program for managing the
safety of food products. A common
preventive control program used by the
fresh-cut industry is a HACCP system. A
HACCP system allows managers to
assess the inherent risks and identify
hazards attributable to a product or a
process, and then determine the
necessary steps to control the hazards.
Monitoring and verification steps,
which include recordkeeping, are
included in the HACCP system to
ensure that potential risks are
controlled. We use HACCP as an
example of a preventive control program
that a firm may choose based on the
recommendations in the guidance to
estimate the burden of developing,
implementing, and reviewing a
preventive control program.
FDA estimated the paperwork burden
of developing and implementing a
HACCP plan based on a plan with two
CCPs. The number of CCPs may vary
depending on how the processor
chooses to identify the CCPs for a
particular operation. Developing a
HACCP plan is a one-time activity that
is estimated to take 100 hours based on
a trained HACCP team working on the
plan full time. The HACCP team
identifies the CCPs and measures
needed to control them, and then
identifies the approach needed to verify
the effectiveness of the controls. During
this plan development period, the firm
chooses the records to be kept and
information and observations to be
recorded. This is a one-time process
during the first year.
In 2007, we previously estimated that,
of the estimated 250 fresh-cut
processors, approximately 50 percent of
the firms already have HACCP plans in
place. We therefore assumed that the
remaining fresh-cut processors (125
existing firms plus the 10 new firms),
would voluntarily develop a HACCP
plan, and estimated that 135 processors
would spend 13,500 hours (135 × 100)
to develop their individual HACCP
plans. Accordingly, we only need to
estimate the burden of this one-time
activity on the 10 new businesses
expected to enter the industry annually
in the next 3 years. We estimate that the
10 new firms will spend 100 hours each
to develop their individual HACCP
plans, for a total of 1,000 hours (10 ×
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16:05 Oct 22, 2010
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100). This burden estimate is shown in
row 4 of table 1 of this document.
After the HACCP plan is developed,
the frequency for recordkeeping for
implementing or maintaining daily
records is estimated to be 510 records
per year. (This is based on a firm
choosing to maintain daily records for 2
CCPs for one 8-hour shift per day for
each of the estimated 255 operational
days per year.) The total time to record
observations for the CCPs was estimated
to take 4 minutes or 0.067 hours per
record. Therefore, the total annual
records kept by 145 firms (the 135 firms
plus the 10 new businesses expected to
enter the industry) is 73,950 (510 × 145),
and the total hours required are 4,955
(73,950 records × 0.067 hours per record
= 4,954.65, rounded to 4,955). This
annual burden is shown in row 5 of
table 1 of this document.
After the HACCP plan has been
developed and implemented, we
recommend that the plan is reviewed
regularly to ensure that it is working
properly. Fresh-cut processors are
estimated to review their HACCP plans
four times per year (once per quarter).
Assuming that it takes each of the 145
firms 4 hours per review each quarter,
the total burden of this activity, for
firms that choose to review their plans
annually, is 2,320 (145 × 4 × 4) hours
per year. This annual burden is shown
in row 6 of table 1 of this document.
Dated: October 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–26829 Filed 10–22–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Award of Three Single-Source
Expansion Supplements to The
University of Colorado Health Sciences
Center in Aurora, CO, The University of
Massachusetts (Institute for
Community Inclusion) in Boston, MA,
and The University of Minnesota (The
Research and Training Center) in
Minneapolis, MN
Administration on
Developmental Disabilities, ACF, HHS.
ACTION: Notice.
AGENCY:
CFDA Number: 93.631.
Statutory Authority: This award will
be made pursuant to Section 161 of the
Developmental Disabilities Assistance
and Bill of Rights Act of 2000 (42 U.S.C.
15081–15083).
PO 00000
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Amount of Award: $200,000 per
award.
Project Period: 9/30/2010–9/29/2012.
SUMMARY: This notice announces that
the Administration for Children and
Families (ACF), Administration on
Developmental Disabilities (ADD) has
awarded three single-source expansion
supplements for data collection,
analyses, and reporting.
The following projects will be funded:
The University of Colorado Health
Sciences Center, Aurora, CO. This
cooperative agreement will allow for
data collection, analysis and reporting
on spending and services for
individuals with intellectual and
developmental disabilities, including
disaggregation of data related to specific
demographic groups. The project will
analyze and report on trends in
utilization of and spending for
institutional services and home and
community-based services. Project staff
will also participate in collaborative
efforts with ADD and other data
collection projects to review and report
on unmet needs in data collection,
analyses, and reporting activities that
would promote the self-determination,
independence, productivity, and
integration and inclusion of people with
intellectual and developmental
disabilities in all facets of community
life.
The University of Massachusetts
(Institute for Community Inclusion),
Boston, MA. This cooperative agreement
will provide for data collection and
analyses related to the effectiveness of
State agencies in promoting community
integrated employment for individuals
with intellectual and developmental
disabilities. The project will collect
data, analyze, and report on the
employment and economic status of
individuals with intellectual and
developmental disabilities including
disaggregation of data related to specific
demographic groups. The project will
also make recommendations related to
the standardization of data and
reporting of employment outcomes.
Project staff will also participate in
collaborative efforts with ADD and other
data collection projects to review and
report on unmet needs in data
collection, analyses, and reporting
activities that would promote the selfdetermination, independence,
productivity, and integration and
inclusion of people with intellectual
and developmental disabilities in all
facets of community life.
The University of Minnesota (The
Research and Training Center),
Minneapolis, MN. This cooperative
agreement will provide for data
collection, analyses, and reporting of
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices
national and State statistics on public
and private residential services for
individuals with intellectual and
developmental disabilities, including
disaggregation of data related to specific
demographic groups. The project will
conduct analyses that describe the
movement of individuals with
intellectual and developmental
disabilities from institutional to
community settings. Project staff will
also participate in collaborative efforts
with ADD and other data collection
projects to review and report on unmet
needs in data collection, analyses, and
reporting activities that would promote
the self-determination, independence,
productivity, and integration and
inclusion of people with intellectual
and developmental disabilities in all
facets of community life.
Contact for Further Information:
Ophelia McLain, Supervisory Program
Specialist, Administration on
Developmental Disabilities, 370
L’Enfant Promenade, SW., Mail Stop:
HHH–405D, Washington, DC 20447.
Telephone: 202–690–7025 E-mail:
ophelia.mclain@acf.hhs.gov.
Dated: October 14, 2010.
Sharon Lewis,
Commissioner, Administration on
Developmental Disabilities.
[FR Doc. 2010–26933 Filed 10–22–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
emcdonald on DSK2BSOYB1PROD with NOTICES
National Institute of Dental and
Craniofacial Research; Interagency
Pain Research Coordinating
Committee; Call for Nominations
The Department of Health and Human
Services has created the Interagency
Pain Research Coordinating Committee
and is seeking nominations for this
committee. As specified in Public Law
111–148 (‘‘Patient Protection and
Affordable Care Act’’) the Committee
will: (a) Develop a summary of advances
in pain care research supported or
conducted by the Federal agencies
relevant to the diagnosis, prevention,
and treatment of pain and diseases and
disorders associated with pain; (b)
identify critical gaps in basic and
clinical research on the symptoms and
causes of pain; (c) make
recommendations to ensure that the
activities of the National Institutes of
Health and other Federal agencies are
free of unnecessary duplication of effort;
(d) make recommendations on how best
to disseminate information on pain care;
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and (e) make recommendations on how
to expand partnerships between public
entities and private entities to expand
collaborative, cross-cutting research.
Membership on the committee will
include six (6) non-Federal members
from among scientists, physicians, and
other health professionals and six (6)
non-Federal members of the general
public who are representatives of
leading research, advocacy, and service
organizations for individuals with painrelated conditions. Members will serve
overlapping three year terms. It is
anticipated that the committee will meet
at least once a year.
The Department strives to ensure that
the membership of HHS Federal
advisory committees is fairly balanced
in terms of points of view represented
and the committee’s function. Every
effort is made to ensure that the views
of women, all ethnic and racial groups,
and people with disabilities are
represented on HHS Federal advisory
committees and, therefore, the
Department encourages nominations of
qualified candidates from these groups.
The Department also encourages
geographic diversity in the composition
of the Committee. Appointment to this
Committee shall be made without
discrimination on the basis of age, race,
ethnicity, gender, sexual orientation,
disability, and cultural, religious, or
socioeconomic status.
Nominations are due by COB
November 26, 2010, and should be sent
to Amy Adams, PhD, NIDCR/NIH, 31
Center Drive, Room 5B55, MSC–2190,
Bethesda MD 20892–2190,
adamsamy@mail.nih.gov by either
USPS mail or e-mail. Nominations
should include contact information and
a current curriculum vitae or resume.
Dated: October 18, 2010.
Amy Adams,
National Institute of Dental and Craniofacial
Research, National Institutes of Health.
[FR Doc. 2010–26937 Filed 10–22–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0529]
Draft Guidance for Industry on
Qualification Process for Drug
Development Tools; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
PO 00000
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Fmt 4703
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65495
availability of a draft guidance for
industry entitled ‘‘Qualification Process
for Drug Development Tools.’’ This draft
guidance describes the qualification
process for drug development tools
(DDTs) intended for potential use, over
time, in multiple drug development
programs. The draft guidance provides a
framework for interactions between the
Center for Drug Evaluation and Research
(CDER) and DDT sponsors to support
work towards qualification of an
identified DDT and creates a mechanism
for formal review of data by CDER to
qualify the DDT and ensure that the
evaluation is comprehensive and
reliable.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by January 24,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Shaniece Gathers, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 4555,
Silver Spring, MD 20993–0002, 301–
796–2600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Qualification Process for Drug
Development Tools.’’ In March 2006,
FDA issued the ‘‘Critical Path
Opportunities Report’’ and the ‘‘Critical
Path Opportunities List.’’ In these
reports, FDA described six key areas
along the critical path to improved
therapies, and a list of specific
opportunities for advancement within
these topic areas. The opportunities
report noted that a new product
E:\FR\FM\25OCN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Pages 65494-65495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26933]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Award of Three Single-Source Expansion Supplements to The
University of Colorado Health Sciences Center in Aurora, CO, The
University of Massachusetts (Institute for Community Inclusion) in
Boston, MA, and The University of Minnesota (The Research and Training
Center) in Minneapolis, MN
AGENCY: Administration on Developmental Disabilities, ACF, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
CFDA Number: 93.631.
Statutory Authority: This award will be made pursuant to Section
161 of the Developmental Disabilities Assistance and Bill of Rights Act
of 2000 (42 U.S.C. 15081-15083).
Amount of Award: $200,000 per award.
Project Period: 9/30/2010-9/29/2012.
SUMMARY: This notice announces that the Administration for Children and
Families (ACF), Administration on Developmental Disabilities (ADD) has
awarded three single-source expansion supplements for data collection,
analyses, and reporting.
The following projects will be funded:
The University of Colorado Health Sciences Center, Aurora, CO. This
cooperative agreement will allow for data collection, analysis and
reporting on spending and services for individuals with intellectual
and developmental disabilities, including disaggregation of data
related to specific demographic groups. The project will analyze and
report on trends in utilization of and spending for institutional
services and home and community-based services. Project staff will also
participate in collaborative efforts with ADD and other data collection
projects to review and report on unmet needs in data collection,
analyses, and reporting activities that would promote the self-
determination, independence, productivity, and integration and
inclusion of people with intellectual and developmental disabilities in
all facets of community life.
The University of Massachusetts (Institute for Community
Inclusion), Boston, MA. This cooperative agreement will provide for
data collection and analyses related to the effectiveness of State
agencies in promoting community integrated employment for individuals
with intellectual and developmental disabilities. The project will
collect data, analyze, and report on the employment and economic status
of individuals with intellectual and developmental disabilities
including disaggregation of data related to specific demographic
groups. The project will also make recommendations related to the
standardization of data and reporting of employment outcomes. Project
staff will also participate in collaborative efforts with ADD and other
data collection projects to review and report on unmet needs in data
collection, analyses, and reporting activities that would promote the
self-determination, independence, productivity, and integration and
inclusion of people with intellectual and developmental disabilities in
all facets of community life.
The University of Minnesota (The Research and Training Center),
Minneapolis, MN. This cooperative agreement will provide for data
collection, analyses, and reporting of
[[Page 65495]]
national and State statistics on public and private residential
services for individuals with intellectual and developmental
disabilities, including disaggregation of data related to specific
demographic groups. The project will conduct analyses that describe the
movement of individuals with intellectual and developmental
disabilities from institutional to community settings. Project staff
will also participate in collaborative efforts with ADD and other data
collection projects to review and report on unmet needs in data
collection, analyses, and reporting activities that would promote the
self-determination, independence, productivity, and integration and
inclusion of people with intellectual and developmental disabilities in
all facets of community life.
Contact for Further Information: Ophelia McLain, Supervisory
Program Specialist, Administration on Developmental Disabilities, 370
L'Enfant Promenade, SW., Mail Stop: HHH-405D, Washington, DC 20447.
Telephone: 202-690-7025 E-mail: ophelia.mclain@acf.hhs.gov.
Dated: October 14, 2010.
Sharon Lewis,
Commissioner, Administration on Developmental Disabilities.
[FR Doc. 2010-26933 Filed 10-22-10; 8:45 am]
BILLING CODE P
