Ajinomoto Co., Inc.; Filing of Food Additive Petition, 35871-35872 [E9-17250]
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35871
Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices
use of information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
Laboratory Medicine Best Practices
Project (LMBP)—New—National Center
for Preparedness, Detection, and Control
of Infectious Diseases (NCPDCID),
Centers for Disease Control and
Prevention (CDC)
Background and Brief Description
CDC is seeking approval from the
Office of Management and Budget
(OMB) to collect information from
healthcare organizations in order to
conduct a systemic review of laboratory
practice effectiveness. The purpose of
information collection is to include
completed unpublished quality
improvement studies/assessments
carried out by healthcare organizations
(laboratories, hospitals, clinics) in
systematic reviews of practice
effectiveness. CDC has been sponsoring
the Laboratory Medicine Best Practices
(LMBP) initiative to develop new
systematic evidence reviews methods
for making evidence-based
recommendations in laboratory
medicine. This initiative supports the
CDC’s mission of improving laboratory
practices.
The focus of the Initiative is on preand post-analytic laboratory medicine
practices that are effective at improving
health care quality. While evidencebased approaches for decision-making
have become standard in healthcare,
this has been limited in laboratory
medicine. No single-evidence-based
model for recommending practices in
publish quality improvement projects or
studies demonstrating practice
effectiveness in the peer reviewed
literature, but that they routinely
conducted quality improvement projects
and had relevant data for completion of
evidence reviews. Phase 2 (September
2007–November 2008) and Phase 3
(December 2008–September 2009),
involved further methods development
and pilot tests to obtain, review, and
evaluate published and unpublished
evidence for practices associated with
the topics of patient specimen
identification, communicating critical
value test results, and blood culture
contamination. Exploratory work by
CDC supports the existence of relevant
unpublished studies or completed
quality improvement projects related to
laboratory medicine practices from
healthcare organizations. The objective
for successive LMBP evidence reviews
of practice effectiveness is to
supplement the published evidence
with unpublished evidence to fill in
gaps in the literature.
Healthcare organizations and facilities
(laboratory, hospital, clinic) will have
the opportunity to voluntarily enroll in
an LMBP network and submit readily
available unpublished studies; quality
improvement projects, evaluations,
assessments, and other analyses relying
on unlinked, anonymous data using the
LMBP Submission Form. LMBP
Network participants will also be able to
submit unpublished studies/data for
evidence reviews on an annual basis
using this form. There is no cost to
respondents other than their time.
laboratory medicine exists, although the
number of laboratories operating in the
United States and the volume of
laboratory tests available certainly
warrant such a model.
The Laboratory Medicine Best
Practices Initiative began in October
2006, when CDC convened the
Laboratory Medicine Best Practices
Workgroup (Workgroup), a
multidisciplinary panel of experts in
several fields including laboratory
medicine, clinical medicine, health
services research, and health care
performance measurement. The
Workgroup has been supported by staff
at CDC and the Battelle Memorial
Institute under contract to CDC.
To date, the Laboratory Medicine Best
Practices (LMBP) project work has been
completed over three phases. During
Phase 1 (October 2006–September 2007)
of the project, CDC staff developed
systematic review methods for
conducting evidence reviews using
published literature, and completed a
proof-of-concept test. Results of an
extensive search and review of
published literature using the methods
for the topic of patient specimen
identification indicated that an
insufficient quality and number of
studies were available for completing
systematic evidence reviews of
laboratory medicine practice
effectiveness for multiple practices, and
hence for making evidence-based
recommendations. These results were
considered likely to be generalizable to
most potential topic areas of interest.
A finding from Phase 1 work was that
laboratories would be unlikely to
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Number of
responses per
respondent
Average burden
(in hours)
Total burden
(in hours)
Healthcare Organizations ................................................................................
150
1
40/60
100
Total ..........................................................................................................
........................
........................
........................
100
Dated: July 15, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–17266 Filed 7–20–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–F–0303]
jlentini on DSKJ8SOYB1PROD with NOTICES
BILLING CODE 4163–18–P
Ajinomoto Co., Inc.; Filing of Food
Additive Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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16:50 Jul 20, 2009
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that Ajinomoto Co., Inc., has filed a
petition proposing that the food additive
regulations be amended to provide for
the safe use of N-[N-[3-(3-hydroxy-4methoxyphenyl) propyl-a-aspartyl]-Lphenylalanine 1-methyl ester,
monohydrate (CAS Reg. No. 714229–
20–6) for use as a non-nutritive
sweetener in tabletop applications and
powdered beverage mixes. Ajinomoto
Co., Inc., also proposes that this additive
be identified as advantame.
DATES: Submit written or electronic
comments on the petitioner’s
E:\FR\FM\21JYN1.SGM
21JYN1
jlentini on DSKJ8SOYB1PROD with NOTICES
35872
Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices
environmental assessment by August
20, 2009.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Blondell Anderson, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–1304.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 9A4778) has been filed by
Ajinomoto Co., Inc., c/o Ajinomoto
Corporate Services LLC, 1120
Connecticut Ave. NW., suite 1010,
Washington, DC 20036. The petition
proposes to amend the food additive
regulations in part 172 Food Additives
Permitted For Direct Addition to Food
for Human Consumption (21 CFR part
172) to provide for the safe use of N-[N[3-(3-hydroxy-4-methoxyphenyl)
propyl-a-aspartyl]-L-phenylalanine 1methyl ester, monohydrate (CAS Reg.
No. 714229–20–6) for use as a nonnutritive sweetener in tabletop
applications and powdered beverage
mixes.
The potential environmental impact
of this petition is being reviewed. To
encourage public participation
consistent with regulations issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see DATES and ADDRESSES) for public
review and comment.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FDA will also place on public display
any amendments to, or comments on,
the petitioner’s environmental
assessment without further
announcement in the Federal Register.
If, based on its review, the agency finds
VerDate Nov<24>2008
16:50 Jul 20, 2009
Jkt 217001
that an environmental impact statement
is not required, and this petition results
in a regulation, the notice of availability
of the agency’s finding of no significant
impact and the evidence supporting that
finding will be published with the
regulation in the Federal Register in
accordance with 21 CFR 25.51(b).
Dated: July 10, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E9–17250 Filed 7–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Health and Nutrition
Examination Survey (NHANES) Stored
Biologic Specimens: Guidelines for
Proposals to Use Samples and
Proposed Cost Schedule
ACTION: Notice and request for
comments.
SUMMARY: The National Health and
Nutrition Examination Survey
(NHANES) is a program of periodic
surveys conducted by the National
Center for Health Statistics (NCHS) of
the Centers for Disease Control and
Prevention (CDC). Examination surveys
conducted since 1960 by NCHS, have
provided national estimates of health
and nutritional status of the United
States civilian non-institutionalized
population. To add to the large amount
of information collected for the purpose
of describing the health of the
population in the most recent survey,
serum, urine and limited plasma
samples were collected and stored for
future research projects. Specimens are
currently available from NHANES III
(conducted from 1988–1994) and from
NHANES 1999–2008. In 1999, NHANES
became a continuous survey with data
release every two years. Specimens are
available from two year survey cycles
after the demographic file has been
released to the public. Participants in
the survey that began in 1999 signed a
separate consent document agreeing to
specimen storage allowing their biologic
specimens to be used for approved
research projects.
Specimens are stored in two
Specimen Banks. Surplus samples that
were initially used for laboratory assays
included in the surveys, have since been
stored at ¥70 °C and have been through
at least two freeze-thaw cycles. They are
stored at a commercial repository under
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Fmt 4703
Sfmt 4703
contract to NCHS. In addition, on
average, six vials of sera were also
stored in vapor-phase liquid nitrogen at
the CDC and ATSTR Specimen
Packaging, Inventory and Repository
(CASPIR) Repository in Lawrenceville,
GA. These specimens have not
undergone a freeze-thaw cycle. The
CASPIR Repository is considered a longterm repository for the NHANES
specimens. NCHS is making both of
these collections available for research
proposals. The research proposals that
can use the surplused specimens will
receive higher priority. Proposals that
request the specimens in CASPIR need
to justify the use of the unthawed
specimens.
The purpose of this notice is to
request comments on this program and
the proposed cost schedule. After
consideration of comments submitted,
CDC will finalize and publish the cost
schedule and accept proposals for use of
the NHANES stored biologic samples.
Please go to https://www.cdc.gov/nchs/
nhanes/proposal_guidelines.htm for
final proposal guidelines.
All interested researchers are
encouraged to submit proposals. No
funding is provided as part of this
solicitation. Samples will not be
provided to those projects requiring
funding until the project has received
funds. Approved projects that do not
obtain funding will be canceled. A more
complete description of this program
follows.
DATES:
• Comment Receipt Date: August 20,
2009.
• Invitation to Submit Proposals: Can
be submitted on an ongoing basis
• Scientific Review Date: Within two
months of proposal submission.
• Institutional Review Date: Within
one month of final proposal acceptance.
• Anticipated distribution of samples:
one month after IRB approval.
ADDRESSES: To send comments and to
request information, contact: Dr.
Geraldine McQuillan, Division of Health
and Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road, Room
4204, Hyattsville, MD 20782,
Phone: 301–458–4371,
Fax: 301–458–4028,
E-mail: gmm2@cdc.gov.
Internet: https://www.cdc.gov/nchs/
about/major/nhanes/serum1b.htm.
Authority: Sections 301,306 and 308 of the
Public Health Service Act (42 U.S.C. 241,
242k and 242M).
SUPPLEMENTARY INFORMATION:
The goals of NHANES are: (1) To
estimate the number and percent of
E:\FR\FM\21JYN1.SGM
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Agencies
[Federal Register Volume 74, Number 138 (Tuesday, July 21, 2009)]
[Notices]
[Pages 35871-35872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17250]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-F-0303]
Ajinomoto Co., Inc.; Filing of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Ajinomoto Co., Inc., has filed a petition proposing that the food
additive regulations be amended to provide for the safe use of N-[N-[3-
(3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-
methyl ester, monohydrate (CAS Reg. No. 714229-20-6) for use as a non-
nutritive sweetener in tabletop applications and powdered beverage
mixes. Ajinomoto Co., Inc., also proposes that this additive be
identified as advantame.
DATES: Submit written or electronic comments on the petitioner's
[[Page 35872]]
environmental assessment by August 20, 2009.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Blondell Anderson, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1304.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food
additive petition (FAP 9A4778) has been filed by Ajinomoto Co., Inc.,
c/o Ajinomoto Corporate Services LLC, 1120 Connecticut Ave. NW., suite
1010, Washington, DC 20036. The petition proposes to amend the food
additive regulations in part 172 Food Additives Permitted For Direct
Addition to Food for Human Consumption (21 CFR part 172) to provide for
the safe use of N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl-[alpha]-
aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (CAS Reg. No.
714229-20-6) for use as a non-nutritive sweetener in tabletop
applications and powdered beverage mixes.
The potential environmental impact of this petition is being
reviewed. To encourage public participation consistent with regulations
issued under the National Environmental Policy Act (40 CFR 1501.4(b)),
the agency is placing the environmental assessment submitted with the
petition that is the subject of this notice on public display at the
Division of Dockets Management (see DATES and ADDRESSES) for public
review and comment.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. FDA will also place on public display any amendments
to, or comments on, the petitioner's environmental assessment without
further announcement in the Federal Register. If, based on its review,
the agency finds that an environmental impact statement is not
required, and this petition results in a regulation, the notice of
availability of the agency's finding of no significant impact and the
evidence supporting that finding will be published with the regulation
in the Federal Register in accordance with 21 CFR 25.51(b).
Dated: July 10, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. E9-17250 Filed 7-20-09; 8:45 am]
BILLING CODE 4160-01-S