DSM Nutritional Products; Food Additive Petition (Animal Use); Ethoxyquin; Environmental Assessment, 67174 [2014-26709]
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67174
Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices
To examine differences between
experimental conditions, we will
conduct inferential statistical tests such
as analysis of variance. With the sample
size described in the following table, we
will have sufficient power to detect
small-to-medium sized effects in the
main study.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
respondents
Average burden per
response
Total hours
Pretest 1 screener completes (assumes 10% eligible)
Pretest 2 screener completes (assumes 10% eligible)
Number of main study screener completes (assumes
10% eligible).
Pretest 1 completes .....................................................
Pretest 2 completes .....................................................
Number of completes, main study ..............................
4,150
4,150
620
1
1
1
4,150
4,150
620
0.08 (5 minutes) .....
0.08 (5 minutes) .....
0.08 (5 minutes) .....
332
332
50
420
420
620
1
1
1
420
420
620
2 .............................
2 .............................
2 .............................
840
840
1240
Total ......................................................................
........................
........................
........................
................................
3,634
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. Singh, S. N., D. Linville, and A. Sukhdial,
‘‘Enhancing the Efficacy of Split ThirtySecond Television Commercials: An
Encoding Variability Application,’’
Journal of Advertising, 24, pp. 13–23
(1995).
2. Haugtvedt, C. P., et al., ‘‘Advertising
Repetition and Variation Strategies:
Implications for Understanding Attitude
Strength,’’ Journal of Consumer
Research, 21, pp. 176–189 (1994).
3. Naples, M. J., ‘‘Effective Frequency: Then
and Now,’’ Journal of Advertising
Research, 37, pp. 7–12 (1997).
Dated: November 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26698 Filed 11–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
TKELLEY on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2013–F–1539]
DSM Nutritional Products; Food
Additive Petition (Animal Use);
Ethoxyquin; Environmental
Assessment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of an environmental
SUMMARY:
VerDate Sep<11>2014
17:55 Nov 10, 2014
Jkt 235001
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 ADDRESSES) for public review and
comment.
ADDRESSES: Submit electronic
Interested persons may submit to the
comments to: https://
Division of Dockets Management (see
www.regulations.gov. Submit written
ADDRESSES) electronic or written
comments to the Division of Dockets
comments regarding this document.
Management (HFA–305), Food and Drug Submit a single copy of electronic
Administration, 5630 Fishers Lane, rm.
comments or two paper copies of any
1061, Rockville, MD 20852.
mailed comments, except that
FOR FURTHER INFORMATION CONTACT:
individuals may submit one paper copy.
Isabel W. Pocurull, Center for Veterinary Comments are to be identified with the
Medicine, Food and Drug
docket number found in brackets in the
Administration, 7519 Standish Pl.,
heading of this document. Received
Rockville, MD 20855, 240–453–6853.
comments may be seen in the Division
SUPPLEMENTARY INFORMATION: In the
of Dockets Management between 9 a.m.
Federal Register of December 23, 2013
and 4 p.m., Monday through Friday.
(78 FR 77384) FDA published notice
FDA will also place on public display
that a food additive petition (FAP) had
any amendments to, or comments on,
been filed by DSM Nutritional Products, the petitioner’s environmental
45 Waterview Blvd., Parsippany, NJ
assessment without further
07054. The petition (FAP 2276)
announcement in the Federal Register.
proposes to amend Title 21 of the Code
If, based on its review, the Agency finds
of Federal Regulations (CFR) in part 573
that an environmental impact statement
Food Additives Permitted in Feed and
Drinking Water of Animals (21 CFR part is not required and this petition results
in a regulation, the notice of availability
573) to provide for the safe use of
of the Agency’s finding of no significant
ethoxyquin as a chemical preservative
in vitamin D formulations, including 25- impact and the evidence supporting that
hydroxyvitamin D3, used in animal food. finding will be published with the
regulation in the Federal Register in
In that document, FDA noted that the
accordance with 21 CFR 25.51(b).
petitioner had requested a categorical
exclusion from preparing an
Dated: November 6, 2014.
environmental assessment or
Bernadette Dunham,
environmental impact statement under
Director, Center for Veterinary Medicine.
21 CFR 25.32(k).
[FR Doc. 2014–26709 Filed 11–10–14; 8:45 am]
Upon further review and request by
BILLING CODE 4164–01–P
FDA, the petitioner has filed an
environmental assessment. To
encourage public participation
consistent with regulations issued under
assessment filed by DSM Nutritional
Products in support of their petition
proposing that the food additive
regulations be amended to provide for
the safe use of ethoxyquin in vitamin D
formulations, including 25hydroxyvitamin D3, used in animal
food.
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[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Page 67174]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26709]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-F-1539]
DSM Nutritional Products; Food Additive Petition (Animal Use);
Ethoxyquin; Environmental Assessment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an environmental assessment filed by DSM Nutritional
Products in support of their petition proposing that the food additive
regulations be amended to provide for the safe use of ethoxyquin in
vitamin D formulations, including 25-hydroxyvitamin D3, used
in animal food.
ADDRESSES: Submit electronic comments 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: Isabel W. Pocurull, Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6853.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 23, 2013
(78 FR 77384) FDA published notice that a food additive petition (FAP)
had been filed by DSM Nutritional Products, 45 Waterview Blvd.,
Parsippany, NJ 07054. The petition (FAP 2276) proposes to amend Title
21 of the Code of Federal Regulations (CFR) in part 573 Food Additives
Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to
provide for the safe use of ethoxyquin as a chemical preservative in
vitamin D formulations, including 25-hydroxyvitamin D3, used
in animal food. In that document, FDA noted that the petitioner had
requested a categorical exclusion from preparing an environmental
assessment or environmental impact statement under 21 CFR 25.32(k).
Upon further review and request by FDA, the petitioner has filed an
environmental assessment. 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 ADDRESSES)
for public review and comment.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written 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: November 6, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-26709 Filed 11-10-14; 8:45 am]
BILLING CODE 4164-01-P
