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

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

respondents 

Average burden per 

response Total hours 

Pretest 1 screener completes (assumes 10% eligible) 4,150 1 4,150 0.08 (5 minutes) ..... 332 

Pretest 2 screener completes (assumes 10% eligible) 4,150 1 4,150 0.08 (5 minutes) ..... 332 

Number of main study screener completes (assumes 

10% eligible).

620 1 620 0.08 (5 minutes) ..... 50 

Pretest 1 completes ..................................................... 420 1 420 2 ............................. 840 

Pretest 2 completes ..................................................... 420 1 420 2 ............................. 840 

Number of completes, main study .............................. 620 1 620 2 ............................. 1240 

Total ...................................................................... ........................ ........................ ........................ ................................ 3,634 

1There 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 http://

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] 

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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: http://

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] 

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