67172 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Trafficking Victims Tracking 

System. 

OMB No.: 0970—NEW. 

Description: The Trafficking Victims 

Protection Act, Public Law 106–386, 

Division A, 114 Stat. 1464 (2000), 

requires the Department of Health and 

Human Services (HHS) to certify adult 

alien (‘‘foreign’’) victims of severe forms 

of trafficking in persons (‘‘human 

trafficking’’) who are willing to assist 

law enforcement in the investigation 

and prosecution of human trafficking, 

unless unable to cooperate due to 

physical or psychological trauma, and 

who have either made a bona fide 

application for T nonimmigrant status 

that has not been denied or been granted 

Continued Presence (CP) from the U.S. 

Department of Homeland Security 

(DHS). Issued by the Office of Refugee 

Resettlement (ORR) within the HHS 

Administration for Children and 

Families, certification letters grant adult 

foreign victims of human trafficking 

access to federal and state benefits and 

services to the same extent as refugees. 

In general, ORR initiates the 

certification process when it receives a 

notice from DHS that DHS has granted 

a foreign victim of trafficking CP or T 

nonimmigrant status, or has determined 

an application for T nonimmigrant 

status is bona fide. To issue certification 

letters, it is necessary for ORR to collect 

information from a victim’s 

representative, such as an attorney, case 

manager, or law enforcement victim 

specialist, including an address to send 

the letter. In line with other ORR AntiTrafficking in Persons Program 

activities, ORR may ask if the victim is 

in need of a service provider and the 

current location (city, state) of the 

victim, and refer the victim to an 

appropriate service provider in his or 

her area, if requested. ORR will also ask 

about the victim’s language and urgent 

concerns, such as medical care or 

housing, and transmit this information 

to the service provider. 

Finally ORR collects information, 

such as the victim’s sex and the type of 

human trafficking the victim 

experienced, to provide to Congress in 

an annual report on U.S. Government 

activities to combat trafficking that is 

prepared by the U.S. Department of 

Justice. Congress requires HHS and 

other appropriate Federal agencies to 

report, at a minimum, information on 

the number of persons who received 

benefits or other services under 

subsections (b) and (f) of section 7105 of 

Title 22 of the U.S. Code, the TVPA, in 

connection with programs or activities 

funded or administered by HHS. HHS 

includes in these annual reports 

additional information about the victims 

that it collects when assisting each 

victim to obtain certification or 

eligibility. ORR will store this 

information and any other details 

regarding the victim’s case in the 

Trafficking Victims Tracking System 

(TVTS) on ORR’s secure database. Other 

details maintained in the victim’s file 

may include ORR staff actions, referrals, 

and notes regarding the victim’s interest 

in receiving services. Maintaining 

victim records on TVTS will ensure 

efficient service for victims, allow ORR 

staff to track victims’ progress toward 

certification, verify their eligibility for 

benefits, and organize information for 

reporting to Congress. 

The TVTS also includes information 

about foreign victims of trafficking and 

potential victims who were minors 

when an eligibility letter was sought 

from ORR. Information about these 

individuals is collected pursuant to an 

OMB-approved collection, OMB Control 

Number 0970–0362. 

In January 2011, the Archivist of the 

United States approved an Electronic 

System Schedule for the disposition of 

TVTS records. 

Respondents: Respondents can 

include attorneys, legal representatives, 

social service providers, case managers, 

and volunteers acting on behalf of the 

adult foreign victim of trafficking. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

800 1 .1 80 

Estimated Total Annual Burden 

Hours: 80. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–26723 Filed 11–10–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1794] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Impact of Ad 

Exposure Frequency on Perception 

and Mental Processing of Risk and 

Benefit Information in Direct-toConsumer Prescription Drug Ads 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices 67173 

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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

research entitled, ‘‘Impact of Ad 

Exposure Frequency on Perception and 

Mental Processing of Risk and Benefit 

Information in DTC Prescription Drug 

Ads.’’ This project will examine the 

effects of variation in ad exposure 

frequency on perception and mental 

processing of risk and benefit 

information in direct-to-consumer (DTC) 

prescription drug ads. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 12, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

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 requests 

or requirements that members of the 

public 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 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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. 

Impact of Ad Exposure Frequency on 

Perception and Mental Processing of 

Risk and Benefit Information in DTC 

Prescription Drug Ads—(OMB Control 

Number 0910—NEW) 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 393(b)(2)(c)) 

authorizes FDA to conduct research 

relating to drugs and other FDA 

regulated products in carrying out the 

provisions of the FD&C Act. 

In a typical promotional campaign, 

consumers may be exposed to a DTC 

prescription drug ad any number of 

times. Perceptual and cognitive effects 

of increased ad exposure frequency have 

been studied extensively using non-drug 

ads. For instance, one study 

demonstrated that a commercial 

message repeated twice generates better 

recall than a message broadcast only 

once (Ref. 1). Another study 

demonstrated that increased ad 

exposures improve product attitudes 

and recall for product attributes, 

particularly when the substance of the 

repeat messages is varied (Ref. 2). 

Generally, it has been argued that first 

exposure to an ad results in attention, 

second exposure affects learning of the 

advertised message, and third and 

subsequent exposures reinforce the 

learning effects of the second exposure 

(Ref. 3). To our knowledge, the literature 

concerning ad exposure frequency has 

not been extended to include specific 

attention to prescription drug ads. 

Prescription drug ads are unique in that 

they are required to provide both benefit 

and risk information whereas other ad 

types tend to include only benefit 

information. The Office of Prescription 

Drug Promotion plans to examine the 

effects of variation in ad exposure 

frequency on perception and mental 

processing of risk and benefit 

information in DTC prescription drug 

ads through empirical research. 

The main study will be preceded by 

up to two pretests designed to delineate 

the procedures and measures used in 

the main study. Across pretests and the 

main study, participants will be 

individuals who have been diagnosed 

with seasonal allergies. All participants 

will be 18 years of age or older. We will 

exclude individuals who work in 

healthcare or marketing settings because 

their knowledge and experiences may 

not reflect those of the average 

consumer. Participants will be recruited 

in one of two geographic locations 

(Washington, DC and Raleigh-Durham, 

NC) for in-person administration of 

protocols. 

The experimental design is 

summarized in Table 1. Participants 

will be randomly assigned to view a 

prescription drug ad one, three, or six 

times as part of clutter reels embedded 

in a 42 minute TV program. They will 

then answer preprogrammed survey 

questions on laptops. Preliminary 

measures are designed to assess 

perception, memory, judgments about 

the ad, intentions to use the medication 

advertised, and possible moderators of 

effects, such as need for cognition and 

demographics. The questionnaire is 

available upon request. Participation is 

estimated to take up to 2 hours. 

TABLE 1—EXPERIMENTAL DESIGN

Experimental Arm No. 

42 Minute television show, clutter reel No. 

1 2 3 4 5 6 

1 (views ad 1 time) ........... ............................ ............................ ............................ ............................ ............................ Mock DTC ad. 

2 (views ad 3 times) ......... Mock DTC ad .... ............................ ............................ Mock DTC ad .... ............................ Mock DTC ad. 

3 (views ad 6 times) ......... Mock DTC ad .... Mock DTC ad .... Mock DTC ad .... Mock DTC ad .... Mock DTC ad .... Mock DTC ad. 


TKELLEY on DSK3SPTVN1PROD with NOTICES
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] 

BILLING CODE 4164–01–P 

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] 

BILLING CODE 4164–01–P 


TKELLEY on DSK3SPTVN1PROD with NOTICES