57798 Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 

1While the Federal Food, Drug and Cosmetic Act 

(the FD&C Act) provides FDA with authority to 

regulate prescription drug advertisements that are 

false or misleading, the FD&C Act does not provide 

FDA with the authority to regulate the pricing of 

prescription drugs. Thus, FDA is merely interested 

in studying the effects, if any, of the presence of 

various promotional offers in DTC advertisements 

on consumers’ perceptions of product risks and 

benefits, and recognizes that it does not actually 

regulate the dollar or other incentive amount of 

coupons, price incentives, or rebate offers with 

respect to how they affect the price of prescription 

drugs or biological products. 

Address: 2500 NW. 79th Avenue, 

Suite 200, Miami, FL 33122. 

Date Revoked: August 26, 2010. 

Reason: Failed to maintain a valid 

bond. 

Sandra L. Kusumoto, 

Director, Bureau of Certification and 

Licensing. 

[FR Doc. 2010–23679 Filed 9–21–10; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL MARITIME COMMISSION 

Rescission of Order of Revocation 

Notice is hereby given that the Order 

revoking the following license is being 

rescinded by the Federal Maritime 

Commission pursuant to section 19 of 

the Shipping Act of 1984 (46 U.S.C. 

Chapter 409) and the regulations of the 

Commission pertaining to the licensing 

of Ocean Transportation Intermediaries, 

46 CFR Part 515. 

License Number: 004063F. 

Name: VIP Transport, Inc. 

Address: 2703 Wardlow Road, 

Corona, CA 91720. 

Order Published: FR: 9/1/2010 

(Volume 75, No. 169, Pg. 53697). 

Sandra L. Kusumoto, 

Director, Bureau of Certification and 

Licensing. 

[FR Doc. 2010–23675 Filed 9–21–10; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL MARITIME COMMISSION 

Ocean Transportation Intermediary 

License Applicants 

Notice is hereby given that the 

following applicants have filed with the 

Federal Maritime Commission an 

application for a license as a NonVessel-Operating Common Carrier 

(NVO) and/or Ocean Freight Forwarder 

(OFF)—Ocean Transportation 

Intermediary (OTI) pursuant to section 

19 of the Shipping Act of 1984 as 

amended (46 U.S.C. Chapter 409 and 46 

CFR 515). Notice is also hereby given of 

the filing of applications to amend an 

existing OTI license or the Qualifying 

Individual (QI) for a license. 

Interested persons may contact the 

Office of Transportation Intermediaries, 

Federal Maritime Commission, 

Washington, DC 20573. 

Allright Shipping, Inc. (NVO & OFF), 

1350 Bronx River Avenue, Bronx, NY 

10472. Officer: Denzil Barker, 

President, (Qualifying Individual). 

Application Type: New NVO & OFF 

License. 

Cambria Global Logistics, LLC (OFF), 

12140 Quilting Lane, Boca Raton, FL 

33428. Officers: Panu Virtanen, 

Managing Member, (Qualifying 

Individual). Kathleen Virtanen, 

Managing Member. Application Type: 

New OFF License. 

Glory Express Inc. (NVO), 19825 

Hamilton Avenue, Torrance, CA 

90502. Officer: JinYoung Bae, 

President/Secretary/CFO, (Qualifying 

Individual). Application Type: QI 

Change. 

K&K Express, LLC dba K2 Logistics 

(NVO & OFF), 2980 Commers Drive, 

#100, Eagan, MN 55121. Officers: 

Wanda L. Dessent, Vice PresidentInternational-Houston, (Qualifying 

Individual). Christiaan Walhof, CEO/ 

President/CFO. Application Type: QI 

Change. 

Overseas Cargo, Inc. (NVO & OFF), 9614 

Pondwood Road, Boca Raton, FL 

33428. Officer: Suramya (A.K.A. Ron) 

T. Atapattu, President/Secretary/ 

Treasurer/Director, (Qualifying 

Individual). Application Type: New 

NVO & OFF License. 

Smile Cha dba SMH Global Transport 

(NVO), 8636 York Circle, La Palma, 

CA 90623. Officer: Smile Cha, Sole 

Proprietor, (Qualifying Individual). 

Application Type: New NVO License. 

Westwind Shipping and Logistics, Inc. 

(NVO), 38 West 32nd Street, Suite 

1309B, New York, NY 10001. Officer: 

Harry Taurani, President/Secretary/ 

Treasurer/CFO, (Qualifying 

Individual). Application Type: New 

NVO License. 

World Class Solutions LLC (NVO & 

OFF), 3901 NW 79th Avenue, Suite 

230, Doral, FL 33166. Officer: 

Jorgelina G. Marsaglia, President, 

(Qualifying Individual). Application 

Type: New NVO & OFF License. 

Dated: September 17, 2010. 

Karen V. Gregory, 

Secretary. 

[FR Doc. 2010–23676 Filed 9–21–10; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0465] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study: Effect of Promotional Offers in 

Direct-to-Consumer Prescription Drug 

Print Advertisements on Consumer 

Product Perceptions 

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 

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 

the Experimental Study: Effect of 

Promotional Offers in Direct-toConsumer Prescription Drug Print 

Advertisements on Consumer Product 

Perceptions. This study is designed to 

investigate the impact of the presence of 

coupons offering purchase incentives 

such as free-trial offers, discounts, and 

money-back guarantees on consumers’ 

perceptions of product risks and 

benefits in direct-to-consumer (DTC) 

print ads.1 Notice of proposed 

information collection for this project 

was previously published in the Federal 

Register of December 15, 2008 (73 FR 

76034). This notice is being republished 

due to significant revisions in the 

burden and study design. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 22, 2010. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 57799 

2See for example, deGroot, I.M., G. Antonides, D. 

Read, et al., ‘‘The Effects of Direct Experience on 

Consumer Product Evaluation,’’ Journal of SocioEconomics, 38(3), 509–519, 2009; DelVecchio, D., 

D.H. Henard, and T.H. Freling, ‘‘The Effect of Sales 

Promotion on Post-Promotion Brand Preference: A 

Meta-Analysis,’’ Journal of Retailing, 82(3), 203– 

213, 2006; Mico, C.C. and T.G. Chowdhury, ‘‘The 

Effect of Message’s Regulatory Focus and Product 

Type on Persuasion,’’ Journal of Marketing Theory 

and Practice, 18(2), 181–190, 2010. 

3LeClerc, F. and J.D.C. Little, ‘‘Can Advertising 

Copy Make FSI Coupons More Effective?,’’ Journal 

of Marketing Research, 34(4), 473–484, 1997. 

4Wolk, A. and C. Ebling, ‘‘Multi-Channel Price 

Differentiation: An Empirical Investigation of 

Existence and Causes,’’ International Journal of 

Research in Marketing, 27(2), 142–150, 2010. 

5 Johar, G.V. and C.J. Simmons, ‘‘The Use of 

Concurrent Disclosures to Correct Invalid 

Inferences,’’ Journal of Consumer Research, 26(4), 

307, 2000. 6Chaiken, S., A. Liberman, and A. Eagly, 

‘‘Heuristic and Systematic Proocessing Within and 

Beyond the Persuasion Context,’’ 1989; In J.S. 

Uleman and J.A. Bargh (Eds.), Unintended Thought 

(chapter 7, p. 212–252), Guilford Press: New York; 

Bettman J.R., M.F. Luce, and J.W. Payne, 

‘‘Constructive Consumer Choice Processes,’’ Journal 

of Consumer Research, 25(3), 187–217, 1998. 

7Alba, J.W. and H. Marmorstein, ‘‘The Effects of 

Frequency Knowledge on Consumer Decision 

Making,’’ Journal of Consumer Research, 14(1), 14– 

25, 1987; Inman, J.J., L. McAlister, and W.D. Hoyer, 

‘‘Promotion Signal: Proxy for a Price Cut?,’’ Journal 

of Consumer Research, 17(1), 74–81, 1990. 

8FTC (Federal Trade Commission) (1983), 

Federal Trade Commission policy statement on 

deception, appended to Cliffdale Associates, Inc., 

103 F.T.C. 110 (1984), Available at http:// 

www.ftc.gov/bcp/policystmt/ad-decept.htm, Last 

accessed September 8, 2010; Hoy, M.G and M.O. 

Lwin, ‘‘An International Perspective of Online 

Disclosure Information: A Comparison of Banner 

Ad Disclosures from United States, United 

Kingdom and Singapore Websites,’’ Journal of 

Consumer Policy, 31, 327–347, 2008. 

9See, for example, France, K.R. and P.F. Bone, 

‘‘Policy Makers’ Paradigms and Evidence From 

Continued 

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. 

Experimental Study: Effect of 

Promotional Offers in Direct-toConsumer (DTC) Prescription Drug 

Print Advertisements on Consumer 

Product Perceptions—New 

Regulatory Background—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 903(d)(2)(C) 

of the FD&C Act (21 U.S.C. 393(d)(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. 

FDA regulations require that an 

advertisement that makes claims about 

a prescription drug include a ‘‘fair 

balance’’ of information about the 

benefits and risks of the advertised 

product, in terms of both content and 

presentation (21 CFR 202.1(e)(5)(ii)). In 

part, ‘‘[a]n advertisement for a 

prescription drug is false, lacking in fair 

balance, or otherwise misleading* * * 

if it [c]ontains a representation or 

suggestion, not approved or permitted 

for use in the labeling, that a drug is 

better, more effective, useful in a 

broader range of conditions or 

patients* * *safer, has fewer, or less 

incidence of, or less serious side effects 

or contraindications than has been 

demonstrated by substantial evidence or 

substantial clinical 

experience* * *whether or not such 

representations are made by comparison 

with other drugs or treatments, and 

whether or not such a representation or 

suggestion is made directly’’ (21 CFR 

202.1(e)(6)(i)). Further, the regulations 

state that an advertisement may be 

misleading if it ‘‘[u]ses headline, 

subheadline, or pictorial or other 

graphic matter in a way that is 

misleading’’ (21 CFR 202.1(e)(6)(xviii)). 

Advertisements that draw attention to 

the name of the product but do not 

make representations about the 

product’s indication(s) or dosage 

recommendations are called reminder 

advertisements. As a general matter, 

reminder ads may mention the 

proprietary and established name of the 

product and (optionally) contain 

information about the product’s 

ingredients, dosage form, quantity, 

price, and manufacturer (21 CFR 

202.1(e)(2)(i)). Other written, printed, or 

graphic information is not prohibited in 

reminder ads as long as that information 

does not make a representation or 

suggestion relating to the product 

beyond those permitted. 

Rationale. A topic of ongoing interest 

for consumer product manufacturers 

and retailers is the use of consumeroriented sales promotions such as free 

trial offers, discounts, money-back 

guarantees, rebates, and sweepstakes. 

Coupon promotions are widely used in 

many product categories, including 

prescription drugs. 

Prior research has demonstrated that 

the type of promotion offered can affect 

how consumers respond to the 

promotion.2 For example, a price 

incentive may not only act as an 

economic incentive to buy the product, 

but may also artificially enhance 

consumers’ perceptions of the product’s 

quality.3 In cases where consumers can 

readily test the performance of the 

products (termed ‘‘experience’’ goods4), 

this misperception is quickly corrected 

through the consumer’s use of the 

product. However, because prescription 

drugs are both more complex and riskier 

than simpler experience products, 

misperceptions before product use are a 

serious concern. 

Price incentives may mislead 

consumers because consumers may use 

the incentives as cues about product 

quality. For example, if length of 

warranty is strongly believed to be a 

good predictor of quality, then 

consumers may perceive a product as 

higher quality when a long warranty is 

present than when one is not present.5

Thus, price incentives may have the 

potential to act as an ‘‘inference rule’’ (or 

heuristic6) and, when present, they may 

preempt consumers from thinking 

carefully about the product information 

contained in the advertisement (i.e., 

fully elaborating on the information). 

This could result in either favorable or 

unfavorable beliefs about the product.7

If the promotional offer is used as a 

mental heuristic in such a way as to 

result in a misleading impression of the 

product, however, this raises concerns. 

It may be possible to encourage more 

thorough processing of information and 

reduce reliance on heuristics through 

the inclusion of additional information 

designed to qualify and be processed at 

the same time as the claim in question. 

For example, disclosures (statements 

that qualify, limit, or explain a 

particular claim) are intended to be an 

information remedy to combat potential 

deception.8 Research is mixed on the 


emcdonald on DSK2BSOYB1PROD with NOTICES
57800 Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 

Consumer Interpretations of Dietary Supplement 

Labels,’’ Journal of Consumer Affairs, 39(1), 27–51, 

2005; Mason, M.J., D.L. Scammon, and X. Fang, 

‘‘The Impact of Warnings, Disclaimers and Product 

Experience on Consumers’ Perceptions of Dietary 

Supplements,’’ Journal of Consumer Affairs, 41(1) 

74–99, 2007. 

10 Garretson, J.A. and S. Burton, ‘‘Highly Coupon 

and Sale Prone Consumers: Benefits Beyond Price 

Savings,’’ Journal of Advertising Research, 43, 162– 

172, 2003. 11Bhutada, N.S., C.L. Cook, and M. Perri, 

‘‘Consumer Responses to Cupons in Direct-toConsumer Advertising of Prescription Drugs,’’ 

Health Marketing Quarterly, 26, 333–346, 2009. 

12Because FDA does not have the authority to 

regulate prescription drug pricing we will not 

examine prescription drug prices. 

13Prescription drug full product advertisements 

contain information about both benefits and risks, 

whereas prescription drug reminder advertisements 

do not contain this information. OTC drug 

advertisements contain benefit information but not 

risk information, thus making it a good choice for 

an experimental comparison. 

effectiveness of disclosures, particularly 

those that take the form of a disclaimer.9

However, there may be other ways to 

add information that is effective in 

changing processing. One possibility is 

including specific information about a 

prescription drug product’s efficacy 

from labeling. This information may act 

as a signal with regard to the quality of 

the information (good or bad). By 

extension, this signal may affect the use 

of processing heuristics. Depending on 

the type of signal and the extent to 

which consumers process the signal, 

full elaboration of the product 

information may be enhanced (as use of 

heuristics decreases). 

Consumers vary in their reactions to 

promotions such as coupons and 

researchers and economists have 

proposed a number of explanations for 

why some consumers are sensitive to 

these tactics. Two such traits are ‘‘price 

consciousness’’ and ‘‘belief in the pricequality relationship.’’ Price 

consciousness is defined as the degree 

to which the consumer focuses 

exclusively on paying low prices. Belief 

in the price-quality relationship is 

defined as the degree to which one 

believes a higher price indicates 

superior quality.10 A broader trait of 

‘‘value consciousness’’ has also been 

used. This trait involves assumptions 

about the construct of perceived value 

and its relationship (a ratio) with the 

constructs of perceived quality and 

perceived price. 

While promotions have been 

extensively studied in the context of 

package goods, information on their 

effects in DTC prescription drug ads is 

limited. One relevant study11 found that 

a free-trial offer in a DTC ad for a high 

cholesterol drug resulted in more 

favorable perceptions of the product and 

the ad (both rated as good/bad, 

favorable/unfavorable, and pleasant/ 

unpleasant), perceptions of the product 

and greater intentions to ask about the 

product. No differences were found in 

terms of perceived product risk. 

However, the study did not measure 

perceptions of product risk and benefit 

separately, or comprehension of risk 

and benefit information. Additionally, 

no attempt was made to control for 

factors that may predispose individuals 

toward coupon use nor was the study 

conducted with the target population 

(high cholesterol sufferers). The current 

study will expand on this initial study 

by investigating a variety of promotional 

offers, recruiting a wider range of the 

target audience from malls and online, 

measuring traits that may predispose 

individuals to be susceptible to coupon 

influence, and by exploring the effects 

of disclosures on the processing of 

product information. 

The current study will examine what 

effect, if any, the presence of 

promotional offers in DTC prescription 

drug ads have on the following: (1) 

Consumers’ perceptions of product risks 

and benefits, (2) comprehension of 

product risks and benefits, and (3) 

strongly held beliefs that may act as 

potential moderators. The study will 

also explore ways in which additional 

contextual information can be used to 

enhance processing of the product 

information in the advertisement.12

Design Overview 

This study will examine type of 

promotional offer (for example, free trial 

offer; money off cost; money back 

guarantee; buy one, get one free; and no 

offer) in three types of drug 

advertisements (prescription drug 

reminder ad, prescription drug full 

product ad, and over-the-counter (OTC) 

drug ad13) in a medium prevalence 

medical condition (defined as 10 

percent prevalence in the adult U.S. 

population). The study will be 

administered in two modes, online and 

mall-intercept, in order to assess the 

effects of mode on study results. The 

following table illustrates the design; 

the specific promotional offers 

examined will be determined through 

pretesting. This study is experimental in 

method: participants will be randomly 

assigned to condition. 

Main Study Design 

Type of Advertisement 

Promotional 

Offer 

(examples) 

Full Product Reminder OTC 

Free trial offer Online Mall Online Mall Online Mall 

Buy one, get 

one free Online Mall Online Mall Online Mall 

Money off cost Online Mall Online Mall Online Mall 

Money back 

guarantee Online Mall Online Mall Online Mall 

Control: No offer Online Mall Online Mall Online Mall 

We also propose to conduct a 

supplementary exploratory study to 

examine the influence of additional 

information as a form of context. The 

supplementary study will examine the 

effect of some forms of qualifying 

context in a full product prescription 

drug ad. This supplementary study will 

examine type of context (for example, 

additional information about product 

risks, additional information about 

product benefits, additional information 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices 57801 

about both risks and benefits, and no 

additional information) in three 

different promotional offers (money 

back guarantee and two others) in a 

medium prevalence medical condition 

(defined previously). This supplemental 

study will be conducted online. One 

type of offer examined will be money 

back guarantee; we will choose the other 

two types of promotional offers based 

on the results of the main study. The 

exact wording of the qualifying context 

to be examined will be determined 

through pretesting. This study is 

experimental in method: Participants 

will be randomly assigned to condition. 

Supplementary Study Design 

Type of Offer 

Type of Context 

(examples) 

Money Back 

Guarantee 

Offer 2 

To be determined 

Offer 3 

To be determined 

Additional information about risk 

Additional information about efficacy 

Additional information about efficacy and risk 

Control: No Context 

Interviews are expected to last no 

more than 20 minutes. A total of 10,000 

participants will be involved in the 

pretesting and two phases of the study. 

This will be a one time (rather than 

annual) collection of information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Pretests 1,000 1 1,000 .33 330 

Main study: online 3,750 1 3,750 .33 1,238 

Main study: mall intercept 2,250 1 2,250 .33 743 

Supplementary study 3,000 1 3,000 .33 990 

Total 10,000 3,301 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23632 Filed 9–21–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0447] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices 

Third-Party Review Under the Food 

and Drug Administration 

Modernization Act 

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 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection requirements for 

the information collection in ‘‘Medical 

Devices Third-Party Review under the 

Food and Drug Administration 

Modernization Act of 1997.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 22, 2010. 

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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–796–5156, 

Daniel.Gittleson@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, 

including each proposed extension of an 


emcdonald on DSK2BSOYB1PROD with NOTICES