Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31323 

year, less than once a year, have never 

prescribed a drug for an off-label use). 

For the second suggestion, we agree 

that the frequency of prescribing within 

the practice would be useful to capture 

and have added a question to measure 

this. No difficulties were identified with 

this question during cognitive testing. 

For the third suggestion, we agree that 

this would be a useful measure. In 

response to this comment and peer 

review, we have revised the 

questionnaire to ask about prescribing 

likelihood for the specific off-label use. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Pretest screener ........................................................... 290 1 290 0.08 (5 minutes) .... 23 

Pretest completes ......................................................... 180 1 180 0.33 (20 minutes) .. 59 

Main study screener ..................................................... 2,526 1 2,526 0.08 (5 minutes) .... 202 

Main study completes, Medical Condition 1 ................ 510 1 510 0.33 (20 minutes) .. 168 

Main study completes, Medical Condition 2 ................ 1,090 1 1,090 0.33 (20 minutes) .. 360 

Total ...................................................................... 1,600 ........................ ........................ ............................... 812 

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

II. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, 240–402–7500 and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

*1. ‘‘Distributing Scientific and Medical 

Publications on Unapproved New Uses— 

Recommended Practices—Revised Draft 

Guidance,’’ 2014. https://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

UCM387652.pdf. 

*2. ‘‘Responding to Unsolicited Requests for 

Off-Label Information About Prescription 

Drugs and Medical Devices Draft 

Guidance,’’ 2011. https://www.fda.gov/ 

media/82660/download. 

3. Ajzen, I. 1985. ‘‘From Intentions to 

Actions: A Theory of Planned Behavior.’’ 

In: Action Control: From Cognition to 

Behavior, edited by J. Kuhl and J. 

Beckmann, pp. 11–39. Berlin, Heidelber, 

New York: Springer-Verlag. 

4. Murshid, M.A. and Z. Mohaidin. 2017. 

‘‘Models and Theories of Prescribing 

Decisions: A Review and Suggested a 

New Model.’’ Pharmacy Practice, 15(2), 

990. 

*5. Sable M.R., L.R. Schwartz, P.J. Kelly, et 

al. 2006. ‘‘Using the Theory of Reasoned 

Action to Explain Physician Intention to 

Prescribe Emergency Contraception.’’ 

Perspectives on Sexual and Reproductive 

Health, 38(1), pp. 20–27. https://

www.guttmacher.org/journals/psrh/ 

2006/using-theory-reasoned-actionexplain-physician-intention-prescribe. 

6. Kesselheim, A.S., C.T. Robertson, J.A. 

Myers, et al. 2012. ‘‘A Randomized 

Study of How Physicians Interpret 

Research Funding Disclosures.’’ New 

England Journal of Medicine, 367(12), 

pp. 1119–1127. 

7. Schaeffer, N.C. and S. Presser. 2003. ‘‘The 

Science of Asking Questions.’’ Annual 

Review of Sociology, 29. 

8. Fox, J., M. Earp, and R. Kaplan. 2020. 

‘‘Item Scale Performance.’’ 75th Annual 

American Association for Public 

Opinion Research Virtual Conference. 

9. Ozuru, Y., S. Briner, C.A. Kurby, et al. 

2013. ‘‘Comparing Comprehension 

Measured by Multiple-Choice and OpenEnded Questions. Canadian Journal of 

Experimental Psychology = Revue 

canadienne de psychologie 

experimentale, 67(3), pp. 215–227. 

10. Tanur, J.M. (Ed.). 1992. Questions About 

Questions: Inquiries Into the Cognitive 

Bases of Surveys. Russell Sage 

Foundation. 

Dated: June 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12265 Filed 6–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0371] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Accelerated 

Approval Disclosures on Direct-toConsumer Prescription Drug Websites 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (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 proposed 

study entitled ‘‘Accelerated Approval 

Disclosures on Direct-to-Consumer 

Prescription Drug websites.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 10, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 10, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 10, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 


jbell on DSKJLSW7X2PROD with NOTICES
31324 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0371 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Accelerated Approval Disclosures on 

Direct-to-Consumer Prescription Drug 

websites.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. The questionnaire is 

available upon request from 

DTCResearch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), 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. 

Accelerated Approval Disclosures on 

Direct-to-Consumer Prescription Drug 

Websites 

OMB Control Number 0910–NEW 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

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

conduct research relating to health 

information. Section 1003(d)(2)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(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. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have 

consistently conducted research to 

evaluate the aspects of prescription drug 

promotion that are most central to our 

mission, focusing in particular on three 

main topic areas: Advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and disease and 

product characteristics impact the 


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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31325 

communication and understanding of 

prescription drug risks and benefits. 

Focusing on target populations allows 

us to evaluate how understanding of 

prescription drug risks and benefits may 

vary as a function of audience, and our 

focus on research quality aims at 

maximizing the quality of our research 

data through analytical methodology 

development and investigation of 

sampling and response issues. This 

study will inform the first topic area, 

advertising features, including content 

and format; and the second topic area, 

target populations. 

Because we recognize the strength of 

data and the confidence in the robust 

nature of the findings is improved 

through the results of multiple 

converging studies, we continue to 

develop evidence to inform our 

thinking. We evaluate the results from 

our studies within the broader context 

of research and findings from other 

sources, and this larger body of 

knowledge collectively informs our 

policies as well as our research program. 

Our research is documented on our 

homepage, which can be found at: 

https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/ 

office-prescription-drug-promotionopdp-research. The website includes 

links to the latest Federal Register 

notices and peer-reviewed publications 

produced by our office. The website 

maintains information on studies we 

have conducted, dating back to a directto-consumer (DTC) survey conducted in 

1999. 

Background 

Pursuant to section 506(c) of the 

FD&C Act (21 U.S.C. 356(c)) and 21 CFR 

part 314, subpart H (or 21 CFR part 601, 

subpart E for biological products), FDA 

may grant accelerated approval to a drug 

product under section 505(c) of the 

FD&C Act or a biological product under 

section 351(a) of the Public Health 

Service Act (42 U.S.C. 262(a)). This 

pathway enables faster approval of 

prescription drugs intended to treat 

serious or life-threatening illnesses. 

Accelerated approval may be based on 

a determination that a drug product has 

an effect on a surrogate endpoint (for 

example, a blood test result) that is 

reasonably likely to predict clinical 

benefit, or on a clinical endpoint that 

can be measured earlier than 

irreversible morbidity or mortality, that 

is reasonably likely to predict an effect 

on irreversible morbidity or mortality or 

other clinical benefit (i.e., an 

intermediate clinical endpoint). In 

approving a drug under the accelerated 

approval pathway, the severity, rarity, 

or prevalence of a condition, and the 

availability or lack of alternative 

treatments, are taken into account. 

The accelerated approval pathway is 

limited to certain products intended to 

treat serious or life-threatening illnesses 

as there can be ‘‘[u]ncertainty about 

whether clinical benefit will be verified 

and the possibility of undiscovered 

risks’’ (FDA 2014 guidance for industry 

entitled ‘‘Expedited Programs for 

Serious Conditions—Drugs and 

Biologics,’’ available at https://

www.fda.gov/downloads/Drugs/ 

Guidances/UCM358301.pdf). Sponsors 

are generally required to conduct post 

approval studies to verify and describe 

the predicted clinical benefit, but those 

confirmatory studies are not complete at 

the time that the accelerated approval is 

granted (Ref. 1). In the event that the 

required post-approval confirmatory 

studies fail to verify and describe the 

predicted effect or clinical benefit, a 

drug’s approval can be withdrawn using 

expedited procedures. 

Under FDA regulations governing 

physician labeling for prescription 

drugs, the INDICATIONS AND USAGE 

section of FDA-approved prescribing 

information for a drug approved under 

accelerated approval must include not 

only the indication (21 CFR 201.57(c)) 

but also a ‘‘succinct description of the 

limitations of usefulness of the drug and 

any uncertainty about anticipated 

clinical benefits . . .’’ (21 CFR 

201.57(c)(2)(i)(B)). In a guidance, FDA 

recommended that in addition to these 

required elements, the INDICATIONS 

AND USAGE section for drugs approved 

under accelerated approval should 

generally acknowledge that continued 

approval for the drug or indication may 

be contingent on verification and 

description of clinical benefit in 

confirmatory trials (FDA 2019 guidance 

for industry entitled ‘‘Labeling for 

Human Prescription Drug and Biological 

Products Approved Under the 

Accelerated Approval Pathway,’’ 

available at https://www.fda.gov/

downloads/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/

UCM390058.pdf). 

Some DTC websites have included 

disclosures about accelerated approval, 

and of those, many included similar 

content to that seen in the 

INDICATIONS AND USAGE section of 

approved labeling. A content analysis of 

DTC websites for accelerated approval 

products found that 21 percent of the 

disclosures used language directly from 

the approved physician labeling, 79 

percent of the disclosures used at least 

some medical language, but 27 percent 

of the websites did not include any 

disclosure that the products attained 

approval through this pathway (Ref. 2). 

The same analysis found that 84 percent 

of accelerated approval disclosures on 

DTC websites mentioned the approval 

basis, 68 percent mentioned unknown 

outcomes, and 47 percent mentioned 

confirmatory trials (Ref. 2). 

OPDP recently conducted a generalpopulation study testing the disclosure 

of FDA accelerated approval 

information on a DTC prescription drug 

website (OMB control number 0910– 

0872—Experimental Study of an 

Accelerated Approval Disclosure). The 

study tested a control condition with no 

disclosure; a disclosure based on 

wording used in physician labeling, 

including more complex or technical 

terminology (physician-labeling 

disclosure); and a consumer-friendly 

disclosure drafted using simpler 

language intended to be suited for that 

audience (consumer-friendly 

disclosure). The disclosures had three 

elements: (1) Approval basis, (2) 

unknown outcomes, and (3) 

confirmatory trials. The physician 

labeling disclosure was ‘‘This indication 

is based on response rate. An 

improvement in survival or diseaserelated symptoms has not been 

established. Continued approval for this 

indication may be contingent upon 

verification of clinical benefit in 

subsequent trials.’’ The consumerfriendly disclosure was ‘‘In a clinical 

trial, [Drug X] returned blood counts to 

normal. However, we currently do not 

know if [Drug X] helps people live 

longer or feel better. We continue to 

study [Drug X] in clinical trials to learn 

more about [Drug X]’s benefits.’’ We also 

varied whether the physician-labeling 

and consumer-friendly disclosures were 

presented with low or high prominence 

(varying the size, color, and location of 

the disclosure). Preliminary results 

related to the comprehension of the 

disclosures tested in that study suggest 

that the consumer-friendly disclosure 

helped participants understand 

information related to the drug’s 

accelerated approval, but that 

participants’ understanding was low 

overall. 

New Proposed Study 

The purpose of the current project is 

to replicate and extend our prior 

research through two studies by: (1) 

Testing the same experimental 

conditions with a different study 

population (cancer survivors and cancer 

caregivers in study 1) and (2) testing 

additional consumer-friendly 

disclosures in study 2. Replication is an 

important part of science and, if 

confirmation of prior results is seen, can 


jbell on DSKJLSW7X2PROD with NOTICES
31326 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

increase confidence in the results from 

our first study. 

With regard to proposed Study 1, 

public comments for FDA’s previous 

accelerated approval disclosure study 

and other similar FDA studies have 

suggested conducting studies with 

people who have been diagnosed with 

the medical condition or who are 

caregivers to patients diagnosed with 

the medical condition that the fictitious 

drug in the study is intended to treat. 

Specifically, public comments on the 

previous study suggested enrolling 

participants who have been diagnosed 

with cancer (i.e., cancer survivors) or 

people who have cared for loved ones 

with cancer (i.e., cancer caregivers). 

Because a number of oncology products 

are granted accelerated approval, cancer 

survivors and cancer caregivers are 

more likely to seek out or be exposed to 

promotion for accelerated approval 

products than the general population. 

They may also be more familiar with 

cancer-related terms and concepts than 

the general population. Study 1 will 

involve cancer survivors and cancer 

caregivers, a different population than 

our prior study. It will test the ‘‘three 

element’’ version of the disclosure as 

noted above. We will also test the 

prominence of the disclosure (see table 

1). 

With regard to study 2, public 

comments on the original study (Docket 

No. FDA–2018–N–3138) expressed 

concern that over-disclosure could 

dissuade consumers from considering 

accelerated approval products. One 

public comment specifically suggested 

removing the ‘‘unknown outcomes’’ 

element in the consumer-friendly and 

physician-labeling disclosures. Based on 

these comments, in study 2, we propose 

testing four versions of the consumerfriendly disclosure (table 2): The ‘‘three 

element’’ version of the consumerfriendly disclosure as well as three other 

consumer-friendly disclosures that vary 

with respect to which of these three 

elements they address. This will allow 

us to evaluate the impact on 

participants’ comprehension of the 

disclosure and perception of the 

fictitious drug when they view a 

disclosure with only the approval basis, 

the approval basis plus information 

about the unknown outcomes, the 

approval basis plus information about 

confirmatory trials, and finally the 

approval basis plus information about 

both the unknown outcomes and 

confirmatory trials. In study 2, the 

prominence of all the test conditions 

will be the same and will be the same 

as the ‘‘high prominence’’ version tested 

in study 1. 

We plan to conduct two pretests not 

longer than 20 minutes, administered 

via internet panel, to pilot the main 

study procedures. We then plan to 

conduct two main studies not longer 

than 20 minutes, administered via 

internet panel. For the pretests and 

main studies, we will randomly assign 

the participants to one of the test 

conditions (see table 1 for the study 1 

design and table 2 for the study 2 

design). In both studies, participants 

will view a website for a fictitious 

oncology prescription drug. After 

viewing the website, participants will 

complete a questionnaire that assesses 

whether participants noticed the 

disclosure and their understanding of it, 

as well as perceptions of the drug’s risks 

and benefits. We will also measure 

covariates such as demographics and 

literacy. The questionnaire is available 

upon request from DTCresearch@

fda.hhs.gov. 

For study 1, we hypothesize that 

participants will be more likely to 

notice the disclosure when it is 

presented more, rather than less, 

prominently. In turn, we expect that 

participants’ perceptions of the drug are 

more likely to be affected by the 

disclosure in the high prominence 

condition. We also hypothesize that 

participants will be more likely to 

notice and understand the disclosure 

and use it to form their perceptions of 

the drug if they view the consumerfriendly language. For study 2, we 

hypothesize that participants will be 

more likely to understand each 

accelerated approval concept (i.e., 

confirmatory trials, unknown outcomes) 

when the disclosure directly addresses 

the concept, compared with when the 

disclosure does not directly address the 

concept. Finally, we will explore 

whether the inclusion of the concepts of 

confirmatory trials and unknown 

outcomes in the disclosure affects 

participants’ perceived risk, perceived 

risk-benefit tradeoff, perceptions of the 

website, or information-seeking 

intentions. To test these hypotheses, we 

will conduct inferential statistical tests 

such as logistic regression and analysis 

of variance. 

For the pretests and main studies, we 

plan to recruit individuals who report a 

diagnosis with any cancer (except for 

certain non-melanoma skin cancers) for 

half the sample and individuals who 

report being a caregiver for someone 

with a diagnosis with any cancer 

(except for certain non-melanoma skin 

cancers) for the other half of the sample. 

We will exclude individuals who work 

for the U.S. Department of Health and 

Human Services or work in the health 

care, marketing, advertising, or 

pharmaceutical industries. With the 

sample sizes described below, we will 

have sufficient power to detect smallsized effects in the main study (table 3). 

TABLE 1—STUDY 1 DESIGN

High prominence Low prominence Absent 

Physician-labeling version ........................ Condition 1 .............................................. Condition 3 .............................................. Condition 5. 

Consumer-friendly version ....................... Condition 2 .............................................. Condition 4.

TABLE 2—STUDY 2 DESIGN

Consumer-friendly disclosure elements 

Approval basis Approval basis + unknown 

outcomes 

Approval basis + 

confirmatory trials 

Approval basis + unknown 

outcomes + confirmatory 

trials 

High prominence .................... Condition 6 ....................... Condition 7 ....................... Condition 8 ....................... Study 1 Condition 2. 


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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31327 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Pretest 1 and 2 screener ......................................... 3,600 1 1 0.08 (5 minutes) ........ 288 

Study 1 and 2 screener ........................................... 20,600 1 1 0.08 (5 minutes) ........ 1,648 

Pretest 1 ................................................................... 100 1 1 0.33 (20 minutes) ...... 33 

Main Study 1 ............................................................ 630 1 1 0.33 (20 minutes) ...... 208 

Pretest 2 ................................................................... 80 1 1 .33 (20 minutes) ........ 26 

Main Study 2 ............................................................ 400 1 1 0.33 (20 minutes) ...... 132 

Total .................................................................. ........................ ........................ ........................ .................................... 2,335 

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

References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES), and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

1. Beaver J.A., L.J. Howie L.J., L. Pelosof L, 

et al. ‘‘A 25-Year Experience of U.S. 

Food and Drug Administration 

Accelerated Approval of Malignant 

Hematology and Oncology Drugs and 

Biologics: A Review.’’ JAMA Oncology. 

2018; 4(6):849–856. doi:10.1001/ 

jamaoncol.2017.5618 

2. Sullivan H.W., A.C. O’Donoghue, K.T. 

David, N.J. Patel. ‘‘Disclosing 

Accelerated Approval on Direct-toConsumer Prescription Drug Websites.’’ 

Pharmacoepidemiology and Drug Safety. 

2018;27:1277–1280. https://doi.org/ 

10.1002/pds.4664 

Dated: June 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12264 Filed 6–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0369] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Regulations Under 

the Federal Import Milk Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by July 12, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0212. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Regulations Under the Federal Import 

Milk Act (FIMA)—21 CFR Part 1210 

OMB Control Number 0910–0212— 

Extension 

This information collection supports 

FDA regulations. Under FIMA (21 

U.S.C. 141–149), milk or cream may be 

imported into the United States only by 

the holder of a valid import milk permit 

(21 U.S.C. 141). Before such permit is 

issued: (1) All cows from which import 

milk or cream is produced must be 

physically examined and found healthy; 

(2) if the milk or cream is imported raw, 

all such cows must pass a tuberculin 

test; (3) the dairy farm and each plant 

in which the milk or cream is processed 

or handled must be inspected and found 

to meet certain sanitary requirements; 

(4) bacterial counts of the milk at the 

time of importation must not exceed 

specified limits; and (5) the temperature 

of the milk or cream at time of 

importation must not exceed 50 °F (21 

U.S.C. 142). 

Our regulations in part 1210 (21 CFR 

part 1210) implement the provisions of 

FIMA. Sections 1210.11 and 1210.14 

require reports on the sanitary 

conditions of, respectively, dairy farms 

and plants producing milk and/or cream 

to be shipped to the United States. 

Section 1210.12 requires reports on the 

physical examination of herds, while 

§ 1210.13 requires the reporting of 

tuberculin testing of the herds. In 

addition, the regulations in part 1210 

require that dairy farmers and plants 

maintain pasteurization records 

(§ 1210.15) and that each container of 

milk or cream imported into the United 

States bear a tag with the product type, 

permit number, and shipper’s name and 


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