Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39033 

When paying by check, bank draft, or 

U.S. postal money order, please write 

your application’s unique Payment 

Identification Number (PIN), beginning 

with the letters ‘‘AG’’, on the upper 

right-hand corner of your completed 

Animal Generic Drug User Fee Cover 

Sheet. Also write FDA’s post office box 

number (P.O. Box 979033) and PIN on 

the enclosed check, bank draft, or 

money order. Mail the payment and a 

copy of the completed Animal Generic 

Drug User Fee Cover Sheet to: Food and 

Drug Administration, P.O. Box 979033, 

St. Louis, MO 63197–9000. Note: In no 

case should the payment for the fee be 

submitted to FDA with the application. 

When paying by wire transfer, it is 

required that the invoice number or PIN 

is included; without the invoice number 

or PIN the payment may not be applied, 

and the invoice amount would be 

referred to collections. The originating 

financial institution may charge a wire 

transfer fee. If the financial institution 

charges a wire transfer fee, it is required 

to add that amount to the payment to 

ensure that the invoice is paid in full. 

Use the following account information 

when sending a wire transfer: U.S. 

Department of the Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Account Name: Food and Drug 

Administration, Account No.: 75060099, 

Routing No.: 021030004, SWIFT No.: 

FRNYUS33. 

To send a check by a courier such as 

Federal Express, the courier must 

deliver the check and printed copy of 

the cover sheet to: U.S. Bank, Attn: 

Government Lockbox 979033, 1005 

Convention Plaza, St. Louis, MO 63101. 

(Note: This address is for courier 

delivery only. If you have any questions 

concerning courier delivery, contact 

U.S. Bank at 314–418–4013. This phone 

number is only for questions about 

courier delivery.) 

It is important that the fee arrives at 

the bank at least a day or two before the 

abbreviated application arrives at FDA’s 

CVM. FDA records the official 

abbreviated application receipt date as 

the later of the following: The date the 

application was received by CVM, or the 

date U.S. Bank notifies FDA that your 

payment in the full amount has been 

received, or when the U.S. Department 

of the Treasury notifies FDA of 

payment. U.S. Bank and the United 

States Treasury are required to notify 

FDA within 1 working day, using the 

PIN described previously. 

The tax identification number of FDA 

is 53–0196965. 

B. Application Cover Sheet Procedures 

Step One—Create a user account and 

password. Log onto the AGDUFA 

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

ForIndustry/UserFees/AnimalGeneric

DrugUserFeeActAGDUFA/ 

ucm137049.htm and scroll down the 

page until you find the link ‘‘Create 

AGDUFA User Fee Cover Sheet.’’ Select 

that link and follow the directions. For 

security reasons, each firm submitting 

an application will be assigned an 

organization identification number, and 

each user will also be required to set up 

a user account and password the first 

time you use this site. Online 

instructions will walk you through this 

process. 

Step Two—Create an Animal Generic 

Drug User Fee Cover Sheet, transmit it 

to FDA, and print a copy. After logging 

into your account with your user name 

and password, complete the steps 

required to create an Animal Generic 

Drug User Fee Cover Sheet. One cover 

sheet is needed for each abbreviated 

application for a generic new animal 

drug. Once you are satisfied that the 

data on the cover sheet is accurate and 

you have finalized the cover sheet, you 

will be able to transmit it electronically 

to FDA and you will be able to print a 

copy of your cover sheet showing your 

unique PIN. 

Step Three—Send the payment for 

your application as described in section 

VIII.A. 

Step Four—Please submit your 

application and a copy of the completed 

Animal Generic Drug User Fee Cover 

Sheet to the following address: Food 

and Drug Administration, Center for 

Veterinary Medicine, Document Control 

Unit (HFV–199), 7500 Standish Pl., 

Rockville, MD 20855. 

C. Product and Sponsor Fees 

By December 31, 2021, FDA will issue 

invoices and payment instructions for 

product and sponsor fees for FY 2022 

using this fee schedule. Fees will be due 

by January 31, 2022. FDA will issue 

invoices in November 2022 for any 

products and sponsors subject to fees for 

FY 2022 that qualify for fees after the 

December 2021 billing. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15642 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0363] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prescription Drug 

Advertising 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 August 23, 

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 0910–0686. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St. North Bethesda, MD 

20852, 301–796–5733, 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. 

Prescription Drug Advertising—21 CFR 

Part 202 

OMB Control Number 0910–0686— 

Extension 

This information collection supports 

Agency regulations and associated 

guidance. FDA protects the public 

health by assuring the safety, 

effectiveness, and security of a wide 

range of products. We also help 

consumers get accurate, science-based 

information they need to use medicines 

appropriately and improve their health. 


khammond on DSKJM1Z7X2PROD with NOTICES
39034 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

Section 301 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 331) prohibits the misbranding of 

FDA-regulated products, including 

prescription drugs. Section 502 of the 

FD&C Act (21 U.S.C. 352) requires that 

manufacturers, packers, and 

distributors, or anyone acting on their 

behalf (firms) include certain 

information in human prescription drug 

promotional labeling and 

advertisements. 

Our prescription drug advertising 

regulations in part 202 (21 CFR part 

202) describe requirements and 

standards for print and broadcast 

advertisements. Section 202.1 applies to 

advertisements published in journals, 

magazines, other periodicals, and 

newspapers, and advertisements 

broadcast through media such as radio, 

television, and telephone 

communication systems. Print 

advertisements must include a brief 

summary of each of the risk concepts 

from the product’s approved package 

labeling (§ 202.1(e)(1)). Advertisements 

that are broadcast through media such 

as television, radio, or telephone 

communications systems must disclose 

the major risks from the product’s 

package labeling in either the audio or 

audio and visual parts of the 

presentation (§ 202.1(e)(1)); this 

disclosure is known as the ‘‘major 

statement.’’ If a broadcast advertisement 

omits the major statement, or if the 

major statement minimizes the risks 

associated with the use of the drug, the 

advertisement could render the drug 

misbranded in violation of the FD&C 

Act (21 U.S.C. 352(n) and section 201 of 

the FD&C Act (21 U.S.C. 321(n)), and 

FDA’s implementing regulations at 

§ 202.1(e). 

Section 202.1(e)(6) provides for 

certain waivers. The waiver request 

must set forth clearly and concisely the 

petitioner’s interest in the 

advertisement, the specific provision of 

§ 202.1(e)(6) from which a waiver is 

sought, a complete copy of the 

advertisement, and a showing that the 

advertisement is not false, lacking in fair 

balance or otherwise misleading, or 

otherwise violative of section 502(n) of 

the FD&C Act. 

Under § 202.1(j)(1), a sponsor must 

submit advertisements to FDA for prior 

approval before dissemination if: (1) 

The sponsor or FDA has received 

information that has not been widely 

publicized in medical literature that the 

use of the drug may cause fatalities or 

serious damage; (2) FDA has notified the 

sponsor that the information must be 

part of the advertisements for the drug; 

and (3) the sponsor has failed to present 

to FDA a program for assuring that such 

information will be publicized promptly 

and adequately to the medical 

profession in subsequent 

advertisements, or if such a program has 

been presented to FDA but is not being 

followed by the sponsor. 

Under § 202.1(j)(1)(iii), a sponsor 

must provide to FDA a program for 

assuring that significant new adverse 

information about the drug that becomes 

known (i.e., use of drug may cause 

fatalities or serious damage) will be 

publicized promptly and adequately to 

the medical profession in any 

subsequent advertisements. Under 

§ 202.1(j)(4), a sponsor may voluntarily 

submit advertisements to FDA for 

comment prior to publication. 

While the regulations establish 

requirements for prescription drug 

advertisements, we have developed the 

guidance document entitled, ‘‘Product 

Name Placement, Size, and Prominence 

in Promotional Labeling and 

Advertisements; Guidance for Industry’’ 

to clarify requirements for product name 

placement, size, prominence, and 

frequency in promotional labeling and 

advertisements for human and animal 

prescription drugs and prescription 

biological products. The guidance 

includes recommendations that pertain 

to traditional print promotional labeling 

and advertisements (e.g., journal ads, 

detail aids, brochures), audiovisual 

promotional labeling (e.g., videos shown 

in a healthcare provider’s office), 

broadcast advertisements (e.g., 

television advertisements, radio 

advertisements), and electronic and 

computer-based promotions (e.g., 

internet, social media, emails, CD– 

ROMs, DVDs). The guidance document 

was issued consistent with our Good 

Guidance Practice regulations in part 

10.115 which provide for public 

comment at any time, and is available 

from our website at: https://

www.fda.gov/media/87202/download. 

In the Federal Register of April 29, 

2021 (86 FR 22686), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. Three comments were 

received, all generally supportive of 

FDA’s drug advertising regulations; 

however, some commenters suggested 

FDA might do more to promote truthful 

advertising with regard to prescription 

drug products. We appreciate all 

comments. No comment suggested a 

revision to our current estimate for the 

information collection. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Hours per 

response Total hours 

CDER Regulated Products: 

202.1(e)(6); waiver request ........................................................................ 1 1 1 12 12 

202.1(j)(1); submission of advertisement .................................................. 1 1 1 2 2 

202.1(j)(1)(iii); assuring that adverse information be publicized ............... 1 1 1 12 12 

202.1(j)(4); voluntary submission of ad to FDA ......................................... 59 1.85 109 20 2,180 

CBER Regulated Products: 

202.1(e)(6); waiver request ........................................................................ 1 1 1 12 12 

202.1(j)(1); submission of advertisement .................................................. 1 1 1 2 2 

202.1(j)(1)(iii); assuring that adverse information be publicized ............... 1 1 1 12 12 

202.1(j)(4); voluntary submission of ad to FDA ......................................... 7 2.57 18 20 360 

CVM Regulated Products: 

202.1(e)(6); waiver request ........................................................................ 1 1 1 12 12 

202.1(j)(1); submission of advertisement .................................................. 1 1 1 2 2 

202.1(j)(1)(iii); assuring that adverse information be publicized ............... 1 1 1 12 12 

202.1(j)(4); voluntary submission of ad to FDA ......................................... 7 1 7 20 140 

Total .................................................................................................... ........................ .......................... 143 .......................... 2,758 

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


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39035 

Our estimate of burden we attribute to 

the reporting provisions in part 202 is 

based on our experience with the 

collection and a review of Agency data. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Burden per 

disclosure Total hours 

202.1; ad prepared in accordance with part 202 .............................................. 670 111.08 74,425 400 29,770,000 

202.1(j)(1); info. included re. fatalities or serious damage ............................... 1 1 1 40 40 

Total ........................................................................................................... ........................ .......................... 74,426 .......................... 29,770,040 

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

2 Numbers rounded to the nearest one/one-hundredth. 

Under § 202.1, advertisements for 

human and animal prescription drug 

and biological products must comply 

with the standards described in that 

section. Under § 202.1(j)(1), if 

information that the use of a 

prescription drug may cause fatalities or 

serious damage has not been widely 

publicized in the medical literature, a 

sponsor must include such information 

in the advertisements for that drug. 

Based on a review of Agency data we 

estimate an average of 29,770,040 hours 

is incurred annually by respondents in 

complying with third-party disclosure 

requirements for prescription drug 

advertising. We assume a placeholder of 

1 for disclosures under § 202.1(j)(1). 

TABLE 3—ESTIMATED ANNUAL DISCLOSURE BURDEN DISCUSSED IN AGENCY GUIDANCE

Information collection recommendations Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure 

(in hours) 

Total hours 

Product name placement, size, and prominence in promotional labeling and 

advertisements’ disclosures .......................................................................... 715 190.3 136,069 3 408,207 

The placement, size, prominence, and 

frequency of the proprietary and 

established names for human 

prescription drugs, including 

prescription biological products, and 

animal prescription drugs are specified 

in labeling and advertising regulations 

(§§ 201.10(g) and (h); 202.1(b)–(d)). 

Based on Agency data, we estimate that, 

for human and animal prescription 

drugs and prescription biological 

products, an average of 715 firms 

disseminate approximately 136,069 

advertisements and promotional pieces 

each year. We assume that the burden 

associated with complying with the 

regulatory requirements discussed in 

the guidance would be approximately 3 

hours per response. 

We have adjusted our estimate 

upward to reflect increases in 

prescription drug advertisements and 

associated disclosures. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15648 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0387] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recommended 

Content of Medical Product 

Communications That Are Consistent 

With the Food and Drug 

Administration-Required Labeling and 

Recommendations for Drug and 

Device Manufacturer Communications 

With Payors, Formulary Committees, 

and Similar Entities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 August 23, 

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 numbers for the collections of 

information are 0910–0856 and 0910– 

0857. Also include the FDA docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St. North Bethesda, MD 

20852, 301–796–5733, 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. 

I. Medical Product Communications 

That Are Consistent With the FDARequired Labeling—Questions and 

Answers 

OMB Control Number 0910–0856— 

Extension 

This information collection supports 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) and FDA’s 

implementing regulations that govern 

drug and device labeling and 

prescription drug and restricted device 

advertising. Section 502(a) of the FD&C 

Act (21 U.S.C. 352(a)) specifies that a 

drug or device shall be deemed to be 

misbranded if its labeling is false or 


khammond on DSKJM1Z7X2PROD with NOTICES