Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertising, 39033-39035 [2021-15648]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices
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.
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
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log onto the AGDUFA
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39033
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.
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.
SUMMARY:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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.
E:\FR\FM\23JYN1.SGM
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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).
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 60day 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:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
khammond on DSKJM1Z7X2PROD with NOTICES
CDER Regulated Products:
202.1(e)(6); waiver request ........................................................................
202.1(j)(1); submission of advertisement ..................................................
202.1(j)(1)(iii); assuring that adverse information be publicized ...............
202.1(j)(4); voluntary submission of ad to FDA .........................................
CBER Regulated Products:
202.1(e)(6); waiver request ........................................................................
202.1(j)(1); submission of advertisement ..................................................
202.1(j)(1)(iii); assuring that adverse information be publicized ...............
202.1(j)(4); voluntary submission of ad to FDA .........................................
CVM Regulated Products:
202.1(e)(6); waiver request ........................................................................
202.1(j)(1); submission of advertisement ..................................................
202.1(j)(1)(iii); assuring that adverse information be publicized ...............
202.1(j)(4); voluntary submission of ad to FDA .........................................
Total ....................................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
16:49 Jul 22, 2021
Jkt 253001
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Frm 00065
Total hours
1
1
1
59
1
1
1
1.85
1
1
1
109
12
2
12
20
12
2
12
2,180
1
1
1
7
1
1
1
2.57
1
1
1
18
12
2
12
20
12
2
12
360
1
1
1
7
1
1
1
1
1
1
1
7
12
2
12
20
12
2
12
140
........................
..........................
143
..........................
2,758
are no capital costs or operating and maintenance costs associated with this collection.
VerDate Sep<11>2014
Hours per
response
Fmt 4703
Sfmt 4703
E:\FR\FM\23JYN1.SGM
23JYN1
39035
Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices
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 ..............................................
202.1(j)(1); info. included re. fatalities or serious damage ...............................
670
1
111.08
1
74,425
1
400
40
29,770,000
40
........................
..........................
74,426
..........................
29,770,040
Total ...........................................................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection.
rounded to the nearest one/one-hundredth.
2 Numbers
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
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
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.
khammond on DSKJM1Z7X2PROD with NOTICES
[FR Doc. 2021–15648 Filed 7–22–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:49 Jul 22, 2021
Jkt 253001
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.
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.
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23JYN1.SGM
23JYN1
]]>Agencies
[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39033-39035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15648]
-----------------------------------------------------------------------
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,
[email protected].
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.
[[Page 39034]]
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 (Sec. 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 (Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec.
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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
CDER Regulated Products:
202.1(e)(6); waiver 1 1 1 12 12
request..................
202.1(j)(1); submission of 1 1 1 2 2
advertisement............
202.1(j)(1)(iii); assuring 1 1 1 12 12
that adverse information
be publicized............
202.1(j)(4); voluntary 59 1.85 109 20 2,180
submission of ad to FDA..
CBER Regulated Products:
202.1(e)(6); waiver 1 1 1 12 12
request..................
202.1(j)(1); submission of 1 1 1 2 2
advertisement............
202.1(j)(1)(iii); assuring 1 1 1 12 12
that adverse information
be publicized............
202.1(j)(4); voluntary 7 2.57 18 20 360
submission of ad to FDA..
CVM Regulated Products:
202.1(e)(6); waiver 1 1 1 12 12
request..................
202.1(j)(1); submission of 1 1 1 2 2
advertisement............
202.1(j)(1)(iii); assuring 1 1 1 12 12
that adverse information
be publicized............
202.1(j)(4); voluntary 7 1 7 20 140
submission of ad to FDA..
---------------------------------------------------------------------------------
Total................. .............. ............... 143 ............... 2,758
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
[[Page 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Burden per Total hours
respondents respondent disclosures disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
\2\ Numbers rounded to the nearest one/one-hundredth.
Under Sec. 202.1, advertisements for human and animal prescription
drug and biological products must comply with the standards described
in that section. Under Sec. 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 Sec. 202.1(j)(1).
Table 3--Estimated Annual Disclosure Burden Discussed in Agency Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Information collection recommendations Number of disclosures per Total annual per disclosure Total hours
respondents respondent disclosures (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product name placement, size, and prominence in promotional 715 190.3 136,069 3 408,207
labeling and advertisements' disclosures........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (Sec. Sec. 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
