0686 SS 2017 Extension

FOOD AND DRUG ADMINISTRATION
Prescription Drug Advertisements
OMB Control No. 0910-0686
SUPPORTING STATEMENT

Part A. Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) regulations. Section
502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act, FFDCA) (21 U.S.C.
352(n)) requires that manufacturers, packers, and distributors (sponsors) who advertise
prescription human and animal drugs, including biological products for humans, disclose in
advertisements certain information about the advertised product's uses and risks. For
prescription drugs and biologics, section 502(n) of the FD&C Act requires advertisements to
contain “* * * a true statement * * *” of certain information including “* * * information in brief
summary relating to side effects, contraindications, and effectiveness * * *” as required by
regulations issued by FDA. FDA's prescription drug advertising regulations at § 202.1 (21 CFR
202.1) 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).
Accordingly, FDA is requesting OMB approval of the information collection provisions found in
the regulations regarding prescription drug advertisements as codified in 21 CFR Part 202:
Prescription Drug Advertising.
2. Purpose and Use of the Information Collection
The information collection implements section 502(n) of the FFDCA, which describes
requirements and standards for print and broadcast advertisements. The statute is codified at 21
CFR 202.1 and applies to advertisements published in journals, magazines, other periodicals, and
newspapers, and advertisements broadcast through media such as radio, television, and telephone
communication systems. The information collection allows FDA to determine compliance with
the regulations.

3. Use of Improved Information Technology and Burden Reduction
FDA has issued several guidance documents to assist manufacturers in complying with § 202.1.
These guidance documents are available at FDA's website:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of any duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
According to the Small Business Administration (SBA), “small” is any pharmaceutical
preparations manufacturing entity (NAICS 325412) with fewer than 750 employees and any
biologics product manufacturing entity (NAICS 325414) with fewer than 500 employees. We
therefore estimate that 5 entities may be impacted. At the same time, compliance with the
regulations ensures protection of the public health and thus the regulations provide for no
exemptions from the requirements.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory requirements of the FFDCA.
7. Special Circumstances Relating to the Guidelines in 5 CFR 1320.5
There are no special circumstances relating to the information collection.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the
Federal Register of May 23, 2017 (82 FR 23574). While we received one comment in response
to the notice, it did not respond to any of the four information collection topics solicited in the
notice and was therefore not addressed in our 30 day notice, nor here in this supporting
statement.
9. Explanation of Any Payment or Gift to Respondents
There is no payment or gift to respondents associated with these regulations.

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10. Assurance of Confidentiality Provided to Respondents
Confidentiality of the information submitted under these requirements is protected under 21 CFR
314.430 and under 21 CFR part 20. The unauthorized use or disclosure of trade secrets required
in applications is specifically prohibited under Section 310(j) of the Act.
11. Justification for Sensitive Questions
There are no sensitive questions associated with the information collection.
12. Estimates of Annualized Hour Burden and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden associated with the information collection as follows:
Table 1.--Estimated Annual Reporting Burden1
21 CFR Section or Activity

No. of
Respondents

No. of Responses
per Respondent

Total
Annual
Responses

Hours per
Response

CDER:
202.1(e)(6); waiver request
1
1
1
202.1(j)(1); submission of
1
1
1
advertisement
202.1(j)(1)(iii); assuring that
1
1
1
adverse information be
publicized
202.1(j)(4); voluntary
71
6.97
495
submission of ad to FDA
CBER:
202.1(e)(6); waiver request
0
0
0
202.1(j)(1); submission of
0
0
0
advertisement
202.1(j)(1)(iii); assuring that
0
0
0
adverse information be
publicized
202.1(j)(4); voluntary
9
8
72
submission of ad to FDA
CVM:
202.1(e)(6); waiver request
0
0
0
202.1(j)(1); submission of
0
0
0
advertisement
202.1(j)(1)(iii); assuring that
0
0
0
adverse information be
publicized
202.1(j)(4); voluntary
5
1
5
submission of ad to FDA
Total
1
There are no capital costs or operating and maintenance costs associated with this collection.

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Total Hours

12
2

12
2

12

12

20

9,900

12
2

0
0

12

0

20

1,440

12
2

0
0

12

0

20

100
11,466

Table 2.--Estimated Annual Third-Party Disclosure Burden1, 2
21 CFR Section or
Activity

No. of
Respondents

No. of Disclosures
per Respondent

Total
Annual
Disclosures

Burden per
Disclosure

CDER:
202.1; ad prepared in
394
105.3
41,494
accordance with 21 CFR
Part 202
202.1(j)(1); info. included
1
1
1
re. fatalities or serious
damage
CBER:
202.1; ad prepared in
47
63.4
2,984
accordance with 21 CFR
Part 202
202.1(j)(1); info. included
0
0
0
re. fatalities or serious
damage
CVM:
202.1; ad prepared in
25
36
900
accordance with 21 CFR
Part 202
202.1(j)(1); info. included
0
0
0
re. fatalities or serious
damage
Total
1
There are no capital costs or operating and maintenance costs associated with this collection.
2
Numbers rounded to the nearest one/one-hundredth.

Total Hours

400

16,597,600

40

40

400

1,193,600

40

0

400

360,000

40

0

18,151,240

Reporting to FDA
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.
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Under § 202.1(j)(4), a sponsor may voluntarily submit advertisements to FDA for comment prior
to publication.
Third Party Disclosures to the Public
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.
12b. Annualized Cost Burden Estimate
For the estimated annualized cost to industry we use a wage rate of $75 per hour for labor
costs multiplied by the total number of burden hours calculated above (18,162,706), which
results in $1,362,202,950.
13. Estimates of Other Total Annual Cost Burden to Respondents and/or Recordkeepers/Capital
Costs
There are no other capital expenditure, start-up, operating or maintenance costs associated with
this information collection.
14. Annualized Cost to the Federal Government
FDA currently has allocated approximately 38 FTEs to the review of submissions required by the
information collection. We use a fully-loaded labor cost of $150,000 for each FTE, for a total
estimated cost to the Federal Government of $5,700,000.
15. Explanation for Program Changes or Adjustments
The information collection reflects agency adjustments. While the number of annual burden
hours increased from 10,076,426 hours to 18,162,706 hours (+8,086,280), the number of annual
responses has decreased from 25,839 to 21,804 (-4,035). We attribute the increase to an increase
in third party disclosures, where there is decrease in the number of submissions under 21 CFR
202.1(j)(4). Also, FDA has consolidated the IC list appearing at www.reginfo.gov by
consolidating the previously itemized regulatory provisions into reporting and third party
disclosure categories. We believe this will assist the reader by more easily identifying the
summary of cumulative fluctuations for the collection. At the same time, readers may still view
estimated burden associated with individual provisions by referring to the agency’s 60-day and
30-day notices and in the burden tables found in Q.12: Estimates of Annualized Burden Hours
and Costs of this supporting statement.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans for tabulation and publication and project time scheduling.
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17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration data will be displayed as required.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no new exceptions to the certification.

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