0435 PDMA SSA 2018 Ext

U.S. Food & Drug Administration
Prescription Drug Marketing Regulations:
21 CFR Part 203
OMB Control No. 0910-0435
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations. Specifically, the Federal Food, Drug, and Cosmetic Act (FD&C Act, the act), as
amended by the Prescription Drug Marketing Act of 1987 (PDMA), establishes requirements
for the reimportation and wholesale distribution of prescription drugs; the sale, purchase, or
trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by
hospitals or health care entities, or donated to charitable organizations; and the distribution of
prescription drug samples. Because insufficient safeguards existed over the drug distribution
system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit
drugs, and that a wholesale drug diversion submarket had developed that prevented effective
control over the true sources of drugs, PDMA was enacted. PDMA is intended to ensure that
drug products purchased by consumers are safe and effective and to avoid an unacceptable
risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold.
Requirements under PDMA are codified at 21 CFR Part 203: Prescription Drug Marketing.
We therefore request extension of OMB approval for the information collection provisions set
forth under 21 CFR Part 203 and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The purpose of the Part 203 regulations is to implement the Prescription Drug Marketing Act
of 1987 and the Prescription Drug Amendments of 1992, except for those sections relating to
State licensing of wholesale distributors (see 21 CFR Part 205), to protect the public health,
and to protect the public against drug diversion by establishing procedures, requirements, and
minimum standards for the distribution of prescription drugs and prescription drug samples.
The regulatory requirements provide for records and reports that FDA evaluates to determine
compliance with the regulations.
Respondents: Respondents to the information collection are persons or entities engaged in
prescription drug marketing as described in FDA regulations at 21 CFR Part 203.

3. Use of Improved Information Technology and Burden Reduction
The regulations incorporate by reference Part 11 regulatory requirements, as well as related
guidance for industry entitled “Part 11, Electronic Records; Electronic Signatures — Scope
and Application,” permitting the use of electronic records, electronic signatures, and
handwritten signatures executed to electronic records (either alone or in combination with
paper records) to create and maintain required records and signatures. The regulations
otherwise prescribe no specific requirements regarding the means by which reporting and
recordkeeping is to be satisfied. Respondents are free to choose whatever methods they find
most preferable and we anticipate all will utilize electronic technology to do so.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. While FDA has established
information collections to support other agency regulations, this information collection
specifically covers provisions found in 21 CFR 203 implementing prescription drug
marketing requirements mandated by the FD&C Act.
5. Impact on Small Businesses or Other Small Entities
The regulatory requirements are intended to protect the public health and apply equally to all
respondents. However, we do not believe the requirements impose undue burden on small
entities. Rather, we believe the information collection requirements are the minimum
necessary to ensure the safety and effectiveness of human drug products covered by the
regulations. At the same time, we assist small businesses in complying with our regulations
through contact with scientific and administrative staffs within the agency. A Small Business
Guide is also available on our website at
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements.
7. Special Circumstances Relating to the Guidelines in 5 CFR 1320.5
There are no inconsistencies with this provision.
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 December 14, 2017 (82 FR 58808). One caller responded to the
notice asking about the impact the Drug Supply Chain Security Act (DSCSA) has on the
information collection. We noted that we are currently proposing to amend our regulations at
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21 CFR Part 203 to reflect changes resulting from enactment of the DSCSA (RIN 0910AH56). We also noted that upon finalization of rulemaking we will revise the information
collection accordingly and expect it will result in a reduction of burden to respondents.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
Confidentiality of the information submitted under these requirements is protected under 21
CFR part 20. The unauthorized use or disclosure of trade secrets is specifically prohibited
under section 310(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
11. Justification for Sensitive Questions
There are no questions of a sensitive nature.
12. Estimates of Annualized Hour Burden
12a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
Number of
Average
Total
Number of
Responses
Burden per
Total
21 CFR Section/Activity
Annual
Respondents
per
Response
Hours
Responses
Respondent
(in hours)
203.11--Reimportation
1
1
1
0.5
1
203.30(a)(1) and (b)--Drug sample
61,961
12
743,532
0.06
44,612
requests
203.30(a)(3), (a)(4), and (c)--Drug
61,961
12
743,532
0.06
44,612
sample receipts
203.31(a)(1) and (b)--Drug sample
232,355
135 31,367,925
0.04 1,254,717
requests
203.31(a)(3), (a)(4), and (c)--Drug
232,355
135 31,367,925
0.03
941,038
sample receipts
203.37(a)--Falsification of records
50
4
200
0.25
50
203.37(b)--Loss or theft of samples
50
40
2,000
0.25
500
203.37(c)--Convictions
1
1
1
1
1
203.37(d)--Contact person
50
1
50
0.08
4
203.39(g)--Reconciliation report
1
1
1
1
1
Total
2,285,536
1.
There are no capital costs or operating and maintenance costs associated with this collection of information.

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Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Section/Activity

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average
Burden per
Recordkeeping
(in hours)
0.25
0.08

Total
Hours

203.23(a) and (b)--Returned drugs
31,676
5
158,380
39,595
203.23(c)--Returned drugs
31,676
5
158,380
12,670
documentation
203.30(a)(2) and 203.31(a)(2)-2,208
100
220,800
0.5 110,400
Practitioner verification
203.31(d)(1) and (d)(2)--Inventory
2,208
1
2,208
40
88,320
record and reconciliation report
203.31(d)(4)--Investigation of
442
1
442
24
10,608
discrepancies and losses
203.31(e)--Representatives lists
2,208
1
2,208
1
2,208
203.34--Administrative systems
90
1
90
40
3,600
203.37(a)--Falsification of drug
50
4
200
6
1,200
sample records
203.37(b)--Loss or theft of drug
50
40
2,000
6
12,000
samples
203.39(d)--Destroyed or returned
65
1
65
1
65
drug samples
203.39(e)--Donated drug samples
3,221
1
3,221
0.5
1,611
203.39(f)--Distribution of donated
3,221
1
3,221
8
25,768
drug samples
203.39(g)--Drug samples donated
3,221
1
3,221
8
25,768
to charitable institutions
203.50(a)--Drug origin statement
125
100
12,500
0.17
2,125
203.50(b)--Drug origin statement
125
100
12,500
0.5
6,250
retention
203.50(d)--Authorized distributors
691
1
691
2
1,382
of record
Total
343,570
1.
There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of Agency data, we retain the currently approved burden estimate for the
information collection, as reflected in Tables 1 and 2 above. This assumes 7,500 respondents
to the information collection, based on a cumulative number of entities as described in our
final rule of December 3, 1999 (64 FR 67720).
12b. Annualized Cost Burden Estimate
FDA's Economics Staff estimates an average industry wage rate of approximately $85
per hour for preparing and submitting the information collection requirements under 21 CFR
203. Using this wage rate, and multiplied times the total hour burden estimated above
(2,285,536 + 343,570 X $75), the total cost burden to respondents is $197,182,950.

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13. Estimates of Other Total Annual Costs to Respondents and Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
FDA estimates that 3 FTE's are required to review reports and to inspect records resulting
from the regulation. If each FTE costs $275,000, the total cost to the Federal Government
will be $825,000.
15. Explanation for Program Changes or Adjustments
There are no program changes or adjustments associated with this extension. However, we
have consolidated the ICs previously appearing at www.reginfo.gov as itemized and
associated with the individual regulatory requirements into either reporting or recordkeeping.
Also, and as noted previously under Question 8, upon finalization of agency rulemaking
amending 21 CFR Part 203 (RIN 0910-AH56), we will revise the information collection
accordingly.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA does not intend to publish tabulated results of these information collection requirements.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no forms associated with this information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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