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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
TABLE 3ESTIMATED ANNUAL REPORTING BURDEN FOR CONSULTATION WITH FDA AND TERMINATION OF NOTIFICATION 1
Number of responses per respondent
Number of respondents
Type of respondent
Total annual responses
Average time per response
Total hours
Manufacturers and Repackagers
Wholesale Distributors
Dispensers

100
138
12

1
1 1

100
138
12

1
1 1

100
138
12

Total

250

250

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

TABLE 4ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN
ILLEGITIMATE PRODUCT TERMINATION 1
Number of disclosures per respondent
Number of respondents
Type of respondent
Average time per disclosure
Total disclosures
Total hours
Manufacturers and Repackagers
Wholesale Distributors
Dispensers

100
138
12

30
1,175
2

3,000
162,150
24

0.20
0.20
0.20

600
32,430
5

Total

165,174

33,035

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

TABLE 5ESTIMATED ANNUAL REPORTING BURDEN FOR REQUESTS FOR WAIVERS, EXCEPTIONS, OR EXEMPTIONS 1
Total annual responses
Average time per response
Total hours
Requests to FDA for a Waiver, Exception, or Exemption
Notifications to FDA of a Material Change in Circumstances Warranting the Waiver, Exception, or Exemption
Requests to FDA to Renew a Waiver, Exception, or Exemption

20

1

20

80

1,600

1

1

1

16

16

1

1

1

16

16

Total

22

1,632

1 There
lotter on DSK11XQN23PROD with NOTICES1

Number of responses per respondent
Number of respondents
Type of respondent
are no capital costs or operating and maintenance costs associated with this collection of information.

Based on illegitimate product notifications already received, we estimate a total of 250 respondents to the information collection. Our database for establishment and drug product listing suggests that many companies perform activities of both manufacturers and repackagers and therefore we have combined our estimated number of respondent manufacturers and repackagers. In addition, because statutory provisions specifically define dispensers to include retail pharmacies, hospital pharmacies, and groups of chain pharmacies, our estimate of the number of dispensers is intended to reflect the overall estimated number of respondents we believe to be subject to the requirements under section 582d of the FD&C Act. Because manufacturers, repackagers, and wholesale distributors are collectively responsible for prescription drugs from the point of manufacturing through distribution in the drug supply chain,
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we assume that these three trading partners submit most notifications of illegitimate products. Upon evaluation of those notifications received in fiscal year FY 2020 and, thus far, in FY 2021, we assume those 250 respondents are comprised of 40 percent manufacturers 100, 55 percent wholesale distributors 138, and 5 percent pharmacies 12.
We assume that annual notifications will vary from zero to two for manufacturers and repackagers, as well as from pharmacies, but that most of companies will make no notifications.
Although our establishment and drug product listing database currently reflects approximately 1,400
manufacturers and repackagers, we estimate only 100 manufacturers and repackagers will notify us of illegitimate products an average of one time per year.
Relying on data from the National Association of Chain Drug Stores, the National Community Pharmacists
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Association, and the American Hospital Association, we assume there are approximately 67,000 pharmacy sites in the United States. Based on a review of data, we estimate 12 pharmacies will notify FDA of illegitimate product an average of 1 time per year.
According to the Healthcare Distribution Alliance formerly known as Healthcare Distribution Management Association, approximately 30
wholesale distributors are responsible for over 90 percent of drug distributions.
Based on sales, and because FDA is estimating that over 1,570 small wholesale distributors may be responsible for the remaining 10 percent of drug sales, we estimate that wholesale distributors will be responsible for making approximately an average of 1 notification per year to account for the estimated 138
notifications that FDA will receive regarding illegitimate product. We
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