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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices
the section 582 requirements related to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the required information; and 3 FDA may determine other products or transactions that shall be exempt from requirements of section 582.
FDA has recently published the draft guidance document Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act June 2021; available at:
https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security-act. The draft guidance clarifies the enhanced system requirements listed in section 582g1
of the FD&C Act. This draft guidance also outlines and provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. FDA has also published a draft guidance document entitled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information November 2014;

available at: https www.fda.gov/
regulatory-information/search-fdaguidance-documents/dscsa-standardsinteroperable-exchange-informationtracing-certain-human-finishedprescription-drugs. This draft guidance establishes initial standards for the interoperable exchange of product tracing information, in paper or electronic format, for compliance with sections 582a through e of the FD&C
Act.
Two additional guidance documents help to further explain the statutory requirements of section 582. The Product Identifiers under the Drug Supply Chain Security ActQuestions and Answers guidance for industry June 2021; available at: https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
product-identifiers-under-drug-supplychain-security-act-questions-andanswers is intended to address anticipated questions regarding product identifiers that are required under section 582 for packages and homogenous cases of certain drug products. The Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs draft guidance October 2018; available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/verification-systems-under-

drug-supply-chain-security-act-certainprescription-drugs provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products. The guidance also addresses FDAs recommendation that trading partners submit cleared product notifications.
Finally, the guidance addresses the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on packages and homogenous cases intended to be introduced in a transaction into commerce.
FDA guidance documents are issued consistent with requirements found in section 582, as well as our Good Guidance Practice regulations found in 21 CFR 10.115, which provide for public comment at any time. In addition, since enactment of the DSCSA, our Center for Drug Evaluation and Research has developed and continues to maintain a website communicating DSCSA implementation activity, including relevant resources at:
https www.fda.gov/drugs/drug-supplychain-integrity/drug-supply-chainsecurity-act-dscsa.
We estimate the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDENNOTIFICATIONS TO FDA 1
Number of respondents
Type of respondent
Number of responses per respondent
Total annual responses
Average time per response
Total hours
Manufacturers and Repackagers
Wholesale Distributors
Dispenser

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 2ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN
ILLEGITIMATE PRODUCT 1
Number of respondents
lotter on DSK11XQN23PROD with NOTICES1

Type of respondent
Number of disclosures per respondent
Total disclosures
Average time per disclosure
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.
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