2024-20064. Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security

Table 1—Estimated Annual Reporting Burden

21 U.S.C. 360eee-1(b)-(e); information collection	Number of respondents	Number of responses per respondent	Total annual responses	Average time per response (in hours)	Total hours
Notifications of illegitimate product: Form FDA 3911	500	28.2	14,100	8	112,800
Consultation/Requests for termination of notification of illegitimate product (Suspect Product Guidance, sec. IV.B)	500	1	500	1	500
Requests for waiver, exception or exemption, including material changes and renewals (Waivers Guidance, sec. III)	20	1	20	81	1,620
Total			14,620		114,920

As reflected in table 1, reporting activities include the submission of notifications to FDA regarding illegitimate product and product with a high-risk of illegitimacy using Form FDA 3911. We believe the burden that may be incurred from providing FDA with followup information that may be necessary with regard to suspect and/or illegitimate products is excluded from our accounting in accordance with 5 CFR 1320.3(c) because such followup would entail reporting activities that are usual and customary, and we have therefore not included this activity in our estimate of burden. Reporting activities also include requests for termination of a notification in consultation with FDA, using Form FDA 3911. FDA may request any additional information it determines necessary to complete the consultation. Finally, an authorized trading partner or other stakeholder seeking a waiver, exception, or exemption from requirements of section 582 of the FD&C Act may submit a request to FDA, or a request for material changes to or renewal of an approved initial request. These requests are also included in the scope of reporting activities.

Table 2—Estimated Annual Recordkeeping Burden  ^{1  2}

21 U.S.C. 360eee-1(b)-(e); information collection activity	Number of respondents	Number of records per respondent	Total annual records	Average burden per record (in hours)	Total hours
Documenting transaction (T3) information	70,000	1M	70,000,000,000	0.0000017	119,000
Disclosing illegitimate product notifications and terminations to trading partners	500	620	310,000	6	1,860,000
Product identification & information exchange: encoding packages and homogeneous cases with product identifier; exchange of information only w/authorized trading partners.	1,400	3,125,000	4,300,000,000	0.00007	301,000
Verification: identify and investigate suspect product, coordinate with other trading partners, quarantine product, notify FDA of suspect product that is not determined to be illegitimate product	30,125	8	241,000	0.62	149,420
Total			74,300,551,000 (~74.3B)		2,429,420
1 The recordkeeping requirement includes the requirement to retain, notify third parties, the Federal government, or the public of the existence of such records; disclose such records to third parties, the Federal government, or the public; or report to third parties, the Federal government, or the public regarding such records. See 44 U.S.C. 3502(13); 5 CFR 1320.3(m).
2 We regard activities established in section 582(b)-(e) of the FD&C Act (21 U.S.C. 360eee-1(b)-(e)) to be usual and customary for respondents to the information collection.