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AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collections applicable to the Pharmaceutical Distribution Supply Chain, provided for in Subchapter H of Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES:
Either electronic or written comments on the collection of information must be submitted by November 5, 2024.
ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 5, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Written/Paper Submissions
Submit written/paper submissions as follows:
- Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2024-N-3675 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security.” Received comments, those filed in a timely manner ( see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
- Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
OMB Control Number 0910-0806—Revision
This information collection helps support implementation of sections 581 and 582 (21 U.S.C. 360eee and U.S.C. 360eee-1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which govern the pharmaceutical distribution supply chain. Definitions set forth in section 581 of the FD&C Act prescribe specific activities that apply to the individuals identified in section 582, including recordkeeping requirements intended to effectuate the tracing of certain pharmaceutical drugs as they are distributed within the United States. The recordkeeping provisions expressly provided for in sections 582(b) through (e) of the FD&C Act cover tasks associated with product identification, product tracing, transaction data, record verification, and disclosures (exchange) of information. Submissions to FDA, as provided for in section 582, include making specific product notifications, requesting exemption and/or waiver from any of the statutory requirements, and requesting termination of a notification in consultation with FDA.
The requirements of section 582 of the FD&C Act included in the information collection are self-executing. We regard most of the information collection activities required by the statute to be usual and customary recordkeeping activities by respondents and have therefore excluded from our estimated burden the time, effort, and financial resources attributable to those activities consistent with 5 CFR 1320.3(b)(2). Additionally, we note that some respondents are also subject to related reporting, recordkeeping, and disclosure requirements applicable under the Controlled Substances Act, for which currently active information collection approvals are maintained by the Department of Justice's Drug Enforcement Administration. At the same time, we account for notifications submitted to FDA, and estimate recordkeeping burden attributable to activities corresponding with illegitimate product notifications, including coordination of investigations of suspect products, among trading partners, as required by the statute.
To assist respondents with submitting specific product notifications to FDA regarding illegitimate product and product with a high-risk of illegitimacy, we have developed and utilize Form FDA 3911 entitled “Drug Notification” and the corresponding instructional document “INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911—DRUG NOTIFICATION.” Instruction regarding the submission of Form FDA 3911 using the Center for Drug Evaluation and Research “NextGen” portal is available from our website at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products. Form FDA 3911 is intended to provide a uniform format for initial notifications, followup notifications, and requests for the termination of a notification. We believe followup activities regarding suspect and/or illegitimate drug products includes information obtained during the conduct of an official Agency investigation and thus not covered by the PRA. Please see 5 CFR 1320.4(a)(2) and FDA “General Enforcement Regulations” in 21 CFR part 1. We have revised Form FDA 3911, and the instructions for completing the form, to add a new field requesting information about the geographic location of the incident that is the subject of the notification.
We have also published guidance documents, as provided for in section 582 of the FD&C Act, developed specifically to facilitate the efficient adoption of secure interoperable product tracing at the package level by respondents. The guidance documents discuss the recordkeeping activities expressly provided for in section 582 of the FD&C Act. To date we have developed and issued the following guidance documents:
- “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs” guidance (2023 Standards for Interoperable Exchange Guidance) (September 6, 2023).
- “Standardization of Data and Documentation Practices for Product Tracing” draft guidance (Standardization of Data Guidance) (February 28, 2018).
- “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act” guidance (Enhanced Drug Distribution Security Guidance) (August 31, 2023).
- “Verification Systems Under the Drug Supply Chain Security [DSCSA] Act for Certain Prescription Drugs” guidance (Verification Guidance) (December 7, 2023).
- “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act” guidance (Definitions Guidance) (March 16, 2023).
- “Product Identifiers Under the Drug Supply Chain Security Act—Questions and Answers” guidance (Product Identifier Guidance) (June 3, 2021).
- “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” guidance (Suspect Product Guidance) (June 6, 2021).
- “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act” guidance (Waivers Guidance) (August 4, 2023).
All Agency guidance documents are issued in accordance with our Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time. We maintain a searchable guidance database on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents that utilizes topic specific search terms.
We also maintain a web page at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements that communicates FDA's ongoing implementation of the DSCSA requirements. Since DSCSA enactment on November 27, 2013, FDA has established a public docket to receive information and comments on DSCSA standards for the electronic tracking system, including comments regarding paper and electronic formats of information. In 2018, we initiated a pilot project, consistent with section 582(j) of the FD&C Act and approved in OMB control number 0910-0859, focusing on system attributes and demonstrating interoperability. Since completion of the pilot project, we continue to focus on the interoperability of the electronic systems described in section 582 of the FD&C Act and have revised this information collection to capture standardized transaction information.
Respondents to the information collection are manufacturers, wholesale distributors, dispensers, and repackagers of pharmaceutical drug products, as defined in section 581 of the FD&C Act and identified in section 582(a)(1) of the FD&C Act. Based on Agency data, we assume 70,000 respondents: 1,230 manufacturers and 170 repackagers, (1,400 cumulatively); 1,600 distributors; and 67,000 dispensers (including online and chain pharmacies).
FDA estimates the burden of this collection of information as follows:
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 |
Table 2—Estimated Annual Recordkeeping Burden
| 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 | |||
| 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). | |||||
| 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. |