Notice2025-07569
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
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Published
May 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Full Text
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<title>Federal Register, Volume 90 Issue 83 (Thursday, May 1, 2025)</title>
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[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18675-18678]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07569]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3675]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Pharmaceutical
Distribution Supply Chain; Drug Supply Chain Security
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by June 2, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0806. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#df8f8d9e8cabbeb9b99fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="0b5b594a587f6a6d6d4b6d6f6a25636378256c647d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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)
[[Page 18676]]
of information. Submissions to FDA, as provided for in section 582 of
the FD&C Act, 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 (Pub. L.
91-513), 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 <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products</a>. 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:
<bullet> ``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).
<bullet> ``Standardization of Data and Documentation Practices for
Product Tracing'' draft guidance (Standardization of Data Guidance)
(February 28, 2018).
<bullet> ``Enhanced Drug Distribution Security at the Package Level
Under the Drug Supply Chain Security Act'' guidance (Enhanced Drug
Distribution Security Guidance) (August 31, 2023).
<bullet> ``Verification Systems Under the Drug Supply Chain
Security Act [DSCSA] for Certain Prescription Drugs'' guidance
(Verification Guidance) (December 7, 2023).
<bullet> ``Definitions of Suspect Product and Illegitimate Product
for Verification Obligations Under the Drug Supply Chain Security Act''
guidance (Definitions Guidance) (March 16, 2023).
<bullet> ``Product Identifiers Under the Drug Supply Chain Security
Act--Questions and Answers'' guidance (Product Identifier Guidance)
(June 3, 2021).
<bullet> ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification'' guidance (Suspect
Product Guidance) (June 6, 2021).
<bullet> ``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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that utilizes topic specific search terms.
We also maintain a web page at <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements</a> 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).
In the Federal Register of September 6, 2024 (89 FR 72848), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment from a trade
association suggesting our estimate for burden attendant to requests
for waiver, exception, or exemption (WEE) might not include submissions
by those respondents who lack readiness to implement final DSCSA
requirements and who have more recently submitted such requests to FDA.
In anticipation of the end of the enhanced drug security requirements
12-month stabilization period on November 27, 2024, we received an
increased number of waiver and exemption requests and have issued two
exemptions from the enhanced drug distribution security requirements of
section 582 of the FD&C Act for eligible trading partners. The comment
thanked FDA for the recent exemptions, acknowledging they allow a
phased approach to implementing trading partner data exchange as
required under the DSCSA. While the comment proffered no alternative
figures, we have adjusted our estimate for this activity by increasing
the number of respondents submitting WEE requests from 20 to
[[Page 18677]]
100, as reflected in row 3 of table 1. We have made no other adjustment
to our estimates but continue to monitor information collection
elements applicable to the DSCSA.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Average
21 U.S.C. 360eee-1(b) through (e)); Number of Number of Total time per
information collection respondents responses per annual response Total hours
respondent responses (in hours)
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Notifications of illegitimate product: Form 500 28.2 14,100 8 112,800
FDA 3911....................................
Consultation/Requests for termination of 500 1 500 1 500
notification of illegitimate product
(Suspect Product Guidance, sec. IV.B).......
Requests for waiver, exception or exemption, 100 1 100 81 8,100
including material changes and renewals
(Waivers Guidance, sec. III)................
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Total.................................... ........... .............. 14,700 ........... 121,400
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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. Form FDA
3911 is also used to submit requests for termination of a notification
in consultation with FDA. FDA may request any additional information it
determines necessary to complete the consultation. We believe burden
that may be incurred from providing FDA with follow-up information that
may be necessary with regard to suspect and/or illegitimate products is
excepted from our accounting in accordance with 5 CFR 1320.3(c), and we
have therefore not included this activity in our estimate of burden.
Finally, an authorized trading partner or other stakeholder seeking a
WEE 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
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Average
21 U.S.C. 360eee-1(b)-(e); information Number of Number of Total annual burden per
collection; activity respondents records per records record (in Total hours
respondent hours)
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Documenting transaction (T3) information 70,000 1,000,000 70,000,000,000 0.0000017 119,000
Disclosing illegitimate product 500 620 310,000 6 1,860,000
notifications and terminations to
trading partners.......................
Product identification & information 1,400 3,125,000 4,375,000,000 0.0000688 301,000
exchange: encoding packages and
homogeneous cases with product
identifier; exchange of information
only w/authorized trading partners.....
Verification: identify and investigate 30,125 8 241,000 0.62 149,420
suspect product, coordinate with other
trading partners, quarantine product,
notify FDA of suspect product that is
not determined to be illegitimate
product................................
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Total............................... ............ ............ 74,375,551,000 ........... 2,429,420
~74.4 B
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\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 to be usual and customary for
respondents to the information collection.
As reflected in table 2, the provisions in sections 582(b) through
(e) of the FD&C Act require ongoing recordkeeping that documents
product identification, tracing information, and verification
activities. Records are to be produced to FDA within 24 hours of a
request, consistent with section 582 of the FD&C Act. Each category of
respondent (manufacturer, distributer, wholesaler, repackager) may
expend varying degrees of time, effort, or financial resources to
generate, maintain, retain, notify, or disclose such records
commensurate with the corresponding tasks prescribed for that category.
Data elements required to be documented and disclosed are defined in
section 581 and set forth in section 582 of the FD&C Act. A significant
portion of recordkeeping activity pertains to product identification
and product tracing. Verification activities comprise another
significant portion of activity, where respondents expend time, effort,
or financial resources respective to their role. Although we have
quantified what we believe to be the average amount of time, effort, or
financial resources expended cumulatively by respondents, we regard
these recordkeeping activities as usual and customary and exclude them
from our burden approval request submitted to OMB, consistent with 5
CFR 1320.3(b)(2).
Product Tracing and Product Identification
Information exchange activities with authorized trading partners as
contemplated by section 582 of the FD&C Act include: (1) providing the
[[Page 18678]]
transaction information, the transaction history (when applicable), and
transaction statement (T3) to the subsequent purchaser, providing
relevant transaction information, transaction history, and transaction
statement upon a request for information from FDA or other appropriate
Federal or State officials if a recall or investigation of suspect or
illegitimate product occurs, and, after the Statutory Date,
facilitating the gathering of information necessary to produce the
transaction information for each transaction \1\ going back to the
manufacturer at an authorized trading partner's request, or at the
request of FDA or other appropriate Federal or State officials; and (2)
capturing and maintaining transaction information, transaction history,
and transaction statements for each transaction for not less than 6
years after the transaction. Product identification activities include
the requirement that manufacturers and repackagers affix or imprint a
product identifier to each package and homogeneous case of products
that they intend to be introduced in a transaction into commerce and
that they maintain product identifier information for each package and
homogeneous case of product for not less than 6 years.
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\1\ Transaction is defined in section 581(24) of the FD&C Act.
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Verification Activities
Verification activities include: (1) coordinating with other
trading partners during an investigation of a suspect product to
determine whether the product is illegitimate; (2) for manufacturers
and repackagers, responding to trading partners' requests for
verification of product identifiers; (3) maintaining records of suspect
product investigations and disposition of illegitimate product for not
less than 6 years; (4) identifying suspect product; (5) quarantining
suspect and illegitimate product; (6) investigating suspect product;
(7) notifying FDA of suspect product that is determined not to be
illegitimate product (when applicable); (8) processing saleable
returns; and (9) establishing systems and processes to comply with all
of these requirements.
We assume manufacturers, repackagers, and wholesale distributors
will already have systems and processes to comply with many of these
requirements. Such systems will therefore only need to be updated to
ensure full compliance with the DSCSA. We also anticipate that a chain
pharmacy will develop the required systems and processes centrally at
its headquarters or at its distribution centers and then distribute to
each pharmacy.
Our estimated burden for the information collection reflects some
significant increases; most notably burden we attribute to the task of
documenting individual transaction information. We have also increased
the number of respondents submitting WEE requests.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07569 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
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