[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Notices]
[Pages 72848-72851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20064]



[[Page 72848]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3675]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply 
Chain Security

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, 
[email protected].

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

[[Page 72849]]

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

[[Page 72850]]

dispensers (including online and chain pharmacies).
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                     Average time
   21 U.S.C. 360eee-1(b)-(e);        Number of     responses per   Total annual    per response     Total hours
     information collection         respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
Notifications of illegitimate                500            28.2          14,100               8         112,800
 product: Form FDA 3911.........
Consultation/Requests for                    500               1             500               1             500
 termination of notification of
 illegitimate product (Suspect
 Product Guidance, sec. IV.B)...
Requests for waiver, exception                20               1              20              81           1,620
 or exemption, including
 material changes and renewals
 (Waivers Guidance, sec. III)...
                                 -------------------------------------------------------------------------------
    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);                      Number of                       Average burden
    information collection        Number of      records per      Total annual    per record (in    Total hours
           activity              respondents     respondent         records           hours)
----------------------------------------------------------------------------------------------------------------
Documenting transaction (T3)           70,000              1M     70,000,000,000       0.0000017         119,000
 information.................
Disclosing illegitimate                   500             620            310,000               6       1,860,000
 product notifications and
 terminations to trading
 partners....................
Product identification &                1,400       3,125,000      4,300,000,000         0.00007         301,000
 information exchange:
 encoding packages and
 homogeneous cases with
 product identifier; exchange
 of information only w/
 authorized trading partners.
Verification: identify and             30,125               8            241,000            0.62         149,420
 investigate suspect product,
 coordinate with other
 trading partners, quarantine
 product, notify FDA of
 suspect product that is not
 determined to be
 illegitimate product........
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............     74,300,551,000  ..............       2,429,420
                                                                        (~74.3B)
----------------------------------------------------------------------------------------------------------------
\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.

    As reflected in table 2, the provisions in sections 582(b) through 
(e) 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 estimate, 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

[[Page 72851]]

FD&C Act include: (1) providing the 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.
---------------------------------------------------------------------------

    \1\ Transaction is defined in section 581(24) of the FD&C Act.
---------------------------------------------------------------------------

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 as revised 
reflects a significant decrease in the burden estimates for annual 
responses and hours. We have excluded from our estimated burden the 
time, effort, and financial resources attributable to those activities 
we consider usual and customary by respondents, consistent with 5 CFR 
1320.3(b)(2). We invite comment on our assumption.

    Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20064 Filed 9-5-24; 8:45 am]
BILLING CODE 4164-01-P