[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62585-62589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0609]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Drug Supply Chain 
Security Act Implementation: Identification of Suspect Product and 
Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of

[[Page 62586]]

information has been submitted to the Office of Management and Budget 
(OMB) for review and clearance under the Paperwork Reduction Act of 
1995.

DATES: Fax written comments on the collection of information by January 
3, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0806. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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.

Guidance for Industry: Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification

OMB Control Number 0910-0806--Extension

    This information collection supports the previously captioned 
Agency guidance and associated Form FDA 3911. The Drug Supply Chain 
Security Act (DSCSA) (Title II of Pub. L. 113-54) added new section 
582(h)(2) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 360eee-1(h)(2)), requiring FDA to issue guidance to aid trading 
partners in identifying a suspect product and terminating a 
notification regarding an illegitimate product and, for a manufacturer, 
a product with a high risk of illegitimacy. Suspect product is defined 
in section 581(21) of the FD&C Act (21 U.S.C. 360eee(21)), as a product 
for which there is reason to believe it: (1) Is potentially 
counterfeit, diverted, or stolen; (2) is potentially intentionally 
adulterated such that the product would result in serious adverse 
health consequences or death to humans; (3) is potentially the subject 
of a fraudulent transaction; or (4) appears otherwise unfit for 
distribution such that the product would result in serious adverse 
health consequences or death to humans.
    Beginning January 1, 2015, section 582 of the FD&C Act requires 
certain trading partners, upon determining that a product in their 
possession or control is a suspect product, to quarantine the product 
while they promptly conduct an investigation to determine whether the 
product is an illegitimate product. Illegitimate product is defined in 
section 581(8) of the FD&C Act as a product for which credible evidence 
shows that it: (1) Is counterfeit, diverted, or stolen; (2) is 
intentionally adulterated such that the product would result in serious 
adverse health consequences or death to humans; (3) is the subject of a 
fraudulent transaction; or (4) appears otherwise unfit for distribution 
such that the product would be reasonably likely to result in serious 
adverse health consequences or death to humans. Also beginning January 
1, 2015, trading partners must, upon determining that a product in 
their possession or control is illegitimate, notify FDA and all 
immediate trading partners that they have reason to believe they may 
have received the illegitimate product not later than 24 hours after 
making the determination. Under section 582(b)(4)(B)(ii)(II) of the 
FD&C Act, manufacturers are additionally required to notify FDA and any 
immediate trading partners that they believe may possess a product 
manufactured by or purportedly manufactured by the manufacturer not 
later than 24 hours after the determination is made or being notified 
by FDA or a trading partner that the product has a high risk of 
illegitimacy.
    Under section 202 of the DSCSA, manufacturers, repackagers, 
wholesale distributors, and dispensers (e.g., pharmacies) must: (1) 
Notify FDA when they have determined that a product in their possession 
or control is illegitimate (and, for manufacturers, when they have 
determined or been notified by FDA or a trading partner that a product 
has a high risk of illegitimacy); (2) notify certain immediate trading 
partners about an illegitimate product that they may have received 
(and, for manufacturers, that a product has a high risk of 
illegitimacy); (3) terminate notifications regarding illegitimate 
products (and, for manufacturers, a product with a high risk of 
illegitimacy), in consultation with FDA, when the notifications are no 
longer necessary; and (4) notify immediate trading partners when the 
notifications are terminated. Trading partners should use Form FDA 3911 
to submit notifications and requests for terminations of notifications 
to FDA. Form FDA 3911 is available on FDA's web page (https://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm).

A. Notifications to FDA

    Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii), 
and (e)(4)(B)(ii) of the FD&C Act, as amended by the DSCSA, and 
beginning not later than January 1, 2015, a manufacturer, repackager, 
wholesale distributor, or dispenser who determines that a product in 
its possession or control is illegitimate must notify FDA of that 
determination not later than 24 hours after the determination is made. 
In addition, section 582(b)(4)(B)(ii)(II) of the FD&C Act requires 
manufacturers to notify FDA when a manufacturer determines that a 
product poses a high risk of illegitimacy.
    We originally estimated that all manufacturers, repackagers, 
wholesale distributors, and dispensers would collectively submit 5,000 
notifications per year. This estimate included the notifications by 
trading partners that have determined that illegitimate product is in 
their possession or control, as well as notifications by manufacturers 
that have determined a product poses a high risk of illegitimacy. As 
discussed in our Federal Register notice of June 11, 2014 (79 FR 
33564), the estimate was based on our experience with field alert 
reports (Form FDA 3331) that holders of approved drug applications are 
required to submit for certain drug quality issues (21 CFR 
314.81(b)(1)) and with reports of the falsification of drug sample 
records, diversion, loss, and known theft of prescription drug samples 
as currently required under Sec.  203.37 (21 CFR 203.37). Upon 
evaluation of the number of notifications we received for fiscal years 
2016 and 2017, however, we are lowering our estimate to 150 
notifications.
    We are also combining the estimates for manufacturers and 
repackagers because FDA's establishment and drug product listing 
database indicates that many companies perform activities of both 
manufacturers and repackagers. Although the DSCSA specifically defines 
dispensers, for estimation purposes, we are using estimates for 
pharmacies in general terms based on those that must comply with the 
new requirements under section 582(d) of the FD&C Act.
    Because manufacturers, repackagers, and wholesale distributors are 
collectively responsible for prescription drugs from the point of 
manufacturing through distribution in the drug supply chain, we assume 
that most notifications of illegitimate products are

[[Page 62587]]

submitted by these three trading partners. The total number of 
respondents is comprised of 80 percent manufacturers (120), 15 percent 
wholesale distributors (22), and 5 percent pharmacies (8).
    We estimate that the number of annual notifications will vary from 
0 to 2 for manufacturers/repackagers, as well as from pharmacies, with 
the vast majority of companies making no notifications. Although FDA's 
establishment and drug product listing database currently contains 
registrations for approximately 6,500 manufacturers and repackagers, we 
estimate that approximately 120 manufacturers/repackagers will notify 
us of illegitimate products an average of one time per year. Although 
we estimate approximately 69,000 pharmacy sites in the United States, 
based on data from the National Association of Chain Drug Stores, the 
National Community Pharmacists Association, and the American Hospital 
Association, we estimate that approximately 8 pharmacies will notify 
FDA of illegitimate product an average of one time per year. According 
to the Healthcare Distribution Alliance (formerly known as Healthcare 
Distribution Management Association), approximately 30 wholesale 
distributors are responsible for over 90 percent of drug distributions; 
based on sales and because FDA is estimating that over 2,200 small 
wholesale distributors might be responsible for the remaining 10 
percent of drug sales, we estimate that wholesale distributors will be 
responsible for making about an average of 1 notification per year to 
account for the estimated 22 notifications that FDA will receive 
regarding illegitimate product. Each notification should include 
information about the person or entity initiating the notification, the 
product determined to be illegitimate or having a high risk of 
illegitimacy, and a description of the circumstances surrounding the 
event that prompted the notification. We estimate that each 
notification will take about 1 hour, as reflected in table 1.

B. Notifications to Trading Partners of an Illegitimate Product or 
Product With a High Risk of Illegitimacy

    Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii), 
and (e)(4)(B)(ii) of the FD&C Act, a trading partner who determines 
that a product in its possession is illegitimate must also notify all 
immediate trading partners that they believe may have received such 
illegitimate product not later than 24 hours after the determination is 
made. In addition, under section 582(b)(4)(B)(ii)(II) of the FD&C Act, 
a manufacturer is required to notify all immediate trading partners 
that the manufacturer believes may possess a product manufactured by or 
purported to be manufactured by the manufacturer not later than 24 
hours after the determination is made or being notified by FDA or a 
trading partner that the product has a high risk of illegitimacy.
    Because the extent of distribution of any illegitimate product is 
likely to vary from one situation to another, we assume a wide 
distribution of each illegitimate product. We estimate that, for each 
notification made by a manufacturer or repackager to FDA, approximately 
30 trading partners (based on the number of distributors) will also be 
notified. This results in approximately 3,600 notifications annually to 
trading partners of manufacturers/repackagers. This estimate includes 
the notifications by manufacturers and repackagers who have determined 
that illegitimate product is in their possession or control, as well as 
notifications by manufacturers that have determined that a product 
poses a high risk of illegitimacy.
    We estimate that a large wholesale distributor may have up to 4,500 
trading partners, but a small wholesale distributor may have 200 
trading partners, for an average of approximately 2,350. We originally 
estimated that a wholesale distributor would notify all 2,350 trading 
partners for each of the illegitimate products identified. However, we 
are lowering our estimate as a result of our experience with the 
collection and informal feedback from industry to reflect that 22 
respondents will make 1,175 disclosures for a total of 25,850 
disclosures annually; and that each disclosure will require 
approximately 12 minutes, for a total of 5,170 hours annually.
    We estimate that a pharmacy purchases prescription drugs from an 
average of two wholesale distributors. Therefore, a pharmacy would 
notify 2 trading partners for each of the 8 illegitimate products 
identified, resulting in approximately 16 notifications annually to 
pharmacy trading partners.
    Manufacturers/repackagers, wholesale distributors, and pharmacies 
may notify their trading partners using existing systems and processes 
used for similar types of communications. Such communications may 
include, but are not limited to, posting notifications on a company 
website, sending an email, telephoning, or mailing or faxing a letter 
or notification. The information contained in the notification to the 
immediate trading partner should be the same as or based on the 
notification that was already submitted to FDA. We estimate that, for 
all trading partners, each notification of immediate trading partners 
will take approximately 0.2 hour (12 minutes). The estimated total 
burden hours that manufacturers/repackagers, wholesale distributors, 
and pharmacies will take to notify trading partners is approximately 
5,893 hours annually, as reflected in table 2.

C. Consultations With FDA and Termination of Notification

    Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and 
(e)(4)(B)(iv) of the FD&C Act requires that a trading partner who 
determines, in consultation with FDA, that a notification made under 
section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or 
(e)(4)(B)(ii) is no longer necessary must terminate the notification. 
The guidance for industry sets forth the process by which trading 
partners should consult with FDA to terminate notifications that are no 
longer necessary.
    Each request for termination of notification must include 
information about the person or entity initiating the request for 
termination, the illegitimate product or product with a high risk of 
illegitimacy, the notification that was issued, and an explanation 
about what actions have taken place or what information has become 
available that make the notification no longer necessary. Trading 
partners should also include the FDA-assigned incident number 
associated with the initial notification on the request for 
termination. The request for a termination will be viewed as a request 
for consultation with FDA. We estimate that the same amount of time 
will be required to provide the information necessary to request 
termination as is required to make the notification. The time required 
to investigate and resolve an illegitimate product notification will 
vary, but we assume that each notification will eventually be 
terminated. We assume that the number of requests for termination of a 
notification per year will be the same as the original number of 
notifications for a given year. The estimated total burden hours of 
making requests for termination of notifications to FDA is 150 hours 
annually, as reflected in table 3.

D. Notifications to Trading Partners That a Notification Has Been 
Terminated

    Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and 
(e)(4)(B)(iv) of the

[[Page 62588]]

FD&C Act requires that a trading partner who, in consultation with FDA, 
terminates a notification made under section 582(b)(4)(B)(ii)(I) or 
(II), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) must also promptly 
inform previously-notified immediate trading partners that the 
notification has been terminated. We estimate that the burden for 
notifying trading partners of an illegitimate product and the number of 
trading partners notified will be the same as the estimates for 
notification of termination. The estimated total burden hours of 
notifying trading partners that the notification is terminated is 
approximately 5,893 hours annually, as reflected in table 4.
    In the Federal Register of September 6, 2018 (83 FR 45254), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                      Table 1--Estimated Annual Reporting Burden--Notifications to FDA \1\
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                                                   Number of
    Respondent description         Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.             120               1             120  1...............             120
Wholesale Distributors........              22               1              22  1...............              22
Dispensers....................               8               1               8  1...............               8
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             150
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


Table 2--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
                                                   Product \1\
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                                                   Number of
    Respondent description         Number of      disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.             120              30           3,600  0.20 (12                     720
                                                                                 minutes).
Wholesale Distributors........              22           1,175          25,850  0.20 (12                   5,170
                                                                                 minutes).
Dispensers....................               8               2              16  0.20 (12                       3
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           5,893
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Table 3--Estimated Annual Reporting Burden for Consultation With FDA and Termination of Notification \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
    Respondent description         Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.             120               1             120  1...............             120
Wholesale Distributors........              22               1              22  1...............              22
Dispensers....................               8               1               8  1...............               8
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             150
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


Table 4--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
                                             Product Termination \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
    Respondent description         Number of      disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.             120              30           3,600  0.2 (12 minutes)             720
Wholesale Distributors........              22           1,175          25,850  0.2 (12 minutes)           5,170
Dispensers....................               8               2              16  0.2 (12 minutes)               3
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           5,893
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 62589]]

    Cumulatively, the total estimated burden is 12,086 annual hours, 
which reflects a significant decrease. We base this adjustment on our 
experience with the information collection since its establishment and 
implementation.

    Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26295 Filed 12-3-18; 8:45 am]
 BILLING CODE 4164-01-P


