[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49538-49542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Drug Supply Chain Security Act Implementation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection associated with the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by November 2, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 2, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 2, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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-2014-D-0609 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Drug Supply Chain Security Act 
Implementation.'' 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

[[Page 49539]]

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, 10A-12M, 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 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.

Drug Supply Chain Security Act Implementation

OMB Control Number 0910-0806--Revision

    This information collection helps to support implementation of 
section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 360eee-1). Enacted in 2013, the Drug Supply Chain Security Act 
(DSCSA) (Title II of Pub. L. 113-54) amended section 582 of the FD&C 
Act and outlines steps to build an electronic, interoperable system to 
identify and trace certain prescription drugs as they are distributed 
in the United States. The DSCSA is intended to enhance FDA's ability to 
help protect consumers from exposure to drugs that may be counterfeit, 
stolen, contaminated, or otherwise harmful. Respondents to the 
information collection are manufacturers, wholesalers, dispensers, and 
repackagers, as defined in section 581 of the FD&C Act (21 U.S.C. 
360eee), of pharmaceutical drug products.
    To assist respondents with statutory requirements set forth in 
section 582 pertaining to notifications of illegitimate products or 
products with a high risk of illegitimacy, we developed Form FDA 3911 
entitled ``Drug Notification'' along with the corresponding 
instructional document ``INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911--
DRUG NOTIFICATION.'' Form FDA 3911 and the instructions are available 
from, and may be completed using, our website at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions. Form FDA 3911 is intended to facilitate 
notifications governed by section 582 by providing a uniform format for 
initial notifications, followup notifications, and requests for the 
termination of a notification.
    Section 582 of the FD&C Act also provides for FDA issuance of 
guidance documents to facilitate implementation of the DSCSA. To that 
end, we continue to develop guidance documents to assist respondents 
with information collection provisions set forth in section 582. The 
procedural guidance document entitled ``Drug Supply Chain Security Act 
Implementation: Identification of Suspect Product and Notification'' 
(June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification) is 
intended to assist respondents in identifying suspect products, as 
defined at section 581, and with terminating notifications of 
illegitimate product or products with a high risk of illegitimacy. As 
explained in the guidance document, beginning January 1, 2015, certain 
trading partners (i.e., manufacturers, repackagers, wholesale 
distributors, or dispensers), upon determining that a product in their 
possession or control is a suspect product, must quarantine the product 
while they promptly conduct an investigation to determine whether the 
product is an illegitimate product, must notify FDA if they determine 
that the product is illegitimate product, and must notify certain 
trading partners of the illegitimate product as prescribed by section 
582. Manufacturers must also notify FDA and certain immediate trading 
partners after determining that a product in their possession or 
control has a high risk of being illegitimate product.
    Similarly, we developed the draft guidance document ``Waivers, 
Exceptions, and Exemptions From the Requirements of Section 582 of the 
Federal Food, Drug, and Cosmetic Act'' (May 2018; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act). The draft guidance explains Agency 
established processes by which: (1) A trading partner may request a 
waiver from certain requirements in section 582 if it would result in 
an undue economic hardship or for emergency medical reasons; (2) a 
manufacturer or repackager may request an exception to

[[Page 49540]]

the section 582 requirements related to product identifiers if a 
product is packaged in a container too small or otherwise unable to 
accommodate a label with sufficient space to bear the required 
information; and (3) FDA may determine other products or transactions 
that shall be exempt from requirements of section 582.
    FDA has recently published the draft guidance document ``Enhanced 
Drug Distribution Security at the Package Level Under the Drug Supply 
Chain Security Act'' (June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act). The draft guidance clarifies the enhanced system requirements 
listed in section 582(g)(1) of the FD&C Act. This draft guidance also 
outlines and provides recommendations on the system attributes 
necessary for enabling the secure tracing of product at the package 
level, including allowing for the use of verification, inference, and 
aggregation, as necessary. FDA has also published a draft guidance 
document entitled ``DSCSA Standards for the Interoperable Exchange of 
Information for Tracing of Certain Human, Finished, Prescription Drugs: 
How to Exchange Product Tracing Information'' (November 2014; available 
at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs). This draft guidance 
establishes initial standards for the interoperable exchange of product 
tracing information, in paper or electronic format, for compliance with 
sections 582(a) through (e) of the FD&C Act.
    Two additional guidance documents help to further explain the 
statutory requirements of section 582. The ``Product Identifiers under 
the Drug Supply Chain Security Act--Questions and Answers'' guidance 
for industry (June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers) is intended to 
address anticipated questions regarding product identifiers that are 
required under section 582 for packages and homogenous cases of certain 
drug products. The ``Verification Systems Under the Drug Supply Chain 
Security Act for Certain Prescription Drugs'' draft guidance (October 
2018; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/verification-systems-under-drug-supply-chain-security-act-certain-prescription-drugs) provides recommendations for a 
robust verification system for the determination, quarantine, and 
investigation of suspect products, as well as the quarantine, 
notification, and disposition of illegitimate products. The guidance 
also addresses FDA's recommendation that trading partners submit 
cleared product notifications. Finally, the guidance addresses the 
statutory requirements for verification, including verification of 
saleable returns, at the package level for product identifiers on 
packages and homogenous cases intended to be introduced in a 
transaction into commerce.
    FDA guidance documents are issued consistent with requirements 
found in section 582, as well as our Good Guidance Practice regulations 
found in 21 CFR 10.115, which provide for public comment at any time. 
In addition, since enactment of the DSCSA, our Center for Drug 
Evaluation and Research has developed and continues to maintain a 
website communicating DSCSA implementation activity, including relevant 
resources at: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa.
    We estimate 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
       Type of respondent            Number of     responses per   Total annual    Average time     Total hours
                                    respondents     respondent       responses     per response
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Manufacturers and Repackagers...             100               1             100               1             100
Wholesale Distributors..........             138               1             138               1             138
Dispenser.......................              12               1              12               1              12
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             250  ..............             250
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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
       Type of respondent            Number of      disclosures        Total       Average time     Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers...             100              30           3,000          * 0.20             600
Wholesale Distributors..........             138           1,175         162,150          * 0.20          32,430
Dispensers......................              12               2              24          * 0.20               5
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............         165,174  ..............          33,035
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (12 minutes.)


[[Page 49541]]


    Table 3--Estimated Annual Reporting Burden for Consultation With FDA and Termination of Notification \1\
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                                                     Number of
       Type of respondent            Number of     responses per   Total annual    Average time     Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers...             100               1             100               1             100
Wholesale Distributors..........             138               1             138               1             138
Dispensers......................              12               1              12               1              12
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             250  ..............             250
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\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\
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                                                     Number of
       Type of respondent            Number of      disclosures        Total       Average time     Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers...             100              30           3,000          * 0.20             600
Wholesale Distributors..........             138           1,175         162,150          * 0.20          32,430
Dispensers......................              12               2              24          * 0.20               5
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............         165,174  ..............          33,035
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* (12 minutes.)


       Table 5--Estimated Annual Reporting Burden for Requests for Waivers, Exceptions, or Exemptions \1\
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                                                     Number of
       Type of respondent            Number of     responses per   Total annual    Average time     Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Requests to FDA for a Waiver,                 20               1              20              80           1,600
 Exception, or Exemption........
Notifications to FDA of a                      1               1               1              16              16
 Material Change in
 Circumstances Warranting the
 Waiver, Exception, or Exemption
Requests to FDA to Renew a                     1               1               1              16              16
 Waiver, Exception, or Exemption
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............              22  ..............           1,632
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on illegitimate product notifications already received, we 
estimate a total of 250 respondents to the information collection. Our 
database for establishment and drug product listing suggests that many 
companies perform activities of both manufacturers and repackagers and 
therefore we have combined our estimated number of respondent 
manufacturers and repackagers. In addition, because statutory 
provisions specifically define ``dispensers'' to include retail 
pharmacies, hospital pharmacies, and groups of chain pharmacies, our 
estimate of the number of dispensers is intended to reflect the overall 
estimated number of respondents we believe to be subject to the 
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 these 
three trading partners submit most notifications of illegitimate 
products. Upon evaluation of those notifications received in fiscal 
year (FY) 2020 and, thus far, in FY 2021, we assume those 250 
respondents are comprised of 40 percent manufacturers (100), 55 percent 
wholesale distributors (138), and 5 percent pharmacies (12). We assume 
that annual notifications will vary from zero to two for manufacturers 
and repackagers, as well as from pharmacies, but that most of companies 
will make no notifications. Although our establishment and drug product 
listing database currently reflects approximately 1,400 manufacturers 
and repackagers, we estimate only 100 manufacturers and repackagers 
will notify us of illegitimate products an average of one time per 
year.
    Relying on data from the National Association of Chain Drug Stores, 
the National Community Pharmacists Association, and the American 
Hospital Association, we assume there are approximately 67,000 pharmacy 
sites in the United States. Based on a review of data, we estimate 12 
pharmacies will notify FDA of illegitimate product an average of 1 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 
1,570 small wholesale distributors may be responsible for the remaining 
10 percent of drug sales, we estimate that wholesale distributors will 
be responsible for making approximately an average of 1 notification 
per year to account for the estimated 138 notifications that FDA will 
receive regarding illegitimate product. We

[[Page 49542]]

assume wholesale distributors will expend 1 hour for each notification.
    Because the extent of distribution of any illegitimate product will 
vary, we assume a wide distribution for each illegitimate product for 
purposes of establishing our burden estimate. We estimate that, for 
each notification that a manufacturer or repackager makes to FDA, the 
manufacturer or repackager will notify approximately 30 trading 
partners (relying on the number of distributors). This formula results 
in approximately 3,000 notifications annually to trading partners of 
manufacturers and repackagers. This estimate includes the notifications 
by manufacturers and repackagers who have determined that an 
illegitimate product is in their possession or control, as well as 
notifications by manufacturers who have determined that a product poses 
a high risk of illegitimacy.
    We assume that a large wholesale distributor may have up to 4,500 
trading partners, where a small wholesale distributor may have 200 
trading partners, averaging approximately 2,350. We had originally 
estimated that a wholesale distributor would notify all 2,350 trading 
partners for each of the illegitimate products identified. However, as 
a result of our experience with the collection and informal feedback 
from industry, we have lowered our estimate to reflect that 138 
respondents will make 1,175 disclosures for a total of 162,150 
disclosures annually and that each disclosure will require 
approximately 12 minutes, for a total of 32,430 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 12 illegitimate products 
identified. This estimate results in in approximately 24 notifications 
annually to pharmacy trading partners.
    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 to notify trading partners that the 
notification is terminated is approximately 33,035 hours annually.
    We assume a comparable amount of time is required to provide the 
information necessary for requesting to terminate a 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 to make requests for termination of notifications to FDA is 250 
hours annually.
    Based on communications we have had with trading partners and 
stakeholders since the 2013 enactment of the DSCSA, we estimate that 20 
trading partners or stakeholders will submit approximately 20 requests 
for a waiver, an exception, or an exemption. Also based on feedback 
from industry stakeholders, we estimate that respondents will expend an 
average of 80 hours to prepare and submit each request and to submit 
any additional followup information that we may request. We estimate 
the total burden as approximately 1,600 hours.
    We estimate that we will receive from approximately one respondent 
approximately one notification or other information informing us that 
there has or has not been a material change in the circumstances that 
warranted the waiver, exception, or exemption and that each 
notification will require approximately 16 hours to prepare and submit 
to us. We estimate the total burden as approximately 16 hours.
    We estimate that we will receive approximately one renewal request 
from approximately one respondent and that each request will require 
approximately 16 hours to prepare and submit to us. We estimate the 
total burden as approximately 16 hours.
    Our estimated burden for the information collection reflects an 
overall increase of 56,116 hours and a corresponding increase of 
271,638 responses annually. We attribute this adjustment to an increase 
in the number of illegitimate product notification submissions we 
received in the last couple of years and the number of such submissions 
we have received so far this fiscal year.

    Dated: August 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19061 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P