[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1419-1421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00327]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, 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.

DATES: Submit written comments (including recommendations) on the 
collection of information by February 10, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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-45, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#f5a5a7b4a681949393b5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="bbebe9fae8cfdaddddfbdddfda95d3d3c895dcd4cd">[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.

Drug Supply Chain Security Act Implementation

OMB Control Number 0910-0806--Revision

    This information collection supports Agency implementation of 
provisions in section 582 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) regarding the pharmaceutical distribution supply chain. 
Section 202 of the Drug Supply Chain Security Act (DSCSA) (Title II of 
Pub. L. 113-54), added sections 581 and 582 to the FD&C Act (21 U.S.C. 
360eee and 360eee-1) and governs the tracing of certain pharmaceutical 
drugs, outlining critical steps for an electronic interoperable system 
to identify these

[[Page 1420]]

products as they are distributed within the United States.
    To strengthen FDA's ability to help protect consumers from exposure 
to drugs that may be counterfeit, stolen, contaminated, or otherwise 
harmful, section 203 of the DSCSA added enhanced security provisions to 
section 582 of the FD&C Act. The terms and definitions established in 
section 581 of the FD&C Act are applicable to provisions set forth in 
section 582, which require the capture, exchange, and verification of 
pharmaceutical drug product transaction information, transaction 
history, and transaction statements by respondents. Section 582 of the 
FD&C Act also requires that certain notifications are made by 
respondents to FDA and provides for respondent notification disclosures 
applicable to suspect and illegitimate product data elements. The 
recordkeeping and notification provisions included in section 582 also 
provide for inspection of records by FDA and establish minimum 
retention schedules. Finally, section 582 of the FD&C Act provides for 
the establishment of waivers, exceptions, and exemptions from any of 
the requirements.
    To assist respondents with reporting requirements, we developed 
Form FDA 3911 entitled Drug Notification and 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 provide a 
uniform format for initial notifications, followup notifications, and 
requests for the termination of a notification. The guidance document 
entitled ``Drug Supply Chain Security Act Implementation: 
Identification of Suspect Product and Notification'' (Revision 1, 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) was developed to 
assist respondents with identifying a suspect product as defined at 
section 581(21) of the FD&C Act and in making determinations in this 
regard.
    We also developed the draft guidance document entitled ``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). Respondents seeking waivers, exceptions, 
or exemptions from any of the requirements may submit a request to FDA. 
The draft guidance explains Agency established processes by which: (1) 
A trading partner may request a waiver from certain requirements in 
section 582 of the FD&C Act if it would result in an undue economic 
hardship or for emergency medical reasons; (2) a manufacturer or 
repackager may request an exception to 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.
    Respondents to the information collection are manufacturers, 
wholesale distributors (``wholesalers''), dispensers, and repackagers, 
as defined in section 581 of the FD&C Act, of pharmaceutical drug 
products.
    In the Federal Register of September 3, 2021 (86 FR 49538), we 
published a 60-day notice soliciting public comment on the proposed 
collection of information. A few comments were received requesting that 
FDA clarify the scope of the information collection request. We 
appreciate these comments. Although our 60-day notice discussed both 
draft and final guidance documents pertaining to topic-specific 
statutory requirements found in section 582 of the FD&C Act, not all 
the guidance documents discussed in the notice included information 
collection as defined by the PRA and subject to review and approval by 
OMB. Rather, consistent with regulations found in 21 CFR 10.115, 
guidance documents are intended to communicate the Agency's thinking on 
a particular topic and can therefore be helpful to respondents in 
understanding related information collection activities.
    To clarify however, this information collection request is intended 
to account for the burden respondents may incur from completing and 
submitting notifications as required by section 582 of the FD&C Act 
using Form FDA 3911, consistent with the corresponding instructions, as 
well as the burden that may be attributable to information collection 
associated with the required disclosures/notifications to trading 
partners and discussed in the guidance document entitled ``Drug Supply 
Chain Security Act Implementation: Identification of Suspect Product 
and Notification.'' The information collection request is also intended 
to account for the burden that respondents may incur associated with 
requesting waivers, exceptions, and exemptions provided for in section 
582(a)(3) of the FD&C Act. To enable respondents to make such requests, 
we are currently utilizing information collection recommendations 
discussed in the draft guidance document entitled ``Waivers, 
Exceptions, and Exemptions from the Requirements of Section 582 of the 
Federal Food, Drug, and Cosmetic Act.'' Specifically, the draft 
guidance instructs respondents on submitting requests and identifies 
responsible Agency review components.
    The comments also provided feedback on the accuracy of our burden 
estimates. In response to these comments, we have revised our estimate 
of the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                     Average time
    Sec. 582 of the FD&C Act;        Number of     responses per   Total annual    per response     Total hours
            activity                respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
Notifications of illegitimate                500            28.2          14,100               8         112,800
 product: Form FDA 3911.........
Consultation/terminations of                 500               1             500               1             500
 notification of illegitimate
 product (Notifications
 Guidance, sec. IV.B)...........
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                       582(a)(3); Waivers, exceptions, and exemptions of any requirement:
----------------------------------------------------------------------------------------------------------------
Request submissions (Waivers                  20               1              20              80           1,600
 Guidance, sec. III.A.).........
Material changes (Waivers                      1               1               1              16              16
 Guidance, sec. III.D)..........

[[Page 1421]]

 
Request renewals (Waivers                      1               1               1              16              16
 Guidance, sec. III)............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         114,932
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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 Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                     Average time
    Sec. 582 of the FD&C Act;        Number of      disclosures        Total      per disclosure    Total hours
            activity                respondents   per respondent    disclosures     (in hours)
----------------------------------------------------------------------------------------------------------------
Illegitimate product                         500             310         155,000               8       1,240,000
 notifications to trading
 partners (Notifications
 Guidance, sec. III.B)..........
Illegitimate product                         500             310         155,000               4         620,000
 notification terminations to
 trading partners (Notifications
 Guidance, sec. III)............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,860,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have reorganized the information collection by respondent 
activity and clarified where information collection elements are 
discussed in the respective guidance documents. Based on illegitimate 
product notifications FDA has already received, we previously estimated 
a total of 250 respondents. However, we have considered industry 
feedback indicating that more notifications may be submitted based on 
stakeholder understanding of FDA's recent clarification of stolen 
product in the ``Definitions of Suspect Product and Illegitimate 
Product for Verification Obligations Under the Drug Supply Chain 
Security Act'' draft guidance (June 2021; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply). As such, we have increased our number 
of estimated respondents to 500 and assume 40 percent are manufacturers 
(200), 50 percent are wholesale distributors (250), and 10 percent are 
pharmacies (50). 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 continue to assume that these three trading partners submit 
most notifications of illegitimate products.
    In response to industry feedback, we have increased our estimate of 
the average time per response from 1 hour to 8 hours to more accurately 
reflect the burden respondents may incur in satisfying the information 
collection. We have otherwise retained the average burden per response 
for activities associated with consultations and waiver/exception/
exemption requests. Finally, also based on public comment and industry 
feedback, we have increased our estimate of the average number of 
disclosures/notifications per respondent, as well as our assumption of 
the average time necessary for each disclosure notification, for an 
increase from 66,070 to 1,860,000 hours annually.
    As a result of these adjustments, our estimated burden for the 
information collection reflects a cumulative increase since the last 
OMB review and approval. We attribute this increase to a more recent 
evaluation of the information collection and informal communications 
with industry and other interested stakeholders regarding burden 
estimates.

    Dated: January 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00327 Filed 1-10-22; 8:45 am]
BILLING CODE 4164-01-P


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