Notice2022-00327
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 11, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 7 (Tuesday, January 11, 2022)</title>
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[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1419-1421]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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-45, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#015153405275606767416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="feaeacbfad8a9f9898be989a9fd096968dd0999188">[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 <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions</a>. 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification</a>) 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act</a>). 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\
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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)
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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:
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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)..........
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Request renewals (Waivers 1 1 1 16 16
Guidance, sec. III)............
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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\
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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)
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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)............
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Total....................... .............. .............. .............. .............. 1,860,000
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\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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply</a>). 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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