Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation, 1419-1421 [2022-00327]
Download as PDF
<![CDATA[
1419
Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents or
https://www.fda.gov/vaccines-bloodbiologics/guidance-compliance-
regulatory-information-biologics/
biologics-guidances. Persons unable to
download an electronic copy of
‘‘Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the FD&C Act’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 21003 and complete
title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in section
506J of the FD&C Act have been
approved by OMB as listed in the
following table:
OMB Control
No.
21 CFR part; guidance; or FDA form
Topic
506J ............................................................................................
Shortages Data Collection ..........................................................
IV. Other Issues for Consideration
The Agency invites comments on the
‘‘Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the FD&C Act’’ draft
guidance, in general, and on the
following questions, in particular:
• Section 506J of the FD&C Act
requires notifications ‘‘during, or in
advance of’’ a public health emergency.
Does the draft guidance provide
sufficient clarity regarding what FDA
considers to be ‘‘in advance of a public
health emergency’’? Is there additional
information that you believe would be
helpful? If so, what?
• Are there other situations or
circumstances that could lead to a
situation that could be considered to be
‘‘in advance of a public health
emergency’’?
• FDA has proposed providing
supplemental information during
specific public health emergencies,
which is intended to contain
information specific to that public
health emergency to assist
manufacturers in providing
notifications. Is there specific
information that you believe should be
conveyed in such supplements?
• Are there circumstances where it is
unclear whether you should notify
FDA? How could FDA provide clarity?
• Should FDA notify stakeholders
when an event is considered to be ‘‘in
advance of a public health emergency’’,
and if so, how should FDA best do so?
• FDA recommends that
manufacturers provide updates to
notifications every two weeks unless
otherwise indicated based on the nature
of the situation, including the expected
timeline for recovery, even if the status
remains unchanged. Please provide
feedback on this proposed frequency.
• How can FDA best disseminate
supplemental information during or in
VerDate Sep<11>2014
20:03 Jan 10, 2022
Jkt 256001
advance of a public health emergency to
manufacturers and other stakeholders?
• How can FDA keep all stakeholders,
including healthcare providers and
patients, better informed regarding
shortages during or in advance of a
public health emergency?
• In the draft guidance document,
Appendix A displays an example of
supplemental information for an
epidemic or pandemic that FDA
believes would be helpful to assess the
overall state of the market and help
inform potential mitigations. What
additional information might be helpful
for other public health emergencies?
Dated: January 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–00321 Filed 1–10–22; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
0910–0491
collection of information by February
10, 2022.
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.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
E:\FR\FM\11JAN1.SGM
11JAN1
1420
Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices
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-supplychain-security-act-dscsa/drugnotifications-frequently-askedquestions. 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-guidancedocuments/drug-supply-chain-securityact-implementation-identificationsuspect-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-exemptionsrequirements-section-582-federal-fooddrug-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
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Sec. 582 of the FD&C Act; activity
Notifications of illegitimate product: Form FDA 3911 ..........
Consultation/terminations of notification of illegitimate
product (Notifications Guidance, sec. IV.B) .....................
Number of
responses per
respondent
Total annual
responses
Average time
per response
(in hours)
Total hours
500
28.2
14,100
8
112,800
500
1
500
1
500
20
1
80
16
1,600
16
582(a)(3); Waivers, exceptions, and exemptions of any requirement:
Request submissions (Waivers Guidance, sec. III.A.) ........
Material changes (Waivers Guidance, sec. III.D) ................
VerDate Sep<11>2014
20:03 Jan 10, 2022
Jkt 256001
PO 00000
Frm 00029
20
1
Fmt 4703
Sfmt 4703
1
1
E:\FR\FM\11JAN1.SGM
11JAN1
1421
Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Sec. 582 of the FD&C Act; activity
Average time
per response
(in hours)
Total annual
responses
Total hours
Request renewals (Waivers Guidance, sec. III) ..................
1
1
1
16
16
Total ..............................................................................
........................
........................
........................
........................
114,932
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
respondents
Sec. 582 of the FD&C Act; activity
Illegitimate product notifications to trading partners (Notifications Guidance, sec. III.B) ............................................
Illegitimate product notification terminations to trading partners (Notifications Guidance, sec. III) ..............................
Total ..............................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
disclosures
per respondent
Total
disclosures
Average time
per disclosure
(in hours)
Total hours
500
310
155,000
8
1,240,000
500
310
155,000
4
620,000
........................
........................
........................
........................
1,860,000
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-andillegitimate-product-verificationobligations-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.
VerDate Sep<11>2014
20:03 Jan 10, 2022
Jkt 256001
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Telehealth
Resource Center Performance
Measurement Tool, OMB No. 0915–
0361—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 14, 2022.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
SUMMARY:
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[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.
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)...........
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
