[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32437-32439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4597]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Shortages Data 
Collections

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 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 May 28, 2024.

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

[[Page 32438]]

by using the search function. The OMB control number for this 
information collection is 0910-0491. Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

Shortages Data Collections

OMB Control Number 0910-0491--Extension

    Under section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)), the 
Commissioner of Food and Drugs is authorized to implement general 
powers (including conducting research) to carry out effectively the 
mission of FDA. After the events of September 11, 2001, and as part of 
broader counterterrorism and emergency preparedness activities, FDA's 
Center for Devices and Radiological Health (CDRH) began developing 
operational plans and interventions that would enable CDRH to 
anticipate and respond to medical device shortages that might arise in 
the context of federally declared disasters/emergencies or regulatory 
actions. In particular, CDRH identified the need to acquire and 
maintain detailed data on domestic inventory, manufacturing 
capabilities, distribution plans, and raw material constraints for 
medical devices that would be in high demand and/or would be vulnerable 
to shortages in specific disaster/emergency situations or following 
specific regulatory actions. Such data could support prospective risk 
assessment, help inform risk mitigation strategies, support real-time 
decision making by the Department of Health and Human Services during 
actual emergencies or emergency preparedness exercises, and mitigate or 
prevent harm to the public health.
    This voluntary data collection process consists of outreach to 
firms that have been identified as producing or distributing medical 
devices that may be considered essential to the response effort. In 
this initial outreach, the intent and goals of the data collection 
effort will be described, and the specific data request made. Data are 
collected, using the least burdensome methods, in a structured manner 
to answer specific questions. After the initial outreach, we will 
request updates to the information periodically to keep the data 
current and accurate. Additional followup correspondence may 
occasionally be needed to verify/validate data, confirm receipt of 
followup correspondence(s), and/or request additional details to 
further inform FDA's public health response.
    The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 
(Pub. L. 116-136) was enacted on March 27, 2020. Section 3121 of the 
CARES Act amended the FD&C Act by adding section 506J to the FD&C Act 
(21 U.S.C. 356j). Section 506J of the FD&C Act provides FDA with new 
authorities intended to help prevent or mitigate medical device 
shortages by requiring medical device manufacturers to inform FDA about 
changes in device manufacturing that could potentially lead to a device 
shortage. Apprised with that information, section 506J of the FD&C Act 
authorizes FDA to take several actions that may help to mitigate or 
avoid supply disruptions.
    Section 506J of the FD&C Act requires manufacturers of certain 
devices,\1\ to notify FDA ``of a permanent discontinuance in the 
manufacture of the device'' or ``an interruption of the manufacture of 
the device that is likely to lead to a meaningful disruption in supply 
of that device in the United States'' during or in advance of a 
declared public health emergency, and the reason for such 
discontinuance or interruption.\2\ Section 506J of the FD&C Act 
requires FDA to take action based on that information, including (1) 
publicly posting a list of devices it determines to be in shortage, (2) 
publicly posting the reasons for the shortage, and (3) issuing letters 
to manufacturers that fail to comply with the notification requirements 
of section 506J of the FD&C Act.
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    \1\ Under section 506J of the FD&C Act, manufacturers of the 
following devices must notify FDA of an interruption or permanent 
discontinuance in manufacturing:
     Devices that are critical to public health during a 
public health emergency, including those that are life-supporting, 
life-sustaining, or intended for use in emergency medical care or 
during surgery; or
     Devices for which FDA determines information on 
potential meaningful supply disruptions is needed during a public 
health emergency. See section 506J(a)(1), (2) of the FD&C Act.
    \2\ See section 506J(a) of the FD&C Act.
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    On December 29, 2022, the Prepare for and Respond to Existing 
Viruses, Emerging New Threats, and Pandemics Act was signed into law as 
part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) 
(hereafter referred to as the ``FY 2023 Omnibus''). Section 2514(c) of 
the fiscal year (FY) 2023 Omnibus directed FDA to issue or revise 
guidance regarding requirements under section 506J of the FD&C Act and 
include a list of each device product code for which a manufacturer of 
such device is required to notify FDA in accordance with section 506J. 
Section 2514 of the FY 2023 Omnibus amended section 506J of the FD&C 
Act to add section 506J(h), ``Additional Notifications'' and directed 
FDA to issue guidance ``to facilitate voluntary notifications.''
    In the Federal Register of November 17, 2023 (88 FR 80310), FDA 
announced the availability of the final guidance entitled ``Notifying 
FDA of a Permanent Discontinuance or Interruption in Manufacturing of a 
Device Under Section 506J of the FD&C Act'' \3\ and the draft guidance 
entitled ``Select Updates for the 506J Guidance: 506J Device List and 
Additional Notifications.'' \4\ The final guidance, ``Notifying FDA of 
a Permanent Discontinuance or Interruption in Manufacturing of a Device 
Under Section 506J of the FD&C Act'' (hereafter referred to as the 
``506J Guidance'') assists stakeholders in the Agency's implementation 
of section 506J of the FD&C Act. This final guidance serves as the 
baseline for information about notifications under section 506J of the 
FD&C Act during or in advance of any public health emergency (PHE). FDA 
provides additional clarification on who is required to notify FDA, 
when such notifications are required, what information FDA expects 
manufacturers to include in such notifications, and how to submit 
notifications. Additionally, FDA describes how FDA determines that a 
device is in shortage and additional actions FDA may take to help 
prevent or mitigate a potential device shortage.
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    \3\ https://www.fda.gov/media/155245/download.
    \4\ https://www.fda.gov/media/173800/download.
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    In the draft guidance ``Select Updates for the 506J Guidance: 506J 
Device List and Additional Notifications,'' FDA proposes updates to the 
506J Guidance. Specifically, FDA has developed a list of devices, by 
FDA product code, for which a manufacturer of such devices is required 
to notify FDA in accordance with section 506J of the FD&C Act 
(hereafter referred to as the ``506J Device List''). The 506J Device 
List is based on the requirements under section 506J(a) of the FD&C 
Act. In section 2514 of the FY 2023 Omnibus, Congress directed FDA to 
issue guidance on the requirements under section 506J of the FD&C Act 
and to include ``a list of each device product code for which a 
manufacturer of such device is required

[[Page 32439]]

to notify the Secretary in accordance with section 506J.'' Thus, 
manufacturers of a device on the 506J Device List must notify FDA in 
accordance with 506J of the FD&C Act for each such device. For more 
information, manufacturers should see the 506J Device List web page, 
available at https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/506j-device-list. Additionally, consistent with 
section 506J(h) of the FD&C Act, FDA is proposing to clarify for 
stakeholders that manufacturers may submit, and FDA may receive, 
voluntary notifications regarding supply chain issues at any time, 
unrelated to the declaration or potential declaration of a PHE.
    The guidance documents include additional voluntary items that 
manufacturers could provide the Agency, including additional 
information about device manufacturing and supply, and updates to 
initial notifications.
    Respondents may notify FDA about an interruption or permanent 
discontinuance in device manufacturing (506J notification) on our 
website at https://fda-cdrh.my.salesforce-sites.com/shortages/.
    In the Federal Register of November 28, 2023 (88 FR 83134), 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 \1\
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                                                  Number of                      Average burden
           Activity               Number of     responses per   Total annual      per response      Total hours
                                 respondents     respondent       responses         (hours)
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Shortages outreach data                 1,000               4           4,000                  1           4,000
 collection..................
Information collection under            8,400               1           8,400  0.25 (15 minutes)           2,100
 section 506J................
Additional voluntary                    8,400               1           8,400  0.25 (15 minutes)           2,100
 collections related to
 section 506J................
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    Total....................  ..............  ..............          20,800  .................           8,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

I. Shortages Outreach Data Collection

    FDA bases these estimates on our recent experience and informal 
direct contact with respondents. We estimate up to 1,000 manufacturers, 
distributors, healthcare systems, healthcare providers, group 
purchasing organizations, and sterilizers for which there may be 
targeted outreach because their devices may be essential to the 
response effort. This targeted outreach will be conducted periodically 
either to obtain primary data or to verify/validate updated data 
(although additional outreach may be undertaken as needed). The data 
being requested represent common data elements that respondents monitor 
and track as part of routine business operations and, therefore, are 
readily available. It is anticipated that for most respondents, the 
estimated time to fulfill CDRH's data request will not exceed 1 hour 
per request, or 4 hours per year.

II. Information Collection Under Section 506J of the FD&C Act and 
Related Voluntary Collections

    Based on current registration and listing data (approved under OMB 
control number 0910-0625), we estimate the number of respondents that 
will submit a notification under section 506J of the FD&C Act to be 
approximately 20 percent of currently registered manufacturers. Data 
from our Registration and Listing system indicate that there are 
approximately 42,000 unique FDA Establishment Identification registered 
manufacturers. Therefore, we estimate 8,400 respondents per year. We 
believe that the burden, including the provision of required 
information under section 506J of the FD&C Act, as well as additional 
voluntary information (including additional issues that may impact the 
availability of the device, such as information about critical 
suppliers, potential mitigations, production capacity and market share, 
and notification updates), is minimal and such information is readily 
available to respondents. Therefore, we estimate the burden of this 
information collection to be 15 minutes or less per notification.
    Since the last OMB approval, we have updated the Number of 
Respondents and Average Burden per Response for the Shortages Outreach 
Data Collection element based on our recent experience with the 
information collection and informal direct contact with respondents. 
The updates result in an adjustment of an additional 3,000 hours and 
2,000 responses annually.

    Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09023 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P