[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83134-83136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Shortages Data Collections

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 collections 
associated with Shortages Data Collections and with notifications to 
FDA of an interruption or permanent discontinuance in manufacturing of 
certain medical devices as required by the Federal Food, Drug, and 
Cosmetic Act (FD&C Act).

DATES: Either electronic or written comments on the collection of 
information must be submitted by January 29, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 29, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received 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-2023-N-4597 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Shortages Data Collections.'' 
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 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three

[[Page 83135]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 301-796-8867, [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.

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 (HHS) 
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. This guidance serves as the baseline for information 
about notifications under section 506J during or in advance of any 
public health emergency (PHE). FDA provides additional clarification on 
who is

[[Page 83136]]

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 (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 and to include ``a list of each device 
product code for which a manufacturer of such device is required 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 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), 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/.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                    Number of       Total
                    Activity                        Number of     responses per     annual       Average burden per response  (hours)       Total hours
                                                   respondents     respondent     responses
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Shortages outreach data collection.............           1,000               4        4,000  1.........................................           4,000
Information collection under section 506J......           8,400               1        8,400  0.25 (15 minutes).........................           2,100
Additional voluntary collections related to               8,400               1        8,400  0.25 (15 minutes).........................           2,100
 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: November 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26199 Filed 11-27-23; 8:45 am]
BILLING CODE 4164-01-P