[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Notices]
[Pages 28116-28118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0197]


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, 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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by June 24, 2021.

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 0910-0491. 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--Revision

    Under section 1003(d)(2) of the Federal Food, Drug, and Cosmetic 
Act (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

[[Page 28117]]

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 follow-up correspondence may 
occasionally be needed to verify/validate data, confirm receipt of 
follow-up correspondence(s), and/or request additional details to 
further inform FDA's public health response. These data, collected 
under section 1003(d)(2) of the FD&C Act, are currently approved under 
OMB control number 0910-0491. We have made minor changes to this 
``Shortages data collection'' at this time (see first row of table 1 of 
this document) to reflect additional learnings from recent experience.
    The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) 
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 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 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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    Section 3087 of the 21st Century Cures Act, signed into law in 
December 2016, added subsection (f) to section 319 of the Public Health 
Service Act (42 U.S.C. 247d). This new subsection gives the HHS 
Secretary (Secretary) the authority to waive PRA requirements with 
respect to voluntary collections of information during a public health 
emergency, as declared by the Secretary, or when a disease or disorder 
is significantly likely to become a public health emergency. In 2020, 
FDA published the guidance entitled ``Notifying CDRH of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under 
Section 506J of the FD&C Act During the COVID-19 Public Health 
Emergency (Revised)'' (86 FR 106),\3\ to implement section 506J of the 
FD&C Act, as it relates to device shortages and potential device 
shortages occurring during the COVID-19 pandemic, for the duration of 
the COVID-19 public health emergency. The guidance includes additional 
voluntary items that manufacturers could provide the Agency, including 
additional information about device manufacturing and supply, and 
updates to initial notifications. While PRA requirements for the 
voluntary information collections recommended in the guidance are 
waived \4\ during the COVID-19 pandemic, public health emergency using 
this new authority, mandatory collections, such as those under section 
506J of the FD&C Act, may not be part of the waiver. FDA requested 
emergency clearance under 44 U.S.C. 3507(j) and 5 CFR 1320.13 to 
immediately approve revision of OMB control number 0910-0491 to add the 
information collection required by section 506J of the FD&C Act, as 
amended. The emergency clearance approval expires on May 31, 2021; 
therefore, CDRH is requesting a revision of OMB control number 0910-
0491 to add the information collection required by 506J of the FD&C 
Act.
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    \3\ See https://www.fda.gov/media/137712/download.
    \4\ See https://aspe.hhs.gov/system/files/pdf/258866/FDA-PHE-PRA-Waiver-Notice_COVID-19_03.19.20.pdf.
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    In the Federal Register of February 23, 2021 (86 FR 10972), 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:

I. Shortages Data Collection Currently Approved Under OMB Control 
Number 0910-0491

    FDA bases these estimates on past experiences with direct contact 
with the medical device manufacturers and distributors, and anticipated 
changes in the medical device manufacturing and distributions patterns 
for the specific devices that may be monitored. FDA estimates that 
there may be up to 500 manufacturers and distributors for which there 
may be targeted outreach because their devices may be essential to the 
response effort. This targeted outreach will be conducted periodically 
to either obtain primary data or to verify/validate updated data 
(although additional outreach may be undertaken as needed).
    From the manufacturer and distributor's point of view, the data 
being requested represent common data elements that they monitor and 
track as part of routine business operations and, therefore, are 
readily available. It is anticipated that for most manufacturers and 
distributors, the estimated time to fulfill CDRH's data request will 
not exceed 30 minutes per request.

[[Page 28118]]

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, as well as the provision of required 
information under section 506J of the FD&C Act--as well as additional 
voluntary information related to the determination (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 manufacturers of 
the applicable devices. Therefore, we estimate the burden of this 
information collection to be 15 minutes or less per determination and 
notification.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                   Number of
                   Activity                        Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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Shortages data collection.....................             500               4           2,000  0.5 (30 minutes)........................           1,000
Information collection under section 506J of             8,400               1           8,400  0.25 (15 minutes).......................           2,100
 the FD&C Act.
Additional voluntary collections related to              8,400               1           8,400  0.25 (15 minutes).......................           2,100
 section 506J of the FD&C Act.
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    Total.....................................  ..............  ..............          18,800  ........................................           5,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The information collection reflects a revision to add the 
information collection required by section 506J of the FD&C Act (as 
amended by section 3121 of the CARES Act) and additional voluntary 
collections related to section 506J of the FD&C Act to OMB control 
number 0910-0491.
    Upon review of OMB control number 0910-0491, we note that there is 
a data-entry error in the RISC/ORIA Combined Information System (ROCIS) 
for a previous information collection approval on February 3, 2020. 
Currently, ROCIS lists the total burden hours for that approval as 390 
hours; the correct total burden hour estimate is 520 hours. This error 
has carried through to the current total hour burden listed in ROCIS as 
2,481 hours for the approval on November 24, 2020; the correct total 
burden hour estimate should be 2,611 hours. We will correct this error 
upon submission of this information collection request to OMB.
    Additionally, we have updated the number of respondents in each 
information collection to reflect our current data and estimations.
    These revisions and adjustments reflect an overall increase of 
2,589 hours to the (corrected) estimated total burden.

    Dated: May 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11028 Filed 5-24-21; 8:45 am]
BILLING CODE 4164-01-P