[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10972-10974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 or Agency) 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 revision 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: Submit either electronic or written comments on the collection 
of information by April 26, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 26, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 26, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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-2012-N-0197 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Shortages Data Collection.'' 
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

[[Page 10973]]

``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 White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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 revision 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--Revision

    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 who 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 will 
be collected, using least burdensome methods, in a structured manner to 
answer specific questions. After the initial outreach, we will request 
updates to the information on a quarterly basis 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. 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 (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 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 in ``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 (PHE), and the reason for such 
discontinuance or interruption.\2\ Section 506J 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.
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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) and (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. This new subsection gives the HHS Secretary the authority 
to waive PRA requirements with respect to voluntary collections of 
information during a PHE, as declared by the Secretary, or when a 
disease or disorder is significantly likely to become a PHE. In 2020 
FDA published the immediately in effect guidance document 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)--Guidance for Industry and 
Food and Drug Administration Staff'' (see 86 FR 106, January 4, 2021) 
\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 PHE. The guidance includes

[[Page 10974]]

additional voluntary items that manufacturers could provide the
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    \3\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc.
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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 PHE 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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    \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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    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 quarterly 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, or 2 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 & Listing system indicates 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: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03630 Filed 2-22-21; 8:45 am]
BILLING CODE 4164-01-P


