Document ID: FDA-2012-N-0197-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Shortages Data Collection System
Posted Date: 2019-11-22T05:00Z

[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64535-64536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25368]

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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; Medical Devices; 
Shortages Data Collection System

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: Fax written comments on the collection of information by 
December 23, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0491. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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.

Medical Devices; Shortages Data Collection System

OMB Control Number 0910-0491--Reinstatement

    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 
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.
    The data collection process will consist of an initial telephone 
call to firms who have been identified as

[[Page 64536]]

producing an essential medical device. In this initial call, 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.
    In the Federal Register of December 28, 2018 (83 FR 67298), 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
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Shortages Data Collection.....             260               4           1,040  0.5 (30 minutes)             520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA based the burden estimates in table 1 on past experience with 
direct contact with the medical device manufacturers and anticipated 
changes in the medical device manufacturing patterns for the specific 
devices being monitored. FDA estimates that approximately 260 
manufacturers would be contacted by telephone and/or electronic mail 4 
times per year either to obtain primary data or to verify/validate 
data. Because the requested data represent data elements that are 
monitored or tracked by manufacturers as part of routine inventory 
management activities, it is anticipated that for most manufacturers, 
the estimated time required of manufacturers to complete the data 
request will not exceed 30 minutes per request cycle.
    This information collection is a reinstatement without change. 
There is an increase (an adjustment) of 332 hours in the total 
estimated burden compared with that identified in the information 
collection request previously approved by OMB. This increase reflects 
changes in market demands, in which manufacturers are increasingly 
adopting just-in-time production methods.

    Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25368 Filed 11-21-19; 8:45 am]
 BILLING CODE 4164-01-P