[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5965-5966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01992]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0719]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Planning for the 
Effects of High Absenteeism To Ensure Availability of Medically 
Necessary Drug Products

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 March 
4, 2020.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0675. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

[[Page 5966]]

Planning for the Effects of High Absenteeism To Ensure Availability of 
Medically Necessary Drug Products

OMB Control Number 0910-0675--Extension

    This information collection supports recommendations found in 
Agency guidance. Specifically, we have developed guidance intended to 
encourage manufacturers of drug and therapeutic biological products, 
and any raw materials and components used in those products, to develop 
a written Emergency Plan (Plan) for maintaining an adequate supply of 
medically necessary drug products (MNPs) during an emergency that 
results in high employee absenteeism. The guidance entitled, ``Planning 
for the Effects of High Absenteeism to Ensure Availability of Medically 
Necessary Drug Products,'' discusses the elements that should be 
covered by such a Plan, and is available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/planning-effects-high-absenteeism-ensure-availability-medically-necessary-drug-products.
    In the Federal Register of October 25, 2019 (84 FR 57448), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate 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
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Activate/deactivate Plan as recommended in the guidance............               2                1                2               16               32
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records        recordkeeper
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Develop initial Plan as recommended in the guidance................              70                1               70              250           17,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As explained in the guidance, we provide recommendations for 
developing and implementing a written Plan, including: (1) Identifying 
a person or position title (as well as two designated alternates) with 
the authority to activate and deactivate the Plan and make decisions 
during the emergency; (2) prioritizing the manufacturer's drug products 
based on medical necessity; (3) identifying actions that should be 
taken prior to an anticipated period of high absenteeism; (4) 
identifying criteria for activating the Plan; (5) performing quality 
risk assessments to determine which manufacturing activities may be 
reduced to enable the company to meet a demand for MNPs; (6) returning 
to normal operations and conducting a post-execution assessment of the 
execution outcomes; and (7) testing the Plan.
    The guidance also encourages manufacturers to include and document 
procedures in the Plan for notifying the FDA Center for Drug Evaluation 
and Research (CDER) when the Plan is activated and when returning to 
normal operations. The guidance recommends that these notifications 
occur within 1 day of a Plan's activation and within 1 day of a Plan's 
deactivation. The guidance identifies the information that should be 
included in these notifications, such as which drug products will be 
manufactured under altered procedures, which products' manufacturing 
will be temporarily delayed, and any anticipated or potential drug 
shortages. We assume two notifications (for purposes of this analysis, 
we consider an activation and a deactivation notification to equal one 
notification) will be submitted to CDER annually, and assume each 
notification requires 16 hours to prepare and submit.
    Finally, the guidance recommends developing a Plan for each 
individual manufacturing facility as well as a broader Plan that 
addresses multiple sites within the organization. For purposes of this 
information collection analysis, we consider the Plan for an individual 
manufacturing facility and the broader Plan to comprise one Plan for 
each manufacturer. Based on available data on the number of 
manufacturers that would be covered by the guidance, we previously 
estimated 70 manufacturers will develop a Plan as recommended by the 
guidance (i.e., one Plan per manufacturer, to include all manufacturing 
facilities, sites, and drug products) and that each Plan would take 
approximately 500 hours to develop. Upon development of the plan, 
however, we believe fewer hours are necessary to maintain and update it 
as needed. As FDA issued the guidance in 2011, we now assume that most 
respondents have developed the recommended plan, and therefore we limit 
our current burden estimate to updates and maintenance. Accordingly, we 
have reduced our estimate by half, reasoning that, although it takes 
fewer hours for updates and maintenance, new respondents may choose to 
adopt recommendations found in the guidance.

    Dated: January 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01992 Filed 1-31-20; 8:45 am]
 BILLING CODE 4164-01-P