[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57448-57450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2013-N-0719]


Agency Information Collection Activities; Proposed Collection; 
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 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 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 the information collection for the guidance 
on planning for the effects of high absenteeism to ensure availability 
of medically necessary drug products.

DATES: Submit either electronic or written comments on the collection 
of information by December 24, 2019.

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 December 24, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 24, 2019. 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-2013-N-0719 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Planning for the Effects of High 
Absenteeism to Ensure Availability of Medically Necessary Drug 
Products.'' 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.
     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.gpo.gov/fdsys/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://

[[Page 57449]]

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.

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, 
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 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.

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 document 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.
    We estimate the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
                      Activity                             Number of         responses per       Total annual       Average  burden       Total hours
                                                          respondents         respondent           responses         per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Activate/deactivate Plan as recommended in the                        2                   1                   2                  16                  32
 guidance...........................................
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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      Number of  records     Total annual       Average  burden
                      Activity                           recordkeepers     per  recordkeeper        records        per  recordkeeper      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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

[[Page 57450]]

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: October 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23272 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P


