[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,
[email protected].
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
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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 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
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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
[[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