Agency Information Collection Activities; Proposed Collection; Comment Request; Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products, 57448-57450 [2019-23272]
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57448
Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
voucher. FDA has determined that an
efficacy supplement for DESCOVY
(emtricitabine and tenofovir
alafenamide) approved October 3, 2019,
meets the redemption criteria.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9858,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA,
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that an efficacy
supplement for DESCOVY
(emtricitabine and tenofovir
alafenamide) approved October 3, 2019,
meets the redemption criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about DESCOVY (emtricitabine and
tenofovir alafenamide) efficacy
supplement approved October 3, 2019,
go to the ‘‘Drugs@FDA’’ website at
https://www.accessdata.fda.gov/scripts/
cder/daf/.
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23252 Filed 10–24–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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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:
PO 00000
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• 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/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
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.
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,
SUPPLEMENTARY 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.
57449
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/regulatoryinformation/search-fda-guidancedocuments/planning-effects-highabsenteeism-ensure-availabilitymedically-necessary-drug-products.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Activate/deactivate
Plan
as
recommended in the guidance ................
2
1
2
16
32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
Total hours
Develop initial Plan as recommended in
the guidance .......................................
70
1
70
250
17,500
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
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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
PO 00000
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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
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4310]
Allergan Pharmaceuticals
International, LTD; Withdrawal of
Approval of a New Drug Application for
LO MINASTRIN FE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
withdrawing approval of a new drug
application (NDA) for LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01
milligrams (mg); ethinyl estradiol and
norethindrone acetate tablets, 0.01 mg/
1mg; and ferrous fumarate tablets, 75
mg), held by Allergan Pharmaceuticals
International, LTD, c/o Allergan Sales,
LLC, 5 Giralda Farms, Madison, NJ
07940 (Allergan). Allergan notified the
Agency in writing that the drug product
was no longer marketed and requested
that the approval of the application be
withdrawn.
Approval is withdrawn as of
November 25, 2019.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
Allergan
has informed FDA that LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01 mg;
ethinyl estradiol and norethindrone
acetate tablets, 0.01 mg/1 mg; and
ferrous fumarate tablets, 75 mg) is no
longer marketed and has requested that
FDA withdraw approval of NDA 204654
under the process in § 314.150(c) (21
CFR 314.150(c)). Allergan has also, by
its request, waived its opportunity for a
hearing. Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
Therefore, approval of NDA 204654,
and all amendments and supplements
thereto, is hereby withdrawn as of
November 25, 2019. Approval of the
entire application is withdrawn,
including any strengths and dosage
forms inadvertently missing from this
notice. Introduction or delivery for
introduction into interstate commerce of
a product without an approved new
drug application violates section 301(a)
and (d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Any Lo Minastrin Fe that is in inventory
on November 25, 2019 may continue to
be dispensed until the inventories have
been depleted or the drug products have
reached their expiration dates or
otherwise become violative, whichever
occurs first.
SUPPLEMENTARY INFORMATION:
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23309 Filed 10–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–3163; FDA–
2012–D–0429; FDA–2012–D–0049; FDA–
2018–N–3031; FDA–2011–D–0125; FDA–
2018–N–4428; FDA–2012–N–0560; FDA–
2010–N–0414; FDA–2012–N–1203; and
FDA–2019–N–0430]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
publishing a list of information
collections that have been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA).
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional
Pieces ...................................................................................................................................................................
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products .......................................................................................................................................................................
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Date approval
expires
0910–0875
9/30/2021
0910–0731
8/31/2022
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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...........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
