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, 5965-5966 [2020-01992]
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Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until December 31, 2021.
DATES: Authority for the Vaccines and
Related Biological Products Advisory
Committee will expire on December 31,
2021, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6306, Silver Spring, MD 20993–0002,
240–402–8006, Prabhakara.Atreya@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3, FDA is announcing
the renewal of the Vaccines and Related
Biological Products Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective vaccines and related biological
products for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
that are intended for use in the
prevention, treatment, or diagnosis of
human diseases and, as required, any
other products for which FDA has
regulatory responsibility. The
Committee also considers the quality
and relevance of FDA’s research
program, which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner.
Pursuant to its Charter, the Committee
shall consist of a core of 15 voting
members, including the Chairperson
(the Chair). Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
immunology, molecular biology, rDNA,
virology, bacteriology, epidemiology or
biostatistics, vaccine policy, vaccine
safety science, Federal immunization
activities, vaccine development
including translational and clinical
evaluation programs, allergy, preventive
medicine, infectious diseases,
pediatrics, microbiology, and
biochemistry. Members will be invited
to serve for overlapping terms of up to
4 years. Almost all non-Federal
members of this Committee serve as
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16:47 Jan 31, 2020
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Special Government Employees. Ex
Officio voting members, one each from
the Department of Health and Human
Services, the Centers for Disease Control
and Prevention, and the National
Institutes of Health, may be included.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests. There
may also be an alternate industry
representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) Expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
Committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a Committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Blood
VaccinesandOtherBiologics/
VaccinesandRelatedBiologicalProducts
AdvisoryCommittee/ucm129571.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the Committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
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5965
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01988 Filed 1–31–20; 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; 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.
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.
SUMMARY:
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 0910–0675. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\03FEN1.SGM
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5966
Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
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-guidancedocuments/planning-effects-highabsenteeism-ensure-availabilitymedically-necessary-drug-products.
In the Federal Register of October 25,
2019 (84 FR 57448), we published a 60day 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
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
lotter on DSKBCFDHB2PROD with NOTICES
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
VerDate Sep<11>2014
16:47 Jan 31, 2020
Jkt 250001
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
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Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1072]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Application for
Participation in Food and Drug
Administration Fellowship and
Traineeship Programs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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
