Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products, 72091-72092 [2013-28735]
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Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Notices
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: November 7, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2013–28733 Filed 11–29–13; 8:45 am]
BILLING CODE 4120–01–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; Guidance for
Industry on 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.
SUMMARY:
Fax written comments on the
collection of information by January 2,
2014.
DATES:
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:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
emcdonald on DSK67QTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
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:
VerDate Mar<15>2010
20:41 Nov 29, 2013
Jkt 232001
Guidance for Industry on Planning for
the Effects of High Absenteeism To
Ensure Availability of Medically
Necessary Drug Products—(OMB
Control Number 0910–0675)—Extension
The guidance recommends that
manufacturers of drug and therapeutic
biological products and manufacturers
of raw materials and components used
in those products 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
discusses the issues that should be
covered by the Plan, such as: (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 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 as
well as the broader Plan to comprise one
Plan for each manufacturer. Based on
FDA’s data on the number of
manufacturers that would be covered by
the guidance, we estimate that
approximately 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 will take
approximately 500 hours to develop,
maintain, and update.
The guidance also encourages
manufacturers to include a procedure in
their Plan for notifying the 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
specifies the information that should be
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
72091
included in these notifications, such as
which drug products will be
manufactured under altered procedures,
which products will have
manufacturing temporarily delayed, and
any anticipated or potential drug
shortages. We expect that approximately
2 notifications (for purposes of this
analysis, we consider an activation and
a deactivation notification to equal one
notification) will be sent to CDER by
approximately 2 manufacturers each
year, and that each notification will take
approximately 16 hours to prepare and
submit.
The guidance also refers to previously
approved collections of information
found in FDA regulations. Under the
guidance, if a manufacturer obtains
information after releasing an MNP
under its Plan, leading to suspicion that
the product might be defective, CDER
should be contacted immediately at
drugshortages@fda.hhs.gov in
adherence to existing recall reporting
regulations (21 CFR 7.40; OMB control
number 0910–0249), or defect reporting
requirements for drug application
products (21 CFR 314.81(b)(1)) and
therapeutic biological products
regulated by CDER (21 CFR 600.14)
(OMB control numbers 0910–0001 and
0910–0458, respectively).
In addition, the following collections
of information found in FDA current
good manufacturing practice (CGMP)
regulations in part 211 (21 CFR part
211) are approved under OMB control
number 0910–0139. The guidance
encourages manufacturers to maintain
records, in accordance with the CGMP
requirements (see, e.g., § 211.180) that
support decisions to carry out changes
to approved procedures for
manufacturing and release of products
under the Plan. The guidance states that
a Plan should be developed, written,
reviewed, and approved within the
site’s change control quality system in
accordance with the requirements in
§§ 211.100(a) and 211.160(a); execution
of the Plan should be documented in
accordance with the requirements
described in § 211.100(b); and standard
operating procedures should be
reviewed and revised or supplementary
procedures developed and approved to
enable execution of the Plan.
In the Federal Register of June 21,
2013 (78 FR 37548), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
information collection as follows:
E:\FR\FM\02DEN1.SGM
02DEN1
72092
Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Absenteeism guidance
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notify FDA of Plan Activation and Deactivation ..................
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 RECORDKEEPING BURDEN 1
Absenteeism guidance
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Develop Initial Plan ..............................................................
70
1
70
500
35,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–28735 Filed 11–29–13; 8:45 am]
OMB control number 0910–0677. Also
include the FDA docket number found
in brackets in the heading of this
document.
BILLING CODE 4160–01–P
FOR FURTHER INFORMATION CONTACT:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0748]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups
About Drug Products as Used by the
Food and Drug Administration
AGENCY:
Focus Groups About Drug Products as
Used by the Food and Drug
Administration—(OMB Control
Number 0910–0677)—Extension
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 January 2,
2014.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:41 Nov 29, 2013
Jkt 232001
Focus groups provide an important
role in gathering information because
they allow for a more in-depth
understanding of individuals’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies. Focus groups
serve the narrowly defined need for
direct and informal opinion on a
specific topic and as a qualitative
research tool have three major purposes:
• To obtain information that is useful
for developing variables and measures
for quantitative studies,
• To better understand people’s
attitudes and emotions in response to
topics and concepts, and
• To further explore findings
obtained from quantitative studies.
FDA will use focus group findings to
test and refine its ideas and to help
develop messages and other
communications, but will generally
conduct further research before making
important decisions such as adopting
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
new policies and allocating or
redirecting significant resources to
support these policies.
FDA’s Center for Drug Evaluation and
Research, Office of the Commissioner,
and any other Centers or Offices
conducting focus groups about regulated
drug products may need to conduct
focus groups on a variety of subjects
related to consumer, patient, or
healthcare professional perceptions and
use of drug products and related
materials, including but not limited to:
• Direct-to-consumer prescription
drug promotion,
• physician labeling of prescription
drugs,
• Medication Guides,
• over-the-counter drug labeling,
• emerging risk communications,
• patient labeling,
• online sales of medical products,
and
• consumer and professional
education.
Annually, FDA projects about 20
focus group studies using 160 focus
groups with an average of 9 persons per
group, and lasting an average of 1.75
hours each. FDA is requesting this
burden for unplanned focus groups so
as not to restrict the Agency’s ability to
gather information on public sentiment
for its proposals in its regulatory and
communications programs.
In the Federal Register of June 28,
2013 (78 FR 38993), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
information collection as follows:
E:\FR\FM\02DEN1.SGM
02DEN1
]]>Agencies
[Federal Register Volume 78, Number 231 (Monday, December 2, 2013)]
[Notices]
[Pages 72091-72092]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28735]
-----------------------------------------------------------------------
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; Guidance for Industry
on 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 January
2, 2014.
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 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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
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.
Guidance for Industry on Planning for the Effects of High Absenteeism
To Ensure Availability of Medically Necessary Drug Products--(OMB
Control Number 0910-0675)--Extension
The guidance recommends that manufacturers of drug and therapeutic
biological products and manufacturers of raw materials and components
used in those products 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 discusses the issues that should be covered by the Plan,
such as: (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 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 as well as the broader Plan to comprise one Plan
for each manufacturer. Based on FDA's data on the number of
manufacturers that would be covered by the guidance, we estimate that
approximately 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
will take approximately 500 hours to develop, maintain, and update.
The guidance also encourages manufacturers to include a procedure
in their Plan for notifying the 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 specifies the information that should be
included in these notifications, such as which drug products will be
manufactured under altered procedures, which products will have
manufacturing temporarily delayed, and any anticipated or potential
drug shortages. We expect that approximately 2 notifications (for
purposes of this analysis, we consider an activation and a deactivation
notification to equal one notification) will be sent to CDER by
approximately 2 manufacturers each year, and that each notification
will take approximately 16 hours to prepare and submit.
The guidance also refers to previously approved collections of
information found in FDA regulations. Under the guidance, if a
manufacturer obtains information after releasing an MNP under its Plan,
leading to suspicion that the product might be defective, CDER should
be contacted immediately at drugshortages@fda.hhs.gov in adherence to
existing recall reporting regulations (21 CFR 7.40; OMB control number
0910-0249), or defect reporting requirements for drug application
products (21 CFR 314.81(b)(1)) and therapeutic biological products
regulated by CDER (21 CFR 600.14) (OMB control numbers 0910-0001 and
0910-0458, respectively).
In addition, the following collections of information found in FDA
current good manufacturing practice (CGMP) regulations in part 211 (21
CFR part 211) are approved under OMB control number 0910-0139. The
guidance encourages manufacturers to maintain records, in accordance
with the CGMP requirements (see, e.g., Sec. 211.180) that support
decisions to carry out changes to approved procedures for manufacturing
and release of products under the Plan. The guidance states that a Plan
should be developed, written, reviewed, and approved within the site's
change control quality system in accordance with the requirements in
Sec. Sec. 211.100(a) and 211.160(a); execution of the Plan should be
documented in accordance with the requirements described in Sec.
211.100(b); and standard operating procedures should be reviewed and
revised or supplementary procedures developed and approved to enable
execution of the Plan.
In the Federal Register of June 21, 2013 (78 FR 37548), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this information collection as follows:
[[Page 72092]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Absenteeism guidance Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notify FDA of Plan Activation and Deactivation..................... 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 Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Absenteeism guidance Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop Initial Plan............................................... 70 1 70 500 35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28735 Filed 11-29-13; 8:45 am]
BILLING CODE 4160-01-P
