Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products, 37548-37549 [2013-14812]
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37548
Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Type of respondent
Parent of Youth Baseline
Survey Participants.
Youth aged 13–18 in the
United States.
Total ...........................
1 There
Outcome Evaluation Parent Baseline Questionnaire.
Screener ............................
1st Media Tracking Questionnaire.
Screener ............................
2nd Media Tracking Questionnaire.
Screener ............................
3rd Media Tracking Questionnaire.
...........................................
BILLING CODE 4160–01–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; Guidance for
Industry on Planning for the Effects of
High Absenteeism To Ensure
Availability of Medically Necessary
Drug Products
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 in 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 August 20, 2013.
SUMMARY:
TKELLEY on DSK3SPTVN1PROD with NOTICES
Average burden
per response
Total hours
12,940
1
12,940
0.17 (10 min.) ...
2,200
40,000
4,000
1
1
40,000
4,000
0.03 (2 min.) .....
0.5 (30 min.) .....
1,200
2,000
40,000
4,000
........................
1
40,000
4,000
0.03 (2 min.) .....
0.5 (30 min.) .....
1,200
2,000
40,000
4,000
1
1
40,000
4,000
0.03 (2 min.) .....
0.5 (30 min.) .....
1,200
2,000
238,833
........................
........................
...........................
35,523
VerDate Mar<15>2010
18:32 Jun 20, 2013
Jkt 229001
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane., Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
ADDRESSES:
[FR Doc. 2013–14809 Filed 6–20–13; 8:45 am]
ACTION:
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
Number of
respondents
Activity
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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.
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
E:\FR\FM\21JNN1.SGM
21JNN1
37549
Federal Register / Vol. 78, No. 120 / Friday, June 21, 2013 / Notices
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., 1 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
two 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 two 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 0190–0139. 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.
FDA estimates the burden of this
information collection as follows:
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: June 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–14812 Filed 6–20–13; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2013–N–0010]
BILLING CODE 4160–01–P
TKELLEY on DSK3SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Cooperative Agreement To Support the
North Carolina State University,
Prestage Department of Poultry
Science and the Piedmont Research
Station
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing its
SUMMARY:
VerDate Mar<15>2010
18:32 Jun 20, 2013
Jkt 229001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
intention to receive and consider a
single-source application for the award
of a cooperative agreement in fiscal year
2013 (FY13) to the North Carolina State
University, Prestage Department of
Poultry Science and the Piedmont
Research Station Poultry Unit located in
Salisbury, NC. Egg-associated illness
due to Salmonella is a major public
health concern, with table eggs being
the primary source of Salmonella
Enteritidis. Therefore, an FDA priority
is to implement preventative measures
to reduce the vertical and horizontal
transmission of Salmonella Enteritidis
and other Salmonella serovars to table
eggs and poultry products. The goal of
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[Federal Register Volume 78, Number 120 (Friday, June 21, 2013)]
[Notices]
[Pages 37548-37549]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14812]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0719]
Agency Information Collection Activities: Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 in
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 August 20, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-7726, Ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.
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
[[Page 37549]]
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., 1 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 two 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 two 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 0190-0139. 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.
FDA estimates the burden of this information collection as follows:
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: June 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14812 Filed 6-20-13; 8:45 am]
BILLING CODE 4160-01-P
