[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Notices]
[Pages 1060-1062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0568]
Draft Guidance for Industry on Planning for the Effects of High
Absenteeism to Ensure Availability of Medically Necessary Drug
Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Planning for
the Effects of High Absenteeism to Ensure Availability of Medically
Necessary Drug Products.'' The draft guidance encourages manufacturers
of medically necessary drug products (MNPs) and components to develop
contingency production plans in the event of an emergency that results
in high absenteeism at one or more production
[[Page 1061]]
facilities. The purpose of the draft guidance is to provide to industry
considerations for developing such emergency plans, as well as to
discuss the Center for Drug Evaluation and Research's (CDER's) intended
approach to assist in avoiding drug product shortages that may have a
negative impact on the national public health during such emergencies.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 9, 2010. Submit written comments on the proposed collection of
information by March 9, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Thomas Christl, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., WO Bldg. 51, rm. 3359, Silver Spring, MD 20993, 301-
796-2057.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Planning for the Effects of High Absenteeism to Ensure
Availability of Medically Necessary Drug Products.'' The draft guidance
encourages manufacturers of medically necessary drug products (MNPs)
and components to develop contingency production plans in the event of
an emergency that results in high absenteeism at one or more production
facilities. In particular, the draft guidance provides recommendations
regarding considerations for the development and implementation of a
contingency production plan, including specific elements to include in
such a plan. The draft guidance is intended for manufacturers of
finished drug products as well as manufacturers of the raw materials
necessary for manufacturing an MNP.
The purpose of this draft guidance is to provide to industry
considerations for developing emergency plans, as well as to discuss
CDER's intended approach to assist in avoiding shortages that may have
a negative impact on the national public health during such
emergencies. This draft guidance applies to manufacturers of drug and
therapeutic biologic products regulated by CDER, and any components of
those products. These considerations include, but are not limited to:
General preparedness through employee education and
immunization,
Prioritization of manufactured products based on medical
necessity,
Developing training, manufacturing and laboratory
contingencies for high absenteeism, and
How to plan for returning to normal operations.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 that
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 before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing this
notice of the proposed collection of information set forth in this
document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on these topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
The draft 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 MNPs during an emergency
that results in high employee absenteeism. The draft 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 draft 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 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 CDER's
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data on the number of manufacturers that would be covered by the draft
guidance, we estimate that approximately 70 manufacturers will develop
an Emergency Plan as recommended by the draft 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 draft guidance also encourages manufacturers to include a
procedure in their Plan for notifying CDER when the Plan is activated
and when returning to normal operations. The draft guidance recommends
that these notifications occur within 1 day of a Plan's activation and
within 1 day of a Plan's deactivation. The draft 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.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. Under the draft guidance, if a
manufacturer obtains information after releasing a MNP under its Plan
leading to suspicion that the product might be defective, CDER should
be contacted immediately ([email protected]) 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).
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 draft 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 draft guidance states: 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 collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Number of Number of Responses Hours per
Respondents per Respondent Total Responses Response Total Hours
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Notify FDA of Plan activation and deactivation 2 1 2 16 32
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Total 32
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
Table 2.--Estimated Recordkeeping Burden\1\
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Number of Number of Records
Recordkeepers per Recordkeeping Total Records Hours per Record Total Hours
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Develop initial Plan 70 1 70 500 35,000
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Total 35,000
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: January 4, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-87 Filed 1-7-10; 8:45 am]
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