
[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Notices]
[Pages 1060-1062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: X10-380108]


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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Draft Guidance for Industry on Planning for the Effects of High 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availability of a draft guidance for industry entitled ``Planning for 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 The draft guidance encourages manufacturers 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 The purpose of the draft guidance is to provide to industry 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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

[[Page 1062]]

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 (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).
    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]
BILLING CODE 4160-01-S


