
[Federal Register: October 18, 2010 (Volume 75, Number 200)]
[Notices]               
[Page 63832-63833]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc10-59]                         


[[Page 63832]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0568]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 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.

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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 
November 17, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title Draft Guidance for Industry on Planning for the Effects of High 
Absenteeism to Ensure Availability of Medically Necessary Drug Products 
(MNPs). Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400Q, Rockville, MD 20850, 301-796-7392, 
Elizabeth.berbakos@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.

Draft Guidance for Industry on Planning for the Effects of High 
Absenteeism to Ensure Availability of Medically Necessary Drug Products

    The draft guidance recommends that manufacturers of drug and 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 FDA's 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 an 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.
    In the Federal Register of January 8, 2010 (75 FR 1060), FDA 
announced the availability of the draft guidance. In that Federal 
Register notice, FDA provided the public with 60 days to comment on the 
proposed collection of information. FDA received the following comments 
that pertained to the information collection in the draft guidance.
    Some comments stated that pharmaceutical companies already have 
business continuity plans that address shortages of medically necessary 
products and that these plans take into account high absenteeism and 
other factors that could affect production. FDA believes that a general 
business continuity plan is unlikely to take into account individual 
products or how execution of the plan would affect product quality.
    Some comments stated that the recommendation that the Plan be

[[Page 63833]]

maintained in the Quality System is burdensome and provides no value to 
ensuring protection of public health. FDA agrees with these comments 
and has revised the guidance to recommend that only the parts of the 
Plan that could have an effect on product quality be reviewed and 
approved by the Quality Unit before implementation of the Plan.
    One comment stated that with adequate inventory on hand, an 
absenteeism-specific business plan might not be needed. FDA disagrees 
with the comment. As we discussed in the guidance, potential shortages 
could arise from emergencies not contemplated by inventory policy.
    One comment stated that establishing provisions to use resources 
available at other sites will require significant effort. FDA 
recommends that these provisions be considered as part of the overall 
Plan for handling emergencies.
    Some comments suggested different timeframes for notifying FDA of 
activation and deactivation of the Plan, stating that 1 day is too 
short a time. FDA did not change its recommendation for 1-day 
notification for Plan activation and deactivation because informing FDA 
of this activity in as close to real time as possible will assist the 
FDA in making critical decisions related to managing the causal event.
    Some comments stated that testing the implementation of the Plan 
and producing test batches would be impractical and expensive. FDA 
agrees with these comments and has revised its recommendation to test 
the implementation of the Plan and removed its recommendation to 
produce test batches of the drug product.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                      Annual
                                     Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Notify FDA of Plan activation                  2               1               2              16              32
 and deactivation...............
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    Total.......................  ..............  ..............  ..............  ..............              32
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                    Table 2--Estimated Recordkeeping Burden 1
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                                                      Annual
                                     Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
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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 collection of
  information.


    Dated: October 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26103 Filed 10-15-10; 8:45 am]
BILLING CODE 4160-01-P

