[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]


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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.

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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 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\
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                                                                                         Number of
                        Absenteeism guidance                            Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Notify FDA of Plan Activation and Deactivation.....................               2                1                2               16               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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                                                                                         Number of                      Average  burden
                        Absenteeism guidance                            Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Develop Initial Plan...............................................              70                1               70              500           35,000
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\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