
[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]


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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.

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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 http://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\
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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: 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


