
[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76618-76620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26527]


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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 or we) 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 January 3, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''

[[Page 76619]]

    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0719 for ``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.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@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 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 per year to develop, maintain, and 
update.
    The guidance also encourages manufacturers to include a procedure 
in their Plan for notifying the FDA 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

[[Page 76620]]

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 Annual 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: October 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26527 Filed 11-2-16; 8:45 am]
BILLING CODE 4164-01-P


