[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14025-14026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 guidance for industry entitled ``Planning for the 
Effects of High Absenteeism to Ensure Availability of Medically 
Necessary Drug Products.'' The guidance encourages manufacturers of 
medically necessary drug products (MNPs) and components to develop 
production plans in the event of an emergency that results in high 
absenteeism at one or more production facilities. The purpose of the 
guidance is to provide to industry considerations for developing plans 
for these types of emergencies, 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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

[[Page 14026]]

    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Thomas J. Christl, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 3358, Silver Spring, MD 20993-0002, 301-
796-2057.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Planning for the Effects of High Absenteeism to Ensure 
Availability of Medically Necessary Drug Products.'' The guidance 
encourages manufacturers of MNPs and components to develop production 
plans in the event of an emergency that results in high absenteeism at 
one or more production facilities. In particular, the guidance provides 
recommendations regarding considerations for the development and 
implementation of a production plan, including specific elements to 
include in such a plan. The guidance is intended for manufacturers of 
finished drug products as well as manufacturers of the raw materials 
necessary for manufacturing of an MNP.
    The purpose of this guidance is to provide to industry 
considerations for developing plans for these types of emergencies, 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 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:
    <bullet> General preparedness through employee education and 
immunization,
    <bullet> Prioritization of manufactured products based on medical 
necessity,
    <bullet> Developing training, manufacturing and laboratory 
contingencies for high absenteeism, and
    <bullet> How to plan for returning to normal operations.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on planning for the effects of high 
absenteeism to ensure availability of MNPs. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control number 0910-0675.

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: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5949 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P