2011-5949. 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.

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.

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:

• General preparedness through employee education and immunization,
• Prioritization of manufactured products based on medical necessity,
• Developing training, manufacturing and laboratory contingencies for high absenteeism, and
• 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.