2011-1001. Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Size of Beads in Drug Products Labeled for Sprinkle.” This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 19, 2011.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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:

Laurie Muldowney, Center for Drug Evaluation and Research (HFD-003), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4154, Silver Spring, MD 20993-0002, 301-796-1571.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Size of Beads in Drug Products Labeled for Sprinkle.” This draft guidance provides sponsors of NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

Certain drug products that contain beads within a capsule indicate on the labeling that the capsule can be broken and the internal beads can be sprinkled on soft foods and swallowed without chewing as an alternative administration technique. This is particularly common with drug products designed to have extended- or delayed-release characteristics (i.e., the beads are manufactured to release the drug product at different rates). To make certain that the intended product performance is achieved—be it from a capsule that has been broken or from a packet containing beads—it is important to have reasonable assurance that the patient will be able to swallow the beads with the food that the beads are mixed with without stimulating the urge to chew. Additional assurances may be needed when the label also includes language for alternate administration via an enteral feeding tube.

The recommendations in this draft guidance are based on literature on chewing and swallowed particle size and on Agency experience with NDAs and ANDAs submitted for these dosage forms. Three parameters are considered in this draft guidance as they relate to drug products labeled for sprinkle: (1) Appropriate maximum size for the beads, (2) special considerations for sprinkle drug products that include language for alternate administration via an enteral feeding tube, and (3) how to address potential bead size differences between reference listed drugs and ANDAs and meet bioavailability (BA) or bioequivalence (BE) recommendations.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on size of beads in drug products labeled for sprinkle. 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. The Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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). Information submitted in an NDA, ANDA, or BLA supporting the appropriate size for beads in drug products that are labeled to be administered via sprinkling, including related BA and BE studies, is approved by OMB under control number 0910-0001 for NDAs and ANDAs and control number 0910-0338 for BLAs.

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: January 12, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.