[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12311-12312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0024]


Guidance for Industry on Size of Beads in Drug Products Labeled 
for Sprinkle; 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 ``Size of Beads in 
Drug Products Labeled for Sprinkle.'' This guidance provides applicants 
preparing or submitting 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).
    In the Federal Register of January 19, 2011 (76 FR 3144), FDA 
announced the availability of the draft version of this guidance. The 
public comment period closed on April 19, 2011. A number of comments 
were received from the public, all of which the Agency considered 
carefully as it finalized the guidance and made appropriate changes.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This 
guidance provides applicants preparing or submitting 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 
in 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--whether from a capsule that has been broken or 
from

[[Page 12312]]

a packet containing beads--it is important to have reasonable assurance 
that the patient will be able to swallow the beads (uncrushed) with the 
food with which the beads are mixed without stimulating the urge to 
chew. Additional assurances may be needed when the label also includes 
specific language concerning alternate administration via an enteral 
feeding tube.
    The recommendations in this guidance are based on literature on 
chewing and swallowing particle size and on Agency experience with NDAs 
and ANDAs submitted for these dosage forms. This guidance provides the 
following information related to drug products labeled for sprinkle: 
Appropriate maximum size for the beads, special considerations for 
sprinkle drug products that include language in labeling concerning 
alternate administration via an enteral feeding tube, and 
bioavailability (BA) or bioequivalence (BE) recommendations.
    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 the 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. 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 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: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4784 Filed 2-28-12; 8:45 am]
BILLING CODE 4160-01-P