[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3144-3145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Size of Beads in Drug Products 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availability of a draft guidance for industry entitled ``Size of Beads 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 This draft guidance provides 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 19, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

[[Page 3145]]


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    FDA is announcing the availability of a draft guidance for industry 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.
[FR Doc. 2011-1001 Filed 1-18-11; 8:45 am]
BILLING CODE 4160-01-P