[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Draft Guidance for Industry on Size of Beads in Drug Products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availability of a draft guidance for industry entitled ``Size of Beads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 This draft guidance provides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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 19, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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FDA is announcing the availability of a draft guidance for industry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