[Federal Register Volume 59, Number 244 (Wednesday, December 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31297]
[[Page Unknown]]
[Federal Register: December 21, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 88N-0004]
Pediatric Dosing with Over-the-Counter Drug Products; Summary
Information Document for Advisory Committee Meeting; Availability;
Establishment of a Public Docket and Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Availability of summary information document; establishment of
a public docket and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a summary information document for the Nonprescription
Drugs Advisory Committee meeting on pediatric dosing with over-the-
counter (OTC) drug products. Elsewhere in this issue of the Federal
Register, the agency is announcing a forthcoming meeting of this
advisory committee. The action is being taken to ensure that all
interested parties are aware of the issues that are the subject of the
committee discussion. FDA is also announcing that it has established a
public docket for comments, views, and other information submitted to
the agency on these subjects from interested persons.
DATES: Submit written comments by March 14, 1994. Comments received
before the January 13, 1995, advisory committee meeting will be
distributed to the committee as soon as possible.
ADDRESSES: Submit written comments or relevant data and requests for
single copies of the summary information document to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Comments and requests should
be identified with the docket number found in brackets in the heading
of this document. Send two self-addressed adhesive labels to assist the
branch in processing your requests. Please note that copying charges
may be assessed. Three copies of written comments should be submitted,
except that individuals may submit one copy. The summary information
document and received comments are available for public examination at
the Dockets Management Branch (address above), between 9 a.m. and 4
p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger or Liz Ortuzar,
Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455.
SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the Federal
Register, FDA is announcing a forthcoming meeting of the
Nonprescription Drugs Advisory Committee on pediatric dosing (use by
children under 12 years of age) of OTC drug products. FDA is holding
this meeting to discuss topics such as:
(1) What is the most preferred and practical basis for determining
and labeling OTC systemic pediatric dosages, e.g., age, weight, height
(length), body surface area, or a combination of these?
(2) Is the dosing approach (adult-1 full dose, children 6 to 12-\1/
2\ adult dose, and children 2 to 6- \1/4\ adult dose) currently being
used for most OTC oral drugs an adequate method of dosing?
(3) Should there be differences in systemic pediatric dosing ranges
for specific ingredients or different classes of OTC drug products? If
yes, for which specific ingredients or classes of products?
(4) Should calibrated dosage devices be required for (specific or
all) pediatric products? If yes, for which product(s) and how should
they be calibrated (e.g., devices expressing dosage levels in teaspoon
or milliliter units)?
(5) What are the lowest limits (e.g., age, weight, etc.) for which
specific dosing instructions should appear in OTC product labeling?
Would these limits be different for certain classes of OTC drugs, such
as internal analgesics, antihistamines, etc.?
The purpose of this meeting is to address specific topics and
questions contained in the summary information document that could
result in future rulemaking. FDA has established public docket no. 88N-
0004 to enable interested persons to submit comments or other relevant
data on the summary information document.
Dated: December 14, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-31297 Filed 12-20-94; 8:45 am]
BILLING CODE 4160-01-F