[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]



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]