[Federal Register Volume 61, Number 251 (Monday, December 30, 1996)]
[Rules and Regulations]
[Pages 68623-68624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-33098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 201

[Docket No. 92N-0165]


Specific Requirements on Content and Format of Labeling for Human 
Prescription Drugs; Revision of ``Pediatric Use'' Subsection in the 
Labeling; Extension of Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of compliance date.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
compliance date of a final rule, that published in the Federal Register 
of December 13, 1994. The document revised the ``Pediatric use'' 
subsection of the professional labeling requirements for prescription 
drugs. This final rule extends to April 7, 1997, the date for 
submission of supplemental applications to comply with the new 
regulation for those manufacturers who notify FDA in writing by January 
29, 1997 of their intent to submit a supplement. The agency is taking 
this action in response to a request for an extension of the compliance 
date.

EFFECTIVE DATE: December 30, 1996

FOR FURTHER INFORMATION CONTACT: Erica L. Keys, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1046.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 13, 1994 
(59 FR 64240), FDA published a final rule that amended its regulations 
governing the content and format of labeling for human prescription 
drug products. The regulation revised the ``Pediatric use'' subsection 
of the professional labeling requirements for prescription drugs (21 
CFR 201.57(f)(9)) to provide for the inclusion of more complete 
information about the use of a drug in the pediatric population (ages 
birth to 16 years). The regulation requires sponsors to reexamine 
existing data to determine whether the ``Pediatric use'' subsection of 
the labeling can be modified based on adequate and well-controlled 
studies in adults and other information supporting pediatric use, and, 
if appropriate, submit a supplemental application to comply with the 
new requirements by December 13, 1996. The final regulation gave 
manufacturers 2 years in which to submit supplements, in response to 
comments requesting that FDA extend the 1-year implementation period 
originally proposed.
    On November 6, 1996, FDA sent a letter to 250 manufacturers asking 
them to notify the agency whether and when they intended to file 
supplements. FDA has received responses from only 40 manufacturers. On 
November 20, 1996, the Pharmaceutical Research and Manufacturers of 
America (PhRMA) requested that FDA extend the compliance date of the 
final rule because some of their members with large numbers of products 
had encountered unexpected problems in gathering the required 
information.
    The absence of adequate pediatric labeling continues to present a 
significant public health issue and the level of response to the 
December 13, 1994, final rule is cause for concern. To

[[Page 68624]]

identify appropriate next steps to address this issue, it is essential 
that FDA identify the number of supplements that will be filed. 
Therefore, FDA is extending the compliance date under the following 
condition. If a manufacturer notifies FDA in writing by January 29, 
1997, of their intent to submit a supplement, the agency will not 
consider the manufacturer's supplement to be late if it is received by 
April 7, 1997.
    Because this action only extends the compliance date, FDA finds 
that there is good cause to dispense with a notice of proposed 
rulemaking, under 5 U.S.C. 553(b)(3)(B), as impracticable and 
unnecessary and is publishing this revision as a final rule effective 
December 30, 1996.

    Dated: December 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-33098 Filed 12-27-96; 8:45 am]
BILLING CODE 4160-01-F