[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
