[Federal Register Volume 65, Number 233 (Monday, December 4, 2000)]
[Notices]
[Page 75720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30697]



[[Page 75720]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1595]


Draft Guidance for Industry on Recommendations for Complying With 
the Pediatric Rule; 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availability of a draft guidance for industry entitled 
``Recommendations for Complying With the Pediatric Rule (21 CFR 
314.55(a) and 601.27(a)).'' The draft guidance provides recommendations 
for sponsors of new drug applications (NDA's) and biologics license 
applications (BLA's) on how to meet the requirements of the final rule 
requiring manufacturers to assess the safety and effectiveness of new 
drugs and biological products in pediatric patients (pediatric rule).

DATES: Submit written comments on the draft guidance by March 5, 2001. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Terrie L. Crescenzi, Center for Drug Evaluation and Research (HFD-
104), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-7337, FAX 301-827-2520, e-mail [email protected], 
or
    Elaine C. Esber, Center for Biologics Evaluation and Research (HFM-
30), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-0641, FAX 301-827-0644, e-mail [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Recommendations for Complying 
With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)).'' In the 
Federal Register of December 2, 1998 (63 FR 66632), FDA published the 
pediatric rule. Under the pediatric rule, applications for new active 
ingredients, new indications, new dosage forms, new dosing regimens, 
and new routes of administration must contain a pediatric assessment 
unless the applicant has obtained a waiver or deferral of pediatric 
studies (21 CFR 314.55(a) and 601.27(a)). The rule became effective on 
April 1, 1999. Under the compliance dates in the final rule, pediatric 
assessments must be included in applications after December 2, 2000, 
for: (1) NDA's; (2) BLA's; and (3) abbreviated new drug applications 
(ANDA's) that are based on suitability petitions for a change in active 
ingredient, dosage form, or route of administration.\1\ This draft 
guidance describes how the pediatric rule will be implemented. Areas 
covered include an overview of pediatric assessments, pediatric plans, 
waivers and deferrals, compliance issues, pediatric exclusivity, and 
the role of FDA's Pediatric Advisory Subcommittee.
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    \1\ On November 4, 1999, FDA received a citizen petition raising 
issues associated with the relationship between the pediatric rule 
and ANDA suitability petitions. The issues raised in the petition 
are still under consideration by the agency. Therefore, this 
guidance does not address pediatric studies associated with 
suitability petitions.
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    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance regulation (21 CFR 10.115; 65 FR 56468, September 19, 
2000). The draft guidance represents the agency's current thinking on 
how to comply with the pediatric rule. 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.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 22, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-30697 Filed 12-1-00; 8:45 am]
BILLING CODE 4160-01-F