[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.28]

[Page 35]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 601--LICENSING--Table of Contents
 
                     Subpart C--Biologics Licensing
 
Sec. 601.28  Annual reports of postmarketing pediatric studies.

    Sponsors of licensed biological products shall submit the following 
information each year within 60 days of the anniversary date of approval 
of the license to the Director, Center for Biologics Evaluation and 
Research:
    (a) Summary. A brief summary stating whether labeling supplements 
for pediatric use have been submitted and whether new studies in the 
pediatric population to support appropriate labeling for the pediatric 
population have been initiated. Where possible, an estimate of patient 
exposure to the drug product, with special reference to the pediatric 
population (neonates, infants, children, and adolescents) shall be 
provided, including dosage form.
    (b) Clinical data. Analysis of available safety and efficacy data in 
the pediatric population and changes proposed in the labeling based on 
this information. An assessment of data needed to ensure appropriate 
labeling for the pediatric population shall be included.
    (c) Status reports. A statement on the current status of any 
postmarketing studies in the pediatric population performed by, or on 
behalf of, the applicant. The statement shall include whether 
postmarketing clinical studies in pediatric populations were required or 
agreed to, and if so, the status of these studies, e.g., to be 
initiated, ongoing (with projected completion date), completed 
(including date), completed and results submitted to the biologics 
license application (including date).

[65 FR 59718, Oct. 6, 2000]

    Effective Date Note: At 65 FR 64618, Oct. 30, 2000, Sec. 601.28 was 
amended by revising the second sentence in paragraph (c), effective Feb. 
27, 2001. At 66 FR 10815, Feb. 20, 2001, the effective date was delayed 
until Apr. 30, 2001. For the convenience of the user, the revised text 
is set forth as follows:

Sec. 601.28  Annual reports of postmarketing pediatric studies.

                                * * * * *

    (c) * * * The statement shall include whether postmarketing clinical 
studies in pediatric populations were required or agreed to, and, if so, 
the status of these studies shall be reported to FDA in annual progress 
reports of postmarketing studies under Sec. 601.70 rather than under 
this section.

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