[Federal Register Volume 65, Number 195 (Friday, October 6, 2000)]
[Rules and Regulations]
[Page 59718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25705]



Food and Drug Administration

21 CFR Part 601

[Docket No. 97N-0165]

Regulations Requiring Manufacturers to Assess the Safety and 
Effectiveness of New Drugs and Biological Products in Pediatric 
Patients; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.


SUMMARY: The Food and Drug Administration (FDA) is amending the 
biologics regulations to reincorporate a regulation that was 
inadvertently omitted. This action is being taken to improve the 
accuracy of the regulations.

DATES: This rule is effective October 6, 2000.

Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-

SUPPLEMENTARY INFORMATION: FDA has discovered that an error has caused 
an omission in the agency's codified regulations for part 601 (21 CFR 
part 601). In the Federal Register of May 17, 1999 (64 FR 26657), FDA 
published a final rule that inadvertently omitted Sec. 601.37 when 
subpart D was revised. Accordingly, Sec. 601.37, which was added in the 
Federal Register of December 2, 1998 (63 FR 66672), is being 
reincorporated into the regulations and redesignated as Sec. 601.28. In 
addition, FDA is removing subpart B and reorganizing subpart C in part 
601. Accordingly, current Sec. 601.28 is redesignated as Sec. 601.15. 
This document corrects those errors. Publication of this document 
constitutes final action under the Administrative Procedure Act (5 
U.S.C. 553). FDA has determined that notice and public comment are 
unnecessary because this amendment is nonsubstantive.

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential 
business information.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:


    1. The authority citation for 21 CFR part 601 continues to read as 

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 
355, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 
241, 262, 263; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 
355 note).

Sec. 601.12  [Redesignated to subpart C]

    2. Section 601.12 Changes to an approved application is 
redesignated from subpart B to subpart C.

Subpart B [Removed and Reserved]

    3. Subpart B is removed and reserved.

Subpart C--Biologics Licensing

    4. The heading for subpart C is revised to read as set forth above.

Sec. 601.28  [Redesignated as Sec. 601.15]

    5. Section 601.28 is redesignated as Sec. 601.15 in subpart C, and 
a new Sec. 601.28 is added to subpart C to read as follows:

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).

    Dated: September 29, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-25705 Filed 10-5-00; 8:45 am]