[Printable PDF]
[Federal Register: October 6, 2000 (Volume 65, Number 195)]
[Rules and Regulations]
[Page 59718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc00-14]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
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:
PART 601--LICENSING
1. The authority citation for 21 CFR part 601 continues to read as
follows:
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]
BILLING CODE 4160-01-F