Agency Information Collection Activities; Announcement of OMB Approval; Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

---
identifier: "/us/fr/03-1401"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Agency Information Collection Activities; Announcement of OMB Approval; Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients"
title_number: 0
title_name: "Federal Register"
section_number: "03-1401"
section_name: "Agency Information Collection Activities; Announcement of OMB Approval; Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients"
positive_law: false
currency: "2003-01-23"
last_updated: "2003-01-23"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "03-1401"
document_type: "notice"
publication_date: "2003-01-23"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "68 FR 3261"
fr_volume: 68
docket_ids:
  - "Docket No. 01N-0400"
fr_action: "Notice."
---


#  Agency Information Collection Activities; Announcement of OMB Approval; Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA).

**FOR FURTHER INFORMATION CONTACT:**

Karen L. Nelson, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of August 13, 2002 (67 FR 52726), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under section 3507 of the PRA (44 U.S.C. 3507). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0392. The approval expires on October 31, 2005. A copy of the supporting statement for this information collection is available on  the Internet at *http://www.fda.gov/ohrms/dockets* .

Dated:  January 14, 2003.

Margaret M. Dotzel,

Assistant Commissioner for Policy.