Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment, 24599 [E8-9726]

Download as PDF Federal Register / Vol. 73, No. 87 / Monday, May 5, 2008 / Notices document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202– 395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: April 28, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–9762 Filed 5–2–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0257] Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft drug safety 5-year plan entitled ‘‘Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan.’’ This plan is intended to communicate FDA’s strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program. DATES: Submit written or electronic comments on the draft drug safety 5year plan by June 19, 2008. ADDRESSES: Submit written requests for single copies of the draft plan to the Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft drug safety 5-year plan to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the document. FOR FURTHER INFORMATION CONTACT: Jayne C. Ware, Food and Drug rfrederick on PROD1PC67 with NOTICES SUMMARY: VerDate Aug<31>2005 15:16 May 02, 2008 Jkt 214001 Administration, Center for Drug Evaluation and Research, Office of Executive Programs, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, Silver Spring, MD 20993–0002, 301– 796–3200. SUPPLEMENTARY INFORMATION: I. Background On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007, which includes the reauthorization and expansion of PDUFA. The reauthorization of PDUFA will significantly broaden and modernize the agency’s drug safety program and facilitate more efficient development of safe and effective new medications for the American public. During the user fee negotiation process leading up to the renewal of PDUFA, FDA and the relevant regulated industries mutually agreed to certain commitments that the FDA will carry out during fiscal years 2008 through 2012. Congress signaled its agreement with the commitments by authorizing PDUFA funds for them. Among those commitments is the responsibility of the FDA to develop and periodically update a 5-year plan describing activities that will lead to enhancing and modernizing FDA’s drug safety system. FDA is announcing for public comment the availability of the draft drug safety 5-year plan entitled ‘‘Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan.’’ This plan is intended to communicate FDA’s strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program. The plan describes the agency’s strategy for achieving the commitments defined in section VIII, Enhancement and Modernization of the FDA Drug Safety System, and section IX, Review of Proprietary Names to Reduce Medication Errors, of the PDUFA IV Performance Goals (https:// www.fda.gov/oc/pdufa4/ pdufa4goals.html). At the end of the comment period, FDA will review the comments, update the ‘‘PDUFA IV Drug Safety Five-Year Plan,’’ and publish the final version. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 24599 docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/cder/pdufa/ PDUFA_IV_5yr_plan_draft.pdf. Dated: April 25, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–9726 Filed 5–2–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The 11th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration (FDA) is announcing the following conference: 11th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the Drug, Device, and Biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive questions and answers, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues. Date and Time: The conference will be held on June 11 and 12, 2008, from 7:30 a.m. to 5 p.m. Location: The conference will be held at the Irvine Marriott Hotel, 18000 Von Karman Ave., Irvine, CA 92612. E:\FR\FM\05MYN1.SGM 05MYN1

Agencies

[Federal Register Volume 73, Number 87 (Monday, May 5, 2008)]
[Notices]
[Page 24599]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9726]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0257]


Draft Prescription Drug User Fee Act IV Drug Safety Five-Year 
Plan; Availability for Comment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability for public comment of the draft drug safety 5-year plan 
entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-
Year Plan.'' This plan is intended to communicate FDA's strategy for 
meeting the commitments for enhancing and modernizing the drug safety 
system within the context of the PDUFA IV program.

DATES:  Submit written or electronic comments on the draft drug safety 
5-year plan by June 19, 2008.

ADDRESSES:  Submit written requests for single copies of the draft plan 
to the Office of Executive Programs, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6100, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft drug safety 5-year plan to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to https://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the document.

FOR FURTHER INFORMATION CONTACT:  Jayne C. Ware, Food and Drug 
Administration, Center for Drug Evaluation and Research, Office of 
Executive Programs, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, 
Silver Spring, MD 20993-0002, 301-796-3200.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, President Bush signed into law the Food and 
Drug Administration Amendments Act of 2007, which includes the 
reauthorization and expansion of PDUFA. The reauthorization of PDUFA 
will significantly broaden and modernize the agency's drug safety 
program and facilitate more efficient development of safe and effective 
new medications for the American public. During the user fee 
negotiation process leading up to the renewal of PDUFA, FDA and the 
relevant regulated industries mutually agreed to certain commitments 
that the FDA will carry out during fiscal years 2008 through 2012. 
Congress signaled its agreement with the commitments by authorizing 
PDUFA funds for them. Among those commitments is the responsibility of 
the FDA to develop and periodically update a 5-year plan describing 
activities that will lead to enhancing and modernizing FDA's drug 
safety system.
    FDA is announcing for public comment the availability of the draft 
drug safety 5-year plan entitled ``Prescription Drug User Fee Act 
(PDUFA) IV Drug Safety Five-Year Plan.'' This plan is intended to 
communicate FDA's strategy for meeting the commitments for enhancing 
and modernizing the drug safety system within the context of the PDUFA 
IV program. The plan describes the agency's strategy for achieving the 
commitments defined in section VIII, Enhancement and Modernization of 
the FDA Drug Safety System, and section IX, Review of Proprietary Names 
to Reduce Medication Errors, of the PDUFA IV Performance Goals (https://www.fda.gov/oc/pdufa4/pdufa4goals.html). At the end of the comment 
period, FDA will review the comments, update the ``PDUFA IV Drug Safety 
Five-Year Plan,'' and publish the final version.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf.

    Dated: April 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9726 Filed 5-2-08; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.