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11678 Federal Register / Vol. 70, No.

45 / Wednesday, March 9, 2005 / Notices

For technical questions about this Food, Drug, and Cosmetic Act (21 U.S.C. You can access this new system from
program, contact: Dr. Trudy Messmer, 379g and 379h), FDA has the authority the http://www.fda.gov/oc/pdufa/
Scientific Review Administrator, 1600 to assess and collect user fees for certain coversheet.html Web site. You may then
Clifton Rd, MS C–19, Atlanta, GA drug and biologics license applications select ‘‘PDUFA User Fee Cover Sheet’’
30333, Telephone: 404–639–3770, e- and supplements. Under this authority, from Web site. Detailed instructions on
mail: TMessmer@cdc.gov. pharmaceutical companies pay fees for how to use the user fee system are
Dated: March 3, 2005. certain new human drug applications, included at the Web site.
William P. Nichols,
biologics applications, and supplements Dated: March 1, 2005.
submitted to the agency for review.
Director, Procurement and Grants Office, Jeffrey Shuren,
Because the submission of user fees
Centers for Disease Control and Prevention. Assistant Commissioner for Policy.
concurrently with applications and
[FR Doc. 05–4552 Filed 3–8–05; 8:45 am] [FR Doc. 05–4635 Filed 3–8–05; 8:45 am]
supplements is required, review of an
BILLING CODE 4163–18–P
application by FDA cannot begin until BILLING CODE 4160–01–S
the fee has been submitted. Form FDA
3397, the user fee cover sheet, is
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
designed to provide the minimum
HUMAN SERVICES HUMAN SERVICES
necessary information to determine
Food and Drug Administration whether a fee is required for review of
Food and Drug Administration
an application, to determine the amount
[Docket No. 2005N–0075] of the fee required, and to help FDA Cardiovascular and Renal Drugs
track payments. Advisory Committee; Notice of Meeting
Notice to Industry on the Development The form provides a cross-reference of
of a Web-Based System for Obtaining the fee submitted for an application AGENCY: Food and Drug Administration,
a User Fee Payment Identification with the actual application by using a HHS.
Number and Prescription Drug User unique number tracking system to ACTION: Notice.
Fee Cover Sheet (FDA Form 3397); assign the user fee payment
Availability identification number. The information This notice announces a forthcoming
collected is used by FDA’s Center for meeting of a public advisory committee
AGENCY: Food and Drug Administration,
Drug Evaluation and Research (CDER) of the Food and Drug Administration
HHS.
and Center for Biologics Evaluation and (FDA). The meeting will be open to the
ACTION: Notice. public.
Research (CBER) to initiate the
SUMMARY: The Food and Drug administrative screening of new drug Name of Committee: Cardiovascular
Administration (FDA) is announcing the applications, biologics license and Renal Drugs Advisory Committee.
availability of a new Web-based system applications, and supplemental General Function of the Committee:
to electronically obtain a user fee applications. To provide advice and
payment identification number and to FDA has created an on-line user fee recommendations to the agency on
submit your Prescription Drug User Fee cover sheet which will assist FDA and FDA’s regulatory issues.
(PDUFA) cover sheet (FDA Form 3397) pharmaceutical companies by Date and Time: The meeting will be
to the Office of Financial Management. improving service and reducing the time held on April 5, 2005, from 8 a.m. to 5
The system will enable FDA to for applicants and their affiliates to file p.m.
electronically track your company’s and comply with PDUFA through more Location: Hilton Washington DC
application payments and will allow automated channels. The new system North/Gaithersburg, The Ballrooms, 620
your organization to obtain the user fee will allow customers to obtain a user fee Perry Pkwy., Gaithersburg, MD.
payment identification number, create Contact Person: Cathy Groupe, Center
payment identification number over the
and complete a user fee cover sheet on- for Drug Evaluation and Research (HFD–
Web. By making the user fee payment
line, and submit it electronically to 21), Food and Drug Administration,
identification number and the PDUFA
FDA’s Office of Financial Management. 5600 Fishers Lane (for express delivery,
cover sheet available on-line, we will be
It will decrease the administrative 5630 Fishers Lane, rm. 1093), Rockville,
able to improve service, one of PDUFA’s
burden on FDA, improve service by MD 20857, 301–827–7001, e-mail:
performance goals.
automating the cover sheet application groupec@cder.fda.gov, or FDA Advisory
DATES: Submit written or electronic
process, and allow applicants to Committee Information Line, 1–800–
comments by April 8, 2005. 741–8138 (301–443–0572 in the
securely view their payments received
ADDRESSES: Submit written comments Washington, DC area), code
by FDA on-line. This new system,
to the Division of Dockets Management which replaces the previous process, 3014512533. Please call the Information
(HFA–305), Food and Drug will be available on February 15, 2005. line for up-to-date information on this
Administration, 5630 Fishers Lane, rm. Interested persons may submit to the meeting.
1061, Rockville, MD 20857. Submit Division of Dockets Management (see Agenda: The committee will discuss
electronic comments to http:// ADDRESSES) written or electronic supplemental new drug application
www.fda.gov/dockets.ecomments. See comments regarding this document. (sNDA) S–036 to approved new drug
the SUPPLEMENTARY INFORMATION section Submit a single copy of electronic application (NDA) 19–787, NORVASC
for electronic access to the new system. comments or two paper copies of any (amlodipine besylate) Tablets (2.5
FOR FURTHER INFORMATION CONTACT: mailed comments, except that milligrams (mg), 5 mg, and 10 mg),
Martha Louviere, Office of Financial individuals may submit one paper copy. Pfizer Inc., proposing a change in
Management (HFA–100), Food and Drug Comments are to be identified with the labeling for the following two additional
Administration, 5600 Fishers Lane, rm. docket number found in brackets in the indications of: (1) Reducing the risk of
11–83, Rockville, MD 20857, 301–827– heading of this document. Received fatal coronary heart disease and nonfatal
3912, e-mail: userfees@fda.gov. comments may be seen in the Division myocardial infarction and (2) reducing
SUPPLEMENTARY INFORMATION: Under of Dockets Management between 9 a.m. the risk of stroke, based on the
sections 735 and 736 of the Federal and 4 p.m., Monday through Friday. effectiveness demonstrated in the

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Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices 11679

antihypertensive and lipid lowering Date and Time: The workshop will be Dated: March 3, 2005.
treatment to prevent heart attack trial held on April 13, 2005, from 8 a.m. to Jeffrey Shuren,
(ALLHAT). 5:30 p.m. Assistant Commissioner for Policy.
Procedure: Interested persons may Location: The workshop will be held [FR Doc. 05–4634 Filed 3–8–05; 8:45 am]
present data, information, or views, at the Lister Hill Auditorium, Bldg. 38A, BILLING CODE 4160–01–S
orally or in writing, on issues pending National Institutes of Health, 8600
before the committee. Written Rockville Pike, Bethesda, MD 20894.
submissions may be made to the contact DEPARTMENT OF HEALTH AND
Contact Person: Rhonda Dawson,
person by March 29, 2005. Oral HUMAN SERVICES
Center for Biologics Evaluation and
presentations from the public will be
Research (HFM–302), Food and Drug Food and Drug Administration
scheduled between approximately 1
Administration, 1401 Rockville Pike,
p.m. and 2 p.m. Time allotted for each [Docket No. 1993D–0394]
Rockville, MD 20852–1448, 301–827–
presentation may be limited. Those
3514, FAX: 301–827–2843, e-mail:
desiring to make formal oral Draft Guideline for the Validation of
dawsonr@cber.fda.gov.
presentations should notify the contact Blood Establishment Computer
person before March 29, 2005, and Registration: Mail or fax your
Systems; Withdrawal of Guidance
submit a brief statement of the general registration information (including
nature of the evidence or arguments name, title, firm name, address, AGENCY: Food and Drug Administration,
they wish to present, the names and telephone, and fax numbers) to the HHS.
addresses of proposed participants, and contact person by April 1, 2005. There ACTION: Notice; withdrawal.
an indication of the approximate time is no registration fee for the public
workshop. Because seating is limited, SUMMARY: The Food and Drug
requested to make their presentation. Administration (FDA) is announcing the
Persons attending FDA’s advisory we recommend early registration.
Registration on the day of the public withdrawal of a guidance that was
committee meetings are advised that the issued on September 28, 1993.
agency is not responsible for providing workshop will be provided on a space
available basis beginning at 7:15 a.m. DATES: March 9, 2005.
access to electrical outlets.
FDA welcomes the attendance of the If you need special accommodations FOR FURTHER INFORMATION CONTACT: Paul
public at its advisory committee due to a disability, please contact E. Levine, Jr., Center for Biologics
meetings and will make every effort to Rhonda Dawson (see Contact Person) at Evaluation and Research (HFM–17),
accommodate persons with physical least 7 days in advance. Food and Drug Administration, 1401
disabilities or special needs. If you Rockville Pike, suite 200N, Rockville,
SUPPLEMENTARY INFORMATION: FDA, in MD 20852, 301–827–6210.
require special accommodations due to cooperation with the Primary Immune
a disability, please contact John SUPPLEMENTARY INFORMATION: In a notice
Deficiency Foundation, is announcing
Lauttman at 301–827–7001 at least 7 containing a cumulative list of
the following public workshop:
days in advance of the meeting. guidances available from the agency that
‘‘Intravenous Immune Globulins in the
Notice of this meeting is given under published on January 5, 2005 (70 FR
21st Century: Progress and Challenges
the Federal Advisory Committee Act (5 824), FDA included the guidance
in Efficacy, Safety, and Paths to
U.S.C. app. 2). document entitled, ‘‘Draft Guideline for
Licensure.’’ The 1-day workshop,
Dated: March 2, 2005.
the Validation of Blood Establishment
consisting of three successive sessions,
Computer Systems.’’ This document is
Sheila Dearybury Walcoff, will discuss the following topics:
being withdrawn because it no longer
Associate Commissioner for External • Specific antibody levels in reflects all of FDA’s current
Relations. intravenous immune globulins (IGIVs) considerations on a guidance to assist
[FR Doc. 05–4522 Filed 3–8–05; 8:45 am] to common and emerging pathogens, manufacturers of blood and blood
BILLING CODE 4160–01–S including research questions concerning components, including blood banks,
antibody levels and efficacy; plasmapheresis centers, and transfusion
• Adverse events, including specific services in developing a computerized
DEPARTMENT OF HEALTH AND categories of adverse events, as well as system validation program. FDA is
HUMAN SERVICES current methods of surveillance, revising the guidance and a draft
Food and Drug Administration responses to adverse event information, guidance for public comment will be
and the utility of different monitoring issued in the future.
Intravenous Immune Globulins in the strategies; and Dated: March 1, 2005.
21st Century: Progress and Challenges • Paradigms for IGIV and Jeffrey Shuren,
in Efficacy, Safety, and Paths to subcutaneous immune globulin Assistant Commissioner for Policy.
Licensure; Public Workshop licensure for treatment of Primary [FR Doc. 05–4633 Filed 3–8–05; 8:45 am]
Immune Deficiency.
AGENCY: Food and Drug Administration, BILLING CODE 4160–01–S
HHS. Transcripts: Transcripts of the public
workshop may be requested in writing
ACTION: Notice of public workshop.
from the Freedom of Information Office DEPARTMENT OF HEALTH AND
The Food and Drug Administration (HFI–35), Food and Drug HUMAN SERVICES
(FDA) is announcing a public workshop Administration, 5600 Fishers Lane,
entitled: ‘‘Intravenous Immune Rockville, MD 20857, approximately 15 National Institutes of Health
Globulins in the 21st Century: Progress working days after the public workshop
at a cost of 10 cents per page. National Library of Medicine; Amended
and Challenges in Efficacy, Safety, and
Notice of Meeting
Paths to Licensure.’’ The purpose of the A transcript of the public workshop
workshop is to address current topics on will be available on the Internet at http:/ Notice is hereby given of a change in
the safety and efficacy of immune /www.fda.gov/cber/minutes/workshop– the meeting of the Commission on
globulin products. min.htm. Systemic Interoperability, March 15,

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