Notice to Industry on the Development of a Web-Based System for Obtaining a User Fee Payment Identification Number and Prescription Drug User Fee Cover Sheet (FDA Form 3397); Availability, 11678 [05-4635]
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Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices
For technical questions about this
program, contact: Dr. Trudy Messmer,
Scientific Review Administrator, 1600
Clifton Rd, MS C–19, Atlanta, GA
30333, Telephone: 404–639–3770, email: TMessmer@cdc.gov.
Dated: March 3, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–4552 Filed 3–8–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0075]
Notice to Industry on the Development
of a Web-Based System for Obtaining
a User Fee Payment Identification
Number and Prescription Drug User
Fee Cover Sheet (FDA Form 3397);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a new Web-based system
to electronically obtain a user fee
payment identification number and to
submit your Prescription Drug User Fee
(PDUFA) cover sheet (FDA Form 3397)
to the Office of Financial Management.
The system will enable FDA to
electronically track your company’s
application payments and will allow
your organization to obtain the user fee
payment identification number over the
Web. By making the user fee payment
identification number and the PDUFA
cover sheet available on-line, we will be
able to improve service, one of PDUFA’s
performance goals.
DATES: Submit written or electronic
comments by April 8, 2005.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20857. Submit
electronic comments to https://
www.fda.gov/dockets.ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the new system.
FOR FURTHER INFORMATION CONTACT:
Martha Louviere, Office of Financial
Management (HFA–100), Food and Drug
Administration, 5600 Fishers Lane, rm.
11–83, Rockville, MD 20857, 301–827–
3912, e-mail: userfees@fda.gov.
SUPPLEMENTARY INFORMATION: Under
sections 735 and 736 of the Federal
VerDate jul<14>2003
18:06 Mar 08, 2005
Jkt 205001
Food, Drug, and Cosmetic Act (21 U.S.C.
379g and 379h), FDA has the authority
to assess and collect user fees for certain
drug and biologics license applications
and supplements. Under this authority,
pharmaceutical companies pay fees for
certain new human drug applications,
biologics applications, and supplements
submitted to the agency for review.
Because the submission of user fees
concurrently with applications and
supplements is required, review of an
application by FDA cannot begin until
the fee has been submitted. Form FDA
3397, the user fee cover sheet, is
designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to help FDA
track payments.
The form provides a cross-reference of
the fee submitted for an application
with the actual application by using a
unique number tracking system to
assign the user fee payment
identification number. The information
collected is used by FDA’s Center for
Drug Evaluation and Research (CDER)
and Center for Biologics Evaluation and
Research (CBER) to initiate the
administrative screening of new drug
applications, biologics license
applications, and supplemental
applications.
FDA has created an on-line user fee
cover sheet which will assist FDA and
pharmaceutical companies by
improving service and reducing the time
for applicants and their affiliates to file
and comply with PDUFA through more
automated channels. The new system
will allow customers to obtain a user fee
payment identification number, create
and complete a user fee cover sheet online, and submit it electronically to
FDA’s Office of Financial Management.
It will decrease the administrative
burden on FDA, improve service by
automating the cover sheet application
process, and allow applicants to
securely view their payments received
by FDA on-line. This new system,
which replaces the previous process,
will be available on February 15, 2005.
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.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
You can access this new system from
the https://www.fda.gov/oc/pdufa/
coversheet.html Web site. You may then
select ‘‘PDUFA User Fee Cover Sheet’’
from Web site. Detailed instructions on
how to use the user fee system are
included at the Web site.
Dated: March 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4635 Filed 3–8–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 5, 2005, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Cathy Groupe, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, e-mail:
groupec@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. Please call the Information
line for up-to-date information on this
meeting.
Agenda: The committee will discuss
supplemental new drug application
(sNDA) S–036 to approved new drug
application (NDA) 19–787, NORVASC
(amlodipine besylate) Tablets (2.5
milligrams (mg), 5 mg, and 10 mg),
Pfizer Inc., proposing a change in
labeling for the following two additional
indications of: (1) Reducing the risk of
fatal coronary heart disease and nonfatal
myocardial infarction and (2) reducing
the risk of stroke, based on the
effectiveness demonstrated in the
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Page 11678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4635]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0075]
Notice to Industry on the Development of a Web-Based System for
Obtaining a User Fee Payment Identification Number and Prescription
Drug User Fee Cover Sheet (FDA Form 3397); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a new Web-based system to electronically obtain a user
fee payment identification number and to submit your Prescription Drug
User Fee (PDUFA) cover sheet (FDA Form 3397) to the Office of Financial
Management. The system will enable FDA to electronically track your
company's application payments and will allow your organization to
obtain the user fee payment identification number over the Web. By
making the user fee payment identification number and the PDUFA cover
sheet available on-line, we will be able to improve service, one of
PDUFA's performance goals.
DATES: Submit written or electronic comments by April 8, 2005.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20857. Submit electronic comments to https://
www.fda.gov/dockets.ecomments. See the SUPPLEMENTARY INFORMATION
section for electronic access to the new system.
FOR FURTHER INFORMATION CONTACT: Martha Louviere, Office of Financial
Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane,
rm. 11-83, Rockville, MD 20857, 301-827-3912, e-mail: userfees@fda.gov.
SUPPLEMENTARY INFORMATION: Under sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g and 379h), FDA has the
authority to assess and collect user fees for certain drug and
biologics license applications and supplements. Under this authority,
pharmaceutical companies pay fees for certain new human drug
applications, biologics applications, and supplements submitted to the
agency for review. Because the submission of user fees concurrently
with applications and supplements is required, review of an application
by FDA cannot begin until the fee has been submitted. Form FDA 3397,
the user fee cover sheet, is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to help
FDA track payments.
The form provides a cross-reference of the fee submitted for an
application with the actual application by using a unique number
tracking system to assign the user fee payment identification number.
The information collected is used by FDA's Center for Drug Evaluation
and Research (CDER) and Center for Biologics Evaluation and Research
(CBER) to initiate the administrative screening of new drug
applications, biologics license applications, and supplemental
applications.
FDA has created an on-line user fee cover sheet which will assist
FDA and pharmaceutical companies by improving service and reducing the
time for applicants and their affiliates to file and comply with PDUFA
through more automated channels. The new system will allow customers to
obtain a user fee payment identification number, create and complete a
user fee cover sheet on-line, and submit it electronically to FDA's
Office of Financial Management. It will decrease the administrative
burden on FDA, improve service by automating the cover sheet
application process, and allow applicants to securely view their
payments received by FDA on-line. This new system, which replaces the
previous process, will be available on February 15, 2005.
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.
You can access this new system from the https://www.fda.gov/oc/
pdufa/coversheet.html Web site. You may then select ``PDUFA User Fee
Cover Sheet'' from Web site. Detailed instructions on how to use the
user fee system are included at the Web site.
Dated: March 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4635 Filed 3-8-05; 8:45 am]
BILLING CODE 4160-01-S
