[Federal Register: November 24, 2003 (Volume 68, Number 226)]
[Notices]
[Page 65940-65941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no03-78]
[[Page 65940]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0512]
Guidance for Industry and Food and Drug Administration Staff;
User Fees and Refunds for Premarket Approval Applications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``User Fees and Refunds for
Premarket Approval Applications.'' This guidance outlines the types of
premarket approval applications (PMAs), including supplements and other
submissions, that are subject to user fees as well as those that do not
have an associated fee. The guidance also identifies industry and FDA
actions on these submissions that may result in a partial refund of the
fee. The guidance document is immediately in effect, but it remains
subject to comment in accordance with the agency's good guidance
practices (GGPs).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``User Fees and Refunds for
Premarket Approval Applications'' to the Division of Small
Manufacturers, International, and Consumer Assistance (HFZ-220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Regarding device issues: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
Regarding biologics issues: Sayah Nedjar, Center for Biologics
Evaluation and Research (HFM-380), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-3524.
SUPPLEMENTARY INFORMATION:
I. Background
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Public Law 107-250), amends the Federal Food, Drug, and Cosmetic Act
to allow FDA to collect user fees for certain premarket reviews. The
new law also permits partial refunds under certain circumstances, such
as in the case of a non-filing decision for a PMA. In other cases, the
statute permits a refund but stipulates that it is to be in an amount
determined by the level of effort expended by the agency during its
review of the application. The guidance outlines the user fees due with
certain PMAs, the refunds set by statute, and FDA's plan for
determining the amount of the fee to be refunded when the exact amount
is not prescribed by the new law.
FDA is making this guidance document immediately available because
prior public participation was not feasible. MDUFMA's user fee
provisions were effective immediately, and it is essential for the
agency to provide guidance to its stakeholders on the user fee program
as quickly as possible. Although it was not feasible to obtain comments
before issuing the guidance, in accordance with this agency's GGP
procedures, FDA will accept comments on the guidance at any time.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(21 CFR 10.115). The guidance represents the agency's current thinking
on user fees and refunds for PMAs. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
To receive a copy of ``User Fees and Refunds for Premarket Approval
Applications'' by fax machine, call the Center for Devices and
Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. Press 1 to enter the system.
At the second voice prompt, press 1 to order a document. Enter the
document number (1224) followed by the pound sign ([numsign]). Follow
the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information including text, graphics, and files that may
be downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH Web site may be accessed at
http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the user fee
forms (OMB control number 0910-0511), which expires on August 31, 2006,
and the regulations governing administrative practices and procedures
(21 CFR part 10, OMB control number 0910-0192).
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
guidance. Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments
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. Comments received may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 65941]]
Dated: November 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29196 Filed 11-21-03; 8:45 am]
BILLING CODE 4160-01-S