[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Page 11117-11118]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. FDA-2009-D-0051]

Draft Guidance for Industry and Food and Drug Administration; 
User Fees and Refunds for Premarket Approval Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``User Fees and Refunds for 
Premarket Approval Applications'' (PMAs). The purpose of this draft 
guidance document is to outline the types of PMAs subject to user fees, 
including supplements and other submissions, as well as those that do 
not have an associated user fee. The draft guidance also identifies 
industry and FDA actions on these submissions that may result in a 
refund of the fee.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 15, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``User Fees and Refunds for Premarket 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, or to the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448. The draft guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this draft guidance to the 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

    Nicole Wolanski, Center for Devices and Radiological Health (HFZ-
402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 240-276-4010.
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 5515 Security Lane, rm. 130, 
Rockville, MD 20852, 301-827-6210.


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 
(the act) to provide FDA new responsibilities and resources associated 
with the collection and refund of user fees. The primary difference 
between this draft guidance and the November 24, 2003, version now in 
effect is the addition of user fee and user fee refund information for 
30-day notices and periodic reports. Additionally, the draft guidance 
discusses the modified user fee refund provisions for modular PMAs. If 
finalized, this draft guidance will supersede the 2003 guidance.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on user fees 
and refunds for premarket approval applications. 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

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``User Fees and Refunds for 
Premarket Approval Applications,'' you may either send an e-mail 
request to dsmica@fda.hhs.gov to receive an electronic copy of the 
document, or send a fax request to 240-276-3151 to receive a hard copy. 
Please use the document number (1681) to identify the guidance you are 

[[Page 11118]]

    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov or the CBER Internet site at 

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: User Fees and Refunds for Premarket Approval Applications.
    Description: Section 738 of the act requires the payment of user 
fees for devices subject to premarket approval (PMA) under section 515 
of the act (21 U.S.C. 360e). Section 738(j) of the act allows for 
refunds of these fees in certain circumstances. This draft guidance 
document describes requirements associated with user fees and FDA's 
recommendation for the kind of information to include in a request for 
a refund.
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
 Federal Food,
   Drug, and          No. of         Annual Frequency       Total Annual        Hours per         Total Hours
 Cosmetic Act      Respondents         per Response          Responses           Response
738(j)                         17                     1                 17                0.5                  9
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The industry-wide burden estimate is based on an FDA actual average 
fiscal year (FY) annual rate of receipt of 17 refund requests, using FY 
2005 through 2007 data.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR part 814, subparts B and E have been approved under OMB 
control number 0910-0231.

V. 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.

    Dated: March 4, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-5543 Filed 3-13-09; 8:45 am]