Document ID: FDA-2010-D-0144-0003
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Availability: User Fees for 513(g); Requests for Information
Posted Date: 2010-04-29T04:00Z

[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Notices]               
[Page 22601-22602]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap10-77]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0144]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; User Fees for 513(g); Requests for Information; 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availability of the draft guidance entitled ``Draft Guidance for 
Industry and FDA Staff; User Fees for 513(g) Requests for 
Information.'' This draft guidance describes the user fees associated 
with 513(g) requests for information.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 July 28, 2010. Submit written or electronic comments on the 
collection of information June 28, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance entitled ``Draft Guidance for Industry and FDA Staff; User 
Fees for 513(g) Requests for Information'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (DSMICA), WO66, 
rm. 4613, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, or 
to the Office of Communication, Outreach and Development (HFM-40), 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, 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draft guidance may also be obtained by mail by calling CBER at 1-800-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 
CDRH to 301-847-8149. 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://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., WO66, rm. 1532, Silver Spring, MD 20993, 301-796-
6571, or Stephen Ripley, Center for Biologics Evaluation and Research, 
HFM-17, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 513(g) of the Federal Food Drug and Cosmetic Act (act) (21 
U.S.C. 360c(g)) provides a means for obtaining the FDA's views about 
classification information and the regulatory requirements that may be 
applicable to a particular device. Title II of the Food and Drug 
Administration Amendments Act of 2007 (FDAAA), also termed the Medical 
Device User Fee Amendments of 2007 (Public Law 110-85), extends FDA's 
authority to collect medical device user fees by establishing a fee for 
``a request for classification information.'' Elsewhere in this Federal 
Register we are publishing a document announcing the availability of a 
guidance document entitled ``Draft Guidance for Industry and FDA Staff; 
FDA and Industry Procedures for Section 513(g) Requests for Information 
under the Federal Food, Drug, and Cosmetic Act.'' This guidance 
describes the procedures we recommend when seeking the Agency's views 
about classification information and regulatory requirements that may 
be applicable to a particular device.

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 for 
requests for classification information submitted in accordance with 
section 513(g) of the act. 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 ``Draft Guidance for Industry and 
Food and Drug Administration Staff; User Fees for 513(g) Requests for 
Information,'' 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 301-847-8149 to receive a hard copy. Please use 
the document number 1709 to identify the guidance you are requesting.
    A search capability for all CDRH guidance documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov/search/Regs/home.html#home or on the CBER 
Internet site at http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/default.htm.

IV. Paperwork Reduction Act of 1995

    Under 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

[[Page 22602]]

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: Draft Guidance for Industry and FDA Staff: User Fees for 
513(g) Requests for Information
    Description: Section 513(g) of the act (21 U.S.C. 360c(g)) provides 
a means for obtaining the FDA's views about classification information 
and the regulatory requirements that may be applicable to a particular 
device. Title II of the Food and Drug Administration Amendments Act of 
2007 (FDAAA), also termed the Medical Device User Fee Amendments of 
2007, Public Law 110-85, extends FDA's authority to collect medical 
device user fees by establishing a fee for ``a request for 
classification information.'' Form No. 3601, Medical Device User Fee 
Cover Sheet, is being revised to include the addition of user fees for 
513(g) Request for Information.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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    Sec. 738(a)(2)(A)(ix) of FDAAA                               No. of        Annual Frequency     Total Annual        Hours per
      Sec.513(g) of the FD&C Act          Form FDA  No.       Respondents        per Response        Responses           Response         Total hours
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CDRH                                                 3601                110                  1                110                  2                220
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CBER                                                 3601                  4                  1                  4                  2                  8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours                                                                                                                                          228
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based these estimates on the number of 513(g) Requests for 
Information received by CDRH and CBER during calendar year (CY) 2008. 
Elsewhere in this Federal Register we are publishing a document 
announcing the availability of a draft guidance document entitled 
``Guidance for Industry and FDA Staff; FDA and Industry Procedures for 
Section 513(g) Requests for Information under the Federal Food, Drug, 
and Cosmetic Act.'' This guidance describes the procedures we recommend 
when seeking the Agency's views about classification information and 
regulatory requirements that may be applicable to a particular device. 
The burden estimate is based on the amount of time needed to satisfy 
the completion of these procedures.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 807 subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814 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: April 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9938 Filed 4-28-10; 8:45 am]
BILLING CODE 4160-01-S