[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30724-30725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0153]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry and Food and Drug Administration Staff: Food and Drug 
Administration and Industry Procedures for Section 513(g) Requests for 
Information Under the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by June 
27, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Draft Guidance for Industry and FDA Staff: FDA and Industry 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.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures 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--(OMB Control Number 0910-NEW)

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain 
approval from 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

[[Page 30725]]

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, in the Federal Register of April 29, 2010 
(75 FR 22599), FDA published a notice of availability of the draft 
guidance document providing a 60-day public comment period on the 
proposed collection of information provisions.
    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: FDA and Industry 
Procedures for Section 513(g) Requests for Information Under the 
Federal Food, Drug, and Cosmetic Act.
    Description: Section 513(g) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining 
the Agency's views about the classification and regulatory requirements 
that may be applicable to your particular device. Section 513(g) 
provides that within 60 days of the receipt of a written request of any 
person for information respecting the class in which a device has been 
classified or the requirements applicable to a device under the FD&C 
Act, the Secretary of Health and Human Services shall provide such 
person a written statement of the classification (if any) of such 
device and the requirements of the FD&C Act applicable to the device.
    Section 513(g) of the FD&C Act provides a means for obtaining FDA's 
views about the classification and the regulatory requirements that may 
be applicable to a particular device. The purpose of this draft 
guidance is to establish procedures for submitting, reviewing, and 
responding to requests for information respecting the class in which a 
device has been classified or the requirements applicable to a device 
under the FD&C Act that are submitted in accordance with section 513(g) 
of the FD&C Act. FDA does not review data related to substantial 
equivalence or safety and effectiveness in a 513(g) request for 
information. FDA's responses to 513(g) requests for information are not 
device classification decisions and do not constitute FDA clearance or 
approval for marketing. Classification decisions and clearance or 
approval for marketing require submissions under different sections of 
the FD&C Act. Additionally, the FD&C Act, as amended by the FDA 
Amendments Act of 2007 (Pub. L. 110-85), requires FDA to collect user 
fees for 513(g) requests for information.
    In the Federal Register of April 29, 2010, FDA published a 60-day 
notice requesting public comment on the proposed collection of 
information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
         FD&C Act 513(g)            respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
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Center for Devices and                       110               1             110              12           1,320
 Radiological Health (CDRH).....
Center for Biologics Evaluation                4               1               4              12              48
 and Research (CBER)............
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    Total.......................  ..............  ..............  ..............  ..............           1,368
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents to this collection of information are mostly device 
manufacturers; however, anyone may submit a 513(g) request for 
information. The total number of annual responses is based on the 
average number of 513(g) requests received each year by the Agency. FDA 
based its estimates on the number of 513(g) requests for information 
received by both CDRH and CBER from 2007 to 2009.

    Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13058 Filed 5-25-11; 8:45 am]
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