
[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Notices]
[Pages 20826-20827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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; 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 ``Guidance for Industry and Food 
and Drug Administration Staff; FDA and Industry Procedures for Section 
513(g) Requests for Information under the Federal Food, Drug, and 
Cosmetic Act.'' This guidance document establishes the procedures for 
the submission, FDA review, and FDA response to requests for 
information regarding the class in which a device has been classified.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry and Food and Drug 
Administration Staff; FDA and Industry Procedures for Section 513(g) 
Requests for Information under the Federal Food, Drug, and Cosmetic 
Act'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, 
Silver Spring, MD 20993-0002 or Office of Communication, Outreach and 
Development (HFM-40), 1401 Rockville Pike, suite 200N, Rockville, MD 
20852. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8419. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Bob Gatling, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1640, Silver 
Spring, MD 20993-0002, 301-796-6560; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    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 FDA's 
views about the classification and the regulatory requirements that may 
be applicable to a particular device. This guidance describes 
procedures for the submission, FDA review, and FDA response to requests 
for information with respect to the classification of a device or the 
requirements applicable to a device under the FD&C Act that are 
submitted in accordance with section 513(g) requests for information. 
FDA's response to section 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.
    In the Federal Register of April 29, 2010 (75 FR 22599), FDA 
announced the availability of the draft guidance. Comments on the draft 
guidance were due by July 28, 2010. No comments were received. The 
guidance announced in this notice finalizes the draft guidance of the 
same title.
    Additionally, the FD&C Act, as amended by the FDA Amendments Act of 
2007 (FDAAA) (Pub. L. 110-85), requires FDA to collect user fees for 
section 513(g) requests for information. Elsewhere in this issue of the 
Federal Register, FDA is publishing a document announcing the 
availability of a guidance entitled ``Guidance for Industry and Food 
and Drug Administration Staff; User Fees for 513(g) Requests for 
Information.''

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on procedures regarding section 513(g) 
requests. 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 guidance may do so by 
using the Internet. 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 or from the 
CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Guidance for Industry and Food and Drug Administration Staff; FDA and 
Industry Procedures for Section 513(g) Requests for Information under 
the Federal Food, Drug, and Cosmetic Act,'' you may either send an 
email request to dsmica@fda.hhs.gov to receive an electronic copy of 
the document or send a fax request to 301-847-8419 to receive a hard 
copy. Please use the document number 1671 to identify the guidance you 
are requesting.

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 (44 U.S.C. 3501-3520). The 
collection(s) of information in this guidance was approved under OMB 
control number 0910-0705.
    This guidance also refers to currently approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR part 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; the collections of 
information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485; and the collections of information in 21 CFR 860.123 
have been approved under OMB control number 0910-0138.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is

[[Page 20827]]

only necessary to send one set of comments. Identify comments 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 29, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-8226 Filed 4-5-12; 8:45 am]
BILLING CODE 4160-01-P


