Document ID: FDA-2010-D-0153-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff: Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act
Posted Date: 2010-04-29T04:00Z

[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Notices]               
[Page 22599-22601]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ap10-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Industry and Food and Drug Administration 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 the 
availability of the draft guidance entitled ``Draft Guidance for 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 This draft guidance is not final nor is it in effect at this 
time. Elsewhere in this issue of the Federal Register, FDA is also 
publishing a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) 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 comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on this draft guidance 
by July 28, 2010. Submit written or electronic comments on the 
collection of information by June 28, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written requests for single 
copies of the draft guidance document entitled ``Draft Guidance for 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'' 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 to the Office of Communication, 
Outreach and Development (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 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 and the 
collection of information 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., Bldg. 66, rm., 1532, Silver Spring, MD 20993-0002, 
301-796-6571, or Steve Ripley, Center for Biologics Evaluation and 
Research, (HFM-17),

[[Page 22600]]

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 act) 
(21 U.S.C. 360c(g) provides a means for obtaining the 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 
act that are submitted in accordance with section 513(g) of the 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 act. 
Additionally, the act, as amended by the FDA Amendments Act of 2007 
(FDAAA) (Public Law 110-85), requires FDA to collect user fees for 
513(g) Request for Information. Elsewhere in this issue of the Federal 
Register, FDA is also publishing a notice of availability for a draft 
guidance entitled ``Draft Guidance for Industry and FDA Staff; User 
Fees for 513(g) Requests for Information.''

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's current 
thinking on this topic. 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 
requirement of the applicable statutes 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 
FDA 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 301-847-8149 
to receive a hard copy. Please use the document number 1671 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 or on the 
CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Guidance 
documents are also available at http://www.regulations.gov.

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 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: 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 act provides a means for 
obtaining the agency's views about the classification and the 
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 this 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 this act applicable to the 
device.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                        Number of       Annual Frequency     Total Annual         Hours per
 FD&C Act  513(g)      Respondents        per Response         Responses          Response         Total Hours
----------------------------------------------------------------------------------------------------------------
CDRH                              110                  1                 110                12             1,320
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CBER                                4                  1                   4                12                48
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,368
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA based its estimates on the number of 513(g) Requests for 
Information received by both CDRH and CBER in 2007-2009. Elsewhere in 
this issue of the Federal Register, FDA is publishing a document 
announcing the availability of a draft guidance document entitled 
``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) 
Requests for Information.''
    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-
3502). The collections

[[Page 22601]]

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; 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), 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. 2010-9937 Filed 4-28-10; 8:45 am]
BILLING CODE 4160-01-S