[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Pages 22599-22601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9937]
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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Draft Guidance for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 This draft guidance is not final nor is it in effect at this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publishing a notice of availability for a draft guidance entitled
``Draft Guidance for Industry and FDA Staff; User Fees for 513(g)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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on this draft guidance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copies of the draft guidance document entitled ``Draft Guidance for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 The draft guidance may also be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 [email protected] 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
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CDRH 110 1 110 12 1,320
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CBER 4 1 4 12 48
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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.
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