Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information; Availability, 20825-20826 [2012-8227]

Download as PDF Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 27, 2012. Armando Zamora, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2012–8342 Filed 4–5–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Submit electronic comments on the guidance to https://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. 301–796–6210. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2010–D–0144] I. Background Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information; Availability 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 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 (Pub. L. 110– 85), extends FDA’s authority to collect medical device user fees by establishing a fee for ‘‘a request for classification information.’’ In the Federal Register of April 29, 2010 (75 FR 22601), FDA announced the availability of the draft guidance. Comments on the draft guidance were due by July 28, 2010.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 The guidance announced in this notice finalizes the draft guidance of the same title. Elsewhere in this issue of the Federal Register, FDA is publishing a document announcing the availability of a 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.’’ 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 submitted in accordance with section 513(g) requests for information. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information.’’ This guidance document describes the user fees associated with 513(g) requests for information. 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; User Fees for 513(g) Requests for Information’’ 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– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:17 Apr 05, 2012 Jkt 226001 II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 20825 The guidance represents the Agency’s current thinking on user fees for 513(g) requests for information. 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from the CBER Internet site at https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information,’’ 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 1709 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 and 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), either electronic or written comments regarding this document. It is 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. E:\FR\FM\06APN1.SGM 06APN1 20826 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices Dated: March 29, 2012. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2012–8227 Filed 4–5–12; 8:45 am] BILLING CODE 4160–01–P 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. 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 https://www.regulations.gov. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:17 Apr 05, 2012 Jkt 226001 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from the CBER Internet site at https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/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 E:\FR\FM\06APN1.SGM 06APN1

Agencies

[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Notices]
[Pages 20825-20826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8227]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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.

-----------------------------------------------------------------------

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

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; User Fees for 513(g) Requests for Information''
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 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to https://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. 301-796-6210.

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 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 (Pub. L. 110-85), extends
FDA's authority to collect medical device user fees by establishing a
fee for ``a request for classification information.''
In the Federal Register of April 29, 2010 (75 FR 22601), 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.
Elsewhere in this issue of the Federal Register, FDA is publishing
a document announcing the availability of a 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.'' 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 submitted in accordance with
section 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 user fees for 513(g) requests for
information. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov or from the
CBER Internet site at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Guidance for Industry and Food and Drug Administration Staff; User
Fees for 513(g) Requests for Information,'' 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 1709 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 and 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), either electronic or written comments regarding this
document. It is 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.

[[Page 20826]]

Dated: March 29, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-8227 Filed 4-5-12; 8:45 am]
BILLING CODE 4160-01-P

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