Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the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, 22599-22601 [2010-9937]

Download as PDF 22599 Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices Management, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301–796–3793. 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. Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine—(OMB Control Number 0910–0524)—Extension Protocols for nonclinical laboratory studies (safety studies), are required under 21 CFR 58.120 for approval of new animal drugs. Protocols for adequate and well-controlled effectiveness studies are required under 21 CFR 514.117(b). Upon request by the animal drug sponsors, the Center for Veterinary Medicine (CVM) reviews protocols for safety and effectiveness studies for which CVM and the sponsor consider this to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application. The establishment of a process for acceptance of the electronic submission of protocols for studies conducted by sponsors in support of new animal drug applications, is part of CVM’s ongoing initiative to provide a method for paperless submissions. Sponsors may submit protocols to CVM in paper format. CVM’s guidance on how to submit a study protocol permits sponsors to submit a protocol without data as an e-mail attachment via the Internet. Further, this guidance also electronically implements provisions of the Government Paperwork Elimination Act (GPEA). The GPEA required Federal agencies, by October 21, 2003, to provide the following: (1) The option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitution for paper and (2) the use and acceptance of electronic signatures, where applicable. FDA Form 3536 is used to facilitate the use of electronic submission of protocols. This collection of information is for the benefit of animal drug sponsors, giving them the flexibility to submit data for review via the Internet. The likely respondents are sponsors of new animal drug applications. FDA estimates the burden for this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section/ Form No. 3536 Number of Respondents 514.117(b) & 58.120 1 There Annual Frequency per Response 40 Total Annual Responses 2 1.8 Hours per Response 72 Total Hours 20 14.4 are no capital or operating and maintenance costs associated with this collection of information. submissions received between January 1, 2008, and December 31, 2008. 2 Electronic The number of respondents in table 1 of this document is the number of sponsors registered to make electronic submissions (40). The number of total annual responses is based on a review of the actual number of such submissions made between January 1, 2008, and December 31, 2008, (72 x hours per response (.20) = 14.4 total hours)). Dated: April 26, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–10023 Filed 4–28–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSKH9S0YB1PROD with NOTICES [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. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance VerDate Mar<15>2010 16:19 Apr 28, 2010 Jkt 220001 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 https:// 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 https:// 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), E:\FR\FM\29APN1.SGM 29APN1 22600 Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. 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.’’ 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 https://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm or on the CBER Internet site at https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Guidance documents are also available at https://www.regulations.gov. 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. 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 BURDEN1 FD&C Act 513(g) Number of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours CDRH 110 1 110 12 1,320 CBER 4 1 4 12 48 Total mstockstill on DSKH9S0YB1PROD with NOTICES 1 There 1,368 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 VerDate Mar<15>2010 16:19 Apr 28, 2010 Jkt 220001 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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 E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0144] Draft 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. mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.’’ This draft guidance describes the user fees associated with 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 comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 28, 2010. Submit VerDate Mar<15>2010 16:19 Apr 28, 2010 Jkt 220001 written or electronic comments on the collection of information June 28, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information’’ to the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA), WO66, rm. 4613, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 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, 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 to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// 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., WO66, rm. 1532, Silver Spring, MD 20993, 301–796–6571, or Stephen Ripley, Center for Biologics Evaluation and Research, HFM–17, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background Section 513(g) of the Federal Food Drug and Cosmetic Act (act) (21 U.S.C. 360c(g)) provides a means for obtaining the 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 (Public Law 110–85), extends FDA’s authority to collect medical device user fees by establishing a fee for ‘‘a request for classification information.’’ Elsewhere in this Federal Register we are publishing a document PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 22601 announcing the availability of a 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.’’ This guidance describes the procedures we recommend when seeking the Agency’s views about classification information and regulatory requirements that may be applicable to a particular device. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the Agency’s current thinking on user fees for requests for classification information submitted in accordance with section 513(g) of the act. 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 draft guidance may do so by using the Internet. To receive ‘‘Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information,’’ you may either send an e-mail 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 1709 to identify the guidance you are requesting. 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/search/ Regs/home.html#home or on the CBER Internet site at https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm. 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 E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Pages 22599-22601]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9937]

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

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.

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

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 https://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 https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or on the
CBER Internet site at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Guidance
documents are also available at https://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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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

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