Draft Guidance for Industry on Cell-Based Products for Animal Use; Availability, 44803-44804 [2014-18134]

Download as PDF Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices agent for each foreign facility (section 743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send the invoice for any fees that are assessed under this section. C. How much will this fee be? The fee is based on the number of direct hours spent on such reinspections, including time spent conducting the physical surveillance and/or compliance reinspection at the facility, or whatever components of such an inspection are deemed necessary, making preparations and arrangements for the reinspection, traveling to and from the facility, preparing any reports, analyzing any samples or examining any labels if required, and performing other activities as part of the OAI reinspection until the facility is again determined to be in compliance. The direct hours spent on each such reinspection will be billed at the appropriate hourly rate shown in table 2 of this document. IV. Fees for Non-Compliance With a Recall Order Under Section 743(a)(1)(B) A. What will cause this fee to be assessed? The fee will be assessed for not complying with a recall order under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C Act (21 U.S.C. 350a(f)) to cover food recall activities associated with such order performed by the Secretary (and by delegation, FDA) (section 743(a)(1)(B) of the FD&C Act). Non-compliance may include the following: (1) Not initiating a recall as ordered by FDA; (2) not conducting the recall in the manner specified by FDA in the recall order; or (3) not providing FDA with requested information regarding the recall, as ordered by FDA. tkelley on DSK3SPTVN1PROD with NOTICES B. Who will be responsible for paying this fee? Section 743(a)(1)(B) of the FD&C Act states that the fee is to be paid by the responsible party for a domestic facility (as defined in section 415(b) of the FD&C Act) and an importer who does not comply with a recall order under section 423 or under section 412(f) of the FD&C Act. In other words, the party paying the fee would be the party that received the recall order. C. How much will this fee be? The fee is based on the number of direct hours spent on taking action in response to the firm’s failure to comply with a recall order. Types of activities could include conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and VerDate Mar<15>2010 22:09 Jul 31, 2014 Jkt 232001 the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition. The direct hours spent on each such recall will be billed at the appropriate hourly rate shown in table 2 of this document. V. How must the fees be paid? An invoice will be sent to the responsible party for paying the fee after FDA completes the work on which the invoice is based. Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. Detailed payment information will be included with the invoice when it is issued. VI. What are the consequences of not paying these fees? Under section 743(e)(2) of the FD&C Act, any fee that is not paid within 30 days after it is due shall be treated as a claim of the U.S. Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code. Dated: July 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18172 Filed 7–31–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0634] Draft Guidance for Industry on CellBased Products for Animal Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry #218 entitled ‘‘Cell-Based Products for Animal Use.’’ This draft guidance describes FDA’s Center for Veterinary Medicine’s (CVM) current thinking on cell-based products for animal use that meet the definition of a new animal drug. This draft guidance is for firms and individuals developing cell-based products, including animal stem cell-based products (ASCPs). 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 SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 44803 final version of the guidance, submit either electronic or written comments on the draft guidance by September 30, 2014. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft 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. FOR FURTHER INFORMATION CONTACT: Lynne Boxer, Center for Veterinary Medicine (HFV–114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0611, lynne.boxer@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #218 entitled ‘‘Cell-Based Products for Animal Use.’’ CVM is aware that many veterinary therapies may be produced using cell-based products. Developers of such products for veterinary use have approached CVM for clarification regarding the regulation of these products. This draft guidance for industry describes CVM’s current thinking on cell-based products for animal use that meet the definition of a new animal drug. Cell-based products meeting the definition of a new animal drug are subject to the same statutory and regulatory requirements as other new animal drugs. Although this draft guidance relates to other cell-based products, this draft guidance focuses on ASCPs meeting the definition of a new animal drug. This draft guidance addresses the following topics: • How existing regulations apply to cell-based products for veterinary use; • A common vocabulary for ASCPs; • A risk-based category structure for ASCPs; and • Industry interaction with CVM early in product development. II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR E:\FR\FM\01AUN1.SGM 01AUN1 44804 Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices 10.115). The draft guidance, when finalized, will represent the Agency’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 requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft guidance 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. 3501–3520). The collections of information in 21 CFR part 514 and 21 CFR 511.1 have been approved under OMB control numbers 0910–0032 and 0910–0117 respectively. IV. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: July 28, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–18134 Filed 7–31–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration tkelley on DSK3SPTVN1PROD with NOTICES [Docket No. FDA–2014–D–0967] Intent To Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.’’ This draft guidance describes FDA’s intent to exempt certain Class II medical devices and certain Class I medical devices, subject to the reserved criteria, from premarket notification requirements. FDA believes devices identified in this guidance document are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness. This draft guidance is not final nor is it in effect at this time. SUMMARY: 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 either electronic or written comments on the draft guidance by September 30, 2014. DATES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Abiy Desta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1682, Silver Spring, MD 20993–0002, 301–796–0293. SUPPLEMENTARY INFORMATION: 22:09 Jul 31, 2014 Jkt 232001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 I. Background In the commitment letter (section 1.G of the Performance Goals and Procedures) that was drafted as part of the reauthorization process for the Medical Device User Fee Amendments of 2012 (Pub. L. 112–144), FDA committed to identifying low-risk medical devices to exempt from premarket notification. This draft guidance describes FDA’s intent to exempt certain Class II medical devices and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) from premarket submission requirements. FDA believes devices identified in this guidance document are sufficiently well understood and do not present risks that require 510(k) review. 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 identifying low risk medical devices to exempt from premarket notification. 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 downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive ‘‘Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements,’’ you may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1300046 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance 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 E:\FR\FM\01AUN1.SGM 01AUN1

Agencies

[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44803-44804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0634]


Draft Guidance for Industry on Cell-Based Products for Animal 
Use; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry 218 entitled 
``Cell-Based Products for Animal Use.'' This draft guidance describes 
FDA's Center for Veterinary Medicine's (CVM) current thinking on cell-
based products for animal use that meet the definition of a new animal 
drug. This draft guidance is for firms and individuals developing cell-
based products, including animal stem cell-based products (ASCPs).

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 either electronic or written comments on the draft 
guidance by September 30, 2014.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft 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.

FOR FURTHER INFORMATION CONTACT: Lynne Boxer, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0611, lynne.boxer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
218 entitled ``Cell-Based Products for Animal Use.'' CVM is 
aware that many veterinary therapies may be produced using cell-based 
products. Developers of such products for veterinary use have 
approached CVM for clarification regarding the regulation of these 
products. This draft guidance for industry describes CVM's current 
thinking on cell-based products for animal use that meet the definition 
of a new animal drug.
    Cell-based products meeting the definition of a new animal drug are 
subject to the same statutory and regulatory requirements as other new 
animal drugs. Although this draft guidance relates to other cell-based 
products, this draft guidance focuses on ASCPs meeting the definition 
of a new animal drug.
    This draft guidance addresses the following topics:
     How existing regulations apply to cell-based products for 
veterinary use;
     A common vocabulary for ASCPs;
     A risk-based category structure for ASCPs; and
     Industry interaction with CVM early in product 
development.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR

[[Page 44804]]

10.115). The draft guidance, when finalized, will represent the 
Agency'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 requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance 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. 3501-3520). The 
collections of information in 21 CFR part 514 and 21 CFR 511.1 have 
been approved under OMB control numbers 0910-0032 and 0910-0117 
respectively.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18134 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P