80_FR_54743 80 FR 54568 - Distributor Labeling for New Animal Drugs; Draft Guidance for Industry; Availability

80 FR 54568 - Distributor Labeling for New Animal Drugs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 175 (September 10, 2015)

Page Range54568-54569
FR Document2015-22772

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GIF) #231 entitled ``Distributor Labeling for New Animal Drugs.'' This draft guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a New Animal Drug Application or Abbreviated New Animal Drug Application (NADA/ANADA) in ways other than those permitted by regulation.

Federal Register, Volume 80 Issue 175 (Thursday, September 10, 2015) 
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54568-54569]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3056]


Distributor Labeling for New Animal Drugs; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (GIF) #231 entitled 
``Distributor Labeling for New Animal Drugs.'' This draft guidance 
discusses FDA's current thinking with respect to the factors it 
considers in determining whether to take regulatory action against 
distributor labeling for a new animal drug that differs from the 
labeling approved as part of a New Animal Drug Application or 
Abbreviated New Animal Drug Application (NADA/ANADA) in ways other than 
those permitted by regulation.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 9, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Policy and Regulations Staff (HFV-6), Center for 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: Dorothy McAdams, Center for Veterinary 
Medicine, Division of Surveillance (HFV-210), Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5763, 
email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of draft GFI #231 entitled 
``Distributor Labeling for New Animal Drugs.'' ``Distributor labeling'' 
refers to the labeling of an approved new animal drug marketed by a 
distributor who distributes the product under its own label or 
proprietary name. Unlike the approved labeling, which the Center for 
Veterinary Medicine reviews as part of a NADA/ANADA approval process to 
ensure the safe and effective use of the drug and compliance with the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and its 
implementing regulations, distributor labeling does not ordinarily go 
through a premarket approval process.
    FDA regulations (21 CFR 514.80) require that distributor labeling 
be identical to the labeling approved in the NADA/ANADA, except for a 
different and suitable proprietary name and the name and address of the 
distributor preceded by an appropriate qualifying phrase. These 
requirements are meant to ensure that distributor labeling complies 
with the requirements of the FD&C Act and its implementing regulations 
and to prevent distributor label products from reaching the market with 
labeling that compromises the safe and effective use of the new animal 
drug.

II. Significance of Guidance

    This level 1 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 current thinking of FDA on 
distributor labeling for new animal drugs. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it 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 Sec.  514.80 have been approved under OMB 
control number 0910-0284.

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

[[Page 54569]]

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: September 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22772 Filed 9-9-15; 8:45 am]
 BILLING CODE 4164-01-P

54568 Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices they wish to present, the names and DEPARTMENT OF HEALTH AND I. Background addresses of proposed participants, and HUMAN SERVICES FDA is announcing the availability of an indication of the approximate time draft GFI #231 entitled ‘‘Distributor requested to make their presentation. Food and Drug Administration Labeling for New Animal Drugs.’’ Oral presentations from the public will ‘‘Distributor labeling’’ refers to the be scheduled between approximately 2 [Docket No. FDA–2015–D–3056] labeling of an approved new animal p.m. and 3 p.m. Time allotted for each drug marketed by a distributor who presentation may be limited. If the Distributor Labeling for New Animal distributes the product under its own number of registrants requesting to Drugs; Draft Guidance for Industry; label or proprietary name. Unlike the speak is greater than can be reasonably Availability approved labeling, which the Center for accommodated during the scheduled Veterinary Medicine reviews as part of AGENCY: Food and Drug Administration, open public hearing session, FDA may a NADA/ANADA approval process to HHS. conduct a lottery to determine the ensure the safe and effective use of the speakers for the scheduled open public ACTION: Notice. drug and compliance with the Federal hearing session. The contact person will Food, Drug, and Cosmetic Act (the SUMMARY: The Food and Drug FD&C Act) and its implementing notify interested persons regarding their Administration (FDA) is announcing the regulations, distributor labeling does not requests to speak by October 28, 2015. availability of a draft guidance for ordinarily go through a premarket B. Comments industry (GIF) #231 entitled ‘‘Distributor approval process. Labeling for New Animal Drugs.’’ This FDA regulations (21 CFR 514.80) Regardless of whether you attend this draft guidance discusses FDA’s current require that distributor labeling be meeting, you can submit either thinking with respect to the factors it identical to the labeling approved in the electronic comments regarding this considers in determining whether to NADA/ANADA, except for a different public workshop to http:// take regulatory action against distributor and suitable proprietary name and the www.regulations.gov or written labeling for a new animal drug that name and address of the distributor comments to the Division of Dockets differs from the labeling approved as preceded by an appropriate qualifying Management (HFA–305), Food and Drug part of a New Animal Drug Application phrase. These requirements are meant to Administration, 5630 Fishers Lane, Rm. or Abbreviated New Animal Drug ensure that distributor labeling complies 1061, Rockville, MD 20852. All Application (NADA/ANADA) in ways with the requirements of the FD&C Act comments should be identified with the other than those permitted by and its implementing regulations and to docket number found in brackets in the regulation. prevent distributor label products from heading of this document and must be reaching the market with labeling that DATES: Although you can comment on compromises the safe and effective use received by December 29, 2015. any guidance at any time (see 21 CFR of the new animal drug. Received comments may be seen in the 10.115(g)(5)), to ensure that the Agency Division of Dockets Management considers your comment on this draft II. Significance of Guidance between 9 a.m. and 4 p.m., Monday guidance before it begins work on the This level 1 draft guidance is being through Friday, and will be posted to final version of the guidance, submit issued consistent with FDA’s good the docket at http:// either electronic or written comments guidance practices regulation (21 CFR www.regulations.gov. on the draft guidance by November 9, 10.115). The draft guidance, when 2015. finalized, will represent the current C. Transcripts thinking of FDA on distributor labeling ADDRESSES: Submit written requests for for new animal drugs. It does not Transcripts of the workshop will be single copies of the draft guidance to the available for review at the Division of establish any rights for any person and Policy and Regulations Staff (HFV–6), is not binding on FDA or the public. Dockets Management (see Comments) Center for Veterinary Medicine, Food You can use an alternative approach if and at http://www.regulations.gov and Drug Administration, 7519 Standish it satisfies the requirements of the approximately 30 days after the Pl., Rockville, MD 20855. Send one self- applicable statutes and regulations. workshop. A transcript will also be addressed adhesive label to assist that available in either hardcopy or on CD– office in processing your requests. See III. Paperwork Reduction Act of 1995 ROM, after submission of a Freedom of the SUPPLEMENTARY INFORMATION section This draft guidance refers to Information request. The Freedom of for electronic access to the draft previously approved collections of Information office address is available guidance document. information found in FDA regulations. on the Agency’s Web site at http:// Submit electronic comments on the These collections of information are www.fda.gov. draft guidance to http:// subject to review by the Office of Dated: September 3, 2015 www.regulations.gov. Submit written Management and Budget (OMB) under comments to the Division of Dockets the Paperwork Reduction Act of 1995 Leslie Kux, Management (HFA–305), Food and Drug (44 U.S.C. 3501–3520). The collections Associate Commissioner for Policy. Administration, 5630 Fishers Lane, Rm. of information in § 514.80 have been [FR Doc. 2015–22784 Filed 9–9–15; 8:45 am] 1061, Rockville, MD 20852. approved under OMB control number BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: 0910–0284. mstockstill on DSK4VPTVN1PROD with NOTICES Dorothy McAdams, Center for IV. Comments Veterinary Medicine, Division of Interested persons may submit either Surveillance (HFV–210), Food and Drug electronic comments regarding this Administration, 7519 Standish Pl., document to http://www.regulations.gov Rockville, MD 20855, 240–402–5763, or written comments to the Division of email: dorothy.mcadams@fda.hhs.gov. Dockets Management (see ADDRESSES). SUPPLEMENTARY INFORMATION: It is only necessary to send one set of VerDate Sep<11>2014 17:28 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1

Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices 54569 comments. Identify comments with the 1996’’ (Pub. L. 104–134, amended by for the same product(s) in response to docket number found in brackets in the Pub. L. 104–180) amended sections the same request generally cost FDA less heading of this document. Received 801(e) and 802 of the Federal Food, than $175 to prepare. The fee for all comments may be seen in the Division Drug, and Cosmetic Act (the FD&C Act) subsequent certificates for the same of Dockets Management between 9 a.m. (21 U.S.C. 381(e) and 382). It was product(s) issued in response to the and 4 p.m., Monday through Friday, and designed to ease restrictions on same request reflects reduced FDA costs will be posted to the docket at http:// exportation of unapproved for preparing those certificates. www.regulations.gov. pharmaceuticals, biologics, and devices The following fees will be assessed regulated by FDA. Section 801(e)(4) of starting October 1, 2015, for animal food V. Electronic Access the FD&C Act provides that persons export certificates: Persons with access to the Internet exporting certain FDA regulated may obtain the draft guidance at either products may request FDA to certify TABLE 1—CVM FEES FOR FIRST, http://www.fda.gov/AnimalVeterinary/ that the products meet the requirements SECOND, AND SUBSEQUENT EXPORT GuidanceComplianceEnforcement/ of section 801(e)(1), section 802, or CERTIFICATES GuidanceforIndustry/default.htm or other applicable requirements of the http://www.regulations.gov. FD&C Act. Section 801(e)(4) of the Type of certificate Fee FD&C Act also requires FDA to issue (dollars) Dated: September 1, 2015. Leslie Kux, certification within 20 days of receipt of First certificate ...................... 175 the request and authorizes us to charge Associate Commissioner for Policy. Second certificate for the up to $175 for each certification issued same product(s) issued in [FR Doc. 2015–22772 Filed 9–9–15; 8:45 am] within 20 days. In January 2011, section response to the same re- BILLING CODE 4164–01–P 801(e)(4)(A) of the FD&C Act was quest ................................. 155 amended by FSMA (Pub. L. 111–353) to Subsequent certificates for provide authorization for export the same product(s) DEPARTMENT OF HEALTH AND certification fees for regulated food, issued in response to the HUMAN SERVICES including animal food (referred to as same request .................... 70 animal feed in section 107(b) of FSMA). Food and Drug Administration The fee for issuing the first export Section 801(e)(4) of the FD&C Act [Docket No. FDA–2015–N–3106] authorizes FDA to issue export certificate for animal food will be at the certificates for regulated food, drugs, maximum allowable amount and Animal Food; Export Certificates; Food and devices that are legally marketed in consistent with the export certification and Drug Administration Food Safety the United States, as well as for these fees assessed since FY 1997 by other Modernization Act of 2011; same products that are not legally FDA Centers that provide export Certification Fees marketed but are legally exported under certification for drugs and devices. The section 801(e) or 802 of the FD&C Act. fees for issuing subsequent certificates AGENCY: Food and Drug Administration, continue to differ among the Centers, HHS. The focus of this notice is on export certificates issued by the Center for based on varying costs. ACTION: Notice. Veterinary Medicine (CVM) for animal Dated: September 1, 2015. SUMMARY: The Food and Drug food. Leslie Kux, Administration (FDA or we) is II. Fees To Be Assessed for Export Associate Commissioner for Policy. announcing the fees we will assess for Certificates [FR Doc. 2015–22795 Filed 9–9–15; 8:45 am] issuing export certificates for animal BILLING CODE 4164–01–P food. The FDA Food Safety CVM estimates the costs of the export Modernization Act (FSMA) of 2011 certification program for animal food to authorizes us to charge fees to cover our be approximately $548,000 per year for DEPARTMENT OF HEALTH AND payroll and operating expenses. There HUMAN SERVICES costs associated with issuing export are four cost categories for preparing certificates for regulated food including and issuing export certificates in Food and Drug Administration animal food. This notice provides the general. They are: (1) Direct personnel fee schedule for issuing these [Docket No. FDA–2011–N–0481] for research, review, tracking, writing, certificates and the basis for the fees. We and assembly; (2) purchase of Agency Information Collection have not previously collected fees to equipment and supplies used for issue export certificates for animal food. Activities; Announcement of Office of tracking, processing, printing, and DATES: The fees described in this Management and Budget Approval; packaging. Recovery of the cost of the document for export certificates for New Animal Drugs for Investigational equipment is calculated over its useful animal food will be effective October 1, Use life; (3) billing and collection of fees; 2015. and (4) overhead and administrative AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: support. In fiscal year (FY) 2014 CVM HHS. Joanne Kla, Office of Surveillance and issued approximately 933 animal food ACTION: Notice. Compliance, Center for Veterinary export certificates. Because CVM has Medicine (HFV–235), Food and Drug not been charging fees for issuing export SUMMARY: The Food and Drug Administration (FDA) is announcing mstockstill on DSK4VPTVN1PROD with NOTICES Administration, 7500 Standish Pl., certificates for animal food, the program Rockville, MD 20855, 240–402–5605, has been covered by appropriated funds. that a collection of information entitled, CVMExportCertification@fda.hhs.gov. As mentioned previously in this ‘‘New Animal Drugs for Investigational SUPPLEMENTARY INFORMATION: document, FDA may charge up to $175 Use’’ has been approved by the Office of for each certificate. Certificates for some Management and Budget (OMB) under I. Background classes of products, including animal the Paperwork Reduction Act of 1995. In April 1996, a law entitled the ‘‘FDA food, cost the Agency more than $175 to FOR FURTHER INFORMATION CONTACT: FDA Export Reform and Enhancement Act of prepare. Subsequent certificates issued PRA Staff, Office of Operations, Food VerDate Sep<11>2014 17:28 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1


Document Created: 2015-12-15 10:03:25
Document Modified: 2015-12-15 10:03:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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 November 9, 2015.
ContactDorothy McAdams, Center for Veterinary Medicine, Division of Surveillance (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5763, email: [email protected]
FR Citation80 FR 54568 
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