81_FR_83468 81 FR 83244 - Report of the Center for Veterinary Medicine Working Group on the Regulation of Animal Drug Availability Act Combination Drug Medicated Feeds; Availability

81 FR 83244 - Report of the Center for Veterinary Medicine Working Group on the Regulation of Animal Drug Availability Act Combination Drug Medicated Feeds; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 224 (November 21, 2016)

Page Range83244-83245
FR Document2016-27942

The Food and Drug Administration (FDA) is announcing the availability of a report of a Center for Veterinary Medicine (CVM) working group proposing possible changes to the current review processes for new animal drug applications (NADAs) providing for the use of multiple new animal drugs in combination drug medicated feeds. This report was developed for the use of the CVM committee that will be participating in discussions concerning the reauthorization of the animal drug user fee program for 5 additional years through fiscal year 2023 (per the Animal Drug User Fee Amendments (ADUFA) IV).

Federal Register, Volume 81 Issue 224 (Monday, November 21, 2016) 
[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83244-83245]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1050]


Report of the Center for Veterinary Medicine Working Group on the 
Regulation of Animal Drug Availability Act Combination Drug Medicated 
Feeds; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report of a Center for Veterinary Medicine (CVM) 
working group proposing possible changes to the current review 
processes for new animal drug applications (NADAs) providing for the 
use of multiple new animal drugs in combination drug medicated feeds. 
This report was developed for the use of the CVM committee that will be 
participating in discussions concerning the reauthorization of the 
animal drug user fee program for 5 additional years through fiscal year 
2023 (per the Animal Drug User Fee Amendments (ADUFA) IV).

ADDRESSES: For access to the docket to read background documents or the 
electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

[[Page 83245]]

    Submit written requests for single copies of the report 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 document.

FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary 
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0829, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2014 
(79 FR 53431), CVM announced that it was beginning to explore possible 
changes to the current review processes for NADAs for the use of 
multiple new animal drugs in combination drug medicated feeds. In the 
same Federal Register notice, FDA announced the opening of a docket to 
receive input from the public on this issue. This effort is consistent 
with the stated performance goal in the Animal Drug User Fee Amendments 
of 2013 (ADUFA III) goals letter.
    In the Federal Register of April 29, 2016 (81 FR 25677), FDA 
published a notice of availability of a draft CVM report, giving 
interested persons until July 29, 2016, to comment. Those comments were 
considered as the CVM working group report was finalized without 
substantive changes. This report was developed for the discussions with 
the regulated industry for reauthorization of ADUFA.
    Persons with access to the Internet may obtain this document on the 
CVM ADUFA Meetings Web page: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.

    Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27942 Filed 11-18-16; 8:45 am]
 BILLING CODE 4164-01-P

83244 Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Notices for an extension to allow interested • Confidential Submissions—To Following publication of the persons additional time to submit submit a comment with confidential September 9, 2016, notice of comments. information that you do not wish to be availability, we received a request for a DATES: Submit either electronic or made publicly available, submit your 90-day extension of the comment written comments by February 21, 2017. comments only as a written/paper period. The request expressed concern ADDRESSES: You may submit comments submission. You should submit two that the current 60-day comment period as follows: copies total. One copy will include the does not allow sufficient time to information you claim to be confidential develop a thoughtful and Electronic Submissions with a heading or cover note that states comprehensive response to the draft Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS guidance. We have considered the following way: CONFIDENTIAL INFORMATION.’’ We request and are reopening the comment • Federal eRulemaking Portal: http:// will review this copy, including the period for an additional 90 days, until www.regulations.gov. Follow the claimed confidential information, in our February 21, 2017. We believe that this instructions for submitting comments. consideration of comments. The second reopening allows adequate time for Comments submitted electronically, copy, which will have the claimed interested persons to submit comments including attachments, to http:// confidential information redacted/ without significantly delaying finalizing www.regulations.gov will be posted to blacked out, will be available for public the guidance. the docket unchanged. Because your viewing and posted on http:// Dated: November 15, 2016. comment will be made public, you are www.regulations.gov. Submit both Leslie Kux, solely responsible for ensuring that your copies to the Division of Dockets Associate Commissioner for Policy. comment does not include any Management. If you do not wish your [FR Doc. 2016–27941 Filed 11–18–16; 8:45 am] confidential information that you or a name and contact information to be third party may not wish to be posted, made publicly available, you can BILLING CODE 4164–01–P such as medical information, your or provide this information on the cover anyone else’s Social Security number, or sheet and not in the body of your confidential business information, such DEPARTMENT OF HEALTH AND comments and you must identify this as a manufacturing process. Please note HUMAN SERVICES information as ‘‘confidential.’’ Any that if you include your name, contact information marked as ‘‘confidential’’ Food and Drug Administration information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other [Docket No. FDA–2014–N–1050] comments, that information will be applicable disclosure law. For more posted on http://www.regulations.gov. information about FDA’s posting of Report of the Center for Veterinary • If you want to submit a comment comments to public dockets, see 80 FR Medicine Working Group on the with confidential information that you 56469, September 18, 2015, or access Regulation of Animal Drug Availability do not wish to be made available to the the information at: http://www.fda.gov/ Act Combination Drug Medicated public, submit the comment as a regulatoryinformation/dockets/ Feeds; Availability written/paper submission and in the default.htm. AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper Docket: For access to the docket to HHS. Submissions’’ and ‘‘Instructions’’). read background documents or the ACTION: Notice of availability. Written/Paper Submissions electronic and written/paper comments received, go to http:// SUMMARY: The Food and Drug Submit written/paper submissions as www.regulations.gov and insert the Administration (FDA) is announcing the follows: docket number, found in brackets in the availability of a report of a Center for • Mail/Hand delivery/Courier (for heading of this document, into the Veterinary Medicine (CVM) working written/paper submissions): Division of group proposing possible changes to the ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food current review processes for new animal and/or go to the Division of Dockets and Drug Administration, 5630 Fishers drug applications (NADAs) providing Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. for the use of multiple new animal • For written/paper comments 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: drugs in combination drug medicated submitted to the Division of Dockets Gillian Robert-Baldo, Center for Food feeds. This report was developed for the Management, FDA will post your Safety and Applied Nutrition (HFS– use of the CVM committee that will be comment, as well as any attachments, 850), Food and Drug Administration, participating in discussions concerning except for information submitted, marked and identified, as confidential, 5001 Campus Dr., College Park, MD the reauthorization of the animal drug if submitted as detailed in 20740, 240–402–1451. user fee program for 5 additional years ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: In the through fiscal year 2023 (per the Animal Instructions: All submissions received Federal Register of September 9, 2016 Drug User Fee Amendments (ADUFA) must include the Docket No. FDA– (81 FR 62509), we published a notice IV). 2016–D–2241 for ‘‘Substantiation for announcing the availability of a draft ADDRESSES: For access to the docket to Structure/Function Claims Made in guidance entitled, ‘‘Substantiation for read background documents or the Infant Formula Labels and Labeling.’’ Structure/Function Claims Made in electronic and written/paper comments asabaliauskas on DSK3SPTVN1PROD with NOTICES Received comments will be placed in Infant Formula Labels and Labeling.’’ received, go to https:// the docket and, except for those Although you can comment on any www.regulations.gov and insert the submitted as ‘‘Confidential guidance at any time, to ensure that we docket number, found in brackets in the Submissions,’’ publicly viewable at consider comments on this draft heading of this document, into the http://www.regulations.gov or at the guidance before we begin work on the ‘‘Search’’ box and follow the prompts Division of Dockets Management final version, interested persons were and/or go to the Division of Dockets between 9 a.m. and 4 p.m., Monday originally given until November 8, 2016, Management, 5630 Fishers Lane, rm. through Friday. to comment on the draft guidance. 1061, Rockville, MD 20852. 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Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Notices 83245 Submit written requests for single DEPARTMENT OF HEALTH AND color additive petitions, GRAS copies of the report to the Policy and HUMAN SERVICES affirmation petitions, requests for Regulations Staff (HFV–6), Center for exemption from regulation as a food Veterinary Medicine, Food and Drug Food and Drug Administration additive, and actions on certain food Administration, 7519 Standish Pl., [Docket No. FDA–2013–N–1147] labeling citizen petitions, nutrient Rockville, MD 20855. Send one self- content claims petitions, and health addressed adhesive label to assist that Agency Information Collection claims petitions. In 1997, we amended office in processing your requests. See Activities; Submission for Office of our regulations in part 25 (21 CFR part the SUPPLEMENTARY INFORMATION section Management and Budget Review; 25) to provide for categorical exclusions for electronic access to the document. Comment Request; Preparing a Claim for additional classes of actions that do of Categorical Exclusion or an not individually or cumulatively have a FOR FURTHER INFORMATION CONTACT: significant effect on the human Environmental Assessment for Linda M. Wilmot, Center for Veterinary Submission to the Center for Food environment (62 FR 40570, July 29, Medicine (HFV–120), Food and Drug Safety and Applied Nutrition 1997). As a result of that rulemaking, we Administration, 7500 Standish Pl., no longer routinely require submission Rockville, MD 20855, 240–402–0829, AGENCY: Food and Drug Administration, of information about the manufacturing linda.wilmot@fda.hhs.gov. HHS. and production of our regulated articles. ACTION: Notice. We also have eliminated the previously SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2014 SUMMARY: The Food and Drug required Environmental Assessment (79 FR 53431), CVM announced that it Administration (FDA) is announcing (EA) and abbreviated EA formats from was beginning to explore possible that a proposed collection of the amended regulations. Instead, we changes to the current review processes information has been submitted to the have provided guidance that contains for NADAs for the use of multiple new Office of Management and Budget sample formats to help industry submit animal drugs in combination drug (OMB) for review and clearance under a claim of categorical exclusion or an medicated feeds. In the same Federal the Paperwork Reduction Act of 1995. EA to the Center for Food Safety and Applied Nutrition (CFSAN). The Register notice, FDA announced the DATES: Fax written comments on the guidance document entitled ‘‘Preparing opening of a docket to receive input collection of information by December a Claim of Categorical Exclusion or an from the public on this issue. This effort 21, 2016. Environmental Assessment for is consistent with the stated ADDRESSES: To ensure that comments on Submission to the Center for Food performance goal in the Animal Drug the information collection are received, Safety and Applied Nutrition’’ User Fee Amendments of 2013 (ADUFA OMB recommends that written identifies, interprets, and clarifies III) goals letter. comments be faxed to the Office of existing requirements imposed by In the Federal Register of April 29, Information and Regulatory Affairs, statute and regulation, consistent with 2016 (81 FR 25677), FDA published a OMB, Attn: FDA Desk Officer, FAX: the Council on Environmental Quality notice of availability of a draft CVM 202–395–7285, or emailed to oira_ regulations (40 CFR 1507.3). It consists report, giving interested persons until submission@omb.eop.gov. All of recommendations that do not July 29, 2016, to comment. Those comments should be identified with the themselves create requirements; rather, OMB control number 0910–0541. Also they are explanatory guidance for our comments were considered as the CVM include the FDA docket number found own procedures in order to ensure full working group report was finalized in brackets in the heading of this compliance with the purposes and without substantive changes. This document. report was developed for the provisions of NEPA. discussions with the regulated industry FOR FURTHER INFORMATION CONTACT: FDA The guidance provides information to for reauthorization of ADUFA. PRA Staff, Office of Operations, Food assist in the preparation of claims of and Drug Administration, Three White categorical exclusion and EAs for Persons with access to the Internet Flint North, 10A63, 11601 Landsdown may obtain this document on the CVM submission to CFSAN. The following St., North Bethesda, MD 20852, questions are covered in this guidance: ADUFA Meetings Web page: http:// PRAStaff@fda.hhs.gov. www.fda.gov/ForIndustry/UserFees/ (1) What types of industry-initiated SUPPLEMENTARY INFORMATION: In actions are subject to a claim of AnimalDrugUserFeeActADUFA/ compliance with 44 U.S.C. 3507, FDA ucm042891.htm. categorical exclusion? (2) What must a has submitted the following proposed claim of categorical exclusion include Dated: November 15, 2016. collection of information to OMB for by regulation? (3) What is an EA? (4) Leslie Kux, review and clearance. When is an EA required by regulation Associate Commissioner for Policy. Preparing a Claim of Categorical and what format should be used? (5) [FR Doc. 2016–27942 Filed 11–18–16; 8:45 am] Exclusion or an Environmental What are extraordinary circumstances? BILLING CODE 4164–01–P Assessment for Submission to the and (6) What suggestions does CFSAN Center for Food Safety and Applied have for preparing an EA? Although Nutrition—OMB Control Number CFSAN encourages industry to use the 0910–0541—Extension EA formats described in the guidance asabaliauskas on DSK3SPTVN1PROD with NOTICES As an integral part of its decision because standardized documentation making process, we are obligated under submitted by industry increases the the National Environmental Policy Act efficiency of the review process, of 1969 (NEPA) to consider the alternative approaches may be used if environmental impact of our actions, these approaches satisfy the including allowing notifications for food requirements of the applicable statutes contact substances to become effective and regulations. We are requesting the and approving food additive petitions, extension of OMB approval for the VerDate Sep<11>2014 18:09 Nov 18, 2016 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1


Document Created: 2018-02-14 08:33:52
Document Modified: 2018-02-14 08:33:52
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 of availability.
ContactLinda M. Wilmot, Center for Veterinary Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0829, [email protected]
FR Citation81 FR 83244 
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