Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Guidance for Industry; Availability, 12498-12499 [2016-05222]

Download as PDF 12498 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices Estimated total annual burden hours: 95. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@ acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, ACF Certifying Officer. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). [FR Doc. 2016–05240 Filed 3–8–16; 8:45 am] Written/Paper Submissions BILLING CODE 4184–01–P Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–D–1180 for ‘‘Ensuring Safety of Animal Feed Maintained and Fed OnFarm.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1180] Ensuring Safety of Animal Feed Maintained and Fed On-Farm; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) # 203 entitled ‘‘Ensuring Safety of Animal Feed Maintained and Fed On-Farm.’’ This guidance is intended to help animal producers (persons who feed animals) develop and implement onfarm practices to ensure the safety of animal feed maintained and fed to animals on the farm. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Lhorne on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// 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. Submit written requests for single copies of the 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 selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Phares Okelo, Center for Veterinary Medicine (HFV–226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5921, email: phares.okelo@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 20, 2015 (80 FR 15014), FDA published the notice of availability for a draft GFI #203 entitled ‘‘Ensuring Safety of Animal Feed Maintained and Fed On-Farm’’ giving interested persons until June 3, 2015, to comment on the draft guidance. FDA received several comments on the E:\FR\FM\09MRN1.SGM 09MRN1 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated March 2015. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ensuring safety of animal feed maintained and fed onfarm. 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 FDA concludes that there are no collections of information under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: IV. Electronic Access Persons with access to the Internet may obtain the guidance at either http:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. I. Background BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2016–N–0001] Tenth Annual Drug Information Association/Food and Drug Administration Statistics Forum— 2016; Public Conference Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ‘‘Tenth Annual DIA/Food and Drug Administration Statistics Forum— 2016.’’ This public conference is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop and review new drugs and biologics. A primary focus for this public conference will be to establish an Lhorne on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 Meredith Kaganovskiy, DIA, 800 Enterprise Rd., Horsham, PA 19044, 215–442–6117, Meredith.Kaganovskiy@DIAglobal.orgM; or Stephen Wilson, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver Spring, MD 20993–0002, 301–796–0579, Stephen.Wilson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: [FR Doc. 2016–05222 Filed 3–8–16; 8:45 am] AGENCY: ongoing dialogue between industry and regulatory Agencies—emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials and measuring the progress being made in designing and implementing innovative solutions. DATES: The main meeting will be held over 3 days: April 25, 2016, from 1 p.m. to 5:30 p.m.; April 26, 2016, from 8:30 a.m. to 5 p.m.; and April 27, 2016, from 8:30 a.m. to 3:30 p.m. On April 25, there will also be pre-meeting tutorials from 8:30 a.m. to 12 p.m. and a scientific working group session from 5:40 p.m. to 7 p.m. ADDRESSES: The meeting will be held at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852, 301–822– 9200. FDA and DIA will sponsor an open public discussion between industry, academia, contract research organizations, regulatory scientists, and other parties on topics related to the innovative statistical methodologies and quantitative approaches used by sponsors to provide evidence for the approval of new therapies. The forum will provide a unique opportunity for all of the relevant stakeholders to collaboratively describe the issues and discuss appropriate solutions. It is important that all of the stakeholders examine their roles in making the necessary changes and improvements in the framework used to develop evidence for the regulatory decisions and work to foster a mutual understanding of relevant scientific issues and challenges. The conference will benefit FDA by enhancing communication with the broader statistical community. The goals of the program are as follows: • Explore and implement innovative statistical solutions to important issues associated with the quantitative evidence needed for the regulatory review of therapeutic drugs and biologics PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 12499 • Describe the application of statistical methodologies and thinking regarding the development of new therapeutic biologics and drugs • Assess the impact of regulations and guidance on statistical practice • Discuss ideas for improving the communication between industry statisticians and regulatory reviewers A description of the planned activities of the working groups can be found at http://www.diaglobal.org/en/ conference-listing/meetings/2016/04/ dia-fda-statistics-2016-forum. II. Registration and Accommodations A. Registration There is a registration fee to attend this meeting. The registration fee is to help defray the costs of the event; including meeting facilities, program materials, refreshments, staff time and administrative overhead, and costs involved in getting speakers to the events; and will not result in any profits. Seats are limited, and registration will be on a first-come, firstserved basis. On-site registration will be available to the extent that space is available on the day of the conference. Please note: Registration will open at 7:30 a.m. each day. To register, please complete registration online at http:// www.diaglobal.org/en/conferencelisting/meetings/2016/04/dia-fdastatistics-2016-forum/register. (FDA has verified the Web address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) The costs of registration for the different categories of attendees are as follows: Category Industry Representatives ................ Charitable Nonprofit/Academic (Full time) ............................................ Government (Full time) ................... Tutorial Fees ................................... Cost $1,350 675 405 405 All registrants will be required to pay the applicable fee, with the exception of a limited number of speakers/organizers who will have a complimentary registration. B. Accommodations Attendees are responsible for their own hotel accommodations. Attendees making reservations at the Bethesda North Marriot Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852 are eligible for a reduced rate of $199, not including applicable taxes. The Marriott Bethesda North Hotel and Conference Center has a limited E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12498-12499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1180]


Ensuring Safety of Animal Feed Maintained and Fed On-Farm; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry (GFI) # 203 entitled 
``Ensuring Safety of Animal Feed Maintained and Fed On-Farm.'' This 
guidance is intended to help animal producers (persons who feed 
animals) develop and implement on-farm practices to ensure the safety 
of animal feed maintained and fed to animals on the farm.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-1180 for ``Ensuring Safety of Animal Feed Maintained and Fed 
On-Farm.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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.
    Submit written requests for single copies of the 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Phares Okelo, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5921, email: phares.okelo@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 20, 2015 (80 FR 15014), FDA 
published the notice of availability for a draft GFI #203 entitled 
``Ensuring Safety of Animal Feed Maintained and Fed On-Farm'' giving 
interested persons until June 3, 2015, to comment on the draft 
guidance. FDA received several comments on the

[[Page 12499]]

draft guidance and those comments were considered as the guidance was 
finalized. The guidance announced in this notice finalizes the draft 
guidance dated March 2015.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ensuring safety of animal feed 
maintained and fed on-farm. 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

    FDA concludes that there are no collections of information under 
the Paperwork Reduction Act of 1995.

IV. Electronic Access

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

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05222 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P