General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Guidance for Industry; Availability, 27333-27334 [2018-12607]

Download as PDF 27333 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices In the Federal Register of January 26, 2018, (83 FR 3734), FDA published a 60day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 179.25(e); records for large processors .............................. 179.25(e); records for small processors .............................. 4 4 300 30 1,200 120 1 1 1,200 120 Total .............................................................................. ........................ ........................ ........................ ........................ 1,320 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Upon review of the information collection we have retained the currently approved burden estimate. FDA’s estimate of the recordkeeping burden under § 179.25(e) is based on experience regulating the safe use of radiation as a direct food additive. The number of firms who process food using irradiation is extremely limited. We estimate that there are four irradiation plants whose business is devoted primarily (i.e., approximately 100 percent) to irradiation of food and other agricultural products. Four other firms also irradiate small quantities of food. We estimate that this irradiation accounts for no more than 10 percent of the business for each of these firms. Therefore, the average estimated burden is based on four facilities devoting 100 percent of their business to food irradiation (4 × 300 hours = 1,200 hours for recordkeeping annually), and four facilities devoting 10 percent of their business to food irradiation (4 × 30 hours = 120 hours for recordkeeping annually). No burden has been estimated for the labeling requirements in §§ 179.21(b)(1), 179.21(b)(2), and 179.26(c) because the disclosures are supplied by FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not subject to review by the OMB under the Paperwork Reduction Act of 1995. Dated: June 7, 2018. Leslie Kux, Associate Commissioner for Policy. sradovich on DSK3GMQ082PROD with NOTICES [FR Doc. 2018–12614 Filed 6–11–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0155] General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; 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 final guidance for industry (GFI) #3 entitled ‘‘General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals.’’ This guidance describes the type of information that the FDA’s Center for Veterinary Medicine (CVM) recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals. The human food safety evaluation of new animal drugs used in food-producing animals helps ensure that food derived from treated animals is safe for human consumption. CVM developed this guidance to inform sponsors of the scientific data and/or information that may provide an acceptable basis to determine that the residue of a new animal drug in or on food, when consumed, presents a reasonable certainty of no harm to humans. DATES: The announcement of the guidance is published in the Federal Register on June 12, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 16:21 Jun 11, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2005–D–0155 for ‘‘General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in FoodProducing Animals.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly E:\FR\FM\12JNN1.SGM 12JNN1 sradovich on DSK3GMQ082PROD with NOTICES 27334 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Julia Oriani, Center for Veterinary Medicine (HFV–151), Food and Drug FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 16:21 Jun 11, 2018 Jkt 244001 Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0788, julia.oriani@fda.hhs.gov. Dated: June 7, 2018. Leslie Kux, Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: [FR Doc. 2018–12607 Filed 6–11–18; 8:45 am] BILLING CODE 4164–01–P I. Background In the Federal Register of July 21, 2016 (81 FR 47397), FDA published the notice of availability for a draft revised GFI #3 entitled ‘‘General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in FoodProducing Animals’’ giving interested persons until September 19, 2016, to comment on the draft revised GFI. FDA received several comments on the draft revised GFI, and those comments were considered as the guidance was finalized. Revisions to the document were made for accuracy and clarification based on comments received from the public, including reinsertion of information specific to endogenous sex steroids, and minor editorial edits. The guidance announced in this notice finalizes the draft revised GFI dated July 2016. 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 ‘‘General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in FoodProducing Animals.’’ 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. This guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This 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 have been approved under OMB control number 0910–0032. IV. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine: Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, Lister Hill National Center for Biomedical Communications. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the National Library of Medicine, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, Lister Hill National Center for Biomedical Communications. Date: September 6–7, 2018. Open: September 6, 2018, 9:00 a.m. to 12:00 p.m. Agenda: Review of research and development programs and preparation of reports of the Lister Hill National Center for Biomedical Communications. Place: National Library of Medicine, Building 38, 2nd Floor, The Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892. Closed: September 6, 2018, 12:00 p.m. to 4:30 p.m. Agenda: To review and evaluate personal qualifications, performance, and competence of individual investigators. Place: National Library of Medicine, Building 38, 2nd Floor, The Lindberg Room, 8600 Rockville Pike, Bethesda, MD 20892. Closed: September 7, 2018, 9:00 a.m. to 10:00 a.m. Agenda: To review and evaluate personal qualifications, performance, and competence of individual investigators. E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)]
[Notices]
[Pages 27333-27334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12607]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0155]


General Principles for Evaluating the Human Food Safety of New 
Animal Drugs Used in Food-Producing Animals; 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 final guidance for industry (GFI) #3 entitled 
``General Principles for Evaluating the Human Food Safety of New Animal 
Drugs Used in Food-Producing Animals.'' This guidance describes the 
type of information that the FDA's Center for Veterinary Medicine (CVM) 
recommends sponsors provide to address the human food safety of new 
animal drugs used in food-producing animals. The human food safety 
evaluation of new animal drugs used in food-producing animals helps 
ensure that food derived from treated animals is safe for human 
consumption. CVM developed this guidance to inform sponsors of the 
scientific data and/or information that may provide an acceptable basis 
to determine that the residue of a new animal drug in or on food, when 
consumed, presents a reasonable certainty of no harm to humans.

DATES: The announcement of the guidance is published in the Federal 
Register on June 12, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2005-D-0155 for ``General Principles for Evaluating the Human Food 
Safety of New Animal Drugs Used in Food-Producing Animals.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly

[[Page 27334]]

viewable at https://www.regulations.gov or at the Dockets Management 
Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary 
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0788, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 21, 2016 (81 FR 47397), FDA 
published the notice of availability for a draft revised GFI #3 
entitled ``General Principles for Evaluating the Human Food Safety of 
New Animal Drugs Used in Food-Producing Animals'' giving interested 
persons until September 19, 2016, to comment on the draft revised GFI. 
FDA received several comments on the draft revised GFI, and those 
comments were considered as the guidance was finalized. Revisions to 
the document were made for accuracy and clarification based on comments 
received from the public, including reinsertion of information specific 
to endogenous sex steroids, and minor editorial edits. The guidance 
announced in this notice finalizes the draft revised GFI dated July 
2016.

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 ``General Principles for Evaluating the 
Human Food Safety of New Animal Drugs Used in Food-Producing Animals.'' 
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. This 
guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This 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 have been approved under 
OMB control number 0910-0032.

IV. Electronic Access

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

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12607 Filed 6-11-18; 8:45 am]
 BILLING CODE 4164-01-P

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