83 FR 27333 - General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 113 (June 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 113 (June 12, 2018)
| Page Range | 27333-27334 | |
| FR Document | 2018-12607 |
[Federal Register Volume 83, Number 113 (Tuesday, June 12, 2018)] [Notices] [Pages 27333-27334] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
![Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices 27333
In the Federal Register of January 26, on the proposed collection of FDA estimates the burden of this
2018, (83 FR 3734), FDA published a 60- information. No comments were collection of information as follows:
day notice requesting public comment received.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
179.25(e); records for large processors .............................. 4 300 1,200 1 1,200
179.25(e); records for small processors .............................. 4 30 120 1 120
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 DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
collection we have retained the HUMAN SERVICES https://www.regulations.gov. Follow the
currently approved burden estimate. instructions for submitting comments.
FDA’s estimate of the recordkeeping Food and Drug Administration Comments submitted electronically,
burden under § 179.25(e) is based on [Docket No. FDA–2005–D–0155] including attachments, to https://
experience regulating the safe use of www.regulations.gov will be posted to
radiation as a direct food additive. The General Principles for Evaluating the the docket unchanged. Because your
number of firms who process food using Human Food Safety of New Animal comment will be made public, you are
irradiation is extremely limited. We Drugs Used in Food-Producing solely responsible for ensuring that your
Animals; Guidance for Industry; comment does not include any
estimate that there are four irradiation
Availability confidential information that you or a
plants whose business is devoted
third party may not wish to be posted,
primarily (i.e., approximately 100 AGENCY: Food and Drug Administration, such as medical information, your or
percent) to irradiation of food and other HHS. anyone else’s Social Security number, or
agricultural products. Four other firms ACTION: Notice of availability. confidential business information, such
also irradiate small quantities of food. as a manufacturing process. Please note
We estimate that this irradiation SUMMARY: The Food and Drug
that if you include your name, contact
accounts for no more than 10 percent of Administration (FDA or Agency) is
information, or other information that
the business for each of these firms. announcing the availability of a final
guidance for industry (GFI) #3 entitled identifies you in the body of your
Therefore, the average estimated burden comments, that information will be
‘‘General Principles for Evaluating the
is based on four facilities devoting 100 posted on https://www.regulations.gov.
Human Food Safety of New Animal
percent of their business to food • If you want to submit a comment
Drugs Used in Food-Producing
irradiation (4 × 300 hours = 1,200 hours Animals.’’ This guidance describes the
with confidential information that you
for recordkeeping annually), and four do not wish to be made available to the
type of information that the FDA’s
facilities devoting 10 percent of their public, submit the comment as a
Center for Veterinary Medicine (CVM)
business to food irradiation (4 × 30 recommends sponsors provide to
written/paper submission and in the
hours = 120 hours for recordkeeping address the human food safety of new manner detailed (see ‘‘Written/Paper
annually). No burden has been animal drugs used in food-producing Submissions’’ and ‘‘Instructions’’).
estimated for the labeling requirements animals. The human food safety Written/Paper Submissions
in §§ 179.21(b)(1), 179.21(b)(2), and evaluation of new animal drugs used in Submit written/paper submissions as
179.26(c) because the disclosures are food-producing animals helps ensure follows:
supplied by FDA. Under 5 CFR that food derived from treated animals • Mail/Hand delivery/Courier (for
1320.3(c)(2), the public disclosure of is safe for human consumption. CVM written/paper submissions): Dockets
information originally supplied by the developed this guidance to inform Management Staff (HFA–305), Food and
Federal Government to the recipient for sponsors of the scientific data and/or Drug Administration, 5630 Fishers
the purpose of disclosure to the public information that may provide an Lane, Rm. 1061, Rockville, MD 20852.
is not subject to review by the OMB acceptable basis to determine that the • For written/paper comments
under the Paperwork Reduction Act of residue of a new animal drug in or on submitted to the Dockets Management
1995. food, when consumed, presents a Staff, FDA will post your comment, as
reasonable certainty of no harm to well as any attachments, except for
Dated: June 7, 2018. humans. information submitted, marked and
Leslie Kux, DATES: The announcement of the identified, as confidential, if submitted
Associate Commissioner for Policy. guidance is published in the Federal as detailed in ‘‘Instructions.’’
[FR Doc. 2018–12614 Filed 6–11–18; 8:45 am] Register on June 12, 2018. Instructions: All submissions received
must include the Docket No. FDA–
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P ADDRESSES: You may submit either
electronic or written comments on 2005–D–0155 for ‘‘General Principles
Agency guidances at any time as for Evaluating the Human Food Safety
follows: of New Animal Drugs Used in Food-
Producing Animals.’’ Received
Electronic Submissions comments will be placed in the docket
Submit electronic comments in the and, except for those submitted as
following way: ‘‘Confidential Submissions,’’ publicly
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![27334 Federal Register / Vol. 83, No. 113 / Tuesday, June 12, 2018 / Notices
viewable at https://www.regulations.gov Administration, 7500 Standish Pl., Dated: June 7, 2018.
or at the Dockets Management Staff Rockville, MD 20855, 240–402–0788, Leslie Kux,
between 9 a.m. and 4 p.m., Monday julia.oriani@fda.hhs.gov. Associate Commissioner for Policy.
through Friday. [FR Doc. 2018–12607 Filed 6–11–18; 8:45 am]
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
submit a comment with confidential I. Background
information that you do not wish to be
made publicly available, submit your In the Federal Register of July 21, DEPARTMENT OF HEALTH AND
comments only as a written/paper 2016 (81 FR 47397), FDA published the HUMAN SERVICES
submission. You should submit two notice of availability for a draft revised
copies total. One copy will include the GFI #3 entitled ‘‘General Principles for National Institutes of Health
information you claim to be confidential Evaluating the Human Food Safety of
with a heading or cover note that states New Animal Drugs Used in Food- National Library of Medicine: Notice of
‘‘THIS DOCUMENT CONTAINS Producing Animals’’ giving interested Meetings
CONFIDENTIAL INFORMATION.’’ The persons until September 19, 2016, to
Agency will review this copy, including Pursuant to section 10(d) of the
comment on the draft revised GFI. FDA
the claimed confidential information, in Federal Advisory Committee Act, as
received several comments on the draft
its consideration of comments. The amended, notice is hereby given of a
revised GFI, and those comments were meeting of the Board of Scientific
second copy, which will have the considered as the guidance was
claimed confidential information Counselors, Lister Hill National Center
finalized. Revisions to the document for Biomedical Communications.
redacted/blacked out, will be available
were made for accuracy and
for public viewing and posted on The meeting will be open to the
clarification based on comments
https://www.regulations.gov. Submit public as indicated below, with
received from the public, including
both copies to the Dockets Management attendance limited to space available.
Staff. If you do not wish your name and reinsertion of information specific to
Individuals who plan to attend and
contact information to be made publicly endogenous sex steroids, and minor
need special assistance, such as sign
available, you can provide this editorial edits. The guidance announced language interpretation or other
information on the cover sheet and not in this notice finalizes the draft revised reasonable accommodations, should
in the body of your comments and you GFI dated July 2016. notify the Contact Person listed below
must identify this information as II. Significance of Guidance in advance of the meeting.
‘‘confidential.’’ Any information marked The meeting will be closed to the
as ‘‘confidential’’ will not be disclosed This level 1 guidance is being issued public as indicated below in accordance
except in accordance with 21 CFR 10.20 consistent with FDA’s good guidance with the provisions set forth in section
and other applicable disclosure law. For practices regulation (21 CFR 10.115). 552b(c)(6), Title 5 U.S.C., as amended
more information about FDA’s posting The guidance represents the current for review, discussion, and evaluation of
of comments to public dockets, see 80 thinking of FDA on ‘‘General Principles individual intramural programs and
FR 56469, September 18, 2015, or access for Evaluating the Human Food Safety projects conducted by the National
the information at: https://www.gpo.gov/ of New Animal Drugs Used in Food- Library of Medicine, including
fdsys/pkg/FR-2015-09-18/pdf/2015- Producing Animals.’’ It does not consideration of personnel
23389.pdf. establish any rights for any person and qualifications and performance, and the
Docket: For access to the docket to is not binding on FDA or the public. competence of individual investigators,
read background documents or the the disclosure of which would
You can use an alternative approach if
electronic and written/paper comments constitute a clearly unwarranted
it satisfies the requirements of the
received, go to https:// invasion of personal privacy.
www.regulations.gov and insert the applicable statutes and regulations. This
docket number, found in brackets in the guidance is not subject to Executive Name of Committee: Board of Scientific
heading of this document, into the Order 12866. Counselors, Lister Hill National Center for
Biomedical Communications.
‘‘Search’’ box and follow the prompts III. Paperwork Reduction Act of 1995 Date: September 6–7, 2018.
and/or go to the Dockets Management Open: September 6, 2018, 9:00 a.m. to
Staff, 5630 Fishers Lane, Rm. 1061, This guidance refers to previously 12:00 p.m.
Rockville, MD 20852. approved collections of information Agenda: Review of research and
You may submit comments on any found in FDA regulations. These development programs and preparation of
guidance at any time (see 21 CFR collections of information are subject to reports of the Lister Hill National Center for
10.115(g)(5)). review by the Office of Management and Biomedical Communications.
Submit written requests for single Budget (OMB) under the Paperwork Place: National Library of Medicine,
copies of the guidance to the Policy and Building 38, 2nd Floor, The Lindberg Room,
Reduction Act of 1995 (44 U.S.C. 3501– 8600 Rockville Pike, Bethesda, MD 20892.
Regulations Staff (HFV–6), Center for 3520). The collections of information in Closed: September 6, 2018, 12:00 p.m. to
Veterinary Medicine, Food and Drug 21 CFR part 514 have been approved 4:30 p.m.
Administration, 7500 Standish Pl., under OMB control number 0910–0032. Agenda: To review and evaluate personal
Rockville, MD 20855. Send one self- qualifications, performance, and competence
addressed adhesive label to assist that IV. Electronic Access of individual investigators.
sradovich on DSK3GMQ082PROD with NOTICES
office in processing your request. See Place: National Library of Medicine,
the SUPPLEMENTARY INFORMATION section Persons with access to the internet Building 38, 2nd Floor, The Lindberg Room,
for electronic access to the guidance may obtain the guidance at either 8600 Rockville Pike, Bethesda, MD 20892.
document. https://www.fda.gov/AnimalVeterinary/ Closed: September 7, 2018, 9:00 a.m. to
GuidanceComplianceEnforcement/ 10:00 a.m.
FOR FURTHER INFORMATION CONTACT: Julia Agenda: To review and evaluate personal
GuidanceforIndustry/default.htm or
Oriani, Center for Veterinary Medicine qualifications, performance, and competence
https://www.regulations.gov.
(HFV–151), Food and Drug of individual investigators.
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Document Created: 2018-06-12 00:47:57
Document Modified: 2018-06-12 00:47:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on June 12, 2018. | |
| Contact | Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0788, [email protected] | |
| FR Citation | 83 FR 27333 |
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