83 FR 18569 - The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 82 (April 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 82 (April 27, 2018)
| Page Range | 18569-18570 | |
| FR Document | 2018-08926 |
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)] [Notices] [Pages 18569-18570] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08926] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-2462] The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of guidance for industry #210 entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This final guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of a certain section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: The announcement of the guidance is published in the Federal Register on April 27, 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-2017-D-2462 for ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Dorothy Bailey, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0565, dorothy.bailey@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 15, 2017 (82 FR 43381), FDA published the notice of availability for a draft guidance entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species'' giving interested persons until November 14, 2017, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated September 2017. The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of section 572 of the FD&C Act. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance [[Page 18570]] practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. 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 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 21 CFR 516.119 through 516.165 have been approved under OMB control number 0910-0620. 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: April 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-08926 Filed 4-26-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices 18569
210,328; Total Annual Hours: 630,984. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
(For policy questions regarding this confidential business information, such as ‘‘confidential’’ will not be disclosed
collection contact Anita Crosier at 410– as a manufacturing process. Please note except in accordance with 21 CFR 10.20
786–0217). that if you include your name, contact and other applicable disclosure law. For
Dated: April 24, 2018. information, or other information that more information about FDA’s posting
identifies you in the body of your of comments to public dockets, see 80
William N. Parham, III,
comments, that information will be FR 56469, September 18, 2015, or access
Director, Paperwork Reduction Staff, Office
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
of Strategic Operations and Regulatory
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Affairs.
with confidential information that you 23389.pdf.
[FR Doc. 2018–08893 Filed 4–26–18; 8:45 am]
do not wish to be made available to the Docket: For access to the docket to
BILLING CODE 4120–01–P
public, submit the comment as a read background documents or the
written/paper submission and in the electronic and written/paper comments
manner detailed (see ‘‘Written/Paper received, go to https://
DEPARTMENT OF HEALTH AND
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
HUMAN SERVICES
Written/Paper Submissions docket number, found in brackets in the
Food and Drug Administration heading of this document, into the
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
[Docket No. FDA–2017–D–2462] follows: and/or go to the Dockets Management
• Mail/Hand delivery/Courier (for
The Index of Legally Marketed Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
Unapproved New Animal Drugs for Rockville, MD 20852.
Management Staff (HFA–305), Food and
Minor Species; Guidance for Industry; You may submit comments on any
Drug Administration, 5630 Fishers
Availability guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments 10.115(g)(5)).
AGENCY: Food and Drug Administration, submitted to the Dockets Management Submit written requests for single
HHS. Staff, FDA will post your comment, as copies of the guidance to the Policy and
ACTION: Notice of availability. well as any attachments, except for Regulations Staff (HFV–6), Center for
information submitted, marked, and Veterinary Medicine, Food and Drug
SUMMARY: The Food and Drug Administration, 7500 Standish Pl.,
identified as confidential, if submitted
Administration (FDA) is announcing the Rockville, MD 20855. Send one self-
as detailed in ‘‘Instructions.’’
availability of guidance for industry Instructions: All submissions received addressed adhesive label to assist that
#210 entitled ‘‘The Index of Legally must include the Docket No. FDA– office in processing your requests. See
Marketed Unapproved New Animal 2017–D–2462 for ‘‘The Index of Legally the SUPPLEMENTARY INFORMATION section
Drugs for Minor Species.’’ This final Marketed Unapproved New Animal for electronic access to the draft
guidance describes the process for Drugs for Minor Species.’’ Received guidance document.
adding a new animal drug to the Index comments will be placed in the docket FOR FURTHER INFORMATION CONTACT:
of Legally Marketed Unapproved New and, except for those submitted as Dorothy Bailey, Center for Veterinary
Animal Drugs for Minor Species (the ‘‘Confidential Submissions,’’ publicly Medicine (HFV–50), Food and Drug
Index). The Index consists of a list of viewable at https://www.regulations.gov Administration, 7500 Standish Pl.,
legally marketed unapproved new or at the Dockets Management Staff Rockville, MD 20855, 240–402–0565,
animal drugs for minor species that between 9 a.m. and 4 p.m., Monday dorothy.bailey@fda.hhs.gov.
meet the requirements of a certain through Friday. SUPPLEMENTARY INFORMATION:
section of the Federal Food, Drug, and • Confidential Submissions—To
Cosmetic Act (FD&C Act). submit a comment with confidential I. Background
DATES: The announcement of the information that you do not wish to be In the Federal Register of September
guidance is published in the Federal made publicly available, submit your 15, 2017 (82 FR 43381), FDA published
Register on April 27, 2018. comments only as a written/paper the notice of availability for a draft
ADDRESSES: You may submit either submission. You should submit two guidance entitled ‘‘The Index of Legally
electronic or written comments on copies total. One copy will include the Marketed Unapproved New Animal
Agency guidances at any time as information you claim to be confidential Drugs for Minor Species’’ giving
follows: with a heading or cover note that states interested persons until November 14,
‘‘THIS DOCUMENT CONTAINS 2017, to comment on the draft guidance.
Electronic Submissions CONFIDENTIAL INFORMATION’’. The FDA received several comments on the
Submit electronic comments in the Agency will review this copy, including draft guidance and those comments
following way: the claimed confidential information, in were considered as the guidance was
• Federal eRulemaking Portal: its consideration of comments. The finalized. Editorial changes were made
https://www.regulations.gov. Follow the second copy, which will have the to improve clarity. The guidance
instructions for submitting comments. claimed confidential information announced in this notice finalizes the
Comments submitted electronically, redacted/blacked out, will be available draft guidance dated September 2017.
including attachments, to https:// for public viewing and posted on The Index consists of a list of legally
www.regulations.gov will be posted to https://www.regulations.gov. Submit marketed unapproved new animal drugs
daltland on DSKBBV9HB2PROD with NOTICES
the docket unchanged. Because your both copies to the Dockets Management for minor species that meet the
comment will be made public, you are Staff. If you do not wish your name and requirements of section 572 of the FD&C
solely responsible for ensuring that your contact information to be made publicly Act.
comment does not include any available, you can provide this
confidential information that you or a information on the cover sheet and not II. Significance of Guidance
third party may not wish to be posted, in the body of your comments and you This level 1 guidance is being issued
such as medical information, your or must identify this information as consistent with FDA’s good guidance
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![18570 Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
practices regulation (21 CFR 10.115). DATES: Submit either electronic or a.m. and 4 p.m., Monday through
The guidance represents the current written comments on the draft guidance Friday.
thinking of FDA on The Index of Legally by June 26, 2018 to ensure that the • Confidential Submissions—To
Marketed Unapproved New Animal Agency considers your comment on this submit a comment with confidential
Drugs for Minor Species. It does not draft guidance before it begins work on information that you do not wish to be
establish any rights for any person and the final version of the guidance. made publicly available, submit your
is not binding on FDA or the public. ADDRESSES: You may submit comments comments only as a written/paper
You can use an alternative approach if on any guidance at any time as follows: submission. You should submit two
it satisfies the requirements of the copies total. One copy will include the
Electronic Submissions information you claim to be confidential
applicable statutes and regulations. This
guidance is not subject to Executive Submit electronic comments in the with a heading or cover note that states
Order 12866. following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
III. Paperwork Reduction Act of 1995 https://www.regulations.gov. Follow the Agency will review this copy, including
This draft guidance refers to instructions for submitting comments. the claimed confidential information, in
previously approved collections of Comments submitted electronically, its consideration of comments. The
information found in FDA regulations. including attachments, to https:// second copy, which will have the
These collections of information are www.regulations.gov will be posted to claimed confidential information
subject to review by the Office of the docket unchanged. Because your redacted/blacked out, will be available
Management and Budget (OMB) under comment will be made public, you are for public viewing and posted on
the Paperwork Reduction Act of 1995 solely responsible for ensuring that your https://www.regulations.gov. Submit
(44 U.S.C. 3501–3520). The collections comment does not include any both copies to the Dockets Management
of information in 21 CFR 516.119 confidential information that you or a Staff. If you do not wish your name and
through 516.165 have been approved third party may not wish to be posted, contact information to be made publicly
under OMB control number 0910–0620. such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
IV. Electronic Access confidential business information, such in the body of your comments and you
Persons with access to the internet as a manufacturing process. Please note must identify this information as
may obtain the guidance at either that if you include your name, contact ‘‘confidential.’’ Any information marked
https://www.fda.gov/AnimalVeterinary/ information, or other information that as ‘‘confidential’’ will not be disclosed
GuidanceComplianceEnforcement/ identifies you in the body of your except in accordance with 21 CFR 10.20
GuidanceforIndustry/default.htm or comments, that information will be and other applicable disclosure law. For
https://www.regulations.gov. posted on https://www.regulations.gov. more information about FDA’s posting
• If you want to submit a comment of comments to public dockets, see 80
Dated: April 23, 2018.
with confidential information that you FR 56469, September 18, 2015, or access
Leslie Kux, the information at: https://www.gpo.gov/
do not wish to be made available to the
Associate Commissioner for Policy. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
[FR Doc. 2018–08926 Filed 4–26–18; 8:45 am] written/paper submission and in the 23389.pdf.
BILLING CODE 4164–01–P manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
DEPARTMENT OF HEALTH AND Written/Paper Submissions received, go to https://
HUMAN SERVICES Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
Food and Drug Administration • Mail/Hand delivery/Courier (for heading of this document, into the
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
[Docket No. FDA–2018–D–1339]
Management Staff (HFA–305), Food and and/or go to the Dockets Management
Multiple Function Device Products: Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Policy and Considerations; Draft Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
Guidance for Industry and Food and • For written/paper comments You may submit comments on any
Drug Administration Staff; Availability submitted to the Dockets Management guidance at any time (see 21 CFR
Staff, FDA will post your comment, as 10.115(g)(5)).
AGENCY: Food and Drug Administration, well as any attachments, except for An electronic copy of the guidance
HHS. information submitted, marked and document is available for download
ACTION: Notice of availability. identified, as confidential, if submitted from the internet. See the
as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION section for
SUMMARY: The Food and Drug Instructions: All submissions received information on electronic access to the
Administration (FDA or Agency) is must include the Docket No. FDA– guidance. Submit written requests for a
announcing the availability of the draft 2018–D–1339 for ‘‘Multiple Function single hard copy of the draft guidance
guidance entitled ‘‘Multiple Function Device Products: Policy and document entitled ‘‘Multiple Function
Device Products: Policy and Considerations; Draft Guidance for Device Products: Policy and
Considerations.’’ This draft guidance Industry and Food and Drug Considerations’’ to the Office of the
daltland on DSKBBV9HB2PROD with NOTICES
provides FDA’s regulatory approach for Administration Staff; Availability.’’ Center Director, Guidance and Policy
products with multiple functions, Received comments will be placed in Development, Center for Devices and
including at least one device function, the docket and, except for those Radiological Health, Food and Drug
in accordance with the 21st Century submitted as ‘‘Confidential Administration, 10903 New Hampshire
Cures Act (Cures Act). This draft Submissions,’’ publicly viewable at Ave., Bldg. 66, Rm. 5431, Silver Spring,
guidance is not final nor is it in effect https://www.regulations.gov or at the MD 20993–0002, or the Office of
at this time. Dockets Management Staff between 9 Communication, Outreach, and
VerDate Sep<11>2014 18:18 Apr 26, 2018 Jkt 244001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\27APN1.SGM 27APN1](https://thefederalregister.org/doc/83_FR_18651/page/2.svg)
Document Created: 2018-04-27 01:44:49
Document Modified: 2018-04-27 01:44:49
| 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 April 27, 2018. | |
| Contact | Dorothy Bailey, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0565, [email protected] | |
| FR Citation | 83 FR 18569 |
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