81 FR 23307 - Distributor Labeling for New Animal Drugs; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 76 (April 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23307-23308 | |
| FR Document | 2016-09141 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23307-23308] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09141] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3056] Distributor Labeling for New Animal Drugs; 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 guidance for industry #231 entitled ``Distributor Labeling for New Animal Drugs.'' This guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a new animal drug application or abbreviated new animal drug application in ways other than those permitted by regulation. 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 [[Page 23308]] 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-2015-D-3056 for ``Distributor Labeling for New Animal Drugs.'' 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: Dorothy McAdams, Center for Veterinary Medicine, Division of Surveillance (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5763, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 10, 2015 (80 FR 54568), FDA published the notice of availability for a draft guidance entitled ``Distributor Labeling for New Animal Drugs'' giving interested persons until November 9, 2015, to comment on the draft guidance. FDA received no comments on the draft guidance. The guidance announced in this notice finalizes the draft guidance dated September 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 distributor labeling for new animal drugs. 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 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 514.80 have been approved under OMB control number 0910-0284. 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: April 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09141 Filed 4-19-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23307
information marked as ‘‘confidential’’ performance of the WSI system and the Reduction Act of 1995 (44 U.S.C. 3501–
will not be disclosed except in components in the imaging chain—from 3520). The collections of information in
accordance with 21 CFR 10.20 and other image acquisition to image display, and 21 CFR part 807, subpart E (premarket
applicable disclosure law. For more their effect on pathologist’s diagnostic notification) have been approved under
information about FDA’s posting of performance and workflow. OMB control number 0910–0120; the
comments to public dockets, see 80 FR This guidance provides industry and collections of information in 21 CFR
56469, September 18, 2015, or access Agency staff with recommendations part 814 (premarket approval) have been
the information at: http://www.fda.gov/ regarding the technical performance approved under OMB control number
regulatoryinformation/dockets/ assessment for regulatory evaluation of 0910–0231; and the collections of
default.htm. a digital WSI system. This document information in 21 CFR part 801 and 21
Docket: For access to the docket to does not cover the clinical submission CFR 809.10 (labeling) have been
read background documents or the data that may be necessary to support approved under OMB control number
electronic and written/paper comments approval or clearance. The guidance 0910–0485.
received, go to http:// provides suggestions on how to best Dated: April 13, 2016.
www.regulations.gov and insert the characterize the technical aspects that
Leslie Kux,
docket number, found in brackets in the are relevant to WSI performance for
their intended use and determine any Associate Commissioner for Policy.
heading of this document, into the
possible limitations that might affect [FR Doc. 2016–09140 Filed 4–19–16; 8:45 am]
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets their safety and effectiveness. BILLING CODE 4164–01–P
Management, 5630 Fishers Lane, Rm. In the Federal Register of February
1061, Rockville, MD 20852. 25, 2015 (80 FR 10122), FDA announced
An electronic copy of the guidance the availability of the draft guidance and DEPARTMENT OF HEALTH AND
document is available for download interested persons were invited to HUMAN SERVICES
from the Internet. See the comment by May 25, 2015.
Food and Drug Administration
SUPPLEMENTARY INFORMATION section for II. Significance of Guidance
information on electronic access to the [Docket No. FDA–2015–D–3056]
guidance. Submit written requests for a This guidance is being issued
single hard copy of the guidance consistent with FDA’s good guidance Distributor Labeling for New Animal
document entitled ‘‘Technical practices regulation (21 CFR 10.115). Drugs; Guidance for Industry;
Performance Assessment of Digital The guidance represents the current Availability
Pathology Whole Slide Imaging thinking of FDA on technical
AGENCY: Food and Drug Administration,
Devices’’ to the Office of the Center performance assessment of digital
HHS.
Director, Guidance and Policy pathology whole slide imaging devices.
It does not establish any rights for any ACTION: Notice of availability.
Development, Center for Devices and
Radiological Health, Food and Drug person and is not binding on FDA or the SUMMARY: The Food and Drug
Administration, 10903 New Hampshire public. You can use an alternative Administration (FDA or Agency) is
Ave., Bldg. 66, Rm. 5431, Silver Spring, approach if it satisfies the requirements announcing the availability of guidance
MD 20993–0002. Send one self- of the applicable statutes and for industry #231 entitled ‘‘Distributor
addressed adhesive label to assist that regulations. Labeling for New Animal Drugs.’’ This
office in processing your request. III. Electronic Access guidance discusses FDA’s current
FOR FURTHER INFORMATION CONTACT: Persons interested in obtaining a copy thinking with respect to the factors it
Nicholas Anderson, Center for Devices of the guidance may do so by considers in determining whether to
and Radiological Health, Food and Drug downloading an electronic copy from take regulatory action against distributor
Administration, 10903 New Hampshire the Internet. A search capability for all labeling for a new animal drug that
Ave., Bldg. 66, Rm. 5662, Silver Spring, Center for Devices and Radiological differs from the labeling approved as
MD 20993–0002, 301–796–4310; or Health guidance documents is available part of a new animal drug application or
Aldo Badano, Center for Devices and at http://www.fda.gov/MedicalDevices/ abbreviated new animal drug
Radiological Health, Food and Drug DeviceRegulationandGuidance/ application in ways other than those
Administration, 10903 New Hampshire GuidanceDocuments/default.htm. permitted by regulation.
Ave., Bldg. 62, Rm. 3116, Silver Spring, Guidance documents are also available DATES: Submit either electronic or
MD 20993–0002, 301–796–2534. at http://www.regulations.gov. Persons written comments on Agency guidances
SUPPLEMENTARY INFORMATION: unable to download an electronic copy at any time.
of ‘‘Technical Performance Assessment ADDRESSES: You may submit comments
I. Background
of Digital Pathology Whole Slide as follows:
Recent technological advances in Imaging Devices’’ may send an email
digital microscopy, in particular the Electronic Submissions
request to CDRH-Guidance@fda.hhs.gov
development of whole slide scanning to receive an electronic copy of the Submit electronic comments in the
systems, have accelerated the adoption document. Please use the document following way:
of digital imaging in pathology, similar number 1400053 to identify the • Federal eRulemaking Portal: http://
to the digital transformation that guidance you are requesting. www.regulations.gov. Follow the
radiology departments have experienced instructions for submitting comments.
IV. Paperwork Reduction Act of 1995
Lhorne on DSK5TPTVN1PROD with NOTICES
over the last decade. FDA regulates WSI Comments submitted electronically,
system manufacturers to help ensure This guidance refers to previously including attachments, to http://
that the images produced for intended approved collections of information www.regulations.gov will be posted to
clinical uses are safe and effective for found in FDA regulations. These the docket unchanged. Because your
such purposes. Essential to the collections of information are subject to comment will be made public, you are
regulation of these systems is the review by the Office of Management and solely responsible for ensuring that your
understanding of the technical Budget (OMB) under the Paperwork comment does not include any
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![23308 Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
confidential information that you or a provide this information on the cover it satisfies the requirements of the
third party may not wish to be posted, sheet and not in the body of your applicable statutes and regulations.
such as medical information, your or comments and you must identify this
III. Paperwork Reduction Act of 1995
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any
confidential business information, such information marked as ‘‘confidential’’ This guidance refers to previously
as a manufacturing process. Please note will not be disclosed except in approved collections of information
that if you include your name, contact accordance with 21 CFR 10.20 and other found in FDA regulations. These
information, or other information that applicable disclosure law. For more collections of information are subject to
identifies you in the body of your information about FDA’s posting of review by the Office of Management and
comments, that information will be comments to public dockets, see 80 FR Budget (OMB) under the Paperwork
posted on http://www.regulations.gov. 56469, September 18, 2015, or access Reduction Act of 1995 (44 U.S.C. 3501–
• If you want to submit a comment the information at: http://www.fda.gov/ 3520). The collections of information in
with confidential information that you regulatoryinformation/dockets/ 21 CFR 514.80 have been approved
do not wish to be made available to the default.htm. under OMB control number 0910–0284.
public, submit the comment as a Docket: For access to the docket to IV. Electronic Access
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments Persons with access to the Internet
Submissions’’ and ‘‘Instructions’’). received, go to http:// may obtain the guidance at either http://
www.regulations.gov and insert the www.fda.gov/AnimalVeterinary/
Written/Paper Submissions GuidanceComplianceEnforcement/
docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the GuidanceforIndustry/default.htm or
follows: ‘‘Search’’ box and follow the prompts http://www.regulations.gov.
• Mail/Hand delivery/Courier (for
and/or go to the Division of Dockets Dated: April 13, 2016.
written/paper submissions): Division of
Management, 5630 Fishers Lane, Rm. Leslie Kux,
Dockets Management (HFA–305), Food
1061, Rockville, MD 20852. Associate Commissioner for Policy.
and Drug Administration, 5630 Fishers
Submit written requests for single [FR Doc. 2016–09141 Filed 4–19–16; 8:45 am]
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments copies of the guidance to the Policy and BILLING CODE 4164–01–P
submitted to the Division of Dockets Regulations Staff (HFV–6), Center for
Management, FDA will post your Veterinary Medicine, Food and Drug
comment, as well as any attachments, Administration, 7519 Standish Pl., DEPARTMENT OF HEALTH AND
except for information submitted, Rockville, MD 20855. Send one self- HUMAN SERVICES
marked and identified, as confidential, addressed adhesive label to assist that
if submitted as detailed in office in processing your requests. See Food and Drug Administration
‘‘Instructions.’’ the SUPPLEMENTARY INFORMATION section [Docket No. FDA–2016–N–1024]
Instructions: All submissions received for electronic access to the guidance
must include the Docket No. FDA– document. Preparation for International
2015–D–3056 for ‘‘Distributor Labeling FOR FURTHER INFORMATION CONTACT: Cooperation on Cosmetics Regulation
for New Animal Drugs.’’ Received Dorothy McAdams, Center for AGENCY: Food and Drug Administration,
comments will be placed in the docket Veterinary Medicine, Division of HHS.
and, except for those submitted as Surveillance (HFV–210), Food and Drug
ACTION: Notice of meeting.
‘‘Confidential Submissions,’’ publicly Administration, 7519 Standish Pl.,
viewable at http://www.regulations.gov Rockville, MD 20855, 240–402–5763, The Food and Drug Administration
or at the Division of Dockets email: dorothy.mcadams@fda.hhs.gov. (FDA or we) is announcing a public
Management between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: meeting entitled ‘‘International
Monday through Friday. Cooperation on Cosmetics Regulation
• Confidential Submissions—To I. Background
(ICCR)—Preparation for ICCR–10
submit a comment with confidential In the Federal Register of September Meeting.’’ The purpose of the meeting is
information that you do not wish to be 10, 2015 (80 FR 54568), FDA published to invite public input on various topics
made publicly available, submit your the notice of availability for a draft pertaining to the regulation of
comments only as a written/paper guidance entitled ‘‘Distributor Labeling cosmetics. We may use this input to
submission. You should submit two for New Animal Drugs’’ giving help us prepare for the ICCR–10 meeting
copies total. One copy will include the interested persons until November 9, that will be held July 12–14, 2016, in
information you claim to be confidential 2015, to comment on the draft guidance. Bethesda, MD.
with a heading or cover note that states FDA received no comments on the draft Date and Time: The public meeting
‘‘THIS DOCUMENT CONTAINS guidance. The guidance announced in will be held on June 15, 2016, from 2
CONFIDENTIAL INFORMATION.’’ The this notice finalizes the draft guidance p.m. to 4 p.m.
Agency will review this copy, including dated September 2015. Location: This meeting will be held at
the claimed confidential information, in the Food and Drug Administration,
its consideration of comments. The II. Significance of Guidance Center for Food Safety and Applied
second copy, which will have the This level 1 guidance is being issued Nutrition, 5100 Paint Branch Pkwy.,
claimed confidential information consistent with FDA’s good guidance Wiley Auditorium, College Park, MD
Lhorne on DSK5TPTVN1PROD with NOTICES
redacted/blacked out, will be available practices regulation (21 CFR 10.115). 20740.
for public viewing and posted on http:// The guidance represents the current Contact Person: Maria Rossana
www.regulations.gov. Submit both thinking of FDA on distributor labeling (Rosemary) Cook, Office of Cosmetics
copies to the Division of Dockets for new animal drugs. It does not and Colors, Food and Drug
Management. If you do not wish your establish any rights for any person and Administration, 4300 River Rd., College
name and contact information to be is not binding on FDA or the public. Park, MD 20740, maria.cook@
made publicly available, you can You can use an alternative approach if fda.hhs.gov, or FAX: 301–436–2975.
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Document Created: 2016-04-20 01:51:56
Document Modified: 2016-04-20 01:51:56
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Dorothy McAdams, Center for Veterinary Medicine, Division of Surveillance (HFV-210), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5763, email: [email protected] | |
| FR Citation | 81 FR 23307 |
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