Proprietary Names for New Animal Drugs; Guidance for Industry; Availability, 33162-33163 [2020-11679]

Download as PDF 33162 Federal Register / Vol. 85, No. 105 / Monday, June 1, 2020 / Notices performed its core functions, independent of project-specific outcomes. We do have some concerns regarding (1.b.1). Discuss CAC involvement in evaluating UCEDD activities, and in the development and review of the final program progress report. At every CAC meeting, we provide updates on the UCEDDs activities, where CAC members are encouraged to comment and make suggestions. An indepth annual report is provided at our full-day in person CAC meeting every November. If that coincides with a fiveyear renewal application earlier that year, then a 5-year cumulative report is shared. Previously, there has been no requirement for CAC members to be delete the requirement for CAC involvement in the development of the final five-year report. Response #4 ACL estimates the burden associated with this collection of information as follows: Regarding Part (1.b1): ACL reviewed and accepts your recommendation to Comment # 5 Recommend ensuring enough time is allocated between the year 5 annual report due date and the due date of the overall 5-year report. Response # 5 The year 5 annual report is due July 30 and the 5-year closeout report is due 90 days after the end of the grant period or September 30 for time allocation. Estimated Program Burden Respondent/data collection activity Number of respondents Responses per respondent Hours per response Annual burden hours UCEDD Annual Report ................................................................................ 67 1 1,462 97,954 Dated: May 21, 2020. Mary Lazare, Principal Deputy Administrator. DATES: [FR Doc. 2020–11685 Filed 5–29–20; 8:45 am] ADDRESSES: The announcement of the guidance is published in the Federal Register on June 1, 2020. You may submit either electronic or written comments on Agency guidances at any time as follows: BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions Food and Drug Administration [Docket No. FDA–2018–D–0626] Proprietary Names for New Animal Drugs; 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 #240 entitled ‘‘Proprietary Names for New Animal Drugs.’’ This guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This guidance proposes a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how new animal drug sponsors can request that CVM evaluate a proposed proprietary name. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES directly involved in the development of this report. Essentially, this is a technical report, aggregating 5- years’ worth of NIRS data with additional narrative and impact statements. As such, we feel it is both burdensome and somewhat irrelevant to involve the CAC in the development of a report that is submitted to AoD. Rather than ask about CAC involvement in the development, perhaps it would be more beneficial and direct to require that CAC members be surveyed about their experiences and satisfaction with the structure and function of their respective CACs over the preceding 5 years. VerDate Sep<11>2014 19:40 May 29, 2020 Jkt 250001 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’’). PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 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– 2018–D–0626 for ‘‘Proprietary Names for New Animal Drugs.’’ 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 E:\FR\FM\01JNN1.SGM 01JNN1 Federal Register / Vol. 85, No. 105 / Monday, June 1, 2020 / Notices 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. 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, 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 questions regarding this document, contact Tom Modric, Center for Veterinary Medicine (HFV–216), Food and Drug Administration, 7519 Standish Place, Rockville, Rockville, MD 20855, 240–402–5853, tomislav.modric@ fda.hhs.gov or AskCVM@fda.hhs.gov. SUPPLEMENTARY INFORMATION: jbell on DSKJLSW7X2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: I. Background In the Federal Register of March 12, 2018 (83 FR 10732), FDA published the notice of availability for a draft guidance entitled ‘‘Proprietary Names for New Animal Drugs,’’ giving interested persons until May 11, 2018, to comment on the draft guidance. FDA received comments on the draft guidance, and those comments were considered as the guidance was finalized. Changes made include revisions to the definitions. In VerDate Sep<11>2014 19:40 May 29, 2020 Jkt 250001 addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated March 2018. 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 proprietary names 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 FDA concludes that there are no collections of information under the 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. 3501–3521). The collections of information in 21 CFR part 514 have been approved under OMB control numbers 0910–0032 and 0910–0699; the collections of information in 21 CFR part 511 have been approved under OMB control number 0910–0117. 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: May 26, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–11679 Filed 5–29–20; 8:45 am] BILLING CODE 4164–01–P 33163 The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that NURTEC ODT (rimegepant), approved February 27, 2020, meets the redemption criteria. FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4061, Fax: 301–796–9858, email: althea.cuff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that NURTEC ODT (rimegepant), approved February 27, 2020, meets the redemption criteria. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRare DiseasesConditions/RarePediatric DiseasePriorityVoucherProgram/ default.htm. For further information about NURTEC ODT (rimegepant), approved February 27, 2020, go to the ‘‘Drugs@FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. Dated: May 26, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–11681 Filed 5–29–20; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–1262] Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. SUMMARY: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0837] Rare Disease Clinical Trial Networks; Request for Information and Comments AGENCY: Food and Drug Administration, HHS. Notice; request for information and comments. ACTION: E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Notices]
[Pages 33162-33163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11679]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0626]


Proprietary Names 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 a final guidance for industry #240 entitled 
``Proprietary Names for New Animal Drugs.'' This guidance provides 
recommendations to help new animal drug sponsors develop proprietary 
names for new animal drugs that do not contribute to medication errors, 
negatively impact safe use of the drug, or misbrand the drug. This 
guidance proposes a framework for evaluating proposed proprietary names 
before submitting them for review by the Center for Veterinary Medicine 
(CVM or we). It also explains how new animal drug sponsors can request 
that CVM evaluate a proposed proprietary name.

DATES: The announcement of the guidance is published in the Federal 
Register on June 1, 2020.

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-2018-D-0626 for ``Proprietary Names for New Animal Drugs.'' 
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

[[Page 33163]]

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.govinfo.gov/content/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, 240-402-7500.
    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, 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: For questions regarding this document, 
contact Tom Modric, Center for Veterinary Medicine (HFV-216), Food and 
Drug Administration, 7519 Standish Place, Rockville, Rockville, MD 
20855, 240-402-5853, [email protected] or [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 12, 2018 (83 FR 10732), FDA 
published the notice of availability for a draft guidance entitled 
``Proprietary Names for New Animal Drugs,'' giving interested persons 
until May 11, 2018, to comment on the draft guidance. FDA received 
comments on the draft guidance, and those comments were considered as 
the guidance was finalized. Changes made include revisions to the 
definitions. In addition, editorial changes were made to improve 
clarity. The guidance announced in this notice finalizes the draft 
guidance dated March 2018.

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 proprietary names 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

    FDA concludes that there are no collections of information under 
the 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. 3501-3521). The collections of information in 21 CFR part 
514 have been approved under OMB control numbers 0910-0032 and 0910-
0699; the collections of information in 21 CFR part 511 have been 
approved under OMB control number 0910-0117.

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: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11679 Filed 5-29-20; 8:45 am]
BILLING CODE 4164-01-P

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