Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Draft Guidance for Industry; Availability; Extension of Comment Period, 71659-71660 [2020-24970]

Download as PDF Federal Register / Vol. 85, No. 218 / Tuesday, November 10, 2020 / Notices FOR FURTHER INFORMATION CONTACT: jbell on DSKJLSW7X2PROD with NOTICES Peter Chen, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301–796–7900, CDERCollections@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a revised guidance for industry entitled ‘‘Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.’’ We are issuing this revised final guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this revised guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). The change reflected in the revised guidance needs to be implemented and communicated in a timely manner in light of the ongoing user fee billing process. Although this revised guidance document is immediately in effect, it remains subject to comment in accordance with FDA’s GGP regulation. In May 2018, FDA issued guidance concerning the Agency’s implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and clarifying certain changes in policies and procedures surrounding its application (83 FR 19564). Section VI.B. of the May 2018 guidance provided an interpretation of the term ‘‘same product’’ as it is used in the prescription drug program fee exception for certain prescription drug products under section 736(a)(2)(B)(ii) (21 U.S.C. 379h(a)(2)(B)(ii)) of the Federal Food, Drug, and Cosmetic Act. After further consideration of the issue, we have decided to withdraw the interpretation in our May 2018 guidance and return to our prior practice. Accordingly, for FY 2020 and FY 2021 billing we are considering drug products to be the ‘‘same product’’ if they were pharmaceutically equivalent to a prescription drug product as determined through the process for assigning therapeutic equivalence codes. Therefore, this revised guidance removes section VI.B. as described in the May 2018 guidance. There are no other changes to the guidance. This revised guidance is being issued consistent with FDA’s good guidance VerDate Sep<11>2014 17:21 Nov 09, 2020 Jkt 253001 practices regulation (§ 10.115). The revised guidance represents the current thinking of FDA on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017. 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. II. Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the document at https:// www.fda.gov/RegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances or https:// www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: November 5, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–24941 Filed 11–9–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1997–D–0444] Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of July 15, 2020. In that notice, FDA requested comments on draft guidance for industry (GFI) #61 entitled ‘‘Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.’’ SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 71659 FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period announced in the notice of availability published July 15, 2020 (85 FR 42876). Submit either electronic or written comments by January 11, 2021, to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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– 1997–D–0444 for ‘‘Special Considerations, Incentives, and Programs to Support the Approval of E:\FR\FM\10NON1.SGM 10NON1 jbell on DSKJLSW7X2PROD with NOTICES 71660 Federal Register / Vol. 85, No. 218 / Tuesday, November 10, 2020 / Notices New Animal Drugs for Minor Uses and 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, 240–402–7500. • 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.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. FOR FURTHER INFORMATION CONTACT: Margaret Oeller, Center for Veterinary Medicine (HFV–50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0566, margaret.oeller@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of July 15, 2020, FDA published a notice announcing the availability of draft GFI #61 entitled ‘‘Special Considerations, Incentives, and Programs to Support the Approval of VerDate Sep<11>2014 17:21 Nov 09, 2020 Jkt 253001 New Animal Drugs for Minor Uses and for Minor Species’’ with a 120-day comment period. Interested persons were originally given until November 12, 2020, to comment on the draft guidance. The Agency received a request to allow interested persons additional time to comment. The request conveyed concern that the initial 120-day comment period did not allow sufficient time to develop a comprehensive response. FDA believes that an extension of 60 days allows adequate time for interested persons to submit comments. Dated: November 5, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–24970 Filed 11–9–20; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting 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, NICHD. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT, 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, NICHD. Date: December 4, 2020. Time: 10:00 a.m. to 4:00 p.m. Agenda: A report by the Acting Scientific Director, NICHD, on the status of the NICHD Division of Intramural Research; current organizational structure; to review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, 31 Center Drive, Bethesda, MD 20892 (VideoAssisted Meeting). Fmt 4703 [FR Doc. 2020–24870 Filed 11–9–20; 8:45 am] Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Frm 00058 Dated: November 4, 2020. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P BILLING CODE 4164–01–P PO 00000 Contact Person: Mary C. Dasso, Ph.D., Acting Scientific Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 9000 Rockville Pike, Building 31A, Room 2A46, Bethesda, MD 20892, (301) 594–5984, dassom@ mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/meetings/Pages/ index.aspx, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Emergency Awards: Rapid Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS–CoV–2) and Coronavirus Disease 2019 (COVID–19). Date: December 18, 2020. Time: 11:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G53, Rockville, MD 20892 (Virtual Meeting). Contact Person: Konrad J. Krzewski, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G53, Rockville, MD E:\FR\FM\10NON1.SGM 10NON1

Agencies

[Federal Register Volume 85, Number 218 (Tuesday, November 10, 2020)]
[Notices]
[Pages 71659-71660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24970]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1997-D-0444]


Special Considerations, Incentives, and Programs To Support the 
Approval of New Animal Drugs for Minor Uses and for Minor Species; 
Draft Guidance for Industry; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability that 
appeared in the Federal Register of July 15, 2020. In that notice, FDA 
requested comments on draft guidance for industry (GFI) #61 entitled 
``Special Considerations, Incentives, and Programs to Support the 
Approval of New Animal Drugs for Minor Uses and for Minor Species.'' 
FDA is taking this action in response to a request for an extension to 
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period announced in the notice of 
availability published July 15, 2020 (85 FR 42876). Submit either 
electronic or written comments by January 11, 2021, to ensure that the 
Agency considers your comments on this draft guidance before it begins 
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-1997-D-0444 for ``Special Considerations, Incentives, and Programs 
to Support the Approval of

[[Page 71660]]

New Animal Drugs for Minor Uses and 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, 240-402-7500.
     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.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.

FOR FURTHER INFORMATION CONTACT: Margaret Oeller, Center for Veterinary 
Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0566, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of July 15, 2020, 
FDA published a notice announcing the availability of draft GFI #61 
entitled ``Special Considerations, Incentives, and Programs to Support 
the Approval of New Animal Drugs for Minor Uses and for Minor Species'' 
with a 120-day comment period.
    Interested persons were originally given until November 12, 2020, 
to comment on the draft guidance. The Agency received a request to 
allow interested persons additional time to comment. The request 
conveyed concern that the initial 120-day comment period did not allow 
sufficient time to develop a comprehensive response. FDA believes that 
an extension of 60 days allows adequate time for interested persons to 
submit comments.

    Dated: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24970 Filed 11-9-20; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.