[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42876-42877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15203]
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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Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of draft guidance for industry (GFI) #61 entitled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.''
This draft guidance is intended to assist those interested in pursuing
FDA approval of new animal drugs intended for minor uses in major
species or for use in minor species (MUMS drugs). It outlines the basic
statutory and regulatory requirements and special considerations for
these approvals, and describes the incentives available to encourage
the development of MUMS drugs.
DATES: Submit either electronic or written comments on the draft
guidance by November 12, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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
[[Page 42877]]
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, 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: 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:
I. Background
FDA is 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.''
This draft guidance replaces final GFI #61, issued in April 1999 (with
a minor update in May 2008) entitled ``FDA Approval of New Animal Drugs
for Minor Uses and for Minor Species.'' This draft guidance, when
finalized, should assist those interested in pursuing FDA approval of
MUMS drugs. It outlines the basic statutory and regulatory requirements
and special considerations for these approvals, and describes the
incentives available to encourage the development of MUMS drugs.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on approval
MUMS 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.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required.
However, this draft guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR part 511 have been approved under OMB control number 0910-
0117; in 21 CFR part 514 have been approved under OMB control numbers
0910-0032 and 0910-0284; and in 21 CFR part 516 have been approved
under OMB control numbers 0910-0605 and 0910-0620.
III. 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: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15203 Filed 7-14-20; 8:45 am]
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