Priority Zoonotic Animal Drug Designation and Review Process; Draft Guidance for Industry; Availability, 87433-87435 [2023-27655]
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Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff.
Although FDA verified the website
addresses in this document, please note
that websites are subject to change over
time.
*1. Sullivan, H.W., K.J. Aikin, and L.B.
Squiers, ‘‘Quantitative Information on
Oncology Prescription Drug websites,’’
Journal of Cancer Education, vol. 33,
Issue 2, pp. 371–374, 2018. (https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC5334459)
2. Dillman, D.A., J.D. Smyth, and L.M.
Christian, internet, Phone, Mail, and
Mixed-Mode Surveys: The Tailored
Design Method, 4th ed., John Wiley &
Sons, Inc.: Hoboken, NJ, 2014.
*3. Cheung, Y.T.D., X. Weng, M.P. Wang, et
al., ‘‘Effect of Prepaid and Promised
Financial Incentive on Follow-Up
Survey Response in Cigarette Smokers: A
Randomized Controlled Trial,’’ BMC
Medical Research Methodology, vol. 19,
Article 138, 2019. (https://link.
springer.com/article/10.1186/s12874019-0786-9)
4. Mercer, A., A. Caporaso, D. Cantor, et al.,
‘‘How Much Gets You How Much?
Monetary Incentives and Response Rates
in Household Surveys,’’ Public Opinion
Quarterly, vol. 79, pp. 105–129, 2015.
5. Sun, H., J. Newsome, J. McNulty, et al.,
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27652 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5323]
Hoffmann-La Roche, Inc., et al.;
Withdrawal of Approval of Two New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Drug
NDA 021455 ......
Boniva (ibandronate sodium) Tablets, equivalent to (EQ) 2.5
milligrams (mg) base and EQ 150 mg base.
Flowtuss (guaifenesin 200 mg/5 milliliters (mL) and
hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 17,
2024. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
listed in the table without an approved
NDA violates sections 505(a) and 301(d)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(a) and 331(d)). Drug
products that are listed in the table that
are in inventory on January 17, 2024
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of two new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
January 17, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application under § 314.150(c) is
without prejudice to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
NDA 022424 ......
khammond on DSKJM1Z7X2PROD with NOTICES
‘‘What Works, What Doesn’t? Three
Studies Designed to Improve Survey
Response,’’ Field Methods, vol. 32, Issue
3, pp. 235–252, 2020. (https://doi.org/
10.1177/1525822X20915464)
6. Ellis, J., J. Charbonnier, C. Lowenstein, et
al., ‘‘Assessing the Impacts of Different
Incentives and Use of Postal Mail on
Response Rates,’’ American Association
for Public Opinion Research (AAPOR)
Conference, Chicago, IL, 2022, May.
*7. Yu, S., H.E. Alper, A.M. Nguyen, et al.,
‘‘The Effectiveness of a Monetary
Incentive Offer on Survey Response
Rates and Response Completeness in a
Longitudinal Study,’’ BMC Medical
Research Methodology, vol. 17, Article
77, 2017. (https://bmcmedresmethodol.
biomedcentral.com/articles/10.1186/
s12874-017-0353-1)
87433
Applicant
Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080–4990.
Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY
10920.
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27661 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–3740]
Priority Zoonotic Animal Drug
Designation and Review Process; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
announcing the availability of a draft
guidance for industry (GFI) #283
entitled ‘‘Priority Zoonotic Animal Drug
Designation and Review Process.’’ This
draft guidance is intended to assist
sponsors pursuing priority zoonotic
animal drug (PZAD) designation for a
new animal drug. This draft guidance is
intended to provide the eligibility
criteria for PZAD designation, the
process for requesting PZAD
designation, and enhancements in the
FDA review process for PZADs.
Submit either electronic or
written comments on the draft guidance
by February 16, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
E:\FR\FM\18DEN1.SGM
18DEN1
87434
Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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–
2023–D–3740 for ‘‘Priority Zoonotic
Animal Drug Designation and Review
Process.’’ 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
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
‘‘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.
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 selfaddressed 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:
Evgenij Evdokimov, Center for
Veterinary Medicine (HFV–108), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–402–
0712, evgenij.evdokimov@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
draft GFI #283 entitled ‘‘Priority
Zoonotic Animal Drug Designation and
Review Process.’’ The Coronavirus Aid,
Relief, and Economic Security (CARES)
Act (Pub. L. 116–136), signed into law
on March 27, 2020, added section 512A
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
‘‘Priority zoonotic animal drugs’’ to the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b–1), which provides for
the designation of a new animal drug as
a PZAD. This legislation is intended to
expedite the development and review of
certain new animal drugs that have the
potential to prevent or treat a zoonotic
disease in animals, including a vectorborne disease, that has the potential to
cause serious adverse health
consequences for, or serious or lifethreatening diseases in, humans.
This draft guidance is intended to
assist sponsors pursuing designation of
a new animal drug as a PZAD. This draft
guidance proposes the eligibility criteria
a new animal drug should meet to
obtain PZAD designation and describes
the process sponsors may use to request
such designation. In addition, this draft
guidance identifies the enhancements
FDA intends to implement to expedite
the PZAD review process.
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 ‘‘Priority Zoonotic
Animal Drug Designation and Review
Process.’’ 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
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR 514 have been
approved under OMB control number
0910–0032; 21 CFR 511.1 have been
approved under OMB control number
0910–0117.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
E:\FR\FM\18DEN1.SGM
18DEN1
Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
Dated: December 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27655 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5344]
Pharmacyclics LLC.; Withdrawal of
Approval of Indications for Mantle Cell
Lymphoma and Marginal Zone
Lymphoma for IMBRUVICA (ibrutinib)
Capsules and Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that it is withdrawing
approval of the indications for mantle
cell lymphoma (MCL) and marginal
zone lymphoma (MZL) for IMBRUVICA
(ibrutinib) Capsules and Tablets
approved, respectively, under new drug
applications (NDAs) 205552 and
210563. These NDAs are held by
Pharmacyclics LLC, 1000 Gateway
Blvd., South San Francisco, CA 94080
(Pharmacyclics). Pharmacyclics
voluntarily requested that the Agency
withdraw approval of these indications
and waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of
December 18, 2023.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
November 13, 2013, FDA approved
NDA 205552 for IMBRUVICA (ibrutinib)
Capsules for the treatment of adult
patients with MCL who have received at
least one prior therapy (the MCL
indication). On January 18, 2017, FDA
approved a prior approval supplement
for NDA 205552 for IMBRUVICA
(ibrutinib) Capsules for the treatment of
adult patients with MZL who require
systemic therapy and have received at
least one prior anti-CD20-based therapy
(the MZL indication). On February 16,
2018, FDA approved NDA 210563 for
IMBRUVICA (ibrutinib) Tablets, a new
dosage form of IMBRUVICA (ibrutinib),
for the MCL and MZL indications. FDA
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
approved the MCL and MZL indications
for both products under the Agency’s
accelerated approval regulations, 21
CFR part 314, subpart H. As a condition
of accelerated approval of IMBRUVICA
(ibrutinib) Capsules and Tablets for the
MCL and MZL indications, the
applicant was required to conduct
postmarketing trials to verify the
clinical benefit of ibrutinib for the MCL
and MZL indications.
On February 8, 2023, FDA met with
Pharmacyclics to inform the applicant
of the plans to convene the Oncologic
Drugs Advisory Committee regarding
the accelerated approvals for the MCL
and MZL indications because the
required postmarketing trials did not
verify the clinical benefit of ibrutinib for
these indications. On March 21, 2023,
FDA met with Pharmacyclics to discuss
the applicant’s request to voluntarily
withdraw approval of the MCL and MZL
indications for IMBRUVICA (ibrutinib)
Capsules and Tablets. On April 6, 2023,
Pharmacyclics submitted a letter
requesting withdrawal of the MCL and
MZL indications for IMBRUVICA
(ibrutinib) Capsules and Tablets
pursuant to § 314.150(d) (21 CFR
314.150(d)) and waiving its opportunity
for a hearing.
Therefore, under § 314.150(d),
approvals of the MCL and MZL
indications for IMBRUVICA (ibrutinib)
Capsules and Tablets are withdrawn as
of December 18, 2023. Withdrawal of
approval of these indications does not
affect any other approved indication for
IMBRUVICA (ibrutinib) Capsules and
Tablets.
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27662 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Funding Opportunity for the
Community Opioid Intervention
Prevention Program
Announcement Type: New.
Funding Announcement Number:
HHS–2024–IHS–COIPP–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.654.
Key Dates
Application Deadline Date: February
7, 2024.
Earliest Anticipated Start Date: April
1, 2024.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
87435
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS),
Office of Clinical and Preventive
Services, Division of Behavioral Health
(DBH) is accepting applications for
grants for the Community Opioid
Intervention Prevention Program
(COIPP). This program is authorized
under the Snyder Act, 25 U.S.C. 13, and
the Transfer Act, 42 U.S.C. 2001(a).
Funding for this program is provided in
the Consolidated Appropriations Act,
2023, Public Law 117–328, 136 Stat.
4459, 4808 (2022). The Assistance
Listings section of SAM.gov (https://
sam.gov/content/home) describes this
program under 93.654.
Background
The initial opioid prevention
program, called the Community Opioid
Intervention Pilot Project, was first
established in Fiscal Year (FY) 2019,
pursuant to Congressional instruction to
better combat the opioid epidemic. The
goal was to create a pilot program to
address the opioid epidemic in Indian
Country and award grants that
supported the development,
documentation, and sharing of locally
designed and culturally appropriate
prevention, treatment, recovery, and
aftercare services for opioid use
disorders in the American Indian and
Alaska Native (AI/AN) communities.
Evidence-based activities are available
for reference at https://www.ihs.gov/
asap/coipp/. A total of 35 grants were
awarded to Tribal and Urban Indian
communities in the pilot phase. Based
on evaluation results from the pilot
project, this funding opportunity will
continue to provide grant support to
Tribal and Urban Indian communities to
continue efforts to combat the opioid
epidemic and develop strategies that
align with the Department of Health and
Human Services Overdose Prevention
Strategy.
The Centers for Disease Control and
Prevention (CDC) reported that the AI/
AN population had the highest drug
overdose death rates in both 2020 and
2021, at rates of 42.5 and 56.6 deaths
per 100,000 persons, respectively. The
AI/AN population also experienced a 33
percent increase in drug overdose
deaths from 2020 through 2021.
Overdose deaths among AI/AN have
continued to increase over the last 20
years. The CDC reported from 2019 to
2020, overdose death rates increased 39
percent for the non-Hispanic AI/AN
population and drug overdose death
rates were highest for AI/AN people
compared to other racial and ethnic
groups.
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87433-87435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27655]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-3740]
Priority Zoonotic Animal Drug Designation and Review Process;
Draft 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 draft guidance for industry (GFI) #283 entitled
``Priority Zoonotic Animal Drug Designation and Review Process.'' This
draft guidance is intended to assist sponsors pursuing priority
zoonotic animal drug (PZAD) designation for a new animal drug. This
draft guidance is intended to provide the eligibility criteria for PZAD
designation, the process for requesting PZAD designation, and
enhancements in the FDA review process for PZADs.
DATES: Submit either electronic or written comments on the draft
guidance by February 16, 2024 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:
[[Page 87434]]
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-2023-D-3740 for ``Priority Zoonotic Animal Drug Designation and
Review Process.'' 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.
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: Evgenij Evdokimov, Center for
Veterinary Medicine (HFV-108), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0712,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft GFI #283 entitled
``Priority Zoonotic Animal Drug Designation and Review Process.'' The
Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L.
116-136), signed into law on March 27, 2020, added section 512A
``Priority zoonotic animal drugs'' to the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b-1), which provides for the designation of
a new animal drug as a PZAD. This legislation is intended to expedite
the development and review of certain new animal drugs that have the
potential to prevent or treat a zoonotic disease in animals, including
a vector-borne disease, that has the potential to cause serious adverse
health consequences for, or serious or life-threatening diseases in,
humans.
This draft guidance is intended to assist sponsors pursuing
designation of a new animal drug as a PZAD. This draft guidance
proposes the eligibility criteria a new animal drug should meet to
obtain PZAD designation and describes the process sponsors may use to
request such designation. In addition, this draft guidance identifies
the enhancements FDA intends to implement to expedite the PZAD review
process.
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
``Priority Zoonotic Animal Drug Designation and Review Process.'' 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR 514 have been approved under OMB control number 0910-0032; 21
CFR 511.1 have been approved under OMB control number 0910-0117.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
[[Page 87435]]
Dated: December 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27655 Filed 12-15-23; 8:45 am]
BILLING CODE 4164-01-P
