International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Pharmaceutical Development; Draft Guidance for Industry; Availability, 37230-37231 [2024-09777]
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Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: New
Technology Services for Ambulatory
Payment Classifications Under
Outpatient Prospective Payment
System; Use: In the April 7, 2000 final
rule with comment period first
implementing the hospital outpatient
prospective payment system (OPPS), we
created a set of New Technology
ambulatory payment classifications
(APCs) to pay for certain new
technology services under the OPPS.
These APCs are intended to pay for new
technology services that were not
covered by the transitional pass-through
payments provisions authorized by the
Balanced Budget Refinement Act
(BBRA) of 1999.
Since implementation of the hospital
outpatient prospective payment system
(OPPS) on August 1, 2000, transitional
pass-through payments have been made
to hospitals for certain drugs,
biologicals, and medical devices. These
are temporary additional payments
required by section 1833(t)(6) of the
Social Security Act (the Act), which was
added by section 201(b) of the Balanced
Budget Act of 1999 (BBRA). The law
required the Secretary to make these
additional payments to hospitals for at
least 2 but no more than 3 years.
In the April 7, 2000 final rule with
comment period, we specified an
application process and the information
that must be supplied for us to consider
a request for payment under the New
Technology APCs (65 FR 18478). We
posted the application process on our
website at www.cms.hhs.gov. Services
were only considered eligible for
assignment to a New Technology APC if
we listed them in one of a number of
lists published in Medicare Program
Memoranda, which are posted to our
website (https://www.cms.gov/
medicare/regulations-guidance/
transmittals/cms-program-memoranda).
We established a quarterly application
process by which interested parties
could submit applications to us for
particular services. We assign new
services to the New Technology APCs
that we determine cannot be placed
appropriately in clinical APCs. Under
our current policy, we retain services in
VerDate Sep<11>2014
18:02 May 03, 2024
Jkt 262001
a New Technology APC until we gain
sufficient information about actual
hospital costs incurred to furnish a new
technology service. Form Number:
CMS–10054 (OMB control number:
0938–0860); Frequency: Once; Affected
Public: Private sector, Business or other
for-profit; Number of Respondents: 25;
Number of Responses: 25; Total Annual
Hours: 400. (For policy questions
regarding this collection contact Josh
Mcfeeters at 410–786–9732.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–09745 Filed 5–3–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–1133]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products;
Pharmaceutical Development; Draft
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 draft
guidance for industry (GFI) #290 (VICH
GL61) entitled ‘‘Pharmaceutical
Development.’’ This draft guidance has
been developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
This draft guidance describes the
suggested contents for the
Pharmaceutical Development section,
which provides an opportunity to
present the knowledge gained through
the application of scientific approaches
and quality risk management to the
development of a product and its
manufacturing process.
DATES: Submit either electronic or
written comments on the draft guidance
by July 5, 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:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
• 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–
2024–D–1133 for ‘‘Pharmaceutical
Development.’’ 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
E:\FR\FM\06MYN1.SGM
06MYN1
Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
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: Mai
Huynh, Center for Veterinary Medicine
(HFV–140), Food and Drug
Administration, 7500 Standish Place,
Rockville, MD 20855, 240–402–0669,
Mai.Huynh@fda.hhs.gov
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft GFI #290 (VICH GL61) entitled
‘‘Pharmaceutical Development.’’ This
draft guidance describes the suggested
contents for the Pharmaceutical
Development section, which provides
an opportunity to present the
knowledge gained through the
application of scientific approaches and
quality risk management to the
development of a product and its
manufacturing process. The
VerDate Sep<11>2014
18:02 May 03, 2024
Jkt 262001
Pharmaceutical Development section is
intended to provide a comprehensive
understanding of the product and
manufacturing process for reviewers
and investigators.
FDA has participated in efforts to
enhance international harmonization
and is committed to seeking
scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries. FDA has actively participated
in the International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The goal of the
VICH is to develop harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and receives input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission and
European Medicines Agency;
AnimalhealthEurope; FDA—Center for
Veterinary Medicine and U.S.
Department of Agriculture—Center for
Veterinary Biologics; the U.S. Animal
Health Institute; the Japanese Ministry
of Agriculture, Forestry and Fisheries;
and the Japanese Veterinary Products
Association. There are 10 observers to
the VICH Steering Committee: one
representative from government and one
representative from industry of
Australia, New Zealand, Canada, South
Africa, and the United Kingdom. The
World Organisation for Animal Health
is an associate member of the VICH. The
VICH Secretariat, which coordinates the
preparation of documentation, is
provided by HealthforAnimals.
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 ‘‘Pharmaceutical
Development.’’ 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.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
37231
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 part 514 have
been approved under OMB control
numbers 0910–0032; the collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117; and the collections
of information in 512(n)(1) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(n)(1)) have been
approved under OMB control number
0910–0669.
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.
Dated: May 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09777 Filed 5–3–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
The Tobacco Products Scientific
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Tobacco Products
Scientific Advisory Committee
(TPSAC). The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on June
26, 2024, from 9 a.m. to 4:30 p.m. EST.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993. The
SUMMARY:
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37230-37231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09777]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1133]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Pharmaceutical Development; 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) #290 (VICH
GL61) entitled ``Pharmaceutical Development.'' This draft guidance has
been developed for veterinary use by the International Cooperation on
Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). This draft guidance describes the suggested
contents for the Pharmaceutical Development section, which provides an
opportunity to present the knowledge gained through the application of
scientific approaches and quality risk management to the development of
a product and its manufacturing process.
DATES: Submit either electronic or written comments on the draft
guidance by July 5, 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:
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-2024-D-1133 for ``Pharmaceutical Development.'' 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
[[Page 37231]]
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: Mai Huynh, Center for Veterinary
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855, 240-402-0669, [email protected]
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft GFI #290 (VICH GL61)
entitled ``Pharmaceutical Development.'' This draft guidance describes
the suggested contents for the Pharmaceutical Development section,
which provides an opportunity to present the knowledge gained through
the application of scientific approaches and quality risk management to
the development of a product and its manufacturing process. The
Pharmaceutical Development section is intended to provide a
comprehensive understanding of the product and manufacturing process
for reviewers and investigators.
FDA has participated in efforts to enhance international
harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify, and then reduce, differences
in technical requirements for drug development among regulatory
agencies in different countries. FDA has actively participated in the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
goal of the VICH is to develop harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and receives input from both regulatory
and industry representatives.
The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency;
AnimalhealthEurope; FDA--Center for Veterinary Medicine and U.S.
Department of Agriculture--Center for Veterinary Biologics; the U.S.
Animal Health Institute; the Japanese Ministry of Agriculture, Forestry
and Fisheries; and the Japanese Veterinary Products Association. There
are 10 observers to the VICH Steering Committee: one representative
from government and one representative from industry of Australia, New
Zealand, Canada, South Africa, and the United Kingdom. The World
Organisation for Animal Health is an associate member of the VICH. The
VICH Secretariat, which coordinates the preparation of documentation,
is provided by HealthforAnimals.
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
``Pharmaceutical Development.'' 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 part 514 have been approved under OMB control numbers 0910-
0032; the collections of information in 21 CFR part 511 have been
approved under OMB control number 0910-0117; and the collections of
information in 512(n)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(n)(1)) have been approved under OMB control number
0910-0669.
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.
Dated: May 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09777 Filed 5-3-24; 8:45 am]
BILLING CODE 4164-01-P
