Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate, 23304-23305 [2016-09152]
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Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
Lhorne on DSK5TPTVN1PROD with NOTICES
Silver Spring, MD 20993–0002, 301–
796–7579 or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, Bldg.
71, Rm. 7268, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Comparability Protocols for Human
Drugs and Biologics: Chemistry,
Manufacturing, and Controls
Information.’’ This draft guidance is a
revised version of a draft guidance that
published in February 2003 entitled
‘‘Comparability Protocols: Chemistry,
Manufacturing, and Controls
Information.’’ A related draft guidance
entitled ‘‘Comparability Protocols—
Protein Drug Products and Biological
Products—Chemistry, Manufacturing,
and Controls Information,’’ which
published in September 2003, was
withdrawn on May 6, 2015 (80 FR
26059).
The revised draft guidance provides
recommendations to holders of
applications for human drugs and
biologics on implementing a chemistry,
manufacturing, controls (CMC)
postapproval change(s) through the use
of a comparability protocol (CP). The
revised draft guidance applies to new
drug applications (NDAs), abbreviated
new drug applications (ANDAs), or
biologics license applications (BLAs)
regulated by the Center for Drug
Evaluation and Research (CDER) or the
Center for Biologics Evaluation and
Research (CBER) or supplements
following 21 CFR 314.70 or 21 CFR
601.12.
On February 25, 2003 (68 FR 8772),
FDA announced the availability of the
first draft version of this guidance. The
public comment period closed on June
25, 2003. A number of comments were
received, which the Agency considered
carefully as it prepared this revised draft
guidance.
We revised the guidance for the
following reasons:
• To provide more flexibility
regarding filing procedures for a
notification of change in a condition
established in an approved application.
• To include current pharmaceutical
quality concepts.
• To add an appendix to address
commonly asked questions.
This revised draft guidance provides
recommendations to human drug
manufacturers on implementing CMC
postapproval change(s) through the use
of a CP. By using an approved CP,
manufacturers whom fall within the
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Jkt 238001
scope of this guidance will not have to
submit commercial-scale CMC
information on postchange products to
FDA before making the proposed
changes. The draft guidance is intended
to establish a framework to promote
manufacturing of quality drug products
by employing the following:
• Effective use of knowledge and
understanding of the product and
manufacturing process.
• A robust control strategy.
• Risk management activities over a
product’s life cycle.
• An effective pharmaceutical quality
system.
This draft guidance incorporates the
modern regulatory concepts stated in
the guidance for industry entitled
‘‘PAT—A Framework for Innovative
Pharmaceutical Development,
Manufacturing, and Quality Assurance,’’
(https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM070305.pdf) the Pharmaceutical
Current Good Manufacturing Practices
for the 21st Century Initiative (https://
www.fda.gov/Drugs/Development
ApprovalProcess/Manufacturing/
QuestionsandAnswersonCurrentGood
ManufacturingPracticescGMPforDrugs/
UCM071836), the Critical Path Initiative
(https://www.fda.gov/scienceresearch/
specialtopics/criticalpathinitiative/
default.htm), and the quality by design
principles described in the guidance for
industry entitled ‘‘Q8(R2)
Pharmaceutical Development’’ (https://
www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/
document/ucm073507.pdf). In
publishing this draft guidance, FDA is
communicating its expectations and
support for the described approach.
This 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 Agency’s current thinking
on comparability protocols for
applications regulated in CDER and
CBER as described previously. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information requested in the draft
guidance is covered under FDA
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regulations 21 CFR 314.50, 314.70, and
314.81(b)(2) for human drugs and 21
CFR 601.2 and 601.12 for biologics. The
collection of information is approved
under the following OMB Control
Numbers: 0910–0001 for human drugs
and 0910–0338 for biologics.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.regulations.gov, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: April 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–09137 Filed 4–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0655]
Animal Generic Drug User Fee Act;
Stakeholder Consultation Meetings on
the Animal Generic Drug User Fee Act
Reauthorization; Request for
Notification of Stakeholder Intention
To Participate
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders notify FDA of their intent
to participate in periodic consultation
meetings on reauthorization of the
Animal Generic Drug User Fee Act
(AGDUFA). The statutory authority for
AGDUFA expires September 30, 2018.
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) requires that FDA
consult with a range of stakeholders—
including patient and consumer
advocacy groups, veterinary
professionals, and scientific and
academic experts—in developing
recommendations for the next AGDUFA
program, and hold discussions with
these stakeholders at least once every 4
months during FDA’s negotiations with
the regulated industry. The purpose of
this request for notification is to ensure
continuity and progress in these regular
discussions by establishing consistent
stakeholder representation.
SUMMARY:
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
Submit notification of intention
to participate in continued periodic
stakeholder consultation meetings
regarding AGDUFA reauthorization by
May 16, 2016. These stakeholder
meetings are expected to commence in
June/July 2016 and will continue at
least once every 4 months during
reauthorization negotiations with the
regulated industry. See the
SUPPLEMENTARY INFORMATION section for
further information regarding
notification of intention to participate.
ADDRESSES: The stakeholder meetings
will be held at the Food and Drug
Administration, Center for Veterinary
Medicine, 7519 Standish Pl., Rockville,
MD 20855.
FOR FURTHER INFORMATION CONTACT:
Cassie Ravo, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6866,
FAX: 240–276–9744, Cassie.Ravo@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Lhorne on DSK5TPTVN1PROD with NOTICES
DATES:
I. Introduction
In 2013 Congress passed the Animal
Generic Drug User Fee Amendments of
2013 (Pub. L. 113–14; AGDUFA II). The
authority for AGDUFA II expires
September 30, 2018. Without new
legislation to reauthorize the program,
FDA will no longer be able to collect
user fees for future fiscal years to fund
the generic new animal drug review
process. Section 742(d)(1) of the FD&C
Act (21 U.S.C. 379j–22(d)(1)) requires
that FDA consult with a range of
stakeholders in developing
recommendations for consideration for
the next AGDUFA program, including
representatives from patient and
consumer advocacy groups, veterinary
professionals, and scientific and
academic experts. To initiate this
process of consultation, elsewhere in
this issue of the Federal Register, we are
announcing a public meeting to be held
on May 16, 2016, where stakeholders
and other members of the public will be
given an opportunity to present their
views on the reauthorization. The
meeting and written comments
submitted to the docket will provide
critical input as the Agency prepares for
reauthorization discussions. Section
742(d)(3) of the FD&C Act further
requires that FDA continue meeting
with these stakeholders at least once
every 4 months during negotiations with
the regulated industry to continue
discussions of their views on the
reauthorization, including suggested
changes to the AGDUFA program.
FDA is issuing this Federal Register
notice to request that stakeholders—
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14:53 Apr 19, 2016
Jkt 238001
including veterinary, patient and
consumer groups, as well as scientific
and academic experts—notify FDA of
their intent to participate in the periodic
consultation meetings on AGDUFA
reauthorization. FDA believes that
consistent stakeholder representation at
these meetings will be important to
ensure progress in these discussions. If
you wish to participate in this part of
the reauthorization process, please
designate one or more representatives
from your organization who will
commit to attending these meetings and
preparing for the discussions.
Stakeholders who identify themselves
through this notice will be included in
all future stakeholder discussion while
FDA negotiates with the regulated
industry. If a stakeholder decides to
participate in these meetings at a later
time, they may still participate in
remaining meetings by notifying FDA
(see ADDRESSES). These stakeholder
discussions will satisfy the requirement
in section 742(d)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding
AGDUFA reauthorization, please submit
notification by email to: cvmagdufa@
fda.hhs.gov by May 16, 2016. Your
email should contain complete contact
information for each attendee, including
name, title, affiliation, address, email
address, telephone number, and notice
of any special accommodations required
due to a disability. Stakeholders will
receive confirmation and additional
information about the first meeting after
FDA receives this notification.
Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–09152 Filed 4–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0656]
Animal Drug User Fee Act; Stakeholder
Consultation Meetings on the Animal
Drug User Fee Act Reauthorization;
Request for Notification of Stakeholder
Intention To Participate
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
23305
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders notify FDA of their intent
to participate in periodic consultation
meetings on reauthorization of the
Animal Drug User Fee Act (ADUFA).
The statutory authority for ADUFA
expires September 30, 2018. The
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) requires that FDA
consult with a range of stakeholders—
including patient and consumer
advocacy groups, veterinary
professionals, and scientific and
academic experts—in developing
recommendations for the next ADUFA
program, and hold discussions with
these stakeholders at least once every 4
months during FDA’s negotiations with
the regulated industry. The purpose of
this request for notification is to ensure
continuity and progress in these regular
discussions by establishing consistent
stakeholder representation.
DATES: Submit notification of intention
to participate in continued periodic
stakeholder consultation meetings
regarding ADUFA reauthorization by
May 16, 2016. These stakeholder
meetings are expected to commence in
September/October 2016 and will
continue at least once every 4 months
during reauthorization negotiations with
the regulated industry. See the
SUPPLEMENTARY INFORMATION section for
further information regarding
notification of intention to participate.
ADDRESSES: The stakeholder meetings
will be held at the Food and Drug
Administration, Center for Veterinary
Medicine, 7519 Standish Pl., Rockville,
MD 20855.
FOR FURTHER INFORMATION CONTACT:
Cassie Ravo, Center for Veterinary
Medicine, Food and Drug
Administration,7519 Standish Pl.,
Rockville, MD 20855, 240–402–6866,
FAX: 240–276–9744, Cassie.Ravo@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Introduction
In 2013 Congress passed the Animal
Drug User Fee Amendments of 2013
(Pub. L. 113–14; ADUFA III). The
authority for ADUFA III expires
September 30, 2018. Without new
legislation to reauthorize the program,
FDA will no longer be able to collect
user fees for future fiscal years to fund
the animal drug review process. Section
740A(d)(1) of the FD&C Act (21 U.S.C.
379j–13(d)(1)) requires that FDA consult
with a range of stakeholders in
developing recommendations for
consideration for the next ADUFA
program, including representatives from
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23304-23305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09152]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0655]
Animal Generic Drug User Fee Act; Stakeholder Consultation
Meetings on the Animal Generic Drug User Fee Act Reauthorization;
Request for Notification of Stakeholder Intention To Participate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of participation.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing
this notice to request that public stakeholders notify FDA of their
intent to participate in periodic consultation meetings on
reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The
statutory authority for AGDUFA expires September 30, 2018. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult
with a range of stakeholders--including patient and consumer advocacy
groups, veterinary professionals, and scientific and academic experts--
in developing recommendations for the next AGDUFA program, and hold
discussions with these stakeholders at least once every 4 months during
FDA's negotiations with the regulated industry. The purpose of this
request for notification is to ensure continuity and progress in these
regular discussions by establishing consistent stakeholder
representation.
[[Page 23305]]
DATES: Submit notification of intention to participate in continued
periodic stakeholder consultation meetings regarding AGDUFA
reauthorization by May 16, 2016. These stakeholder meetings are
expected to commence in June/July 2016 and will continue at least once
every 4 months during reauthorization negotiations with the regulated
industry. See the SUPPLEMENTARY INFORMATION section for further
information regarding notification of intention to participate.
ADDRESSES: The stakeholder meetings will be held at the Food and Drug
Administration, Center for Veterinary Medicine, 7519 Standish Pl.,
Rockville, MD 20855.
FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-402-6866, FAX: 240-276-9744, Cassie.Ravo@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
In 2013 Congress passed the Animal Generic Drug User Fee Amendments
of 2013 (Pub. L. 113-14; AGDUFA II). The authority for AGDUFA II
expires September 30, 2018. Without new legislation to reauthorize the
program, FDA will no longer be able to collect user fees for future
fiscal years to fund the generic new animal drug review process.
Section 742(d)(1) of the FD&C Act (21 U.S.C. 379j-22(d)(1)) requires
that FDA consult with a range of stakeholders in developing
recommendations for consideration for the next AGDUFA program,
including representatives from patient and consumer advocacy groups,
veterinary professionals, and scientific and academic experts. To
initiate this process of consultation, elsewhere in this issue of the
Federal Register, we are announcing a public meeting to be held on May
16, 2016, where stakeholders and other members of the public will be
given an opportunity to present their views on the reauthorization. The
meeting and written comments submitted to the docket will provide
critical input as the Agency prepares for reauthorization discussions.
Section 742(d)(3) of the FD&C Act further requires that FDA continue
meeting with these stakeholders at least once every 4 months during
negotiations with the regulated industry to continue discussions of
their views on the reauthorization, including suggested changes to the
AGDUFA program.
FDA is issuing this Federal Register notice to request that
stakeholders--including veterinary, patient and consumer groups, as
well as scientific and academic experts--notify FDA of their intent to
participate in the periodic consultation meetings on AGDUFA
reauthorization. FDA believes that consistent stakeholder
representation at these meetings will be important to ensure progress
in these discussions. If you wish to participate in this part of the
reauthorization process, please designate one or more representatives
from your organization who will commit to attending these meetings and
preparing for the discussions. Stakeholders who identify themselves
through this notice will be included in all future stakeholder
discussion while FDA negotiates with the regulated industry. If a
stakeholder decides to participate in these meetings at a later time,
they may still participate in remaining meetings by notifying FDA (see
ADDRESSES). These stakeholder discussions will satisfy the requirement
in section 742(d)(3) of the FD&C Act.
II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding AGDUFA reauthorization, please submit
notification by email to: cvmagdufa@fda.hhs.gov by May 16, 2016. Your
email should contain complete contact information for each attendee,
including name, title, affiliation, address, email address, telephone
number, and notice of any special accommodations required due to a
disability. Stakeholders will receive confirmation and additional
information about the first meeting after FDA receives this
notification.
Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09152 Filed 4-19-16; 8:45 am]
BILLING CODE 4164-01-P
