Exploring the Expansion of Conditional Approval to Appropriate Categories of New Animal Drugs, 53430-53431 [2014-21227]
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53430
Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–21379 Filed 9–8–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Georgia Tuberculosis Outbreak Among
Homeless
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice of award.
The Centers for Disease
Control and Prevention (CDC) located
within the United States Department of
Health and Human Services (HHS)
announces a notice of award to the
Georgia Department of Public Health,
Tuberculosis (TB) Program. This award
will be in the amount of $419,095.00.
The purpose of this award is to halt
the further spread of a drug-resistant
strain of tuberculosis associated with
multiple homeless shelters in Fulton
County, Georgia.
SUMMARY:
It is expected the notice of award
will begin on or about September 3,
2014. The project period will be for one
year.
FOR FURTHER INFORMATION CONTACT: Gail
Burns-Grant, Division of Tuberculosis
Elimination, Field Services and
Evaluation Branch, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE., MS E–10, Atlanta, GA 30333;
phone: 404–639–5344; email: GAB2@
cdc.gov.
SUPPLEMENTARY INFORMATION: Currently,
the state of Georgia is experiencing a
public health emergency in Fulton
County where there has been extensive
transmission of a drug-resistant strain of
tuberculosis (TB) associated with
multiple homeless shelters in the
county. The Georgia Department of
Public Health asked CDC to provide
emergency funding for the immediate
implementation of CDC
recommendations provided as a result
of a May 2014 outbreak investigation to
prevent further transmission of this
drug-resistant strain of tuberculosis and
to prevent further deaths associated
with this outbreak. Project number is
CDC–RFA–PS14–1416.
DATES:
Dated: September 4, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2014–21455 Filed 9–4–14; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Advisory Committee Renewals;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Advisory Committee
Renewals’’ that appeared in the Federal
Register of August 25, 2014 (79 FR
50658). The document announced the
renewal of certain FDA advisory
committees by the Commissioner of
Food and Drugs. The table in the
document contained several errors. This
document corrects those errors.
SUMMARY:
Lisa
Granger, Office of Policy, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3330, Silver Spring,
MD 20993–0002, 301–796–9115.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of Monday, August 25,
2014, in FR Doc. 2014–20017, on page
50659 the table is corrected to read:
SUPPLEMENTARY INFORMATION:
Name of committee
Date of expiration
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology .......................................................................
Gastrointestinal Drugs Advisory Committee ............................................................................................................................
Bone, Reproductive and Urologic Drugs Advisory Committee (formerly Reproductive Health Drugs Advisory Committee)
Arthritis Advisory Committee ...................................................................................................................................................
Pharmacy Compounding Advisory Committee ........................................................................................................................
Anesthetic and Analgesic Drugs Advisory Committee ............................................................................................................
Blood Products Advisory Committee .......................................................................................................................................
Pulmonary-Allergy Drugs Advisory Committee .......................................................................................................................
Drug Safety and Risk Management Advisory Committee .......................................................................................................
Science Advisory Board to the National Center for Toxicological Research ..........................................................................
Peripheral and Central Nervous System Drugs Advisory Committee ....................................................................................
Psychopharmacologic Drugs Advisory Committee .................................................................................................................
Transmissible and Spongiform Encephalopathies Advisory Committee .................................................................................
Science Board to the Food and Drug Administration .............................................................................................................
Allergenic Products Advisory Committee ................................................................................................................................
Dated: September 3, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–1049]
Exploring the Expansion of
Conditional Approval to Appropriate
Categories of New Animal Drugs
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
17:39 Sep 08, 2014
Jkt 232001
Notice.
The Food and Drug
Administration (FDA) is announcing
that it is beginning the exploration
process described in a stated
performance goal in the Animal Drug
User Fee Amendments of 2013 (ADUFA
III) goals letter. Consistent with the
performance goal, the FDA is inviting
comments in regard to the Agency
exploring the use of statutory changes to
expand the use of conditional approval
SUMMARY:
Food and Drug Administration
[FR Doc. 2014–21369 Filed 9–8–14; 8:45 am]
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ACTION:
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January 22, 2016.
March 3, 2016.
March 23, 2016.
April 5, 2016.
April 25, 2016.
May 1, 2016.
May 13, 2016.
May 30, 2016.
May 31, 2016.
June 2, 2016.
June 4, 2016.
June 4, 2016.
June 9, 2016.
June 26, 2016.
July 9, 2016.
E:\FR\FM\09SEN1.SGM
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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
beyond new animal drugs intended for
minor species or for minor uses in major
species to additional categories of new
animal drugs as appropriate.
DATES: Although you can comment on
this document at any time, to ensure
that the Agency considers your
comment before finalizing work on the
exploration process described in this
document, submit either electronic or
written comments by March 9, 2015.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Matthew Lucia, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl., Rm.
E444, Rockville, MD 20855, 240–402–
0811, matthew.lucia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA considers the timely review of
the safety and effectiveness of new
animal drugs to be central to the
Agency’s mission to protect and
promote the public health. Before 2004,
the timeliness and predictability of the
new animal drug review program was a
concern. The Animal Drug User Fee Act
enacted in 2003 (Pub. L. 108–130;
hereinafter referred to as ‘‘ADUFA I’’),
authorized FDA to collect user fees for
5 years—fiscal year (FY) 2004 to FY
2008—that were to be dedicated to
expediting the review of new animal
drug applications according to certain
performance goals and to expand and
modernize the new animal drug review
program. The Agency agreed to meet a
comprehensive set of performance goals
established to show significant
improvement in the timeliness and
predictability of the new animal drug
review process. The implementation of
ADUFA I provided a significant funding
increase that enabled FDA to increase
the number of staff dedicated to the new
animal drug application review process.
In 2008, before ADUFA I expired,
Congress passed the Animal Drug User
Fee Amendments of 2008 (Pub. L. 110–
316; hereinafter referred to as ‘‘ADUFA
II’’) which included an extension of
ADUFA for an additional 5 years—FY
2009 to FY 2013. ADUFA II
performance goals were established
based on ADUFA I FY 2008 review
timeframes. In addition, FDA provided
program enhancements to reduce review
VerDate Mar<15>2010
17:39 Sep 08, 2014
Jkt 232001
cycles and improve communications
during reviews.
In 2013, before ADUFA II expired,
Congress passed the Animal Drug User
Fee Amendments of 2013 (Pub. L. 113–
14; hereinafter referred to as ADUFA
III), which was signed by the President
on June 13, 2013. Like its predecessors,
ADUFA III included its own
comprehensive set of performance goals.
One such goal, as stated in the ADUFA
III goals letter, was: ‘‘Beginning in early
FY 2014, the Agency agrees to explore,
in concert with industry, the feasibility
of pursuing statutory revisions,
consistent with the Agency’s mission to
protect and promote the public health,
that may expand the use of conditional
approvals to other appropriate
categories of new animal drug
applications and develop
recommendations by September 30,
2015.’’
The conditional approval provisions
are found in section 571 of the Federal
Food, Drug and Cosmetic Act (the FD&C
Act). These provisions allow an
applicant to market a new animal drug
intended for a minor species or a minor
use in a major species after the
applicant has demonstrated that the
drug is safe and can be manufactured
according to standards applicable to
approval of applications under section
512(b)(1) of the FD&C Act (21 U.S.C.
360b(b)(1)), but before meeting the full
requirements for demonstrating
effectiveness by providing ‘‘substantial
evidence’’ that the drug is effective.
Instead, the applicant seeking
conditional approval must demonstrate
a ‘‘reasonable expectation of
effectiveness’’ and has up to 5 years to
meet the requirements for
demonstrating ‘‘substantial evidence’’ of
effectiveness and receive complete
approval of an application filed under
section 512(b) of the FD&C Act.
Today, FDA is announcing that it is
beginning the exploration process
described in the ADUFA III goals letter.
With this document, FDA is requesting
comments in regard to the Agency
exploring the use of statutory changes to
expand the use of conditional approval
to appropriate categories of new animal
drugs beyond those intended for use
either in minor species or for minor uses
in major species. FDA is opening a
public docket to receive comments on
the issue. In particular, FDA is inviting
comments on the following specific
questions:
1. Which categories of new animal
drugs, if any, beyond those intended for
minor species or minor uses in major
species, should be considered by FDA
for conditional approval in accordance
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
53431
with the current conditional approval
process and why?
2. How would expanding conditional
approval positively or negatively affect
animal health?
FDA will be reviewing the docket and
considering comments submitted as it
moves forward with this process. The
docket will remain open for 180 days
following publication of this document
in the Federal Register.
II. Comments
Interested persons may submit
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21227 Filed 9–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1050]
Exploring the Feasibility of Pursuing
Statutory Revisions and Other
Modifications to Existing Procedures
and Requirements Related to the
Approval of Combination Drug
Medicated Feeds
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that it is beginning the exploration
process described in a stated
performance goal in the Animal Drug
User Fee Amendments of 2013 (ADUFA
III) goals letter. Consistent with the
performance goal, FDA is inviting
comments in regard to the Agency
exploring the use of statutory changes to
modify the current requirement that the
use of multiple new animal drugs in a
combination drug medicated feed be the
subject of an approved new animal drug
application (NADA). The Agency also is
inviting comment on potential changes
to procedures and requirements related
to the NADA approval process for such
SUMMARY:
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53430-53431]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21227]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1049]
Exploring the Expansion of Conditional Approval to Appropriate
Categories of New Animal Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that it
is beginning the exploration process described in a stated performance
goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals
letter. Consistent with the performance goal, the FDA is inviting
comments in regard to the Agency exploring the use of statutory changes
to expand the use of conditional approval
[[Page 53431]]
beyond new animal drugs intended for minor species or for minor uses in
major species to additional categories of new animal drugs as
appropriate.
DATES: Although you can comment on this document at any time, to ensure
that the Agency considers your comment before finalizing work on the
exploration process described in this document, submit either
electronic or written comments by March 9, 2015.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rm. E444,
Rockville, MD 20855, 240-402-0811, matthew.lucia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA considers the timely review of the safety and effectiveness of
new animal drugs to be central to the Agency's mission to protect and
promote the public health. Before 2004, the timeliness and
predictability of the new animal drug review program was a concern. The
Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-130; hereinafter
referred to as ``ADUFA I''), authorized FDA to collect user fees for 5
years--fiscal year (FY) 2004 to FY 2008--that were to be dedicated to
expediting the review of new animal drug applications according to
certain performance goals and to expand and modernize the new animal
drug review program. The Agency agreed to meet a comprehensive set of
performance goals established to show significant improvement in the
timeliness and predictability of the new animal drug review process.
The implementation of ADUFA I provided a significant funding increase
that enabled FDA to increase the number of staff dedicated to the new
animal drug application review process.
In 2008, before ADUFA I expired, Congress passed the Animal Drug
User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to
as ``ADUFA II'') which included an extension of ADUFA for an additional
5 years--FY 2009 to FY 2013. ADUFA II performance goals were
established based on ADUFA I FY 2008 review timeframes. In addition,
FDA provided program enhancements to reduce review cycles and improve
communications during reviews.
In 2013, before ADUFA II expired, Congress passed the Animal Drug
User Fee Amendments of 2013 (Pub. L. 113-14; hereinafter referred to as
ADUFA III), which was signed by the President on June 13, 2013. Like
its predecessors, ADUFA III included its own comprehensive set of
performance goals. One such goal, as stated in the ADUFA III goals
letter, was: ``Beginning in early FY 2014, the Agency agrees to
explore, in concert with industry, the feasibility of pursuing
statutory revisions, consistent with the Agency's mission to protect
and promote the public health, that may expand the use of conditional
approvals to other appropriate categories of new animal drug
applications and develop recommendations by September 30, 2015.''
The conditional approval provisions are found in section 571 of the
Federal Food, Drug and Cosmetic Act (the FD&C Act). These provisions
allow an applicant to market a new animal drug intended for a minor
species or a minor use in a major species after the applicant has
demonstrated that the drug is safe and can be manufactured according to
standards applicable to approval of applications under section
512(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1)), but before meeting
the full requirements for demonstrating effectiveness by providing
``substantial evidence'' that the drug is effective. Instead, the
applicant seeking conditional approval must demonstrate a ``reasonable
expectation of effectiveness'' and has up to 5 years to meet the
requirements for demonstrating ``substantial evidence'' of
effectiveness and receive complete approval of an application filed
under section 512(b) of the FD&C Act.
Today, FDA is announcing that it is beginning the exploration
process described in the ADUFA III goals letter. With this document,
FDA is requesting comments in regard to the Agency exploring the use of
statutory changes to expand the use of conditional approval to
appropriate categories of new animal drugs beyond those intended for
use either in minor species or for minor uses in major species. FDA is
opening a public docket to receive comments on the issue. In
particular, FDA is inviting comments on the following specific
questions:
1. Which categories of new animal drugs, if any, beyond those
intended for minor species or minor uses in major species, should be
considered by FDA for conditional approval in accordance with the
current conditional approval process and why?
2. How would expanding conditional approval positively or
negatively affect animal health?
FDA will be reviewing the docket and considering comments submitted
as it moves forward with this process. The docket will remain open for
180 days following publication of this document in the Federal
Register.
II. Comments
Interested persons may submit electronic comments regarding this
document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21227 Filed 9-8-14; 8:45 am]
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