Office of the Director; Notice of Charter Renewal, 53432 [2014-21338]
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53432
Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Notices
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products that can be accomplished
under the Agency’s existing statutory
authority.
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 September 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:
Linda Wilmot, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl., Rm.
E442, Rockville, MD 20855, 240–402–
0829, linda.wilmot@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
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cycles and improve communications
during reviews.
In 2013, before ADUFA II expired,
Congress passed ADUFA III (Pub. L.
113–14), which was signed by the
President on June 13, 2013. Like its
predecessors, ADUFA III includes its
own comprehensive set of performance
goals. One such goal, as stated in the
ADUFA III goals letter, is: Beginning in
early FY 2014, the Agency agrees to
explore, in concert with affected parties,
the feasibility of pursuing statutory
revisions, consistent with the Agency’s
mission to protect and promote the
public health, that may modify the
current requirement that the use of
multiple new animal drugs in the same
medicated feed be subject to an
approved application and develop
recommendations by September 30,
2016.
Currently the use of multiple new
animal drugs in the same medicated
feed (i.e., a combination drug medicated
feed) requires an approved NADA for
each new animal drug in the
combination and a separate approved
NADA for the combination new animal
drug itself (21 U.S.C. 360b(d)(4); 21 CFR
514.4(c)). FDA and members of
regulated industry jointly agreed to
explore, as part of the performance goals
outlined in the ADUFA III goals letter,
potential changes to the approval
process for the use of a combination
drug medicated feed. The intent of this
exploration is to consider changes
intended to allow combination drug
medicated feeds to be made available to
the end user in the most efficient
manner possible while protecting and
promoting the public health.
Today, FDA is announcing that it is
beginning the exploration process
described in the ADUFA III goals letter.
With this document, FDA is requesting
public comment on potential statutory
changes, consistent with its mission to
protect and promote the public health,
to modify the current requirements
related to feed use combination drugs.
In addition, although in the ADUFA III
performance goals letter FDA only
agreed to explore the feasibility of
pursuing statutory changes, the Agency
also invites comment on potential
changes to procedures and requirements
related to the approval process for these
products that can be accomplished
under the Agency’s existing statutory
authority.
FDA is opening a public docket to
receive comments on the issue. FDA
will be reviewing the docket and
considering comments submitted as it
moves forward with this process. The
docket will remain open for 365 days
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following publication of this document
in the Federal Register.
II. Comments
Interested persons may submit
electronic comments to regarding this
document 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. 2014–21226 Filed 9–8–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Fogarty
International Center Advisory Board
(FICAB) was renewed for an additional
two-year period on August 31, 2014.
It is determined that the FICAB is in
the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquires may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: September 3, 2014.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–21338 Filed 9–8–14; 8:45 am]
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[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Page 53432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21338]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter Renewal
In accordance with Title 41 of the U.S. Code of Federal
Regulations, Section 102-3.65(a), notice is hereby given that the
Charter for the Fogarty International Center Advisory Board (FICAB) was
renewed for an additional two-year period on August 31, 2014.
It is determined that the FICAB is in the public interest in
connection with the performance of duties imposed on the National
Institutes of Health by law, and that these duties can best be
performed through the advice and counsel of this group.
Inquires may be directed to Jennifer Spaeth, Director, Office of
Federal Advisory Committee Policy, Office of the Director, National
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda,
Maryland 20892 (Mail Code 4875), Telephone (301) 496-2123, or
spaethj@od.nih.gov.
Dated: September 3, 2014.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-21338 Filed 9-8-14; 8:45 am]
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