Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims; Withdrawal of Guidance, 30176 [2011-12624]
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30176
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
and review of clinical investigators’
financial disclosures. Specifically, the
draft guidance will describe: (1) The
sponsor’s responsibility to collect the
financial disclosure information prior to
an investigator participating in a study
and ensure that all required forms and
attachments are submitted in marketing
applications; (2) what is meant by ‘‘due
diligence’’ in obtaining financial
disclosures from investigators; and (3)
how FDA will review financial
disclosure information. The guidance
will also seek comment on the
circumstances under which FDA should
consider public release of financial
disclosure information related to an
approved marketing application.
This draft guidance is being issued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The draft guidance, when finalized, will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 this topic. 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. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 collections
of information in part 54 and 21 CFR
parts 312 and 812 have been approved
under OMB control number 0910–0396;
OMB control number 0910–0014; and
OMB control number 0910–0078.
jlentini on DSK4TPTVN1PROD with NOTICES
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this draft guidance
document. It is no longer necessary to
send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov or https://
www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
ProposedRegulationsand
DraftGuidances/default.htm.
VerDate Mar<15>2010
16:47 May 23, 2011
Jkt 223001
Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12623 Filed 5–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2001–D–0066] (Formerly
Docket No. 2001D–0107)
Expedited Review for New Animal Drug
Applications for Human Pathogen
Reduction Claims; Withdrawal of
Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12624 Filed 5–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Dermatologic and Ophthalmic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
The Food and Drug
Administration (FDA) is announcing the
withdrawal of a guidance that was
issued on March 9, 2001.
DATES: May 24, 2011.
FOR FURTHER INFORMATION CONTACT:
Steven Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8300.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
March 9, 2001 (66 FR 14155), FDA
announced the availability of a guidance
for industry #121 entitled ‘‘Expedited
Review for New Animal Drug
Applications for Human Pathogen
Reduction Claims.’’
The guidance predates the enactment
of the Animal Drug User Fee Act
(ADUFA) of 2003, which was
reauthorized by Congress in 2008.
ADUFA authorized FDA to collect fees
for certain animal drug applications and
for the establishments, products, and
sponsors associated with these and
previously approved animal drug
applications, in support of the review of
animal drug products. As a result of
these increased resources, the
efficiencies of our current
administrative processes, including the
phased review and end review
amendment processes, we have
significantly reduced our review
timeframes and afford sponsors a more
efficient pathway to regulatory
approval.
At the time the guidance was issued,
FDA’s review timeframes for new
animal drug applications were
considerably longer. As noted
previously, significant changes have
occurred in the Agency’s processes and
timeframes for reviewing new animal
SUMMARY:
drug applications and the process for
expedited review status contained in
this guidance is outdated and no longer
needed to assure the efficient review of
these new animal drug applications.
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dermatologic
and Ophthalmic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 17, 2011, from 8 a.m. to
4:30 p.m.
Location: The Marriott Inn and
Conference Center, University of
Maryland University College (UMUC),
3501 University Blvd. East, Adelphi,
MD. The conference center telephone
number is 301–985–7300.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, e-mail:
DODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Page 30176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12624]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2001-D-0066] (Formerly Docket No. 2001D-0107)
Expedited Review for New Animal Drug Applications for Human
Pathogen Reduction Claims; Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a guidance that was issued on March 9, 2001.
DATES: May 24, 2011.
FOR FURTHER INFORMATION CONTACT: Steven Vaughn, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240-276-8300.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 9, 2001 (66 FR 14155), FDA announced the availability
of a guidance for industry 121 entitled ``Expedited Review for
New Animal Drug Applications for Human Pathogen Reduction Claims.''
The guidance predates the enactment of the Animal Drug User Fee Act
(ADUFA) of 2003, which was reauthorized by Congress in 2008. ADUFA
authorized FDA to collect fees for certain animal drug applications and
for the establishments, products, and sponsors associated with these
and previously approved animal drug applications, in support of the
review of animal drug products. As a result of these increased
resources, the efficiencies of our current administrative processes,
including the phased review and end review amendment processes, we have
significantly reduced our review timeframes and afford sponsors a more
efficient pathway to regulatory approval.
At the time the guidance was issued, FDA's review timeframes for
new animal drug applications were considerably longer. As noted
previously, significant changes have occurred in the Agency's processes
and timeframes for reviewing new animal drug applications and the
process for expedited review status contained in this guidance is
outdated and no longer needed to assure the efficient review of these
new animal drug applications.
Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12624 Filed 5-23-11; 8:45 am]
BILLING CODE 4160-01-P
