Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions, 32851-32852 [E7-11425]
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Federal Register / Vol. 72, No. 114 / Thursday, June 14, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0219]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fees and Fee Waivers and Reductions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting requirements for the
animal drug user fees, fee waivers and
reductions.
DATES: Submit written or electronic
comments on the collection of
information by August 13, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information 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:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506 (c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Animal Drug User Fees and Fee
Waivers and Reductions (OMB Control
Number 0910–0540)—Extension
Enacted on November 18, 2003, the
Animal Drug User Fee Act (ADUFA)
(Public Law 108–130), amended the
Federal Food, Drug, and Cosmetic Act
and requires FDA to assess and collect
user fees for certain applications,
products, establishments, and sponsors.
It also requires the agency to grant a
waiver from, or a reduction of those fees
in certain circumstances. Thus, to
implement this statutory provision of
ADUFA, FDA developed a guidance
entitled ‘‘Guidance for Industry: Animal
Drug User Fees and Fee Waivers and
Reductions.’’ This document provides
guidance on the types of fees FDA is
authorized to collect under ADUFA, and
how to request waivers and reductions
from FDA’s animal drug user fees.
Further, this guidance also describes the
types of fees and fee waivers and
reductions; what information FDA
recommends be submitted in support of
a request for a fee waiver or reduction;
how to submit such a request; and
FDA’s process for reviewing requests.
Requests for waivers or reductions may
be submitted by a person paying any of
the animal drug user fees assessed-application fees, product fees,
establishment fees, or sponsor fees.
Respondents to this collection of
information are new animal drug
sponsors.
FDA estimates the burden for this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
5
1 time for each
application
5
2
10
740(d)(1)(B) Fees exceed cost
1
1 time for each
application
1
2
2
740(d)(1)(C) Free choice feeds
5
1 time for each
application
5
2
10
740(d)(1)(D) Minor use or minor
species
jlentini on PROD1PC65 with NOTICES
740(d)(1)(A) Significant barrier to
innovation
10
1 time for each
application
10
2
20
2
1 time for each
application
2
2
4
740(d)(1)(E) Small business
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17:22 Jun 13, 2007
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32852
Federal Register / Vol. 72, No. 114 / Thursday, June 14, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Request for reconsideration of a
decision
5
1 time for each
application
5
2
10
Request for review—(user fee appeal officer)
2
1 time for each
application
2
2
4
Total
60
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system,
there are an estimated 250 sponsors of
products subject to ADUFA. However,
not all sponsors will have any
submissions in a given year and some
may have multiple submissions. The
total number of waiver requests is based
on the number of submission types
received by FDA in fiscal year 2003.
FDA’s Center for Veterinary Medicine
estimates 30 waiver requests that
include the following: 5 significant
barriers to innovation, 1 fee exceed cost,
5 free choice feeds, 10 minor use or
minor species, 2 small business waiver
requests, 5 requests for reconsideration
of a decision, and 2 requests for user fee
appeal officer. The estimated hours per
response are based on past FDA
experience with the various waiver
requests in FDA’s Center for Drug
Evaluation and Research. The hours per
response are based on the average of
these estimates.
Dated: June 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11425 Filed 6–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0221]
Otsuka Pharmaceutical Co., Ltd.;
Withdrawal of Approval of a New Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for RAXAR (grepafloxacin
hydrochloride (HCl)) Tablets held by
Otsuka Pharmaceutical Co., Ltd.
(Otsuka), c/o Otsuka Pharmaceutical
Development & Commercialization, Inc.,
VerDate Aug<31>2005
17:22 Jun 13, 2007
Jkt 211001
2440 Research Blvd., Rockville, MD
20850. Otsuka has voluntarily requested
that approval of this application be
withdrawn because the product is no
longer marketed, thereby waiving its
opportunity for a hearing.
DATES: Effective June 14, 2007.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION: In a letter
dated March 5, 2003, Otsuka requested
that FDA withdraw approval of NDA
20–695 for RAXAR (grepafloxacin HC1)
Tablets, stating that the product was no
longer being marketed. In FDA’s
acknowledgment letter of June 20, 2003,
the agency informed Otsuka that
RAXAR (grepafloxacin HCl) Tablets,
indicated for the treatment of a variety
of infections, had been removed from
the market because of safety concerns;
in its follow-up letter of January 12,
2007, the agency also informed Otsuka
that it had determined that the RAXAR
NDA should be withdrawn under
§ 314.150(d) (21 CFR 314.150(d))
because of its effect on cardiac
repolarization, manifested as QTc
interval prolongation on the
electrocardiogram, which could put
patients at risk of Torsade de Pointes. In
its letter of March 20, 2007, Otsuka
concurred in the agency’s determination
to initiate withdrawal of the RAXAR
NDA and waived its opportunity for a
hearing, provided under 21 CFR
314.150(a) and (b).
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(e)), § 314.150(d),
and under authority delegated to the
Director, Center for Drug Evaluation and
Research (21 CFR 5.105(a)), approval of
the NDA 20–695, and all amendments
and supplements thereto, is withdrawn,
effective (see DATES). Distribution of this
product in interstate commerce without
an approved application is illegal and
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
subject to regulatory action (see sections
505(a) and 301(d) of the act (21 U.S.C.
331(d)).
Dated: May 31, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–11427 Filed 6–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
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: Oncologic 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 July 24, 2007, from 8 a.m. to 5
p.m.
Location: Advisors and Consultants
Staff Conference Room, 5630 Fishers
Lane, rm. 1066, Rockville, MD 20857.
Contact Person: Johanna Clifford,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
6761, FAX: 301–827–6776, e-mail:
Johanna.Clifford@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
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]]>Agencies
[Federal Register Volume 72, Number 114 (Thursday, June 14, 2007)]
[Notices]
[Pages 32851-32852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11425]
[[Page 32851]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0219]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Drug User Fees and Fee Waivers and Reductions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements for
the animal drug user fees, fee waivers and reductions.
DATES: Submit written or electronic comments on the collection of
information by August 13, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information 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: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506
(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Animal Drug User Fees and Fee Waivers and Reductions (OMB Control
Number 0910-0540)--Extension
Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA)
(Public Law 108-130), amended the Federal Food, Drug, and Cosmetic Act
and requires FDA to assess and collect user fees for certain
applications, products, establishments, and sponsors. It also requires
the agency to grant a waiver from, or a reduction of those fees in
certain circumstances. Thus, to implement this statutory provision of
ADUFA, FDA developed a guidance entitled ``Guidance for Industry:
Animal Drug User Fees and Fee Waivers and Reductions.'' This document
provides guidance on the types of fees FDA is authorized to collect
under ADUFA, and how to request waivers and reductions from FDA's
animal drug user fees. Further, this guidance also describes the types
of fees and fee waivers and reductions; what information FDA recommends
be submitted in support of a request for a fee waiver or reduction; how
to submit such a request; and FDA's process for reviewing requests.
Requests for waivers or reductions may be submitted by a person paying
any of the animal drug user fees assessed--application fees, product
fees, establishment fees, or sponsor fees.
Respondents to this collection of information are new animal drug
sponsors.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(d)(1)(A) Significant barrier to innovation 5 1 time for each 5 2 10
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(d)(1)(B) Fees exceed cost 1 1 time for each 1 2 2
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(d)(1)(C) Free choice feeds 5 1 time for each 5 2 10
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(d)(1)(D) Minor use or minor species 10 1 time for each 10 2 20
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(d)(1)(E) Small business 2 1 time for each 2 2 4
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 32852]]
Request for reconsideration of a decision 5 1 time for each 5 2 10
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for review--(user fee appeal officer) 2 1 time for each 2 2 4
application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA's database system, there are an estimated 250 sponsors
of products subject to ADUFA. However, not all sponsors will have any
submissions in a given year and some may have multiple submissions. The
total number of waiver requests is based on the number of submission
types received by FDA in fiscal year 2003. FDA's Center for Veterinary
Medicine estimates 30 waiver requests that include the following: 5
significant barriers to innovation, 1 fee exceed cost, 5 free choice
feeds, 10 minor use or minor species, 2 small business waiver requests,
5 requests for reconsideration of a decision, and 2 requests for user
fee appeal officer. The estimated hours per response are based on past
FDA experience with the various waiver requests in FDA's Center for
Drug Evaluation and Research. The hours per response are based on the
average of these estimates.
Dated: June 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11425 Filed 6-13-07; 8:45 am]
BILLING CODE 4160-01-S
