Submission for OMB Review; Comment Request; Evaluation of National Cancer Institute's Central Institutional Review Board To Improve Cancer Clinical Trials System, 25092-25093 [05-9510]
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Federal Register / Vol. 70, No. 91 / Thursday, May 12, 2005 / Notices
ERTACZO and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
that claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Claudia Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6699.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted, as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product ERTACZO
(sertaconazole nitrate). ERTACZO is
indicated for the topical treatment of
athlete’s foot (interdigital tinea pedis)
caused by certain fungus (Trichophyton
rubrum, T. mentagrophytes, and
Epidermophyton floccosum). ERTACZO
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is for people 12 years of age and older
who have a normal immune system.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
ERTACZO (U.S. Patent No. 5,135,943)
from Ferrer Internacional, S.A., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated August 31,
2004, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
ERTACZO represented the first
permitted commercial marketing or use
of the product. Thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
ERTACZO is 2,718 days. Of this time,
1,914 days occurred during the testing
phase of the regulatory review period,
while 804 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355) became effective: July 3, 1996. The
applicant claims June 11, 1996, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was July 3, 1996,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the act: September 28, 2001. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
ERTACZO (NDA 21–385) was initially
submitted on September 28, 2001.
3. The date the application was
approved: December 10, 2003. FDA has
verified the applicant’s claim that NDA
21–385 was approved on December 10,
2003.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,776 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written
comments and ask for a redetermination
by July 11, 2005. Furthermore, any
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Frm 00079
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Sfmt 4703
interested person may petition FDA for
a determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by November 8, 2005. To meet its
burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: March 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 05–9462 Filed 5–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Evaluation of
National Cancer Institute’s Central
Institutional Review Board To Improve
Cancer Clinical Trials System
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on July 19, 2004 on page 43003
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Evaluation
of National Cancer Institute’s Central
Institutional Review Board to Improve
Cancer Clinical Trials System. Type of
E:\FR\FM\12MYN1.SGM
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25093
Federal Register / Vol. 70, No. 91 / Thursday, May 12, 2005 / Notices
Information Collection Request: NEW.
Need and Use of Information Collection:
This study will evaluate the
effectiveness of the Central Institutional
Review Board (CIRB), a pilot project
designed to streamline the protocol
activation process by conducting human
subject protection reviews that can be
utilized by local Institutional Review
Boards (IRB) for facilitated approval of
multi-institutional, NCI-sponsored
Phase 3 clinical trials. This evaluation
includes two surveys that will be made
available online to minimize respondent
burden. The CIRB survey will assess
acceptance level and satisfaction of
local IRB chairs, coordinators, and
principal investigators with the CIRB.
The Cooperative Group Staff Survey
will assess the opinions and experiences
of the operations and regulations staff of
the nine Clinical Trials Cooperative
Groups about CIRB operations, office
processes, and procedures. The findings
will provide valuable information
concerning whether the CIRB is meeting
its intended goals and will provide
recommendations for change and
further study. Frequency of Response:
Once. Affected Public: Registered
members of the CIRB and Clinical Trials
Cooperative Group Staff. Type of
Respondents: IRB chairs, IRB
coordinators, principal investigators,
and the operations and regulations staff
of Clinical Trials Cooperative Groups.
The annualized cost to respondents is
estimated at $5,500. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report. Estimated Number of
Respondents: 279. Estimated Number of
Responses per Respondent: 1. Average
Burden per Response: 0.50 hours.
Estimated Total Annual Burden Hours
Requested: 139.50. The total burden
estimate per respondent is shown
below.
TABLE 1.—TOTAL BURDEN ESTIMATE PER RESPONDENT
Estimated
number of responses per
respondent
Estimated
number of
respondents
Type of respondent
Average burden per
response
Estimated total
annual burden
hour request
IRB Chairs, IRB Coordinators, principal investigators .....................................
Clinical Trials Cooperative Group operations and regulations staff ................
225
54
1
1
0.50
0.50
112.50
27
Total ..........................................................................................................
........................
........................
........................
139.50
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’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 those who are able to respond,
including the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the items contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Bryce B.
Reeve, PhD, Outcomes Research Branch,
ARP, DCCPS, National Cancer Institute,
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19:04 May 11, 2005
Jkt 205001
6130 Executive Blvd. MSC 7344,
Bethesda, MD 20892–7344. Phone: (301)
594–6574, e-mail: reeveb@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of this
publication.
Dated: May 1, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 05–9510 Filed 5–11–05; 8:45 am]
BILLING CODE 4101–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment
Request, Survey of Colorectal Cancer
Screening Policies, Programs, and
Systems in U.S. Health Plans
Summary: In compliance with the
provisions of Section 3507(1)(D) of the
Paperwork Reduction Act of 1995, for
opportunity for public comments on
proposed data collection projects, the
National Institutes of Health (NIH),
National Cancer Institute (NCI) has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on October 29,
2004 (Volume 69, No. 209, pages 63159–
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
63160) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB number.
Proposed Collection: Title: Survey of
Colorectal Cancer Screening Policies,
Programs, and Systems in U.S. Health
Plans. Type of Information Collection
Request: New. Need and Use of
Information collection: This study will
obtain information on policies,
programs, and practices for colorectal
cancer screening among health plans in
the U.S. The purpose of the study is to
assess (1) Health plan policies,
programs, and practices for colorectal
cancer screening; (2) health plan
activities in response to the National
Committee on Quality Assurance’s new
Health Employer Data Information Set
measure for colorectal cancer screening;
and (3) characteristics of health plans
and plan policies and activities that may
be associated with higher rates of
colorectal cancer screening. A
questionnaire will be administered by
mail or Internet using a national sample
of health plans. Study participants will
be health plan medical directors or
administrators, and they will select their
E:\FR\FM\12MYN1.SGM
12MYN1
]]>Agencies
[Federal Register Volume 70, Number 91 (Thursday, May 12, 2005)]
[Notices]
[Pages 25092-25093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9510]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Evaluation of
National Cancer Institute's Central Institutional Review Board To
Improve Cancer Clinical Trials System
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Cancer Institute (NCI),
the National Institutes of Health has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on July 19,
2004 on page 43003 and allowed 60 days for public comment. No public
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Evaluation of National Cancer
Institute's Central Institutional Review Board to Improve Cancer
Clinical Trials System. Type of
[[Page 25093]]
Information Collection Request: NEW. Need and Use of Information
Collection: This study will evaluate the effectiveness of the Central
Institutional Review Board (CIRB), a pilot project designed to
streamline the protocol activation process by conducting human subject
protection reviews that can be utilized by local Institutional Review
Boards (IRB) for facilitated approval of multi-institutional, NCI-
sponsored Phase 3 clinical trials. This evaluation includes two surveys
that will be made available online to minimize respondent burden. The
CIRB survey will assess acceptance level and satisfaction of local IRB
chairs, coordinators, and principal investigators with the CIRB. The
Cooperative Group Staff Survey will assess the opinions and experiences
of the operations and regulations staff of the nine Clinical Trials
Cooperative Groups about CIRB operations, office processes, and
procedures. The findings will provide valuable information concerning
whether the CIRB is meeting its intended goals and will provide
recommendations for change and further study. Frequency of Response:
Once. Affected Public: Registered members of the CIRB and Clinical
Trials Cooperative Group Staff. Type of Respondents: IRB chairs, IRB
coordinators, principal investigators, and the operations and
regulations staff of Clinical Trials Cooperative Groups. The annualized
cost to respondents is estimated at $5,500. There are no Capital Costs
to report. There are no Operating or Maintenance Costs to report.
Estimated Number of Respondents: 279. Estimated Number of Responses per
Respondent: 1. Average Burden per Response: 0.50 hours. Estimated Total
Annual Burden Hours Requested: 139.50. The total burden estimate per
respondent is shown below.
Table 1.--Total Burden Estimate Per Respondent
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondent number of responses per per response burden hour
respondents respondent request
----------------------------------------------------------------------------------------------------------------
IRB Chairs, IRB Coordinators, principal 225 1 0.50 112.50
investigators..................................
Clinical Trials Cooperative Group operations and 54 1 0.50 27
regulations staff..............................
-----------------
Total....................................... .............. .............. .............. 139.50
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility; (2) the
accuracy of the agency'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 those who are able to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the items contained in this notice, especially regarding the
estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact Bryce B. Reeve, PhD, Outcomes Research Branch,
ARP, DCCPS, National Cancer Institute, 6130 Executive Blvd. MSC 7344,
Bethesda, MD 20892-7344. Phone: (301) 594-6574, e-mail:
reeveb@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of this publication.
Dated: May 1, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 05-9510 Filed 5-11-05; 8:45 am]
BILLING CODE 4101-01-P
