Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank, 59295-59297 [E7-20662]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices
practices in programs, services and
supports for persons with intellectual
disabilities, and for reviewing legislative
proposals that impact the quality of life
experienced by citizens with
intellectual disabilities and their
families.
Dated: October 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20632 Filed 10–18–07; 8:45 am]
Dated: October 3, 2007.
Sally D. Atwater,
Executive Director, President’s Committee for
People With Intellectual Disabilities.
[FR Doc. E7–20617 Filed 10–18–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4184–01–P
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information
Program on Clinical Trials for Serious
or Life-Threatening Diseases:
Maintaining a Data Bank
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guide to Minimize Food Safety
Hazards for Fresh-Cut Fruits and
Vegetables
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guide to Minimize Food Safety
Hazards for Fresh-Cut Fruits and
Vegetables’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of March 13, 2007 (72
FR 11364), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0609. The
approval expires on October 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
pwalker on PROD1PC71 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
16:46 Oct 18, 2007
Food and Drug Administration
[Docket No. 2007N–0182]
AGENCY:
[Docket No. 2006D–0079]
AGENCY:
BILLING CODE 4160–01–S
Jkt 214001
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
19, 2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0459. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Information Program on Clinical Trials
for Serious or Life-Threatening
Diseases: Maintaining a Data Bank—
(OMB Control Number 0910–0459)—
Extension
In the Federal Register of March 18,
2002 (67 FR 12022), FDA issued a
guidance to industry on
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
59295
recommendations for investigational
new drug application (IND) sponsors on
submitting information about clinical
trials for serious or life-threatening
diseases to a Clinical Trials Data Bank
developed by the National Library of
Medicine (NLM), National Institutes of
Health (NIH). This information is
especially important for patients and
their families seeking opportunities to
participate in clinical trials of new drug
treatments for serious or life-threatening
diseases. The guidance describes three
collections of information: Mandatory
submissions, voluntary submissions,
and certifications.
Mandatory Submissions
Section 113 of the Food and Drug
Administration Modernization Act
(FDAMA) of 1997 (the Modernization
Act) (Public Law 105–115) requires that
sponsors shall submit information to the
Clinical Trials Data Bank when the
clinical trial: (1) Involves a treatment for
a serious or life-threatening disease and
(2) is intended to assess the
effectiveness of the treatment. The
guidance discusses how sponsors can
fulfill the requirements of section 113 of
the Modernization Act. Specifically,
sponsors should provide: (1)
Information about clinical trials, both
federally and privately funded, of
experimental treatments (drugs,
including biological products) for
patients with serious or life-threatening
diseases; (2) a description of the
purpose of the experimental drug; (3)
patient eligibility criteria; (4) the
location of clinical trial sites; and (5) a
point of contact for patients wanting to
enroll in the trial.
Senate 1789, ‘‘Best Pharmaceuticals
for Children Act’’ (Public Law 107–109)
(BPCA), established a new requirement
for the Clinical Trials Data Bank
mandated by section 113 of FDAMA.
Information submitted to the data bank
must now include ‘‘a description of
whether and through what procedure,
the manufacturer or sponsor of the
investigation of a new drug will respond
to requests for protocol exception, with
appropriate safeguards, for singlepatient and expanded protocol use of
the new drug, particularly in children.’’
The guidance was updated on January
27, 2004, to include a discussion of how
sponsors can fulfill the BPCA
requirements.
As part of the resubmission process
for OMB approval, this information
collection request (ICR) has been revised
to include the burden associated with
new requirements imposed by the
Centers for Medicare and Medicaid
Services (CMS). On September 19, 2000,
the Health Care Financing
Administration (now CMS)
E:\FR\FM\19OCN1.SGM
19OCN1
pwalker on PROD1PC71 with NOTICES
59296
Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices
implemented a Clinical Trial Policy
through the National Coverage
Determination process. The Clinical
Trial Policy was developed in response
to a June 7, 2000, executive
memorandum, issued by President
Clinton, requiring Medicare to pay for
routine patient costs in clinical trials.
The original policy suggested that a
registry be established into which
studies meeting the criteria for coverage
under the policy would be enrolled for
administrative purposes. This registry
was never established.
On July 10, 2006, CMS opened a
reconsideration of its national coverage
determination on clinical trials. The
purpose of the reconsideration is to
further refine the policy to rename it the
Clinical Research Policy (CRP) to
address several ambiguities, including
the link between the CRP and the
Coverage with Evidence Development
concept, and the authority to allow the
agency to pay for the costs of limited
investigational items. One requirement
to qualify for coverage of clinical costs
under the proposed policy is that the
study must be enrolled in the NLM
Clinical Trials Data Bank.
Voluntary Submissions
Section 113 of the Modernization Act
also specifies that sponsors may
voluntarily submit information
pertaining to results of clinical trials,
including information on potential
toxicities or adverse effects associated
with the use or administration of the
investigational treatment. Sponsors may
also voluntarily submit studies that are
not trials to test effectiveness, or not for
serious or life-threatening diseases, to
the Clinical Trials Data Bank.
Certifications
Section 113 of the Modernization Act
specifies that the data bank will not
include information relating to a trial if
the sponsor certifies to the Secretary of
Health and Human Services (the
Secretary) that disclosure of the
information would substantially
interfere with the timely enrollment of
subjects in the investigation, unless the
Secretary makes a determination to the
contrary.
Description of Respondents: A
sponsor of a drug or biologic product
regulated by the agency under the
Federal Food, Drug, and Cosmetic Act
or section 351 of the Public Health
Service Act (42 U.S.C. 262) who submits
a clinical trial to test effectiveness of a
drug or biologic product for a serious or
life-threatening disease.
For the purposes of CMS, the
respondents will be providers that are
conducting or sponsoring clinical trials
that are seeking to have the clinical
VerDate Aug<31>2005
16:46 Oct 18, 2007
Jkt 214001
costs of their studies reimbursed by
Medicare.
Burden Estimate: The information
required under section 113(a) of the
Modernization Act is currently
submitted to FDA under 21 CFR part
312, and this collection of information
is approved under OMB Control
Number 0910–0014 until May 31, 2009,
and, therefore, does not represent a new
information collection requirement.
Instead, preparation of submissions
under section 113 of the Modernization
Act involves extracting and reformatting
information already submitted to FDA.
Procedures (where and how) for the
actual submission of this information to
the Clinical Trials Data Bank are
addressed in the guidance.
The Center for Drug Evaluation and
Research (CDER) received 4,858 new
protocols in 2005. CDER anticipates that
protocol submission rates will remain at
or near this level in the near future. Of
these new protocols, an estimated twothirds1 are for serious or life-threatening
diseases and would be subject to either
voluntary or mandatory reporting
requirements under section 113 of the
Modernization Act. Two-thirds of 4,858
protocols per year is 3,239 new
protocols per year. An estimated 50
percent1 of the new protocols for serious
or life-threatening diseases submitted to
CDER are for clinical trials involving
assessment for effectiveness, and are
subject to the mandatory reporting
requirements under section 113 of the
Modernization Act. Fifty percent of
3,239 protocols per year is 1,620 new
protocols per year subject to mandatory
reporting. The remaining 3,238 new
protocols per year are subject to
voluntary reporting.
The Center for Biologics Evaluation
and Research (CBER) received 474 new
protocols in 2005. CBER anticipates that
protocol submission rates will remain at
or near this level in the near future. An
estimated two-thirds1 of the new
protocols submitted to CBER are for
clinical trials involving a serious or lifethreatening disease, and would be
subject to either voluntary or mandatory
reporting requirements under section
113 of the Modernization Act. Twothirds of 474 new protocols per year is
316 new protocols per year. An
estimated 50 percent1 of the new
protocols for serious or life-threatening
diseases submitted to CBER are for
clinical trials involving assessments for
effectiveness. Fifty percent of 316
protocols per year is an estimated 158
new protocols per year subject to the
1Estimate obtained from a review of 2,062
protocols submitted to CDER between January 1,
2002, and September 30, 2002.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
mandatory reporting requirements
under section 113 of the Modernization
Act. The remaining 316 new protocols
per year are subject to voluntary
reporting.
The estimated total number of new
protocols for serious or life-threatening
diseases subject to mandatory reporting
requirements under section 113 of the
Modernization Act is 1,620 for CDER
plus 158 for CBER, or 1,778 new
protocols per year. The remainder of
protocols submitted to CDER or CBER
will be subject to voluntary reporting,
including clinical trials not involving a
serious or life-threatening disease as
well as trials in a serious or lifethreatening disease but not involving
assessment of effectiveness. Therefore,
the total number of protocols (5,332)
minus the protocols subject to
mandatory reporting requirements
(1,778) will be subject to voluntary
reporting, or 3,554 protocols.
Our total burden estimate includes
multi-center studies and accounts for
the quality control review of the data
before it is submitted to the data bank.
The number of IND amendments
submitted in 2005 for protocol changes
(e.g., changes in eligibility criteria) was
7,597 for CDER and 855 for CBER. The
number of IND amendments submitted
in 2005 for new investigators was
11,287 for CDER and 532 for CBER. The
number of protocol changes and new
investigators was apportioned
proportionally between mandatory and
voluntary submissions. We recognize
that single submissions may include
information about multiple sites.
Generally, there is no submission to
FDA when an individual study site is no
longer recruiting study subjects. For this
analysis, we assumed that the number of
study sites closed each year is similar to
the number of new investigator
amendments received by FDA (11,287
CDER and 532 CBER).
Generally, there is no submission to
FDA when the study is closed to
enrollment. We estimate the number of
protocols closed to enrollment each year
is similar to the number of new
protocols submitted (4,858 CDER and
474 CBER).
The hours per response is the
estimated number of hours that a
respondent would spend preparing the
information to be submitted under
section 113(a) of the Modernization Act,
including the time it takes to extract and
reformat the information. FDA has been
advised that some sponsors lack
information system capabilities enabling
efficient collection of company-wide
information on clinical trials subject to
reporting requirements under section
113(a) of the Modernization Act.
E:\FR\FM\19OCN1.SGM
19OCN1
59297
Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices
The estimation of burden under
section 113(a) reflects the relative
inefficiency of this process for these
firms.
Based on its experience reviewing
INDs, consideration of the information
in the previous paragraphs, and further
consultation with sponsors who submit
protocol information to the Clinical
Trials Data Bank, FDA estimated that
approximately 4.6 hours on average
would be needed per response. The
estimate incorporates 2.6 hours for data
extraction and 2.0 hours for reformatting
based on data collected from
organizations currently submitting
protocols to the Clinical Trials Data
Bank. We considered quality control
issues when developing the current
burden estimates of 2.6 hours for data
extraction and the 2.0 hours estimated
for reformatting. Additionally, the
Internet-based data entry system
developed by NIH incorporates features
that further decrease the sponsor’s time
requirements for quality control
procedures. The Clinical Trials Data
Bank was set up to receive protocol
information transmitted electronically
by sponsors. Approximately 10 percent
of sponsors electronically transmit
information to the Clinical Trials Data
Bank. If the sponsor chooses to
manually enter the protocol
information, the data entry system
allows it to be entered in a uniform and
efficient manner primarily through
pulldown menus. As sponsors’
familiarity with the data entry system
increases, the hourly burden will
continue to decrease.
A sponsor of a study subject to the
requirements of section 113 of the
Modernization Act will have the option
of submitting data under that section or
certifying to the Secretary that
disclosure of information for a specific
protocol would substantially interfere
with the timely enrollment of subjects
in the clinical investigation. FDA has no
means to accurately predict the
proportion of protocols subject to the
requirements of section 113 of the
Modernization Act that will be subject
to a certification submission. To date,
no certifications have been received. It
is anticipated that the burden associated
with such certification will be
comparable to that associated with
submission of data regarding a protocol.
Therefore, the overall burden is
anticipated to be the same, regardless of
whether the sponsor chooses data
submission or certification for
nonsubmission. Table 1 of this
document reflects the estimate of this
total burden.
In the Federal Register of May 14,
2007 (72 FR 27140), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
New Protocols
Recruitment
Complete
Protocol
Changes
New
Investigators
Sites Closed
Total
Responses
Hours Per
Response
Total
Hours
CDER (mandatory)
1,620
1,620
2,507
3,725
13,197
4.6
60,706
CBER (mandatory)
158
158
282
176
950
4.6
4,370
CDER (voluntary)
3,238
3,238
5,090
7,562
26,690
4.6
122,774
CDER (voluntary)
316
316
573
356
1,917
4.6
8,818
Total
pwalker on PROD1PC71 with NOTICES
1There
196,668
are no capital costs or operating and maintenance costs associated with this collection of information.
CMS Burden Estimate:
The burden associated with CMS’
requirements is the time and effort
necessary for the provider to extract the
data elements from the study protocol
and reformatting and entering the
information into the data bank. We
estimate that approximately 745 clinical
research studies will register on the
NLM data bank. The number was
derived from a search of the database on
September 1, 2006, restricting the search
by age (e.g., > 65 years of age); sponsor
(e.g., NIH, industry, other federal
agency, university/organization); Phase
II, III, or IV; and by type of study (e.g.,
cancers and other neoplasms, diagnosis,
and devices). The age, sponsor, and
study phase was applied to each of the
three separate searches by type of study.
The following number of studies by
study type, including trials no longer
recruiting was 562 for diagnosis, 164 for
cancers and other neoplasms, and 19 for
devices. In determining the total
number of hours requested, the CMS
estimate uses the same assumptions
VerDate Aug<31>2005
16:46 Oct 18, 2007
Jkt 214001
used by FDA to estimate its total
number of burden hours. Therefore, the
total annual burden associated with this
requirement is 27,480 hours (5,974
responses x 4.6 hours per response).
We believe the combined estimate of
burden attributable to FDA and CMS
requirements, 224,148 burden hours
(196,668 burden hours + 27,480 burden
hours) accurately reflects the total
burden associated with this information
collection request. We recognize that
companies who are less familiar with
the data entry system and the Clinical
Trials Data Bank will require greater
than 4.6 hours per response. However,
as sponsor familiarity with the system
increases, the hourly estimate will
decrease.
Dated: October 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20662 Filed 10–18–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0327]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Remote Medication Management
System; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Class II Special Controls Guidance
Document: Remote Medication
Management System.’’ This guidance
document describes a means by which
remote medication management systems
may comply with the requirement of
special controls for class II devices.
Elsewhere in this issue of the Federal
E:\FR\FM\19OCN1.SGM
19OCN1
]]>Agencies
[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Notices]
[Pages 59295-59297]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20662]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0182]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Information Program
on Clinical Trials for Serious or Life-Threatening Diseases:
Maintaining a Data Bank
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 19, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0459. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Information Program on Clinical Trials for Serious or Life-Threatening
Diseases: Maintaining a Data Bank--(OMB Control Number 0910-0459)--
Extension
In the Federal Register of March 18, 2002 (67 FR 12022), FDA issued
a guidance to industry on recommendations for investigational new drug
application (IND) sponsors on submitting information about clinical
trials for serious or life-threatening diseases to a Clinical Trials
Data Bank developed by the National Library of Medicine (NLM), National
Institutes of Health (NIH). This information is especially important
for patients and their families seeking opportunities to participate in
clinical trials of new drug treatments for serious or life-threatening
diseases. The guidance describes three collections of information:
Mandatory submissions, voluntary submissions, and certifications.
Mandatory Submissions
Section 113 of the Food and Drug Administration Modernization Act
(FDAMA) of 1997 (the Modernization Act) (Public Law 105-115) requires
that sponsors shall submit information to the Clinical Trials Data Bank
when the clinical trial: (1) Involves a treatment for a serious or
life-threatening disease and (2) is intended to assess the
effectiveness of the treatment. The guidance discusses how sponsors can
fulfill the requirements of section 113 of the Modernization Act.
Specifically, sponsors should provide: (1) Information about clinical
trials, both federally and privately funded, of experimental treatments
(drugs, including biological products) for patients with serious or
life-threatening diseases; (2) a description of the purpose of the
experimental drug; (3) patient eligibility criteria; (4) the location
of clinical trial sites; and (5) a point of contact for patients
wanting to enroll in the trial.
Senate 1789, ``Best Pharmaceuticals for Children Act'' (Public Law
107-109) (BPCA), established a new requirement for the Clinical Trials
Data Bank mandated by section 113 of FDAMA. Information submitted to
the data bank must now include ``a description of whether and through
what procedure, the manufacturer or sponsor of the investigation of a
new drug will respond to requests for protocol exception, with
appropriate safeguards, for single-patient and expanded protocol use of
the new drug, particularly in children.'' The guidance was updated on
January 27, 2004, to include a discussion of how sponsors can fulfill
the BPCA requirements.
As part of the resubmission process for OMB approval, this
information collection request (ICR) has been revised to include the
burden associated with new requirements imposed by the Centers for
Medicare and Medicaid Services (CMS). On September 19, 2000, the Health
Care Financing Administration (now CMS)
[[Page 59296]]
implemented a Clinical Trial Policy through the National Coverage
Determination process. The Clinical Trial Policy was developed in
response to a June 7, 2000, executive memorandum, issued by President
Clinton, requiring Medicare to pay for routine patient costs in
clinical trials. The original policy suggested that a registry be
established into which studies meeting the criteria for coverage under
the policy would be enrolled for administrative purposes. This registry
was never established.
On July 10, 2006, CMS opened a reconsideration of its national
coverage determination on clinical trials. The purpose of the
reconsideration is to further refine the policy to rename it the
Clinical Research Policy (CRP) to address several ambiguities,
including the link between the CRP and the Coverage with Evidence
Development concept, and the authority to allow the agency to pay for
the costs of limited investigational items. One requirement to qualify
for coverage of clinical costs under the proposed policy is that the
study must be enrolled in the NLM Clinical Trials Data Bank.
Voluntary Submissions
Section 113 of the Modernization Act also specifies that sponsors
may voluntarily submit information pertaining to results of clinical
trials, including information on potential toxicities or adverse
effects associated with the use or administration of the
investigational treatment. Sponsors may also voluntarily submit studies
that are not trials to test effectiveness, or not for serious or life-
threatening diseases, to the Clinical Trials Data Bank.
Certifications
Section 113 of the Modernization Act specifies that the data bank
will not include information relating to a trial if the sponsor
certifies to the Secretary of Health and Human Services (the Secretary)
that disclosure of the information would substantially interfere with
the timely enrollment of subjects in the investigation, unless the
Secretary makes a determination to the contrary.
Description of Respondents: A sponsor of a drug or biologic product
regulated by the agency under the Federal Food, Drug, and Cosmetic Act
or section 351 of the Public Health Service Act (42 U.S.C. 262) who
submits a clinical trial to test effectiveness of a drug or biologic
product for a serious or life-threatening disease.
For the purposes of CMS, the respondents will be providers that are
conducting or sponsoring clinical trials that are seeking to have the
clinical costs of their studies reimbursed by Medicare.
Burden Estimate: The information required under section 113(a) of
the Modernization Act is currently submitted to FDA under 21 CFR part
312, and this collection of information is approved under OMB Control
Number 0910-0014 until May 31, 2009, and, therefore, does not represent
a new information collection requirement. Instead, preparation of
submissions under section 113 of the Modernization Act involves
extracting and reformatting information already submitted to FDA.
Procedures (where and how) for the actual submission of this
information to the Clinical Trials Data Bank are addressed in the
guidance.
The Center for Drug Evaluation and Research (CDER) received 4,858
new protocols in 2005. CDER anticipates that protocol submission rates
will remain at or near this level in the near future. Of these new
protocols, an estimated two-thirds\1\ are for serious or life-
threatening diseases and would be subject to either voluntary or
mandatory reporting requirements under section 113 of the Modernization
Act. Two-thirds of 4,858 protocols per year is 3,239 new protocols per
year. An estimated 50 percent\1\ of the new protocols for serious or
life-threatening diseases submitted to CDER are for clinical trials
involving assessment for effectiveness, and are subject to the
mandatory reporting requirements under section 113 of the Modernization
Act. Fifty percent of 3,239 protocols per year is 1,620 new protocols
per year subject to mandatory reporting. The remaining 3,238 new
protocols per year are subject to voluntary reporting.
---------------------------------------------------------------------------
\1\Estimate obtained from a review of 2,062 protocols submitted
to CDER between January 1, 2002, and September 30, 2002.
---------------------------------------------------------------------------
The Center for Biologics Evaluation and Research (CBER) received
474 new protocols in 2005. CBER anticipates that protocol submission
rates will remain at or near this level in the near future. An
estimated two-thirds\1\ of the new protocols submitted to CBER are for
clinical trials involving a serious or life-threatening disease, and
would be subject to either voluntary or mandatory reporting
requirements under section 113 of the Modernization Act. Two-thirds of
474 new protocols per year is 316 new protocols per year. An estimated
50 percent\1\ of the new protocols for serious or life-threatening
diseases submitted to CBER are for clinical trials involving
assessments for effectiveness. Fifty percent of 316 protocols per year
is an estimated 158 new protocols per year subject to the mandatory
reporting requirements under section 113 of the Modernization Act. The
remaining 316 new protocols per year are subject to voluntary
reporting.
The estimated total number of new protocols for serious or life-
threatening diseases subject to mandatory reporting requirements under
section 113 of the Modernization Act is 1,620 for CDER plus 158 for
CBER, or 1,778 new protocols per year. The remainder of protocols
submitted to CDER or CBER will be subject to voluntary reporting,
including clinical trials not involving a serious or life-threatening
disease as well as trials in a serious or life-threatening disease but
not involving assessment of effectiveness. Therefore, the total number
of protocols (5,332) minus the protocols subject to mandatory reporting
requirements (1,778) will be subject to voluntary reporting, or 3,554
protocols.
Our total burden estimate includes multi-center studies and
accounts for the quality control review of the data before it is
submitted to the data bank. The number of IND amendments submitted in
2005 for protocol changes (e.g., changes in eligibility criteria) was
7,597 for CDER and 855 for CBER. The number of IND amendments submitted
in 2005 for new investigators was 11,287 for CDER and 532 for CBER. The
number of protocol changes and new investigators was apportioned
proportionally between mandatory and voluntary submissions. We
recognize that single submissions may include information about
multiple sites.
Generally, there is no submission to FDA when an individual study
site is no longer recruiting study subjects. For this analysis, we
assumed that the number of study sites closed each year is similar to
the number of new investigator amendments received by FDA (11,287 CDER
and 532 CBER).
Generally, there is no submission to FDA when the study is closed
to enrollment. We estimate the number of protocols closed to enrollment
each year is similar to the number of new protocols submitted (4,858
CDER and 474 CBER).
The hours per response is the estimated number of hours that a
respondent would spend preparing the information to be submitted under
section 113(a) of the Modernization Act, including the time it takes to
extract and reformat the information. FDA has been advised that some
sponsors lack information system capabilities enabling efficient
collection of company-wide information on clinical trials subject to
reporting requirements under section 113(a) of the Modernization Act.
[[Page 59297]]
The estimation of burden under section 113(a) reflects the relative
inefficiency of this process for these firms.
Based on its experience reviewing INDs, consideration of the
information in the previous paragraphs, and further consultation with
sponsors who submit protocol information to the Clinical Trials Data
Bank, FDA estimated that approximately 4.6 hours on average would be
needed per response. The estimate incorporates 2.6 hours for data
extraction and 2.0 hours for reformatting based on data collected from
organizations currently submitting protocols to the Clinical Trials
Data Bank. We considered quality control issues when developing the
current burden estimates of 2.6 hours for data extraction and the 2.0
hours estimated for reformatting. Additionally, the Internet-based data
entry system developed by NIH incorporates features that further
decrease the sponsor's time requirements for quality control
procedures. The Clinical Trials Data Bank was set up to receive
protocol information transmitted electronically by sponsors.
Approximately 10 percent of sponsors electronically transmit
information to the Clinical Trials Data Bank. If the sponsor chooses to
manually enter the protocol information, the data entry system allows
it to be entered in a uniform and efficient manner primarily through
pulldown menus. As sponsors' familiarity with the data entry system
increases, the hourly burden will continue to decrease.
A sponsor of a study subject to the requirements of section 113 of
the Modernization Act will have the option of submitting data under
that section or certifying to the Secretary that disclosure of
information for a specific protocol would substantially interfere with
the timely enrollment of subjects in the clinical investigation. FDA
has no means to accurately predict the proportion of protocols subject
to the requirements of section 113 of the Modernization Act that will
be subject to a certification submission. To date, no certifications
have been received. It is anticipated that the burden associated with
such certification will be comparable to that associated with
submission of data regarding a protocol. Therefore, the overall burden
is anticipated to be the same, regardless of whether the sponsor
chooses data submission or certification for nonsubmission. Table 1 of
this document reflects the estimate of this total burden.
In the Federal Register of May 14, 2007 (72 FR 27140), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recruitment Protocol New Total Hours Per
New Protocols Complete Changes Investigators Sites Closed Responses Response Total Hours
------------------------------------------------------------------------------------------------------------------------------------------
CDER (mandatory) 1,620 1,620 2,507 3,725 13,197 4.6 60,706
--------------------------------------------------------------------------------------------------------------------------------------------
CBER (mandatory) 158 158 282 176 950 4.6 4,370
--------------------------------------------------------------------------------------------------------------------------------------------
CDER (voluntary) 3,238 3,238 5,090 7,562 26,690 4.6 122,774
--------------------------------------------------------------------------------------------------------------------------------------------
CDER (voluntary) 316 316 573 356 1,917 4.6 8,818
--------------------------------------------------------------------------------------------------------------------------------------------
Total 196,668
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
CMS Burden Estimate:
The burden associated with CMS' requirements is the time and effort
necessary for the provider to extract the data elements from the study
protocol and reformatting and entering the information into the data
bank. We estimate that approximately 745 clinical research studies will
register on the NLM data bank. The number was derived from a search of
the database on September 1, 2006, restricting the search by age (e.g.,
> 65 years of age); sponsor (e.g., NIH, industry, other federal agency,
university/organization); Phase II, III, or IV; and by type of study
(e.g., cancers and other neoplasms, diagnosis, and devices). The age,
sponsor, and study phase was applied to each of the three separate
searches by type of study. The following number of studies by study
type, including trials no longer recruiting was 562 for diagnosis, 164
for cancers and other neoplasms, and 19 for devices. In determining the
total number of hours requested, the CMS estimate uses the same
assumptions used by FDA to estimate its total number of burden hours.
Therefore, the total annual burden associated with this requirement is
27,480 hours (5,974 responses x 4.6 hours per response).
We believe the combined estimate of burden attributable to FDA and
CMS requirements, 224,148 burden hours (196,668 burden hours + 27,480
burden hours) accurately reflects the total burden associated with this
information collection request. We recognize that companies who are
less familiar with the data entry system and the Clinical Trials Data
Bank will require greater than 4.6 hours per response. However, as
sponsor familiarity with the system increases, the hourly estimate will
decrease.
Dated: October 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20662 Filed 10-18-07; 8:45 am]
BILLING CODE 4160-01-S
