Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674), 11926-11928 [E8-4158]
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11926
Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Notices
2 In accordance with 45 CFR 96.85, each State’s estimated median income for a four-person family is multiplied by the following percentages
to adjust for family size for LIHEAP: 52 percent for one person, 68 percent for two persons, 84 percent for three persons, 100 percent for four
persons, 116 percent for five persons, and 132 percent for six persons. For each additional family member above six persons, add 3 percentage
points to the percentage for a six-person family (132 percent), and multiply the new percentage by the State’s estimated median income for a
four-person family.
3 These figures were calculated by the Division of Energy Assistance (DEA). DEA calculated these figures by multiplying the estimated State
median income for a four-person family for each State by 60 percent.
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0144]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Certification to
Accompany Drug, Biological Product,
and Device Applications or
Submissions (Form FDA 3674)
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
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 certification to accompany human
drug, biological product, and device
applications or submissions (Form FDA
3674).
DATES: Submit written or electronic
comments on the collection of
information by May 5, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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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.
SUPPLEMENTARY INFORMATION:
[FR Doc. E8–4190 Filed 3–4–08; 8:45 am]
Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions (Form
FDA 3674)—(OMB Control Number
0910–0616)—Extension
The information required under
section 402(j)(5)(B) of the Public Health
Service Act (PHS Act) (42 U.S.C.
282(j)(5)(B)) will be submitted in the
form of a certification with applications
and submissions currently submitted to
FDA under part 312 (21 CFR part 312)
and 21 CFR part 314 (human drugs) and
approved under OMB control numbers
0910–0014 (expires May 31, 2009) and
0910–0001 (expires May 31, 2008),
PO 00000
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respectively; submitted to FDA under
part 312 and 21 CFR part 601 (biological
products) and approved under OMB
control numbers 0910–0014 and 0910–
0338 (expires June 30, 2010); and
submitted to FDA under 21 CFR parts
807 and 814 (devices) and approved
under OMB control numbers 0910–0120
(expires August 31, 2010) and 0910–
0231 (expires November 30, 2010),
respectively.
Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Public Law 110–85)
amended the PHS Act by adding section
402(j) (42 U.S.C. 282(j)). The new
provisions require additional
information to be submitted to the
clinical trials data bank
(ClinicalTrials.gov)1 previously
established by the National Institutes of
Health/National Library of Medicine,
including expanded information on
clinical trials and information on the
results of clinical trials. The provisions
include new responsibilities for FDA as
well as several amendments to the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
One new provision, section
402(j)(5)(B) of the PHS Act, requires that
a certification accompany human drug,
biological, and device product
submissions made to FDA. Specifically,
at the time of submission of an
application under sections 505, 515, or
520(m) of the FD&C Act (21 U.S.C. 355,
360e, or 360j(m)), or under section 351
of the PHS Act (42 U.S.C. 262), or
submission of a report under section
510(k) of the FD&C Act (21 U.S.C.
360(k)), such application or submission
must be accompanied by a certification
that all applicable requirements of
section 402(j) of the PHS Act have been
met. Where available, such certification
must include the appropriate National
Clinical Trial (NCT) numbers.
The proposed collection of
information is necessary to satisfy the
previously mentioned statutory
requirement.
The importance of obtaining these
data relates to adherence to the legal
requirements for submissions to the
clinical trials registry and results data
bank and ensuring that individuals and
1 (FDA has verified the Web site address, but FDA
is not responsible for any subsequent changes to the
Web site after this document publishes in the
Federal Register.)
E:\FR\FM\05MRN1.SGM
05MRN1
Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Notices
organizations submitting applications or
reports to FDA under the listed
provisions of the FD&C Act or the PHS
Act adhere to the appropriate legal and
regulatory requirements for certifying to
having complied with those
requirements. The failure to submit the
certification required by section
402(j)(5)(B) of the PHS Act, and the
knowing submission of a false
certification are both prohibited acts
under section 301 of the FD&C Act (21
U.S.C. 331). Violations are subject to
civil money penalties.
Investigational New Drug Applications
FDA’s Center for Drug Evaluation and
Research (CDER) received 1,837
investigational new drug applications
(INDs) and 24,581 new IND
amendments in fiscal year (FY) 2004.
CDER anticipates that IND and
amendment submission rates will
remain at or near this level in the near
future.
FDA’s Center for Biologics Evaluation
and Research (CBER) received 227 new
INDs and 6,689 new IND amendments
in FY 2004. CBER anticipates that IND
and amendment submission rates will
remain at or near this level in the near
future.
The estimated total number of
submissions (new INDs and new
submissions) subject to mandatory
certification requirements under section
402(j)(5)(B) of the PHS Act is 26,418 for
CDER plus 6,916 for CBER, or 33,334
submissions per year. The minutes per
response is the estimated number of
minutes that a respondent would spend
preparing the information to be
submitted to FDA under section
402(j)(5)(B) of the PHS Act, including
the time it takes to type the necessary
information.
Based on its experience reviewing
INDs and consideration of the
previously mentioned information, FDA
estimated that approximately 15.0
minutes on average would be needed
per response for certifications which
accompany IND applications and
submissions. It is assumed that most
submissions to investigational
applications will reference only a few
protocols for which the sponsor/
applicant/submitter has obtained an
NCT number from ClinicalTrials.gov
prior to making the submission to FDA.
It is also assumed that the sponsor/
applicant/submitter has electronic
capabilities allowing them to retrieve
the information necessary to complete
the form in an efficient manner.
Marketing Applications/Submissions
CDER and CBER received 214 new
drug applications (NDA)/biologics
license applications (BLA)/
resubmissions and 8,535 NDA/BLA
amendments in FY 2004. CDER and
CBER received 259 efficacy
supplements/resubmissions to
previously approved NDAs/BLAs; 2,500
manufacturing submissions; and 1,273
labeling submissions in FY 2004. CDER
and CBER anticipate that new drug/
biologic and efficacy supplement
submission rates will remain at or near
this level in the near future.
FDA’s Center for Devices and
Radiological Health (CDRH) received 51
new applications for premarket
approvals (PMA); 3,635 premarket
notification submissions under section
510(k) of the FD&C Act; and 9
applications for humanitarian device
exemptions (HDE), for a total of 3,695
11927
new applications/submissions in FY
2004. CDRH received 2,267 PMA/
510(k)/HDE amendments in FY 2004.
CDRH received 2,705 PMA/510(k)/HDE
supplements in FY 2004. CDRH
anticipates that application,
amendment, and supplement rates will
remain at or near this level in the near
future.
The estimated total number of new
submissions (new marketing
applications/submissions, amendments,
and supplements) subject to the
mandatory certification requirements
under section 402(j)(5)(B) of the PHS
Act is 12,781 for CDER and CBER plus
8,667 for CDRH, or 21,448 new
submissions per year. The hours per
response is the estimated number of
hours that a respondent would spend
preparing the information to be
submitted to FDA under section
402(j)(5)(B) of the PHS Act, including
the time it takes to type the necessary
information and compile a list of
relevant NCT numbers.
Based on its experience reviewing
NDAs, BLAs, PMAs, HDEs, and 510(k)s,
and consideration of the previously
mentioned information, FDA estimated
that approximately 45.0 minutes on
average would be needed per response
for certifications which accompany
NDA, BLA, PMA, HDE, and 510(k)
applications and submissions. It is
assumed that the sponsor/applicant/
submitter has electronic capabilities
allowing them to retrieve the
information necessary to complete the
form in an efficient manner.
Table 1 of this document provides an
estimate of the annual reporting burden
for the submission of information to
satisfy the requirements of section
402(j)(5)(B) of the PHS Act.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Investigational
Applications
Marketing
Applications
Hours per
Response
Total Hours
1,837
----
.25
459
CBER (new application)
227
----
.25
57
CDER (amendment)
24,581
----
.25
6,145
CBER (amendment)
6,689
----
.25
1,672
CDER/CBER (new application/resubmission)
----
214
.75
161
CDRH (new application)
----
3,695
.75
2,771
CDER/CBER (amendment)
jlentini on PROD1PC65 with NOTICES
CDER (new application)
----
8,535
.75
6,401
CDRH (amendment)
----
2,267
.75
1,700
CDER/CBER (efficacy supplement/resubmission)
----
259
.75
194
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11928
Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Investigational
Applications
Marketing
Applications
Hours per
Response
Total Hours
CDER/CBER (manufacturing supplement)
----
2,500
.75
1,875
CDER/CBER (labeling supplement)
----
1,273
.75
955
CDRH (supplement)
----
2,705
.75
2,029
Total
24,419
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We believe the estimate of 24,419
hours per year accurately reflects the
burden. We recognize that individuals
or entities less familiar with FDA forms
and the clinical trials data bank
(ClinicalTrials.gov) may require greater
than 15 and 45 minutes (depending on
the type of application/submission) per
response.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: February 28, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–4158 Filed 3–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of a meeting of the Oncologic
Drugs Advisory Committee. This
meeting was announced in the Federal
Register of January 25, 2008 (73 FR
4580). The amendment is being made to
reflect a change in the Date and Time,
Agenda, and Procedure portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Nicole Vesely, 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, 301–827–6793, FAX: 301–827–
6776, e-mail: nicole.vesely@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
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(301–443–0572 in the Washington, DC
area), code 3014512542. Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 25, 2008,
FDA announced that a meeting of the
Oncologic Drugs Advisory Committee
would be held on March 12 and 13,
2008.
On page 4580, in the third column,
the Date and Time portion of the
meeting is amended to read as follows:
Date and Time: The meeting will be
held on March 12 and 13, 2008, from 8
a.m. to 4 p.m.
On page 4580, beginning in the third
column, the Agenda portion of the
meeting is amended to read as follows:
Agenda: On March 12, 2008, the
committee will discuss biologic license
application (BLA) 125268, proposed
trade name NPLATE (romiplostim),
Amgen, Inc., proposed indication for the
treatment of thrombocytopenia in adults
with chronic immune (idiopathic)
thrombocytopenia purpura (ITP) who
are nonsplenectomized and have had an
inadequate response or are intolerant to
corticosteroids and/or
immunoglobulins; or patients who are
splenectomized and have an inadequate
response to splenectomy. On March 13,
2008, the committee will discuss the
cumulative data, including recent study
results, on the risks of erythropoeisisstimulating agents when administered
to patients with cancer. Agents to be
discussed include ARANESP
(darbepoetin alfa), EPOGEN (epoetin
alfa), PROCRIT (epoetin alfa), Amgen,
Inc.) and MIRCERA (methoxy
polyethylene glycol-epoetin beta,
Hoffman-La Roche, Inc.). This is a
followup to the May 10, 2007,
Oncologic Drugs Advisory Committee
Meeting.
On page 4581, beginning in the first
column, the Procedure portion of the
meeting is amended to read as follows:
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
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person on or before February 27, 2008.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 2 p.m. on March 12, 2008, and
between approximately 1 p.m. to 2 p.m.
on March 13, 2008. Those desiring to
make formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 19, 2008. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 20, 2008.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Nicole
Vesely at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 26, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–4157 Filed 3–4–08; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 73, Number 44 (Wednesday, March 5, 2008)]
[Notices]
[Pages 11926-11928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4158]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0144]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Certification to Accompany Drug, Biological Product,
and Device Applications or Submissions (Form FDA 3674)
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 certification to accompany
human drug, biological product, and device applications or submissions
(Form FDA 3674).
DATES: Submit written or electronic comments on the collection of
information by May 5, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: 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: 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.
Certification to Accompany Drug, Biological Product, and Device
Applications or Submissions (Form FDA 3674)--(OMB Control Number 0910-
0616)--Extension
The information required under section 402(j)(5)(B) of the Public
Health Service Act (PHS Act) (42 U.S.C. 282(j)(5)(B)) will be submitted
in the form of a certification with applications and submissions
currently submitted to FDA under part 312 (21 CFR part 312) and 21 CFR
part 314 (human drugs) and approved under OMB control numbers 0910-0014
(expires May 31, 2009) and 0910-0001 (expires May 31, 2008),
respectively; submitted to FDA under part 312 and 21 CFR part 601
(biological products) and approved under OMB control numbers 0910-0014
and 0910-0338 (expires June 30, 2010); and submitted to FDA under 21
CFR parts 807 and 814 (devices) and approved under OMB control numbers
0910-0120 (expires August 31, 2010) and 0910-0231 (expires November 30,
2010), respectively.
Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Public Law 110-85) amended the PHS Act by adding section
402(j) (42 U.S.C. 282(j)). The new provisions require additional
information to be submitted to the clinical trials data bank
(ClinicalTrials.gov)\1\ previously established by the National
Institutes of Health/National Library of Medicine, including expanded
information on clinical trials and information on the results of
clinical trials. The provisions include new responsibilities for FDA as
well as several amendments to the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
---------------------------------------------------------------------------
\1\ (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
---------------------------------------------------------------------------
One new provision, section 402(j)(5)(B) of the PHS Act, requires
that a certification accompany human drug, biological, and device
product submissions made to FDA. Specifically, at the time of
submission of an application under sections 505, 515, or 520(m) of the
FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the
PHS Act (42 U.S.C. 262), or submission of a report under section 510(k)
of the FD&C Act (21 U.S.C. 360(k)), such application or submission must
be accompanied by a certification that all applicable requirements of
section 402(j) of the PHS Act have been met. Where available, such
certification must include the appropriate National Clinical Trial
(NCT) numbers.
The proposed collection of information is necessary to satisfy the
previously mentioned statutory requirement.
The importance of obtaining these data relates to adherence to the
legal requirements for submissions to the clinical trials registry and
results data bank and ensuring that individuals and
[[Page 11927]]
organizations submitting applications or reports to FDA under the
listed provisions of the FD&C Act or the PHS Act adhere to the
appropriate legal and regulatory requirements for certifying to having
complied with those requirements. The failure to submit the
certification required by section 402(j)(5)(B) of the PHS Act, and the
knowing submission of a false certification are both prohibited acts
under section 301 of the FD&C Act (21 U.S.C. 331). Violations are
subject to civil money penalties.
Investigational New Drug Applications
FDA's Center for Drug Evaluation and Research (CDER) received 1,837
investigational new drug applications (INDs) and 24,581 new IND
amendments in fiscal year (FY) 2004. CDER anticipates that IND and
amendment submission rates will remain at or near this level in the
near future.
FDA's Center for Biologics Evaluation and Research (CBER) received
227 new INDs and 6,689 new IND amendments in FY 2004. CBER anticipates
that IND and amendment submission rates will remain at or near this
level in the near future.
The estimated total number of submissions (new INDs and new
submissions) subject to mandatory certification requirements under
section 402(j)(5)(B) of the PHS Act is 26,418 for CDER plus 6,916 for
CBER, or 33,334 submissions per year. The minutes per response is the
estimated number of minutes that a respondent would spend preparing the
information to be submitted to FDA under section 402(j)(5)(B) of the
PHS Act, including the time it takes to type the necessary information.
Based on its experience reviewing INDs and consideration of the
previously mentioned information, FDA estimated that approximately 15.0
minutes on average would be needed per response for certifications
which accompany IND applications and submissions. It is assumed that
most submissions to investigational applications will reference only a
few protocols for which the sponsor/applicant/submitter has obtained an
NCT number from ClinicalTrials.gov prior to making the submission to
FDA. It is also assumed that the sponsor/applicant/submitter has
electronic capabilities allowing them to retrieve the information
necessary to complete the form in an efficient manner.
Marketing Applications/Submissions
CDER and CBER received 214 new drug applications (NDA)/biologics
license applications (BLA)/resubmissions and 8,535 NDA/BLA amendments
in FY 2004. CDER and CBER received 259 efficacy supplements/
resubmissions to previously approved NDAs/BLAs; 2,500 manufacturing
submissions; and 1,273 labeling submissions in FY 2004. CDER and CBER
anticipate that new drug/biologic and efficacy supplement submission
rates will remain at or near this level in the near future.
FDA's Center for Devices and Radiological Health (CDRH) received 51
new applications for premarket approvals (PMA); 3,635 premarket
notification submissions under section 510(k) of the FD&C Act; and 9
applications for humanitarian device exemptions (HDE), for a total of
3,695 new applications/submissions in FY 2004. CDRH received 2,267 PMA/
510(k)/HDE amendments in FY 2004. CDRH received 2,705 PMA/510(k)/HDE
supplements in FY 2004. CDRH anticipates that application, amendment,
and supplement rates will remain at or near this level in the near
future.
The estimated total number of new submissions (new marketing
applications/submissions, amendments, and supplements) subject to the
mandatory certification requirements under section 402(j)(5)(B) of the
PHS Act is 12,781 for CDER and CBER plus 8,667 for CDRH, or 21,448 new
submissions per year. The hours per response is the estimated number of
hours that a respondent would spend preparing the information to be
submitted to FDA under section 402(j)(5)(B) of the PHS Act, including
the time it takes to type the necessary information and compile a list
of relevant NCT numbers.
Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, and
510(k)s, and consideration of the previously mentioned information, FDA
estimated that approximately 45.0 minutes on average would be needed
per response for certifications which accompany NDA, BLA, PMA, HDE, and
510(k) applications and submissions. It is assumed that the sponsor/
applicant/submitter has electronic capabilities allowing them to
retrieve the information necessary to complete the form in an efficient
manner.
Table 1 of this document provides an estimate of the annual
reporting burden for the submission of information to satisfy the
requirements of section 402(j)(5)(B) of the PHS Act.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Investigational Marketing
Applications Applications Hours per Response Total Hours
----------------------------------------------------------------------------------------------------------------
CDER (new application) 1,837 ---- .25 459
----------------------------------------------------------------------------------------------------------------
CBER (new application) 227 ---- .25 57
----------------------------------------------------------------------------------------------------------------
CDER (amendment) 24,581 ---- .25 6,145
----------------------------------------------------------------------------------------------------------------
CBER (amendment) 6,689 ---- .25 1,672
----------------------------------------------------------------------------------------------------------------
CDER/CBER (new ---- 214 .75 161
application/
resubmission)
----------------------------------------------------------------------------------------------------------------
CDRH (new application) ---- 3,695 .75 2,771
----------------------------------------------------------------------------------------------------------------
CDER/CBER (amendment) ---- 8,535 .75 6,401
----------------------------------------------------------------------------------------------------------------
CDRH (amendment) ---- 2,267 .75 1,700
----------------------------------------------------------------------------------------------------------------
CDER/CBER (efficacy ---- 259 .75 194
supplement/
resubmission)
----------------------------------------------------------------------------------------------------------------
[[Page 11928]]
CDER/CBER (manufacturing ---- 2,500 .75 1,875
supplement)
----------------------------------------------------------------------------------------------------------------
CDER/CBER (labeling ---- 1,273 .75 955
supplement)
----------------------------------------------------------------------------------------------------------------
CDRH (supplement) ---- 2,705 .75 2,029
----------------------------------------------------------------------------------------------------------------
Total 24,419
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We believe the estimate of 24,419 hours per year accurately
reflects the burden. We recognize that individuals or entities less
familiar with FDA forms and the clinical trials data bank
(ClinicalTrials.gov) may require greater than 15 and 45 minutes
(depending on the type of application/submission) per response.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: February 28, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4158 Filed 3-4-08; 8:45 am]
BILLING CODE 4160-01-S
