Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674), 26305-26307 [2011-11073]
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26305
Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
(in hours)
Total annual
records
Total hours
821.25(b) ..............................................................................
821.25(c) 2 ............................................................................
821.25(c)(3) ..........................................................................
12
12
12
46,260
1
1,124
555,120
12
13,488
1
63
1
555,120
756
13,488
Total ..............................................................................
........................
........................
........................
........................
569,364
1 There
2 One
are no capital costs or operating and maintenance costs associated with this collection of information.
time burden.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Average
burden per
disclosure
(in hours)
Total annual
disclosures
Total hours
821.30(a) and (b) .................................................................
821.30(c)(2) and (d) .............................................................
17,000
17,000
1
1
17,000
17,000
1
1
17,000
17,000
Total ..............................................................................
........................
........................
........................
........................
34,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–11072 Filed 5–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0275]
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.
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 requirements for certain FDA
applications or submissions to be
accompanied by a certification, Form
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:58 May 05, 2011
Jkt 223001
FDA 3674, to ensure all applicable
statutory requirements have been met.
DATES: Submit either electronic or
written comments on the collection of
information by July 5, 2011.
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
Office of Management and Budget
(OMB) control number 0910–0616. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
3794,
jonnalynn.capezzuto@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
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 extension of an existing
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 extension of the 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)) is submitted in the form of
E:\FR\FM\06MYN1.SGM
06MYN1
emcdonald on DSK2BSOYB1PROD with NOTICES
26306
Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices
a certification, Form FDA 3674, which
accompanies applications and
submissions currently submitted to FDA
and is already approved by OMB. The
OMB control numbers and expiration
dates for submitting FDA 3674 under
the following parts are: 21 CFR parts
312 and 314 (human drugs) are 0910–
0014, expiring August 31, 2011, and
0910–0001, expiring May 31, 2011; 21
CFR parts 312 and 601 (biological
products) are 0910–0014 and 0910–
0338, expiring December 31, 2013; 21
CFR parts 807 and 814 (devices) are
0910–0120, expiring December 31, 2013,
and 0910–0231, expiring December 31,
2013.
Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110–85)
amended the PHS Act by adding section
402(j). The 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 responsibilities for FDA as well
as several amendments to the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act).
One 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, Form
FDA 3674, 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 extension of the
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
organizations submitting applications or
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.
VerDate Mar<15>2010
17:26 May 05, 2011
Jkt 223001
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.
In January 2009, FDA issued
‘‘Guidance for Sponsors, Industry,
Researchers, Investigators, and Food
and Drug Administration Staff—
Certifications To Accompany Drug,
Biological Product, and Device
Applications/Submissions: Compliance
with Section 402(j) of The Public Health
Service Act, Added By Title VIII of The
Food and Drug Administration
Amendments Act of 2007’’ available at
https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm125335.htm. This guidance
identified the applications and
submissions that FDA considered
should be accompanied by the
certification form, Form FDA 3674. The
applications and submissions noted in
the guidance are reflected in the burden
analysis.
Investigational New Drug Applications
FDA’s Center for Drug Evaluation and
Research (CDER) received 1,752
investigational new drug applications
(INDs) and 11,769 clinical protocol IND
amendments in Fiscal Year (FY) 2010.
CDER anticipates that IND and clinical
protocol amendment submission rates
will remain at or near this level in the
near future.
FDA’s Center for Biologics Evaluation
and Research (CBER) received 281 new
INDs and 1,471 clinical protocol IND
amendments in FY 2010. CBER
anticipates that IND and clinical
protocol amendment submission rates
will remain at or near this level in the
near future.
The estimated total number of
submissions (new INDs and new
protocol submissions) subject to
mandatory certification requirements
under section 402(j)(5)(B) of the PHS
Act, is 13,521 for CDER plus 1,752 for
CBER, or 15,273 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 enter
the necessary information on the form.
Based on its experience with current
submissions, FDA estimates that
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Fmt 4703
Sfmt 4703
approximately 15.0 minutes on average
would be needed per response for
certifications which accompany IND
applications and clinical protocol
amendment submissions. It is assumed
that most submissions to investigational
applications will reference only a few
protocols for which the sponsor/
applicant/submitter has obtained a 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
In 2010, CDER and CBER received 165
new drug applications (NDA)/biologics
license applications (BLA)/
resubmissions and 1,483 NDA/BLA
amendments for which certifications are
needed. CDER and CBER received 191
efficacy supplements/resubmissions to
previously approved NDAs/BLAs in FY
2010. CDER and CBER anticipate that
new drug/biologic applications/
resubmissions 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 a
total of 892 new applications for
premarket approvals (PMA), 510(k)
submissions containing clinical
information, PMA supplements,
applications for humanitarian device
exemptions (HDE) and amendments, for
a total of 424 new applications/
submissions in FY 2010. CDRH
anticipates that application,
amendment, supplement, and annual
report submission rates will remain at or
near this level in the near future.
FDA’s Office of Generic Drugs (OGD)
received 854 abbreviated new drug
applications (ANDAs) in FY 2010. OGD
received 495 bioequivalence
amendments/supplements FY 2010.
OGD anticipates that application,
amendment, and supplement
submission rates will remain at or near
this level in the near future.
Based on its experience reviewing
NDAs, BLAs, PMAs, HDEs, 510(k)s, and
ANDAs and experience with current
submissions of Form FDA 3674, FDA
estimates that approximately 45.0
minutes on average would be needed
per response for certifications which
accompany NDA, BLA, PMA, HDE,
510(k), and ANDA marketing
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.
E:\FR\FM\06MYN1.SGM
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Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
(investigational
applications)
FDA Center Activity
Number of
respondents
(marketing
applications)
Number of
responses per
respondent
Average
burden per
response
(in hours) 2
Total annual
responses
Total hours
CDER
New Applications (IND) ............................
Clinical Protocol Amendments (IND) .......
New Marketing Applications/Resubmissions (NDA/BLA) ..................................
Clinical Amendments to Marketing Applications ..................................................
Efficacy Supplements/Resubmissions .....
1,752
11,769
........................
........................
1
1
1,752
11,769
15/60
15/60
438
2,943
........................
157
1
157
45/60
118
........................
........................
1,466
166
1
1
1,466
166
45/60
45/60
1,100
125
CBER
New Applications (IND) ............................
Clinical Protocol Amendments (IND) .......
New Marketing Applications/Resubmissions .....................................................
Clinical Amendments to Marketing Applications ..................................................
Efficacy
Supplements/Resubmissions
(BLA only) .............................................
281
1,471
........................
........................
1
1
281
1,471
15/60
15/60
70
368
........................
8
1
8
45/60
6
........................
17
1
17
45/60
13
........................
25
1
25
45/60
19
1
892
45/60
669
CDRH
New Marketing Applications (includes
PMAs, HDEs, Supplements and
510(k)s expected to contain clinical
data) .....................................................
........................
892
OGD
Original Applications ................................
BE Supplements/Amendments ................
........................
........................
854
495
1
........................
854
........................
45/60
45/60
641
372
Total ..................................................
........................
........................
........................
........................
........................
6,882
1 There
are no capitol costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
Dated: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–11073 Filed 5–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK2BSOYB1PROD with NOTICES
[Docket No. FDA–2009–D–0126]
Guidance for Industry on the
Submission of Summary
Bioequivalence Data for Abbreviated
New Drug Applications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
SUMMARY:
VerDate Mar<15>2010
18:58 May 05, 2011
Jkt 223001
entitled ‘‘Submission of Summary
Bioequivalence Data for Abbreviated
New Drug Applications.’’ The guidance
is intended to assist abbreviated new
drug application (ANDA) applicants in
complying with the requirements in the
final rule on the submission of
bioequivalence data that published in
the Federal Register in January 2009 (74
FR 2849, January 16, 2009). The final
rule requires ANDA applicants to
submit data from all bioequivalence
studies (BE studies) the applicant
conducts on a drug product formulation
submitted for approval, including both
studies that demonstrate and studies
that fail to demonstrate that a generic
product meets the current
bioequivalence criteria. The guidance
provides recommendations to
applicants planning to include BE
studies for submission in ANDAs and is
applicable to BE studies conducted
during both preapproval and
postapproval periods.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Aida L. Sanchez, Center for Drug
Evaluation and Research (HFD–650),
DATES:
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26305-26307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11073]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0275]
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 requirements for certain
FDA applications or submissions to be accompanied by a certification,
Form FDA 3674, to ensure all applicable statutory requirements have
been met.
DATES: Submit either electronic or written comments on the collection
of information by July 5, 2011.
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 Office
of Management and Budget (OMB) control number 0910-0616. Also include
the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-3794, jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from 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 extension of an existing
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 extension of
the 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)) is submitted in
the form of
[[Page 26306]]
a certification, Form FDA 3674, which accompanies applications and
submissions currently submitted to FDA and is already approved by OMB.
The OMB control numbers and expiration dates for submitting FDA 3674
under the following parts are: 21 CFR parts 312 and 314 (human drugs)
are 0910-0014, expiring August 31, 2011, and 0910-0001, expiring May
31, 2011; 21 CFR parts 312 and 601 (biological products) are 0910-0014
and 0910-0338, expiring December 31, 2013; 21 CFR parts 807 and 814
(devices) are 0910-0120, expiring December 31, 2013, and 0910-0231,
expiring December 31, 2013.
Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-85) amended the PHS Act by adding section
402(j). The 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
responsibilities for FDA as well as several amendments to the Federal
Food, Drug, and Cosmetic Act (the 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 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, Form FDA 3674, 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 extension of the 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 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.
In January 2009, FDA issued ``Guidance for Sponsors, Industry,
Researchers, Investigators, and Food and Drug Administration Staff--
Certifications To Accompany Drug, Biological Product, and Device
Applications/Submissions: Compliance with Section 402(j) of The Public
Health Service Act, Added By Title VIII of The Food and Drug
Administration Amendments Act of 2007'' available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. This
guidance identified the applications and submissions that FDA
considered should be accompanied by the certification form, Form FDA
3674. The applications and submissions noted in the guidance are
reflected in the burden analysis.
Investigational New Drug Applications
FDA's Center for Drug Evaluation and Research (CDER) received 1,752
investigational new drug applications (INDs) and 11,769 clinical
protocol IND amendments in Fiscal Year (FY) 2010. CDER anticipates that
IND and clinical protocol amendment submission rates will remain at or
near this level in the near future.
FDA's Center for Biologics Evaluation and Research (CBER) received
281 new INDs and 1,471 clinical protocol IND amendments in FY 2010.
CBER anticipates that IND and clinical protocol amendment submission
rates will remain at or near this level in the near future.
The estimated total number of submissions (new INDs and new
protocol submissions) subject to mandatory certification requirements
under section 402(j)(5)(B) of the PHS Act, is 13,521 for CDER plus
1,752 for CBER, or 15,273 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 enter the
necessary information on the form.
Based on its experience with current submissions, FDA estimates
that approximately 15.0 minutes on average would be needed per response
for certifications which accompany IND applications and clinical
protocol amendment submissions. It is assumed that most submissions to
investigational applications will reference only a few protocols for
which the sponsor/applicant/submitter has obtained a 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
In 2010, CDER and CBER received 165 new drug applications (NDA)/
biologics license applications (BLA)/resubmissions and 1,483 NDA/BLA
amendments for which certifications are needed. CDER and CBER received
191 efficacy supplements/resubmissions to previously approved NDAs/BLAs
in FY 2010. CDER and CBER anticipate that new drug/biologic
applications/resubmissions 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 a
total of 892 new applications for premarket approvals (PMA), 510(k)
submissions containing clinical information, PMA supplements,
applications for humanitarian device exemptions (HDE) and amendments,
for a total of 424 new applications/submissions in FY 2010. CDRH
anticipates that application, amendment, supplement, and annual report
submission rates will remain at or near this level in the near future.
FDA's Office of Generic Drugs (OGD) received 854 abbreviated new
drug applications (ANDAs) in FY 2010. OGD received 495 bioequivalence
amendments/supplements FY 2010. OGD anticipates that application,
amendment, and supplement submission rates will remain at or near this
level in the near future.
Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510(k)s,
and ANDAs and experience with current submissions of Form FDA 3674, FDA
estimates that approximately 45.0 minutes on average would be needed
per response for certifications which accompany NDA, BLA, PMA, HDE,
510(k), and ANDA marketing 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.
[[Page 26307]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Number of Average
respondents respondents Number of Total annual burden per
FDA Center Activity (investigational (marketing responses per responses response (in Total hours
applications) applications) respondent hours) \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)................................ 1,752 .............. 1 1,752 15/60 438
Clinical Protocol Amendments (IND).................... 11,769 .............. 1 11,769 15/60 2,943
New Marketing Applications/Resubmissions (NDA/BLA).... ................ 157 1 157 45/60 118
Clinical Amendments to Marketing Applications......... ................ 1,466 1 1,466 45/60 1,100
Efficacy Supplements/Resubmissions.................... ................ 166 1 166 45/60 125
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CBER
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New Applications (IND)................................ 281 .............. 1 281 15/60 70
Clinical Protocol Amendments (IND).................... 1,471 .............. 1 1,471 15/60 368
New Marketing Applications/Resubmissions.............. ................ 8 1 8 45/60 6
Clinical Amendments to Marketing Applications......... ................ 17 1 17 45/60 13
Efficacy Supplements/Resubmissions (BLA only)......... ................ 25 1 25 45/60 19
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CDRH
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New Marketing Applications (includes PMAs, HDEs, ................ 892 1 892 45/60 669
Supplements and 510(k)s expected to contain clinical
data)................................................
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OGD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Original Applications................................. ................ 854 1 854 45/60 641
BE Supplements/Amendments............................. ................ 495 .............. .............. 45/60 372
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Total............................................. ................ .............. .............. .............. .............. 6,882
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\1\ There are no capitol costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of minutes per response]/60''.
Dated: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11073 Filed 5-5-11; 8:45 am]
BILLING CODE 4160-01-P
