Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674), 59401-59404 [2011-24581]
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59401
Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Notices
manufacturers may need current
inspections of their establishments to
operate in global commerce.
There are approximately 8,000 foreign
and 10,000 domestic manufacturers of
medical devices. Approximately 5,000
of these firms only manufacture class I
devices and are, therefore, not eligible
for the AP Program. In addition, 40
percent of the domestic firms do not
export devices and therefore are not
eligible to participate in the AP
Program. Further, 10 to 15 percent of the
firms are not eligible due to the results
of their previous inspection. FDA
estimates there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP Program. Based
on communications with industry, FDA
estimates that on an annual basis
approximately 100 of these
manufacturers may use an AP in any
given year.
In the Federal Register of May 23,
2011 (76 FR 29764), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 U.S.C. section
374(g) ...................................................................................
1 There
FOR FURTHER INFORMATION CONTACT:
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; Submission for Office of
Management and Budget Review;
Comment Request; Certification to
Accompany Drug, Biological Product,
and Device Applications or
Submissions (Form FDA 3674)
Food and Drug Administration,
HHS.
Notice.
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 October 26,
2011.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0616. Also
include the FDA docket number found
SUMMARY:
jlentini on DSK4TPTVN1PROD with NOTICES
1
in brackets in the heading of this
document.
[FR Doc. 2011–24582 Filed 9–23–11; 8:45 am]
ACTION:
100
Total annual
responses
100
Average
burden per
response
15
Total hours
1,500
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
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17:37 Sep 23, 2011
Jkt 223001
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
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. 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
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 Form 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, 2011; 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) (42 U.S.C. 282(j)). The provisions
require additional information to be
submitted to the clinical trials data bank
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
(https://ClinicalTrials.gov) 1 previously
established by the National Institutes of
Health (NIH)/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
reports to FDA under the listed
1 FDA has verified the Web site addresses
throughout this document, but FDA is not
responsible for any subsequent changes to the Web
sites after this document publishes in the Federal
Register.
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Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
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.
I. 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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17:37 Sep 23, 2011
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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 https://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.
II. 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.
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In the Federal Register of May 6, 2011
(76 FR 26305), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
There were four comments submitted in
response to the 60-day Federal Register
notice. Only two comments were
directly related to the information
collection. One comment was unrelated
to the information collection. The
remaining comment requested that FDA
define a term contained in section
402(j)(1)(A)(ii) of the PHS Act (42 U.S.C.
282(j)(1)(A)(ii)). The implementation of
this provision, including defining any
statutory terms, is the responsibility of
NIH. NIH has indicated in the Unified
Agenda that proposed rulemaking is
anticipated in 2011. In addition, NIH
has provided an elaboration of the
definition of that term on its Web site
at https://prsinfo.clinicaltrials.gov/
ElaborationsOnDefinitions.pdf.
One of the comments that directly
addressed the information collection
commented on the utility of the
information collected through Form
FDA 3674 and requested that FDA
consider a means to associate the NCT
number with the study numbers. Since
the enactment of FDAAA, FDA has been
involved in a technological effort
designed to accomplish what has been
suggested by the comment. FDA is
currently involved in designing a
software/computer system that can link
the information provided on the Form
FDA 3674 with actions taken in relation
to that study, a future marketing
application, and future actions taken in
relation to the approved medical
product. Part of this effort is designed to
provide NIH information which will be
displayed on its Web site for each
clinical trial for which specific
information is provided. An additional
aspect for the effort is designed to link
this information internally for various
purposes including compliance efforts.
This commenter also proposed changes
to the timing of the certification
submissions accompanying INDs based
upon the requirements for submission of
clinical trial information to https://
ClinicalTrials.gov. FDA appreciates the
comment but has implemented the
statutory requirements in the most
efficient manner possible. The statute
requires FDA to obtain the certification
upon submission of an IND despite the
fact that submission of clinical trial
information to https://ClinicalTrials.gov
generally is not required at the time an
IND is required to be submitted. In order
to collect information on trials that are
not applicable clinical trials, as
suggested by the comment, either a
E:\FR\FM\26SEN1.SGM
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Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Notices
statutory change or, possibly,
rulemaking would be required.
The remaining comment contended
that the estimates FDA used in its
burden estimates should be adjusted
significantly upward. We do not agree
with the comment’s conclusions. FDA
has based the burden hours on the
totality of the time needed for the
information collection and not (as
claimed by the commenter) on the
completion of the form itself. As noted
in our previous information collection
and this one, we anticipated that
entities submitting Form FDA 3674
would implement systems that would
simplify collection of the information.
We have received feedback based on
submitters’ experience over the past 31⁄2
years that suggests these types of
systems have been implemented.
Furthermore, given the responsibilities
required for registering and updating
trials on https://ClinicalTrials.gov and
current FDA requirements, unrelated to
Form FDA 3674, for submission of trial
information for marketing applications,
the information required for completion
of this form should be easy to compile.
FDA’s experience in responding to calls
59403
on the form and questions presented at
meetings and conferences does not
accord with the practices noted in this
comment and does not support the
burden estimates proposed by the
comment. In fact, the only other
comment submitted directly related to
the information collection indicated that
the ‘‘estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumption used,
seems reasonable.’’
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
(investigational
applications)
FDA Center activity
No. of
respondents
(marketing
applications)
No. of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
CDER
New Applications (IND) ............................
1,752
........................
1
1,752
11,769
0.25
(15 min.)
0.25
(15 min.)
Clinical Protocol Amendments (IND) .......
11,769
........................
1
New Marketing Applications/Resubmissions (NDA/BLA) ..................................
........................
157
Clinical Amendments to Marketing Applications ..................................................
........................
Efficacy Supplements/Resubmissions .....
........................
438
2,943
1
157
0.75
(45 min.)
118
1,466
1
1,466
1,100
166
1
166
0.75
(45 min.)
0.75
(45 min.)
70
368
125
CBER
New Applications (IND) ............................
281
........................
1
281
Clinical Protocol Amendments (IND) .......
1,471
........................
1
1,471
0.25
(15 min.)
0.25
(15 min.)
New Marketing Applications/Resubmissions .....................................................
........................
8
1
8
0.75
(45 min.)
6
Clinical Amendments to Marketing Applications ..................................................
........................
17
1
17
0.75
(45 min.)
13
Efficacy
Supplements/Resubmissions
(BLA only) .............................................
........................
25
1
25
0.75
(45 min.)
19
1
892
0.75
(45 min.)
669
0.75
(45 min.)
0.75
(45 min.)
........................
641
CDRH
New Marketing Applications (includes
PMAs, HDEs, Supplements and
510(k)s expected to contain clinical
data) .....................................................
........................
892
OGD
........................
854
1
854
BE Supplements/Amendments ................
jlentini on DSK4TPTVN1PROD with NOTICES
Original Applications ................................
........................
495
........................
........................
Total ..................................................
........................
........................
........................
........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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E:\FR\FM\26SEN1.SGM
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372
6,882
59404
Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Notices
Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–24581 Filed 9–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Gastrointestinal Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSK4TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastrointestinal
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 17, 2011, from 8 a.m.
to 5 p.m.
Location: Holiday Inn WashingtonCollege Park, The Ballroom, 10000
Baltimore Ave., College Park, MD. The
hotel telephone number is 301–345–
6700.
Contact Person: Minh Doan, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, e-mail:
GIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On November 17, 2011, the
committee will provide
recommendations to the Agency on the
design and size of premarketing
cardiovascular safety development
programs necessary to support approval
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17:37 Sep 23, 2011
Jkt 223001
of products in the class of serotonin (5hydroxytryptamine) receptor 4 agonists
for the proposed indications of chronic
idiopathic (of unknown cause)
constipation, constipation predominant
irritable bowel syndrome, gastroparesis,
and gastroesophageal reflux disease that
does not respond to a proton pump
inhibitor.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
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
person on or before November 2, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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 October
25, 2011. 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 October 26, 2011.
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 Minh Doan
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
PO 00000
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Fmt 4703
Sfmt 4703
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.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: September 20, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–24603 Filed 9–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Gastrointestinal Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastrointestinal
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 16, 2011, from 8 a.m.
to 5 p.m.
Location: Holiday Inn WashingtonCollege Park, The Ballroom, 10000
Baltimore Ave., College Park, MD. The
hotel telephone number is 301–345–
6700.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, fax:
301–847–8533, e-mail:
GIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59401-59404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24581]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0275]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 October
26, 2011.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the 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., PI50-400B,
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@fda.hhs.gov.
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. 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 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 Form 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, 2011; 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) (42 U.S.C. 282(j)). The provisions require additional
information to be submitted to the clinical trials data bank (https://ClinicalTrials.gov) \1\ previously established by the National
Institutes of Health (NIH)/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 addresses throughout this
document, but FDA is not responsible for any subsequent changes to
the Web sites 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
[[Page 59402]]
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.
I. 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
https://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.
II. 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.
In the Federal Register of May 6, 2011 (76 FR 26305), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. There were four comments submitted in response to the 60-
day Federal Register notice. Only two comments were directly related to
the information collection. One comment was unrelated to the
information collection. The remaining comment requested that FDA define
a term contained in section 402(j)(1)(A)(ii) of the PHS Act (42 U.S.C.
282(j)(1)(A)(ii)). The implementation of this provision, including
defining any statutory terms, is the responsibility of NIH. NIH has
indicated in the Unified Agenda that proposed rulemaking is anticipated
in 2011. In addition, NIH has provided an elaboration of the definition
of that term on its Web site at https://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.
One of the comments that directly addressed the information
collection commented on the utility of the information collected
through Form FDA 3674 and requested that FDA consider a means to
associate the NCT number with the study numbers. Since the enactment of
FDAAA, FDA has been involved in a technological effort designed to
accomplish what has been suggested by the comment. FDA is currently
involved in designing a software/computer system that can link the
information provided on the Form FDA 3674 with actions taken in
relation to that study, a future marketing application, and future
actions taken in relation to the approved medical product. Part of this
effort is designed to provide NIH information which will be displayed
on its Web site for each clinical trial for which specific information
is provided. An additional aspect for the effort is designed to link
this information internally for various purposes including compliance
efforts. This commenter also proposed changes to the timing of the
certification submissions accompanying INDs based upon the requirements
for submission of clinical trial information to https://ClinicalTrials.gov. FDA appreciates the comment but has implemented the
statutory requirements in the most efficient manner possible. The
statute requires FDA to obtain the certification upon submission of an
IND despite the fact that submission of clinical trial information to
https://ClinicalTrials.gov generally is not required at the time an IND
is required to be submitted. In order to collect information on trials
that are not applicable clinical trials, as suggested by the comment,
either a
[[Page 59403]]
statutory change or, possibly, rulemaking would be required.
The remaining comment contended that the estimates FDA used in its
burden estimates should be adjusted significantly upward. We do not
agree with the comment's conclusions. FDA has based the burden hours on
the totality of the time needed for the information collection and not
(as claimed by the commenter) on the completion of the form itself. As
noted in our previous information collection and this one, we
anticipated that entities submitting Form FDA 3674 would implement
systems that would simplify collection of the information. We have
received feedback based on submitters' experience over the past 3\1/2\
years that suggests these types of systems have been implemented.
Furthermore, given the responsibilities required for registering and
updating trials on https://ClinicalTrials.gov and current FDA
requirements, unrelated to Form FDA 3674, for submission of trial
information for marketing applications, the information required for
completion of this form should be easy to compile. FDA's experience in
responding to calls on the form and questions presented at meetings and
conferences does not accord with the practices noted in this comment
and does not support the burden estimates proposed by the comment. In
fact, the only other comment submitted directly related to the
information collection indicated that the ``estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumption used, seems reasonable.''
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of
respondents respondents No. of Total annual Average burden
FDA Center activity (investigational (marketing responses per responses per response Total hours
applications) applications) respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)................................ 1,752 .............. 1 1,752 0.25 438
(15 min.)
Clinical Protocol Amendments (IND).................... 11,769 .............. 1 11,769 0.25 2,943
(15 min.)
New Marketing Applications/Resubmissions (NDA/BLA).... ................ 157 1 157 0.75 118
(45 min.)
Clinical Amendments to Marketing Applications......... ................ 1,466 1 1,466 0.75 1,100
(45 min.)
Efficacy Supplements/Resubmissions.................... ................ 166 1 166 0.75 125
(45 min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Applications (IND)................................ 281 .............. 1 281 0.25 70
(15 min.)
Clinical Protocol Amendments (IND).................... 1,471 .............. 1 1,471 0.25 368
(15 min.)
New Marketing Applications/Resubmissions.............. ................ 8 1 8 0.75 6
(45 min.)
Clinical Amendments to Marketing Applications......... ................ 17 1 17 0.75 13
(45 min.)
Efficacy Supplements/Resubmissions (BLA only)......... ................ 25 1 25 0.75 19
(45 min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Marketing Applications (includes PMAs, HDEs, ................ 892 1 892 0.75 669
Supplements and 510(k)s expected to contain clinical (45 min.)
data)................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
OGD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Original Applications................................. ................ 854 1 854 0.75 641
(45 min.)
BE Supplements/Amendments............................. ................ 495 .............. .............. 0.75 372
(45 min.)
Total............................................. ................ .............. .............. .............. .............. 6,882
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 59404]]
Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24581 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P
