[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Notices]
[Page 11926-11928]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr08-80]
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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.
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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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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).
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\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.)
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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\
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Investigational Marketing
Applications Applications Hours per Response Total Hours
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CDER (new application) 1,837 ---- .25 459
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CBER (new application) 227 ---- .25 57
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CDER (amendment) 24,581 ---- .25 6,145
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CBER (amendment) 6,689 ---- .25 1,672
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CDER/CBER (new ---- 214 .75 161
application/
resubmission)
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CDRH (new application) ---- 3,695 .75 2,771
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CDER/CBER (amendment) ---- 8,535 .75 6,401
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CDRH (amendment) ---- 2,267 .75 1,700
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CDER/CBER (efficacy ---- 259 .75 194
supplement/
resubmission)
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CDER/CBER (manufacturing ---- 2,500 .75 1,875
supplement)
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CDER/CBER (labeling ---- 1,273 .75 955
supplement)
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CDRH (supplement) ---- 2,705 .75 2,029
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Total 24,419
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\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]
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