[Federal Register Volume 73, Number 44 (Wednesday, March 5, 2008)]
[Notices]
[Pages 11926-11928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4158]


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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://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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[[Page 11928]]

 
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]
BILLING CODE 4160-01-S