
[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]


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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.

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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 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 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 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).
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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 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 http://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\
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                                                                          CDER
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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
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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


