[Federal Register Volume 72, Number 238 (Wednesday, December 12, 2007)]
[Notices]
[Pages 70599-70601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-6023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0472]


Agency Emergency Processing Under the Office of Management and 
Budget Review; Certification to Accompany Drug, Biological Product, and 
Device Applications or Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns the certification to accompany human drug, 
biological product, and device applications or submissions.

DATES: Fax written comments on the collection of information by 
December 17, 2007.

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: 202-395-6974, or e-mailed to <a href="/cdn-cgi/l/email-protection#ea888b8d9f83868b98aa858788c48f859ac48d859c"><span class="__cf_email__" data-cfemail="22404345574b4e4350624d4f400c474d520c454d54">[email protected]</span></a>. All comments 
should be identified with the OMB control number 0910-NEW and title, 
``Certification to Accompany Drug, Biological Product, and Device 
Applications or Submissions.'' Also include the FDA 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: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The emergency processing was 
requested in order to comply with the provisions of Title VIII of the 
Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 
110-85), which require this certification to be submitted to FDA 
beginning no later than December 26, 2007. This information will be 
needed immediately to implement these provisions of FDAAA, and it is 
essential to the agency's mission of protecting and promoting the 
public health. Since the statutory deadline for collecting the 
information is December 26, 2007, the lack of a form would result in 
confusion for the sponsors/applicants as the information necessary for 
FDA to carry out its future statutory responsibilities would not be 
obvious without the form. While some sponsors/applicants may submit 
information, it most likely would neither be complete nor provided in a 
systematic fashion so that it can be more easily retrieved.
    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

    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) approved under OMB control numbers 
0910-0014 (expires May 31, 2009) and 0910-0001 (expires May 31, 2008), 
respectively, part 312 and 21 CFR part 601 (biological products) 
approved under OMB control numbers 0910-0014 and 0910-0338 (expires 
June 30, 2010) and 21 CFR parts 807 and 814 (devices) approved under 
OMB control numbers 0910-0120 (expires August 31, 2010) and 0910-0231 
(expires November 30, 2010), respectively.
    Title VIII of FDAAA 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) 
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).
    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. 354, 360e, or 360j(m)), or under section 351 of the 
PHS Act (21 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 
above 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.

[[Page 70600]]

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 with NCT numbers prior to FDA submission. 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 premarket approvals (PMA), 3,635 510(k) submissions, and 9 
humanitarian device exemptions (HDE) or 3,695 new applications 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, 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 total burden estimate includes all submissions for possible 
inclusion in the clinical trials data bank (results). The minutes 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          Hours per
                                         applications       applications         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 application/                        ----                214                .75                161
 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 supplement/                    ----                259                .75                194
 resubmission)
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CDER/CBER (manufacturing supplement)               ----              2,500                .75              1,875
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CDER/CBER (labeling supplement)                    ----              1,273                .75                955
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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.


[[Page 70601]]

    We believe the estimate, 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 may require greater 
than 15 and 45 minutes (depending on the type of application/
submission) per response.

    Dated: December 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-6023 Filed 12-7-07; 1:06 pm]
BILLING CODE 4160-01-S


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