
[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Notices]               
[Page 21142-21144]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap08-72]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0224]

 
Draft Guidance for Sponsors, Industry, Researchers, 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or agency) is announcing 
the availability of a draft guidance for industry entitled ``Guidance 
for Sponsors, Industry, Researchers, Investigators, and FDA Staff: 
Certifications To Accompany Drug, Biological Product, and Device 
Applications/Submissions: Compliance with Section 402(j) of The Public 
Health Service Act (PHS Act), Added By Title VIII of The Food and Drug 
Administration Amendments Act of 2007.'' The draft guidance provides 
sponsors, industry, researchers, investigators, and FDA staff with the 
agency's views on some types of information and documents submitted to 
FDA that typically need not be accompanied by the certification 
described in section 402(j)(5)(B) of the PHS Act.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the

[[Page 21143]]

final version of the guidance, submit written or electronic comments on 
the draft guidance by June 17, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Policy (HF-11), Office of Commissioner, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send 
one self addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, 
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    Title VIII of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Public Law 110-85) amended the PHS Act by adding new 
section 402(j) (42 U.S.C. 282(j)). The new provisions require that 
additional information be submitted to the clinical trials data bank 
(www.ClinicalTrials.gov) previously established by the National 
Institutes of Health (NIH)/National Library of Medicine, including 
expanded information on clinical trials and information regarding the 
results of clinical trials.
    One new provision, section 402(j)(5)(B) of the PHS Act, requires 
that a certification accompany certain human drug, biological product, 
and device applications and submissions to FDA. The purpose of title 
VIII of FDAAA is to provide a means for ensuring that the public has 
access to information about certain clinical trials. Specifically, 
title VIII is intended to provide a mechanism for the public to learn 
about clinical trials that are being conducted, as well as the results 
of those trials. The certification, which accompanies certain 
applications and submissions to FDA, plays a role in helping to achieve 
the purposes of title VIII of FDAAA. One purpose of the certification 
is to require the submitter to confirm that it has complied with all 
applicable requirements of title VIII, including the requirement to 
register applicable clinical trials. Failure to submit a certification, 
knowingly submitting a false certification, failure to submit required 
clinical trial information, and submission of clinical trial 
information that is false or misleading are all newly added prohibited 
acts under section 301(jj) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 331(jj)). Requiring a certification to 
accompany certain information and documents submitted to FDA is, 
therefore, one way of encouraging compliance with the provisions of the 
law.
    The certification also serves the purpose of enabling FDA to 
exercise its responsibilities under the new law. The certification is 
critical to the agency's ability to determine whether the law has been 
complied with and whether a party has committed any of the new 
prohibited acts under section 301(jj) of the FD&C Act such that an 
enforcement action is appropriate. Section 402(j)(3)(F) of the PHS Act 
also requires FDA to notify the Director of NIH of certain actions 
taken on applications and reports that were accompanied by a 
certification. That notification alerts NIH to the fact that the 
responsible party must submit the results of the trials within a 
certain period of time, thereby enabling NIH to exercise its 
responsibilities under title VIII of FDAAA. The information in the 
certification form also will help FDA assist NIH in ``linking'' 
information posted on FDA's Web site regarding certain FDA regulatory 
actions to specific applicable clinical trials included in 
ClinicalTrials.gov. This linking, using the information in the 
certification form, eventually will allow FDA to help the public more 
easily correlate various reports, medical reviews, advisories, health 
alerts, advisory committee actions, and other materials with specific 
applicable clinical trials registered with ClinicalTrials.gov.
    The certification requirement went into effect on December 26, 
2007. To assist sponsors, industry, researchers, and investigators in 
complying with the requirement, FDA created a certification form, FDA 
Form 3674, that they may use to satisfy the certification requirement. 
Since the provision went into effect, FDA has received numerous 
inquiries asking whether various kinds of information and documents 
that sponsors, industry, researchers, and investigators submit to the 
agency should be accompanied by the certification.
    The purpose of this draft guidance document is to provide FDA's 
current thinking regarding specific types of information and documents 
submitted to FDA under section 505, 515, 520(m), or 510(k) of the FD&C 
Act (21 U.S.C. 355, 360e, 360j(m), or 360(k)), or under section 351 of 
the PHS Act (42 U.S.C. 262) that typically need not be accompanied by 
the certification described in section 402(j)(5)(B) of the PHS Act. In 
determining whether specific information or documents submitted under 
the previously noted statutory sections typically should be accompanied 
by a certification, FDA has focused on the role the certification plays 
in achieving the purposes of title VIII of FDAAA. We believe that it 
would not further the purposes of the legislation if a certification 
were to accompany every type of information or document submitted to 
the agency regarding a medical product regulated by FDA.
    While we intend the draft guidance to assist submitters in 
determining whether to submit a certification based on the type of 
document being submitted to FDA, this guidance does not address, nor 
does it make a recommendation on, all possible information and 
documents that may be submitted to FDA under those sections of the FD&C 
Act or the PHS Act. The guidance is currently limited to those specific 
types of submissions of information or documents described in the draft 
guidance. We will continue to review the types of information and 
documents that a certification typically does not need to accompany. We 
are interested in receiving comments from sponsors, industry, 
researchers, and investigators about additional types of information 
and documents submitted to FDA that typically need not be accompanied 
by a certification. (See section II of this document for instructions 
on how to submit comments on the draft guidance.) We intend to update 
this draft guidance document as appropriate to address additional 
information and documents that may be submitted under those sections 
and whether a certification should accompany those types of submissions 
of information or documents.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on those types 
of submissions of information or documents a certification typically 
does not need to accompany. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of applicable statutes and regulations.

[[Page 21144]]

II. Comments

    We are interested in receiving comments from sponsors, industry, 
researchers, investigators, and other interested stakeholders on other 
types of information and documents that typically need not be 
accompanied by a certification. A description of the specific type of 
information or document and an explanation of the rationale for why a 
certification should not be necessary will assist us in evaluating the 
need for an accompanying certification.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information have been approved under OMB control no. 
0910-0616.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at either http://www.fda.gov/oc/initiatives/advance/fdaaa.html 
or http://www.regulations.gov.

    Dated: April 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8349 Filed 4-17-08; 8:45 am]

BILLING CODE 4160-01-S
