[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]
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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Draft Guidance for Sponsors, Industry, Researchers,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.
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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the availability of a draft guidance for industry entitled ``Guidance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 The draft guidance provides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draft guidance before it begins work on the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the draft guidance by June 17, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of Commissioner, Food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access to the draft guidance document.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]
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