[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3614-3615]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja09-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0224]
Final 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; Availability
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 guidance for industry entitled ``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'' dated January
2009. The guidance provides sponsors, industry, researchers,
investigators, and FDA staff with the agency's current thinking
regarding the types of applications and submissions that sponsors,
industry, researchers, and investigators submit to FDA and accompanying
certifications as described in Title VIII of the Food and Drug
Administration Amendments Act of 2007 (FDAAA).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Policy, Office of Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4305, Silver
Spring, MD 20993-0002, 301-796-4830. Send one self addressed adhesive
label to assist that office in processing your requests. 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. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy,
Office of Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, rm. 4305, Silver Spring, MD 20993-0002, 301-
796-4830.
SUPPLEMENTARY INFORMATION:
I. Background
Title VIII of FDAAA, Public Law 110-85, amended the Public Health
Service (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 (NLM), including expanded information on clinical trials
and information regarding the results of clinical trials.
The purpose of Title VIII 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. One provision of Title VIII (section
401(j)(5)(B) of the PHS Act, 42 U.S.C. 282(j)(5)(B)) requires that a
certification accompany certain human drug, biological product, and
device applications and submissions to FDA.
The certification required under section 402(j)(5)(B) of the PHS
Act (42 U.S.C. 282(j)(5)(B)) 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. ``Applicable clinical trial'' is
defined at section 402(j)(1)(A)(i) of the PHS Act (42 U.S.C.
282(j)(1)(A)(i)). For additional information on this definition and
other relevant definitions, visit the NIH Web site at http://
prsinfo.clinicaltrials.gov.
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, as added by Title VIII of FDAAA, prohibited acts
under section 301(jj) of the Federal Food, Drug, and Cosmetic Act (the
act). Requiring a certification to accompany certain applications and
submissions submitted to FDA is, therefore, one way of encouraging
compliance with the provisions of the law.
The certification also facilitates FDA's exercise of its
responsibilities under the law. The certification requirement is
critical to the agency's ability to determine whether the law has been
complied with and whether an enforcement action is appropriate under
any of the prohibited acts under section 301(jj) of the act.
Additionally, section 402(j)(3)(F) of the PHS Act (42 U.S.C.
282(j)(3)(F)) 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. The information provided 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 the registry
and results databases. This linking, using the information in the
certification form, particularly the NCT (National Clinical Trial)
number(s) required in the 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 and identified by the NCT number.
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, OMB Control No. 0910-0616, to be used 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
[[Page 3615]]
the agency must be accompanied by the certification. On April 18, 2008,
FDA published a draft guidance on the certification requirement. In the
draft guidance FDA provided a list of the types of submissions and
applications that typically did not need to be accompanied by a
certification. We received a number of comments to the docket
concerning whether a certification should accompany the types of
submissions and applications listed in the draft guidance, as well as
other types of documents and information submitted to FDA. We also
received a number of comments on this issue during the process for
obtaining clearance under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520) for the certification form itself. In addition, FDA
also has had more experience with the submission of the certification
form since the form was implemented.
The comments we received in response to the draft guidance and the
development of the certification form, the inquiries to the agency, and
our evolving experience caused us to reconsider our initial approach of
identifying those documents and information that did not need to be
accompanied by a certification. Instead, we concluded that it was more
useful to identify those applications and submissions that must be
accompanied by a certification. This approach is also consistent with
many of the comments, which asked that we provide more specific
information than was included in the draft guidance. Thus, we intend to
exercise enforcement discretion concerning the submission of a
certification with certain categories of applications and submissions
to FDA, as noted in the guidance.
This guidance describes FDA's current thinking, for purposes of
implementing Title VIII of FDAAA, regarding specific types of
applications and submissions submitted to FDA under section 505, 515,
520(m), or 510(k) of the act, or under section 351 of the PHS Act, and
accompanying certifications described in section 402(j)(5)(B) of the
PHS Act, 42 U.S.C. 282(j)(5)(B). We note that the Agency's discussion
of ``applications'' and ``submissions'' in this guidance is not
necessarily applicable to any other provision of law. In determining
how to interpret the certification requirement, FDA has focused on the
plain language of Title VIII of FDAAA, as well as information that
Title VIII is intended to capture.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking regarding the certification requirement in
section 402(j)(5)(B) of the PHS Act (42 U.S.C. 282(j)(5)(B)). 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.
II. Comments
Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding the guidance. 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. A copy of the
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Paperwork Reduction Act of 1995
This guidance refers to a previously approved collection of
information. This collection of information is 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 collection of information has been
approved under OMB Control No. 0910-0616.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance
document at eitherhttp://www.fda.gov/oc/initiatives/advance/fdaaa.html
or http://www.regulations.gov.
Dated: January 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-1183 Filed 1-15-09; 11:15 am]
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