[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Notices]
[Pages 3614-3615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-1183]


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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]
BILLING CODE 4160-01-S