
[Federal Register: February 19, 2010 (Volume 75, Number 33)]
[Proposed Rules]               
[Page 7412-7426]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe10-20]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 58, 71, 101, 170, 171, 190, 312, 511, 571, and 812

[Docket No. FDA-2008-N-0115]
RIN 0910-AC59

 
Reporting Information Regarding Falsification of Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations to require sponsors to report information indicating 
that any person has, or may have, engaged in the falsification of data 
in the course of reporting study results, or in the course of 
proposing, designing, performing, recording, supervising, or reviewing 
studies that involve human subjects or animal subjects conducted by or 
on behalf of a sponsor or relied on by a sponsor. A sponsor would be 
required to report this information to the appropriate FDA center 
promptly, but no later than 45 calendar days after the sponsor becomes 
aware of the information. This proposal is necessary because ambiguity 
in the current reporting scheme has caused confusion among sponsors. 
The proposed rule is intended to help ensure the validity of data that 
the agency receives in support of applications and petitions for FDA 
product approvals and authorization of certain labeling claims and to 
protect research subjects.

DATES: Submit written or electronic comments on this proposed rule by 
May 20, 2010. See section V of this document for the proposed effective 
date of a final rule based on this document. Submit comments regarding 
the information collection by March 22, 2010 to OMB (see ADDRESSES).

[[Page 7413]]


ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0115 and/RIN number 0910-AC59, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described previously, in 
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Information Collection Provisions: Submit written comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB). To ensure 
that comments on the information collection are received, please submit 
written comments to OMB by FAX to 202-395-7285 or by e-mail to OIRA_
submission@omb.eop.gov. Mark your comments to the attention of the FDA 
desk officer and reference this rulemaking.

FOR FURTHER INFORMATION CONTACT:
    For information regarding human drugs: Leslie K. Ball, Center for 
Drug Evaluation and Research, Office of Compliance, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5342, Silver 
Spring, MD 20993-0002, 301-796-3150, FAX: 301-847-8750.
    For information regarding biologics: Steve Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 5515 Security Lane, rm. 5130, Rockville, MD 20852, 301-
827-6210.
    For information regarding medical devices and radiological health: 
Michael E. Marcarelli, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3444, 
Silver Spring, MD 20993-0002, 301-796-5490.
    For information regarding veterinary medicine: Gail L. Schmerfeld, 
Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 240-276-8300.
    For information regarding foods: Linda Katz, Center for Food Safety 
and Applied Nutrition (HFS-032), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1910.
    For information regarding good laboratory practices for nonclinical 
laboratory studies: Karen Stutsman, Office of Regulatory Affairs (HFC-
230), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, 
MD 20855, 240-632-6847.
    For information regarding good clinical practice: Kathleen 
Pfaender, Office of Good Clinical Practice (HF-34), 5600 Fishers Lane, 
rm. 16-85, Rockville, MD 20857, 301-827-3340.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is proposing to require that sponsors\1\ report information 
indicating that any person has, or may have, engaged in the 
falsification of data in the course of reporting study results, or in 
the course of proposing, designing, performing, recording, supervising, 
or reviewing studies\2\ that involve human subjects (e.g., clinical 
investigations) or animal subjects (e.g., nonclinical laboratory 
studies and clinical studies in animals) conducted by or on behalf of a 
sponsor or relied on by a sponsor. The sponsor would be required to 
report this information to the appropriate FDA center promptly, but no 
later than 45 calendar days after the sponsor becomes aware of the 
information. The proposed requirement for a sponsor to report 
information regarding falsification of data would be ongoing and cover 
the periods before and after study completion, including after the 
review, approval, or authorization of the affected product or labeling.
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    \1\ FDA regulations on food additive, color additive, health 
claim, and nutrient content claim petitions refer to petitioners, 
rather than sponsors. In addition, the FDA regulation for the 
submission of new dietary ingredient notifications refers to a 
manufacturer or distributor, and the FDA regulation for the 
submission of a food contact notification (FCN) refers to a 
manufacturer or supplier, rather than sponsor. For the sake of 
brevity, FDA is using the term ``sponsor'' in this document to refer 
to petitioners submitting food additive, color additive, nutrient 
content claim, and health claim petitions; manufacturers or 
distributors submitting new dietary ingredient notifications; and 
sponsors as defined in Sec. Sec.  58.3(f), 312.3(b), 510.3(k), and 
812.3(n) (21 CFR 58.3(f), 312.3(b), 510.3(k), and 812.3(n)). The 
term ``sponsor'' as used in this document does not include a Federal 
agency that sponsors research or investigations through funding or 
contracts or an entity identified as a ``sponsor'' under other 
Federal programs (e.g., a recipient of funding from the National 
Institutes of Health), except to the extent that any such Federal 
agency or entity is a petitioner, manufacturer, distributor, or 
sponsor as specified in the preceding sentence.
    \2\Henceforth, the term ``studies'' means studies involving 
human subjects (e.g., clinical investigations) or animal subjects 
(e.g., nonclinical laboratory studies and clinical studies in 
animals).
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    We are proposing to amend the appropriate regulations that govern 
the conduct of FDA-regulated research and the submission of information 
in support of applications and petitions for FDA product approvals and 
authorization of certain labeling claims. This requirement would be 
added to FDA's regulations on:
     Good laboratory practice for nonclinical laboratory 
studies (21 CFR part 58),
     Color additive petitions in part 71 (21 CFR part 71),
     Petitions for nutrient content claims and petitions for 
health claims in part 101 (21 CFR part 101),
     Information in a premarket notification for a food contact 
substance (FCN) in part 170 (21 CFR part 170),
     Food additive petitions (21 CFR part 171),
     Dietary supplements (21 CFR part 190),
     Investigational new drug applications (21 CFR part 312),
     New animal drugs for investigational use (21 CFR part 
511),
     Food additive petitions (21 CFR part 571), and
     Investigational device exemptions (21 CFR part 812).

[[Page 7414]]

A. Background

    Falsification of data can, if not detected, undermine subject 
protection and the underlying basis for FDA actions. Each year, FDA 
discovers falsification of data at study sites and in application 
submissions. Sometimes, falsification at a study site is not an 
isolated event and can lead to a finding of falsification of 
information at another site, or relating to other drugs being studied 
at the same site. It is critical that participants in the product 
development process assist FDA in detecting falsification of data.
    FDA's proposal to amend the regulations has its origins in events 
that occurred in the mid- to late-1990s, when complaints to FDA and 
followup through FDA's bioresearch monitoring program revealed some 
particularly egregious cases of falsification of data by clinical 
investigators. For example, in one case, an investigator falsified data 
that extended across studies in 91 applications submitted to FDA by 47 
different sponsors.
    After discovering this widespread falsification, FDA attempted to 
determine why so widespread a practice remained unreported to FDA. In a 
series of FDA meetings, as well as congressional briefings, FDA 
reviewed the current requirements for sponsor reporting of noncompliant 
investigators, reviewed study monitoring procedures, and listened to 
the views of an industry trade association. In addition, the Center for 
Drug Evaluation and Research (CDER) established an internal working 
group to evaluate the effectiveness of the current reporting 
requirements for sponsors. The working group identified several areas 
of ambiguity in the current regulations related to: (1) The extent to 
which possible falsification of data had to be reported to the agency; 
(2) the amount and type of information that sponsors must report when a 
study and/or an investigator's participation in a study has terminated; 
(3) whose falsification of data must be reported; and (4) the timing of 
reporting.

B. Why FDA Is Proposing This Rule

    We are proposing this rule for two principal reasons. First, it is 
important for the agency to have confidence in any data from studies 
conducted by, or on behalf of, a sponsor, or relied on by a sponsor for 
product approvals or authorization of labeling claims. This proposed 
rule is intended to help ensure the integrity of data submitted to FDA 
because reliance on falsified data could lead to clinical testing of 
unsafe products, approval of ineffective or unsafe products, or 
marketing of products with false or misleading claims. Second, it is 
important that the rights, safety, and welfare of subjects be 
protected. This proposed rule is intended to help protect research 
subjects\3\ by making it less likely that persons who falsify data will 
continue to conduct studies, come in contact with research subjects, or 
jeopardize the rights, safety, and welfare of such subjects through 
unsound scientific practices.
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    \3\ For the sake of brevity, FDA is using the term ``subjects'' 
to refer to human and animal subjects.
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    Although our own inspections sometimes uncover falsification of 
data, sponsors of studies are responsible for ensuring the integrity of 
study data and are in a better position to discover possible 
falsification of data through their monitoring, auditing, and reviewing 
of data. We understand that in the process of reviewing and monitoring 
studies, some sponsors have discovered falsification of data and have 
been reluctant, or uncertain as to whether it was necessary, to report 
the information to us. For example, we are aware that in some cases, 
sponsors, believing that an investigator may have falsified data, have 
decided to retain the investigator but exclude the investigator's data 
without specifying the reason. In other cases, sponsors have terminated 
the investigator's participation in the study without notifying us of 
the specific reason. We are concerned that when these situations occur, 
an investigator who may have falsified data might continue to conduct 
studies, thereby jeopardizing the rights, safety, and welfare of the 
subjects involved in future research and the integrity of data in other 
studies.
    Therefore, the agency is proposing this rule to clarify sponsors' 
reporting requirements for studies conducted by, or on behalf of, a 
sponsor or on which a sponsor relies to support product approvals, new 
dietary ingredient notifications, or authorization of labeling claims, 
including nutrient content claims and health claims. This proposed rule 
makes it clear that sponsors would be required to promptly report 
information indicating that any person has, or may have, engaged in the 
falsification of data in the course of reporting study results, or in 
the course of proposing, designing, performing, recording, supervising, 
or reviewing studies conducted by, or on behalf of, a sponsor or relied 
on by a sponsor. This proposed rule, when finalized, would require 
sponsors to report information to the appropriate FDA center about 
possible falsification of data whenever (before, during, or after the 
completion of a study) a sponsor becomes aware of the information, but 
in no case later than 45 calendar days after the sponsor becomes aware 
of that information.
    The proposed regulation would allow the agency to more rapidly 
identify persons who have falsified data and more effectively address 
problems. Such persons may include those who have falsified data 
submitted to FDA for product reviews, approvals, and authorizations of 
certain labeling claims, in addition to those who have falsified data 
in the course of conducting FDA-regulated research. We intend to use 
the information collected from sponsors who notify us of possible 
falsification of data to identify patterns, potential signals, or other 
indications of misconduct, so that we can conduct further 
investigations. These investigations, in turn, may form the basis of 
administrative or enforcement actions, such as excluding clinical 
trials from consideration by FDA, placing a clinical trial on hold, or 
initiating disqualification of investigators or criminal proceedings. 
Taking effective action in response to falsification could lessen the 
magnitude and impact of the falsification in a current study, reduce 
the potential for delays or compromise to other studies and 
applications (including studies and applications from other sponsors 
for whom such a person might also be working), and protect the rights, 
safety, and welfare of research subjects.

II. Description of the Proposed Rule

A. What Changes Are We Proposing to Make?

    Under proposed Sec. Sec.  58.11(a), 71.1(k), 101.69(p), 101.70(k), 
170.101(f), 171.1(o), 190.6(g), 312.56(e), 511.1(c), 571.1(l), and 
812.46(d), sponsors would be required to report to the appropriate FDA 
center information indicating that any person has, or may have, engaged 
in the falsification of data in the course of reporting study results, 
or in the course of proposing, designing, performing, recording, 
supervising, or reviewing studies conducted by or on behalf of a 
sponsor or relied on by a sponsor. For the purposes of this proposed 
rule, ``falsification of data'' means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. These reporting requirements would apply to 
information related to studies including, but not limited to, clinical 
investigations, nonclinical laboratory studies, and clinical studies in 
animals.
    FDA does not intend to impose any additional monitoring 
responsibilities under this proposed rule. This proposal

[[Page 7415]]

does not relieve sponsors of any other applicable statutory or 
regulatory requirements.

B. Who Would Be Required to Report Information to FDA?

    The proposed rule would require sponsors, as defined earlier in 
this preamble, to report certain information related to confirmed or 
possible falsification of data.

C. Whose Falsification of Data Would a Sponsor Be Required to Report?

    FDA is seeking information on falsification of data by any person 
involved in studies conducted by or on behalf of a sponsor or relied on 
by a sponsor. In FDA's experience, falsification may be committed by 
individuals responsible for conducting studies and/or by their 
colleagues or subordinates. FDA believes that all persons involved in 
such actions must be identified so that future falsification of data 
can be prevented. Therefore, FDA is proposing in this regulation to 
require sponsors to inform FDA of any confirmed or possible 
falsification of data by any person involved in studies conducted by or 
on behalf of a sponsor or relied on by a sponsor.

D. Can FDA Provide Any Examples of Falsification of Data That Would Be 
Subject to the Reporting Requirements of This Proposed Rule?

    ``Falsification of data'' is defined for the purpose of this 
proposed rule as creating, altering, recording, or omitting data in 
such a way that the data do not represent what actually occurred. 
Instances of falsification of data may fall into one or several of 
these categories. The following, although not comprehensive, represent 
examples of falsification of data that would be reportable under this 
proposed rule:
     Creating data that were never obtained (e.g., making up 
data or results and recording or reporting them; reporting enrollment 
in a study of a subject who did not exist; forging the signature on an 
informed consent form)
     Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal)
     Recording or obtaining data from a specimen, sample, or 
test whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject)
     Omitting data that were obtained and would be appropriate 
for recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed)
    Although the examples above are each characterized as a particular 
type of falsification of data, we recognize that even these examples 
can fall into one or more categories. Because instances of 
falsification of data might fall into one or more of these categories, 
sponsors would not need to specifically characterize the falsification 
(e.g., creating, recording, altering, or omitting data) in the reports 
they would be required to submit to us.

E. Would Sponsors Be Required to Report Errors Under This Proposed 
Rule?

    Errors, which can include, as noted in the proposed codified 
language, typographical errors and transposed numbers or characters, 
should not be reported under this proposed rule. The proposed rule is 
designed to address falsification of data rather than unintentional 
errors in recording and reporting information for several reasons:
     Falsification is more difficult for FDA to detect than 
errors during the normal inspectional process, in part because persons 
who engage in falsification are more likely to attempt to conceal their 
actions.
     Persons who engage in falsification of data often repeat 
that conduct when they are participating in multiple studies that 
affect multiple sponsors, so the impact of the conduct is often greater 
than that for errors.
     Although significant errors could potentially compromise 
the integrity of data submitted to FDA, it is more likely that these 
errors will be addressed through FDA inspections, sponsor monitoring 
activities, and the agency's application review processes than is the 
case with falsification of data.
     Requiring sponsors to report every observed error in data 
recording and processing could overwhelm the agency with information, 
much of which would already be detected through the activities noted 
above and would ultimately be of little concern with respect to the 
safety or effectiveness of regulated products.
    For these reasons, at this time we are proposing to exclude errors 
from the proposed reporting requirement to best utilize the agency's 
resources.
    We also are soliciting comments on whether we should include 
additional descriptions of what we consider ``errors'' and, if so, what 
would be specific examples of such errors.

F. Would a Sponsor Be Required to Report Possible Falsification?

    The proposed codified language includes the phrase ``has, or may 
have, engaged in the falsification of data'' to make clear that the 
sponsor is required to report not only confirmed, but also possible, 
falsification. It is not always possible for an observer to know the 
intent of a person who may have falsified data. The proposed rule would 
not require a sponsor to determine definitively that data have been 
falsified, nor would the proposed rule require that a sponsor determine 
the intent of the person who has, or may have, falsified data. Rather, 
a sponsor would be required to report information of which it is aware 
suggesting that a person has, or may have, engaged in the falsification 
of data in connection with studies conducted by, or on behalf of, the 
sponsor, or relied on by the sponsor. This reporting obligation would 
exist regardless of the amount of evidence, if any, the sponsor has 
with regard to the intent of the person who has, or may have, falsified 
data.
    We purposely are not proposing to specify in the regulations any 
particular information threshold that must be met before the reporting 
requirements are triggered, such as the exact form, quantity, or 
reliability of information about possible falsification that would 
require a sponsor to report to FDA. We do not believe that it is 
feasible to codify all forms of information on possible falsification 
(e.g., discovery of possibly altered document, report by coworker, 
complaint by study subject) or specify a quantity of information that 
would constitute a minimum threshold for sponsor reporting, and we do 
not want to inadvertently exclude information that, upon further 
investigation by the agency, could help uncover falsification. However, 
we invite comment on whether the regulation should specify some form of 
evidentiary standard or minimum threshold, such as what form(s) or 
quantity of information is needed to create a requirement to report 
and, if so, what the standard should be (see also section IX of this 
document).

G. How Will FDA Use This Information?

    FDA would determine whether further agency investigation is 
warranted based on the information reported under this proposed rule in

[[Page 7416]]

conjunction with other information available to us. These 
investigations, in turn, might form the basis of administrative or 
enforcement actions, such as excluding clinical trials from 
consideration by FDA, placing a clinical trial on hold, or initiating 
disqualification of investigators or criminal proceedings.
    Although a single sponsor may have only a small amount of 
information about a particular person or incident, the reporting that 
would be required by this proposed rule, independently or when 
aggregated with reports from other sources, may provide sufficient 
information from multiple sources about a person or situation to 
indicate that FDA should conduct an investigation. FDA would determine 
whether further agency investigation is warranted based on the 
information reported under this proposed rule in conjunction with other 
information available to FDA. Sponsors should therefore not wait to 
determine conclusively whether falsification actually occurred, or seek 
to determine the circumstances that led to it, before reporting this 
information to FDA.
    The intent of this proposed requirement is for FDA to obtain 
information about possible falsification as soon as possible, with the 
full recognition that further investigation may be needed to 
substantiate allegations of possible falsification before any 
administrative or enforcement actions are taken. The act of being 
reported to FDA for possible data falsification would not necessarily 
mean that falsification had occurred or that the agency would make such 
a determination. The information likely would be assessed in light of 
the existing legal and regulatory framework and, as appropriate, would 
be considered in the context of administrative or enforcement 
proceedings. Persons suspected of data falsification would be entitled 
to the legal and procedural rights that would typically apply in any 
such administrative or enforcement proceedings.
    Early reporting by sponsors could alert FDA to conditions that may 
affect data integrity and the rights, safety, and welfare of subjects. 
This reporting requirement would have the effect of providing FDA with 
an early alert to potentially serious lapses in subject protection or 
data integrity. If FDA were made aware of possible falsification of 
data sooner, FDA could undertake appropriate action, such as reviewing 
other studies conducted by the persons who have, or may have, falsified 
data to assess the reliability of the data and/or conducting site 
inspections.

H. What Information Should Sponsors Include in the Required Report to 
FDA?

    The proposed rule would require the sponsor to report to FDA 
information it possesses regarding the possible falsification of data. 
The information a sponsor should report to FDA includes the following:
     The name of the person who has, or may have, falsified 
data;
     The last known address(es) and phone number(s) of that 
person;
     The specific identity of the potentially affected study, 
including, when applicable, application information such as the 
application number, investigational protocol number, study title, study 
site(s), and study dates; and
     Information suggesting that falsification occurred and 
describing the falsification. A sponsor may provide this information by 
any means, including telephone, mail, electronic mail, or facsimile.
    We are considering whether additional information should be 
included in the report to FDA. One such element could be the National 
Clinical Trial (NCT) number assigned to a study when an applicable 
clinical trial is registered with ClinicalTrials.gov. We also are 
considering whether the regulations should specify what information 
about possible falsification must be reported to FDA.
    Although the proposal would require only sponsors to report 
information about possible falsification of data, FDA also encourages 
other persons to report such information. FDA reminds sponsor-
investigators that they would be responsible for reporting 
falsification of data under this proposed rule because they must adhere 
to the requirements applicable to both sponsors and investigators.

I. How Does a Sponsor Become Aware of Data Falsification?

    There are many ways a sponsor can become aware of possible 
falsification, including, but not limited to, monitoring the conduct of 
studies, reviewing and evaluating study data (e.g., noticing unusual 
data in case report forms and/or analytical reports), and receiving 
complaints from employees or former employees.

J. When Would a Sponsor Be Required to Report Information About 
Falsification of Data?

    The agency is proposing to require sponsors to report information 
regarding falsification of data ``promptly,'' but no later than 45 
calendar days after the sponsor becomes aware of the information. It is 
important for FDA to receive information about the falsification of 
data in a timely manner to ensure protection of the integrity of data 
reviewed by the agency and protection of subjects. We believe that 45 
calendar days would provide a sponsor a reasonable amount of time to 
review the information and report any actual or suspected falsification 
to FDA. The proposed requirement for a sponsor to report information 
regarding falsification of data would be ongoing and cover the periods 
before and after study completion, including after the review, 
approval, or authorization of the affected product or labeling.

K. What Are the Consequences of Not Reporting Confirmed or Possible 
Falsification?

    Failure to report possible falsification of data might constitute a 
violation of section 301(e) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 331(e)) (concerning failure to make a required 
report) or 18 U.S.C. 1001 (concerning the submission of a false 
statement to the Federal government).

L. Whom Would a Sponsor Inform About Falsification?

    As proposed, a sponsor would be required to report information it 
discovered regarding falsification of data to the appropriate FDA 
center. For investigations involving a combination product, the sponsor 
should report information on falsification to the FDA center that has 
primary jurisdiction for the premarket review and regulation of the 
product.
    Current contact information for each center is listed below as 
follows:
    Center for Biologics Evaluation and Research (CBER): Office of 
Compliance and Biologics Quality (HFM-650), Division of Inspections and 
Surveillance, Center for Biologics Evaluation and Research, FDA, 1401 
Rockville Pike, rm. 200N, Rockville, MD 20852-1448, 301-827-6221, FAX 
301-827-6748.
    Center for Devices and Radiological Health (CDRH): Office of 
Compliance, Division of Bioresearch Monitoring (HFZ-310), Center for 
Devices and Radiological Health, FDA, 10903 New Hampshire Ave., Bldg. 
66, rm. 3444, Silver Spring, MD 20993-0002, 301-796-5490, FAX 301-847-
8136.
    Center for Drug Evaluation and Research (CDER): Division of 
Scientific Investigations, Office of Compliance, Center for Drug 
Evaluation and Research, FDA, 10903 New Hampshire Ave., Bldg. 51, rm. 
5311, Silver Spring, MD 20993-0002, 301-796-3150, FAX 301-847-8748.

[[Page 7417]]

    Center for Food Safety and Applied Nutrition (CFSAN): Office of 
Compliance, Division of Enforcement (HFS-605), Center for Food Safety 
and Applied Nutrition, FDA, 5100 Paint Branch Pkwy., College Park, MD 
20740-3835, 301-436-2417, FAX 301-436-2656.
    Center for Veterinary Medicine (CVM): Office of Surveillance and 
Compliance, Division of Compliance (HFV-230), Center for Veterinary 
Medicine, FDA, 7500 Standish Pl., Rockville, MD 20850, 240-276-9200, 
FAX 240-276-9241.
    Office of Regulatory Affairs (ORA): Office of Enforcement (HFC-
230), FDA, 15800 Crabbs Branch Way, Rockville, MD 20855, 240-632-6853.

M. What Is the Proposed Definition of ``Data'' for the Purposes of This 
Proposal?

    In this proposal, the term ``data'' includes, but is not limited 
to, individual facts, tests, specimens, samples, results, statistics, 
items of information, or statements made by individuals. This proposed 
rule would apply to data from studies conducted by or on behalf of a 
sponsor or relied on by a sponsor. Thus, it would apply not only to 
data from studies conducted by a sponsor, but also to data from studies 
not sponsored or conducted by a sponsor but cited in a petition, new 
dietary ingredient notification, or application to FDA in support of a 
claim, product marketing, or other regulatory action such as 
reclassification of a device.

N. Why Does FDA Want to Issue This Proposal Given Existing Regulations 
on Research Misconduct?

    The Public Health Service (PHS) regulations at 42 CFR part 93 and 
the National Science Foundation (NSF) regulations at 45 CFR part 689 
address ``research misconduct.'' The PHS research misconduct 
regulations generally apply to PHS-conducted or PHS-supported 
biomedical and behavioral research, research training, research-related 
activities, and applications and proposals for such PHS-supported 
research, research training, and related activities. The NSF 
regulations on research misconduct address research proposals submitted 
to NSF and funded by NSF. As a result, neither of these regulations 
encompasses sufficiently the scope of research subject to evaluation by 
FDA.\4\ FDA's proposed rule is intended to cover all studies that are 
subject to FDA evaluation, regardless of the source of funding.
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    \4\ References made in this proposed rule to ``research'' and 
``studies'' that are ``subject to evaluation by FDA'' include 
research and studies that are otherwise within the scope of the 
codified provisions in this proposed rule.
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    Furthermore, FDA is not adopting any definition of ``research 
misconduct'' for the purpose of this proposal for two additional 
reasons. First, FDA's proposed definition of ``falsification of data`` 
describes the kinds of falsification of data that the agency has 
actually encountered that can affect both application reviews and the 
safety of subjects. Second, the PHS and NSF research misconduct 
regulations include the category ``plagiarism'' in the definitions of 
``research misconduct.'' Although plagiarism is an important issue in 
the context of Federal research grants and contracts, it is an area 
generally outside the scope of FDA compliance oversight. Accordingly, 
FDA is proposing to not include plagiarism in the category of activity 
that would trigger reporting under the proposed rule.

O. Why Is FDA Proposing to Change the Section Heading of Sec.  312.56?

    FDA is proposing to change the section heading of Sec.  312.56 from 
``Review of ongoing investigations'' to ``Review of ongoing 
investigations; reporting falsification of data'' to reflect the 
addition of this proposed reporting requirement to this section.

P. Why Is FDA Proposing to Renumber Sec.  58.217 to Sec.  58.12?

    FDA is proposing to renumber Sec.  58.217 to Sec.  58.12 to place 
sponsor responsibilities under the regulations in consecutive sections. 
The proposed revisions to the language in current Sec.  58.217 include 
changing the first sentence to read ``subpart K of this part'' instead 
of ``this subpart'' and several minor plain language edits.

Q. Why Is FDA Not Proposing to Amend Parts 314, 514, 601, and 814?

    We recognize that the applicant (under 21 CFR parts 314, 514, 601, 
807, and 814) is not always the sponsor for a given study and that 
arrangements between sponsors and applicants can sometimes be complex. 
We currently believe that sponsors are in the best position to detect 
and report falsification of data as described in this proposal. 
However, this proposal does not relieve applicants of any 
responsibilities under applicable statutes and regulations (e.g., parts 
314, 514, 601, 807, and 814). It may be appropriate to extend the 
reporting requirements described in this proposed rule to nonsponsor 
applicants if we have reason to believe that they are also in a 
position to discover falsification of data described in this proposed 
rule and that existing statutes and regulations are not adequate to 
capture this information. Therefore, we request comment on whether we 
should require nonsponsor applicants to comply with the requirements in 
the proposed rule and whether such applicants are in a position to 
discover falsification of data.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Legal Authority

    FDA is proposing this rule under the authority granted to it by the 
act (21 U.S.C. 301 et seq.) and the Public Health Service Act (PHS Act) 
(42 U.S.C. 201 et seq.). By delegation from the Secretary of the 
Department of Health and Human Services (the Secretary), FDA is 
authorized to issue regulations for the efficient enforcement of the 
act (21 U.S.C. 371). Any final rule upon which this proposal is based 
would help with the efficient enforcement of provisions relating to the 
following: (1) Investigational use of human drugs, animal drugs, 
biologics, and devices; (2) investigational and approved use of food 
additives and color additives; (3) safety and, as appropriate, 
effectiveness of human and animal drugs, biological products, and 
medical devices; (4) accuracy of a health claim or nutrient content 
claim in food labeling; and (5) establishing that a new dietary 
ingredient will reasonably be expected to be safe.
    FDA may require the establishment and maintenance of such records, 
and the making of such reports to FDA, of data obtained as a result of 
the investigational use of an animal drug (21 U.S.C. 360b(j)), a 
biologic (42 U.S.C. 262(a)(3)), a device (21 U.S.C. 360j(g)(2)(B)(ii)), 
a human drug (21 U.S.C. 355(i)), a food additive (21 U.S.C. 348(b), 
(j), and (h)), or a color additive (21 U.S.C. 379e(b)). FDA may require 
the submission of balanced information, which is necessary for FDA to 
evaluate: The safety of a food additive (21 U.S.C. 348), the safety and 
suitability of a color additive (21 U.S.C. 379e), the accuracy of a 
health claim or nutrient content claim in food labeling (21 U.S.C. 
343(r)(2)(A), (r)(3)(B)), and the basis on which a manufacturer or 
distributor concluded that a new dietary ingredient will reasonably be 
expected to be safe

[[Page 7418]]

(21 U.S.C. 350b(a)(2)). FDA may also require the establishment and 
maintenance of such records, and the making of such reports to FDA, as 
are necessary to determine whether there are, or may be, grounds to 
withdraw the approval or authorization of an animal drug (21 U.S.C. 
360b(l)), a biologic (42 U.S.C. 262(a)(2)(A)), a device (21 U.S.C. 
360i), a human drug (21 U.S.C. 355(k)), a food additive (21 U.S.C. 
348), a color additive (21 U.S.C. 379e), a health claim (21 U.S.C. 
343(r)(2)(A)), or a nutrient content claim (21 U.S.C. 343(r)(2)(B)), or 
when reasonably necessary to determine that a dietary supplement 
containing a new dietary ingredient may no longer meet the provisions 
in 21 U.S.C. 350b(a)(2).
    Moreover, other provisions, such as 21 U.S.C. 355(i), 42 U.S.C. 
262, and 21 U.S.C. 360b(j) and 360j(g)(2), confer broad authority upon 
the Secretary (and, by delegation, to FDA) to issue regulations 
governing the investigational use of new drugs, biologics, new animal 
drugs, and devices to protect the rights, safety, and welfare of 
subjects and otherwise protect the public health. Other provisions, 
such as 21 U.S.C. 355(b) to (d), 360b(b) to (d), 360e(2)(A), and 
360e(c)(1), give the agency the authority to obtain the information we 
need to adequately assess the safety and effectiveness of drugs and 
devices. In determining whether a drug or device is ``safe for use'' 
under the conditions proposed, the agency may consider not only 
information such as data from studies, but also ``any other 
information'' or ``new information'' before the agency relevant to the 
approval decisions under 21 U.S.C. 355(d), 360b(d), and 360e(d)(2). The 
language in 21 U.S.C. 355(d), 360b(d), and 360e(c)(1) is intended to 
help ensure that consumers are not exposed to products for which safety 
and effectiveness have not been demonstrated.
    Similarly, 21 U.S.C. 360e gives the agency the authority to obtain 
the information we need to determine whether a premarket approval 
application provides reasonable assurances of the safety and 
effectiveness of a device. Under 21 U.S.C. 360c(i), persons submitting 
premarket notifications are required to submit a summary of any 
information respecting safety and effectiveness or state that such 
information will be made available upon request.
    In addition, under 21 U.S.C. 355(e), 360b(e)(1), and 360e(e)(1), 
approval of an application is to be withdrawn if, inter alia, new 
information shows that the drug or device is unsafe or has not been 
shown to be either safe or effective under the conditions of use.
    As discussed previously, the proposal, when final, would help 
efficiently enforce provisions relating to: (1) The safety and, as 
appropriate, effectiveness of human and animal drugs, biological 
products, and medical devices; (2) the safety of food additives and new 
dietary ingredients; (3) the safety and suitability of color additives; 
and (4) the accuracy of nutrient content claims and health claims. FDA 
believes the proposal would help prevent the use of falsified data in 
evaluating the safety and, as appropriate, suitability, accuracy, or 
effectiveness of such products. The proposed changes would also help to 
protect research subjects.
    Provisions for misbranding (21 U.S.C. 352 and 343) and adulteration 
(21 U.S.C. 351 and 342) also provide authority for issuance of these 
regulations.

V. Proposed Implementation Plan

    FDA proposes that any final rule that may issue based on this 
proposal become effective 90 days after the date of publication in the 
Federal Register.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is not an economically significant regulatory action 
as defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of the 
rule on small entities. Because most firms would not generally submit 
more than one report of potential data falsification per year at the 
estimated cost of only $210 per report, the agency does not believe 
that this proposed rule would have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $133 million, using the most current (2008) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The proposed rule would amend FDA's regulations to require sponsors 
to report information indicating that any person has, or may have, 
falsified data in the course of reporting study results, or in the 
course of proposing, designing, performing, recording, supervising, or 
reviewing studies conducted by or on behalf of a sponsor or relied on 
by a sponsor. For the purpose of this proposal, ``falsification of 
data'' means creating, altering, recording, or omitting data in such a 
way that the data do not represent what actually occurred. Sponsors 
would be required to report this information to the appropriate FDA 
center promptly, but no later than 45 calendar days after the sponsor 
becomes aware of the information.

A. Benefits

    The benefits of the changes being proposed would be the decreased 
likelihood that FDA would rely on falsified data for product reviews 
and approvals, or for authorization of certain labeling claims. The 
proposed changes would also decrease the likelihood of harm to research 
subjects by making it less likely that clinical studies would begin or 
continue if falsified data from nonclinical laboratory studies were 
reported. The proposed changes would also prevent researchers who 
falsify data from continuing studies, coming in contact with research 
subjects, or jeopardizing the safety of such subjects through unsound 
scientific practices.

B. Costs

    Regulatory costs will reflect the added paperwork cost of 
submitting the information reports. Given the great flexibility 
provided in the manner in which the reports can be made, FDA believes 
that they will be simple to complete. Therefore, FDA estimates that it 
will take about 5 hours to prepare and report this information to the 
agency. The agency is uncertain of the average number of these reports 
to expect annually. As explained in section VII of this document, the 
agency estimates that it may receive 73 reports per year in compliance 
with this rule (see Table 1.--Estimated Annual Reporting

[[Page 7419]]

Burden). FDA is basing this estimate on several types of information, 
including reports received from sponsors of errors and reports of 
suspensions and terminations of clinical investigators. Because most 
errors do not involve falsification and because investigators may be 
suspended or terminated for reasons other than for falsifying data, 
this estimate of 73 reports is likely to be greater than the number the 
agency would actually receive. At a benefit-adjusted hourly wage rate 
of about $42 for a regulatory affairs official, these assumptions imply 
a total annual cost of about $15,330 per year.\5\ As mentioned 
previously, the agency expects the total number of reports of falsified 
data, and therefore the total cost, to be lower. Although a small 
number of firms may submit more than one report in a year, most firms 
would not generally submit more than one report per year. At an 
estimated cost of only about $210 per report, the agency concludes that 
the proposed rule would not have a significant economic impact on a 
substantial number of small entities. The Unfunded Mandates Reform Act 
of 1995 does not require FDA to prepare a statement of costs and 
benefits for the proposed rule, because the proposed rule is not 
expected to result in any 1-year expenditure that would meet or exceed 
$100 million adjusted for inflation. The current inflation-adjusted 
statutory threshold is $133 million.
---------------------------------------------------------------------------

    \5\ 2004 National Industry-Specific Occupational Employment and 
Wage Estimates, US Department of Labor, Bureau of Labor Statistics 
(www.bls.gov/oes/current/naics4_325400.htm); compliance officer 
wage rate for pharmaceutical and medicine manufacturing (NAICS 
325400) plus a 30-percent increase for benefits.
---------------------------------------------------------------------------

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection requirements 
that 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 
PRA). Collections of information include any request or requirement 
that persons obtain, maintain, retain, or report information to the 
agency, or disclose information to a third party or to the public (44 
U.S.C. 3502(3) and 5 CFR 1320.3(c)). A description of the information 
collection requirements included in this proposed rule is given below 
with an estimate of the annual reporting burden. Included in this 
estimate is the time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing each collection of information.
    FDA invites comments on: (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.
    Title: Reporting Information Regarding Falsification of Data.
    Description: FDA is proposing to amend its regulations on review of 
studies to require sponsors to report information indicating that any 
person has, or may have, engaged in the falsification of data in the 
course of reporting study results, or in the course of proposing, 
designing, performing, recording, supervising, or reviewing studies 
conducted by or on behalf of a sponsor or relied on by a sponsor. The 
sponsor would be required to report this information to the appropriate 
FDA center promptly, but no later than 45 calendar days after the 
sponsor becomes aware of the information. For the purpose of this 
proposal, ``falsification of data'' means creating, altering, 
recording, or omitting data in such a way that the data do not 
represent what actually occurred.
    FDA believes that this proposal is necessary because ambiguity in 
the current regulations has caused considerable confusion among 
sponsors. FDA intends to make it absolutely clear that sponsors would 
be required to report information pertaining to the possible 
falsification of data as described in this proposal. This proposal is 
intended to help ensure the integrity of data received by FDA in 
support of applications and petitions for product approval and 
authorization of certain labeling claims and to help protect research 
subjects. In addition, this proposal would protect research subjects by 
making it less likely that falsified nonclinical laboratory studies 
would be relied on by the agency and that researchers who falsify data 
could continue to conduct studies, come in contact with research 
subjects, and/or jeopardize the rights, safety, and welfare of such 
subjects through unsound scientific practices.
    Based on data concerning the number of reports of falsification 
received annually by FDA, FDA estimates that it will receive 
approximately 73 reports of falsification of data per year. FDA bases 
this estimate on the fact that CDER receives approximately 20 reports a 
year from sponsors, CBER receives approximately 30 per year, and CDRH 
receives approximately 15. There are approximately three incidents a 
year concerning nonclinical laboratory studies. CFSAN receives 
approximately three reports a year concerning food additive petitions 
and color additive petitions. CFSAN has received no reports concerning 
nutrient content claims, health claims, or new dietary ingredients. CVM 
receives approximately two reports a year.
    FDA estimates that it will take approximately 5 hours to prepare 
and submit to FDA each report. FDA bases this estimate on the time it 
would take a sponsor to gather the information to report to FDA, 
contact FDA to report the information, and meet with FDA to present the 
report, if necessary.
    The reporting burden posed by the proposed rule is considerably 
less than the burden posed by the PHS research misconduct regulations, 
primarily because the proposed rule would require fewer specific 
actions by sponsors. The PRA section of the final rule on the PHS 
research misconduct regulations (70 FR 28370, 28382 to 28384; May 17, 
2005) describes the extensive efforts that a research institution must 
undertake to investigate and document research misconduct, including 
promptly taking custody of all records and evidence, performing an 
inventory of these items, and sequestering them, as well as taking 
custody of additional records and evidence discovered during the course 
of a research misconduct proceeding. FDA's proposed rule on 
falsification would not require extensive investigation, documentation, 
and recordkeeping, but rather would simply require reporting of known 
or potential data falsification when a sponsor becomes aware of 
information indicating that such activity may have occurred. This would 
impose a substantially lesser burden than that created by the PHS rule.
    Description of Respondents: Persons and businesses, including small 
businesses and manufacturers.

[[Page 7420]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
58.11(a)                                                                3                     1                  3                  5                 15
--------------------------------------------------------------------------------------------------------------------------------------------------------
71.1(k)                                                                 1                     1                  1                  5                  5
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.69(p)                                                               0                     0                  0                  0                  0
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.70(k)                                                               0                     0                  0                  0                  0
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101(f)                                                              1                     1                  1                  5                  5
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1(o)                                                                1                     1                  1                  5                  5
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6(g)                                                                0                     0                  0                  0                  0
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.56(e)                                                              50                     1                 50                  5                250
--------------------------------------------------------------------------------------------------------------------------------------------------------
511.1(c)(1)                                                             2                     1                  2                  5                 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(l)                                                                0                     0                  0                  0                  0
--------------------------------------------------------------------------------------------------------------------------------------------------------
812.46(d)                                                              15                     1                 15                  5                 75
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                  73                     7                 73                 35                365
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), the agency has submitted the information collection 
provisions of this proposed rule to OMB for review. Interested persons 
are requested to send comments regarding this information collection to 
the Office of Information and Regulatory Affairs, OMB (see ADDRESSES).
    Before this proposed rule becomes final, FDA will publish a notice 
in the Federal Register announcing OMB's decision to approve, modify, 
or disapprove the information collection provisions in the final rule. 
An agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless the information 
collection displays a current OMB control number.

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
the agency has concluded that the proposed rule does not contain 
policies that have federalism implications as defined in the Executive 
order and, consequently, a federalism summary impact statement is not 
required.

IX. Request for Comments

    In addition to requesting general comments on the proposed rule, 
FDA has also identified several specific issues on which it invites 
public comment. The public comments will help FDA decide whether 
additional revisions to the proposed regulations are needed. The issues 
are as follows:
    (1) We welcome comments concerning the definition of 
``falsification of data.''
    (2) The proposed rule states that the information should be 
reported to FDA ``promptly,'' but no later than 45 calendar days after 
the sponsor becomes aware of the information. We believe that 45 
calendar days would provide a sponsor a reasonable amount of time to 
review the information to determine if it must be reported to FDA. 
However, we welcome comments on whether this timeframe is appropriate.
    (3) Although we have not proposed to amend regulations related to 
marketing applications (i.e., parts 314, 514, 807, and 814), we invite 
comments as to whether we should amend these regulations to require 
applicants to report possible falsification of data.
    (4) We invite comments on whether the proposed rule should specify 
an evidentiary standard or threshold, such as a certain form or 
quantity of information that a sponsor must be aware of before the 
sponsor would be required to report possible falsification of data.
    (5) We invite comments on whether we should include additional 
descriptions of what we consider ``errors'' (beyond the listing of 
examples such as typographical errors and transposed numbers or 
characters) that sponsors would not be required to report.
    (6) We invite comments on the information that should be provided 
to FDA when a sponsor reports possible falsification of data, as well 
as on whether the regulations should specify what information must be 
reported.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this proposal. 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.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 58

    Laboratories, Reporting and recordkeeping requirements.

21 CFR Part 71

    Administrative practice and procedure, Color additives, 
Confidential business information, Cosmetics, Drugs,

[[Page 7421]]

Reporting and recordkeeping requirements.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 170

    Administrative practice and procedure, Food additives, Reporting 
and recordkeeping requirements.

21 CFR Part 171

    Administrative practice and procedure, Food additives.

21 CFR Part 190

    Dietary foods, Foods, Food additives, Reporting and recordkeeping 
requirements.

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 511

    Animal drugs, Medical research, Reporting and recordkeeping 
requirements.

21 CFR Part 571

    Administrative practice and procedure, Animal feeds, Animal foods, 
Food additives.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR parts 16, 
58, 71, 101, 170, 171, 190, 312, 511, 571, and 812 be amended as 
follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    1. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.


Sec.  16.1   [Amended]

    2. Section 16.1 is amended in paragraph (b)(2) by removing 
``511.1(c)(1)`` and adding in its place ``511.1(d)(1)'' and by removing 
the phrase ``511.1(c)(4) and (d)'' and adding in its place the phrase 
``511.1(d)(4) and (e)''.

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY 
STUDIES

    3. The authority citation for 21 CFR part 58 continues to read as 
follows:

    Authority:  21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 
360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-
263n.

    4. Section 58.11 is added to subpart A to read as follows:


Sec.  58.11   Reporting falsification of data.

    (a) When a sponsor becomes aware of information indicating that any 
person has, or may have, engaged in the falsification of data in the 
course of reporting study results, or in the course of proposing, 
designing, performing, recording, supervising, or reviewing studies 
conducted by or on behalf of a sponsor or relied on by a sponsor 
involving studies subject to this part, the sponsor must report this 
information to FDA. A sponsor must report this information regardless 
of whether the sponsor has evidence as to the intent of the person who 
has, or may have, falsified data. The sponsor must report this 
information to FDA promptly, but no later than 45 calendar days after 
the sponsor becomes aware of the information. For the purpose of this 
section only, the following definitions apply:
    (1) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (i) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (ii) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (iii) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (iv) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (2) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (b) Sponsors should not report errors (e.g., typographical errors, 
transposed numbers or characters) to FDA under this section.
    5. Section 58.217 is transferred to subpart A and redesignated as 
Sec.  58.12 and newly redesignated Sec.  58.12 is revised to read as 
follows:


Sec.  58.12   Suspension or termination of a testing facility by a 
sponsor.

    Termination of a testing facility by a sponsor is independent of, 
and neither in lieu of nor a precondition to, proceedings or actions 
authorized by subpart K of this part. If a sponsor terminates or 
suspends a testing facility from further participation in a nonclinical 
laboratory study that is being conducted as part of any application for 
a research or marketing permit that has been submitted to any Center of 
the Food and Drug Administration (whether approved or not), the sponsor 
must notify that center in writing within 15 working days of the 
action; the notice must include a statement of the reasons for such 
action. Suspension or termination of a testing facility by a sponsor 
does not relieve it of any obligation under any other applicable 
regulation to submit the results of the study to the Food and Drug 
Administration.

PART 71--COLOR ADDITIVE PETITIONS

    6. The authority citation for 21 CFR part 71 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 
360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.

    7. Section 71.1 is amended by adding paragraph (k) to read as 
follows:


Sec.  71.1   Petitions.

* * * * *
    (k)(1) When a petitioner becomes aware of information indicating 
that any person has, or may have, engaged in the falsification of data 
in the course of reporting study results, or in the course of 
proposing, designing, performing, recording, supervising, or reviewing 
studies conducted by or on behalf of a petitioner, relied on by a 
petitioner, or otherwise cited in a petition under this

[[Page 7422]]

part, the petitioner must report this information to the Center for 
Food Safety and Applied Nutrition (Center). A petitioner must report 
this information regardless of whether the petitioner has evidence as 
to the intent of the person who has, or may have, falsified data. The 
petitioner must report this information to the Center promptly, but no 
later than 45 calendar days after the petitioner becomes aware of the 
information. For the purpose of this section only, the following 
definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Petitioners should not report errors (e.g., typographical 
errors, transposed numbers or characters) to FDA under paragraph (k) of 
this section.

PART 101--FOOD LABELING

    8. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.
    9. Section 101.69 is amended by adding paragraph (p) to read as 
follows:


Sec.  101.69   Petitions for nutrient content claims.

* * * * *
    (p)(1) When a petitioner becomes aware of information indicating 
that any person has, or may have, engaged in the falsification of data 
in the course of reporting study results, or in the course of 
proposing, designing, performing, recording, supervising, or reviewing 
studies conducted by or on behalf of a petitioner, relied on by a 
petitioner, or otherwise cited in a petition under this part, the 
petitioner must report this information to the Center for Food Safety 
and Applied Nutrition (Center). A petitioner must report this 
information regardless of whether the petitioner has evidence as to the 
intent of the person who has, or may have, falsified data. The 
petitioner must report this information to the Center promptly, but no 
later than 45 calendar days after the petitioner becomes aware of the 
information. For the purpose of this section only, the following 
definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Petitioners should not report errors (e.g., typographical 
errors, transposed numbers or characters) to FDA under paragraph (p) of 
this section.
    10. Section 101.70 is amended by adding paragraph (k) to read as 
follows:


Sec.  101.70   Petitions for health claims.

* * * * *
    (k)(1) When a petitioner becomes aware of information indicating 
that any person has, or may have, engaged in the falsification of data 
in the course of reporting study results, or in the course of 
proposing, designing, performing, recording, supervising, or reviewing 
studies conducted by or on behalf of a petitioner, relied on by a 
petitioner, or otherwise cited in a petition under this part, the 
petitioner must report this information to the Center for Food Safety 
and Applied Nutrition (Center). A petitioner must report this 
information regardless of whether the petitioner has evidence as to the 
intent of the person who has, or may have, falsified data. The 
petitioner must report this information to the Center promptly, but no 
later than 45 calendar days after the petitioner becomes aware of the 
information. For the purpose of this section only, the following 
definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject

[[Page 7423]]

when it came from a source other than the subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Petitioners should not report errors (e.g., typographical 
errors, transposed numbers or characters) to FDA under paragraph (k) of 
this section.

PART 170--FOOD ADDITIVES

    11. The authority citation for 21 CFR part 170 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 341, 342, 346a, 348, 371.

    12. Section 170.101 is amended by adding paragraph (f) to read as 
follows:


Sec.  170.101   Information in a premarket notification for a food 
contact substance (FCN).

* * * * *
    (f)(1) When a manufacturer or supplier who submits a FCN becomes 
aware of information indicating that any person has, or may have, 
engaged in the falsification of data in the course of reporting study 
results, or in the course of proposing, designing, performing, 
recording, supervising, or reviewing studies conducted by or on behalf 
of a manufacturer or supplier, relied on by a manufacturer or supplier, 
or otherwise cited in the notification under this part, the 
manufacturer or supplier must report this information to the Center for 
Food Safety and Applied Nutrition (Center). A manufacturer or supplier 
must report this information regardless of whether the manufacturer or 
supplier has evidence as to the intent of the person who has, or may 
have, falsified data. The manufacturer or supplier must report this 
information to the Center promptly, but no later than 45 calendar days 
after the manufacturer or supplier becomes aware of the information. 
For the purpose of this section only, the following definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Manufacturers or suppliers should not report errors (e.g., 
typographical errors, transposed numbers or characters) to FDA under 
paragraph (f) of this section.

PART 171--FOOD ADDITIVE PETITIONS

    13. The authority citation for 21 CFR part 171 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348, 371.

    14. Section 171.1 is amended by adding paragraph (o) to read as 
follows:


Sec.  171.1   Petitions.

* * * * *
    (o)(1) When a petitioner becomes aware of information indicating 
that any person has, or may have, engaged in the falsification of data 
in the course of reporting study results, or in the course of 
proposing, designing, performing, recording, supervising, or reviewing 
studies conducted by or on behalf of a petitioner, relied on by a 
petitioner, or otherwise cited in the petition under this part, the 
petitioner must report this information to the Center for Food Safety 
and Applied Nutrition (Center). A petitioner must report this 
information regardless of whether the petitioner has evidence as to the 
intent of the person who has, or may have, falsified data. The 
petitioner must report this information to the Center promptly, but no 
later than 45 calendar days after the petitioner becomes aware of the 
information. For the purpose of this section only, the following 
definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Petitioners should not report errors (e.g., typographical 
errors, transposed numbers or characters) to FDA under paragraph (o) of 
this section.

PART 190--DIETARY SUPPLEMENTS

    15. The authority citation for 21 CFR part 190 is revised to read 
as follows:

    Authority:  21 U.S.C. 321(ff), 331, 342, 350(b), 371.

    16. Section 190.6 is amended by adding paragraph (g) to read as 
follows:

[[Page 7424]]

Sec.  190.6   Requirement for premarket notification.

* * * * *
    (g)(1) When a manufacturer or distributor who submits a 
notification becomes aware of information indicating that any person 
has, or may have, engaged in the falsification of data in the course of 
reporting study results, or in the course of proposing, designing, 
performing, recording, supervising, or reviewing studies conducted by 
or on behalf of a manufacturer or distributor, relied on by a 
manufacturer or distributor, or otherwise cited in the petition under 
this part, the manufacturer or distributor must report this information 
to the Center for Food Safety and Applied Nutrition (Center). A 
manufacturer or distributor must report this information regardless of 
whether the manufacturer or distributor has evidence as to the intent 
of the person who has, or may have, falsified data. The manufacturer or 
distributor must report this information to the Center promptly, but no 
later than 45 calendar days after the manufacturer or distributor 
becomes aware of the information. For the purpose of this section only, 
the following definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Manufacturers or distributors should not report errors (e.g., 
typographical errors, transposed numbers or characters) to FDA under 
paragraph (g) of this section.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

    17. The authority citation for 21 CFR part 312 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 371, 
381, 382, 383, 393; 42 U.S.C. 262.

    18. Section 312.56 is amended by revising the section heading and 
by adding new paragraph (e) to read as follows:


Sec.  312.56   Review of ongoing investigations; reporting 
falsification of data.

* * * * *
    (e)(1) When a sponsor becomes aware of information indicating that 
any person has, or may have, engaged in the falsification of data in 
the course of reporting study results, or in the course of proposing, 
designing, performing, recording, supervising, or reviewing studies 
conducted by or on behalf of a sponsor or relied on by a sponsor 
involving studies subject to this part, the sponsor must report this 
information to the Center for Drug Evaluation and Research (Center). A 
sponsor must report this information regardless of whether the sponsor 
has evidence as to the intent of the person who has, or may have, 
falsified data. The sponsor must report this information to the Center 
promptly, but no later than 45 calendar days after the sponsor becomes 
aware of the information. For the purpose of this section only, the 
following definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Sponsors should not report errors (e.g., typographical errors, 
transposed numbers or characters) to FDA under paragraph (e) of this 
section.

PART 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE

    19. The authority citation for 21 CFR part 511 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 360b, 371.

    20. Section 511.1 is amended by redesignating paragraphs (c), (d), 
(e), (f), and (g) as paragraphs (d), (e), (f), (g), and (h), 
respectively, and by adding new paragraph (c) to read as follows:


Sec.  511.1   New animal drugs for investigational use exempt from 
section 512(a) of the act.

* * * * *
    (c) Reporting falsification of data. (1) When a sponsor becomes 
aware of information indicating that any person has, or may have, 
engaged in the falsification of data in the course of reporting study 
results, or in the course of proposing, designing, performing, 
recording, supervising, or reviewing studies conducted by or on behalf 
of a sponsor or relied on by a sponsor, the sponsor must report this 
information to the Center for Veterinary Medicine (Center). A sponsor 
must report this information regardless of whether the sponsor has 
evidence as to the intent of the person who has, or may have, falsified 
data. The sponsor must report this information to the Center promptly, 
but no later than 45 calendar days after the sponsor becomes aware of 
the

[[Page 7425]]

information. For the purpose of this paragraph only, the following 
definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Sponsors should not report errors (e.g., typographical errors, 
transposed numbers or characters) to FDA under paragraph (c) of this 
section.
* * * * *

PART 571--FOOD ADDITIVE PETITIONS

    21. The authority citation for 21 CFR part 571 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348, 371; 42 U.S.C. 241.

    22. Section 571.1 is amended by adding paragraph (l) to read as 
follows:


Sec.  571.1   Petitions.

* * * * *
    (l)(1) When a petitioner becomes aware of information indicating 
that any person has, or may have, engaged in the falsification of data 
in the course of reporting study results, or in the course of 
proposing, designing, performing, recording, supervising, or reviewing 
studies conducted by or on behalf of the petitioner, relied on by the 
petitioner, or otherwise cited in the petition under this part, the 
petitioner must report this information to the Center for Food Safety 
and Applied Nutrition (Center). A petitioner must report this 
information regardless of whether the petitioner has evidence as to the 
intent of the person who has, or may have, falsified data. The 
petitioner must report this information to the Center promptly, but no 
later than 45 calendar days after the petitioner becomes aware of the 
information. For the purpose of this section only, the following 
definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting data in such a way that the data do not represent what 
actually occurred. Examples of falsification of data include, but are 
not limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Petitioners should not report errors (e.g., typographical 
errors, transposed numbers or characters) to FDA under paragraph (l) of 
this section.

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

    23. The authority citation for 21 CFR part 812 continues to read as 
follows:

    Authority:  21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 
262, 263b-263n.

    24. Section 812.2 is amended by revising paragraph (c) introductory 
text to read as follows:


Sec.  812.2   Applicability.

* * * * *
    (c) Exempted investigations. This part, with the exception of 
Sec. Sec.  812.46(d) and 812.119, does not apply to investigations of 
the following categories of devices:
* * * * *
    25. Section 812.46 is amended by adding paragraph (d) to read as 
follows:


Sec.  812.46   Monitoring investigations.

* * * * *
    (d) Falsification. (1) When a sponsor becomes aware of information 
indicating that any person has, or may have, engaged in the 
falsification of data in the course of reporting study results, or in 
the course of proposing, designing, performing, recording, supervising, 
or reviewing studies conducted by or on behalf of a sponsor or relied 
on by a sponsor involving studies subject to this part, the sponsor 
must report this information to FDA. A sponsor must report this 
information regardless of whether the sponsor has evidence as to the 
intent of the person who has, or may have, falsified data. The sponsor 
must report this information to FDA promptly, but no later than 45 
calendar days after the sponsor becomes aware of the information. Such 
reports should be submitted to the Center with jurisdiction over the 
product or clinical trial. For studies involving devices regulated by 
the Center for Devices and Radiological Health (CDRH), reports should 
be submitted to the Division of Bioresearch Monitoring (HFZ-310), 
Office of Compliance, Center for Devices and Radiological Health, Food 
and Drug Administration. For studies involving products regulated by 
the Center for Biologics Evaluation and Research (CBER), reports should 
be submitted to the Division of Inspections and Surveillance (HFM-650), 
Office of Compliance and Biologics Quality, Center for Biologics 
Evaluation and Research, Food and Drug Administration. For the purpose 
of this section only, the following definitions apply:
    (i) Falsification of data means creating, altering, recording, or 
omitting

[[Page 7426]]

data in such a way that the data do not represent what actually 
occurred. Examples of falsification of data include, but are not 
limited to, the following:
    (A) Creating data that were never obtained (e.g., making up data or 
results and recording or reporting them; reporting enrollment in a 
study of a subject who did not exist; forging the signature on an 
informed consent form);
    (B) Altering data by replacing original data with something 
different that does not accurately reflect study conduct or results 
(e.g., changing a laboratory measurement to a less extreme deviation 
from normal);
    (C) Recording or obtaining data from a specimen, sample, or test 
whose origin is not accurately described or in a way that does not 
accurately reflect the data (e.g., changing the date of a specimen, 
sample, or test; adding a substance not called for in the study to a 
specimen or sample; identifying a specimen, sample, or test as coming 
from a specific subject when it came from a source other than the 
subject);
    (D) Omitting data that were obtained and would be appropriate for 
recording based on study design and conduct (e.g., not recording 
exclusionary medical history or prohibited concomitant medications or 
treatments; omitting data so that a statistical analysis yields a 
result that would not have been obtained had all data been analyzed).
    (ii) The term data includes, but is not limited to, individual 
facts, tests, specimens, samples, results, statistics, items of 
information, or statements made by individuals.
    (2) Sponsors should not report errors (e.g., typographical errors, 
transposed numbers or characters) to FDA under paragraph (d) of this 
section.

    Dated: February 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3123 Filed 2-18-10; 8:45 am]
BILLING CODE 4160-01-S

