7412 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

Recent plant closures in the basin are 

expected to result in reductions of 

approximately $500K annually (about 

20 percent) in water sale revenues, 

while the costs of reservoir maintenance 

and operations, contractual services and 

administration continue to rise. 

DRBC’s Current Schedule of Water 

Charges. Resolution No. 71–4 provided 

that water rates would consist of ‘‘the 

weighted-average unit cost of all water 

stored by or on behalf of the 

Commission’’ and specified that the unit 

cost of all water would be determined 

‘‘by dividing all of the commission’s 

annual project cost by the net yield of 

the water supply in federal reservoirs 

authorized in the commission’s 

Comprehensive Plan.’’ Res. No. 71–4, 

par. A.2.a. Also see Res. No. 78–14, 

preamble. 

In accordance with this formula, the 

current schedule of water charges was 

established by Resolution No. 78–14 in 

October of 1978, based on the unit cost 

of water stored by the Commission in 

the Beltzville and Blue Marsh 

reservoirs. It was codified at section 

5.3.1 of the Commission’s 

Administrative Manual—Part III—Basin 

Regulations—Water Supply Charges 

(hereinafter, ‘‘WSC’’). Section 5.3.1 

provides that the Commission ‘‘will 

from time to time, after public notice 

and hearing, make, amend and revise a 

schedule of water charges’’ and that 

until changed, the charges for water 

shall be $.06 per thousand gallons for 

consumptive use ($60 per million 

gallons) and six-tenths of a mill per 

thousand gallons ($.60 per million 

gallons) for non-consumptive use. WSC 

§ 5.3.1. These rates which have remain 

unchanged for more than 30 years, lag 

far behind the rates charged for raw 

(untreated) water by the Commission’s 

sister agency the Susquehanna River 

Basin Commission (SRBC) and by the 

New Jersey Water Supply Authority 

(NJWSA) for raw water from its Raritan 

System. 

The consumptive use rate established 

by SRBC in May of 1992, effective 

January 1, 1993, was $140 per million 

gallons, nearly two-and-a-half times the 

current rate charged by DRBC. In June 

of 2008, SRBC approved a two-step 

increase to $210 per million gallons 

effective January 1, 2009, and $280 per 

million gallons (more than four-and-ahalf times DRBC’s current rate) effective 

January 1, 2010. NJWSA charged $216 

per million gallons as of July 1, 2010 

and will charge $220 per million gallons 

(more than three-and-a-half times 

DRBC’s current rate) as of July 1, 2011, 

for raw water from its Raritan System. 

DRBC’s proposed 2010 and 2011 rates 

for consumptively used water remain 

well below those of its counterparts. 

Proposed Rate Increase. Resolution 

No. 71–4 provided that ‘‘[c]osts, rates 

and charges will be recomputed * * * 

as often as necessary to reflect relevant 

changes in any cost components 

associated with sustaining specific base 

flows.’’ Res. No. 71–4, par. A.2.a. At this 

time, in order to maintain net income to 

the Storage Fund and ensure financial 

stability to address future operating and 

maintenance costs, the Commission is 

proposing its first water charging rate 

increase in 32 years. Because many 

people find the expression of the rates 

confusing, the Commission also is 

proposing that the new rates be 

established per million gallons rather 

than per thousand. 

In light of the difficult economic 

climate, the rate change is proposed in 

two stages. The proposed rates, 

calculated using the formula established 

by Resolution No. 71–4 and set forth 

above, are as follows: The consumptive 

use rate is proposed to be increased 

from $60 to $90 per million gallons 

effective on January 1, 2010, and from 

$90 to $120 per million gallons effective 

on January 1, 2011. The nonconsumptive use rate is proposed to be 

increased from $.60 to $.90 per million 

gallons effective on January 1, 2010, and 

from $.90 to $1.20 per million gallons 

effective on January 1, 2011. 

Even with the proposed increases, 

Delaware Basin water will remain 

inexpensive when compared to raw 

water in neighboring jurisdictions. 

Notably, the proposed 2012 rate of $120 

per million gallons for raw water 

consumptively used in the Delaware 

Basin is less than half the rate of $280 

currently in effect in the Susquehanna 

Basin and only a little more than half 

the rate of $216 currently charged by the 

NJWSA for its Raritan System water, 

which rate will increase to $220 

effective January 1, 2011. The 

Commission’s proposed 2012 rate is 

below the current (2010) rate of $60 per 

million if adjusted for inflation, which 

would be approximately $200 per 

million gallons. 

No Change to Exempt Uses. No 

change to the list of uses exempt from 

charges, as set forth at WSC § 5.3.3 is 

proposed. The following categories of 

uses are currently exempt from water 

charges: Non-consumptive uses of less 

than 1,000 gallons a day and less than 

100,000 gallons during any quarter 

(§ 5.3.3 A.); ballast water used for 

shipping purposes (§ 5.3.3 B.); water 

taken, withdrawn or diverted from 

streams tributary to the River Master’s 

gauging station at Montague, New Jersey 

(§ 5.3.3 C.); and water taken, diverted or 

withdrawn below the mouth of the 

Cohansey River and such proportion of 

water withdrawn above that point and 

below the mouth of the Schuylkill River 

as the Executive Director may determine 

would have no discernable effect upon 

the maintenance of the salt front below 

the mouth of the Schuylkill River 

(§ 5.3.3 D.). 

Pamela M. Bush, 

Commission Secretary. 

[FR Doc. 2010–3219 Filed 2–18–10; 8:45 am] 

BILLING CODE 6360–01–P 

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. 

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). 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 7413 

1FDA 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 §§ 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. 

2Henceforth, 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). 

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 email. 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 

sponsors1 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 studies2 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. 

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). 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7414 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

3For the sake of brevity, FDA is using the term 

‘‘subjects’’ to refer to human and animal subjects. 

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 

subjects3 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. 

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 §§ 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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7416 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

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. 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 7417 

4References 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. 

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. 

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 § 312.56? 

FDA is proposing to change the 

section heading of § 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 

§ 58.217 to § 58.12? 

FDA is proposing to renumber 

§ 58.217 to § 58.12 to place sponsor 

responsibilities under the regulations in 

consecutive sections. The proposed 

revisions to the language in current 

§ 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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7418 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

(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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 7419 

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. 

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 benefitadjusted 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. 

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. 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7420 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

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 

1There 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, 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 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. 

§ 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: 

§ 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 § 58.12 

and newly redesignated § 58.12 is 

revised to read as follows: 

§ 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: 

§ 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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7422 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

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: 

§ 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: 

§ 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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 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: 

§ 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: 

§ 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: 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7424 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

§ 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: 

§ 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: 

§ 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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 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: 

§ 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: 

§ 812.2 Applicability. 

* * * * * 

(c) Exempted investigations. This part, 

with the exception of §§ 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: 

§ 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 


srobinson on DSKHWCL6B1PROD with PROPOSALS
7426 Federal Register / Vol. 75, No. 33 / Friday, February 19, 2010 / Proposed Rules 

1Petition of the United States Postal Service 

Requesting Initiation of a Proceeding to Consider a 

Proposed Change in Analytic Principles (Proposal 

One), February 9, 2010 (Petition). 

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 

POSTAL REGULATORY COMMISSION 

39 CFR Part 3050 

[Docket No. RM2010–8; Order No. 406] 

Periodic Reporting 

AGENCY: Postal Regulatory Commission. 

ACTION: Advance notice of proposed 

rulemaking; availability of rulemaking 

petition. 

SUMMARY: The Commission is noticing a 

Postal Service petition proposing a 

change in transportation cost system 

sampling. The proposal involves 

distributing rail costs using inter-BMC 

highway distribution factors. This 

notice briefly describes the Postal 

Service’s rationale for proposing this 

change and addresses procedural steps 

associated with the petition. 

DATES: Comments are due: February 24, 

2010. 

ADDRESSES: Submit comments 

electronically via the Commission’s 

Filing Online system at http:// 

www.prc.gov. Commenters who cannot 

submit their views electronically should 

contact the person identified in FOR

FURTHER INFORMATION CONTACT by 

telephone for advice on alternatives to 

electronic filing. 

FOR FURTHER INFORMATION CONTACT: 

Stephen L. Sharfman, General Counsel, 

202–789–6820 or 

stephen.sharfman@prc.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Procedural Matters 

III. Ordering Paragraphs 

I. Background 

On February 9, 2010, the Postal 

Service filed a petition to initiate an 

informal rulemaking proceeding to 

consider a change in the analytical 

methods approved for use in periodic 

reporting.1 The Postal Service labels its 

proposal ‘‘Proposal One’’ because it 

intends that it relate to the FY 2010 

rather than the FY 2009 compliance 

reporting cycle. Proposal One seeks 

authorization from the Commission to 

immediately eliminate the rail portion 

of the Transportation Cost System 

(TRACS) sampling, and proposes 

instead to distribute rail costs using the 

Inter-BC highway distribution factors. 

The Postal Service states that as part 

of a realignment of its transportation 

and distribution systems, it is shifting 

much of its transportation needs from 

rail to truck. Because rail costs are 

rapidly dwindling, it proposes to 

eliminate TRACS rail sampling, and to 

use the TRACS inter-BMC distribtion in 

place of the Rail distribution key in Cost 

Segment 14. Table 1 of the supporting 

material accompanying the Petition 

(Proposal One) shows that Freight Rail 

and Rail Plant Load costs are expected 

to decline by 75 percent from FY 2009 

to FY 2010, when they will amount to 

less than $15 million. Id., Proposal One, 

at 1. Table 2 shows that substituting the 

inter-BMC distribution key for the Rail 

distribution key in FY 2009 would have 

had a small impact on the share of 

Segment 14 costs borne by each market 

dominant product. Id. at 2. The Postal 

Service comments that the impact will 

be de minimis in FY 2010 when Rail 

costs will make up a much smaller share 

of Segment 14 costs. The Postal Service 

states its desire to make the change 

before Quarter 3 of FY 2010 makes more 

efficient use of its data collection 

resources. Id. 

II. Procedural Matters 

The Commission sets February 24, 

2010 as the due date for public 

comments. The Commission will 

determine the need for reply comments 

after reviewing the initial comments 

received. 

Kenneth Moeller is designated as the 

Public Representative to represent the 

interests of the general public in this 

proceeding. 

III. Ordering Paragraphs 

It is ordered: 

1. The Petition of the United States 

Postal Service Requesting Initiation of a 

Proceeding to Consider a Proposed 

Change in Analytic Principles (Proposal 

One), filed February 9, 2010, is granted. 

2. The Commission establishes Docket 

No. RM2010–8 to consider the matters 

raised by the Postal Service’s Petition. 

3. Interested persons may submit 

comments on Proposal One no later 

than February 24, 2010. 

4. Pursuant to 39 U.S.C. 505, Kenneth 

Moeller is appointed to serve as the 

Public Representative representing the 

interests of the general public. 

5. The Secretary shall arrange for 

publication of this notice in the Federal 

Register. 

By the Commission. 

Shoshana M. Grove, 

Secretary. 

[FR Doc. 2010–3225 Filed 2–18–E8; 8:45 am] 

BILLING CODE 7710–FW–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 80, 85, and 86 

[EPA–HQ–OAR–2010–0052; FRL–9113–8] 

RIN 2060–AI23; 2060–AQ12 

Tier 2 Light-Duty Vehicle and LightDuty Truck Emission Standards and 

Gasoline Sulfur Control Requirements 

(Section 610 Review) 

AGENCY: Environmental Protection 

Agency (EPA). 


srobinson on DSKHWCL6B1PROD with PROPOSALS