18826 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0280] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Financial 

Disclosure by Clinical Investigators 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection on financial 

disclosure by clinical investigators. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 29, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (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. 

Financial Disclosure by Clinical 

Investigators (OMB Control Number 

0910–0396)—Extension 

Respondents to this collection are 

sponsors of marketing applications that 

contain clinical data from studies 

covered by the regulations. These 

sponsors represent pharmaceutical, 

biologic, and medical device firms. 

Respondents are also clinical 

investigators who provide financial 

information to the sponsors of 

marketing applications. 

Under § 54.4(a) (21 CFR 54.4(a)), 

applicants submitting an application 

that relies on clinical studies must 

submit a complete list of clinical 

investigators who participated in a 

covered clinical study, and must either 

certify to the absence of certain financial 

arrangements with clinical investigators 

(Form FDA 3454) or, under § 54.4(a)(3), 

disclose to FDA the nature of those 

arrangements and the steps taken by the 

applicant or sponsor to minimize the 

potential for bias (Form FDA 3455). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

54.4(a)(1) and (a)(2)—Form FDA 3454 ............................... 902 1 902 1 902 

54.4(a)(3)—Form FDA 3455 ................................................ 90 1 90 5 450 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,352 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Under § 54.6, the sponsors of covered 

studies must maintain complete records 

of compensation agreements with any 

compensation paid to nonemployee 

clinical investigators, including 

information showing any financial 

interests held by the clinical 

investigator, for a time period of 2 years 

after the date of approval of the 

applications. Sponsors of covered 

studies maintain many records with 

regard to clinical investigators, 

including protocol agreements and 

investigator resumes or curriculum 

vitae. FDA estimates than an average of 

15 minutes will be required for each 

recordkeeper to add this record to the 

clinical investigators’ file. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 18827 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

Total hours 

54.6 ...................................................................................... 1,000 1 1,000 0.25 250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Under § 54.4(b), clinical investigators 

supply to the sponsor of a covered study 

financial information sufficient to allow 

the sponsor to submit complete and 

accurate certification or disclosure 

statements. Clinical investigators are 

accustomed to supplying such 

information when applying for research 

grants. Also, most people know the 

financial holdings of their immediate 

family and records of such interests are 

generally accessible because they are 

needed for preparing tax records. For 

these reasons, FDA estimates that it will 

take clinical investigators 15 minutes to 

submit such records to the sponsor. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden 

per disclosure 

Total hours 

54.4(b) .................................................................................. 10,554 1 10,554 0.17 1,794 

1There are no capital costs or operating and maintenance costs associated with the collection of information. 

Dated: March 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7405 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Draft Guidance for Industry on 

Bioequivalence Recommendations for 

Iron Sucrose Injection; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for Iron Sucrose.’’ 

The recommendations provide specific 

guidance on the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for iron sucrose injection. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 29, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Doan T. Nguyen, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855, 240– 

276–8608. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm. As described in 

that guidance, FDA adopted this process 

as a means to develop and disseminate 

product-specific BE recommendations 

and provide a meaningful opportunity 

for the public to consider and comment 

on those recommendations. This notice 

announces the availability of draft BE 

recommendations for iron sucrose 

injection. 

Venofer (iron sucrose injection), new 

drug application 021135, was initially 

approved by FDA in November 2000. 

There are no approved ANDAs for this 

product. FDA is now issuing a draft 

guidance for industry on BE 

recommendations for generic iron 

sucrose injection (Draft Iron Sucrose 

Injection BE Recommendations). 

In March 2005, Luitpold 

Pharmaceuticals, Inc. (Luitpold), 

manufacturer of the reference listed 

drug (RLD), Venofer, submitted (through 

its attorneys) a citizen petition 

requesting that FDA withhold approval 

of any ANDA or 505(b)(2) application 

for a generic iron sucrose injection 

unless certain conditions were satisfied, 

including conditions related to 

demonstrating BE (Docket No. FDA– 

2005–P–0319, formerly 2005P–0095/ 

CP1). FDA is reviewing the issues raised 

in the petition and is also reviewing the 

supplemental information and 

comments that have been submitted to 

the docket for that petition. FDA will 

consider any comments on the Draft 

Iron Sucrose Injection BE 

Recommendations before responding to 

Luitpold’s citizen petition. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the design of BE studies to support 

ANDAs for iron sucrose injection. It 

does not create or confer any rights for 


tkelley on DSK3SPTVN1PROD with NOTICES