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Draft Guidance for Industry on 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availability of a draft guidance for 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
18828 Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: March 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7456 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–2011–D–0577] 

Guidance for Industry and Food and 

Drug Administration Staff; Factors To 

Consider When Making Benefit-Risk 

Determinations in Medical Device 

Premarket Approval and de Novo 

Classifications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Factors to Consider When 

Making Benefit-Risk Determinations in 

Medical Device Premarket Approval and 

De Novo Classifications.’’ This guidance 

is intended to provide greater clarity on 

FDA’s decisionmaking process with 

regard to benefit-risk determinations in 

the premarket review of medical devices 

in the premarket approval and de novo 

pathways. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Factors to Consider When 

Making Benefit-Risk Determinations in 

Medical Device Premarket Approval and 

De Novo Classifications’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 4613, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

For devices regulated by CDRH: Ruth 

Fischer, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4424, Silver Spring, 

MD 20993–0002, 301–796–5735. 

For devices regulated by CBER: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

There are many factors that go into 

assessing the probable benefit of a 

device versus its probable risk. This 

guidance sets out the principal factors 

FDA considers when making this 

determination and explains them in 

detail. This guidance also gives 

examples of how the factors interrelate 

and how they may affect FDA’s 

decisions. By clarifying FDA’s 

decisionmaking process in this way, we 

hope to improve the predictability, 

consistency, and transparency of the 

review process for applicable devices. 

The factors described in this guidance 

apply to devices submitted under 

premarket approval applications and de 

novo petitions. 

This guidance also includes a 

worksheet that reviewers will use in 

making benefit-risk determinations for 

applicable devices. The worksheet is 

attached as Appendix B to the guidance, 

and examples of how reviewers might 

use the worksheet are attached as 

Appendix C to the guidance. This level 

of documentation is very helpful to 

maintaining the consistency of review 

across the different review divisions and 

better assuring that an appropriate 

decision is reached. 

In the Federal Register of August 15, 

2011 (76 FR 50483), FDA announced the 

availability of the draft guidance. 

Interested persons were invited to 

comment by November 14, 2011. FDA 

considered the comments and revised 

the guidance, as appropriate. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on factors to consider 

when making benefit-risk 

determinations in medical device 

premarket approval and de novo 

classifications. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability is available 

for all CDRH guidance documents at 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at either http://www.regulations.gov or 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm. To 

receive ‘‘Factors to Consider When 

Making Benefit-Risk Determinations in 

Medical Device Premarket Approval and 

De Novo Classifications’’ from CDRH, 

you may either send an email request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1772 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

FDA concludes that this guidance 

contains no new collections of 

information. The guidance refers to 

currently approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 


tkelley on DSK3SPTVN1PROD with NOTICES