73108 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

accordance with the Agency’s good 

guidance practices. 

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 ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

Blood Lancet Labeling’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office 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: 

Shelia Murphey, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2510, Silver Spring, 

MD 20993–0002, 301–796–6302. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 26, 2010, the FDA and 

Centers for Disease Control and 

Prevention (CDC) issued a joint Initial 

Communications warning that the use of 

fingerstick devices (blood lancets) to 

obtain blood from more than one patient 

poses a risk of transmitting bloodborne 

pathogens. The Agencies recommended 

that blood lancet devices should never 

be used to obtain blood samples from 

more than one person. 

CDC has noted a progressive increase 

in reports of bloodborne pathogen 

transmission (primarily hepatitis B) 

resulting from the use of a blood lancet 

in multiple patients in various 

healthcare provision settings. These 

settings include acute care hospitals, 

long term care facilities and assisted 

living facilities as well as nonresidential care settings. 

Blood lancet devices may be unsafe 

when used to draw blood from more 

than one patient for several reasons. 

Improper device design, device 

malfunction, or user error may leave the 

blood from one patient on the reusable 

lancet device base and in a position to 

contaminate a new lancet blade. 

Healthcare users of blood lancets may 

have difficulty ensuring that all blood 

contamination has been successfully 

removed from a reusable lancet base 

device. The cleaning and disinfection 

instructions provided with reusable 

lancet devices may not be adequately 

validated for efficacy or followed in 

their entirety. FDA recommends that all 

blood lancet devices be labeled for use 

only on a single patient. A statement 

limiting use to a single patient should 

also appear on the label attached to the 

device, if possible. 

FDA is making this guidance 

document immediately available 

because prior public participation is not 

appropriate. Due to the urgent public 

health need to support the joint Initial 

Communications issued by CDC and 

FDA concerning the risk of hepatitis 

transmission caused by the use of blood 

lancets on more than one patient, FDA 

believes that current lancet labeling 

which does not restrict the use of 

lancets to a single patient must be 

corrected as quickly as possible. FDA 

believes that this guidance will provide 

significant assistance to lancet 

manufacturers as they work to improve 

their labeling as recommended. 

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 blood lancet 

labeling. 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 for all 

CDRH guidance documents is available 

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

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Guidance for Industry and Food 

and Drug Administration Staff; Blood 

Lancet Labeling,’’ you may either send 

an e-mail 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 1732 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions 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 collection of information in 

this guidance was approved under OMB 

control number 0910–0485. 

V. 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. It is no longer necessary to 

send two copies of mailed 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. 

Dated: November 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29795 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0584] 

Guidance for Industry on Abbreviated 

New Drug Applications: Impurities in 

Drug Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘ANDAs: Impurities in Drug 

Products.’’ This guidance updates 

recommendations regarding degradation 

products and updates the draft guidance 

‘‘ANDAs: Impurities in Drug Products’’ 

announced in December 1998 in 

conformance with the revision of the 

International Conference on 

Harmonisation (ICH) guidance for 

industry ‘‘Q3B(R) Impurities in New 

Drug Products,’’ which was announced 

in August 2006. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

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Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73109 

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 guidance document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Devinder Gill, Center for Drug 

Evaluation and Research (HFD–630), 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855, 240– 

276–8483. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘ANDAs: Impurities in Drug Products.’’ 

In December 1998, FDA issued the draft 

guidance ‘‘ANDAs: Impurities in Drug 

Products,’’ and in August 2005, FDA 

revised it in conformance with the 

‘‘Q3B(R) Impurities in New Drug 

Products’’ guidance for industry that 

was announced in August 2006. 

We are issuing the final guidance to: 

(1) Update information on listing of 

degradation products, setting 

acceptance criteria, and qualifying 

degradation products (thresholds and 

procedures) in abbreviated new drug 

applications (ANDAs) in conformance 

with the revision of the guidance for 

industry on Q3B(R) and (2) remove 

those sections of the 1998 draft 

guidance containing recommendations 

that are no longer needed because they 

are addressed in the more recent 

Q3B(R). The Q3B(R) was developed by 

the ICH to provide guidance on 

impurities in drug products for new 

drug applications (NDAs). However, the 

Agency believes that many of the 

recommendations provided on 

impurities in NDAs also apply to 

ANDAs. 

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 impurities in drug 

products submitted as ANDAs. 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 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. It is no longer necessary to 

send two copies of mailed 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: November 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29896 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0150; Formerly 

Docket No. 2007D–0367] 

Guidance for Industry on Antibacterial 

Drug Products: Use of Noninferiority 

Trials to Support Approval; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Antibacterial Drug Products: 

Use of Noninferiority Trials to Support 

Approval.’’ The purpose of this guidance 

is to provide information on FDA’s 

current thinking regarding appropriate 

use of noninferiority (NI) clinical trial 

designs to evaluate antibacterial drug 

products. The Agency’s thinking in this 

area has evolved in recent years in 

response to a number of public 

discussions on the use of activecontrolled trials designed to show NI as 

the basis for approval of antibacterial 

drug products. This guidance finalizes 

the draft guidance published in the 

Federal Register of October 15, 2007. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this 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 guidance document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Joseph G. Toerner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6244, 

Silver Spring, MD 20993–0002, 301– 

796–1300. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Antibacterial Drug Products: Use of 

Noninferiority Trials to Support 

Approval.’’ The purpose of this guidance 

is to inform industry, sponsors, 

applicants, researchers, and the public 

on the appropriate uses of NI clinical 

trial designs to evaluate antibacterial 

drug products and to amend ongoing or 

completed trials accordingly. In the 

Federal Register of October 15, 2007 (72 

FR 58312), FDA announced a notice of 

availability of the draft guidance for 

industry entitled ‘‘Antibacterial Drug 

Products: Use of Noninferiority Studies 

to Support Approval’’ in response to 

numerous public discussions that 

focused primarily on the following 

indications: Acute bacterial sinusitis, 

acute bacterial exacerbation of chronic 

bronchitis, and acute bacterial otitis 

media. Since FDA issued the draft 

guidance, there have been public 

discussions on consistent and reliable 

estimates of the efficacy of active 

treatment to placebo for other infectious 

disease indications for the NI trial 

design. The public comments received 

on the draft guidance have been 

considered and the guidance has been 

revised as appropriate. The guidance 

emphasizes that adequate scientific 

evidence should be provided to support 

the proposed NI margin for any 

indication being studied in any 

proposed, ongoing, or completed activecontrolled trial designed to show NI. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

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