Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73107 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0589] 

Draft Guidance for Industry on 

Hospital-Acquired Bacterial 

Pneumonia and Ventilator-Associated 

Bacterial Pneumonia: Developing 

Drugs for Treatment; 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availability of a draft guidance for 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 ‘‘Hospital-Acquired 

Bacterial Pneumonia and VentilatorAssociated Bacterial Pneumonia: 

Developing Drugs for Treatment.’’ The 

purpose of this draft guidance is to 

assist clinical trial sponsors and 

investigators in the development of 

antimicrobial drugs for the treatment of 

hospital-acquired bacterial pneumonia 

(HABP) and ventilator-associated 

bacterial pneumonia (VABP). The 

science of clinical trial design and our 

understanding of these diseases have 

advanced in recent years, and this draft 

guidance, when finalized, will inform 

sponsors of the recommendations for 

clinical development. 

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 comment 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on the draft guidance by February 28, 

2011. 

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single copies of the draft guidance to the 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access to the draft guidance document.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draft guidance to http:// 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: 

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 draft guidance for industry entitled 

‘‘Hospital-Acquired Bacterial 

Pneumonia and Ventilator-Associated 

Bacterial Pneumonia: Developing Drugs 

for Treatment.’’ The purpose of this draft 

guidance is to assist clinical trial 

sponsors and investigators in the 

development of antimicrobial drugs for 

the treatment of HABP and VABP. This 

guidance revises and replaces the draft 

guidance regarding nosocomial 

pneumonia published in 1998. The 

guidance also addresses the clinical 

development of new drugs to treat drugresistant bacterial pathogens implicated 

in HABP/VABP. 

The issues in HABP/VABP clinical 

trials were discussed at a 2009 

workshop co-sponsored by FDA and 

professional societies. The science of 

clinical trial design and our 

understanding of these diseases have 

advanced in recent years, and this draft 

guidance informs sponsors of the 

changes in our recommendations. 

Specifically, the guidance defines a 

primary efficacy endpoint of all-cause 

mortality and provides a justification for 

a noninferiority margin for the design of 

active-controlled clinical trials that can 

be used to provide evidence of efficacy 

for the treatment of HABP/VABP. 

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 this topic. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 312 have 

been approved under 0910–0014, the 

collections of information in 21 CFR 

part 314 have been approved under 

0910–0001, and the collections of 

information referred to in the guidance 

‘‘Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees’’ have been approved under 

0910–0581. 

III. 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. 

IV. 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. 2010–29799 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–0590] 

Guidance for Industry and Food and 

Drug Administration Staff; Blood 

Lancet Labeling; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; Blood Lancet 

Labeling.’’ FDA is issuing this guidance 

with labeling recommendations because 

of concerns that both healthcare 

providers and patients may be unaware 

of the serious adverse health risks 

associated with using the same blood 

lancet device for assisted withdrawal of 

blood from more than one patient, even 

when the lancet blade is changed for 

each blood draw. 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. The guidance 

document is immediately in effect, but 

it remains subject to comment in 

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

mstockstill on DSKH9S0YB1PROD with NOTICES