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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73110 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

The guidance represents 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 (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively, and the collection of 

information under the guidance for 

industry ‘‘Special Protocol Assessment’’ 

has been approved under OMB control 

number 0910–0470. 

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/

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: November 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29796 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Health Center Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of Noncompetitive 

Replacement Awards to Upper Room 

AIDS Ministry, Inc. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) will 

transfer Health Center Program (section 

330 of the Public Health Service Act) 

Increased Demand for Services (IDS) 

and Capital Improvement Project (CIP) 

funds, awarded under the American 

Recovery and Reinvestment Act 

(ARRA), originally awarded to Harlem 

United Community AIDS Center, Inc. 

(HUCAC) to Upper Room AIDS 

Ministry, Inc. to ensure the provision of 

critical primary health care services and 

continuity of services to low-income, 

underserved homeless patients in New 

York City. 

SUPPLEMENTARY INFORMATION: 

Former Grantee of Record: Harlem 

United Community AIDS Center, Inc. 

Original Period of Grant Support: 

March 27, 2009, to March 26, 2011 (IDS) 

and June 29, 2009, to June 28, 2011 

(CIP). 

Replacement Awardee: Upper Room 

AIDS Ministry, Inc. 

Amount of Replacement Award: 

$103,317 (IDS) and $262,740 (CIP). 

Period of Replacement Award: The 

period of support for the replacement 

awards is March 27, 2009 to March 26, 

2011 (IDS) and June 29, 2009 to June 28, 

2011 (CIP). 

Authority: Section 330(h) of the 

Public Health Service Act, 42 U.S.C. 

245b. 

CDFA Number: 93.703 

Justification for Exception to 

Competition: Under the original grant 

applications approved by HRSA, 

Harlem United Community AIDS 

Center, Inc. (HUCAC) was identified as 

the grantee of record. HUCAC had a 

subrecipient agreement in place with 

Upper Room AIDS Ministry, Inc., a 

HUCAC-subsidiary organization. 

Through this arrangement, Upper Room 

AIDS Ministry, Inc. provided all 

services and carried out the full scope 

of project for the homeless program. 

Instead of continuing this agreement, 

both organizations decided that Upper 

Room AIDS Ministry, Inc. should 

become the direct grantee recipient for 

the ARRA IDS and CIP grants. Upper 

Room AIDS Ministry, Inc. competed 

successfully for fiscal year 2010 Service 

Areas Competition funding and has 

become the direct grant recipient of the 

health center homeless grant. HUCAC 

and the Upper Room AIDS Ministry, 

Inc. requested that full responsibility for 

the grants be transferred from HUCAC to 

Upper Room AIDS Ministry. Upper 

Room AIDS Ministry has provided 

documentation to HRSA that it meets 

Section 330 statutory and regulatory 

requirements as well as applicable grant 

management requirements. 

The transfer of these grants will 

ensure critical primary health care 

services continue and remain available 

to low income, underserved homeless 

populations with no interruption in 

services to the target population. 

Transferring the funds to Upper Room 

AIDS Ministry, Inc. does not materially 

change the projects as originally 

proposed and funded. Upper Room 

AIDS Ministry, Inc. will fulfill the 

expectations of the former grantee’s 

originally funded IDS and CIP grant 

applications. In order to ensure that 

critical primary health care services 

continue to be available to the original 

target population in a timely manner, 

these ARRA CIP and IDS awards will 

not be competed. 

FOR FURTHER INFORMATION, CONTACT: 

Marquita Cullom-Stott via e-mail at 

MCullom-Stott@hrsa.gov or 301–594– 

4300. 

Dated: November 19, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–29866 Filed 11–26–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Part C Early Intervention Services 

Grant under the Ryan White HIV/AIDS 

Program 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of a non-competitive 

one-time replacement award from Ryan 

White HIV/AIDS Program, Part C funds 

for the Louisiana State University, 

Health Sciences Center, Viral Disease 

Clinic in Shreveport, Department of 

Medicine, Shreveport, Louisiana. 

SUMMARY: HRSA will be giving a noncompetitive one-time replacement 

award to support comprehensive 

primary care services for persons living 

with HIV/AIDS, including primary 

medical care, laboratory testing, oral 

health care, outpatient mental health 

and substance abuse treatment, 

specialty and subspecialty care, referrals 

for health and support services and 

adherence monitoring/education 

services to the Louisiana State 

University, Health Sciences Center, 

Viral Disease Clinic to ensure continuity 

of critical HIV medical care and 

treatment services, to clients in 

Shreveport, Louisiana. 

SUPPLEMENTARY INFORMATION: 

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