14024 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list ROCEPHIN (ceftriaxone 

sodium) Injection, 250mg, 500mg, 1g, 

2g, and 10g base/vial, approved under 

NDA 050585, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

withdrawn from sale for reasons other 

than safety or effectiveness. ANDAs that 

refer to any of the products described in 

this notice may be approved by FDA as 

long as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. If FDA determines that 

labeling for any of these drug products 

should be revised to meet current 

standards, the Agency will advise 

ANDA applicants to submit such 

labeling. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5947 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0104] 

Draft Guidance for Industry on NonPenicillin Beta-Lactam Risk 

Assessment: A CGMP Framework; 

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availability of a draft guidance for 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 ‘‘Non-Penicillin BetaLactam Risk Assessment: A CGMP 

Framework.’’ This guidance describes 

the importance of implementing 

appropriate steps during the 

manufacturing process to prevent crosscontamination of finished 

pharmaceuticals and active 

pharmaceutical ingredients (APIs) with 

non-penicillin beta-lactam antibiotics. 

The draft guidance is intended to assist 

manufacturers in assessing whether 

separate facilities should be used based 

on the relative health risk of crossreactivity. 

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on the draft guidance by May 16, 2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research (CDER), 

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 

request. The guidance may also be 

obtained by mail by calling CDER at 

301–796–3400. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments 

concerning 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Edwin Melendez, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4370, 

Silver Spring, MD 20993–0002, 301– 

796–3284. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Non-Penicillin Beta-Lactam Risk 

Assessment: A CGMP Framework.’’ This 

draft guidance describes the importance 

of implementing appropriate steps 

during the manufacturing process to 

prevent cross-contamination of finished 

pharmaceuticals and APIs with nonpenicillin beta-lactam antibiotics. It also 

provides information regarding the 

relative health risk of, and the potential 

for, cross-reactivity in the classes of 

sensitizing beta-lactams (penicillins and 

non-penicillin beta-lactams). 

Drug cross-contamination is the 

contamination of one drug with one or 

more different drugs. Crosscontamination with non-penicillin betalactam drugs can initiate drug-induced 

hypersensitivity reactions, including 

anaphylaxis, an allergic reaction that 

may be a life-threatening event. One 

critical aspect of manufacturing nonpenicillin beta-lactam drugs is 

preventing cross-contamination to 

reduce the potential for drug-induced, 

life-threatening allergic reactions. FDA 

is recommending that manufacturers 

establish appropriate separation and 

control systems designed to prevent the 

following types of cross-contamination: 

(1) Non-penicillin beta-lactam 

contamination in a non-beta-lactam 

product (e.g., cefaclor in aspirin) and (2) 

non-penicillin beta-lactam 

contamination in another non-penicillin 

beta-lactam (e.g., cephalexin in 

imipenem). 

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 non-penicillin beta-lactam risk 

assessment. 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. 

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/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5948 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0150] 

Guidance for Industry on Hypertension 

Indication: Drug Labeling for 

Cardiovascular Outcome Claims; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 14025 

availability of a guidance for industry 

entitled ‘‘Hypertension Indication: Drug 

Labeling for Cardiovascular Outcome 

Claims.’’ This guidance is intended to 

assist applicants in developing labeling 

for outcome claims for drugs that are 

indicated to treat hypertension. With 

few exceptions, current labeling for 

antihypertensive drugs includes only 

the information that these drugs are 

indicated to reduce blood pressure; the 

labeling does not include information 

on the clinical benefits related to 

cardiovascular outcomes expected from 

such blood pressure reduction. 

However, blood pressure control is well 

established as beneficial in preventing 

serious cardiovascular events, and 

inadequate treatment of hypertension is 

acknowledged as a significant public 

health problem. The Agency believes 

that the appropriate use of these drugs 

can be encouraged by making the 

connection between lower blood 

pressure and improved cardiovascular 

outcomes more explicit in labeling. 

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: Devi 

Kozeli, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 4183, Silver Spring, 

MD 20993–0002, 301–796–1128. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Hypertension Indication: Drug Labeling 

for Cardiovascular Outcome Claims.’’ 

The intent of the guidance is to provide 

common labeling for antihypertensive 

drugs except where differences are 

clearly supported by clinical data. With 

publication of this guidance, applicants 

are encouraged to submit labeling 

supplements containing the new 

language. 

A draft guidance of the same title was 

announced in the Federal Register on 

March 13, 2008 (73 FR 13546), and 

Docket No. FDA–2008–D–0150 was 

open for comments until May 12, 2008. 

Comments received from industry, 

professional societies, and consumer 

groups on the draft guidance were taken 

into consideration by FDA in finalizing 

this guidance. Throughout the guidance, 

the language has been condensed and 

simplified to be more concise and clear. 

A section has been added to clarify 

procedures for obtaining approval of 

new labeling and its applicability to 

advertising. The guidance describes 

how applicants can provide clinical 

evidence for any drugs they perceive to 

be missing from Table 1, Approved 

Drugs for Chronic Treatment of 

Hypertension, by submitting the 

information to the docket number listed 

in brackets in the heading of this 

document. The division will review the 

information and revise the guidance to 

include any new labeling changes 

supported by clinical data submitted to 

the docket. 

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 labeling for 

cardiovascular outcome claims for drugs 

to treat hypertension. 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 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 0910–0670. 

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/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5945 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0568] 

Guidance for Industry on Planning for 

the Effects of High Absenteeism To 

Ensure Availability of Medically 

Necessary 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 ‘‘Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products.’’ 

The guidance encourages manufacturers 

of medically necessary drug products 

(MNPs) and components to develop 

production plans in the event of an 

emergency that results in high 

absenteeism at one or more production 

facilities. The purpose of the guidance 

is to provide to industry considerations 

for developing plans for these types of 

emergencies, as well as to discuss the 

Center for Drug Evaluation and 

Research’s (CDER’s) intended approach 

to assist in avoiding drug product 

shortages that may have a negative 

impact on the national public health 

during such emergencies. 

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. 


srobinson on DSKHWCL6B1PROD with NOTICES