Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 14023 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total 

hours 

806.10 ................................................................................................. 666 1 666 10 6660 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1

CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total 

hours 

806.20 ................................................................................................. 90 1 90 10 900 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5916 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–P–0177] 

Determination that ROCEPHIN 

(Ceftriaxone Sodium) Injection, 250 

Milligrams, 500 Milligrams, 1 Gram, 2 

Grams, and 10 Grams Base/Vial, 

Approved Under New Drug Application 

050585, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

ROCEPHIN (ceftriaxone sodium) 

Injection, 250 milligrams (mg), 500mg, 1 

gram (g), 2g, and 10g base/vial, 

approved under new drug application 

(NDA) 050585, were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for any of 

these products if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Raulerson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6368, 

Silver Spring, MD 20993–0002, 301– 

796–3522. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of an NDA. 

The only clinical data required in an 

ANDA are data to show that the drug 

that is the subject of the ANDA is 

bioequivalent to the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the Agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

ROCEPHIN (ceftriaxone sodium) 

Injection, 250mg, 500mg, 1g, 2g, and 10g 

base/vial, are the subject of NDA 050585 

held by F. Hoffman-La Roche Ltd. (La 

Roche). ROCEPHIN (ceftriaxone 

sodium) is a semisynthetic 

cephalosporin antibiotic for intravenous 

or intramuscular administration and is 

indicated for the treatment of certain 

infections as described in the labeling. 

The drug products approved under NDA 

050585 are currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Steven H. Sklar of Leydig, Voit & 

Mayer, Ltd., submitted a citizen petition 

dated April 3, 2009 (Docket No. FDA– 

2009–P–0177), under 21 CFR 10.30, 

requesting that FDA determine that 

ROCEPHIN (ceftriaxone sodium) 

Injection, 250mg, 500mg, 1g, 2g, and 10g 

base/vial, approved under NDA 050585, 

were withdrawn from sale for reasons 

other than safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

ROCEPHIN (ceftriaxone sodium) 

Injection, 250mg, 500mg, 1g, 2g, and 10g 

base/vial, approved under NDA 050585, 

were not withdrawn from sale for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that these 

products were withdrawn from sale for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

these products from sale. We have also 

independently evaluated the relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that any of these products were 


srobinson on DSKHWCL6B1PROD with NOTICES
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