Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework; Availability, 14024 [2011-5948]

Download as PDF 14024 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices withdrawn from sale for reasons of safety or effectiveness.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 The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been withdrawn from sale for reasons other than safety or effectiveness.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CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0104] Draft Guidance for Industry on NonPenicillin Beta-Lactam Risk Assessment: A CGMP Framework; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Non-Penicillin BetaLactam Risk Assessment: A CGMP Framework.’’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 The draft guidance is intended to assist manufacturers in assessing whether separate facilities should be used based on the relative health risk of crossreactivity.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the srobinson on DSKHWCL6B1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:50 Mar 14, 2011 Jkt 223001 final version of the guidance, submit either electronic or written comments on the draft guidance by May 16, 2011. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm.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 https://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: 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. 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 III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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. 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. The Food and Drug Administration (FDA) is announcing the SUMMARY: E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Page 14024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0104]


Draft Guidance for Industry on Non-Penicillin 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 
Beta-Lactam Risk Assessment: A CGMP Framework.'' This guidance 
describes the importance of implementing appropriate steps during the 
manufacturing process to prevent cross-contamination 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 cross-reactivity.

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 https://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 
non-penicillin 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. Cross-contamination with non-penicillin beta-
lactam drugs can initiate drug-induced hypersensitivity reactions, 
including anaphylaxis, an allergic reaction that may be a life-
threatening event. One critical aspect of manufacturing non-penicillin 
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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
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