[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37870-37871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13513]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing 
Cross-Contamination; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Non-
Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-
Contamination.'' This draft guidance describes methods, facility design 
elements, and controls that are important in preventing drugs from 
being cross-contaminated with non-penicillin beta-lactam antibacterial 
drugs or non-antibacterial beta-lactam compounds, and it makes 
recommendations for how manufacturers can be compliant with current 
good manufacturing practice requirements for preventing cross-
contamination. This draft guidance also provides information regarding 
the relative health risk of, and the potential for, cross-reactivity in 
the classes of non-penicillin beta-lactam antibacterial drugs and non-
antibacterial beta-lactam compounds. This draft guidance revises the 
guidance of the same title issued on April 17, 2013.

DATES: Submit either electronic or written comments on the draft 
guidance by August 23, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-D-0104 for ``Non-Penicillin Beta-Lactam Drugs: A CGMP 
Framework for Preventing Cross-Contamination.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Carla Lankford, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6656, Silver Spring, MD 20993-0002, 301-
796-5203.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for 
Preventing Cross-Contamination.'' This draft guidance describes 
methods, facility design elements, and controls that are important in 
preventing drugs from being cross-contaminated with non-penicillin 
beta-lactam antibacterial drugs or non-antibacterial beta-lactam 
compounds,\1\ and it makes recommendations for how

[[Page 37871]]

manufacturers can be compliant with current good manufacturing practice 
(CGMP) requirements for preventing cross-contamination. This guidance 
also provides information regarding the relative health risk of, and 
the potential for, cross-reactivity in the classes of non-penicillin 
beta-lactam antibacterial drugs and non-antibacterial beta-lactam 
compounds. This guidance recommends that manufacturers should 
manufacture non-penicillin beta-lactam antibacterial drugs with 
complete and comprehensive separation from manufacturing operations of 
other drugs. For manufacturers of non-antibacterial beta-lactam 
compounds, this guidance provides recommendations on cross-
contamination prevention strategies, including examples of relevant 
design features and control approaches for those seeking to justify a 
cross-contamination prevention strategy other than complete and 
comprehensive separation when appropriate.
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    \1\ In the guidance, non-penicillin beta-lactam antibacterial 
drug(s) refers to any drug that is not a penicillin, has a chemical 
structure that includes one or more beta-lactam rings, and has an 
antibacterial mechanism of action. Non-antibacterial beta-lactam 
compound(s) refers to any compound, including an intermediate or 
derivative, that is not a penicillin, has a chemical structure that 
includes one or more beta-lactam rings, and has a mechanism of 
action other than an antibacterial mechanism of action.
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    This guidance revises the guidance of the same title issued on 
April 17, 2013 (78 FR 22887). Significant changes from the 2013 
guidance include:
     Clarifying that the scope of the guidance also includes 
all compounds, including intermediates or derivatives, that are not a 
penicillin, have a chemical structure that includes one or more beta-
lactam rings, and have a mechanism of action other than an 
antibacterial mechanism of action;
     Providing FDA's interpretation of terms, such as allergic 
reaction, cross-reactivity, and complete and comprehensive separation, 
used in this guidance;
     Clarifying the distinction between non-penicillin beta-
lactam antibacterial drug(s) and non-antibacterial beta-lactam 
compound(s)--in terms of the cross-contamination and patient exposure 
risks and the control strategies appropriate for manufacturing 
operations involving each category; and
     Providing recommendations for drug manufacturers that seek 
to justify alternative cross-contamination prevention strategies for 
non-antibacterial beta-lactam compounds.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will replace the 2013 guidance and represent the current 
thinking of FDA on ``Non-Penicillin Beta-Lactam Drugs: A CGMP Framework 
for Preventing Cross-Contamination.'' It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no new 
collection of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3521) is not required. However, this draft 
guidance refers to previously approved FDA collections of information. 
These collections of information are subject to review by OMB under the 
PRA. The collections of information in 21 CFR parts 210 and 211 have 
been approved under OMB control number 0910-0139; and the collections 
of information in 21 CFR part 314 have been approved under OMB control 
number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13513 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P


