37870 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

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. Nonantibacterial 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. 

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Cross-Contamination; Draft Guidance 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. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘NonPenicillin Beta-Lactam Drugs: A CGMP 

Framework for Preventing CrossContamination.’’ This draft guidance 

describes methods, facility design 

elements, and controls that are 

important in preventing drugs from 

being cross-contaminated with nonpenicillin 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 crosscontamination. This draft guidance also 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 This draft guidance revises 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written comments on the draft guidance 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draft guidance before it begins work on 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 BetaLactam 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 CrossContamination.’’ This draft guidance 

describes methods, facility design 

elements, and controls that are 

important in preventing drugs from 

being cross-contaminated with nonpenicillin beta-lactam antibacterial 

drugs or non-antibacterial beta-lactam 

compounds,1 and it makes 

recommendations for how 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 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 nonantibacterial beta-lactam compounds, 

this guidance provides 

recommendations on crosscontamination prevention strategies, 

including examples of relevant design 

features and control approaches for 

those seeking to justify a crosscontamination prevention strategy other 

than complete and comprehensive 

separation when appropriate. 

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, crossreactivity, and complete and 

comprehensive separation, used in this 

guidance; 

• Clarifying the distinction between 

non-penicillin beta-lactam antibacterial 

drug(s) and non-antibacterial betalactam 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 nonantibacterial 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 ‘‘NonPenicillin Beta-Lactam Drugs: A CGMP 

Framework for Preventing CrossContamination.’’ 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/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0319] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Dear Healthcare 

Provider Letters: Improving 

Communication of Important Safety 

Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

requests comments on information 

collection associated with the 

communication of important safety 

information to medical practitioners. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 23, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 23, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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 


jspears on DSK121TN23PROD with NOTICES1