28216 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices committee for their consideration. Comments should be supplied to the appropriate DFO at the address/ contact information noted above in the following formats: One hard copy with original signature, and one electronic copy via e mail ( acceptable file format: WordPerfect, Word, or Rich Text files ( in IBM   PC/ Windows 95/ 98 format). Those providing written comments and who attend face to face meeting are also asked to bring 35 copies of their comments for public distribution.

Dated: May 16, 2003. Vanessa T. Vu, Director, EPA Science Advisory Board Staff Office. [ FR Doc. 03   13001 Filed 5   22   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0123; FRL   7307   4]

MGK   Repellent 326 Risk Assessments; Notice of Availability AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the availability of documents that were developed as part of EPA's process for making pesticide reregistration eligibility decisions and tolerance reassessments consistent with the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996. These documents are the human health, and environmental fate and effects risk assessments, and related documents for MGK   Repellent 326. Additionally, this notice starts a 60   day public comment period, during which the public is encouraged to provide information to help refine the risk assessments and submit risk management proposals for MGK   Repellent 326. Comments are to be limited to issues directly associated with MGK   Repellent 326 and raised by the risk assessment or other documents placed in the docket. By allowing access and opportunity for comment on the risk assessments, EPA is seeking to strengthen stakeholder involvement, and help ensure that decisions under FQPA are transparent and based on the best available information. DATES: Comments, identified by the docket ID number OPP   2003   0123 for MGK   Repellent 326, must be received on or before July 22, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Tawanda Spears, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8050; fax number: ( 703) 308   8005; email address: spears. tawanda@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) or the FFDCA; environmental, human health, and agricultural advocates; pesticide users; and the public interested in the use of pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   123. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket, but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical VerDate Jan< 31> 2003 18: 07 May 22, 2003 Jkt 200001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23MYN1. SGM 23MYN1 28217 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0123. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0123. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID Number OPP   2003   0123. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2003   0123. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at your estimate. 5. Provide specific examples to illustrate your concerns. 6. Offer alternatives. 7. Make sure to submit your comments by the comment period deadline identified. 8. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

II. What Action is the Agency Taking?

EPA is making available risk assessments that have been developed as part of the Agency's public participation process for making reregistration eligibility and tolerance reassessment decisions for pesticides consistent with FFDCA, as amended by FQPA. The Agency's human health, and environmental fate and effects risk assessments, and other related documents for MGK   Repellent 326 are available in the individual pesticide docket, OPP   2003   0123. As additional comments, reviews, and risk assessment modifications become available, these will also be docketed for MGK   Repellent 326. The Agency cautions that refinements to the MGK   Repellent 326 risk assessments may be appropriate pending comments received. Risk assessment documents reflect only the work and analysis conducted as of the time they were produced and it is appropriate that, as new information becomes available and/ or additional analyses are performed, the conclusion they contain may change.

VerDate Jan< 31> 2003 18: 07 May 22, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23MYN1. SGM 23MYN1 28218 Federal Register / Vol. 68, No. 100 / Friday, May 23, 2003 / Notices EPA is providing an opportunity, through this notice, for interested parties to provide written comments and input to the Agency on the risk assessments or risk mitigation proposals for the pesticide specified in this notice. Such comments and proposals could address ideas on how to manage potential residential cancer risks from the use of MGK   Repellent 326 as an insect repellent, for example, the feasibility of using a lower percent active ingredient in final products containing MGK   Repellent 326. Comments could also address the availability of additional data to further refine the risk assessments, such as information on the extent and duration of use of products containing MGK   Repellent 326. Last, comments could address the Agency's risk assessment methodologies and assumptions applied to this specific chemical. Comments should be limited to issues raised within the risk assessment and associated documents. All comments should be submitted by [ insert date 60 days after date of publication in theFederal Register] using the methods in Unit I. of the SUPPLEMENTARY INFORMATION. Comments will become part of the Agency record for MGK   Repellent 326.

List of Subjects Environmental protection, Chemicals, MGK   Repellent 326, Pesticides and pest.

Dated: May 14, 2003. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs.

[ FR Doc. 03   13006 Filed 5   22   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0172; FRL   7307   5]

Flonicamid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0172, must be received on or before June 23, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Ann Sibold, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6502]; e mail address: sibold. ann@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are a commercial grower of food or feed crops. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. EPA Docket. EPA has established an official public docket for this action under docket ID number OPP   2003   0172. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305     5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket, but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The VerDate Jan< 31> 2003 18: 07 May 22, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23MYN1. SGM 23MYN1


[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37870-37871]
[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.

-----------------------------------------------------------------------

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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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