Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis; Draft Guidance for Industry; Availability, 40851-40853 [2021-16175]

Download as PDF Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices Application No. ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA 072420 072421 072609 072751 072923 072953 072954 073093 073122 073334 .... .... .... .... .... .... .... .... .... .... ANDA ANDA ANDA ANDA ANDA 073352 073353 073637 073638 074026 .... .... .... .... .... ANDA 074359 .... ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA 074405 074421 074436 074442 074479 074647 074762 074836 074892 074955 074964 075067 .... .... .... .... .... .... .... .... .... .... .... .... ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA 075069 075262 075284 081165 084503 085054 085084 085085 085208 086710 .... .... .... .... .... .... .... .... .... .... ANDA ANDA ANDA ANDA ANDA ANDA 086813 087773 088348 088349 088350 088497 .... .... .... .... .... .... jbell on DSKJLSW7X2PROD with NOTICES ANDA 089536 .... Drug VerDate Sep<11>2014 Applicant Amoxapine Tablets, 100 mg .................................................... Amoxapine Tablets, 150 mg .................................................... Prazosin HCl Capsules, EQ 5 mg base .................................. Verapamil HCl Tablets, 40 mg ................................................. Verapamil HCl Tablets, 40 mg ................................................. Oxazepam Capsules, 15 mg ................................................... Oxazepam Capsules, 30 mg ................................................... Baclofen Tablets, 20 mg .......................................................... Loperamide HCl Capsules, 2 mg ............................................. Amiloride HCl and Hydrochlorothiazide Tablets, EQ 5 mg anhydrous; 50 mg. Atenolol Tablets, 50 mg ........................................................... Atenolol Tablets, 100 mg ......................................................... Piroxicam Capsules, 10 mg ..................................................... Piroxicam Capsules, 20 mg ..................................................... Triamterene and Hydrochlorothiazide Tablets, 25 mg and 37.5 mg. Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg, 50 mg, 40 mg, and 30 mg. Flurbiprofen Tablets, 50 mg and 100 mg ................................ Cyclobenzaprine HCl Tablets, 10 mg ...................................... Cyclobenzaprine HCl Tablets, 10 mg ...................................... Gemfibrozil Tablets, 600 mg .................................................... Alprazolam Tablets, 0.25 mg, 0.5 mg, and 1 mg .................... Flurbiprofen Tablets, 50 mg and 100 mg ................................ Guanfacine HCl Tablets, EQ 1 mg base and EQ 2 mg base Acyclovir Tablets, 400 mg and 800 mg ................................... Etodolac Tablets, 400 mg and 500 mg ................................... Ketorolac Tromethamine Tablets, 10 mg ................................ Clonazepam Tablets, 0.5 mg, 1 mg, and 2 mg ....................... Cromolyn Sodium Inhalation Solution, 10 mg/mL ................... Etodolac Tablets, 400 mg ........................................................ Albuterol Sulfate Syrup, EQ 2 mg base/5 mL ......................... Ketorolac Tromethamine Tablets, 10 mg ................................ Hydroxyzine Pamoate Capsules, EQ 25 mg HCl .................... Hydralazine HCl Tablets, 50 mg .............................................. Hydrochlorothiazide Tablets, 25 mg ........................................ Prednisone Tablets, 5 mg ........................................................ Prednisolone Tablets, 5 mg ..................................................... Hydrochlorothiazide Tablets, 50 mg ........................................ Aspirin, Butalbital, Caffeine Tablets, 325 mg, 50 mg, and 40 mg. Prednisone Tablets, 20 mg ...................................................... Prednisone Tablets, 10 mg ...................................................... Hydroxyzine HCl Tablets, 10 mg ............................................. Hydroxyzine HCl Tablets, 25 mg ............................................. Hydroxyzine HCl Tablets, 50 mg ............................................. Methylprednisolone Tablets, 4 mg ........................................... Acetaminophen, Butalbital, and Caffeine Tablets, 325 mg, 50 mg, and 40 mg. Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 30, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table 19:19 Jul 28, 2021 Jkt 253001 Do. Do. Do. PLIVA Inc. Watson Laboratories, Inc. Do. Do. Do. Teva Pharmaceuticals USA, Inc. Watson Laboratories, Inc. Do. Do. Teva Pharmaceuticals USA, Inc. Do. PLIVA Inc. Watson Laboratories, Inc. Teva Pharmaceuticals USA, Inc. PLIVA Inc. Watson Laboratories, Inc. Do. Do. PLIVA Inc. Watson Laboratories, Inc. IVAX Pharmaceuticals, Inc. Watson Laboratories, Inc. Do. Do. Actavis Mid Atlantic LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Watson Laboratories, Inc. Actavis Mid Atlantic LLC. PLIVA Inc. Watson Laboratories, Inc. Do. Actavis Mid Atlantic LLC. Watson Laboratories, Inc. Do. Actavis Elizabeth LLC. Do. Watson Laboratories, Inc. Do. Do. Do. Do. Duramed Pharmaceuticals Inc. (an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Watson Laboratories, Inc. that are in inventory on August 30, 2021 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: July 26, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–16178 Filed 7–28–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00050 40851 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0519] Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of PostExposure Prophylaxis; Draft Guidance for Industry; Availability Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: E:\FR\FM\29JYN1.SGM 29JYN1 40852 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis.’’ The purpose of this draft guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as an alternative to anti-rabies virus immunoglobulin (RIG) as the passive immunization component of postexposure prophylaxis (PEP) for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal. DATES: Submit either electronic or written comments on the draft guidance by September 27, 2021 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: SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 19:19 Jul 28, 2021 Jkt 253001 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– 2021–D–0519 for ‘‘Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis.’’ 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-201509-18/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)). PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 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: Stephanie Troy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6381, Silver Spring, MD 20993–0002, 240– 402–4656. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of PostExposure Prophylaxis.’’ The purpose of this draft guidance is to help sponsors in the development of anti-rabies virus mAb cocktails as an alternative to RIG as the passive immunization component of PEP for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal. Because of the unique complexities of drug development in this area, extensive discussion with multiple stakeholders has taken place, including a public workshop in 2017 and an advisory committee meeting in 2019. These discussions helped FDA formulate the considerations for rabies mAb cocktail development that are described in this draft guidance. The draft guidance addresses the following topics: • Considerations when selecting the mAbs included in the cocktail • The nonclinical and clinical data needed to support clinical trials of the mAb cocktail in potentially rabies virusexposed subjects • The clinical data recommended to support an initial biologics license application submission of the mAb cocktail for a second-line indication in situations where human-derived RIG is not available • The clinical data recommended to support a first-line indication for the mAb cocktail 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 current thinking of FDA on ‘‘Rabies: Developing Monoclonal E:\FR\FM\29JYN1.SGM 29JYN1 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices Antibody Cocktails for the Passive Immunization Component of PostExposure Prophylaxis.’’ 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. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections 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 for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information associated with submissions of content and format of labeling for drugs and biologics in 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910–0572; the collections of information associated with submissions of investigational new drug applications in 21 CFR part 312 have been approved under OMB control numbers 0910–0014; the collections of information associated with submissions of applications for approval to market a new drug in 21 CFR part 314 have been approved under 0910–0001; the collections of information associated with the reporting and recordkeeping of postmarketing adverse drug experiences have been approved under OMB control numbers 0910–0001, 0910–0230, 0910– 0291, and 0910–0645; and the collections of information associated with general licensing provisions for biologics in 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access jbell on DSKJLSW7X2PROD with NOTICES 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: July 26, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–16175 Filed 7–28–21; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:19 Jul 28, 2021 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0584] Agency Information Collection Activities; Proposed Collection; Comment Request; Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) 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 solicits comments on information collection associated with a pilot survey to develop standardized reporting forms for capturing performance data for federally funded public health projects. DATES: Submit either electronic or written comments on the collection of information by September 27, 2021. 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 September 27, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 27, 2021. 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. SUMMARY: 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 40853 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– 2021–N–0584 for ‘‘Pilot Survey to Develop Standardized Reporting Forms for Federally Funded Public Health Projects administered by the Office of Regulatory Affairs (ORA).’’ Received comments, those filed in a timely manner (see ADDRESSES), 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 E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40851-40853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16175]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0519]


Rabies: Developing Monoclonal Antibody Cocktails for the Passive 
Immunization Component of Post-Exposure Prophylaxis; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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

[[Page 40852]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Rabies: 
Developing Monoclonal Antibody Cocktails for the Passive Immunization 
Component of Post-Exposure Prophylaxis.'' The purpose of this draft 
guidance is to help sponsors in the development of anti-rabies virus 
monoclonal antibody (mAb) cocktails as an alternative to anti-rabies 
virus immunoglobulin (RIG) as the passive immunization component of 
post-exposure prophylaxis (PEP) for the prevention of rabies when given 
immediately after contact with a rabid or possibly rabid animal.

DATES: Submit either electronic or written comments on the draft 
guidance by September 27, 2021 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-2021-D-0519 for ``Rabies: Developing Monoclonal Antibody Cocktails 
for the Passive Immunization Component of Post-Exposure Prophylaxis.'' 
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: Stephanie Troy, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6381, Silver Spring, MD 20993-0002, 240-
402-4656.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Rabies: Developing Monoclonal Antibody Cocktails for the 
Passive Immunization Component of Post-Exposure Prophylaxis.'' The 
purpose of this draft guidance is to help sponsors in the development 
of anti-rabies virus mAb cocktails as an alternative to RIG as the 
passive immunization component of PEP for the prevention of rabies when 
given immediately after contact with a rabid or possibly rabid animal. 
Because of the unique complexities of drug development in this area, 
extensive discussion with multiple stakeholders has taken place, 
including a public workshop in 2017 and an advisory committee meeting 
in 2019. These discussions helped FDA formulate the considerations for 
rabies mAb cocktail development that are described in this draft 
guidance.
    The draft guidance addresses the following topics:
     Considerations when selecting the mAbs included in the 
cocktail
     The nonclinical and clinical data needed to support 
clinical trials of the mAb cocktail in potentially rabies virus-exposed 
subjects
     The clinical data recommended to support an initial 
biologics license application submission of the mAb cocktail for a 
second-line indication in situations where human-derived RIG is not 
available
     The clinical data recommended to support a first-line 
indication for the mAb cocktail
    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 current thinking of FDA on ``Rabies: 
Developing Monoclonal

[[Page 40853]]

Antibody Cocktails for the Passive Immunization Component of Post-
Exposure Prophylaxis.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections 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 for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information associated with submissions of content and format of 
labeling for drugs and biologics in 21 CFR 201.56 and 201.57 have been 
approved under OMB control number 0910-0572; the collections of 
information associated with submissions of investigational new drug 
applications in 21 CFR part 312 have been approved under OMB control 
numbers 0910-0014; the collections of information associated with 
submissions of applications for approval to market a new drug in 21 CFR 
part 314 have been approved under 0910-0001; the collections of 
information associated with the reporting and recordkeeping of 
postmarketing adverse drug experiences have been approved under OMB 
control numbers 0910-0001, 0910-0230, 0910-0291, and 0910-0645; and the 
collections of information associated with general licensing provisions 
for biologics in 21 CFR part 601 have been approved under OMB control 
number 0910-0338.

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: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16175 Filed 7-28-21; 8:45 am]
BILLING CODE 4164-01-P