Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry; Availability, 47799-47801 [2020-17109]

Download as PDF Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices Dated: August 3, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–17177 Filed 8–5–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3771] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency’s annual report entitled ‘‘Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.’’ Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct is on the FDA’s ‘‘Postmarketing Requirements and Commitments: Reports’’ web page. FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5367, Silver Spring, MD 20993–0002, 301–796–0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: I. Background Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to publish an annual report on the status of postmarketing studies that applicants have committed to, or are required to conduct, and for which annual status reports have been submitted. Under §§ 314.81(b)(2)(vii) and 601.70 (21 CFR 314.81(b)(2)(vii) and 601.70), applicants of approved drugs and licensed biologics are required to submit VerDate Sep<11>2014 17:13 Aug 05, 2020 Jkt 250001 annually a report on the status of each clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study or clinical trial either required by FDA (PMRs) or that they have committed to conduct (PMCs), either at the time of approval or after approval of their new drug application, abbreviated new drug application, or biologics license application. The status of PMCs concerning chemistry, manufacturing, and production controls and the status of other studies or clinical trials conducted on an applicant’s own initiative are not required to be reported under §§ 314.81(b)(2)(vii) and 601.70 and are not addressed in this report. Furthermore, section 505(o)(3)(E) of the FD&C Act (21 U.S.C. 355(o)(3)(E)) requires that applicants report periodically on the status of each required study or clinical trial and each study or clinical trial ‘‘otherwise undertaken . . . to investigate a safety issue . . . . ’’ An applicant must report on the progress of the PMR/PMC on the anniversary of the drug product’s approval 1 until the PMR/PMC is completed or terminated and FDA determines that the PMR/PMC has been fulfilled or that the PMR/PMC is either no longer feasible or would no longer provide useful information. II. Fiscal Year 2019 Report With this notice, FDA is announcing the availability of the Agency’s annual report entitled ‘‘Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.’’ Information in this report covers any PMR/PMC that was established, in writing, at the time of approval or after approval of an application or a supplement to an application and summarizes the status of PMRs/PMCs in fiscal year (FY) 2019 (i.e., as of September 30, 2019). Information summarized in the report reflects combined data from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research and includes the following: (1) The number of applicants with open PMRs/ PMCs; (2) the number of open PMRs/ PMCs; (3) the timeliness of applicant submission of the annual status reports 1 An applicant must submit an annual status report on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application or on an alternate reporting date that was granted by FDA in writing. Some applicants have requested and been granted by FDA alternate annual reporting dates to facilitate harmonized reporting across multiple applications. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 47799 (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in § 314.81(b)(2)(vii) or § 601.70 ASRs; (5) the status of closed PMRs/PMCs; and (6) the distribution of the status by fiscal year of establishment 2 (FY2013 to FY2019) for PMRs and PMCs open at the end of FY2019, or those closed within FY2019. Additional information about PMRs/PMCs is provided on FDA’s website at https://www.fda.gov/drugs/ guidance-compliance-regulatoryinformation/postmarket-requirementsand-commitments. Dated: July 31, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–17113 Filed 8–5–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–2032] Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ This guidance provides information on the implementation of the limited population pathway provision of the 21st Century Cures Act (Cures Act), which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). This guidance finalizes the draft guidance of the same name issued on June 13, 2018. DATES: The announcement of the guidance is published in the Federal Register on August 6, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the 2 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA-required (PMR) or requested (PMC) postmarketing study or clinical trial. E:\FR\FM\06AUN1.SGM 06AUN1 47800 Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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– 2018–D–2032 for ‘‘Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ 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 VerDate Sep<11>2014 17:13 Aug 05, 2020 Jkt 250001 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)). Submit written requests for single copies of this 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; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document. FOR FURTHER INFORMATION CONTACT: Sarah Walinsky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993–0002, 240– 402–4075; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ Section 3042 of the Cures Act added section 506(h) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(h)(5)) to create the LPAD pathway. The LPAD pathway is intended to encourage the development of certain antibacterial and antifungal drugs to help address the critical public health and patient care concern that has resulted from the current decline in antibacterial drug research and development as serious antibacterial and antifungal drug-resistant infections increase. FDA is committed to using the tools at its disposal, including the LPAD pathway, to help encourage the development of safe and effective drugs that address unmet needs of patients with serious bacterial and fungal infections. Section 506(h)(5) of the FD&C Act requires FDA to issue guidance that describes criteria, processes, and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs. This guidance provides this information and is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway. This guidance also is intended to assist sponsors in developing labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section 506(h) of the FD&C Act. This guidance satisfies the requirements under section 506(h)(5) of the FD&C Act. This guidance finalizes the draft guidance of the same name issued on June 13, 2018 (83 FR 27616). Changes made to the guidance were based on the comments submitted to the docket on the draft guidance and public comments received during the FDA public meeting entitled ‘‘Limited Population Pathway for Antibacterial and Antifungal Drugs,’’ which was held on July 12, 2019 (84 FR 12621) (meeting transcript available at https://www.fda.gov/news-events/fdameetings-conferences-and-workshops/ fda-public-meeting-limited-populationpathway-antibacterial-and-antifungaldrugs-07122019-07122019). Based on the comments received, FDA made clarifying changes to this guidance, included examples of labeling and explanations of the meaning of limited population, and provided further E:\FR\FM\06AUN1.SGM 06AUN1 Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES information about presubmission of promotional materials. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ 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 This guidance contains no new collection of information. Therefore, additional clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501–3521) is not required. However, this guidance refers to previously approved FDA collections of information. These collections of information were reviewed by OMB under the PRA. The collections of information in 21 CFR part 314 for the submission of new drug applications (NDAs) under the LPAD pathway, including the submission of labeling under § 314.50(e)(2)(ii) and (l)(1)(i) and advertisements and promotional labeling under § 314.81(b)(3)(i), have been approved under OMB control number 0910–0001. The submission of biologics license applications (BLAs) under the LPAD pathway has been approved under OMB control number 0910–0338. The submission of prescription drug labeling in 21 CFR 201.56 and 201.57 has been approved under OMB control number 0910–0572. The submission of medication guides in 21 CFR part 208 has been approved under OMB control number 0910–0393. The submission of prescription drug advertisements in 21 CFR 202.1 has been approved under OMB control number 0910–0686. The collections of information in 21 CFR part 312, including submissions under subpart E, have been approved under OMB control number 0910–0014. The collections of information in FDA’s draft guidance for industry entitled ‘‘Formal Meetings Between the FDA and Sponsors and Applicants for PDUFA Products’’ (available at https:// www.fda.gov/media/109951/download), including requests for pre-NDA and preBLA meetings and other meetings pertaining to the LPAD pathway, have been approved under OMB control number 0910–0429. The collections of information in FDA’s final guidance for industry entitled ‘‘Expedited Programs for VerDate Sep<11>2014 17:13 Aug 05, 2020 Jkt 250001 Serious Conditions—Drugs and Biologics’’ (available at https:// www.fda.gov/media/86377/download) have been approved under OMB control number 0910–0765. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https:// www.regulations.gov. Dated: July 31, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–17109 Filed 8–5–20; 8:45 am] BILLING CODE 4164–01–P 47801 the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations DEPARTMENT OF HEALTH AND HUMAN SERVICES OMB Control Number 0910–0562— Extension Food and Drug Administration The Food Quality Protection Act of 1996, which amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act), established a new safety standard for pesticide residues in food, with an emphasis on protecting the health of infants and children. The Environmental Protection Agency (EPA) is responsible for regulating the use of pesticides (under FIFRA) and for establishing tolerances or exemptions from the requirement for tolerances for residues of pesticide chemicals in food commodities (under the FD&C Act). EPA may, for various reasons, e.g., as part of a systematic review or in response to new information concerning the safety of a specific pesticide, reassess whether a tolerance for a pesticide residue continues to meet the safety standard in section 408 of the FD&C Act (21 U.S.C. 346a). When EPA determines that a pesticide’s tolerance level does not meet that safety standard, the registration for the pesticide may be canceled under FIFRA for all or certain uses. In addition, the tolerances for that pesticide may be lowered or revoked for the corresponding food commodities. Under section 408(l)(2) of the FD&C Act, when the registration for a pesticide is canceled or modified due to, in whole or in part, dietary risks to humans posed by residues of that pesticide chemical on food, the effective date for the revocation of such tolerance (or exemption in some cases) must be no later than 180 days after the date such cancellation becomes effective or 180 [Docket No. FDA–2017–N–2021] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by September 8, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0562. Also include SUMMARY: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM 06AUN1

Agencies

[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47799-47801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17109]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2032]


Limited Population Pathway for Antibacterial and Antifungal 
Drugs; 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 final guidance for industry entitled ``Limited 
Population Pathway for Antibacterial and Antifungal Drugs.'' This 
guidance provides information on the implementation of the limited 
population pathway provision of the 21st Century Cures Act (Cures Act), 
which established the limited population pathway for antibacterial and 
antifungal drugs (LPAD pathway). This guidance finalizes the draft 
guidance of the same name issued on June 13, 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on August 6, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the

[[Page 47800]]

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-2018-D-2032 for ``Limited Population Pathway for Antibacterial and 
Antifungal Drugs.'' 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 this 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; or the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Sarah Walinsky, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 240-
402-4075; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Limited Population Pathway for Antibacterial and Antifungal 
Drugs.'' Section 3042 of the Cures Act added section 506(h) to the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(h)(5)) 
to create the LPAD pathway. The LPAD pathway is intended to encourage 
the development of certain antibacterial and antifungal drugs to help 
address the critical public health and patient care concern that has 
resulted from the current decline in antibacterial drug research and 
development as serious antibacterial and antifungal drug-resistant 
infections increase. FDA is committed to using the tools at its 
disposal, including the LPAD pathway, to help encourage the development 
of safe and effective drugs that address unmet needs of patients with 
serious bacterial and fungal infections.
    Section 506(h)(5) of the FD&C Act requires FDA to issue guidance 
that describes criteria, processes, and other general considerations 
for demonstrating the safety and effectiveness of limited population 
antibacterial and antifungal drugs. This guidance provides this 
information and is intended to assist sponsors in the development of 
certain new antibacterial and antifungal drugs for approval under the 
LPAD pathway. This guidance also is intended to assist sponsors in 
developing labeling, including prescribing information, patient 
labeling, and carton/container labeling, that incorporates certain 
statements required by section 506(h) of the FD&C Act. This guidance 
satisfies the requirements under section 506(h)(5) of the FD&C Act.
    This guidance finalizes the draft guidance of the same name issued 
on June 13, 2018 (83 FR 27616). Changes made to the guidance were based 
on the comments submitted to the docket on the draft guidance and 
public comments received during the FDA public meeting entitled 
``Limited Population Pathway for Antibacterial and Antifungal Drugs,'' 
which was held on July 12, 2019 (84 FR 12621) (meeting transcript 
available at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-limited-population-pathway-antibacterial-and-antifungal-drugs-07122019-07122019). Based on the 
comments received, FDA made clarifying changes to this guidance, 
included examples of labeling and explanations of the meaning of 
limited population, and provided further

[[Page 47801]]

information about presubmission of promotional materials.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Limited Population Pathway for 
Antibacterial and Antifungal Drugs.'' 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

    This guidance contains no new collection of information. Therefore, 
additional clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved FDA 
collections of information. These collections of information were 
reviewed by OMB under the PRA. The collections of information in 21 CFR 
part 314 for the submission of new drug applications (NDAs) under the 
LPAD pathway, including the submission of labeling under Sec.  
314.50(e)(2)(ii) and (l)(1)(i) and advertisements and promotional 
labeling under Sec.  314.81(b)(3)(i), have been approved under OMB 
control number 0910-0001. The submission of biologics license 
applications (BLAs) under the LPAD pathway has been approved under OMB 
control number 0910-0338.
    The submission of prescription drug labeling in 21 CFR 201.56 and 
201.57 has been approved under OMB control number 0910-0572. The 
submission of medication guides in 21 CFR part 208 has been approved 
under OMB control number 0910-0393. The submission of prescription drug 
advertisements in 21 CFR 202.1 has been approved under OMB control 
number 0910-0686.
    The collections of information in 21 CFR part 312, including 
submissions under subpart E, have been approved under OMB control 
number 0910-0014. The collections of information in FDA's draft 
guidance for industry entitled ``Formal Meetings Between the FDA and 
Sponsors and Applicants for PDUFA Products'' (available at https://www.fda.gov/media/109951/download), including requests for pre-NDA and 
pre-BLA meetings and other meetings pertaining to the LPAD pathway, 
have been approved under OMB control number 0910-0429.
    The collections of information in FDA's final guidance for industry 
entitled ``Expedited Programs for Serious Conditions--Drugs and 
Biologics'' (available at https://www.fda.gov/media/86377/download) 
have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17109 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.