83_FR_27730 83 FR 27616 - Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry; Availability

83 FR 27616 - Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

Page Range27616-27617
FR Document2018-12635

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Limited Population Pathway for Antibacterial and Antifungal Drugs.''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).

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018) 
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27616-27617]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Limited Population Pathway for Antibacterial and Antifungal 
Drugs; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Limited 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).

DATES: Submit either electronic or written comments on the draft 
guidance by August 13, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2018-D-2032 for ``Limited Population Pathway for Antibacterial and 
Antifungal Drugs; Draft Guidance for Industry; Availability.'' 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.
     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

[[Page 27617]]

the information at: https://www.thefederalregister.org/fdsys/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.
    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, or 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 draft 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 draft guidance for industry 
entitled ``Limited Population Pathway for Antibacterial and Antifungal 
Drugs.'' Section 506(h)(5) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 356(h)(5)) requires FDA to issue guidance 
``describing 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, added by section 
3042 of the Cures Act. This guidance satisfies the requirements under 
section 506(h)(5) of the FD&C Act.
    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 drug products that address unmet needs of patients with 
serious bacterial and fungal infections.
    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 the LPAD 
pathway. 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. 
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collection 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), 
has 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 under 21 CFR 201.56 
and 201.57 has been approved under OMB control number 0910-0572. The 
submission of medication guides under 21 CFR part 208 has been approved 
under OMB control number 0910-0393. The submission of prescription drug 
advertisements under 21 CFR 202.1 has been approved under OMB control 
number 0910-0686.
    The collection of information in the draft guidance for industry 
entitled ``Formal Meetings Between the FDA and Sponsors and Applicants 
for PDUFA Products'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm590547.pdf), 
including requests for pre-NDA and pre-BLA meetings and other meetings 
pertaining to the LPAD pathway, has been approved under OMB control 
number 0910-0429.
    The collection of information in the guidance for industry entitled 
``Expedited Programs for Serious Conditions--Drugs and Biologics'' 
(available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm358301.pdf), including fast track 
designation, breakthrough therapy designation, accelerated approval, 
and priority review designation has been approved under OMB control 
number 0910-0765.
    The collection of information in 21 CFR part 312, including 
submissions under subpart E, has been approved under OMB control number 
0910-0014. In accordance with the PRA, prior to publication of any 
final guidance document, FDA intends to solicit public comment and 
obtain OMB approval for any information collections recommended in this 
guidance that are new or that would represent material modifications to 
those previously approved collections of information found in FDA 
regulations or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatory 
Information/Guidances/default.htm, or https://www.regulations.gov.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12635 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P

27616 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices downloading an electronic copy from Dated: June 7, 2018. • If you want to submit a comment the internet. A search capability for all Leslie Kux, with confidential information that you Center for Devices and Radiological Associate Commissioner for Policy. do not wish to be made available to the Health guidance documents is available [FR Doc. 2018–12633 Filed 6–12–18; 8:45 am] public, submit the comment as a at http://www.fda.gov/MedicalDevices/ BILLING CODE 4164–01–P written/paper submission and in the DeviceRegulationandGuidance/ manner detailed (see ‘‘Written/Paper GuidanceDocuments/default.htm. This Submissions’’ and ‘‘Instructions’’). guidance document is also available at DEPARTMENT OF HEALTH AND Written/Paper Submissions http://www.fda.gov/BiologicsBlood HUMAN SERVICES Vaccines/GuidanceCompliance Submit written/paper submissions as Food and Drug Administration follows: RegulatoryInformation/default.htm or • Mail/Hand delivery/Courier (for https://www.regulations.gov. Persons [Docket No. FDA–2018–D–2032] written/paper submissions): Dockets unable to download an electronic copy Management Staff (HFA–305), Food and of ‘‘Humanitarian Device Exemption Limited Population Pathway for Drug Administration, 5630 Fishers (HDE) Program’’ may send an email Antibacterial and Antifungal Drugs; Lane, Rm. 1061, Rockville, MD 20852. request to CDRH-Guidance@fda.hhs.gov Draft Guidance for Industry; • For written/paper comments to receive an electronic copy of the Availability submitted to the Dockets Management document. Please use the document Staff, FDA will post your comment, as number 17040 to identify the guidance AGENCY: Food and Drug Administration, well as any attachments, except for you are requesting. HHS. information submitted, marked and ACTION: Notice of availability. identified, as confidential, if submitted IV. Paperwork Reduction Act of 1995 SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’ This draft guidance refers to Instructions: All submissions received Administration (FDA or Agency) is previously approved collections of must include the Docket No. FDA– announcing the availability of a draft information found in FDA regulations 2018–D–2032 for ‘‘Limited Population guidance for industry entitled ‘‘Limited and guidance. These collections of Pathway for Antibacterial and Population Pathway for Antibacterial Antifungal Drugs; Draft Guidance for information are subject to review by the and Antifungal Drugs.’’ This guidance Office of Management and Budget Industry; Availability.’’ Received provides information on the comments will be placed in the docket (OMB) under the Paperwork Reduction implementation of the limited and, except for those submitted as Act of 1995 (44 U.S.C. 3501–3520). The population pathway provision of the ‘‘Confidential Submissions,’’ publicly collections of information in 21 CFR 21st Century Cures Act (Cures Act), viewable at https://www.regulations.gov part 10 have been approved under OMB which established the limited or at the Dockets Management Staff control number 0910–0191; the population pathway for antibacterial between 9 a.m. and 4 p.m., Monday collections of information in 21 CFR and antifungal drugs (LPAD pathway). through Friday. parts 50 and 56 have been approved DATES: Submit either electronic or • Confidential Submissions—To under OMB control numbers 0910–0755 written comments on the draft guidance submit a comment with confidential and 0910–0130; the collections of by August 13, 2018 to ensure that the information that you do not wish to be information in 21 CFR part 54 have been Agency considers your comment on this made publicly available, submit your approved under OMB control number draft guidance before it begins work on comments only as a written/paper 0910–0396; the collections of the final version of the guidance. submission. You should submit two information in 21 CFR part 803 have ADDRESSES: You may submit comments copies total. One copy will include the been approved under OMB control on any guidance at any time as follows: information you claim to be confidential number 0910–0437; the collections of with a heading or cover note that states information in 21 CFR part 812 have Electronic Submissions ‘‘THIS DOCUMENT CONTAINS been approved under OMB control Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The number 0910–0078; the collections of following way: Agency will review this copy, including information in 21 CFR part 814, • Federal eRulemaking Portal: the claimed confidential information, in subparts A through E, have been https://www.regulations.gov. Follow the its consideration of comments. The approved under OMB control number instructions for submitting comments. second copy, which will have the 0910–0231; the collections of Comments submitted electronically, claimed confidential information information in 21 CFR part 814, subpart including attachments, to https:// redacted/blacked out, will be available H, have been approved under OMB www.regulations.gov will be posted to for public viewing and posted on control number 0910–0332; the the docket unchanged. Because your https://www.regulations.gov. Submit collections of information in 21 CFR comment will be made public, you are both copies to the Dockets Management part 820 have been approved under solely responsible for ensuring that your Staff. If you do not wish your name and OMB control number 0910–0073; the comment does not include any contact information to be made publicly collections of information regarding confidential information that you or a available, you can provide this Information to Accompany HDE third party may not wish to be posted, information on the cover sheet and not Applications and Annual Distribution such as medical information, your or in the body of your comments and you Number Reporting Requirements have anyone else’s Social Security number, or must identify this information as amozie on DSK3GDR082PROD with NOTICES1 been approved under OMB control confidential business information, such ‘‘confidential.’’ Any information marked number 0910–0661; and the collections as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed of information in the guidance that if you include your name, contact except in accordance with 21 CFR 10.20 document ‘‘De Novo Classification information, or other information that and other applicable disclosure law. For Process (Evaluation of Automatic Class identifies you in the body of your more information about FDA’s posting III Designation)’’ have been approved comments, that information will be of comments to public dockets, see 80 under OMB control number 0910–0844. posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1

Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27617 the information at: https://www.gpo.gov/ guidance also is intended to assist 21 CFR part 208 has been approved fdsys/pkg/FR-2015-09-18/pdf/2015- sponsors in developing labeling, under OMB control number 0910–0393. 23389.pdf. including prescribing information, The submission of prescription drug Docket: For access to the docket to patient labeling, and carton/container advertisements under 21 CFR 202.1 has read background documents or the labeling, that incorporates certain been approved under OMB control electronic and written/paper comments statements required by section 506(h) of number 0910–0686. received, go to https:// the FD&C Act, added by section 3042 of www.regulations.gov and insert the The collection of information in the the Cures Act. This guidance satisfies docket number, found in brackets in the the requirements under section draft guidance for industry entitled heading of this document, into the 506(h)(5) of the FD&C Act. ‘‘Formal Meetings Between the FDA and ‘‘Search’’ box and follow the prompts The LPAD pathway is intended to Sponsors and Applicants for PDUFA and/or go to the Dockets Management encourage the development of certain Products’’ (available at https:// Staff, 5630 Fishers Lane, Rm. 1061, antibacterial and antifungal drugs to www.fda.gov/ucm/groups/fdagov- Rockville, MD 20852. help address the critical public health public/@fdagov-drugs-gen/documents/ You may submit comments on any and patient care concern that has document/ucm590547.pdf), including guidance at any time (see 21 CFR resulted from the current decline in requests for pre-NDA and pre-BLA 10.115(g)(5)). antibacterial drug research and meetings and other meetings pertaining Submit written requests for single development as serious antibacterial to the LPAD pathway, has been copies of the draft guidance to the and antifungal drug-resistant infections approved under OMB control number Division of Drug Information, Center for increase. FDA is committed to using the 0910–0429. Drug Evaluation and Research, Food tools at its disposal, including the LPAD and Drug Administration, 10001 New The collection of information in the pathway, to help encourage the Hampshire Ave., Hillandale Building, guidance for industry entitled development of safe and effective drug 4th Floor, Silver Spring, MD 20993– ‘‘Expedited Programs for Serious products that address unmet needs of 0002, or Office of Communication, Conditions—Drugs and Biologics’’ patients with serious bacterial and Outreach, and Development, Center for fungal infections. (available at https://www.fda.gov/ucm/ Biologics Evaluation and Research, This draft guidance is being issued groups/fdagov-public/@fdagov-drugs- Food and Drug Administration, 10903 consistent with FDA’s good guidance gen/documents/document/ New Hampshire Ave., Bldg. 71, Rm. practices regulation (21 CFR 10.115). ucm358301.pdf), including fast track 3128, Silver Spring, MD 20993–0002. The draft guidance, when finalized, will designation, breakthrough therapy Send one self-addressed adhesive label represent the current thinking of FDA designation, accelerated approval, and to assist that office in processing your on the LPAD pathway. It does not priority review designation has been requests. See the SUPPLEMENTARY establish any rights for any person and approved under OMB control number INFORMATION section for electronic is not binding on FDA or the public. 0910–0765. access to the draft guidance document. You can use an alternative approach if The collection of information in 21 FOR FURTHER INFORMATION CONTACT: it satisfies the requirements of the CFR part 312, including submissions Sarah Walinsky, Center for Drug applicable statutes and regulations. This under subpart E, has been approved Evaluation and Research, Food and guidance is not subject to Executive under OMB control number 0910–0014. Drug Administration, 10903 New Order 12866. In accordance with the PRA, prior to Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993–0002, 240– II. Paperwork Reduction Act of 1995 publication of any final guidance 402–4075; or Stephen Ripley, Center for This draft guidance refers to document, FDA intends to solicit public Biologics Evaluation and Research, previously approved collections of comment and obtain OMB approval for Food and Drug Administration, 10903 information found in FDA regulations. any information collections New Hampshire Ave., Bldg. 71, Rm. These collections of information are recommended in this guidance that are 7301, Silver Spring, MD 20993–0002, subject to review by the Office of new or that would represent material 240–402–7911. Management and Budget (OMB) under modifications to those previously SUPPLEMENTARY INFORMATION: the Paperwork Reduction Act of 1995 approved collections of information (PRA) (44 U.S.C. 3501–3520). The found in FDA regulations or guidances. I. Background collection of information in 21 CFR part III. Electronic Access FDA is announcing the availability of 314 for the submission of new drug a draft guidance for industry entitled applications (NDAs) under the LPAD Persons with access to the internet ‘‘Limited Population Pathway for pathway, including the submission of may obtain the draft guidance at either Antibacterial and Antifungal Drugs.’’ labeling under § 314.50(e)(2)(ii) and https://www.fda.gov/Drugs/Guidance Section 506(h)(5) of the Federal Food, (l)(1)(i) and advertisements and ComplianceRegulatoryInformation/ Drug, and Cosmetic Act (FD&C Act) (21 promotional labeling under Guidances/default.htm, https:// U.S.C. 356(h)(5)) requires FDA to issue § 314.81(b)(3)(i), has been approved www.fda.gov/BiologicsBloodVaccines/ guidance ‘‘describing criteria, processes, under OMB control number 0910–0001. GuidanceComplianceRegulatory and other general considerations for The submission of biologics license Information/Guidances/default.htm, or demonstrating the safety and applications (BLAs) under the LPAD amozie on DSK3GDR082PROD with NOTICES1 https://www.regulations.gov. effectiveness of limited population pathway has been approved under OMB antibacterial and antifungal drugs.’’ This control number 0910–0338. Dated: June 7, 2018. guidance provides this information and The submission of prescription drug Leslie Kux, is intended to assist sponsors in the labeling under 21 CFR 201.56 and Associate Commissioner for Policy. development of certain new 201.57 has been approved under OMB [FR Doc. 2018–12635 Filed 6–12–18; 8:45 am] antibacterial and antifungal drugs for control number 0910–0572. The BILLING CODE 4164–01–P approval under the LPAD pathway. This submission of medication guides under VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1


Document Created: 2018-06-12 23:59:10
Document Modified: 2018-06-12 23:59:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactSarah 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.
FR Citation83 FR 27616 
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