27616 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. This 

guidance document is also available at 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Humanitarian Device Exemption 

(HDE) Program’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 17040 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations 

and guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 10 have been approved under OMB 

control number 0910–0191; the 

collections of information in 21 CFR 

parts 50 and 56 have been approved 

under OMB control numbers 0910–0755 

and 0910–0130; the collections of 

information in 21 CFR part 54 have been 

approved under OMB control number 

0910–0396; the collections of 

information in 21 CFR part 803 have 

been approved under OMB control 

number 0910–0437; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 814, 

subparts A through E, have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; the 

collections of information regarding 

Information to Accompany HDE 

Applications and Annual Distribution 

Number Reporting Requirements have 

been approved under OMB control 

number 0910–0661; and the collections 

of information in the guidance 

document ‘‘De Novo Classification 

Process (Evaluation of Automatic Class 

III Designation)’’ have been approved 

under OMB control number 0910–0844. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12633 Filed 6–12–18; 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; 

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 ‘‘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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27617 

the information at: https://www.gpo.gov/ 

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 § 314.50(e)(2)(ii) and 

(l)(1)(i) and advertisements and 

promotional labeling under 

§ 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/fdagovpublic/@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-drugsgen/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/Guidance

ComplianceRegulatoryInformation/

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 


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