60692 Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0544] 

Nontuberculous Mycobacterial 

Pulmonary Disease Caused by 

Mycobacterium Avium Complex: 

Developing Drugs for Treatment; 

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 

‘‘Nontuberculous Mycobacterial 

Pulmonary Disease Caused by 

Mycobacterium avium Complex: 

Developing Drugs for Treatment.’’ This 

guidance assists sponsors in the clinical 

development of drugs for the treatment 

of nontuberculous mycobacterial 

pulmonary disease (NTM–PD) caused 

by Mycobacterium avium complex 

(MAC). This guidance finalizes the draft 

guidance of the same title issued on 

September 29, 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 5, 2023. 

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 

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–0544 for ‘‘Nontuberculous 

Mycobacterial Pulmonary Disease 

Caused by Mycobacterium avium 

Complex: Developing Drugs for 

Treatment.’’ 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. 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: 

Mukil Natarajan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 22, Rm. 6394, 

Silver Spring, MD 20993, 240–402– 

4626. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Nontuberculous Mycobacterial 

Pulmonary Disease Caused by 

Mycobacterium avium Complex: 

Developing Drugs for Treatment.’’ The 

purpose of this guidance is to assist 

sponsors in the clinical development of 

drugs for the treatment of NTM–PD 

caused by MAC. 

This guidance finalizes the draft 

guidance of the same name issued on 

September 29, 2021 (86 FR 53967). FDA 

provided clarifying edits to the final 

guidance and included additional 

information after considering comments 

received on the draft guidance. Changes 

from the draft to the final guidance 

include edits pertaining to the clinical 

trial population and endpoints. 

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 ‘‘Nontuberculous 

Mycobacterial Pulmonary Disease 

Caused by Mycobacterium avium 

Complex: Developing Drugs for 

Treatment.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 60693 

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. The previously approved 

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. 

3501–3521). The collections of 

information in 21 CFR part 312 for the 

submissions of investigational new drug 

applications, including clinical trial 

design and study protocols, have been 

approved under OMB control number 

0910–0014. The collections of 

information in 21 CFR part 314 

pertaining to the submissions of new 

drug applications have been approved 

under OMB control number 0910–0001. 

The collections of information in 21 

CFR part 601 pertaining to the 

submissions of biologics license 

applications have been approved under 

OMB control number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the 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: August 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19060 Filed 9–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Faculty Loan 

Repayment Program OMB No. 0915– 

0150—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than November 6, 

2023. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Faculty Loan Repayment Program OMB 

No. 0915–0150—Revision 

Abstract: HRSA administers the 

Faculty Loan Repayment Program 

(FLRP). FLRP provides health 

professionals from disadvantaged 

backgrounds based on environmental 

and/or economic factors the opportunity 

to enter into a contract with the 

Department of Health and Human 

Services to receive repayment of 

qualifying educational loans in 

exchange for a minimum of 2 years of 

service as a full-time or part-time faculty 

member at an eligible health professions 

school. The applicant completes and 

submits an electronic application that 

identifies for the Secretary of Health and 

Human Services that the applicant 

comes from an economically or 

environmentally disadvantaged 

background who has a contract with an 

eligible health professions school to 

serve as a full-time or part-time faculty 

member for a minimum of 2 years and 

has qualifying outstanding educational 

loans. In addition, for each 

undergraduate and/or graduate loan for 

which repayment is sought, the 

applicant is required to submit loan 

documentation verifying the 

establishment of the educational loan(s) 

and lender account statements, 

promissory notes including the original 

date, and current balance of the 

outstanding educational loan(s). The 

sole change in this version of the ICR 

from previous ICR versions is that there 

is an increase in the estimated burden 

hours related to an increased number of 

respondents/applicants to the FLRP. 

Need and Proposed Use of the 

Information: The information collected 

will be used to evaluate applicants’ 

eligibility to participate in the FLRP and 

to monitor FLRP related activities. 

Likely Respondents: FLRP applicants 

and institutions providing employment 

to the applicants. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Eligible Applications ............................................................. 215 1 215 1.00 215.00 


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