Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Notices 31569 

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copies of the draft guidance to the 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access to the draft guidance document.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: 

Peter Kim, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–0741. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Antibacterial Therapies for Patients 

With an Unmet Medical Need for the 

Treatment of Serious Bacterial 

Diseases—Questions and Answers 

(Revision 1).’’ This draft guidance will 

provide necessary updates to the final 

guidance entitled ‘‘Antibacterial 

Therapies for Patients With an Unmet 

Medical Need for the Treatment of 

Serious Bacterial Diseases’’ published 

on August 2, 2017 (82 FR 35973). 

The purpose of this draft guidance is 

to assist sponsors in the clinical 

development of new antibacterial drugs. 

Specifically, the draft guidance explains 

FDA’s current thinking about possible 

development programs and clinical trial 

designs for antibacterial drugs to treat 

serious bacterial diseases in patients 

with an unmet medical need. Since the 

2017 final guidance was issued, there 

have been some new drug approvals 

that have activity against certain drugresistant organisms. Therefore, it is now 

possible to conduct noninferiority (NI) 

trials that include subjects with 

infections caused by certain drugresistant organisms because an effective 

active control can be provided. In 

addition to clarifying edits, more detail 

was provided for the currently used NI 

trial designs that may be used with a 

wider NI margin, including cases in 

which the trial population is enriched 

for subjects with infections caused by 

certain drug-resistant organisms. 

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 ‘‘Antibacterial Therapies for Patients 

With an Unmet Medical Need for the 

Treatment of Serious Bacterial Diseases’’ 

and will replace the guidance with that 

name issued in 2017. 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 in 21 CFR part 312 have 

been approved under OMB control 

numbers 0910–0014. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. The collections of 

information in 21 CFR 201.56 and 

201.57 have been approved under OMB 

control number 0910–0572. 

III. Electronic Access 

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: May 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11117 Filed 5–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0279] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before June 23, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990–0279–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Department of 

Health and Human Services (HHS) 

Registration of an Institutional Review 

Board Form. 

Type of Collection: Reinstatement 

without change. 

OMB No.: 0990–0279. 


jspears on DSK121TN23PROD with NOTICES1
31570 Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Notices 

Abstract: The Office of the Assistant 

Secretary for Health, Office for Human 

Research Protections is requesting 

reinstatement of the Office of 

Management and Budget (OMB) No. 

0990–0279, Department of Health and 

Human Services (HHS) Institutional 

Review Board (IRB) Registration Form, 

with no changes, for a three-year period. 

That form was previously approved by 

OMB on February 4, 2019 and expired 

on February 28, 2022. The purpose of 

the IRB Registration Form is to provide 

a simplified procedure for: (1) 

Institutions engaged in research 

conducted or supported by HHS to 

satisfy the HHS regulations for the 

protection of human subjects at 45 CFR 

46.103(b) and 45 CFR 46.107 as 

promulgated in 1991 (56 FR 28012, 

28022) and amended on June 23, 2005 

(70 FR 36325), and 45 CFR 46, subpart 

E, Registration of Institutional Review 

Boards; and, (2) IRBs, in the United 

States (US), to satisfy the FDA IRB 

regulations at 21 CFR 56.106. 

Likely Respondents: Institutions or 

organizations operating IRBs that review 

human subjects research conducted or 

supported by HHS; or, in the case of 

FDA’s requirements, each IRB in the 

United States that reviews clinical 

investigations regulated by FDA under 

sections 505(i) or 520(g) of the Federal 

Food, Drug and Cosmetic Act; and each 

IRB in the United States that reviews 

clinical investigations that are intended 

to support applications for research or 

marketing permits for FDA-regulated 

products. 

ANNUALIZED BURDEN HOUR TABLE

IRB registration form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

Total burden 

hours 

Update and Renew Registration ..................................................................... 5,650 2 30/60 5,650 

Initial and Update Registration ........................................................................ 350 2 45/60 525 

Total .......................................................................................................... ........................ ........................ ........................ 6,175 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–11064 Filed 5–23–22; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Member SEP. 

Date: June 16, 2022. 

Time: 10:30 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Ana Olariu, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

NINDS/NIH, NSC, 6001 Executive Boulevard, 

Room 3208, MSC 9529, Rockville, MD 20852, 

301–496–9223, Ana.Olariu@nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; HEAL Biomarker review 

meeting. 

Date: June 21, 2022. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Abhignya Subedi, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

NINDS/NIH, NSC, 6001 Executive Boulevard, 

Room 3208, MSC 9529, Rockville, MD 20852, 

301–496–9223, abhi.subedi@nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; HEAL Initiative: Pain 

Therapeutics Development [Small Molecules 

and Biologics]. 

Date: June 21, 2022. 

Time: 10:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Shanta Rajaram, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

NINDS/NIH, NSC, 6001 Executive Boulevard, 

Room 3208, MSC 9529, Rockville, MD 20852, 

301–435–6033, rajarams@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group; Neurological Sciences and 

Disorders B Study Section. 

Date: June 23–24, 2022. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Joel A. Saydoff, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Activities, 

NINDS/NIH, NSC, 6001 Executive Boulevard, 

Room 3205, MSC 9529, Rockville, MD 20852, 

301–496–9223, joel.saydoff@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: May 18, 2022. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–11054 Filed 5–23–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 


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