Federal Register / Vol. 87, No. 123 / Tuesday, June 28, 2022 / Notices 38415 

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requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Sundeep Agrawal, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2379, 

Silver Spring, MD 20993–0002, 301– 

348–3914; 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, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Bladder Cancer: Developing Drugs and 

Biologics for Adjuvant Treatment.’’ This 

guidance provides recommendations to 

sponsors regarding the development of 

drugs regulated by Center for Drug 

Evaluation and Research and Center for 

Biologics Evaluation and Research for 

the adjuvant treatment of muscleinvasive bladder cancer. The guidance 

includes recommendations regarding 

eligibility criteria, choice of comparator, 

followup imaging assessments, 

determination of disease recurrence, 

analyses of disease-free survival (DFS), 

and interpretation of trial results. 

Although FDA may consider endpoints 

other than DFS for the adjuvant 

treatment of muscle-invasive bladder 

cancer, this guidance is focused on 

cancer trials with DFS as the primary 

efficacy endpoint. 

Adjuvant muscle-invasive bladder 

cancer clinical trials are an active area 

of research. There is significant 

variability in the design, conduct, and 

analysis of these trials, including the 

eligibility criteria, radiological disease 

assessments, the definition of disease 

recurrence, and the date used to define 

the DFS endpoint. Consistency in these 

aspects within and across trials may 

facilitate interpretation of trial results. 

These issues were discussed at an FDANational Cancer Institute public 

workshop held on November 28, 2017. 

This guidance provides 

recommendations on these issues to 

facilitate adjuvant muscle-invasive 

bladder cancer clinical trials. This 

guidance finalizes the draft guidance 

entitled ‘‘Bladder Cancer: Developing 

Drugs and Biologics for Adjuvant 

Treatment: issued on October 1, 2020 

(85 FR 62309). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

The final guidance includes changes to 

improve clarity. 

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 ‘‘Bladder Cancer: 

Developing Drugs and Biologics for 

Adjuvant 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 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 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13753 Filed 6–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 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 

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 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; U24 ATLAS 

Applications. 

Date: July 29, 2022. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

NIDDK, Democracy II , 6707 Democracy 

Blvd., Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ryan G. Morris, Ph.D., 

Scientific Review Officer, Review Branch, 

Division of Extramural Activities, NIDDK, 

National Institutes of Health, Room 7015, 

6707 Democracy Boulevard Bethesda, MD 

20892–2542, 301–594–4721, ryan.morris@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–13700 Filed 6–27–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review 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. 


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