25490 Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 

submit an application to CMS that 

describes how the entity meets all the 

requirements in the PACE program. An 

entity’s application must be 

accompanied by an assurance from the 

SAA of the State in which the PO 

wishes to operate its PACE program. 

CMS accepts applications on a 

designated date four times per year (i.e., 

on a quarterly basis, generally the last 

Friday of March, June, September and 

December). Form Number: CMS–10631 

(OMB control number: 0938–1326); 

Frequency: Occasionally; Affected 

Public: Private Sector, State, Local or 

Tribal governments, Business or other 

for-profits; Number of Respondents: 72; 

Total Annual Responses: 130; Total 

Annual Hours: 7,271. (For policy 

questions regarding this collection 

contact Debbie Vanhoven at 410–786– 

6625.) 

Dated: April 25, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–09164 Filed 4–28–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0140] 

Ulcerative Colitis: Developing Drugs 

for Treatment; Draft Guidance for 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 

‘‘Ulcerative Colitis: Developing Drugs 

for Treatment.’’ This draft guidance 

addresses FDA’s current thinking about 

necessary attributes of clinical trials for 

developing drugs for the treatment of 

ulcerative colitis in adults, including 

recommendations for trial population, 

trial design, and efficacy and safety 

considerations. This draft guidance 

replaces the draft guidance for industry 

entitled ‘‘Ulcerative Colitis: Clinical 

Trial Endpoints,’’ which is being 

withdrawn. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 28, 2022 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draft guidance before it begins work on 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– 

2022–D–0140 for ‘‘Ulcerative Colitis: 

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 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 the 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: 

Kelly Richards, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5378, 

Silver Spring, MD 20993, 240–402– 

4276, or Stephen Ripley, Center for 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 25491 

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 draft guidance for industry entitled 

‘‘Ulcerative Colitis: Developing Drugs 

for Treatment.’’ This guidance addresses 

FDA’s current thinking about necessary 

attributes of clinical trials for 

developing drugs for ulcerative colitis in 

adults including recommendations for 

trial population, trial design, and 

efficacy and safety considerations. This 

draft guidance replaces the draft 

guidance for industry entitled 

‘‘Ulcerative Colitis: Clinical Trial 

Endpoints,’’ issued on August 8, 2016 

(81 FR 52449), which is being 

withdrawn. 

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 ‘‘Ulcerative Colitis: 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 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. FDA receives 

information described in FDA’s 

guidance entitled ‘‘Patient-Reported 

Outcome Measures: Use in Medical 

Product Development to Support 

Labeling Claims’’ to support the medical 

product’s effectiveness and to support 

claims in approved medical product 

labeling; the collections of information 

in 21 CFR 314.50(d)(5) and 21 CFR 

601.2 have been approved under OMB 

control numbers 0910–0001 and 0910– 

0338, respectively, and the collections 

of information in 21 CFR 201.56 and 

201.57 for medical product labeling 

have been approved under OMB control 

number 0910–0572. The collections of 

information in 21 CFR parts 50 and 56 

for protection of human subjects in 

clinical trials and institutional review 

board considerations have been 

approved under OMB control number 

0910–0130. 

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, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics, or https:// 

www.regulations.gov. 

Dated: April 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09237 Filed 4–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0895] 

Issuance of Priority Review Voucher; 

Material Threat Medical 

Countermeasure Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a material threat medical 

countermeasure (MCM) product 

application. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to award 

priority review vouchers to sponsors of 

approved material threat MCM product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that VEKLURY 

(remdesivir), manufactured by Gilead 

Sciences, Inc., meets the criteria for a 

material threat MCM priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Sadove, Office of 

Counterterrorism and Emerging Threats, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796–8515, 

Fax: 301–796–8615, email: EUA.OCET@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a material 

threat MCM priority review voucher to 

the sponsor of an approved material 

threat MCM product application. Under 

section 565A of the FD&C Act (21 U.S.C. 

360bbb–4a), which was added by the 

Cures Act (Pub. L. 114–255), FDA will 

award priority review vouchers to 

sponsors of approved material threat 

MCM product applications that meet 

certain criteria upon approval of those 

applications. FDA has determined that 

VEKLURY, manufactured by Gilead 

Sciences, Inc., meets the criteria for a 

material threat MCM priority review 

voucher. Remdesivir was approved on 

October 22, 2020, for use in adult and 

pediatric patients 12 years of age and 

older and weighing at least 40 kilograms 

(about 88 pounds) for the treatment of 

COVID–19 requiring hospitalization. 

For further information about the 

material threat MCM Priority Review 

Voucher Program and for a link to the 

full text of section 565A of the FD&C 

Act, go to https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further 

information about VEKLURY, go to the 

‘‘Drugs@FDA’’ website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: April 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09233 Filed 4–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–5609] 

Action Levels for Lead in Juice; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Action 

Levels for Lead in Juice: Guidance for 

Industry.’’ The draft guidance, when 

finalized, would establish action levels 

of 10 parts per billion (ppb) for lead in 

single-strength (ready-to-drink) apple 

juice and 20 ppb for lead in all other 

single-strength juice types, including 

juice blends that contain apple juice. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 28, 2022 to ensure that we 

consider your comment on the draft 


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