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a draft guidance for industry entitled 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draft guidance replaces the draft 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withdrawn. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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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