25494 Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 

Accordingly, the Agency will 

continue to list Cupric Sulfate Injection, 

EQ 0.4 mg copper/mL, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to Cupric Sulfate Injection, EQ 0.4 mg 

copper/mL, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: April 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09238 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–2022–D–0091] 

Crohn’s Disease: 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Treatment; Draft Guidance for 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 ‘‘Crohn’s 

Disease: 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 This draft guidance 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 

Crohn’s disease in adults, including 

recommendations for trial population, 

trial design, and efficacy and safety 

considerations. 

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written comments on the draft guidance 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draft guidance before it begins work on 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–0091 for ‘‘Crohn’s Disease: 

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: Jay 

Fajiculay, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5353, Silver Spring, 

MD 20993–0002, 301–796–9007, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 83 / Friday, April 29, 2022 / Notices 25495 

1https://www.selectagents.gov/sat/list.htm. 

2https://www.bis.doc.gov/index.php/regulations/ 

commerce-control-list-ccl. 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Crohn’s Disease: Developing Drugs for 

Treatment.’’ This guidance addresses 

FDA’s current thinking about clinical 

trials for the treatment of Crohn’s 

disease in adults, including 

recommendations for trial population, 

trial design, and efficacy and safety 

considerations. 

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 ‘‘Crohn’s Disease: 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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https:// 

www.regulations.gov. 

Dated: April 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09240 Filed 4–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Screening Framework Guidance for 

Providers and Users of Synthetic 

Oligonucleotides 

AGENCY: Office of the Secretary, 

Assistant Secretary for Preparedness 

and Response (ASPR), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Assistant Secretary for 

Preparedness and Response is issuing 

this revised guidance on a screening 

framework guidance for providers and 

users of synthetic oligonucleotides. The 

Revised Guidance sets forth 

recommended baseline standards for the 

gene and genome synthesis industry, as 

well as best practices for Institutions, 

Principal Users, End Users, and ThirdParty Vendors of oligonucleotides, 

regarding screening orders and 

maintaining records consistent with 

current U.S. regulations. In addition, 

this Revised Guidance seeks to 

encourage best practices to address 

biosecurity concerns associated with the 

potential misuse of synthetic 

oligonucleotides to bypass existing 

regulatory controls and commit 

unlawful acts. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Mariam Lekveishvili; Division of Policy; 

Office of Strategy, Policy, Planning, and 

Requirements; Office of the Assistant 

Secretary for Preparedness and 

Response; U.S. Department of Health 

and Human Services; phone: (202) 260– 

3586; email: Mariam.Lekveishvili@

hhs.gov. 

SUPPLEMENTARY INFORMATION: Questions 

regarding aspects of the Guidance that 

may be appropriate to update based on 

changes in technologies since the 

Guidance was originally issued in 2010 

were published as a Notice in the 

Federal Register on August 26, 2020, for 

a period of more than 120 days for 

public comment. Fourteen individual 

responses were received. The responses 

to that Notice are available at the 

following website: https://aspr.hhs.gov/ 

legal/syndna/Pages/comment.aspx. 

Screening Framework Guidance for 

Providers and Users of Synthetic 

Oligonucleotides 

Introduction: Continuing advances in 

oligonucleotide synthesis technology 

and the open availability of genetic 

sequence data pose potential concerns 

among the scientific community, the 

oligonucleotide synthesis industry, the 

U.S. Government, and the public that 

individuals with ill intent could exploit 

biotechnology for harmful purposes. 

The U.S. Government has acted to 

reduce dangers to human, animal, and 

plant health due to biological pathogens 

and toxins. For instance, it has issued 

the federal Select Agent Regulations, 

which regulate a subset of microbial 

organisms and toxins determined to 

have the potential to pose a severe 

threat to public health and safety, 

animal health, plant health, or animal or 

plant products. These regulations are 

administered by the Federal Select 

Agent Program (FSAP), which sets forth 

requirements for the possession, use, 

and transfer of biological select agents 

and toxins.1 A second layer of 

regulation is provided by the Export 

Administration Regulations’ Commerce 

Control List (CCL) 2 which identifies 

agents and genetic sequences that 

require licenses before export from the 

United States. However, these regulated 

pathogens and toxins do not represent 

the entirety of the potential risks to 

public health, agriculture, plants, 

animals, or the environment that could 

arise from the misuse of synthetic 

oligonucleotides. Non-regulated 

pathogens and toxins as well as other 

novel types of sequences or specific 

types of batch orders, may also pose 

significant risks if they are misused. 

Individuals with no legitimate, bona 

fide, and peaceful need should be 

prevented from accessing genetic 

materials that could contribute to 

pathogenicity or harm, even when they 

are not from FSAP- or CCL-listed 

pathogens or toxins. Purchasing or 

synthesizing oligonucleotides could 

enable individuals without a legitimate 

and peaceful purpose to possess genetic 

sequences that would pose risks if 

misused. Such synthesis, through 

directly ordering either long genomic 

sequences or short genomic sequences— 

that can be used to create longer 

genomic-length oligonucleotides, using 

molecular techniques that have become 

increasingly available—to modify nonVerDate Sep<11>2014 17:08 Apr 28, 2022 Jkt 256001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1

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