22536 Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Notices 

G. Subpart R—Enforcement Procedures 

We have determined that the ASHI 

meets the requirements of subpart R to 

the extent that it applies to accreditation 

organizations. The ASHI policy sets 

forth the actions the organization takes 

when laboratories it accredits do not 

comply with its requirements and 

standards for accreditation. When 

appropriate, the ASHI will deny, 

suspend, or revoke accreditation in a 

laboratory accredited by the ASHI and 

report that action to us within 30 days. 

The ASHI also provides an appeals 

process for laboratories that have had 

accreditation denied, suspended, or 

revoked. 

We have determined that the ASHI’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of part 493 

subpart R as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

laboratories accredited by the ASHI may 

be conducted on a representative 

sample basis or in response to 

substantial allegations of 

noncompliance (that is, complaint 

inspections). The outcome of those 

validation inspections, performed by 

CMS or our agents, or the State survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by the ASHI remain in 

compliance with CLIA requirements. 

This Federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

CLIA regulations at § 493.575 provide 

that we may rescind the approval of an 

accreditation organization, such as that 

of the ASHI, before the end of the 

effective date of approval in certain 

circumstances. For example, If we 

determine that the ASHI has failed to 

adopt, maintain and enforce 

requirements that are equal to, or more 

stringent than, the CLIA requirements, 

or that systemic problems exist in its 

monitoring, inspection or enforcement 

processes, we may impose a 

probationary period, not to exceed 1 

year, in which the ASHI would be 

allowed to address any identified issues. 

Should the ASHI be unable to address 

the identified issues within that 

timeframe, CMS may, in accordance 

with the applicable regulations, revoke 

the ASHI’s deeming authority under 

CLIA. 

Should circumstances result in our 

withdrawal of the ASHI’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget (OMB) under the authority of the 

Paperwork Reduction Act (PRA) of 1995 

(44 U.S.C. Chapter 35). The 

requirements associated with the 

accreditation process for clinical 

laboratories under the CLIA program, 

codified in 42 CFR part 493 subpart E, 

are currently approved by OMB under 

OMB approval number 0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: April 12, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–08153 Filed 4–14–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1238] 

Celiac Disease: Developing Drugs for 

Adjunctive Treatment to a Gluten-Free 

Diet; 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 ‘‘Celiac 

Disease: Developing Drugs for 

Adjunctive Treatment to a Gluten-Free 

Diet.’’ This draft guidance addresses 

FDA’s recommendations regarding 

clinical trials for drugs being developed 

for the treatment of celiac disease as an 

adjunct to a gluten-free diet in adults. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 14, 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– 

2021–D–1238 for ‘‘Celiac Disease: 

Developing Drugs for Adjunctive 

Treatment to a Gluten-Free Diet.’’ 

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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Notices 22537 

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 

(CBER), 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: 

Richard Whitehead, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 3362, 

Silver Spring, MD 20993–0002, 301– 

796–4945; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7268, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Celiac Disease: Developing Drugs for 

Adjunctive Treatment to a Gluten-Free 

Diet.’’ This guidance addresses FDA’s 

current recommendations on clinical 

trials for drugs being developed for the 

treatment of celiac disease as an adjunct 

to a gluten-free diet in adults, including 

recommendations for eligibility criteria, 

trial design features, efficacy 

evaluations, clinical outcome 

assessments, and safety assessments. 

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 ‘‘Celiac Disease: Developing Drugs 

for Adjunctive Treatment to a GlutenFree Diet.’’ 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 parts 50 and 58, 

21 CFR parts 312 and 314, and 21 CFR 

part 601 have been approved under 

OMB control numbers 0910–0130, 

0910–0014, 0910–0001, and 0910–0338 

respectively. 

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 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08116 Filed 4–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4367] 

Bioavailability Studies Submitted in 

NDAs or INDs—General 

Considerations; 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 final 

guidance for industry entitled 

‘‘Bioavailability Studies Submitted in 

NDAs or INDs—General 

Considerations.’’ This guidance 

provides recommendations to sponsors 

planning to include bioavailability (BA) 

information for drug products in 

investigational new drug applications 

(INDs), new drug applications (NDAs), 

and NDA supplements. This guidance 

finalizes the draft guidance of the same 

title issued on February 26, 2019. This 

guidance also replaces the draft 

guidance entitled ‘‘Bioavailability and 

Bioequivalence Studies Submitted in 

NDAs or INDs—General 

Considerations’’ issued March 2014. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 15, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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 


jspears on DSK121TN23PROD with NOTICES1