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copies of the draft guidance to the 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
22538 Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Notices 

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– 

2018–D–4367 for ‘‘Bioavailability 

Studies Submitted in NDAs or INDs— 

General Considerations.’’ 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 this 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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Dakshina Chilukuri, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1515, Dakshina.Chilukuri@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Bioavailability Studies Submitted in 

NDAs or INDs—General 

Considerations.’’ Determining the BA of 

formulations is critical during the life 

cycle of drug products and aids in the 

FDA’s evaluation of the safety and 

effectiveness of a product in INDs, 

NDAs, or NDA supplements. This 

guidance provides recommendations to 

sponsors and applicants planning to 

include BA information for drug 

products in INDs, NDAs, and NDA 

supplements. This guidance contains 

recommendations on how to meet the 

BA requirements set forth in part 320 

(21 CFR part 320) as they apply to 

dosage forms intended for oral 

administration. The guidance is also 

applicable to non-orally administered 

drug products when it is appropriate to 

rely on systemic exposure measures to 

determine the BA of a drug (e.g., 

transdermal delivery systems and 

certain rectal and nasal drug products). 

The guidance provides 

recommendations on conducting 

relative BA studies during the 

investigational period for an NDA and 

bioequivalence (BE) studies during the 

postapproval period for certain changes 

to drug products with an approved 

NDA. 

This guidance finalizes the draft 

guidance entitled ‘‘Bioavailability 

Studies in NDAs or INDs—General 

Considerations’’ issued on February 26, 

2019 (84 FR 6148) (the 2019 draft 

guidance). When FDA issued the 2019 

draft guidance, FDA explained that the 

2019 draft guidance revised and 

replaced the draft guidance entitled 

‘‘Bioavailability and Bioequivalence 

Studies Submitted in NDAs or INDs— 

General Considerations’’ issued on 

March 2014 (the 2014 draft guidance) 

(84 FR 6148). FDA considered 

comments received on the 2014 draft 

guidance in preparing the 2019 draft 

guidance. FDA likewise considered 

comments received on the 2019 draft 

guidance as this guidance was finalized. 

Changes from the 2019 draft guidance to 

the final guidance include the 

following: (1) Specifying that individual 

pharmacokinetic profiles will be 

considered for products with complex 

release characteristics; (2) clarifying that 

if the drug labeling specifies the drug to 

be taken with food but does not 

elaborate on the fed conditions, the 

sponsor should use a high-fat meal as 

the fed condition; (3) adding statistical 

approaches for dissolution; (4) clarifying 

that enzymes can be added to the 

dissolution medium to better 

understand the effect of overencapsulation on drug release; and (5) 

removing the 10 percent alcohol level 

for dose-dumping studies. In addition, 

editorial changes were made 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 ‘‘Bioavailability 

Studies in NDAs or INDs—General 

Considerations.’’ 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. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Notices 22539 

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 314 relating to the submission 

of new drug applications, abbreviated 

new drug applications, and 

supplemental applications and the 

submission of requests to waive in vivo 

BA and BE requirements have been 

approved under OMB control number 

0910–0001. 

The collections of information in 21 

CFR part 312 relating to the submission 

of investigational new drug applications 

and BA/BE studies or pharmacogenomic 

data and the collections of information 

in part 320 for drug safety reporting 

have been approved under OMB control 

numbers 0910–0014 and 0910–0291. 

The collections of information in 21 

CFR parts 50 and 56 relating to the 

protection of human subjects and 

investigational review boards have been 

approved under OMB control number 

0910–0130. 

The collections of information in 21 

CFR 201.56 and 201.57 for the 

Requirements on Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products have been 

approved under OMB control number 

0910–0572. 

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.regulations.gov, or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08114 Filed 4–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Heritable Disorders in Newborns and 

Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces a 

public meeting of the Advisory 

Committee on Heritable Disorders in 

Newborns and Children (ACHDNC or 

Committee), authorized under section 

1111(g) of the Public Health Service Act, 

and the Federal Advisory Committee 

Act, on Thursday, May 12, 2022, and 

Friday, May 13, 2022. Information about 

the ACHDNC and the agenda for this 

meeting can be found on the ACHDNC 

website at https://www.hrsa.gov/ 

advisory-committees/heritabledisorders/index.html. 

DATES: Thursday, May 12, 2022, from 

10:00 a.m. to 3:20 p.m. Eastern Time 

(ET) and Friday, May 13, 2022, from 

10:00 a.m. to 12:40 p.m. ET. 

ADDRESSES: This meeting will be held 

via webinar. While this meeting is open 

to the public, advance registration is 

required. 

Please register online at https://

www.achdncmeetings.org/registration/ 

by the deadline of 12:00 p.m. ET on May 

11, 2022. Instructions on how to access 

the meeting via webcast will be 

provided upon registration. 

FOR FURTHER INFORMATION CONTACT: 

Alaina Harris, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Room 18W66, Rockville, 

Maryland 20857; 301–443–0721; or 

ACHDNC@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACHDNC 

provides advice and recommendations 

to the Secretary of Health and Human 

Services (Secretary) on the development 

of newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. ACHDNC reviews 

and reports regularly on newborn and 

childhood screening practices, 

recommends improvements in the 

national newborn and childhood 

screening programs, and fulfills 

requirements stated in the authorizing 

legislation. In addition, ACHDNC’s 

recommendations regarding inclusion of 

additional conditions for screening on 

the Recommended Uniform Screening 

Panel (RUSP), following adoption by the 

Secretary, are evidence-informed 

preventive health services provided for 

in the comprehensive guidelines 

supported by HRSA pursuant to section 

2713 of the Public Health Service Act 

(42 U.S.C. 300gg–13). Under this 

provision, non-grandfathered group 

health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance are 

required to provide insurance coverage 

without cost-sharing (a co-payment, coinsurance, or deductible) for preventive 

services for plan years (i.e., policy years) 

beginning on or after the date that is one 

year from the Secretary’s adoption of the 

condition for screening. 

During the May 12–13, 2022, meeting, 

ACHDNC will hear from experts in the 

fields of public health, medicine, 

heritable disorders, rare disorders, and 

newborn screening. Agenda items 

include the following: 

(1) Final evidence-based review report 

on the guanidinoacetate 

methyltransferase (GAMT) deficiency 

condition nomination for possible 

inclusion on the RUSP. Following this 

report, the ACHDNC expects to vote on 

whether to recommend the Secretary 

add GAMT deficiency to the RUSP; 

(2) An update on the Krabbe disease 

condition nomination; 

(3) A possible vote on whether to 

move Krabbe disease forward to full 

evidence-based review; 

(4) A presentation on homocystinuria 

newborn screening status; and 

(5) A presentation on the Newborn 

Screening Family Education Program. 

The agenda for this meeting includes 

a potential vote which may lead to a 

decision to recommend a nominated 

condition (GAMT deficiency) to the 

RUSP. In addition, as noted in the 

agenda items, the Committee may hold 

a vote on whether or not to recommend 

a nominated condition (Krabbe disease) 

to full evidence-based review, which 

may lead to a recommendation to add or 

not add a condition/conditions to the 

RUSP at a future time. 

Agenda items are subject to change as 

priorities dictate. Information about the 

ACHDNC, including a roster of members 

and past meeting summaries, is also 

available on the ACHDNC website listed 

above. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may request to 

provide general oral comments and may 

submit written statements in advance of 

the scheduled meeting. Oral comments 

will be honored in the order they are 

requested and may be limited as time 

allows. Subject to change: Members of 

the public registered to submit oral 


jspears on DSK121TN23PROD with NOTICES1