Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Notices 29789 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

RSS and RSS Set Aside Sub-grantee List ......................... 56 3 2 336 112 

Estimated Total Annual Burden 

Hours: 112. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Refugee Act of 1980 

[Immigration and Nationality Act, Title IV, 

Chapter 2 Section 412 (e)] and 45 CFR 

400.28. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–11653 Filed 6–2–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0391] 

Oral Drug Products Administered via 

Enteral Feeding Tube: In Vitro Testing 

and Labeling Recommendations; 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 ‘‘Oral 

Drug Products Administered Via Enteral 

Feeding Tube: In Vitro Testing and 

Labeling Recommendations.’’ This draft 

guidance provides recommendations for 

consistent in vitro testing of oral drug 

products to demonstrate their suitability 

to be administered via enteral tube. In 

addition, it supports the development of 

clear product-specific enteral tube 

administration instructions in labeling 

for administration to patients unable to 

ingest oral drug products. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 2, 2021 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–0391 for ‘‘Oral Drug Products 

Administered Via Enteral Feeding Tube: 

In Vitro Testing and Labeling 

Recommendations.’’ 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 


khammond on DSKJM1Z7X2PROD with NOTICES
29790 Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Notices 

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 Office of Policy, Guidance and 

Policy Development, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed 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: 

Amy Muhlberg, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg., 51, Rm. 3117, 

Silver Spring, MD 20993–0002, 240– 

402–6901; or Shanil Haugen, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg., 66, Rm. 2612, 

Silver Spring, MD 20993–0002, 301– 

796–0301. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Oral Drug Products Administered Via 

Enteral Feeding Tube: In Vitro Testing 

and Labeling Recommendations.’’ This 

draft guidance provides 

recommendations regarding in vitro 

testing of oral drug products, other than 

solutions, administered via enteral 

feeding tube (hereinafter enteral tube) 

that are subject to: (1) New drug 

applications (original or supplemental) 

where applicants are seeking and/or 

revising enteral tube administration 

instructions and related information in 

labeling; (2) abbreviated new drug 

applications where the reference listed 

drug contains enteral tube 

administration instructions and related 

information in labeling; and (3) 

investigational new drug applications 

where the investigational drug product 

is administered or planned for 

administration via enteral tube. 

Specifically, the draft guidance provides 

recommendations for consistent in vitro 

testing of oral drug products to 

demonstrate their suitability to be 

administered via enteral tube. In 

addition, it supports the development of 

clear, product-specific enteral tube 

administration instructions in labeling 

for administration to patients unable to 

ingest oral drug products. 

Enteral tubes are critical for patients 

who are unable to swallow oral dosage 

forms because of feeding disorders, 

severe intellectual disabilities, 

neurological disorders, cancers, and 

other medical conditions or therapies 

that compromise swallowing or the 

function of the proximal gastrointestinal 

system. It is critical that each drug 

administered via enteral tube is 

delivered at the correct dose in a 

manner that preserves the drug’s 

expected safety and efficacy profile and 

does not compromise the integrity of the 

tube. 

Some FDA-approved drug products 

marketed in the United States include 

instructions for enteral tube 

administration in their labeling. 

However, testing is not sufficiently 

widespread or consistent, and the 

content and format of labeling 

statements regarding administration of 

drug products via enteral tube vary. 

The Agency recognizes the need for 

consistent in vitro testing to ensure safe 

and effective delivery of drugs that may 

be administered via enteral tube and to 

identify drugs that cannot be 

administered through an enteral tube 

without altering the safety and 

effectiveness profile of the drug product 

or compromising the integrity of the 

tube. 

The draft guidance covers selection of 

appropriate enteral tubes for testing, 

selection of the dispersion media and 

preparation of the drug dispersion, and 

testing conditions and methods. 

Additional recommendations are given 

for modified release drug products. 

Completion of the recommended testing 

of a drug product prepared in the same 

manner as it will be prepared for 

administration to a patient in the 

clinical setting should allow applicants 

to demonstrate whether a drug product 

is suitable for enteral tube 

administration and identify drug 

products that are incompatible with 

enteral tube administration. 

Finally, the draft guidance covers how 

to summarize information regarding 

administration of the drug product via 

enteral tube in labeling, including 

example labeling statements for drug 

products that can be safely and 

effectively administered via enteral tube 

and labeling statements for drug 

products that are not recommended for 

administration via enteral tube. 

FDA requests comment from the 

public regarding the extent to which the 

recommendations in the guidance could 

be applicable to nonprescription 

products marketed under over-thecounter monographs that could be 

administered via enteral tube. 

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 ‘‘Oral Drug Products Administered 

Via Enteral Feeding Tube: In Vitro 

Testing and Labeling 

Recommendations.’’ 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 draft 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 (44 U.S.C. 3501–3521) is not 

required for this draft guidance. The 

previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. The collections of 

information in 21 CFR 201.56 and 

201.57 have been approved under OMB 

control number 0910–0572. 

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/ 

medical-devices/device-advicecomprehensive-regulatory-assistance/ 

guidance-documents-medical-devicesand-radiation-emitting-products, or 

https://www.regulations.gov. 

Dated: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11622 Filed 6–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Integrative Health; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


khammond on DSKJM1Z7X2PROD with NOTICES