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copies of the draft guidance to the 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a draft guidance for industry entitled 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draft guidance provides 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Specifically, the draft guidance provides 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 


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Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Notices 29791 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Complementary and Integrative Health 

Special Emphasis Panel; ‘‘Limited 

Competition for the Continuation of a 

Multisite Clinical Trial Data Coordinating 

Center (Collaborative U24, Clinical Trial 

Optional)’’. 

Date: June 16, 2021. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Center for Complementary 

and Integrative Democracy II, 6707 

Democracy Blvd., Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Martina Schmidt, Ph.D., 

Chief, Office of Scientific Review, National 

Center for Complementary & Integrative 

Health, NIH, 6707 Democracy Blvd., Suite 

401, Bethesda, MD 20892, 301–594–3456, 

schmidma@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: May 27, 2021. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–11644 Filed 6–2–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; NINDS Special Review 

Group Contracts. 

Date: June 25, 2021. 

Time: 10:30 a.m. to 2:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: Marilyn Moore-Hoon, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Division of Extramural 

Activities, National Institute of Neurological 

Disorders and Stroke, Rockville, MD 20852, 

301–827–9087, mooremar@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: May 27, 2021. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–11640 Filed 6–2–21; 8:45 am] 

BILLING CODE 4140–01–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 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Complementary and Integrative Health 

Special Emphasis Panel; Early Phase Clinical 

Trials of Natural Products (NP). 

Date: July 15, 2021. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Center for Complementary 

and Integrative, Democracy II, 6707 

Democracy Blvd., Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Shiyong Huang, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, Division of Extramural Activities, 

NCCIH/NIH, 6707 Democracy Boulevard, 

Suite 401, Bethesda, MD 20817, 

shiyong.huang@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: May 27, 2021. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–11643 Filed 6–2–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Secretary; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Interagency Pain 

Research Coordinating Committee. 

The meeting will be open to the 

public. Individuals who plan to 

participate and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should notify the Contact Person listed 

below in advance of the meeting. 

Name of Committee: Interagency Pain 

Research Coordinating Committee. 

Date: July 6, 2021. 

Time: 1:30 p.m. to 4:30 p.m. Eastern Time 

(ET). 

Agenda: The meeting will cover committee 

business items including updates on NIH 

HEAL Initiative and Common Fund 

programs. It will include follow up of IPRCC 

recommendations and member updates. 

Webcast Live: http://videocast.nih.gov/. 

Deadline: Submission of intent to submit 

written/electronic statement for comments: 

Tuesday, June 29th, by 5:00 p.m. ET. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: Linda L. Porter, Ph.D., 

Director, Office of Pain Policy and Planning, 

Office of the Director, National Institute of 

Neurological Disorders and Stroke, NIH, 31 

Center Drive, Room 8A31, Bethesda, MD 

20892, Phone: (301) 451–4460, Email: 

Linda.Porter@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 


khammond on DSKJM1Z7X2PROD with NOTICES