73602 Federal Register / Vol. 88, No. 206 / Thursday, October 26, 2023 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4416] 

Remote Interactive Evaluations of Drug 

Manufacturing and Bioresearch 

Monitoring Facilities; Draft Guidance 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 ‘‘Remote 

Interactive Evaluations of Drug 

Manufacturing and Bioresearch 

Monitoring Facilities.’’ FDA is issuing 

this draft guidance to describe how we 

request and conduct voluntary remote 

interactive evaluations at facilities 

where drugs are manufactured, 

processed, packed, compounded, or 

held, and at facilities covered under 

FDA’s bioresearch monitoring program. 

FDA may consider the use of a remote 

interactive evaluation for any of the 

inspection program areas described in 

the guidance. FDA is also announcing 

the withdrawal of the guidance entitled 

‘‘Remote Interactive Evaluations of Drug 

Manufacturing and Bioresearch 

Monitoring Facilities During the 

COVID–19 Public Health Emergency.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 26, 2023 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draft guidance before it begins work on 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– 

2023–D–4416 for ‘‘Remote Interactive 

Evaluations of Drug Manufacturing and 

Bioresearch Monitoring Facilities.’’ 

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; 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; or 

the Policy and Regulations Staff (HFV– 

6), Center for Veterinary Medicine 

(CVM), Food and Drug Administration, 

7500 Standish Pl., Rockville, MD 20855. 

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: Tina 

Kiang, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 4374, Silver Spring, 

MD 20993–0002, 301–796–6487; or 

Anne Taylor, 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; or CVM at AskCVM@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Remote Interactive Evaluations of Drug 

Manufacturing and Bioresearch 

Monitoring Facilities.’’ FDA is issuing 

this draft guidance to describe how we 

request and conduct voluntary remote 

interactive evaluations at: (1) facilities 

where drugs are manufactured, 

processed, packed, or held; (2) facilities 

covered under FDA’s bioresearch 


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Federal Register / Vol. 88, No. 206 / Thursday, October 26, 2023 / Notices 73603 

monitoring program; and (3) 

outsourcing facilities registered under 

section 503B (21 U.S.C. 356b) of the 

FD&C Act. FDA may consider the use of 

a remote interactive evaluation for any 

of the inspection program areas 

described in the draft guidance. 

During the Coronavirus Disease 2019 

(COVID–19) pandemic, FDA expanded 

our use of alternative tools for 

evaluating drug manufacturing facilities 

to support regulatory decision-making. 

When an inspection was not feasible or 

practical because of the public health 

emergency (PHE), FDA used other 

available tools and information to 

support regulatory decisions and 

oversight of facilities. FDA announced 

its policy for using these alternative 

tools in a guidance entitled ‘‘Remote 

Interactive Evaluations of Drug 

Manufacturing and Bioresearch 

Monitoring Facilities During the 

COVID–19 Public Health Emergency’’ 

posted in April 2021 and announced in 

the Federal Register on May 27, 2021 

(86 FR 28627) (‘‘2021 COVID–19 Remote 

Interactive Evaluations Guidance’’). 

FDA issued the guidance to 

communicate its policy for the duration 

of the COVID–19 PHE declared by the 

Secretary of Health and Human Services 

(HHS) on January 31, 2020, including 

any renewals made by the HHS 

Secretary in accordance with section 

319(a)(2) of the Public Health Service 

Act (42 U.S.C. 247d(a)(2)). Furthermore, 

in the Federal Register of March 13, 

2023 (88 FR 15417) FDA listed the: (1) 

guidances that will no longer be 

effective with the expiration of the PHE 

declaration, (2) guidances that FDA was 

revising to continue in effect for 180 

days after the expiration of the PHE 

declaration to provide a period for 

stakeholder transition and then would 

no longer be in effect, and (3) guidances 

that FDA was revising to continue in 

effect for 180 days after the expiration 

of the PHE declaration during which 

time FDA planned to further revise the 

guidances. The 2021 COVID–19 Remote 

Interactive Evaluations Guidance is 

included in the latter category and was 

revised to remain in effect for 180 days 

post expiration of the PHE declaration. 

Although the HHS Secretary of has 

announced that the COVID–19 public 

health emergency declaration has ended 

and FDA has largely resumed 

inspections, FDA has determined that 

continued use of alternative tools, 

including remote interactive 

evaluations, based on risk and program 

needs, will enhance our ability to assess 

facilities. 

This draft guidance describes the 

various remote interactive tools we may 

request to use to conduct an evaluation. 

In this draft guidance, we refer to our 

use of any combination of these 

interactive tools as a remote interactive 

evaluation. FDA may request to conduct 

a remote interactive evaluation prior to 

or following other types of regulatory 

oversight activities (e.g., an inspection 

or a request for records or other 

information). In preparing this draft 

guidance, FDA considered comments 

received on the 2021 COVID–19 Remote 

Interactive Evaluations Guidance. 

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 ‘‘Remote Interactive Evaluations of 

Drug Manufacturing and Bioresearch 

Monitoring Facilities.’’ 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. 

FDA also is announcing that the 2021 

COVID–19 Remote Interactive 

Evaluations Guidance will be 

withdrawn upon publication of this 

draft guidance. FDA has determined 

that the 2021 COVID–19 Remote 

Interactive Evaluations Guidance is no 

longer needed because this new draft 

guidance is available and its 

recommendations, when finalized, will 

be applicable outside the context of the 

COVID–19 public health emergency. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA). The 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

part 58 pertaining to good laboratory 

practices have been approved under 

OMB control number 0910–0119. The 

collection of information pertaining to 

current good manufacturing practices 

have been approved under OMB control 

number 0910–0139. The collections of 

information relating to the registration 

of human drug compounding 

outsourcing facilities under section 

503B of the FD&C Act and associated 

fees under section 744K of the FD&C 

Act (21 U.S.C. 379j–62) have been 

approved under OMB control number 

0910–0776. The collections of 

information pertaining to human drug 

compounding under sections 503A (21 

U.S.C. 356a) and 503B of the FD&C Act 

have been approved under OMB control 

number 0910–0800. The collections of 

information in 21 CFR part 11 have been 

approved under OMB control number 

0910–0303. The collections of 

information in 21 CFR parts 50 and 56 

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/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: October 23, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23677 Filed 10–25–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 1009 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01 Clinical 

Trial Not Allowed). 

Date: November 15, 2023. 

Time: 10:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892 (Virtual Meeting). 


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