Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices 65397 

• 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copies of the draft guidance to the 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 to 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: 

Jessica Dunn, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4214, 

Silver Spring, MD 20993–0002, 240– 

402–8985; or Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Alternative Tools: Assessing Drug 

Manufacturing Facilities Identified in 

Pending Applications.’’ This draft 

guidance provides information to 

applicants on how FDA intends to use 

alternative tools to assess manufacturing 

facilities identified in an NDA, an 

ANDA, a BLA, or a supplement to any 

of these types of applications. As part of 

the negotiations relating to the 

reauthorization of BsUFA and PDUFA, 

FDA agreed to issue guidance on the use 

of alternative tools to assess 

manufacturing facilities named in 

pending applications and to incorporate 

best practices from the use of such tools 

during the COVID–19 pandemic. This 

draft guidance, within the context of 

approval and licensure decisions by 

FDA, describes the use of alternative 

tools to assess manufacturing facilities 

identified in an NDA, an ANDA, or a 

BLA to establish that these facilities 

meet the applicable requirements, 

including under section 501(a)(2)(B) of 

the FD&C Act (21 U.S.C. 351(a)(2)(B)) 

and either section 505 of the FD&C Act 

(21 U.S.C. 355) or section 351 of the 

PHS Act (42 U.S.C. 262). 

During the pandemic, FDA expanded 

its use of alternative tools to evaluate 

drug manufacturing facilities to support 

regulatory decision making when 

facility inspections were not feasible. 

Given the success of these innovative 

approaches, FDA intends to continue 

risk-based use of these alternative tools 

and to apply certain virtual 

technological capabilities within a 

specific inspectional context defined 

within this draft guidance. When used 

in advance or in lieu of preapproval 

inspections (PAIs) and prelicense 

inspections (PLIs) or to support PAIs 

and PLIs, the appropriate use of these 

approaches will help FDA maintain 

operational flexibility to support timely 

facility evaluations and application 

decisions. 

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 ‘‘Alternative Tools: Assessing Drug 

Manufacturing Facilities Identified in 

Pending Applications.’’ 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. 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) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR parts 210 and 

211 pertaining to current good 

manufacturing practice requirements 

and electronic records and signatures 

have been approved under OMB control 

numbers 0910–0139 and 0910–0303, 

respectively. The collections of 

information in 21 CFR part 314 

pertaining to the submission of NDAs 

and ANDAs have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

part 601 pertaining to BLAs have been 

approved under OMB control number 

0910–0338. 

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: September 19, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20590 Filed 9–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0917] 

In-Home Disposal Systems for Opioid 

Analgesics; Request for Information; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 


lotter on DSK11XQN23PROD with NOTICES1
65398 Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

reopening the comment period for the 

notice entitled ‘‘In-Home Disposal 

Systems for Opioid Analgesics; Request 

for Information’’ published in the 

Federal Register of April 4, 2023. FDA 

is reopening the comment period to 

allow interested persons additional time 

to develop and submit comments. 

DATES: FDA is reopening the comment 

period on the notice published April 4, 

2023 (88 FR 19959). Either electronic or 

written comments must be submitted by 

November 6, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 6, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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–N–0917 for ‘‘In-Home Disposal 

Systems for Opioid Analgesics; Request 

for Information.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 4, 2023 (88 FR 

19959), FDA published a notice 

requesting information and comments 

that will assist the Agency in assessing 

whether in-home disposal products can 

be expected to meet the public health 

goal of mitigating the risk of nonmedical 

use or overdose if the Agency were to 

require drug manufacturers to make inhome disposal products available to 

patients under a risk evaluation and 

mitigation strategy. The Agency 

requested information and comments on 

the issues that were discussed at the 

public workshop convened by the 

National Academies of Sciences, 

Engineering, and Medicine’s Forum on 

Drug Discovery, Development, and 

Translation entitled ‘‘Defining and 

Evaluating In-Home Disposal Systems 

for Opioid Analgesics’’ on June 26 and 

27, 2023. Interested persons were 

originally given until August 28, 2023, 

to submit comments on in-home 

disposal systems for opioid analgesics. 

FDA is reopening the public docket to 

allow interested persons additional time 

to submit comments. We note that there 

is a listening session on October 5, 2023, 

with federally recognized American 

Indian and Alaska Native tribes on the 

safe disposal of opioid analgesics. The 

Agency believes that reopening the 

comment period for an additional 45 

days will allow adequate time for 

interested persons to submit comments 

without significantly delaying Agency 

decision-making on these important 

issues. FDA is reopening the comment 

period for 45 days, until November 6, 

2023. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20516 Filed 9–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 


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