Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 97625 

To meet its review performance goals 

in accordance with CDER good review 

management principles and practices 

for products covered by the Prescription 

Drug User Fee Act, CDER generally 

initiates inspection planning early in 

the application review process (i.e., 

during the filing determination and 

review planning phase). CDER’s 

inspection planning includes the 

selection of clinical investigator sites 

and other regulated entities for on-site 

inspections, and the preparation of 

assignment memos and background 

packages that CDER provides to OII 

investigators, who perform FDA’s BIMO 

inspections. CDER uses the data and 

information described in this guidance 

to plan BIMO inspections, including: (1) 

to facilitate the timely identification of 

sites for inspection and (2) to ensure the 

availability of information needed to 

conduct BIMO inspections by OII 

investigators. 

This guidance finalizes the draft 

guidance entitled ‘‘Standardized Format 

for Electronic Submission of NDA and 

BLA Content for the Planning of 

Bioresearch Monitoring (BIMO) 

Inspections for CDER Submissions’’ 

issued on February 16, 2018 (83 FR 

7043). The draft guidance superseded 

the previously issued draft guidance for 

industry ‘‘Providing Submissions in 

Electronic Format—Summary Level 

Clinical Site Data for CDER’s Inspection 

Planning’’ issued on December 19, 2012 

(77 FR 75174). 

We reviewed all comments received 

on the draft guidance issued on 

February 16, 2018, and revised several 

sections of the guidance. The updates 

include: 

• Clarified, throughout the guidance, 

which NDA and BLA supplements the 

requirements in the guidance apply to. 

• Clarified that clinical sites that 

screened, consented, or enrolled trial 

participants are to be included in the 

table listing all clinical sites that 

participated in clinical studies. 

• Clarified that the request for a list 

of all entities that the sponsor has used 

to conduct clinical trial related activities 

includes both entities the sponsor has 

contracted without a transfer of 

regulatory obligations and those to 

whom the sponsor has transferred 

regulatory obligations. 

• Deleted specific directions related 

to eCTD formatting and optional 

submission of a BIMO Reviewer’s Guide 

and clarified that specifications for 

these items are now included in the 

technical specifications document. 

• Additional comments received, 

which were related to the technical 

specifications document ‘‘Bioresearch 

Monitoring Technical Conformance 

Guide,’’ have been addressed separately 

in prior revisions to that document. 

In section 745A(a) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

379k-1(a)), Congress granted explicit 

authorization to FDA to specify, in 

guidance, the electronic format for 

submissions under section 505(b), (i), or 

(j) of the FD&C Act (21 U.S.C. 355(b), (i), 

or (j)) and submissions under section 

351(a) or (k) of the Public Health Service 

Act (42 U.S.C. 262(a) or (k)). 

Accordingly, to the extent that this 

guidance provides such requirements, 

as indicated by the use of the words 

must or required, this guidance will not 

be subject to the usual restrictions in 

FDA’s good guidance practices 

regulations (GGPs), such as the 

requirement that guidances not establish 

legally enforceable responsibilities (see 

21 CFR 10.115(d); see also the guidance 

for industry ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Submissions Under Section 745A(a) of 

the Federal Food, Drug, and Cosmetic 

Act’’ issued on December 18, 2014 (79 

FR 75570)). 

To comply with GGPs and make sure 

that regulated entities and the public 

understand that guidance documents 

are nonbinding, FDA guidances 

ordinarily contain standard language 

explaining that guidance documents 

should be viewed only as 

recommendations unless specific 

regulatory or statutory requirements are 

cited. FDA is not including this 

standard language in this guidance 

document because it is not an accurate 

description of this guidance. Insofar as 

this guidance specifies the format for 

electronic submissions pursuant to 

section 745A(a) of the FD&C Act, 24 

months after the issuance of this 

guidance, electronic submission of 

certain data and information in the 

standardized formats described in the 

guidance will be required. 

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 part 312 relating 

to the submission of investigational new 

drug applications have been approved 

under OMB control number 0910–0014. 

The collections of information in 21 

CFR part 314 relating to the submission 

of new drug applications have been 

approved under OMB control number 

0910–0001. The collections of 

information contained in 21 CFR part 

601 relating to the submission of 

biologics license applications have been 

approved under OMB control number 

0910–0338. 

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.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 2, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28807 Filed 12–6–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5331] 

Joint Meeting of the Drug Safety and 

Risk Management Advisory Committee 

and the Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments— 

Extended-Release/Long-Acting Opioid 

Analgesic Postmarketing Requirement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Drug Safety and Risk 

Management Advisory Committee and 

the Anesthetic and Analgesic Drug 

Products Advisory Committee (the 

Committees). The general function of 

the Committees is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

February 5, 2025, from 8 a.m. to 5 p.m. 

Eastern Time. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

The public will also have the option to 

participate, and the advisory committee 

meeting will be heard, viewed, 

captioned, and recorded through an 

online teleconferencing and/or video 

conferencing platform. 


ddrumheller on DSK120RN23PROD with NOTICES1
97626 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 

Answers to commonly asked 

questions about FDA advisory 

committee meetings, including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–5331. 

The docket will close on February 4, 

2025. 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 February 4, 2025. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Comments received on or before 

January 22, 2025, will be provided to 

the Committees. Comments received 

after that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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– 

2024–N–5331 for ‘‘Joint Meeting of the 

Drug Safety and Risk Management 

Advisory Committee and the Anesthetic 

and Analgesic Drug Products Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments—ExtendedRelease/Long-Acting (ER/LA) Opioid 

Analgesic (OA) Postmarketing 

Requirement (PMR).’’ 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.’’ FDA 

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 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 the 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: 

Jessica Seo, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–7699, email: 

DSaRM@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. The Committees 

will discuss the findings of the 

completed ER/LA OA PMRs 3033–1 and 

3033–2 (link to Release and Reissue 

letter: https://www.fda.gov/media/ 

95546/download). 

These PMRs are prospective (3033–1) 

and retrospective (3033–2) 

epidemiologic studies that examined the 

serious risks and predictors of misuse, 

abuse, addiction, and fatal and non-fatal 

opioid overdose in patients with longterm use of opioid analgesics for 

management of chronic pain, including 

patients prescribed ER/LA OAs. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 97627 

teleconference and/or video conference 

meeting will be available at the location 

of the advisory committee meeting and 

at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The online presentation of 

materials will include slide 

presentations with audio and video 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committees. All electronic 

and written submissions to the Docket 

(see ADDRESSES) on or before January 22, 

2025, will be provided to the 

Committees. Oral presentations from the 

public will be scheduled between 

approximately between 1 p.m. and 2 

p.m. Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, whether they would like to 

present online or in-person, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 13, 2025. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. Similarly, room 

for interested persons to participate inperson may be limited. If the number of 

registrants requesting to speak in-person 

during the open public hearing is 

greater than can be reasonably 

accommodated in the venue for the inperson portion of the advisory 

committee meeting, FDA may conduct a 

lottery to determine the speakers who 

will be invited to participate in-person. 

The contact person will notify 

interested persons regarding their 

request to speak by January 14, 2025. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jessica Seo 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform in conjunction with 

the physical meeting room (see 

location). This waiver is in the interest 

of allowing greater transparency and 

opportunities for public participation, 

in addition to convenience for advisory 

committee members, speakers, and 

guest speakers. The conditions for 

issuance of a waiver under 21 CFR 10.19 

are met. 

Dated: December 2, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28811 Filed 12–6–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; HRSA Ryan White HIV/AIDS 

Program Part F Regional AIDS 

Education and Training Center 

Program Activities 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than January 8, 2025. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments,’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

HRSA Ryan White HIV/AIDS Program 

Part F Regional AIDS Education and 

Training Center Program Activities, 

OMB No. 0906–xxxx—New. 

Abstract: The Ryan White HIV/AIDS 

Program’s (RWHAP) AIDS Education 

and Training Center (AETC) Program, 

authorized under title XXVI of the 

Public Health Service Act, supports a 

network of regional centers that conduct 

targeted, multi-disciplinary education 

and training programs for health care 

providers treating people with HIV. The 

RWHAP Regional AETC Program’s 

purpose is to increase the number of 

health care providers who are 

effectively educated and equipped to 

counsel, diagnose, treat, and medically 

manage people with HIV. The RWHAP 

Regional AETC Program recipients are 

required to report data on the training 

activities and trainees to HRSA once a 

year. HRSA is requesting the approval of 

new AETC data collection forms to 

accurately capture data relating to 

Regional AETC activities, participants, 

and site information for both Practice 

Transformation (PT) and 

Interprofessional Education (IPE) sites 

as well as involvement in the HIV care 

and treatment workforce (1-year postparticipation), knowledge gained 

through participating in an activity, and 

satisfaction with the activity. The 

RWHAP Regional AETC Program 

recipients will gather data on the 

training activities they conduct using 

six data collection instruments. The 

Individual Participant Record is 

completed at least once every reporting 

period by participants actively engaging 

in Regional AETC activities. This form 

includes Regional AETC participant 

demographic, workplace, and clientsserved data for the participant’s 


ddrumheller on DSK120RN23PROD with NOTICES1