97624 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 

Estimated Total Annual Burden 

Hours: 4,058.68. 

Authority: 42 U.S.C. 653(m)(2) and 44 

U.S.C. 3554. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–28761 Filed 12–6–24; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–0481] 

Standardized Format for Electronic 

Submission of Marketing Application 

Content for the Planning of 

Bioresearch Monitoring Inspections for 

Center for Drug Evaluation and 

Research Submissions; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of the 

guidance for industry entitled 

‘‘Standardized Format for Electronic 

Submission of NDA and BLA Content 

for the Planning of Bioresearch 

Monitoring (BIMO) Inspections for 

CDER Submissions.’’ This guidance 

describes the electronic submission of 

certain data and information in 

standardized formats. This information 

is used by the Center for Drug 

Evaluation and Research (CDER) in the 

planning of, and by FDA’s Office of 

Inspections and Investigations (OII) in 

the conduct of, BIMO inspections. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 9, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2018–D–0481 for ‘‘Standardized Format 

for Electronic Submission of NDA and 

BLA Content for the Planning of 

Bioresearch Monitoring (BIMO) 

Inspections for CDER Submissions.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://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 

‘‘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 this 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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Emily Gebbia, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–0980. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Standardized Format for Electronic 

Submission of NDA and BLA Content 

for the Planning of Bioresearch 

Monitoring Inspections (BIMO) for 

CDER Submissions.’’ This guidance 

describes the electronic submission of 

certain data and information in 

standardized formats. CDER uses the 

data and information described in the 

guidance to plan BIMO inspections. The 

guidance addresses major (i.e., pivotal) 

studies used to support safety and 

efficacy claims in new drug applications 

(NDAs), biologic license applications 

(BLAs) regulated by CDER, as well as 

supplements containing new clinical 

study reports. 


ddrumheller on DSK120RN23PROD with NOTICES1
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