[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Notices]
[Pages 97624-97625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28807]


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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.

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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.

[[Page 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/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-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