[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48168-48170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2221]


Standardized Format for Electronic Submission for Marketing 
Applications Content for the Planning of Bioresearch Monitoring 
Inspections for Center for Biologics Evaluation and Research 
Submissions; Draft Guidance for Industry; Availability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 Agency) is

[[Page 48169]]

announcing the availability of a draft document entitled ``Standardized 
Format for Electronic Submission for Marketing Applications Content for 
the Planning of Bioresearch Monitoring (BIMO) Inspections for Center 
for Biologics Evaluation and Research Submissions.'' The draft guidance 
document and BIMO Technical Conformance Guide provide specifications 
for the electronic submission of certain data and information in 
standardized formats. This information is used by FDA's Center for 
Biologics Evaluation and Research (CBER) in the planning of, and by 
FDA's Office of Regulatory Affairs (ORA) in the conduct of, BIMO 
inspections. The draft guidance addresses major (i.e., pivotal) studies 
used to support safety and efficacy claims in biologics license 
applications (BLAs) and new drug applications (NDAs) regulated by CBER, 
as well as certain supplemental applications containing new clinical 
study reports. This draft guidance, when finalized, will provide 
additional information regarding the format to be used for electronic 
submission of BLA and NDA content for the planning and conduct of CBER 
BIMO inspections, using the electronic Common Technical Document.

DATES: Submit either electronic or written comments on the draft 
guidance by August 5, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2024-D-2221 for ``Standardized Format for Electronic Submission for 
Marketing Applications Content for the Planning of Bioresearch 
Monitoring (BIMO) Inspections for Center for Biologics Evaluation and 
Research Submissions.'' 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 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 the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica Gillum, 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Standardized Format for Electronic Submission for Marketing 
Applications Content for the Planning of Bioresearch Monitoring (BIMO) 
Inspections for Center for Biologics Evaluation and Research 
Submissions.'' The draft guidance document and BIMO Technical 
Conformance Guide \1\ provide specifications for the electronic 
submission of certain data and information in standardized formats. 
This information is used by CBER in the planning of, and by ORA in the 
conduct of, BIMO inspections. The draft

[[Page 48170]]

guidance addresses major (i.e., pivotal) studies used to support safety 
and efficacy claims in BLAs and NDAs regulated by CBER, as well as 
certain supplemental applications containing new clinical study 
reports.
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    \1\ The current version of the Bioresearch Monitoring Technical 
Conformance Guide is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioresearch-monitoring-technical-conformance-guide.
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    To meet its review performance goals in accordance with CBER good 
review management principles and practices for products covered by the 
Prescription Drug User Fee Act, CBER generally initiates inspection 
planning early in the application review process (i.e., during the 
filing determination and review planning phase). CBER's inspection 
planning includes the selection of clinical investigator sites and 
other regulated entities for onsite inspections, and the preparation of 
assignment memos and background packages that CBER provides to FDA's 
ORA, which performs FDA's BIMO inspections. CBER 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 ORA investigators.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (GGP) regulation (21 CFR 10.115). However, in 
section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C 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, when finalized, 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 GGP regulations, such 
as the requirement that guidances not establish legally enforceable 
responsibilities (see 21 CFR 10.115(d); see also the guidance for 
industry entitled ``Providing Regulatory Submissions in Electronic 
Format--Submissions Under Section 745A(a) of the Federal Food, Drug, 
and Cosmetic Act,'' available at https://www.fda.gov/Drugs//GuidanceCompliance/Regulatory/Information/Guidances/default.htm.
    To comply with GGP regulations 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, when 
finalized, it will have binding effect.
    The draft guidance, when finalized, and the BIMO Technical 
Conformance Guide will represent the current thinking of FDA on 
standardized format for electronic submission of BLA and NDA content 
for the planning of BIMO inspections for CBER submissions.

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 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; and the collections of 
information in 21 CFR part 601 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12354 Filed 6-4-24; 8:45 am]
BILLING CODE 4164-01-P