Notice2024-12354
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for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability
Primary source
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Published
June 5, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) 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 The draft guidance document and BIMO Technical Conformance Guide provide specifications for the electronic submission of certain data and information in standardized formats.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 The draft guidance addresses major (i.e., pivotal) studies used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs)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 This draft guidance, when finalized, will provide additional information regarding the format to be used for electronic submission of BLA and NDA content for the planning and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.
Full Text
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<title>Federal Register, Volume 89 Issue 109 (Wednesday, June 5, 2024)</title>
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[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48168-48170]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Submissions; Draft Guidance for Industry; Availability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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioresearch-monitoring-technical-conformance-guide">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioresearch-monitoring-technical-conformance-guide</a>.
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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 <a href="https://www.fda.gov/Drugs//GuidanceCompliance/Regulatory/Information/Guidances/default.htm">https://www.fda.gov/Drugs//GuidanceCompliance/Regulatory/Information/Guidances/default.htm</a>.
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 <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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