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for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry; Availability, 48168-48170 [2024-12354]
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48168
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Tribal Maternal, Infant, and
Early Childhood Home Visiting
Program: Guidance for Submitting
Reports (Office of Management and
Budget#: 0970–0409)
Office of Early Childhood
Development, Administration for
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Early Childhood Development (ECD) is
requesting revisions to the Tribal
Maternal, Infant, and Early Childhood
Home Visiting (MIECHV) Program:
Guidance for Submitting Reports (Office
of Management and Budget (OMB)#:
0970–0409; expiration March 31, 2026)
and a 3-year extension of approval.
DATES: Comments due August 5, 2024.
In compliance with the requirements of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUMMARY:
Description: Section 511(e)(8)(A) of
title V of the Social Security Act
requires that grantees under the
MIECHV program for states and
jurisdictions submit an annual report to
the Secretary of Health and Human
Services regarding the program and
activities carried out under the program,
including such data and information as
the Secretary shall require. Section
511(h)(2)(A) further states that the
requirements for the MIECHV grants to
Tribes, Tribal organizations, and urban
Indian organizations are to be
consistent, to the greatest extent
practicable, with the requirements for
grantees under the MIECHV program for
states and jurisdictions.
ECD, in collaboration with the Health
Resources and Services Administration,
Maternal and Child Health Bureau
awarded grants for the Tribal MIECHV
Program (Tribal Home Visiting) to
support cooperative agreements to
conduct community needs assessments;
plan for and implement high-quality,
culturally relevant, evidence-based
home visiting programs in at-risk Tribal
communities; establish, measure, and
report on progress toward meeting
performance measures in six
legislatively mandated benchmark areas;
and participation in research and
evaluation activities to build the
knowledge base on home visiting among
Native populations.
After the first grant year, Tribal Home
Visiting grantees must comply with the
requirement to submit an Annual Report
to the Secretary that should feature
activities carried out under the program
during the past reporting period. To
assist grantees with meeting these
requirements, ACF created guidance for
grantees to use when writing their
annual reports. The guidance specifies
that grantees must address the
following:
• Update on the implementation of the
Home Visiting Program in targeted
community(ies)
• Update on the collection, reporting,
and use of data
• Progress toward fidelity monitoring,
program management, and
improvement
• Update on contribution to MIECHV
Learning Agenda through
participation in research and
evaluation projects
• Dissemination
• Technical Assistance Supports
Previously, the guidance included
information about both the annual and
the final reports from grantees. This
extension request includes updates to
the guidance to make it specific to just
the annual reports. Guidance specific to
the final report may be submitted for
review and approval by OMB in the
future. A comment period will
accompany that request.
Respondents: Tribal Home Visiting
Managers (information collection does
not include direct interaction with
individuals or families that receive the
services).
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual number
of responses
per respondent
Average
burden hours
per response
Annual
burden hours
Guidance for Submitting Annual reports ...............................................................
51
1
25
1,275
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
VerDate Sep<11>2014
16:50 Jun 04, 2024
Jkt 262001
Authority: Title V of the Social
Security Act, sections 511(e)(8)(A) and
511(h)(2)(A).
Mary C. Jones,
ACF/OPRE Certifying Officer.
PO 00000
Food and Drug Administration
[Docket No. FDA–2024–D–2221]
[FR Doc. 2024–12301 Filed 6–4–24; 8:45 am]
BILLING CODE 4184–77–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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05JNN1
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
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.
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.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
khammond on DSKJM1Z7X2PROD with NOTICES
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.
VerDate Sep<11>2014
16:50 Jun 04, 2024
Jkt 262001
• 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
PO 00000
Frm 00028
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48169
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-201509-18/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
1 The current version of the Bioresearch
Monitoring Technical Conformance Guide is
available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/
bioresearch-monitoring-technical-conformanceguide.
E:\FR\FM\05JNN1.SGM
05JNN1
khammond on DSKJM1Z7X2PROD with NOTICES
48170
Federal Register / Vol. 89, No. 109 / Wednesday, June 5, 2024 / Notices
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.
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
VerDate Sep<11>2014
16:50 Jun 04, 2024
Jkt 262001
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-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–5021]
Processes and Practices Applicable to
Bioresearch Monitoring Inspections;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Processes and Practices Applicable to
Bioresearch Monitoring Inspections.’’
The draft guidance is being issued to
comply with the Food and Drug
Omnibus Reform Act of 2022, which
directs the Agency to issue guidance
describing the processes and practices
applicable to inspections of sites and
facilities inspected under FDA’s
Bioresearch Monitoring inspection
program, to the extent not specified in
existing publicly available FDA guides
and manuals. The draft guidance is
intended to cover the following: the
types of records and information
required to be provided, best practices
for communication between FDA and
industry in advance of or during an
inspection or request for records or
other information, and other
inspections-related conduct.
SUMMARY:
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.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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’’).
E:\FR\FM\05JNN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
