Electronic Common Technical Document; Data Standards; Specifications for Electronic Common Technical Document Validation Criteria, 48431-48432 [2021-18587]
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48431
Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices
Ave., Bldg. 66, Rm. 1613, Silver Spring,
MD 20993–0002, 301–796–4908.
SUPPLEMENTARY INFORMATION:
I. Background
These draft device-specific guidance
documents provide performance criteria
for premarket notification (510(k))
submissions to support the optional
Safety and Performance Based Pathway,
as described in the guidance entitled
‘‘Safety and Performance Based
Pathway.’’ As described in that
guidance, substantial equivalence is
rooted in comparisons between new
devices and predicate devices. However,
the Federal Food, Drug, and Cosmetic
Act does not preclude FDA from using
performance criteria to facilitate this
comparison. If a legally marketed device
performs at certain levels relevant to its
safety and effectiveness, and a new
device meets those levels of
performance for the same
characteristics, FDA could find the new
device as safe and effective as the
legally marketed device. Instead of
reviewing data from direct comparison
testing between the two devices, FDA
could support a finding of substantial
equivalence with data demonstrating
the new device meets the level of
performance of an appropriate predicate
device(s). Under this optional Safety
and Performance Based Pathway, a
submitter could satisfy the requirement
to compare its device with a legally
marketed device by, among other things,
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These
guidance documents are also available
at https://www.regulations.gov and at
https://www.fda.gov/regulatory-
information/search-fda-guidancedocuments. Persons unable to download
an electronic copy of ‘‘Denture Base
Resins—Performance Criteria for Safety
and Performance Based Pathway; Draft
Guidance for Industry and Food and
Drug Administration Staff (document
number 20001)’’ or ‘‘Facet Screw
Systems—Performance Criteria for
Safety and Performance Based Pathway;
Draft Guidance for Industry and Food
and Drug Administration Staff
(document number 21001)’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While these guidance documents
contain no new collection of
information, they do refer to previously
approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulation and guidance have been
approved by OMB as listed in the
following table:
21 CFR part; guidance; or FDA form
Topic
807, subpart E ..............................................................................................................
‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’.
Premarket notification ...............................
Q-submissions; Pre-submissions .............
Dated: August 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18592 Filed 8–27–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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independently demonstrating that the
device’s performance meets
performance criteria as established in
the above-listed guidance documents,
when finalized, rather than using direct
predicate comparison testing for some of
the performance characteristics.
These draft guidance documents are
being issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidance
documents, when finalized, will
represent the current thinking of FDA
on performance criteria for the Safety
and Performance Based Pathway for
‘‘Denture Base Resins’’ and ‘‘Facet
Screw Systems.’’ They do not establish
any rights for any person and are not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
[Docket No. FDA–2018–D–1216]
Electronic Common Technical
Document; Data Standards;
Specifications for Electronic Common
Technical Document Validation Criteria
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
VerDate Sep<11>2014
18:40 Aug 27, 2021
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ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is announcing the date that FDA
will begin rejecting submissions that fail
either Electronic Common Technical
Document (eCTD) validation 1551 or
1553, which are high severity validation
errors as described in the Specifications
for eCTD Validation Criteria. Validation
errors 1551 and 1553 have been added
to the Specifications for eCTD
Validation Criteria.
DATES: Rejection for failing to pass
either eCTD validation 1551 or 1553
under a submission to CDER will begin
on October 18, 2021.
FOR FURTHER INFORMATION CONTACT:
Jonathan Resnick, Center for Drug
Evaluation and Research, Food and
SUMMARY:
PO 00000
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OMB control
No.
0910–0120
0910–0756
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3160,
Silver Spring, MD 20993–0002, 301–
796–7997, Jonathan.Resnick@
fda.hhs.gov.
FDA’s
CDER is issuing this Federal Register
notice to announce that eCTD
validations 1551 and 1553 have been
added to the Specifications for eCTD
Validation Criteria (available at https://
www.fda.gov/media/87056/download)
as high validation errors. Beginning
October 18, 2021, FDA will reject
submissions that fail either of these
validations.
Under section 745A(a) (21 U.S.C.
379k–1(a)) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act), at least
24 months after the issuance of a final
guidance document in which FDA has
SUPPLEMENTARY INFORMATION:
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48432
Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices
specified the electronic format for
submitting certain submission types to
the Agency, such content must be
submitted electronically and in the
format specified by FDA. According to
the guidance for industry ‘‘Providing
Regulatory Submissions in Electronic
Format—Certain Human Pharmaceutical
Product Applications and Related
Submissions Using the eCTD
Specifications’’ (available at https://
www.fda.gov/media/135373/download),
submissions subject to section 745A(a)
of the FD&C Act must be submitted in
eCTD format using the version of eCTD
currently supported by FDA (unless
such submission is exempt from the
electronic submission requirements or if
FDA has granted a waiver). The version
of eCTD currently supported by FDA is
specified in the Data Standards Catalog
(available at https://www.fda.gov/
industry/fda-resources-data-standards/
study-data-standards-resources).
As described in the guidance for
industry ‘‘Providing Regulatory
Submissions in Electronic and NonElectronic Format—Promotional
Labeling and Advertising Materials for
Human Prescription Drugs’’ (The
Promotional Labeling Guidance)
(available at https://www.fda.gov/
media/128163/download), certain types
of promotional-material-related
submissions, including postmarketing
submissions of promotional materials
using Form FDA 2253 (required by
§ 314.81(b)(3)(i) (21 CFR 314.81(b)(3)(i))
and 21 CFR 601.12(f)(4)) (called 2253
submissions), fall within the scope of
section 745A(a) of the FD&C Act and
are, therefore, subject to the mandatory
electronic submission requirements
(unless such submission is exempt from
the electronic submission requirements
or if FDA has granted a waiver). The
Promotional Labeling Guidance
provides that 2253 submissions are
required to be accompanied by a
completed fillable Form FDA 2253.
When submitting Form FDA 2253, firms
must submit the most current product
labeling, as required in § 314.81(b)(3)(i),
under eCTD section 1.14.6, as described
in the Promotional Labeling Guidance.
Electronic Common Technical
Document validations 1551 (‘‘2253
submission does not include Product
Labeling’’) and 1553 (‘‘The only valid
FDA Form to include in a 2253
submission is FDA Form 2253’’)
describe parts of the eCTD
specifications that were not followed
correctly (see the Specifications for
eCTD Validation Criteria, pp. 29 and 30,
respectively). Submissions to CDER that
are subject to section 745A(a) of the
FD&C Act and fail to pass either eCTD
VerDate Sep<11>2014
18:40 Aug 27, 2021
Jkt 253001
validation 1551 or 1553 will begin being
rejected on October 18, 2021.
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18587 Filed 8–27–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID 2021 DMID Omnibus
BAA (HHS–NIH–NIAID–BAA2021–01)
Research Area 001: Advanced Development
of Vaccine Candidates for Biodefense and
Emerging Infectious Diseases (1).
Date: September 20, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Frank S. De Silva, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3E72A, Rockville, MD
20852, (240) 669–5023, fdesilva@
niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases, Special
Emphasis Panel; NIAID 2021 DMID Omnibus
BAA (HHS–NIH–NIAID–BAA2021–01)
Research Area 001: Advanced Development
of Vaccine Candidates for Biodefense and
Emerging Infectious Diseases (2).
Date: September 22, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Frank S. De Silva, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3E72A, Rockville, MD
20852, (240) 669–5023, fdesilva@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 24, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–18564 Filed 8–27–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Agency Emergency Information
Collection Clearance Request for
Public Comment
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments on the information
collection request must be received on
or before 10 days of this published
notice.
SUMMARY:
When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted
within 10 days. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
ADDRESSES:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ms. Mikia P. Currie, Office of
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\30AUN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48431-48432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18587]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1216]
Electronic Common Technical Document; Data Standards;
Specifications for Electronic Common Technical Document Validation
Criteria
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is announcing the date that FDA
will begin rejecting submissions that fail either Electronic Common
Technical Document (eCTD) validation 1551 or 1553, which are high
severity validation errors as described in the Specifications for eCTD
Validation Criteria. Validation errors 1551 and 1553 have been added to
the Specifications for eCTD Validation Criteria.
DATES: Rejection for failing to pass either eCTD validation 1551 or
1553 under a submission to CDER will begin on October 18, 2021.
FOR FURTHER INFORMATION CONTACT: Jonathan Resnick, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 20993-0002, 301-
796-7997, [email protected].
SUPPLEMENTARY INFORMATION: FDA's CDER is issuing this Federal Register
notice to announce that eCTD validations 1551 and 1553 have been added
to the Specifications for eCTD Validation Criteria (available at
https://www.fda.gov/media/87056/download) as high validation errors.
Beginning October 18, 2021, FDA will reject submissions that fail
either of these validations.
Under section 745A(a) (21 U.S.C. 379k-1(a)) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act), at least 24 months after the
issuance of a final guidance document in which FDA has
[[Page 48432]]
specified the electronic format for submitting certain submission types
to the Agency, such content must be submitted electronically and in the
format specified by FDA. According to the guidance for industry
``Providing Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' (available at https://www.fda.gov/media/135373/download), submissions subject to section 745A(a) of the FD&C Act must
be submitted in eCTD format using the version of eCTD currently
supported by FDA (unless such submission is exempt from the electronic
submission requirements or if FDA has granted a waiver). The version of
eCTD currently supported by FDA is specified in the Data Standards
Catalog (available at https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources).
As described in the guidance for industry ``Providing Regulatory
Submissions in Electronic and Non-Electronic Format--Promotional
Labeling and Advertising Materials for Human Prescription Drugs'' (The
Promotional Labeling Guidance) (available at https://www.fda.gov/media/128163/download), certain types of promotional-material-related
submissions, including postmarketing submissions of promotional
materials using Form FDA 2253 (required by Sec. 314.81(b)(3)(i) (21
CFR 314.81(b)(3)(i)) and 21 CFR 601.12(f)(4)) (called 2253
submissions), fall within the scope of section 745A(a) of the FD&C Act
and are, therefore, subject to the mandatory electronic submission
requirements (unless such submission is exempt from the electronic
submission requirements or if FDA has granted a waiver). The
Promotional Labeling Guidance provides that 2253 submissions are
required to be accompanied by a completed fillable Form FDA 2253. When
submitting Form FDA 2253, firms must submit the most current product
labeling, as required in Sec. 314.81(b)(3)(i), under eCTD section
1.14.6, as described in the Promotional Labeling Guidance. Electronic
Common Technical Document validations 1551 (``2253 submission does not
include Product Labeling'') and 1553 (``The only valid FDA Form to
include in a 2253 submission is FDA Form 2253'') describe parts of the
eCTD specifications that were not followed correctly (see the
Specifications for eCTD Validation Criteria, pp. 29 and 30,
respectively). Submissions to CDER that are subject to section 745A(a)
of the FD&C Act and fail to pass either eCTD validation 1551 or 1553
will begin being rejected on October 18, 2021.
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18587 Filed 8-27-21; 8:45 am]
BILLING CODE 4164-01-P
