Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3; Correction, 77126-77127 [2022-27346]
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Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices
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-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 a single
hard copy of the draft guidance to the
Division of Operational Policy, Office of
Regulatory Affairs, Food and Drug
Administration, Element Building,
12420 Parklawn Drive, Rockville, MD
20857. Send one self-addressed
adhesive label to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Lola
Burford, Office of Regulatory Affairs,
Food and Drug Administration, Element
Building, 12420 Parklawn Dr.,
Rockville, MD 20857, Lola.Burford@
fda.hhs.gov, 240–402–5865.
SUPPLEMENTARY INFORMATION:
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FOR FURTHER INFORMATION CONTACT:
I. Background
On July 9, 2012, the Food and Drug
Administration Safety and Innovation
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Act (FDASIA) (Pub. L. 112–144) added
section 501(j) to the FD&C Act (21
U.S.C. 351(j)) to deem adulterated a
drug that ‘‘has been manufactured,
processed, packed, or held in any
factory, warehouse, or establishment
and the owner, operator, or agent of
such factory, warehouse, or
establishment delays, denies, or limits
an inspection, or refuses to permit entry
or inspection.’’ Section 707(b) of
FDASIA required the Food and Drug
Administration to issue guidance that
defined the circumstances that would
constitute delaying, denying, or limiting
inspection, or refusing to permit entry
or inspection, for purposes of section
501(j) of the FD&C Act. In the Federal
Register of October 22, 2014 (79 FR
63130), FDA announced the availability
of a guidance for industry entitled,
‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection’’
(hereinafter, 2014 guidance).
Subsequently, on August 18, 2017,
FDARA (Pub. L. 115–52) was signed
into law. Section 702 of FDARA
amended the scope of section 501(j) of
the FD&C Act to provide that, as the
case with drugs, devices are deemed to
be adulterated if an FDA inspection is
delayed, denied, limited, or refused by
the owner, operator, or agent of the
establishment at which the device is
manufactured, processed, packed, or
held. This draft guidance is intended to
update the 2014 final guidance to
incorporate devices and to explain the
circumstances that FDA would consider
to constitute delaying, denying, or
limiting inspection, or refusing to
permit entry or inspection, resulting in
a drug or device manufactured in the
facility being deemed adulterated. The
2014 guidance will remain in effect and
will continue to reflect FDA’s current
thinking regarding circumstances that
would constitute delaying, deny, or
limiting inspection, or refusing to
permit entry or inspection, for purposes
of 501(j) of the FD&C Act with respect
to drug inspections, until this draft
guidance is finalized.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’
and will supersede the 2014 guidance.
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
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II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/searchgeneral-and-cross-cutting-topicsguidance-documents, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug or Device Inspection’’
may send an email request to
ORAPolicyStaffs@fda.hhs.gov to receive
an electronic copy of the document.
Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27344 Filed 12–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1206]
Electronic Study Data Submission;
Data Standards; Support and
Requirement Begin for Study Data
Tabulation Model Version 1.7
Implementation Guide 3.3 and for
Define-Extensible Markup Language
Version 2.1; Requirement Ends for
Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice correction that appeared in the
Federal Register of August 20, 2020.
The document announced the
correction dates that the support and
requirement were to begin for version
1.7 of the Clinical Data Interchange
Standards Consortium (CDISC) Study
Data Tabulation Model (SDTM), and
version 3.3 of the SDTM
Implementation Guide (SDTMIG), and
for version 2.1 of the Define-Extensible
Markup Language (Define-XML). The
document erroneously provided the
SUMMARY:
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Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices
incorrect dates for these electronic study
data standards. This document corrects
those errors.
FOR FURTHER INFORMATION CONTACT:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993–
0002, 240–402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 20, 2020 (85
FR 51450), in FR Doc. 2020–18236, the
following correction is made:
On page 51450, in the second and
third columns, the last paragraph of the
document is corrected to read as
follows: ‘‘On page 40659, in the first
column, the last three sentences of the
document are corrected to read as
follows: Support for version 1.7 of the
CDISC SDTM, version 3.3 of the
SDTMIG, and version 2.1 of the DefineXML will begin on March 15, 2021, and
the date that the requirement begins will
be on March 15, 2022, for new drug
applications, abbreviated new drug
applications, and certain biologics
license applications. For certain
investigational new drug applications,
the date that requirement begins will be
March 15, 2023. Support and
requirement for version 1.3 of the CDISC
SDTM and version 3.1.3 of the SDTMIG
will end on March 15, 2021.’’
Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27346 Filed 12–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990-new]
Agency Information Collection
Request: 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
ACTION:
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In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before January 17, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990-New-30D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: National
Strategy for a Resilient Public Health
Supply Chain Paperwork Reduction Act
Clearance.
Type of Collection: New Father
Generic ICR.
OMB No. 0990-new—Administration
for Strategic Preparedness and
Response—Office of Strategy, Policy,
Planning, and Requirements.
Abstract: The Office of Strategy,
Policy, Planning, and Requirements,
within the Department of Health and
Human Services (HHS), Administration
for Strategic Preparedness and Response
(ASPR), is seeking OMB approval of a
SUMMARY:
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new Generic clearance. In July 2021, the
White House published the National
Strategy for a Resilient Public Health
Supply Chain (National Strategy), which
provides a strategic approach to design,
build, and sustain a long-term capability
in the United States to manufacture
supplies for future pandemics and
biological threats. HHS is working with
the White House and across the federal
interagency to launch a multiyear
implementation of the National Strategy
involving the identification and
coordination of measurable activities
across the U.S. government, State, Local,
Tribal, and Territorial (SLTT)
jurisdictions, and the private sector.
HHS is requesting a 3-year PRA
generic clearance for purposes of
implementation to engage with SLTTs,
trade groups, mixed cross-sector
audiences, non-governmental
organizations, manufacturers, academia,
healthcare providers and facilities, local
communities, and other partners to: gain
a better understanding of the public
health supply chain; develop future
strategic goals and recommendations for
building immediate and long-term
resilience through increased visibility,
agility, and robustness in the public
health supply chain to prepare for and
mitigate future public health
emergencies; and to ensure ASPR, HHS,
and the broader U.S. government have
current data and information to inform
program and policy decision-making.
Cross-sectoral engagement underpins
many of the interdependent
implementation activities. For example,
one such activity involves information
collection from SLTT partners on
facility, local, and state stockpiling
plans to ensure coordinated plans are in
place for a future public health
emergency. Other potential engagements
include, but are not limited to
questionnaires, stakeholder meetings,
requests for information, town hall
meetings, and workshops. Stakeholder
engagement frequency will vary
depending on the type of stakeholder
and the information collection needs.
Therefore, some engagements may only
occur once, while others may require a
series of recurring meetings.
E:\FR\FM\16DEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77126-77127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27346]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1206]
Electronic Study Data Submission; Data Standards; Support and
Requirement Begin for Study Data Tabulation Model Version 1.7
Implementation Guide 3.3 and for Define-Extensible Markup Language
Version 2.1; Requirement Ends for Study Data Tabulation Model Version
1.3 Implementation Guide 3.1.3; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
correction that appeared in the Federal Register of August 20, 2020.
The document announced the correction dates that the support and
requirement were to begin for version 1.7 of the Clinical Data
Interchange Standards Consortium (CDISC) Study Data Tabulation Model
(SDTM), and version 3.3 of the SDTM Implementation Guide (SDTMIG), and
for version 2.1 of the Define-Extensible Markup Language (Define-XML).
The document erroneously provided the
[[Page 77127]]
incorrect dates for these electronic study data standards. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, [email protected], or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 20, 2020
(85 FR 51450), in FR Doc. 2020-18236, the following correction is made:
On page 51450, in the second and third columns, the last paragraph
of the document is corrected to read as follows: ``On page 40659, in
the first column, the last three sentences of the document are
corrected to read as follows: Support for version 1.7 of the CDISC
SDTM, version 3.3 of the SDTMIG, and version 2.1 of the Define-XML will
begin on March 15, 2021, and the date that the requirement begins will
be on March 15, 2022, for new drug applications, abbreviated new drug
applications, and certain biologics license applications. For certain
investigational new drug applications, the date that requirement begins
will be March 15, 2023. Support and requirement for version 1.3 of the
CDISC SDTM and version 3.1.3 of the SDTMIG will end on March 15,
2021.''
Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27346 Filed 12-15-22; 8:45 am]
BILLING CODE 4164-01-P
