Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.8 With Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0; Correction, 30960 [2021-12198]
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30960
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12191 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0315]
Electronic Study Data Submission;
Data Standards; Support and
Requirement Begin for Study Data
Tabulation Model Version 1.8 With
Standard for Exchange of Nonclinical
Data Implementation Guide—Animal
Rule Version 1.0; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register on March 11, 2020. The
document announced that FDA will
begin supporting the Clinical Data
Interchange Standards Consortium
(CDISC) for Study Data Tabulation
Model version 1.8 (SDTM v1.8), and
CDISC Standard for Exchange of
Nonclinical Data Implementation
Guide—Animal Rule version 1.0
(SENDIG–AR v1.0) on March 15, 2020,
and that these new standards will be
required in submissions to FDA
effective March 15, 2022. The document
omitted the 36-month implementation
period for certain investigational new
drugs applications (INDs) as required by
the guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Standardized Study
Data’’ which is referenced in that
document. This document corrects that
error.
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: cderdatastandards@
fda.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
is corrected to read: ‘‘The Food
and Drug Administration (FDA or
Agency) Center for Drug Evaluation and
Research (CDER) is announcing that
FDA will begin supporting the Clinical
Data Interchange Standards Consortium
(CDISC) for Study Data Tabulation
Model version 1.8 (SDTM v1.8), and
CDISC Standard for Exchange of
Nonclinical Data Implementation
Guide—Animal Rule version 1.0
(SENDIG–AR v1.0) on March 15, 2020,
and that these new standards will be
required in submissions for studies that
start after March 15, 2022 (for new drug
applications (NDAs), abbreviated new
drug applications (ANDAs), and
biologics license applications (BLAs)),
and in submissions for studies that start
after March 15, 2023 (for certain
investigational new drug applications
(INDs)), that are submitted to CDER.’’
2. On page 14206, in the first column,
the last sentence of the document is
corrected to read as follows: ‘‘FDA will
begin supporting SDTM v1.8 and
SENDIG–AR v1.0 on March 15, 2020,
and the use of these new standards will
be required in Animal Rule 1
submissions for studies that start after
March 15, 2022 (for NDAs, ANDAs, and
BLAs), and in Animal Rule submissions
for studies that start after March 15,
2023 (for certain INDs), that are
submitted to CDER.’’
SUMMARY
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12198 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0362]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice for Finished
Pharmaceuticals, Including Medical
Gases, and Active Pharmaceutical
Ingredients
AGENCY:
Food and Drug Administration,
HHS.
SUPPLEMENTARY INFORMATION:
ACTION:
Correction
SUMMARY:
In the Federal Register of March 11,
2020 (85 FR 14205), in FR Doc. 2020–
04898, the following corrections are
made:
1. On page 14205, in the second
column, the first sentence of the
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
Notice.
The Food and Drug
Administration (FDA or we) is
1 The Animal Rule refers to FDA’s regulations for
the approval of new drugs and biological products
when human efficacy studies are not ethical or
feasible (see 21 CFR 314.600–650 for drugs and 21
CFR 601.90–95 for biologics).
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by July 12,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0139. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Current Good Manufacturing Practice
for Finished Pharmaceuticals,
Including Medical Gases, and Active
Pharmaceutical Ingredients—21 CFR
Parts 210 and 211 and 21 U.S.C
351(a)(2)(B)
OMB Control Number 0910–0139—
Extension
This information collection supports
FDA regulations that govern the
manufacture, processing, packing, or
holding of finished pharmaceuticals,
including medical gases, and active
pharmaceutical ingredients (APIs).
Under section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C 351(a)(2)(B)), a
drug is adulterated if the methods used
in, or the facilities or controls used for
its manufacture, processing, packing, or
holding do not conform to or are not
operated or administered in conformity
with current good manufacturing
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responsible for enforcing the FD&C Act
as well as related statutes, including the
Public Health Service Act. Congress
enacted these laws to ensure that
covered products meet applicable
requirements regarding the safety,
identity and strength, and the quality
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12198]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0315]
Electronic Study Data Submission; Data Standards; Support and
Requirement Begin for Study Data Tabulation Model Version 1.8 With
Standard for Exchange of Nonclinical Data Implementation Guide--Animal
Rule Version 1.0; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
document that appeared in the Federal Register on March 11, 2020. The
document announced that FDA will begin supporting the Clinical Data
Interchange Standards Consortium (CDISC) for Study Data Tabulation
Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of
Nonclinical Data Implementation Guide--Animal Rule version 1.0 (SENDIG-
AR v1.0) on March 15, 2020, and that these new standards will be
required in submissions to FDA effective March 15, 2022. The document
omitted the 36-month implementation period for certain investigational
new drugs applications (INDs) as required by the guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' which is referenced in that document. This
document corrects that error.
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: [email protected].
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of March 11, 2020 (85 FR 14205), in FR Doc.
2020-04898, the following corrections are made:
1. On page 14205, in the second column, the first sentence of the
SUMMARY is corrected to read: ``The Food and Drug Administration (FDA
or Agency) Center for Drug Evaluation and Research (CDER) is announcing
that FDA will begin supporting the Clinical Data Interchange Standards
Consortium (CDISC) for Study Data Tabulation Model version 1.8 (SDTM
v1.8), and CDISC Standard for Exchange of Nonclinical Data
Implementation Guide--Animal Rule version 1.0 (SENDIG-AR v1.0) on March
15, 2020, and that these new standards will be required in submissions
for studies that start after March 15, 2022 (for new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and biologics
license applications (BLAs)), and in submissions for studies that start
after March 15, 2023 (for certain investigational new drug applications
(INDs)), that are submitted to CDER.''
2. On page 14206, in the first column, the last sentence of the
document is corrected to read as follows: ``FDA will begin supporting
SDTM v1.8 and SENDIG-AR v1.0 on March 15, 2020, and the use of these
new standards will be required in Animal Rule \1\ submissions for
studies that start after March 15, 2022 (for NDAs, ANDAs, and BLAs),
and in Animal Rule submissions for studies that start after March 15,
2023 (for certain INDs), that are submitted to CDER.''
---------------------------------------------------------------------------
\1\ The Animal Rule refers to FDA's regulations for the approval
of new drugs and biological products when human efficacy studies are
not ethical or feasible (see 21 CFR 314.600-650 for drugs and 21 CFR
601.90-95 for biologics).
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12198 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P
