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, 51450 [2020-18236]
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51450
Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Notices
Customer/Partner Service Surveys
OMB Control Number 0910–0360—
Extension
Under section 1003 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the Agency.
Executive Order 12862, entitled ‘‘Setting
Customer Service Standard,’’ directs
Federal Agencies that ‘‘provide
significant services directly to the
public’’ to ‘‘survey customers to
determine the kind and quality of
services they want and their level of
satisfaction with existing services.’’ FDA
is seeking extension of an existing OMB
clearance to conduct a series of surveys
to implement Executive Order 12862.
Participation in the surveys is
voluntary. This request covers
customer/partner service surveys of
regulated entities, such as food
processors; cosmetic, drug, biologic, and
medical device manufacturers;
consumers; and health professionals.
The request also covers ‘‘partner’’ (State
and local governments) customer
service surveys.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness and accuracy of
information, courtesy, and problem
resolution in the context of individual
programs.
FDA estimates conducting 15
customer/partner service surveys per
year, each requiring an average of 15
minutes for review and completion. We
estimate respondents to these surveys to
be between 100 and 20,000 customers.
Some of these surveys will be repeats of
earlier surveys for purposes of
monitoring customer/partner service
and developing long-term data.
Respondents to this collection of
information cover a broad range of
stakeholders who have specific
characteristics related to certain
products or services regulated by FDA.
In the Federal Register of January 21,
2020 (85 FR 3389), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of survey
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Mail, telephone, web-based .................................................
55,000
1
55,000
0.25 (15
minutes)
1 There
Dated: August 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18244 Filed 8–19–20; 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
jbell on DSKJLSW7X2PROD with NOTICES
Food and Drug Administration,
HHS.
ACTION:
13,750
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Total hours
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
document that appeared in the Federal
Register of July 7, 2020. The document
SUMMARY:
VerDate Sep<11>2014
18:01 Aug 19, 2020
Jkt 250001
announced the dates that support and
requirement will begin for version 1.7 of
the Clinical Data Interchange Standards
Consortium (CDISC) for Study Data
Tabulation Model (SDTM)
Implementation Guide (IG) 3.3, and for
version 2.1 of the Define-Extensible
Markup Language (Define-XML). The
document provided the 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, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 7, 2020 (85 FR
40658), in FR Doc. 2020–14512, the
following correction is made:
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 IG 3.3 and version 2.1 of the
Define-XML will begin on March 15,
2021, and the date that the requirement
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
begins for CDISC version 1.7 SDTM IG
3.3 and version 2.1 of the Define-XML
for new drug applications, abbreviated
new drug applications, certain biologics
license applications, and
noncommercial investigational new
drug applications will be March 15,
2022. Support and requirement for
version 1.3 of the CDISC SDTM IG 3.1.3
will end on March 15, 2021.’’
Dated: August 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–18236 Filed 8–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6098]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration-Regulated Products)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\20AUN1.SGM
Notice.
20AUN1
]]>Agencies
[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Page 51450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18236]
-----------------------------------------------------------------------
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
document that appeared in the Federal Register of July 7, 2020. The
document announced the dates that support and requirement will begin
for version 1.7 of the Clinical Data Interchange Standards Consortium
(CDISC) for Study Data Tabulation Model (SDTM) Implementation Guide
(IG) 3.3, and for version 2.1 of the Define-Extensible Markup Language
(Define-XML). The document provided the 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, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 7, 2020 (85
FR 40658), in FR Doc. 2020-14512, the following correction is made:
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 IG 3.3 and version 2.1 of the Define-XML will begin on
March 15, 2021, and the date that the requirement begins for CDISC
version 1.7 SDTM IG 3.3 and version 2.1 of the Define-XML for new drug
applications, abbreviated new drug applications, certain biologics
license applications, and noncommercial investigational new drug
applications will be March 15, 2022. Support and requirement for
version 1.3 of the CDISC SDTM IG 3.1.3 will end on March 15, 2021.''
Dated: August 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18236 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P
