Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1; Correction, 53448 [2019-21784]
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53448
Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
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Dated: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–21834 Filed 10–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2012–N–0477]
[Docket No. FDA–2019–N–3500]
Fit for Use Pilot Program Invitation for
the Clinical Data Interchange
Standards Consortium for Standard for
Exchange of Nonclinical Data
Implementation Guide: Version 3.1;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Tuesday, August 20, 2019.
The document announced a ‘‘Fit for Use
Pilot Program Invitation for the Clinical
Data Interchange Standards Consortium
for Standard for Exchange of
Nonclinical Data Implementation Guide:
Version 3.1.’’ The document was
published with the incorrect contact
name, phone number, and email address
in the FOR FURTHER INFORMATION
CONTACT section. This document
corrects those errors.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jesse Anderson, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
348–1816, Jesse.Anderson@fda.hhs.gov.
In FR Doc.
2019–17877, appearing on page 43139,
in the Federal Register of Tuesday,
August 20, 2019 (84 FR 43139), the
following correction is made:
On page 43140, in the first column, in
the FOR FURTHER INFORMATION CONTACT
section of the document, ‘‘Isaac Chang,
Office of Computational Science, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–4027501, PRAStaff@
fda.hhs.gov.’’ is corrected to read ‘‘Jesse
Anderson, Office of Computational
Science, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
348–1816, Jesse.Anderson@
fda.hhs.gov.’’
SUPPLEMENTARY INFORMATION:
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Fmt 4703
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is 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: Fax written comments on the
collection of information by November
6, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0078. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
[FR Doc. 2019–21784 Filed 10–4–19; 8:45 am]
18:29 Oct 04, 2019
AGENCY:
ACTION:
Correction.
Dated: September 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
VerDate Sep<11>2014
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10a.m.–12p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Investigational Device Exemptions
Reports and Records
OMB Control Number 0910–0078—
Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360j(g)) establishes the statutory
authority to collect information
regarding investigational devices and
establishes rules under which new
medical devices may be tested using
human subjects in a clinical setting. The
Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105–
E:\FR\FM\07OCN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Page 53448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21784]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3500]
Fit for Use Pilot Program Invitation for the Clinical Data
Interchange Standards Consortium for Standard for Exchange of
Nonclinical Data Implementation Guide: Version 3.1; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Tuesday, August 20, 2019. The
document announced a ``Fit for Use Pilot Program Invitation for the
Clinical Data Interchange Standards Consortium for Standard for
Exchange of Nonclinical Data Implementation Guide: Version 3.1.'' The
document was published with the incorrect contact name, phone number,
and email address in the FOR FURTHER INFORMATION CONTACT section. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Jesse Anderson, Office of
Computational Science, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993, 301-348-1816, [email protected].
SUPPLEMENTARY INFORMATION: In FR Doc. 2019-17877, appearing on page
43139, in the Federal Register of Tuesday, August 20, 2019 (84 FR
43139), the following correction is made:
On page 43140, in the first column, in the FOR FURTHER INFORMATION
CONTACT section of the document, ``Isaac Chang, Office of Computational
Science, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
4027501, [email protected].'' is corrected to read ``Jesse Anderson,
Office of Computational Science, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301-348-1816, [email protected].''
Dated: September 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21784 Filed 10-4-19; 8:45 am]
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