[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Page 36792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16561]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0041]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Safety Assurance Case; Withdrawal of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a notice that was published in the Federal Register of
March 15, 2017.
DATES: August 7, 2017.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 15, 2017 (82 FR 13817), ``Agency Information
Collection Activities; Proposed Collection; Comment Request; Safety
Assurance Case,'' FDA requested comment on the information collection
associated with safety assurance cases (SACs).
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies
are required to publish notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, and to allow 60 days for
public comment in response to the notice.
In the March 15, 2017, Federal Register notice, FDA proposed to
extend the information collection related to SACs (OMB control number
0910-0766). However, we are withdrawing the notice because, upon
further review of the information collection request (ICR) associated
with the notice and comments received on the information collection, we
have determined that the estimated burden expressed in the SAC ICR is
included as part of the estimated burden for the information
collections in the premarket notification (510(k)) ICR (OMB control
number 0910-0120).
Because the information collected for safety assurance cases is
already included under another information collection approval, we have
discontinued the ICR and we are withdrawing the March 15, 2017, notice
requesting comment on the information collection.
The guidance entitled ``Infusion Pumps Total Product Life Cycle;
Guidance for Industry and FDA Staff'' (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm209337.pdf),
which provides recommendations on the inclusion of safety assurance
cases as part of the premarket submissions for new, changed, or
modified infusion pumps submitted by device manufacturers, continues to
provide the Agency's current thinking on this topic.
Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16561 Filed 8-4-17; 8:45 am]
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