Document ID: FDA-2017-N-0041-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case; Withdrawal of Notice
Posted Date: 2017-08-07T04:00Z

[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, 
PRAStaff@fda.hhs.gov.

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]
 BILLING CODE 4164-01-P