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Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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. This notice solicits comments on the information collection associated with safety assurance cases.


Submit either electronic or written comments on the collection of information by May 15, 2017.


You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or Start Printed Page 13818confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-0041 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:​regulatoryinformation/​dockets/​default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852,

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Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Safety Assurance Case—OMB Control Number 0910-0766—Extension

In January 2011, the Food and Drug Administration (FDA) announced its intention to evaluate the use of assurance cases as part of our Plan of Action to strengthen the 510(k) program following the publication of the draft guidance on infusion pumps (April 26, 2010, 75 FR 21632). The initial test assurance case focused on infusion pumps because the Infusion Pump Improvement Initiative was also exploring the use of assurance cases as a means of improving premarket review. The infusion pump assurance case beta testing included infusion pump devices classified under 21 CFR 880.5725.

The assurance case consists of a structured argument, supported by a body of valid scientific evidence that provides an organized and comprehensible case that the infusion pump is comparably safe for its intended use within its environment of use. The argument should be commensurate with the potential risk posed by the infusion pump, the complexity of the infusion pump, and the familiarity with the identified risks and mitigation measures.

Assurance cases are dependent on individual product specifications, hazards, design, and documentation. For this reason, assurance cases are considered to be device-specific, meaning any newly developed device would have its own unique assurance case. If the manufacturer submits a 510(k) for modifications to a legally marketed infusion pump for which no assurance case exists, FDA recommends that manufacturers develop and submit a case for their infusion pump.

Following the completion of the assurance case beta testing, FDA has written an Infusion Pump Total Life Cycle final guidance with recommendations for how manufacturers of infusion pumps should submit an assurance case with their premarket notification (510(k)) submissions. The guidance recommends that an assurance case demonstrate mitigation of infusion pump related hazardous situations through analysis of operational, environmental, electrical, hardware, software, mechanical, biological, chemical, and use hazards, as appropriate.

FDA is requesting extension of approval for the information collection requirements contained within an Start Printed Page 13819assurance case. The assurance case requires the device sponsor to explicitly describe how and why their device meets FDA regulatory requirements, as they relate to safety.

The respondents to this collection of information are infusion pump manufacturers subject to FDA's laws and regulations.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden 1

ActivityNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
Assurance Case Report311311123,472
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA's estimate of 31 respondents is based on the number of manufacturers of infusion pumps listed in FDA's Registration and Listing database (FURLS). The estimated average burden per response, 112 hours, is based on FDA's expectation of the amount of information that will be contained in the report, on public comment received regarding the burden, on consultation with stakeholders/industry, and on FDA's experience in the creation of an assurance case argument structures for use in the guidance. Our estimate also reflects that some information used to support the assurance case, such as activities conducted under existing design controls, is already covered in another information collection request (OMB control number 0910-0073) and is therefore not included in the burden estimate in this information collection request. The respondents to this collection of information are infusion pump manufacturers.

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Dated: March 9, 2017.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2017-05095 Filed 3-14-17; 8:45 am]