82 FR 13817 - Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 49 (March 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 49 (March 15, 2017)
| Page Range | 13817-13819 | |
| FR Document | 2017-05095 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13817-13819] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05095] ----------------------------------------------------------------------- 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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. DATES: Submit either electronic or written comments on the collection of information by May 15, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov 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 [[Page 13818]] confidential 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 http://www.regulations.gov. 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 http://www.regulations.gov 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 http://www.regulations.gov. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: 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 [[Page 13819]] assurance 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Assurance Case Report.............................................. 31 1 31 112 3,472 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-05095 Filed 3-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13817
202–395–7285, or emailed to oira_ needs in the treatment of serious or life- burden for each submission will be
submission@omb.eop.gov. All threatening conditions: (1) Fast track approximately 30 hours to develop and
comments should be identified with the designation including rolling review, (2) submit to FDA as part of the application
OMB control number 0910–0765. Also Breakthrough therapy designation, (3) (totaling 2,400 hours).
include the FDA docket number found Accelerated approval, and (4) Priority Breakthrough Therapy Designation
in brackets in the heading of this review designation. In support of these, Request. The guidance describes the
document. the Agency has developed the guidance process for sponsors to request
FOR FURTHER INFORMATION CONTACT: FDA document, ‘‘GFI: Expedited Programs breakthrough therapy designation in an
PRA Staff, Office of Operations, Food for Serious Conditions—Drugs and application. Based on information from
and Drug Administration, Three White Biologics.’’ The guidance outlines the FDA’s databases and information
Flint North, 10A63, 11601 Landsdown programs’ policies and procedures and available to FDA, we estimate that
St., North Bethesda, MD 20852, describes applicable threshold criteria, approximately 87 sponsors will prepare
PRAStaff@fda.hhs.gov. including when to submit information approximately 1.29 breakthrough
SUPPLEMENTARY INFORMATION: In to FDA. Respondents to the information therapy designation submissions in
compliance with 44 U.S.C. 3507, FDA collection are sponsors of drug and accordance with the guidance and that
has submitted the following proposed biological products appropriate for these the added burden for each submission
collection of information to OMB for expedited programs. will be approximately 70 hours to
review and clearance. Priority Review Designation Request. prepare and submit (totaling 7,910
The guidance describes that a sponsor hours).
Guidance for Industry (GFI) on
Expedited Programs for Serious may expressly request priority review of In the Federal Register of November
Conditions—Drugs and Biologics an application. Based on information 29, 2016 (81 FR 85973), we published a
from FDA’s databases and information 60-day notice requesting public
OMB Control Number 0910–0765— available to FDA, we estimate that comment on the proposed extension of
Extension approximately 48 sponsors will prepare this collection of information. No
The FDA has established four and submit approximately 1.7 priority comments were received in response to
programs intended to facilitate and review designation submissions that the notice.
expedite development and review of receive a priority review in accordance FDA estimates the burden of this
new drugs to address unmet medical with the guidance and that the added collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Guidance on expedited programs responses per burden per Total hours
respondents responses
respondent response
Priority Review Designation Request .................................. 48 1.7 80 30 2,400
Breakthrough Therapy Designation Request ...................... 87 1.29 113 70 7,910
Total .............................................................................. ........................ ........................ ........................ ........................ 10,310
1 There are no capital costs or operating and maintenance costs associated with the information collection.
The guidance also refers to previously DEPARTMENT OF HEALTH AND public comment in response to the
approved collections of information HUMAN SERVICES notice. This notice solicits comments on
found in FDA regulations. The the information collection associated
collections of information in 21 CFR Food and Drug Administration with safety assurance cases.
parts 202.1, 314, and 601; sections [Docket No. FDA–2017–N–0041] DATES: Submit either electronic or
505(a), 506(a)(1), 735, and 736 of the written comments on the collection of
Federal Food, Drug, and Cosmetic Act Agency Information Collection information by May 15, 2017.
(21 U.S.C. 355(a), 356(a)(1), 379(g), and Activities; Proposed Collection; ADDRESSES: You may submit comments
379(h)) have been approved under OMB Comment Request; Safety Assurance as follows:
control numbers 0910–0686, 0910–0001, Case Electronic Submissions
0910–0338, 0910–0014, and 0910–0297. AGENCY: Food and Drug Administration, Submit electronic comments in the
Dated: March 9, 2017. HHS. following way:
Leslie Kux, ACTION: Notice. • Federal eRulemaking Portal: http://
Associate Commissioner for Policy. www.regulations.gov. Follow the
SUMMARY: The Food and Drug instructions for submitting comments.
[FR Doc. 2017–05104 Filed 3–14–17; 8:45 am]
Administration (FDA) is announcing an Comments submitted electronically,
BILLING CODE 4164–01–P
opportunity for public comment on the including attachments, to http://
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
proposed collection of certain www.regulations.gov will be posted to
information by the Agency. Under the the docket unchanged. Because your
Paperwork Reduction Act of 1995 comment will be made public, you are
(PRA), Federal Agencies are required to solely responsible for ensuring that your
publish notice in the Federal Register comment does not include any
concerning each proposed collection of confidential information that you or a
information, including each proposed third party may not wish to be posted,
extension of an existing collection of such as medical information, your or
information, and to allow 60 days for anyone else’s Social Security number, or
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![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13819
assurance case. The assurance case meets FDA regulatory requirements, as manufacturers subject to FDA’s laws
requires the device sponsor to explicitly they relate to safety. and regulations.
describe how and why their device The respondents to this collection of FDA estimates the burden of this
information are infusion pump collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
Activity burden per Total hours
respondents per responses response
respondent
Assurance Case Report ....................................................... 31 1 31 112 3,472
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of 31 respondents is Register of January 18, 2017. In the • If you want to submit a comment
based on the number of manufacturers notice, FDA requested comments on with confidential information that you
of infusion pumps listed in FDA’s ‘‘Considerations in Demonstrating do not wish to be made available to the
Registration and Listing database Interchangeability with a Reference public, submit the comment as a
(FURLS). The estimated average burden Product.’’ The Agency is taking this written/paper submission and in the
per response, 112 hours, is based on action in response to several requests for manner detailed (see ‘‘Written/Paper
FDA’s expectation of the amount of an extension to allow interested persons Submissions’’ and ‘‘Instructions’’).
information that will be contained in additional time to submit comments. Written/Paper Submissions
the report, on public comment received DATES: FDA is extending the comment
regarding the burden, on consultation Submit written/paper submissions as
period on the notice published January follows:
with stakeholders/industry, and on
FDA’s experience in the creation of an
18, 2017 (82 FR 5579). Submit either • Mail/Hand delivery/Courier (for
electronic or written comments by May written/paper submissions): Division of
assurance case argument structures for 19, 2017. Late, untimely filed comments
use in the guidance. Our estimate also Dockets Management (HFA–305), Food
will not be considered. Electronic and Drug Administration, 5630 Fishers
reflects that some information used to comments must be submitted on or
support the assurance case, such as Lane, Rm. 1061, Rockville, MD 20852.
before May 19, 2017. The https:// • For written/paper comments
activities conducted under existing www.regulations.gov electronic filing submitted to the Division of Dockets
design controls, is already covered in system will accept comments until Management, FDA will post your
another information collection request midnight Eastern Time at the end of comment, as well as any attachments,
(OMB control number 0910–0073) and May 19, 2017. Comments received by except for information submitted,
is therefore not included in the burden mail/hand delivery/courier (for written/ marked and identified, as confidential,
estimate in this information collection paper submissions) will be considered if submitted as detailed in
request. The respondents to this timely if they are postmarked or the ‘‘Instructions.’’
collection of information are infusion delivery service acceptance receipt is on Instructions: All submissions received
pump manufacturers. or before that date. must include the Docket No. FDA–
Dated: March 9, 2017. 2017–D–0154 for ‘‘Considerations in
ADDRESSES: You may submit comments
Leslie Kux, Demonstrating Interchangeability With a
as follows:
Associate Commissioner for Policy. Reference Product; Draft Guidance for
[FR Doc. 2017–05095 Filed 3–14–17; 8:45 am] Electronic Submissions Industry.’’ Received comments, those
BILLING CODE 4164–01–P
filed in a timely manner (see DATES),
Submit electronic comments in the will be placed in the docket and, except
following way: for those submitted as ‘‘Confidential
DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: Submissions,’’ publicly viewable at
HUMAN SERVICES https://www.regulations.gov. Follow the https://www.regulations.gov or at the
instructions for submitting comments. Division of Dockets Management
Food and Drug Administration Comments submitted electronically, between 9 a.m. and 4 p.m., Monday
including attachments, to https:// through Friday.
[Docket No. FDA–2017–D–0154] www.regulations.gov will be posted to • Confidential Submissions—To
the docket unchanged. Because your submit a comment with confidential
Considerations in Demonstrating
comment will be made public, you are information that you do not wish to be
Interchangeability With a Reference
solely responsible for ensuring that your made publicly available, submit your
Product; Draft Guidance for Industry;
comment does not include any comments only as a written/paper
Availability; Extension of Comment
confidential information that you or a submission. You should submit two
Period
third party may not wish to be posted, copies total. One copy will include the
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
AGENCY: Food and Drug Administration, such as medical information, your or information you claim to be confidential
HHS. anyone else’s Social Security number, or with a heading or cover note that states
ACTION:Notice of availability; extension confidential business information, such ‘‘THIS DOCUMENT CONTAINS
of comment period. as a manufacturing process. Please note CONFIDENTIAL INFORMATION.’’ The
that if you include your name, contact Agency will review this copy, including
SUMMARY: The Food and Drug information, or other information that the claimed confidential information, in
Administration (FDA or the Agency) is identifies you in the body of your its consideration of comments. The
extending the comment period for the comments, that information will be second copy, which will have the
notice that appeared in the Federal posted on https://www.regulations.gov. claimed confidential information
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Document Created: 2017-03-15 06:04:05
Document Modified: 2017-03-15 06:04:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by May 15, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 13817 |
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