81 FR 72593 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pre-Submission Program for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 203 (October 20, 2016)

Page Range		72593-72594
FR Document		2016-25359

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.

Federal Register, Volume 81 Issue 203 (Thursday, October 20, 2016)

[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72593-72594]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Pre-Submission 
Program for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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 21, 2016.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0756. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Pre-Submission Program for Medical Devices--OMB Control Number 0910-
0756--Extension

    The guidance entitled ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' describes the Pre-Submission program for medical 
devices reviewed in the Center for Devices and Radiological Health 
(CDRH) and the Center for Biologics Evaluation and Research (CBER). The 
guidance provides recommendations regarding the information that should 
be submitted in a Pre-Submission package and procedures that should be 
followed for meetings between CDRH and CBER staff and industry 
representatives or application sponsors. In addition to Pre-
Submissions, the guidance addresses other feedback mechanisms including 
Informational Meetings, Study Risk Determinations, Formal Early 
Collaboration Meetings, and Submission Issue Meetings and the 
procedures to request feedback using these mechanisms.
    A Pre-Submission is defined as a formal written request from an 
applicant for feedback from FDA to be provided in the form of a formal 
written response or, if the manufacturer chooses, a meeting or 
teleconference in which the feedback is documented in meeting minutes. 
A Pre-Submission is appropriate when FDA's feedback on specific 
questions is necessary to guide product development and/or application 
preparation. The proposed collections of information are necessary to 
allow the Agency to receive Pre-Submission packages in order to 
implement this voluntary submission program.
    For clarity, we are requesting that the title of the information 
collection request, OMB control number 0910-0756, be changed to ``Pre-
Submission Program for Medical Devices.''
    In the Federal Register of July 28, 2016 (81 FR 49678), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 72594]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
           FDA center                Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
CDRH............................           2,465               1           2,465             137         337,705
CBER............................              79               1              79             137          10,823
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         348,528
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents are medical device manufacturers subject to FDA's laws 
and regulations. FDA's annual estimate of 2,544 submissions is based on 
experienced trends over the past several years. FDA's administrative 
and technical staffs, who are familiar with the requirements for 
current Pre-Submissions, estimate that an average of 137 hours is 
required to prepare a Pre-Submission.

    Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25359 Filed 10-19-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices 72593

long-term care ombudsman programs a reporting entry. These suggestions A reporting form and instructions
are housed within an umbrella agency, were helpful and were incorporated into may be viewed in the ombudsman
this also increases the likelihood that the instructions and form. They did not section of the AoA Web site: http://
state programs have multiple affect the estimated burden. www.aoa.acl.gov/AoA_Programs/Elder_
organizational conflicts that must be NASOP also recommended that AoA/ Rights/Ombudsman/index.aspx. AoA
identified, remedied or removed, and ACL add a reporting option in a check estimates the burden of this collection
reported via NORS. box to indicate a state has identified a and entering the additional report
In response to NASOP’s concerns conflict, but the conflict has not been information as follows: Approximately
about burden estimates, we made a remedied. We do not intend to take this
10 to 60 minutes per respondent,
change in our estimated burden hours recommendation because it would be
depending on the number of conflicts to
from one-half hour per state to one hour contrary to the rule and law which
require states to identify, remove or report, with 52 state Ombudsman
per state.
NASOP requested additions to the remedy conflicts and to report on such programs responding annually. This
instructions and report form such as the remedies. ACL is providing on-going brings the total burden hours to
ability to certify that there was no technical assistance to states on the approximately 7,753 hours, (149 hours
change in conflicts/remedies from the implementation of the Ombudsman on average per program) with 52 Offices
previous reporting year; and to allow for program rule, including technical of Long-Term Care Ombudsman
the ability to report a conflict and assistance on conflicts of interest and programs responding annually.
remedy that applies to many entities as steps to remedy any identified conflicts.

Local Ombudsman Office of state Total burden
Summary 52 Programs
programs Ombudsman hours

Hours ................................................................................... 132.1 17 149.1 7,753 hours.

Dated: October 12, 2016. OMB, Attn: FDA Desk Officer, FAX: application sponsors. In addition to Pre-
Edwin L. Walker, 202–395–7285, or emailed to oira_ Submissions, the guidance addresses
Acting Administrator and Assistant Secretary submission@omb.eop.gov. All other feedback mechanisms including
for Aging. comments should be identified with the Informational Meetings, Study Risk
[FR Doc. 2016–25418 Filed 10–19–16; 8:45 am] OMB control number 0910–0756. Also Determinations, Formal Early
BILLING CODE 4154–01–P include the FDA docket number found Collaboration Meetings, and Submission
in brackets in the heading of this Issue Meetings and the procedures to
document. request feedback using these
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: FDA mechanisms.
HUMAN SERVICES PRA Staff, Office of Operations, Food A Pre-Submission is defined as a
and Drug Administration, Three White formal written request from an applicant
Food and Drug Administration for feedback from FDA to be provided
Flint North 10A63, 11601 Landsdown
[Docket No. FDA–2012–D–0530] St., North Bethesda, MD 20852, in the form of a formal written response
PRAStaff@fda.hhs.gov. or, if the manufacturer chooses, a
Agency Information Collection SUPPLEMENTARY INFORMATION: In meeting or teleconference in which the
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA feedback is documented in meeting
Management and Budget Review; has submitted the following proposed minutes. A Pre-Submission is
Comment Request; Pre-Submission collection of information to OMB for appropriate when FDA’s feedback on
Program for Medical Devices review and clearance. specific questions is necessary to guide
product development and/or
AGENCY: Food and Drug Administration, Pre-Submission Program for Medical application preparation. The proposed
HHS. Devices—OMB Control Number 0910– collections of information are necessary
ACTION: Notice. 0756—Extension to allow the Agency to receive Pre-
The guidance entitled ‘‘Requests for Submission packages in order to
SUMMARY: The Food and Drug implement this voluntary submission
Feedback on Medical Device
Administration (FDA) is announcing Submissions: The Pre-Submission program.
that a proposed collection of Program and Meetings with Food and For clarity, we are requesting that the
information has been submitted to the Drug Administration Staff’’ describes title of the information collection
Office of Management and Budget the Pre-Submission program for medical request, OMB control number 0910–
(OMB) for review and clearance under devices reviewed in the Center for 0756, be changed to ‘‘Pre-Submission
the Paperwork Reduction Act of 1995. Devices and Radiological Health (CDRH) Program for Medical Devices.’’
DATES: Fax written comments on the and the Center for Biologics Evaluation In the Federal Register of July 28,
collection of information by November and Research (CBER). The guidance 2016 (81 FR 49678), FDA published a
21, 2016. provides recommendations regarding 60-day notice requesting public
ADDRESSES: To ensure that comments on the information that should be comment on the proposed collection of
mstockstill on DSK3G9T082PROD with NOTICES

the information collection are received, submitted in a Pre-Submission package information. No comments were
OMB recommends that written and procedures that should be followed received.
comments be faxed to the Office of for meetings between CDRH and CBER FDA estimates the burden of this
Information and Regulatory Affairs, staff and industry representatives or collection of information as follows:

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72594 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
Number of Total annual Hours per
FDA center frequency per Total hours
respondents responses response
response

CDRH ................................................................................... 2,465 1 2,465 137 337,705
CBER ................................................................................... 79 1 79 137 10,823

Total .............................................................................. ........................ ........................ ........................ ........................ 348,528
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Respondents are medical device a proposed inpatient and outpatient reducing ADEs and targets to meet
manufacturers subject to FDA’s laws measure to track national progress in based on those measures.
and regulations. FDA’s annual estimate reduction of ADEs from these drug ODPHP, in conjunction with the
of 2,544 submissions is based on classes. The proposed targets will reflect Federal Interagency Steering Committee
experienced trends over the past several improvement efforts over a four to six and three Federal Interagency
years. FDA’s administrative and year period since the release of the ADE Workgroups, developed and released
technical staffs, who are familiar with Action Plan in August 2014. As such, the final ADE Action Plan in 2014. The
the requirements for current Pre- HHS is proposing a baseline year of ADE Action Plan seeks to engage all
Submissions, estimate that an average of 2014 for five of the measures and 2016 stakeholders in a coordinated, aligned,
137 hours is required to prepare a Pre- for one measure. All targets are to be and multi-sector effort to reduce ADEs
Submission. achieved by 2020. HHS invites that are clinically significant, account
Dated: October 13, 2016. interested public and private for the greatest number of measurable
Leslie Kux,
professionals, organizations, and harms as identified by existing
consumer representatives to submit surveillance systems, and are largely
Associate Commissioner for Policy.
written comments on the proposed 2020 preventable; these were identified as
[FR Doc. 2016–25359 Filed 10–19–16; 8:45 am]
ADE targets, found at https://health.gov/ ADEs resulting from inpatient and
BILLING CODE 4164–01–P hcq/ade-measures.asp. outpatient use of anticoagulants,
DATES: Comments on the proposed ADE diabetes agents, and opioid analgesics
2020 measures and targets must be (with specific focus on ADEs from
DEPARTMENT OF HEALTH AND
received no later than 5 p.m. on therapeutic use of opioids). The ADE
HUMAN SERVICES
November 21, 2016. Action Plan identifies the federal
Request for Comments on the government’s highest priority strategies
ADDRESSES: Interested persons or and opportunities for advancement,
Proposed Measures and 2020 Targets organizations are invited to submit
for the National Action Plan for which will have the greatest impact on
written comments by any of the reducing ADEs. Implementation of these
Adverse Drug Event Prevention: following methods:
Inpatient and Outpatient Measures for strategies is expected to result in safer
Reduction of Adverse Drug Events • Email: OHQ@hhs.gov (please and higher quality health care services,
From Anticoagulants, Diabetes Agents, indicate in the subject line: Proposed reduced health care costs, informed and
and Opioid Analgesics ADE Measures and Targets) engaged consumers and ultimately,
• Mail/Courier: Office of Disease improved health outcomes. The
AGENCY: Office of Disease Prevention Prevention and Health Promotion, Attn: reduction of ADEs subsequent to
and Health Promotion, Office of the Division of Health Care Quality, implementation of these strategies will
Assistant Secretary for Health, Office of Department of Health and Human be tracked by the proposed measures
the Secretary, Department of Health and Services, 1101 Wootton Parkway, Suite and will aim to meet the targeted
Human Services. LL100, Rockville, MD 20852. reduction rate by 2020.
ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
The six proposed measures use data
Anna Gribble, Health Policy Fellow, from the Agency for Healthcare
SUMMARY: The Office of Disease Research and Quality (AHRQ), the
Office of Disease Prevention and Health
Prevention and Health Promotion Promotion, via email at anna.gribble@ Centers for Disease Control and
(ODPHP), on behalf of the U.S. hhs.gov. Prevention (CDC), and the Food and
Department of Health and Human Drug Administration (FDA). The
Services (HHS) Federal Interagency SUPPLEMENTARY INFORMATION: In inpatient and outpatient measures for
Steering Committee for Adverse Drug September 2012, in response to anticoagulants and diabetes agents and
Events, proposes new measures and heightened awareness of the the outpatient measure for opioids will
targets for adverse drug events (ADEs) contribution of ADEs to the burden of set baseline rates using data from 2014
from anticoagulants, diabetes agents, health care-related harm and costs, the and establish targets to be achieved by
and opioid analgesics for the National Office of the Assistant Secretary for 2020. The inpatient opioids measure
Action Plan for Adverse Drug Event Health (OASH) marshaled the wide- will have a 2016 baseline and a 2020
Prevention (ADE Action Plan). Based on ranging and diverse resources of federal target year. The inpatient opioids
mstockstill on DSK3G9T082PROD with NOTICES

input from the Federal Interagency partners to form an extensive measure will use data from AHRQ’s
Workgroups for Adverse Drug Events, interagency partnership, the Federal Quality Safety Review System (QSRS)
six national measures and targets for the Interagency Steering Committee and which will begin collecting data in
reduction of ADEs are being proposed. Workgroups for Adverse Drug Events, 2016. The inpatient measures for
Each drug class highlighted in the ADE whose goals would be to develop the anticoagulants and diabetes agents will
Action Plan (anticoagulants, diabetes ADE Action Plan, as well as identify use AHRQ’s Medicare Patient
agents, and opioid analgesics) includes measures to track national progress in Monitoring System (MPSMS) for 2015

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Document Created: 2016-10-21 09:59:06
Document Modified: 2016-10-21 09:59:06

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		Fax written comments on the collection of information by November 21, 2016.
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		81 FR 72593

81 FR 72593 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pre-Submission Program for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 203 (October 20, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration