Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Shortages Data Collection System, 64535-64536 [2019-25368]
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
PETNet and LivestockNet reports
share the following common data
elements, the majority of which are drop
down menu choices: product details
(product name, lot code, product form,
and the manufacturer or distributor/
packer (if known)), the species affected,
number of animals exposed to the
product, number of animals affected,
body systems affected, product
problem/defect, date of onset or the date
product problem was detected, the State
where the incident occurred, the origin
of the information, whether there are
supporting laboratory results, and
contact information for the reporting
member (i.e., name, telephone number
will be captured automatically when
member logs in to the system). For the
LivestockNet report, additional data
elements specific to livestock animals
are captured: Product details (indication
of whether the product is a medicated
product, product packaging, and
intended purpose of the product), class
of the animal species affected, and
production loss. For PETNet reports, the
only additional data field is the animal
life stage. The SampleNet reports have
the following data elements, many of
which are drop down menu choices:
Product information (product name, lot
code, guarantor information, date and
location of sample collection, and
product description); laboratory
information (sample identification
64535
number, the reason for testing, whether
the food was reported to the Reportable
Food Registry, who performed the
analysis); and results information
(analyte, test method, analytical results,
whether the results contradict a label
claim or guarantee, and whether action
was taken as a result of the sample
analysis).
Description of Respondents:
Voluntary respondents to this collection
of information are Federal, State, and
Territorial regulatory and public health
Agency employees with membership
access to the Animal Feed Network.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total annual
responses
Average burden
per response
Total hours
PETNet ................................................................
LivestockNET ......................................................
SampleNet ...........................................................
20
20
20
5
5
5
100
100
100
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
0.25 (15 minutes) ...........
25
25
25
Total .............................................................
........................
........................
........................
........................................
75
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25327 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Shortages Data Collection System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
Fax written comments on the
collection of information by December
23, 2019.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0491. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2012–N–0197]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Medical Devices; Shortages Data
Collection System
OMB Control Number 0910–0491—
Reinstatement
Under section 1003(d)(2) of the
Federal Food, Drug, and Cosmetic Act
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
(FD&C Act) (21 U.S.C. 393(d)(2)), the
Commissioner of Food and Drugs is
authorized to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
After the events of September 11,
2001, and as part of broader
counterterrorism and emergency
preparedness activities, FDA’s Center
for Devices and Radiological Health
(CDRH) began developing operational
plans and interventions that would
enable CDRH to anticipate and respond
to medical device shortages that might
arise in the context of federally declared
disasters/emergencies or regulatory
actions. In particular, CDRH identified
the need to acquire and maintain
detailed data on domestic inventory,
manufacturing capabilities, distribution
plans, and raw material constraints for
medical devices that would be in high
demand and/or would be vulnerable to
shortages in specific disaster/emergency
situations or following specific
regulatory actions. Such data could
support prospective risk assessment,
help inform risk mitigation strategies,
support real-time decision making by
the Department of Health and Human
Services during actual emergencies or
emergency preparedness exercises, and
mitigate or prevent harm to the public
health.
The data collection process will
consist of an initial telephone call to
firms who have been identified as
E:\FR\FM\22NON1.SGM
22NON1
64536
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
producing an essential medical device.
In this initial call, the intent and goals
of the data collection effort will be
described, and the specific data request
made. Data will be collected, using least
burdensome methods, in a structured
manner to answer specific questions.
After the initial outreach, we will
request updates to the information on a
quarterly basis to keep the data current
and accurate. Additional followup
correspondence may occasionally be
needed to verify/validate data, confirm
receipt of followup correspondence(s),
and/or request additional details to
further inform FDA’s public health
response.
In the Federal Register of December
28, 2018 (83 FR 67298), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Shortages Data Collection ................
1 There
260
Total annual
responses
4
1,040
Average burden
per response
0.5 (30 minutes) ...............................
Total hours
520
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in
table 1 on past experience with direct
contact with the medical device
manufacturers and anticipated changes
in the medical device manufacturing
patterns for the specific devices being
monitored. FDA estimates that
approximately 260 manufacturers
would be contacted by telephone and/
or electronic mail 4 times per year either
to obtain primary data or to verify/
validate data. Because the requested
data represent data elements that are
monitored or tracked by manufacturers
as part of routine inventory management
activities, it is anticipated that for most
manufacturers, the estimated time
required of manufacturers to complete
the data request will not exceed 30
minutes per request cycle.
This information collection is a
reinstatement without change. There is
an increase (an adjustment) of 332 hours
in the total estimated burden compared
with that identified in the information
collection request previously approved
by OMB. This increase reflects changes
in market demands, in which
manufacturers are increasingly adopting
just-in-time production methods.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25368 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3728]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Collection of
Information for Participation in the
Food and Drug Administration NonEmployee Fellowship and Traineeship
Programs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 ‘‘Collection of
Information for Participation in FDA
Non-Employee Fellowship and
Traineeship Programs.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 21, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 21,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 21, 2020.
Comments received by mail/hand
SUMMARY:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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
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 https://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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
E:\FR\FM\22NON1.SGM
22NON1
]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64535-64536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25368]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0197]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Shortages Data Collection System
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
December 23, 2019.
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 0910-0491.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Medical Devices; Shortages Data Collection System
OMB Control Number 0910-0491--Reinstatement
Under section 1003(d)(2) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and
Drugs is authorized to implement general powers (including conducting
research) to carry out effectively the mission of FDA.
After the events of September 11, 2001, and as part of broader
counterterrorism and emergency preparedness activities, FDA's Center
for Devices and Radiological Health (CDRH) began developing operational
plans and interventions that would enable CDRH to anticipate and
respond to medical device shortages that might arise in the context of
federally declared disasters/emergencies or regulatory actions. In
particular, CDRH identified the need to acquire and maintain detailed
data on domestic inventory, manufacturing capabilities, distribution
plans, and raw material constraints for medical devices that would be
in high demand and/or would be vulnerable to shortages in specific
disaster/emergency situations or following specific regulatory actions.
Such data could support prospective risk assessment, help inform risk
mitigation strategies, support real-time decision making by the
Department of Health and Human Services during actual emergencies or
emergency preparedness exercises, and mitigate or prevent harm to the
public health.
The data collection process will consist of an initial telephone
call to firms who have been identified as
[[Page 64536]]
producing an essential medical device. In this initial call, the intent
and goals of the data collection effort will be described, and the
specific data request made. Data will be collected, using least
burdensome methods, in a structured manner to answer specific
questions. After the initial outreach, we will request updates to the
information on a quarterly basis to keep the data current and accurate.
Additional followup correspondence may occasionally be needed to
verify/validate data, confirm receipt of followup correspondence(s),
and/or request additional details to further inform FDA's public health
response.
In the Federal Register of December 28, 2018 (83 FR 67298), 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:
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
----------------------------------------------------------------------------------------------------------------
Shortages Data Collection..... 260 4 1,040 0.5 (30 minutes) 520
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA based the burden estimates in table 1 on past experience with
direct contact with the medical device manufacturers and anticipated
changes in the medical device manufacturing patterns for the specific
devices being monitored. FDA estimates that approximately 260
manufacturers would be contacted by telephone and/or electronic mail 4
times per year either to obtain primary data or to verify/validate
data. Because the requested data represent data elements that are
monitored or tracked by manufacturers as part of routine inventory
management activities, it is anticipated that for most manufacturers,
the estimated time required of manufacturers to complete the data
request will not exceed 30 minutes per request cycle.
This information collection is a reinstatement without change.
There is an increase (an adjustment) of 332 hours in the total
estimated burden compared with that identified in the information
collection request previously approved by OMB. This increase reflects
changes in market demands, in which manufacturers are increasingly
adopting just-in-time production methods.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25368 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P
