Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization, 17837-17838 [2019-08470]
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Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices
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Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
the following FDA regulations have
been approved by OMB as listed in the
following table.
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
OMB control
21 CFR part
Topic
No.
following way:
• Federal eRulemaking Portal:
801, subpart
Unique De0910–0720 https://www.regulations.gov. Follow the
B, and 830.
vice Identiinstructions for submitting comments.
fication.
Comments submitted electronically,
including attachments, to https://
Dated: April 23, 2019.
www.regulations.gov will be posted to
Lowell J. Schiller,
the docket unchanged. Because your
Principal Associate Commissioner for Policy.
comment will be made public, you are
[FR Doc. 2019–08472 Filed 4–25–19; 8:45 am]
solely responsible for ensuring that your
comment does not include any
BILLING CODE P
confidential information that you or a
third party may not wish to be posted,
DEPARTMENT OF HEALTH AND
such as medical information, your or
HUMAN SERVICES
anyone else’s Social Security number, or
confidential business information, such
Food and Drug Administration
as a manufacturing process. Please note
that if you include your name, contact
[Docket No. FDA–2013–N–0375]
information, or other information that
Agency Information Collection
identifies you in the body of your
Activities; Proposed Collection;
comments, that information will be
Comment Request; Agreement for
posted on https://www.regulations.gov.
Shipment of Devices for Sterilization
• If you want to submit a comment
with confidential information that you
AGENCY: Food and Drug Administration,
do not wish to be made available to the
HHS.
public, submit the comment as a
ACTION: Notice.
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
SUMMARY: The Food and Drug
Submissions’’ and ‘‘Instructions’’).
Administration (FDA or Agency) is
announcing an opportunity for public
Written/Paper Submissions
comment on the proposed collection of
Submit written/paper submissions as
certain information by the Agency.
follows:
Under the Paperwork Reduction Act of
• Mail/Hand Delivery/Courier (for
1995 (PRA), Federal Agencies are
written/paper submissions): Dockets
required to publish notice in the
Management Staff (HFA–305), Food and
Federal Register concerning each
Drug Administration, 5630 Fishers
proposed collection of information,
Lane, Rm. 1061, Rockville, MD 20852.
including each proposed extension of an
• For written/paper comments
existing collection of information, and
submitted to the Dockets Management
to allow 60 days for public comment in
Staff, FDA will post your comment, as
response to the notice. This notice
well as any attachments, except for
solicits comments on information
information submitted, marked and
collection requirements relating to
identified, as confidential, if submitted
shipment of nonsterile devices that are
as detailed in ‘‘Instructions.’’
to be sterilized elsewhere or are shipped
Instructions: All submissions received
to other establishments for further
must include the Docket No. FDA–
processing, labeling, or repacking.
2013–N–0375 for ‘‘Agreement for
DATES: Submit either electronic or
Shipment of Devices for Sterilization.’’
written comments on the collection of
Received comments, those filed in a
information by June 25, 2019.
timely manner (see ADDRESSES), will be
ADDRESSES: You may submit comments
placed in the docket and, except for
as follows. Please note that late,
those submitted as ‘‘Confidential
untimely filed comments will not be
Submissions,’’ publicly viewable at
considered. Electronic comments must
https://www.regulations.gov or at the
be submitted on or before June 25, 2019. Dockets Management Staff between 9
The https://www.regulations.gov
a.m. and 4 p.m., Monday through
electronic filing system will accept
Friday.
comments until 11:59 p.m. Eastern Time
• Confidential Submissions—To
at the end of June 25, 2019. Comments
submit a comment with confidential
received by mail/hand delivery/courier
information that you do not wish to be
(for written/paper submissions) will be
made publicly available, submit your
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17837
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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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
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17838
Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices
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.
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150
OMB Control Number 0910–0131—
Extension
Under sections 501(c) and 502(a) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 351(c) and
352(a)), nonsterile devices that are
labeled as sterile but are in interstate
transit to a facility to be sterilized are
adulterated and misbranded. FDA
regulations at § 801.150(e) (21 CFR
801.150(e)) establish a control
mechanism by which firms may
manufacture and label medical devices
as sterile at one establishment and ship
the devices in interstate commerce for
sterilization at another establishment, a
practice that facilitates the processing of
devices and is economically necessary
for some firms.
Under § 801.150(e)(1), manufacturers
and sterilizers may sign an agreement
containing the following: (1) Contact
information of the firms involved and
the identification of the signature
authority of the shipper and receiver, (2)
instructions for maintaining
accountability of the number of units in
each shipment, (3) acknowledgment that
the devices that are nonsterile are being
shipped for further processing, and (4)
specifications for sterilization
processing. This agreement allows the
manufacturer to ship misbranded
products to be sterilized without
initiating regulatory action and provides
FDA with a means to protect consumers
from use of nonsterile products. During
routine plant inspections, FDA normally
reviews agreements that must be kept
for 2 years after final shipment or
delivery of devices (§ 801.150(a)(2)).
The respondents to this collection of
information are device manufacturers
and contract sterilizers. FDA’s estimate
of the reporting burden is based on data
obtained from industry over the past
several years. It is estimated that each of
the firms subject to this requirement
prepares an average of 20 written
agreements each year. This estimate
varies greatly, from 1 to 100, because
some firms provide sterilization services
on a part-time basis for only one
customer, while others are large
facilities with many customers. The
average time required to prepare each
written agreement is estimated to be 4
hours. This estimate varies depending
on whether the agreement is the initial
agreement or an annual renewal, on the
format each firm elects to use, and on
the length of time required to reach
agreement. The estimate applies only to
those portions of the written agreement
that pertain to the requirements
imposed by this regulation. The written
agreement generally also includes
contractual agreements that are a usual
and customary business practice. The
recordkeeping requirements of
§ 801.150(a)(2) consist of making copies
and maintaining the records required
under the third-party disclosure section
of this collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Record retention, 801.150(a)(2) ............................................................................
100
20
2,000
.5
1,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Agreement and labeling requirements, 801.150(e) ..............................................
100
20
2,000
4
8,000
amozie on DSK9F9SC42PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 900 total hours and
a corresponding increase of 400 records/
disclosures. We attribute this increase to
an increase in the number of agreements
that we have seen in inspection data
received over the last few years.
Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08470 Filed 4–25–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1329]
Recommended Content and Format of
Non-Clinical Bench Performance
Testing Information in Premarket
Submissions; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
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ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Recommended
Content and Format of Non-Clinical
Bench Performance Testing Information
in Premarket Submissions.’’ FDA has
developed this document to describe
relevant information that should be
included in test report summaries, test
protocols, and complete test reports for
non-clinical bench performance testing
provided in a premarket submission
SUMMARY:
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[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Notices]
[Pages 17837-17838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08470]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0375]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Agreement for Shipment of Devices for Sterilization
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 information collection requirements
relating to shipment of nonsterile devices that are to be sterilized
elsewhere or are shipped to other establishments for further
processing, labeling, or repacking.
DATES: Submit either electronic or written comments on the collection
of information by June 25, 2019.
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 June 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 25, 2019. Comments received
by mail/hand 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 information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0375 for ``Agreement for Shipment of Devices for
Sterilization.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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
[[Page 17838]]
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.
Agreement for Shipment of Devices for Sterilization--21 CFR 801.150
OMB Control Number 0910-0131--Extension
Under sections 501(c) and 502(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 351(c) and 352(a)), nonsterile
devices that are labeled as sterile but are in interstate transit to a
facility to be sterilized are adulterated and misbranded. FDA
regulations at Sec. 801.150(e) (21 CFR 801.150(e)) establish a control
mechanism by which firms may manufacture and label medical devices as
sterile at one establishment and ship the devices in interstate
commerce for sterilization at another establishment, a practice that
facilitates the processing of devices and is economically necessary for
some firms.
Under Sec. 801.150(e)(1), manufacturers and sterilizers may sign
an agreement containing the following: (1) Contact information of the
firms involved and the identification of the signature authority of the
shipper and receiver, (2) instructions for maintaining accountability
of the number of units in each shipment, (3) acknowledgment that the
devices that are nonsterile are being shipped for further processing,
and (4) specifications for sterilization processing. This agreement
allows the manufacturer to ship misbranded products to be sterilized
without initiating regulatory action and provides FDA with a means to
protect consumers from use of nonsterile products. During routine plant
inspections, FDA normally reviews agreements that must be kept for 2
years after final shipment or delivery of devices (Sec.
801.150(a)(2)).
The respondents to this collection of information are device
manufacturers and contract sterilizers. FDA's estimate of the reporting
burden is based on data obtained from industry over the past several
years. It is estimated that each of the firms subject to this
requirement prepares an average of 20 written agreements each year.
This estimate varies greatly, from 1 to 100, because some firms provide
sterilization services on a part-time basis for only one customer,
while others are large facilities with many customers. The average time
required to prepare each written agreement is estimated to be 4 hours.
This estimate varies depending on whether the agreement is the initial
agreement or an annual renewal, on the format each firm elects to use,
and on the length of time required to reach agreement. The estimate
applies only to those portions of the written agreement that pertain to
the requirements imposed by this regulation. The written agreement
generally also includes contractual agreements that are a usual and
customary business practice. The recordkeeping requirements of Sec.
801.150(a)(2) consist of making copies and maintaining the records
required under the third-party disclosure section of this collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record retention, 801.150(a)(2).................................... 100 20 2,000 .5 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agreement and labeling requirements, 801.150(e).................... 100 20 2,000 4 8,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall increase of 900 total hours and a corresponding increase of 400
records/disclosures. We attribute this increase to an increase in the
number of agreements that we have seen in inspection data received over
the last few years.
Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08470 Filed 4-25-19; 8:45 am]
BILLING CODE 4164-01-P
