Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization, 40420-40421 [2019-17477]
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40420
Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
We base our estimates on our
experience with similar requirements to
maintain written procedures. We base
our estimate of the number of
recordkeepers on inspectional data.
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: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17478 Filed 8–13–19; 8:45 am]
BILLING CODE 4164–01–P
include the FDA docket number found
in brackets in the heading of this
document.
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150
Food and Drug Administration
OMB Control Number 0910–0131—
Extension
[Docket No. FDA–2013–N–0375]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Agreement for
Shipment of Devices for Sterilization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 September
13, 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 0910–0131. Also
SUMMARY:
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 (see § 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.
In the Federal Register of April 26,
2019 (84 FR 17837), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
jspears on DSK3GMQ082PROD with NOTICES
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
0.5
1,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
40421
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
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: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17477 Filed 8–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0403]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Protection of
Human Subjects; Informed Consent;
and Institutional Review Boards
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 the information
collection provisions found in Agency
regulations pertaining to the protection
of human subjects and responsibilities
of institutional review boards (IRBs).
DATES: Submit either electronic or
written comments on the collection of
information by October 15, 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 October 15,
jspears on DSK3GMQ082PROD with NOTICES
SUMMARY:
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18:56 Aug 13, 2019
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2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 15, 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.’’
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Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0403 for ‘‘Protection of Human
Subjects; Informed Consent; and
Institutional Review Boards.’’ 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/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
E:\FR\FM\14AUN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40420-40421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17477]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0375]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) 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
September 13, 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 0910-0131.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (see 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.
In the Federal Register of April 26, 2019 (84 FR 17837), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
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 0.5 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 40421]]
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: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17477 Filed 8-13-19; 8:45 am]
BILLING CODE 4164-01-P
