Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Medical Device Registration and Listing, 20138-20140 [2019-09412]
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20138
Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
information collect tools, as appropriate,
to obtain information concerning the
use of compounded product(s) from
medical experts, outsourcing facilities,
and other stakeholders. Within this
context, the following questions may be
posed:
1. What are the health condition(s)
that the compounded drug is currently
and has been historically used to treat?
What is the patient population for
which the compound drug has been
used to treat?
2. What are the characteristics of the
compounded drug(s) using the bulk
drug substance (e.g., dosage form,
strength, route of administration)?
3. Is the compounded drug considered
standard therapy by healthcare
practitioners, or is it recommended in
clinical practice guidelines? If so, under
what circumstances?
4. Does an approved drug exist for the
health condition that the compounded
drug product is used to treat? If so, what
are the circumstances under which a
compounded drug product using the
bulk drug substance would be used in
lieu of the approved drug product?
5. What is the historical use of the
compounded drug to treat the health
conditions identified, including the
number of years during which the
compounded drug has been prescribed
for each use, and any change regarding
its use over time?
6. To what extent do practitioners
prescribe the compounded drug to treat
each health condition identified? How
many such prescriptions and/or orders
have been written in the past 5 years?
Have there been any notable changes in
the number of prescriptions and/or
orders written over this time?
7. How widespread is the use of the
compounded drug product, including
use in other countries?
8. Do practitioners order the
compounded drug to maintain on hand
before a patient presents with a need for
the drug (‘‘office stock’’), or do
practitioners typically write
prescriptions for a patient after the
patient presents with a need for the
compounded drug? If the former, why
(e.g., emergency situations,
convenience)?
In the Federal Register of September
17, 2018 (83 FR 46957), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was
received, and FDA determined that this
comment was applicable to a different
docket published in the Federal
Register, and not relevant to this
proposed collection of mation.
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
UMD–CERSI Expert Focus Groups and Interviews ............
UMD–CERSI Expert Questionnaire .....................................
JHU–CERSI Parent Questionnaire ......................................
150
750
1,000
Total ..............................................................................
7,250
Number of
responses per
respondent
Total annual
responses
10
10
1
1,500
7,500
1,000
Average
burden per
response
2
* 0.5
* 0.5
Total hours
3,000
3,750
500
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
* 30 minutes.
We base our estimate of the average
burden per response on review activities
familiar to the Agency. Since issuing the
60-day notice, FDA determined an
additional burden estimate related to
completion of questionnaires. We
welcome additional comments
regarding this estimate.
Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09414 Filed 5–7–19; 8:45 am]
Food and Drug Administration
khammond on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2015–N–3815]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Submission of Medical Device
Registration and Listing
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
16:57 May 07, 2019
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 June 7,
2019.
SUMMARY:
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 0910–0625. Also
include the FDA docket number found
in brackets in the heading of this
document.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
Notice.
ADDRESSES:
BILLING CODE 4164–01–P
AGENCY:
ACTION:
Jkt 247001
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Electronic Submission of Medical
Device Registration and Listing—21
CFR Part 807, Subparts A Through D
OMB Control Number 0910–0625—
Extension
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360) and part 807,
subparts A through D (21 CFR part 807,
subparts A through D), medical device
establishment owners and operators are
required to electronically submit
establishment registration and device
listing information.
Complete and accurate registration
and listing information is necessary to
accomplish a number of statutory and
regulatory objectives, such as: (1)
Identification of establishments
producing marketed medical devices,
(2) identification of establishments
E:\FR\FM\08MYN1.SGM
08MYN1
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Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
producing a specific device when that
device is in short supply or is needed
for national emergency, (3) facilitation
of recalls for devices marketed by
owners and operators of device
establishments, (4) identification and
cataloguing of marketed devices, (5)
administering postmarketing
surveillance programs for devices, (6)
identification of devices marketed in
violation of the law, (7) identification
and control of devices imported into the
country from foreign establishments, (8)
and scheduling and planning
inspections of registered establishments
under section 704 of the FD&C Act (21
U.S.C. 374).
Respondents to this information
collection are owners or operators of
establishments that engage in the
manufacturing, preparation,
propagation, compounding, or
processing of a device or devices, who
must register their establishments and
submit listing information for each of
their devices in commercial
distribution. Notwithstanding certain
exceptions, foreign device
establishments that manufacture,
prepare, propagate, compound, or
process a device that is imported or
offered for import into the United States
must also comply with the registration
and listing requirements. The number of
respondents is based on data from the
FDA Unified Registration and Listing
System.
Burden estimates are based on recent
experience with the existing medical
device registration and listing program,
electronic system operating experience,
and previous data estimates.
In the Federal Register of December 4,
2018 (83 FR 62583), 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
21 CFR section
FDA form No.
khammond on DSKBBV9HB2PROD with NOTICES
807.20(a)(5) 2—Submittal of Manufacturer Information by Initial Importers ....
807.20(a)(5) 3—Submittal of Manufacturer Information by Initial Importers ....
807.21(a) 2—Creation of Electronic System Account .........................................
807.21(b) 3—Annual Request for Waiver
from Electronic Registration and Listing .........................................................
807.21(b) 2—Initial Request for Waiver
from Electronic Registration and Listing for ...................................................
807.22(a) 2—Initial Registration and Listing .........................................................
807.22(b)(1) 3—Annual Registration ........
807.22(b)(2) 3—Other Updates of Registration .................................................
807.22(b)(3) 3—Annual Update of Listing
Information ............................................
807.26(e) 3—Labeling and Advertisement
Submitted at FDA Request ..................
807.34(a) 2—Initial Registration and Listing when Electronic Filing Waiver
Granted .................................................
807.34(a) 3—Annual Registration and
Listing when Electronic Filing Waiver
Granted .................................................
807.40(b)(2) 3—Annual Update of US
Agent Information .................................
807.40(b)(3) 3—US Agent Responses to
FDA Requests for Information .............
807.41(a) 3—Identification of Initial Importers by Foreign Establishments ......
807.41(b) 3—Identification of Other Parties that Facilitate Import by Foreign
Establishments .....................................
Annual
frequency per
response
Number of
respondents
Total annual
responses
Hours per
response
Total hours
3673
5,736
1
5,736
1.75
10,038
3673
5,736
1
5,736
0.1
574
3673
2,937
1
2,937
0.5
1,469
........................
1
1
1
1
1
........................
1
1
1
1
1
3673
3673
3,467
23,403
1
1
3,467
23,403
1
0.5
3,467
11,702
3673
2,687
1
2,687
0.5
1,344
3673
22,607
1
22,607
0.5
11,304
........................
71
1
71
1
71
........................
1
1
1
1
1
........................
1
1
1
1
1
3673
1,615
1
1,615
0.5
808
3673
1,535
1
1,535
0.25
384
3673
12,983
1
12,983
0.5
6,492
3673
12,983
1
12,983
0.5
6,492
Total One Time Burden ....................
........................
........................
........................
........................
........................
14,975
Total Recurring Burden ....................
........................
........................
........................
........................
........................
39,173
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
are rounded to the nearest whole number.
3 One-Time Burden—Firm only provides initially.
4 Recurring Burden—Firm is required to review annually.
2 Totals
VerDate Sep<11>2014
16:57 May 07, 2019
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Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Annual
frequency per
recordkeeper
Number of
respondents
21 CFR Section
Total annual
records
Hours per record
Total hours
807.25(d) 2—List of Officers, Directors, and Partners
807.26 2—Labeling and Advertisements Available for
Review.
22,338
17,032
1
4
22,338
68,128
0.25 (15 minutes) ....
0.5 (30 minutes) ......
5,585
34,064
Total ....................................................................
........................
........................
........................
..................................
39,649
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden—Firm is required to keep records.
2 Recurring
The following adjustments and
program changes resulted in a 5,672hour decrease to the overall total hour
burden estimate for this information
collection request.
• We adjusted the number of
respondents based on updated
registration and listing data.
• In the reporting burden table, we
corrected the table footnotes to
accurately indicate whether the
information collection (IC) is a one-time
or reoccurring burden.
• We also adjusted some of the IC
descriptions in the table for increased
clarity.
• We updated our estimate of Hours
per Response for ‘‘807.22(a) Initial
Registration and Listing’’ (+ 0.5 hours),
‘‘807.22(b)(1) Annual Registration’’ (¥
0.25 hours), and ‘‘807.22(b)(3) Annual
Update of Listing Information’’ (¥ 0.25
hours). Based on our review of the
program, we believe these changes to
the burden estimate will more
accurately reflect the current
preparation time for these ICs.
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09412 Filed 5–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–7011]
khammond on DSKBBV9HB2PROD with NOTICES
Laser Products—Conformance With
IEC 60825–1 Ed. 3 and IEC 60601–2–22
Ed. 3.1 (Laser Notice No. 56); Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Laser
Products—Conformance with IEC
SUMMARY:
VerDate Sep<11>2014
16:57 May 07, 2019
Jkt 247001
60825–1 Ed. 3 and IEC 60601–2–22 Ed.
3.1 (Laser Notice No. 56).’’ This
guidance describes the Agency’s
approach regarding compliance with
FDA’s performance standards for laser
products. FDA believes that under the
circumstances described in this
guidance, conformance with certain
International Electrotechnical
Commission (IEC) standards would
provide adequate protection of the
public health and safety for laser
products similar to performance
standards in FDA’s regulations.
Accordingly, for laser product
manufacturers that comply with the
comparable clauses in IEC standards
specified in the guidance, FDA does not
intend to enforce the specified laser
performance standards in FDA’s
regulations.
The announcement of the
guidance is published in the Federal
Register on May 8, 2019.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
• 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–
2017–D–7011 for ‘‘Laser Products—
Conformance with IEC 60825-1 Ed. 3
and IEC 60601-2-22 Ed. 3.1 (Laser
Notice No. 56).’’ Received comments
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
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]]>Agencies
[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20138-20140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09412]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3815]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Submission
of Medical Device Registration and Listing
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 June 7,
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 0910-0625.
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.
Electronic Submission of Medical Device Registration and Listing--21
CFR Part 807, Subparts A Through D OMB Control Number 0910-0625--
Extension
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part
807, subparts A through D), medical device establishment owners and
operators are required to electronically submit establishment
registration and device listing information.
Complete and accurate registration and listing information is
necessary to accomplish a number of statutory and regulatory
objectives, such as: (1) Identification of establishments producing
marketed medical devices, (2) identification of establishments
[[Page 20139]]
producing a specific device when that device is in short supply or is
needed for national emergency, (3) facilitation of recalls for devices
marketed by owners and operators of device establishments, (4)
identification and cataloguing of marketed devices, (5) administering
postmarketing surveillance programs for devices, (6) identification of
devices marketed in violation of the law, (7) identification and
control of devices imported into the country from foreign
establishments, (8) and scheduling and planning inspections of
registered establishments under section 704 of the FD&C Act (21 U.S.C.
374).
Respondents to this information collection are owners or operators
of establishments that engage in the manufacturing, preparation,
propagation, compounding, or processing of a device or devices, who
must register their establishments and submit listing information for
each of their devices in commercial distribution. Notwithstanding
certain exceptions, foreign device establishments that manufacture,
prepare, propagate, compound, or process a device that is imported or
offered for import into the United States must also comply with the
registration and listing requirements. The number of respondents is
based on data from the FDA Unified Registration and Listing System.
Burden estimates are based on recent experience with the existing
medical device registration and listing program, electronic system
operating experience, and previous data estimates.
In the Federal Register of December 4, 2018 (83 FR 62583), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section FDA form No. Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.20(a)(5) \2\--Submittal of Manufacturer Information 3673 5,736 1 5,736 1.75 10,038
by Initial Importers...................................
807.20(a)(5) \3\--Submittal of Manufacturer Information 3673 5,736 1 5,736 0.1 574
by Initial Importers...................................
807.21(a) \2\--Creation of Electronic System Account.... 3673 2,937 1 2,937 0.5 1,469
807.21(b) \3\--Annual Request for Waiver from Electronic .............. 1 1 1 1 1
Registration and Listing...............................
807.21(b) \2\--Initial Request for Waiver from .............. 1 1 1 1 1
Electronic Registration and Listing for................
807.22(a) \2\--Initial Registration and Listing......... 3673 3,467 1 3,467 1 3,467
807.22(b)(1) \3\--Annual Registration................... 3673 23,403 1 23,403 0.5 11,702
807.22(b)(2) \3\--Other Updates of Registration......... 3673 2,687 1 2,687 0.5 1,344
807.22(b)(3) \3\--Annual Update of Listing Information.. 3673 22,607 1 22,607 0.5 11,304
807.26(e) \3\--Labeling and Advertisement Submitted at .............. 71 1 71 1 71
FDA Request............................................
807.34(a) \2\--Initial Registration and Listing when .............. 1 1 1 1 1
Electronic Filing Waiver Granted.......................
807.34(a) \3\--Annual Registration and Listing when .............. 1 1 1 1 1
Electronic Filing Waiver Granted.......................
807.40(b)(2) \3\--Annual Update of US Agent Information. 3673 1,615 1 1,615 0.5 808
807.40(b)(3) \3\--US Agent Responses to FDA Requests for 3673 1,535 1 1,535 0.25 384
Information............................................
807.41(a) \3\--Identification of Initial Importers by 3673 12,983 1 12,983 0.5 6,492
Foreign Establishments.................................
807.41(b) \3\--Identification of Other Parties that 3673 12,983 1 12,983 0.5 6,492
Facilitate Import by Foreign Establishments............
-----------------------------------------------------------------------------------------------
Total One Time Burden............................... .............. .............. .............. .............. .............. 14,975
-----------------------------------------------------------------------------------------------
Total Recurring Burden.............................. .............. .............. .............. .............. .............. 39,173
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals are rounded to the nearest whole number.
\3\ One-Time Burden--Firm only provides initially.
\4\ Recurring Burden--Firm is required to review annually.
[[Page 20140]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per record Total hours
respondents recordkeeper records
----------------------------------------------------------------------------------------------------------------
807.25(d) \2\--List of 22,338 1 22,338 0.25 (15 5,585
Officers, Directors, and minutes).
Partners.
807.26 \2\--Labeling and 17,032 4 68,128 0.5 (30 minutes) 34,064
Advertisements Available for
Review.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 39,649
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Recurring burden--Firm is required to keep records.
The following adjustments and program changes resulted in a 5,672-
hour decrease to the overall total hour burden estimate for this
information collection request.
We adjusted the number of respondents based on updated
registration and listing data.
In the reporting burden table, we corrected the table
footnotes to accurately indicate whether the information collection
(IC) is a one-time or reoccurring burden.
We also adjusted some of the IC descriptions in the table
for increased clarity.
We updated our estimate of Hours per Response for
``807.22(a) Initial Registration and Listing'' (+ 0.5 hours),
``807.22(b)(1) Annual Registration'' (- 0.25 hours), and ``807.22(b)(3)
Annual Update of Listing Information'' (- 0.25 hours). Based on our
review of the program, we believe these changes to the burden estimate
will more accurately reflect the current preparation time for these
ICs.
Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09412 Filed 5-7-19; 8:45 am]
BILLING CODE 4164-01-P
