Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products, 23971-23973 [2020-09175]
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Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
meeting of the Ophthalmic Devices
Panel of the Medical Devices Advisory
Committee scheduled for June 9, 2020.
The meeting was announced in the
Federal Register of April 1, 2020. FDA,
like other government agencies, is
taking the necessary steps to ensure the
Agency is prepared to continue our vital
public health mission in the event that
our day-to-day operations are impacted
by the COVID–19 public health
emergency. Therefore, we are
postponing this meeting and will
reassess on an ongoing basis for future
months. A future meeting date will be
announced in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, Aden.Asefa@
fda.hhs.gov, 301–796–0400, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area) and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: The
meeting of the Ophthalmic Devices
Panel of the Medical Devices Advisory
Committee was originally announced in
the Federal Register of April 1, 2020 (85
FR 18249), and was initially scheduled
for June 9, 2020. FDA continues to
evaluate whether and how to proceed
with upcoming scheduled meetings
while our day-to-day operations are
impacted by the COVID–19 public
health emergency, and we have decided
to postpone this public meeting until
further notice.
Dated: April 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09232 Filed 4–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jbell on DSKJLSW7X2PROD with NOTICES
[Docket No. FDA–2008–N–0424]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Safety Information Sharing by
Constituent Part Applicants for
Combination Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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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 the requirements
under the Postmarketing Safety
Reporting Rule for Combination Product
for Constituent Part Applicants to share
specified adverse event information
with one another.
DATES: Submit either electronic or
written comments on the collection of
information by June 29, 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 June 29, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 29, 2020. 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
PO 00000
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23971
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–
2008–N–0424 for ‘‘Postmarketing Safety
Information Sharing by Constituent Part
Applicants for Combination Products.’’
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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
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. 3501–3521), 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
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.
Information Sharing Among
Constituent Part Applicants—21 CFR
4.103
OMB Control Number 0910–0834—
Extension
This information collection request
applies to ‘‘constituent part applicants’’
as defined under 21 CFR 4.101 (i.e., any
person holding an application under
which a constituent part (drug, device,
or biological product) of a combination
product received marketing
authorization if the other constituent
part(s) received marketing authorization
under an application held by a different
person). Under this collection,
constituent part applicants must share
safety information they receive related
to certain events with the other
constituent part applicant(s) and
maintain associated records.1
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE AND RECORDKEEPING BURDEN
Number of
respondents/
recordkeepers
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR section/activity
Number of
disclosures/
records per
respondent/
recordkeeper
Total annual
disclosures/
records
Average burden
per disclosure/
recordkeeping
Total hours
4.103, Sharing information with other constituent part
applicants.
4.103(b) and 4.105(a)(2), Records of information
shared by constituent part applicants.
33
18
594
0.35 (21 minutes)
208
33
18
594
0.1 (6 minutes) ...
59
Total .........................................................................
........................
........................
........................
............................
267
1 The Postmarketing Safety Reporting (PMSR)
information collections for drugs, biological
products, and devices found in §§ 314.80, 314.81,
600.80, 600.81, 606.170, 606.171, 803.50, 803.53,
803.56, 806.10, and 806.20 (21 CFR 314.80, 314.81,
600.80, 600.81, 606.170, 606.171, 803.50, 803.53,
803.56, 806.10, and 806.20) have already been
approved and are in effect or their extension is
being sought separately as required, including with
respect to burden for combination products
(reflected in the authorization for OMB control
VerDate Sep<11>2014
18:56 Apr 29, 2020
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number 0910–0834, but, therefore, not addressed in
this extension request). The pertinent PMSR
information collection provisions for § 314.80(c)
and (e), as well as for § 314.81(b) are approved
under OMB control numbers 0910–0001, 0910–
0230, and 0910–0291. The information collection
provisions for §§ 600.80 and 600.81 are approved
under OMB control number 0910–0308. Those for
§ 606.170 are approved under OMB control number
0910–0116. Those for § 606.171 are approved under
OMB control number 0910–0458. The information
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collection provisions for §§ 803.50, 803.53, and
803.56 are approved under OMB control numbers
0910–0291 and 0910–0437. The information
collection provisions for §§ 806.10 and 806.20 are
approved under OMB control number 0910–0359.
2 See Compliance Policy for Combination Product
Postmarketing Safety Reporting (April 2019)
(https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/compliance-policycombination-product-postmarketing-safetyreporting).
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Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. We
note in this regard that FDA extended
the compliance date for 21 CFR part 4,
subpart B, until July 2020 for most
combination products, and until January
2021 for the remainder, in response to
stakeholder feedback, to ensure that
Combination Product Applicants have
sufficient time to update reporting and
recordkeeping systems and procedures.2
Consequently, entities subject to this
rule have not yet had to comply with
this information request.
Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09175 Filed 4–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–0661]
Enforcement Priorities for Electronic
Nicotine Delivery Systems and Other
Deemed Products on the Market
Without Premarket Authorization
(Revised); Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
Notice of availability.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance for
industry entitled ‘‘Enforcement
Priorities for Electronic Nicotine
Delivery Systems (ENDS) and Other
Deemed Products on the Market
Without Premarket Authorization
(Revised).’’ This is a revision to the
guidance which describes, among other
things, how FDA intends to prioritize its
enforcement resources with regard to
the marketing of ENDS products that do
not have premarket authorization. FDA
is revising this guidance to change the
date required to submit premarket
authorization applications to the
Agency from May 12, 2020, to
September 9, 2020.
DATES: The announcement of the
guidance is published in the Federal
Register on April 30, 2020.
2 See
Compliance Policy for Combination Product
Postmarketing Safety Reporting (April 2019)
(https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/compliance-policycombination-product-postmarketing-safetyreporting).
VerDate Sep<11>2014
18:56 Apr 29, 2020
Jkt 250001
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.
• 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–
2019–D–0661 for ‘‘Enforcement
Priorities for Electronic Nicotine
Delivery Systems (ENDS) and Other
Deemed Products on the Market
Without Premarket Authorization
(Revised).’’ 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
PO 00000
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23973
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.govinfo.gov/content/pkg/FR-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Center for
Tobacco Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Document Control Center, Bldg.
71, Rm. G335, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the guidance document may be
sent. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Gerie Voss, Center for Tobacco
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Document Control Center, Bldg.
71, Rm. G335, Silver Spring, MD 20993–
E:\FR\FM\30APN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23971-23973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09175]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0424]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Safety Information Sharing by
Constituent Part Applicants for Combination Products
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 the requirements under the Postmarketing
Safety Reporting Rule for Combination Product for Constituent Part
Applicants to share specified adverse event information with one
another.
DATES: Submit either electronic or written comments on the collection
of information by June 29, 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 June 29, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 29, 2020. 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-2008-N-0424 for ``Postmarketing Safety Information Sharing by
Constituent Part Applicants for Combination Products.'' 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
[[Page 23972]]
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. 3501-3521), 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 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.
Information Sharing Among Constituent Part Applicants--21 CFR 4.103
OMB Control Number 0910-0834--Extension
This information collection request applies to ``constituent part
applicants'' as defined under 21 CFR 4.101 (i.e., any person holding an
application under which a constituent part (drug, device, or biological
product) of a combination product received marketing authorization if
the other constituent part(s) received marketing authorization under an
application held by a different person). Under this collection,
constituent part applicants must share safety information they receive
related to certain events with the other constituent part applicant(s)
and maintain associated records.\1\
---------------------------------------------------------------------------
\1\ The Postmarketing Safety Reporting (PMSR) information
collections for drugs, biological products, and devices found in
Sec. Sec. 314.80, 314.81, 600.80, 600.81, 606.170, 606.171, 803.50,
803.53, 803.56, 806.10, and 806.20 (21 CFR 314.80, 314.81, 600.80,
600.81, 606.170, 606.171, 803.50, 803.53, 803.56, 806.10, and
806.20) have already been approved and are in effect or their
extension is being sought separately as required, including with
respect to burden for combination products (reflected in the
authorization for OMB control number 0910-0834, but, therefore, not
addressed in this extension request). The pertinent PMSR information
collection provisions for Sec. 314.80(c) and (e), as well as for
Sec. 314.81(b) are approved under OMB control numbers 0910-0001,
0910-0230, and 0910-0291. The information collection provisions for
Sec. Sec. 600.80 and 600.81 are approved under OMB control number
0910-0308. Those for Sec. 606.170 are approved under OMB control
number 0910-0116. Those for Sec. 606.171 are approved under OMB
control number 0910-0458. The information collection provisions for
Sec. Sec. 803.50, 803.53, and 803.56 are approved under OMB control
numbers 0910-0291 and 0910-0437. The information collection
provisions for Sec. Sec. 806.10 and 806.20 are approved under OMB
control number 0910-0359.
---------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure and Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures/ Total annual
21 CFR section/activity respondents/ records per disclosures/ Average burden per disclosure/ Total hours
recordkeepers respondent/ records recordkeeping
recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.103, Sharing information with other 33 18 594 0.35 (21 minutes)...................... 208
constituent part applicants.
4.103(b) and 4.105(a)(2), Records of 33 18 594 0.1 (6 minutes)........................ 59
information shared by constituent part
applicants.
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Total...................................... .............. .............. .............. ....................................... 267
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[[Page 23973]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. We note in this regard that FDA extended the compliance date
for 21 CFR part 4, subpart B, until July 2020 for most combination
products, and until January 2021 for the remainder, in response to
stakeholder feedback, to ensure that Combination Product Applicants
have sufficient time to update reporting and recordkeeping systems and
procedures.\2\ Consequently, entities subject to this rule have not yet
had to comply with this information request.
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\2\ See Compliance Policy for Combination Product Postmarketing
Safety Reporting (April 2019) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-combination-product-postmarketing-safety-reporting).
Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09175 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P
