Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Combination Products: How To Prepare a Pre-Request for Designation, 16369-16370 [2020-06031]
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Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices
COVID–19 public health emergency.
Therefore, we are canceling or
postponing all non-essential meetings
through the month of April. We will
reassess on an ongoing basis for future
months. Therefore, this meeting is being
postponed. The meeting was announced
in the Federal Register on February 13,
2020.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268,
Silver Spring, MD 20993–0002, 240–
402–8054, christina.vert@fda.hhs.gov, 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, which was announced in the
Federal Register of February 13, 2020,
85 FR 8299.
Dated: March 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06082 Filed 3–20–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2020–N–0956]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Combination
Products: How To Prepare a PreRequest for Designation
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, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the type of
information recommended for a PreRequest for Designation (Pre-RFD)
submission.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:26 Mar 20, 2020
Jkt 250001
Submit either electronic or
written comments on the collection of
information by May 22, 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 May 22, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 22, 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.
DATES:
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 submitte, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA 2020–
N–0956 for ‘‘Combination Products:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
16369
How to Prepare a Pre-Request for
Designation.’’ 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.
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
E:\FR\FM\23MRN1.SGM
23MRN1
16370
Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices
(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.
Guidance for Industry and Food and
Drug Administration Staff;
Combination Products: How to Write a
Pre-Request For Designation
OMB Control Number 0845—Extension
The purpose of this guidance is to
clarify the type of information the Office
of Combination Products (OCP)
recommends that a sponsor include in
a Pre-RFD. This goal of this guidance is
to assist sponsors in obtaining a
preliminary assessment from the U.S.
Food and Drug Administration (FDA or
Agency) through the Pre-RFD process.
The Pre-RFD process is available to
provide informal, non-binding feedback
regarding the regulatory identity or
classification of a human medical
product as a drug, device, biological
product, or combination product. In
addition, this informal process provides
information about a non-combination or
combination product’s assignment to
the appropriate Agency Center (Center
for Drug Evaluation and Research
(CDER), Center for Devices and
Radiological Health (CDRH), or Center
for Biologics Evaluation and Research
(CBER)) for premarket review and
regulation. Specifically, this guidance
explains the Pre-RFD process at the
Office of Combination Products (OCP)
and helps a sponsor understand the type
of information to provide in a Pre-RFD.
This guidance describes how to prepare
a Pre-RFD submission. The guidance
provides recommendations regarding
the information that should be
submitted in a Pre-RFD request and
procedures that should be followed for
meetings or conference calls between
the Office of Combination Products, the
Centers, and industry representatives or
sponsors.
The proposed collections of
information are necessary to allow the
Agency to receive Pre-RFD requests in
order to implement this voluntary
submission program.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses
per
respondent
Total hours
Pre-RFD Submissions .........................................................
Pre-RFD Meetings ...............................................................
83
83
1
1
83
83
12
1
996
83
Total ..............................................................................
........................
........................
........................
........................
1,079
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 decrease of 689 hours. We
attribute this adjustment to a decrease in
response time for the number of
submissions we received over the past
3 years.
Dated: March 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06031 Filed 3–20–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1106]
Policy for Temporary Compounding of
Certain Alcohol-Based Hand Sanitizer
Products During the Public Health
Emergency; Immediately in Effect
Guidance for Industry; 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
guidance for industry entitled ‘‘Policy
for Temporary Compounding of Certain
Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency.’’
Due to the Coronavirus Disease 2019
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Average
burden per
response
Total annual
responses
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17:26 Mar 20, 2020
Jkt 250001
PO 00000
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(COVID–19) pandemic, FDA has
received a number of queries concerning
compounding of alcohol-based hand
sanitizers. The Agency is issuing this
guidance to communicate its policy for
the temporary compounding of certain
alcohol-based hand sanitizer products
by pharmacists in State-licensed
pharmacies or Federal facilities and
registered outsourcing facilities (referred
to collectively in this notice and the
guidance as compounders) for the
duration of the public health emergency
declared by the Secretary of Health and
Human Services on January 31, 2020.
The guidance document is immediately
in effect, but it remains subject to
comment in accordance with the
Agency’s good guidance practices.
The announcement of the
guidance is published in the Federal
Register on March 23, 2020. The
guidance document is immediately in
DATES:
E:\FR\FM\23MRN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16369-16370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2020-N-0956]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff; Combination Products: How To Prepare a Pre-Request for
Designation
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, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on the type of
information recommended for a Pre-Request for Designation (Pre-RFD)
submission.
DATES: Submit either electronic or written comments on the collection
of information by May 22, 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 May 22, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 22, 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 submitte, marked and identified, as
confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA 2020-N-0956 for ``Combination Products: How to Prepare a Pre-
Request for Designation.'' 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.
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
[[Page 16370]]
(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.
Guidance for Industry and Food and Drug Administration Staff;
Combination Products: How to Write a Pre-Request For Designation
OMB Control Number 0845--Extension
The purpose of this guidance is to clarify the type of information
the Office of Combination Products (OCP) recommends that a sponsor
include in a Pre-RFD. This goal of this guidance is to assist sponsors
in obtaining a preliminary assessment from the U.S. Food and Drug
Administration (FDA or Agency) through the Pre-RFD process. The Pre-RFD
process is available to provide informal, non-binding feedback
regarding the regulatory identity or classification of a human medical
product as a drug, device, biological product, or combination product.
In addition, this informal process provides information about a non-
combination or combination product's assignment to the appropriate
Agency Center (Center for Drug Evaluation and Research (CDER), Center
for Devices and Radiological Health (CDRH), or Center for Biologics
Evaluation and Research (CBER)) for premarket review and regulation.
Specifically, this guidance explains the Pre-RFD process at the Office
of Combination Products (OCP) and helps a sponsor understand the type
of information to provide in a Pre-RFD. This guidance describes how to
prepare a Pre-RFD submission. The guidance provides recommendations
regarding the information that should be submitted in a Pre-RFD request
and procedures that should be followed for meetings or conference calls
between the Office of Combination Products, the Centers, and industry
representatives or sponsors.
The proposed collections of information are necessary to allow the
Agency to receive Pre-RFD requests in order to implement this voluntary
submission program.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Pre-RFD Submissions............. 83 1 83 12 996
Pre-RFD Meetings................ 83 1 83 1 83
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,079
----------------------------------------------------------------------------------------------------------------
\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 decrease of 689 hours. We attribute this adjustment to a
decrease in response time for the number of submissions we received
over the past 3 years.
Dated: March 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06031 Filed 3-20-20; 8:45 am]
BILLING CODE 4164-01-P
