Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products, 47389-47390 [2020-17041]
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Federal Register / Vol. 85, No. 151 / Wednesday, August 5, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1339]
Pilot Program for Request for
Designation and Pre-Request for
Designation Electronic Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Office of Combination
Products (OCP) in the Food and Drug
Administration (FDA) is soliciting
applications from members of the public
interested in participating in a voluntary
pilot program to help OCP evaluate a
potential new electronic submissions
process for Requests for Designation
(RFD) and Pre-RFD. This RFD and PreRFD electronic submission process is
intended to improve efficiency and
completeness of RFD and Pre-RFD
submissions. OCP plans to accept up to
nine participants for the pilot program.
The pilot program is intended to
provide OCP input to inform this
evaluation.
DATES: Interested parties should submit
an electronic application to participate
in this pilot program by August 19,
2020. We plan to conduct pilot testing
beginning on or about August 26, 2020.
See section III of this document for
information on applying for
participation.
FOR FURTHER INFORMATION CONTACT:
Danita Dixon, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–2889, danita.dixon@
fda.hhs.gov.
ADDRESSES: If you are interested in
participating in this pilot program,
please submit an electronic application
to combination@fda.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
Since its establishment on December
24, 2002, OCP has served as a resource
for sponsors at various stages of
development of their products.
Sponsors often seek OCP feedback on
whether their medical product will be
regulated as a drug, a device, a
biological product, or a combination
product, and which medical product
FDA Center (Center for Devices and
Radiological Health, Center for Drug
Evaluation and Research, or Center for
Biologics Evaluation and Research) will
regulate it if it is a non-combination
product, or will have the primary
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jurisdiction for the premarket review
and regulation of the product if it is a
combination product.
There are two ways that a sponsor can
receive such feedback from OCP. One
option is to submit an RFD to receive a
formal, binding determination for the
sponsor’s product with respect to
classification and/or center assignment.
The RFD process is codified in 21 CFR
part 3, and OCP has issued a guidance
about this process (see ‘‘How to Write a
Request for Designation (RFD)’’ at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/how-write-requestdesignation-rfd). A second option
referred to as the Pre-RFD submission
process, is for a sponsor to submit an
inquiry to OCP to receive a preliminary
assessment of their product’s
classification and/or assignment, which
is not binding. The Pre-RFD process
allows for more flexible interaction
between sponsors and FDA. RFD and
Pre-RFD submissions to OCP are
currently, typically submitted via email,
although some are submitted in paper
copies. Regardless of format, some
submissions lack sufficient data for
review. Consequently, OCP is
announcing a pilot program to test the
functionality of a more structured RFD
and Pre-RFD electronic submission
process that should enhance efficiency
and ensure sponsors’ understanding of
required and recommended submission
content.
II. Pilot Program Participation
The pilot program to evaluate the RFD
and Pre-RFD electronic submission
processes is to last approximately 2
weeks. During the pilot program, OCP
staff will be available to address
questions or concerns that may arise.
Pilot program participants will receive
training and will be asked to submit
simulated regulatory submissions using
data provided to them by OCP for
testing purposes. Pilot program
participants will also be asked to
provide written and verbal feedback
during their training and after they
submit the simulated regulatory
submissions. This feedback will assist
OCP in developing the electronic
submission processes. OCP estimates
that each individual participant’s
involvement may require about 15 hours
over the 2-week period. OCP is
soliciting applications from members of
the public, such as combination product
and other medical product sponsors, as
well as entities that may act as
authorized agents submitting RFDs or
Pre-RFDs for sponsors. At its discretion,
OCP may withdraw a participant from
the pilot program for not completing the
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47389
requested activities within requested
timeframes.
III. Applications for Participation
Send applications to participate in the
pilot program to combination@fda.gov.
Applications should include the
following information: Company and
contact name, contact phone number,
and contact email address. Additionally,
although not required for consideration,
OCP is particularly interested in
whether you are a sponsor or may act
as an authorized agent, and whether you
have previously submitted an RFD or
Pre-RFD. Once applications for
participation are received, FDA will
contact interested applicants to confirm
selection for the pilot program. FDA is
seeking a limited number of participants
(no more than nine) to participate in
this pilot program.
Dated: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17039 Filed 8–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0424]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarketing
Safety Information Sharing by
Constituent Part Applicants for
Combination Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Submit written comments
(including recommendations) on the
collection of information by September
4, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
SUMMARY:
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47390
Federal Register / Vol. 85, No. 151 / Wednesday, August 5, 2020 / Notices
collection is 0910–0834. Also include
the FDA docket number found in
brackets in the heading of this
document.
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Postmarketing Information Sharing
Among Constituent Part Applicants for
Combination Products—21 CFR 4.103
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
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
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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
In the Federal Register of April 30,
2020 (85 FR 23971), we published a 60day 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 THIRD-PARTY DISCLOSURE AND RECORDKEEPING BURDEN
Number of
respondents/
recordkeepers
21 CFR section; activity
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
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: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17041 Filed 8–4–20; 8:45 am]
BILLING CODE 4164–01–P
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Number of
disclosures/
records per
respondent/
recordkeeper
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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
such as patentable material, and
personal information concerning
individuals associated with the program
documents, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Notice is hereby given of a meeting of
the HEAL (Helping to End Addiction
Long-term) Multi-Disciplinary Working
Group.
The meeting will be open to the
public as indicated below via NIH
Videocast. Individuals who need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
Contact Person listed below in advance
of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended.
The program documents and the
discussions could disclose confidential
trade secrets or commercial property
Name of Committee: HEAL MultiDisciplinary Working Group Meeting.
Date: August 31, 2020.
Open: August 31, 2020, 9:00 a.m. to 1:00
p.m.
Closed: August 31, 2020, 1:00 p.m. to 2:50
p.m.
Open: August 31, 2020, 2:50 p.m. to 4:30
p.m.
Agenda: Provide an update on Helping to
End Addiction Long-Term (HEAL) Initiative
projects and obtain expertise from MDWG
relevant to the NIH HEAL Initiative and to
specific HEAL projects.
Videocast: The open portion of the meeting
will be live webcast at: https://
videocast.nih.gov/.
Place: National Institutes of Health
Building 1, Wilson Hall, 1 Center Drive
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rebecca G. Baker, Ph.D.,
Office of the Director, National Institutes of
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
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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]]>Agencies
[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Pages 47389-47390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0424]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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: Submit written comments (including recommendations) on the
collection of information by September 4, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information
[[Page 47390]]
collection is 0910-0834. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Postmarketing Information Sharing Among Constituent Part Applicants for
Combination Products--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.
---------------------------------------------------------------------------
In the Federal Register of April 30, 2020 (85 FR 23971), we
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 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/recordkeeping Total hours
recordkeepers respondent/ records
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.
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. ............................................ 267
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17041 Filed 8-4-20; 8:45 am]
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