Agency Information Collection Activities; Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey, 58106-58108 [2022-20626]
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
the questionnaire programming works
as expected. For the main study, we will
then recruit 350 consumers who selfidentify as having been diagnosed with
diabetes and 350 primary care
physicians who treat diabetes. Each
participant will see one of five versions
of a consumer web page for a fictitious
prescription diabetes treatment, as
reflected in table 1. They will answer a
questionnaire designed to take no more
than 20 minutes regarding their
perception of the product’s benefits,
risks, and effect on adherence.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
respondents
Average burden
per response
Screener Consumers .....................................................
Screener Primary Care Physicians ...............................
Pretest Consumers ........................................................
Pretest Primary Care Physicians ...................................
Main Study Consumers .................................................
680
680
50
50
350
1
1
1
1
1
680
680
50
50
350
Main Study Primary Care Physicians ............................
Total ........................................................................
350
........................
1
........................
350
........................
1 There
.08
.08
.33
.33
.33
Total hours
(5 minutes) ....
(5 minutes) ....
(20 minutes) ..
(20 minutes) ..
(20 minutes) ..
54.4
54.4
16.5
16.5
115.5
.33 (20 minutes) ..
..............................
115.5
372.8
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
2 Burden
lotter on DSK11XQN23PROD with NOTICES1
References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852) and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also
are available electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
*1. World Health Organization, ‘‘Adherence
to Long-Term Therapies: Evidence for
Action,’’ p. 3, 2003, available at https://
apps.who.int/iris/handle/10665/42682,
accessed May 16, 2022.
2. Frias, J., N. Virdi, P. Raja, et al.,
‘‘Effectiveness of Digital Medicines to
Improve Clinical Outcomes in Patients
with Uncontrolled Hypertension and
Type 2 Diabetes: Prospective, OpenLabel, Cluster-Randomized Pilot Clinical
Trial,’’ Journal of Medical Internet
Research, vol. 19, Issue 7, Article e246,
2017, doi:10.2196/jmir.7833.
3. Kleinsinger, F., ‘‘The Unmet Challenge of
Medication Nonadherence,’’ The
Permanente Journal, vol. 22, Issue 3,
Article 18–033, 2018, doi:10.7812/TPP/
18–033.
4. Karumbi, J. and P. Garner, ‘‘Directly
Observed Therapy for Treating
Tuberculosis,’’ Cochrane Database of
Systematic Reviews, Issue 5, Article
CD003343, 2015, doi:10.1002/
14651858.CD003343.pub4.
VerDate Sep<11>2014
17:04 Sep 22, 2022
Jkt 256001
5. Dayer, L., S. Heldenbrand, P.O. Gubbins,
et al., ‘‘Smartphone Medication
Adherence Apps: Potential Benefits to
Patients and Providers,’’ Journal of the
American Pharmacy Association (2003),
vol. 53, Issue 2, pp. 172–181, 2013,
doi:10.1331/JAPhA.2013.12202.
*6. FDA, ‘‘FDA Approves Pill with Sensor
That Digitally Tracks If Patients Have
Ingested Their Medication,’’ FDA News
Release, November 13, 2017, available at
https://www.fda.gov/news-events/pressannouncements/fda-approves-pillsensor-digitally-tracks-if-patients-haveingested-their-medication, accessed May
16, 2022.
7. Browne, S.H., Y. Behzadi, and G.
Littlewort, ‘‘Let Visuals Tell the Story:
Medication Adherence in Patients with
Type II Diabetes Captured by a Novel
Ingestion Sensor Platform,’’ JMIR
mHealth uHealth, vol. 3, Issue 4, Article
e108, 2015, doi:10.2196/mhealth.4292.
8. Eisenberger, U., R.P. Wu¨thrich, A. Bock, et
al., ‘‘Medication Adherence Assessment:
High Accuracy of the New Ingestible
Sensor System in Kidney Transplants,’’
Transplantation, vol. 96, Issue 3, pp.
245–250, 2013, doi:10.1097/
TP.0b013e31829b7571.
9. Chai, P.R., S. Carreiro, B.J. Innes, et al.,
‘‘Oxycodone Ingestion Patterns in Acute
Fracture Pain with Digital Pills,’’
Anesthesia and Analgesia, vol. 125,
Issue 6, pp. 2105–2112, 2017,
doi:10.1213/ANE.0000000000002574.
*10. Amgen Inc., ‘‘Enbrel (etanercept):
Highlights of Prescribing Information,’’
revised April 2021, available at https://
www.pi.amgen.com/∼/media/amgen/
repositorysites/pi-amgen-com/enbrel/
enbrel_pi.pdf, accessed May 16, 2022.
*11. Reuter, E., ’’ ‘Smart Pill’ Startup EtectRx
Strikes Partnership with Pear
Therapeutics,’’ Med City News, January
14, 2021, available at https://
medcitynews.com/2021/01/smart-pillstartup-etectrx-strikes-partnership-withpear-therapeutics, accessed May 16,
2022.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
12. The Medical Futurist, ‘‘The Present and
Future of Digital Pills,’’ July 21, 2020,
available at https://medicalfuturist.com/
the-present-and-future-of-digital-pills,
accessed May 16, 2022.
13. George, C.E., ‘‘Should a Psychiatrist
Prescribe a Nanodrug to Help Parents
Monitor a Teen’s Adherence?,’’ AMA
Journal of Ethics, vol. 21, issue 4, article
e317–323, 2019, doi:10.1001/
amajethics.2019.317.
*14. Yang, M., ‘‘A Psychiatrist’s Perspective
on the Digital Pill,’’ KevinMD.com,
December 2, 2017, available at https://
www.kevinmd.com/blog/2017/12/
psychiatrists-perspective-digitalpill.html, accessed May 16, 2022.
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20636 Filed 9–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1894]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Yale-Mayo Clinic
Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric
Device Survey
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
SUMMARY:
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on ‘‘Yale-Mayo Clinic
Centers of Excellence in Regulatory
Science and Innovation (CERSI) B12
Pediatric Device Survey.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by
November 22, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 22, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
lotter on DSK11XQN23PROD with NOTICES1
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
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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–
2022–N–1894 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; YaleMayo Clinic Centers of Excellence in
Regulatory Science and Innovation
(CERSI) B12 Pediatric Device Survey.’’
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, 240–402–7500.
• 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, 240–402–7500.
PO 00000
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58107
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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
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.
Yale-Mayo Clinic Centers of Excellence
in Regulatory Science and Innovation
(CERSI) B12 Pediatric Device Survey
OMB Control Number NEW
Despite numerous legislative,
regulatory, and scientific efforts, there
has been little change in the number of
devices approved for use in pediatric
patients. This has often led to devices
being adapted for use in children
without an appropriate level of
evidence, exposing them to inconsistent
benefit risk profiles. This health
inequity highlights the need for devices
that are designed, evaluated, and
labelled for pediatric patients. To
address these challenges, this collection
is being done to survey industry and
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
other key stakeholders in the medical
device ecosystem to identify the barriers
that prevent product developers from
entering the pediatric device market as
well as the proper incentives that would
motivate them to innovate and sustain
within this market.
This survey is a followup to the
public meeting that FDA held in August
2018, entitled, ‘‘Pediatric Medical
Device Development.’’ As mandated by
section 502(d) of the FDA
Reauthorization Act of 2017 (Pub. L.
115–52) the meeting was convened to
address several topics, including
consideration of ways to: (1) increase
FDA assistance to medical device
manufacturers in developing devices for
pediatric populations that are approved
or cleared, and labeled, for their use and
(2) identify current barriers to pediatric
device development and incentives to
address such barriers.
Feedback from this meeting clarified
the need to better understand factors
influencing suboptimal engagement and
participation by diverse innovators in
the pediatric medical device space.
Information garnered from this survey
may help inform strategic plans to
optimize existing programs for the
needs of pediatric medical device
innovators and develop new programs
that will support sustained development
in this space.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours 2
Phone Survey ...................................
Online Survey ...................................
17
56
1
1
17
56
0.5 (30 minutes) ...............................
1 .......................................................
9
56
Total ...........................................
........................
........................
........................
...........................................................
65
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest hour.
lotter on DSK11XQN23PROD with NOTICES1
2 Rounded
The targeted groups for this collection
of information include representatives
from the medical device industry,
academia, recipients of funding under
section 305 of the Pediatric Medical
Device Safety and Improvement Act of
2007 (Pub. L. 110–85; 42 U.S.C. 282
note), and trade organizations, medical
provider organizations, organizations
and individuals involved with financing
and reimbursement associated with
medical devices, pediatric healthcare
leaders, clinicians who regularly use
medical devices in caring for children,
and organizations and individuals
representing patients and consumers.
Phone survey: Respondents
participating in the phone survey will
be executives from companies either
producing products in pediatrics or
from companies that produce products
that could be used in pediatrics.
Executives will be invited to engage in
the 30-minute phone survey.
Online survey: The 1-hour online
survey will be administered to leaders
within pediatric companies and key
decision makers in the pediatric
medical device industry (e.g., venture
capitalists, banking investors, leaders in
children’s hospitals and research
networks, and pediatric patient
advocates).
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20626 Filed 9–22–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:48 Sep 22, 2022
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0317]
Roy Tuccillo, Jr.: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Roy Tuccillo, Jr. for a period of 5 years
from importing articles of food or
offering such articles for importation
into the United States. FDA bases this
order on a finding that Mr. Tuccillo was
convicted of a felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food. Mr. Tuccillo was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of July 15, 2022 (30 days
after receipt of the notice), Mr. Tuccillo
has not responded. His failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable
September 23, 2022.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
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1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food.
On November 9, 2021, Mr. Tuccillo
was convicted as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S.
District Court for the Eastern District of
New York, when the court accepted his
plea of guilty and entered judgment
against him for the offense of conspiracy
to commit wire fraud in violation of 18
U.S.C. 371 and 1343.
FDA’s finding that the debarment is
appropriate is based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows: As stated in the indictment,
filed September 26, 2018, transcript of
guilty pleas, filed December 26, 2019,
and Magistrate Judge Steven Locke’s
report and recommendation, filed May
E:\FR\FM\23SEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58106-58108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20626]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1894]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric Device Survey
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
[[Page 58107]]
1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Yale-Mayo Clinic Centers of Excellence in
Regulatory Science and Innovation (CERSI) B12 Pediatric Device
Survey.''
DATES: Either electronic or written comments on the collection of
information must be submitted by November 22, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2022-N-1894 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of
Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric
Device Survey.'' 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, 240-402-7500.
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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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 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.
Yale-Mayo Clinic Centers of Excellence in Regulatory Science and
Innovation (CERSI) B12 Pediatric Device Survey
OMB Control Number NEW
Despite numerous legislative, regulatory, and scientific efforts,
there has been little change in the number of devices approved for use
in pediatric patients. This has often led to devices being adapted for
use in children without an appropriate level of evidence, exposing them
to inconsistent benefit risk profiles. This health inequity highlights
the need for devices that are designed, evaluated, and labelled for
pediatric patients. To address these challenges, this collection is
being done to survey industry and
[[Page 58108]]
other key stakeholders in the medical device ecosystem to identify the
barriers that prevent product developers from entering the pediatric
device market as well as the proper incentives that would motivate them
to innovate and sustain within this market.
This survey is a followup to the public meeting that FDA held in
August 2018, entitled, ``Pediatric Medical Device Development.'' As
mandated by section 502(d) of the FDA Reauthorization Act of 2017 (Pub.
L. 115-52) the meeting was convened to address several topics,
including consideration of ways to: (1) increase FDA assistance to
medical device manufacturers in developing devices for pediatric
populations that are approved or cleared, and labeled, for their use
and (2) identify current barriers to pediatric device development and
incentives to address such barriers.
Feedback from this meeting clarified the need to better understand
factors influencing suboptimal engagement and participation by diverse
innovators in the pediatric medical device space. Information garnered
from this survey may help inform strategic plans to optimize existing
programs for the needs of pediatric medical device innovators and
develop new programs that will support sustained development in this
space.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response \2\
----------------------------------------------------------------------------------------------------------------
Phone Survey.................. 17 1 17 0.5 (30 minutes) 9
Online Survey................. 56 1 56 1............... 56
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 65
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Rounded to the nearest hour.
The targeted groups for this collection of information include
representatives from the medical device industry, academia, recipients
of funding under section 305 of the Pediatric Medical Device Safety and
Improvement Act of 2007 (Pub. L. 110-85; 42 U.S.C. 282 note), and trade
organizations, medical provider organizations, organizations and
individuals involved with financing and reimbursement associated with
medical devices, pediatric healthcare leaders, clinicians who regularly
use medical devices in caring for children, and organizations and
individuals representing patients and consumers.
Phone survey: Respondents participating in the phone survey will be
executives from companies either producing products in pediatrics or
from companies that produce products that could be used in pediatrics.
Executives will be invited to engage in the 30-minute phone survey.
Online survey: The 1-hour online survey will be administered to
leaders within pediatric companies and key decision makers in the
pediatric medical device industry (e.g., venture capitalists, banking
investors, leaders in children's hospitals and research networks, and
pediatric patient advocates).
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20626 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P
