Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey, 72407-72408 [2024-19865]
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Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Notices
and reports of the withdrawal of an
approved drug from sale under
§ 314.81(b)(3)(iii).
We estimate 1,000 firms will expend
40 hours to prepare, review, and
approve a standard operating procedure
(SOP), for a total of 40,000 hours
annually. Although we expect most
respondents will have already prepared
and implemented an SOP for the
electronic submission of drug
establishment registration and drug
listing information, we retain an
estimate for new firms that will do so,
as recommended in the guidance
document.
Additionally, we assume 10,480
registrants, (accounting for both
biological product and drug product
registrants) are subject to the reporting
provisions under section 510(j)(3) of the
FD&C Act but exclude 1,780
respondents to reflect the reporting
exemptions implemented under section
510(j)(3)(B) pertaining to: (1) blood and
blood components for transfusion and
(2) cell and gene therapy products,
where one lot treats a single patient.
Also, based on informal
communications, we have increased the
estimated burden we attribute to
prepare and submit the requisite
information for reporting provisions
under section 510(j)(3) of the FD&C Act
from 15 minutes to 1 hour.
Regarding notifications to FDA of
changes in the production of animal
drugs associated with the guidance
document entitled ‘‘Reporting and
Mitigating Animal Drug Shortages,’’ we
estimate that 30 respondents will
provide two notifications each year and
that it will take 1 hour to prepare and
submit each notification.
Finally, regarding the information
collection associated with the guidance
document entitled ‘‘Planning for the
Effects of High Absenteeism to Ensure
Availability of Medically Necessary
Drug Products,’’ we assume two
notifications (for purposes of this
analysis, we consider an activation and
a deactivation notification to equal one
notification) will be submitted to CDER
annually, and estimate each notification
requires 16 hours to prepare and submit.
As FDA issued the guidance in 2011, we
now assume that most respondents have
developed the recommended Plan, and
therefore, we limit our current burden
estimate to updates and maintenance.
Accordingly, we estimate 70
manufacturers will update or maintain
the recommended Plan and those
changes would take approximately 250
hours per manufacturer.
Our estimated burden for the
information collection reflects an
overall decrease of 65,934 responses/
VerDate Sep<11>2014
22:19 Sep 04, 2024
Jkt 262001
records but an overall increase of
144,913 hours annually. We attribute
adjustments to our reevaluation of the
number of submissions we received
over the last few years for the provisions
in part 207 and the increase in the
estimated burden per response to 1 hour
to prepare and submit the requisite
information for the reporting provisions
under section 510(j)(3) of the FD&C Act.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19862 Filed 9–4–24; 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; Submission for Office of
Management and Budget Review;
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 we) 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 October 7,
2024.
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
collection is 0910–0912. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
72407
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Yale-Mayo Clinic Centers of Excellence
in Regulatory Science and Innovation
(CERSI) B12 Pediatric Device Survey
OMB Control Number 0910–0912—
Reinstatement
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
labeled for pediatric patients. To
address these challenges, this collection
is being done to survey industry and
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.
In the Federal Register of May 22,
2024 (89 FR 44993), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05SEN1.SGM
05SEN1
72408
Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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).
Substantial turnover in the graduate
students administering the survey made
it necessary to bring in a new cohort of
students and train them in the issues
relevant to the survey. As a result, we
were unable to field the B12 Pediatrics
survey before the OMB approval
expiration date and are seeking a
reinstatement to complete data
collection. To better ensure timely
completion of the data collection, the
Yale CERSI team has shifted
responsibility for conducting the survey
and other aspects of the study to a Yale
Staff Associate Research Scientist.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
VerDate Sep<11>2014
22:19 Sep 04, 2024
Jkt 262001
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19865 Filed 9–4–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1530]
Control of Nitrosamine Impurities in
Human Drugs; 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 final
guidance for industry entitled ‘‘Control
of Nitrosamine Impurities in Human
Drugs.’’ This guidance recommends
steps manufacturers of active
pharmaceutical ingredients (APIs) and
drug products should take to detect and
prevent unacceptable levels of
nitrosamine impurities in
pharmaceutical products. The guidance
describes two general structural classes
of nitrosamine impurities: smallmolecule nitrosamine impurities (i.e.,
nitrosamine impurities that do not share
structural similarity to the API), and
nitrosamine drug substance-related
impurities (NDSRIs), which share
structural similarity to the API and are
generally unique to each API. The
potential root causes of small-molecule
nitrosamine impurities and NDSRI
formation, detection of nitrosamine
impurities, and recommendations for
risk assessments, testing, and
implementation of controls and other
appropriate strategies to prevent or
reduce the presence of small-molecule
nitrosamine impurities and NDSRIs are
provided. This guidance revises the
final guidance of the same name issued
on February 24, 2021.
SUMMARY:
PO 00000
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Fmt 4703
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The announcement of the
guidance is published in the Federal
Register on September 5, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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 submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
E:\FR\FM\05SEN1.SGM
05SEN1
]]>Agencies
[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Notices]
[Pages 72407-72408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19865]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1894]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) 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 October 7, 2024.
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 collection is 0910-0912. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Yale-Mayo Clinic Centers of Excellence in Regulatory Science and
Innovation (CERSI) B12 Pediatric Device Survey
OMB Control Number 0910-0912--Reinstatement
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 labeled for
pediatric patients. To address these challenges, this collection is
being done to survey industry and 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.
In the Federal Register of May 22, 2024 (89 FR 44993), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 72408]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \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).
Substantial turnover in the graduate students administering the
survey made it necessary to bring in a new cohort of students and train
them in the issues relevant to the survey. As a result, we were unable
to field the B12 Pediatrics survey before the OMB approval expiration
date and are seeking a reinstatement to complete data collection. To
better ensure timely completion of the data collection, the Yale CERSI
team has shifted responsibility for conducting the survey and other
aspects of the study to a Yale Staff Associate Research Scientist.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19865 Filed 9-4-24; 8:45 am]
BILLING CODE 4164-01-P
