Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meetings, 63505-63506 [2022-22647]
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63505
Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices
assigned 1 hour acknowledging the
requirement.
Section 1114.15 is an alternative
format of submitting a PMTA that meets
the requirements of § 1114.7 that would
reduce the burden associated with the
submission and review of an
application. Our estimated number of 2
respondents is based on the number
estimated for postmarket reports, which
is 4 bundles (which is approximately 34
products). Not all applicants will
resubmit modifications to previously
authorized products, so we estimate 2
bundles (which is approximately 17
products). FDA estimates further that a
supplemental PMTA will take 25
percent of the time it takes to do an
original submission (including EA
hours) for 428 hours per response. We
estimate a total of 856 burden hours for
this activity.
Under § 1114.17 an applicant may
utilize the resubmission format for the
same tobacco product for which FDA
issued a marketing denial order or for a
new tobacco product that results from
changes necessary to address the
deficiencies described in a marketing
denial order. We are estimating that out
of all bundles received in 2020, 2021,
and 2022, that an average of three
bundles are authorized. If we receive 24
amendments to bundles yearly, we
estimate based on historical data, 58
percent fail at acceptance (down to 8
bundles remaining), 17 percent fail at
filing (down to 7 bundles remaining),
and 25 percent receive marketing orders
(5 left). We also estimate that 50 percent
of the applications that receive
marketing denial orders will try to
resubmit in a year. Thus, this number of
respondents is three (rounded up). FDA
estimates that a resubmission will take
33 percent of the time it takes to
complete an original submission
(including EA hours) at 565 hours per
response for a total of 1,695 hours.
An applicant is required to submit a
PMTA and all supporting and related
documents to FDA in electronic format
that FDA can process, review, and
archive unless an applicant requests,
and FDA grants, a waiver from this
requirement. FDA does not believe we
will receive many waivers, so we have
assigned one respondent to
acknowledge the option to submit a
waiver. Consistent with our other
application estimates for waivers, we
believe it would take .25 hours (15
minutes) per waiver for a total of .25
hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part; activity
Average
burden per
recordkeeping
Total annual
records
Total hours
1114.45; PMTA Records .....................................................
1100.204; Pre-existing Products Records ...........................
1107.3; Exemptions From Substantial Equivalence (SE)
Records ............................................................................
39
1
1
1
39
1
2
2
78
2
1
1
1
2
2
Total ..............................................................................
........................
........................
........................
........................
82
1 There
jspears on DSK121TN23PROD with NOTICES
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2 describes the annual
recordkeeping burden. FDA estimates
that 39 recordkeepers will maintain
records at 2 hours per record. Included
in this estimate are the 15 expected new
recordkeepers of NTN products. Firms
are also required to establish and
maintain records related to SE
exemption requests and pre-existing
products (§ 1100.200 states that subpart
C of part 1100). We expect the burden
hours to be negligible for SE exemption
requests. Firms would have already
established the required records when
submitting the SE exemption request.
Similarly, we expect the hours of to be
negligible for any pre-existing tobacco
products that have already submitted
standalone pre-existing tobacco product
submissions, because firms would have
established the required records when
submitting the standalone pre-existing
tobacco product submissions. We
believe this time is usual and customary
for these firms. We estimate that it
would take 2 hours per record to
establish the required records for a total
of 4 hours.
Relative to the emergency approval by
OMB our estimated burden for the
information collection reflects an
overall increase of 72 hours and a
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corresponding increase of 117
responses/records. We attribute this
adjustment to the addition of NTN
product submissions.
Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22708 Filed 10–18–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Neonatal Research
Network.
Date: November 7–8, 2022.
Closed: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2140, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Joanna Kubler-Kielb,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH 6710B, Rockledge Drive,
Room 2140, Bethesda, MD 20892, (301) 435–
6916, kielbj@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Neonatal Research
Network and Maternal-Fetal Medicine Units
Network: Data Coordinating Centers.
Date: November 10, 2022.
Closed: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\19OCN1.SGM
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63506
Federal Register / Vol. 87, No. 201 / Wednesday, October 19, 2022 / Notices
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Rm. 2127D, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Luis E. Dettin, Ph.D., MS,
MA, Scientific Review Officer, Scientific
Review Branch, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH 6710B, Rockledge
Drive, Rm. 2127D, Bethesda, MD 20892, (301)
219–3400, luis_dettin@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Pediatric Scientist
Development Program.
Date: November 15, 2022.
Closed: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Rm. 2131B, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Jolanta Maria Topczewska,
Ph.D., Scientific Review Branch, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, NIH 6710B,
Rockledge Drive, Rm. 2131B, Bethesda, MD
20892, (202) 309–7153, jolanta.topczewska@
nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Maternal-Fetal
Medicine Units Network: Clinical Centers.
Date: November 17–18, 2022.
Closed: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Rm. 2127D, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Luis E. Dettin, Ph.D., MS,
MA, Scientific Review Officer, Scientific
Review Branch, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH 6710B, Rockledge
Drive, Rm. 2127D, Bethesda, MD 20892, (301)
219–3400, luis_dettin@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Bioprinted Tissues
Constructs.
Date: November 29, 2022.
Closed: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Rm. 2127B, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Chi-Tso Chiu, Ph.D.,
Scientific Review Officer, Scientific Review
Branch (SRB), Eunice Kennedy Shriver
National Institute of Child Health & Human
Development, NIH, DHHS, 6710B Rockledge
Drive, Rm. 2127B, Bethesda, MD 20817, (301)
435–7486, chiuc@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Member Conflict Special Emphasis Panel.
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Jkt 259001
Date: November 30, 2022.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Rm. 2125C, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Moushumi Paul, Ph.D.,
BA, Scientific Review Officer, Scientific
Review Branch (SRB), Eunice Kennedy
Shriver National Institute of Child Health &
Human Development, NIH, DHHS, 6710B
Rockledge Drive, Rm. 2125C, Bethesda, MD
20817, (301) 496–3596, Moushumi.paul@
nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS)
Contact Person: Fungai Chanetsa, Ph.D.,
MPH, Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, National Institutes
of Health, 6705 Rockledge Drive, Room 206–
B, Bethesda, MD 20817, (301) 402–9394,
fungai.chanetsa@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: October 13, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–22645 Filed 10–18–22; 8:45 am]
BILLING CODE 4140–01–P
Dated: October 13, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HOMELAND
SECURITY
[FR Doc. 2022–22647 Filed 10–18–22; 8:45 am]
[Docket No. USCG2022–0349]
Coast Guard
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Member Conflict Institutional
Training T32-Awards.
Date: November 4, 2022.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20817
(Virtual Meeting).
Frm 00033
Fmt 4703
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Coast Guard, DHS.
Notification of issuance of a
certificate of alternative compliance.
AGENCY:
ACTION:
National Institutes of Health
PO 00000
Certificate of Alternative Compliance
for the Hayden Grace, O.N. 1326783
The Coast Guard announces
that the Chief of Prevention, Eighth
Coast Guard District has issued a
certificate of alternative compliance
from the International Regulations for
Preventing Collisions at Sea, 1972 (72
COLREGS), for the HAYDEN GRACE,
O.N. 1326783. We are issuing this notice
because its publication is required by
statute. Due to the construction and
placement of mast lights, stern light,
and sidelights, HAYDEN GRACE cannot
fully comply with the light, shape, or
sound signal provisions of the 72
COLREGS without interfering with the
vessel’s design and construction. This
notification of issuance of a certificate of
alternative compliance promotes the
Coast Guard’s marine safety mission.
DATES: The Certificate of Alternative
Compliance was issued on October 4,
2022.
SUMMARY:
For
information or questions about this
notice call or email Lieutenant
Commander Jessica Flennoy, District
Eight, Prevention Division, U.S. Coast
Guard, telephone 504–671–2156, email
Jessica.Flennoy@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Notices]
[Pages 63505-63506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22647]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and
Human Development; Notice of Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; Neonatal Research Network.
Date: November 7-8, 2022.
Closed: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, 6710B
Rockledge Drive, Room 2140, Bethesda, MD 20892-7510 (Virtual
Meeting).
Contact Person: Joanna Kubler-Kielb, Scientific Review Officer,
Scientific Review Branch, Eunice Kennedy Shriver National Institute
of Child Health and Human Development, NIH 6710B, Rockledge Drive,
Room 2140, Bethesda, MD 20892, (301) 435-6916, [email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; Neonatal Research Network and
Maternal-Fetal Medicine Units Network: Data Coordinating Centers.
Date: November 10, 2022.
Closed: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
[[Page 63506]]
Place: National Institutes of Health, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, 6710B
Rockledge Drive, Rm. 2127D, Bethesda, MD 20892-7510 (Virtual
Meeting).
Contact Person: Luis E. Dettin, Ph.D., MS, MA, Scientific Review
Officer, Scientific Review Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human Development, NIH 6710B,
Rockledge Drive, Rm. 2127D, Bethesda, MD 20892, (301) 219-3400,
[email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; Pediatric Scientist Development
Program.
Date: November 15, 2022.
Closed: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, 6710B
Rockledge Drive, Rm. 2131B, Bethesda, MD 20892-7510 (Virtual
Meeting).
Contact Person: Jolanta Maria Topczewska, Ph.D., Scientific
Review Branch, Eunice Kennedy Shriver National Institute of Child
Health and Human Development, NIH 6710B, Rockledge Drive, Rm. 2131B,
Bethesda, MD 20892, (202) 309-7153, [email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; Maternal-Fetal Medicine Units
Network: Clinical Centers.
Date: November 17-18, 2022.
Closed: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, 6710B
Rockledge Drive, Rm. 2127D, Bethesda, MD 20892-7510 (Virtual
Meeting).
Contact Person: Luis E. Dettin, Ph.D., MS, MA, Scientific Review
Officer, Scientific Review Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human Development, NIH 6710B,
Rockledge Drive, Rm. 2127D, Bethesda, MD 20892, (301) 219-3400,
[email protected].
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; Bioprinted Tissues Constructs.
Date: November 29, 2022.
Closed: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, 6710B
Rockledge Drive, Rm. 2127B, Bethesda, MD 20892-7510 (Virtual
Meeting).
Contact Person: Chi-Tso Chiu, Ph.D., Scientific Review Officer,
Scientific Review Branch (SRB), Eunice Kennedy Shriver National
Institute of Child Health & Human Development, NIH, DHHS, 6710B
Rockledge Drive, Rm. 2127B, Bethesda, MD 20817, (301) 435-7486,
[email protected].
Name of Committee: National Institute of Child Health and Human
Development Member Conflict Special Emphasis Panel.
Date: November 30, 2022.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, 6710B
Rockledge Drive, Rm. 2125C, Bethesda, MD 20892-7510 (Virtual
Meeting).
Contact Person: Moushumi Paul, Ph.D., BA, Scientific Review
Officer, Scientific Review Branch (SRB), Eunice Kennedy Shriver
National Institute of Child Health & Human Development, NIH, DHHS,
6710B Rockledge Drive, Rm. 2125C, Bethesda, MD 20817, (301) 496-
3596, [email protected].
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance Program Nos. 93.865,
Research for Mothers and Children, National Institutes of Health,
HHS)
Dated: October 13, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-22647 Filed 10-18-22; 8:45 am]
BILLING CODE 4140-01-P
