Agency Information Collection Request; 30-Day Public Comment Request, 42131-42132 [2018-17812]
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42131
Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
protocols in fiscal year (FY) 2017, under
the regulations cited previously in this
document. FDA estimates that
approximately 75 manufacturers
submitted protocols under § 610.2 and 2
manufacturers submitted protocols
under the regulation (§ 660.6) for the
other specific product. FDA received no
submissions under §§ 660.36 or 660.46;
however, FDA is using the estimate of
one protocol submission under each
regulation in the event that protocols are
submitted in the future.
regulations, the average burden per
response is based on the higher end of
the estimate (rounded to 5 or 6 hours)
since more information is generally
required to be submitted in the other
protocols than under § 610.2.
In the Federal Register of May 11,
2018, (83 FR 22081), we published a
notice soliciting public comment of the
information collection. No comments
were received.
We therefore estimate the burden of
the information collection as follows:
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2017 for the various
submission requirements of samples
and protocols for the licensed biological
products. The average burden per
response is based on information
provided by industry. The burden
estimates provided by industry ranged
from 1 to 5.5 hours. Under § 610.2, the
hours per response are based on the
average of these estimates and rounded
to 3 hours. Under the remaining
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section/activity
Average
burden per
response
Total annual
responses
Total hours
610.2—Requests for Samples and Protocols; Official Release .................................................................................
660.6(b)—Protocols .............................................................
660.36(a)(2) and (b)—Samples and Protocols ....................
660.46(b)—Protocols ...........................................................
75
2
1
1
86.267
3.5
1
1
6,470
7
1
1
3
5
6
5
19,410
35
6
5
Total ..............................................................................
........................
........................
........................
........................
19,456
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 764 hours and a
corresponding increase of 262
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17859 Filed 8–17–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
ADDRESSES:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
SUPPLEMENTARY INFORMATION:
[Document Identifier: OS–0990–0438]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS
Notice.
AGENCY:
ACTION:
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 19,
2018.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
SUMMARY:
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Office of
Adolescent Health Teen Pregnancy
Prevention, FY 2015–2020 Performance
Measure Collection.
Type of Collection: Extension.
OMB No. 0990–0438.
Abstract: The Office of Adolescent
Health (OAH), U.S. Department of
Health and Human Services (HHS), is
requesting renewal by OMB of the
existing information collection request
for performance measures collection
from the TPP grant recipients.
Performance measure data collection is
a requirement of TPP grants; the
extension will allow for the completion
of data collection from cohort 2. The
collection will provide OAH with
performance data to inform planning
decisions; identify technical assistance
needs for grantees; facilitate grantees’
continuous quality improvement in
program implementation; and provide
HHS, Congress, OMB, and the general
public with information about the
individuals who participate in TPPfunded activities.
daltland on DSKBBV9HB2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Grant Recipient—Dissemination Form ......................................................
Grant Recipient—Partnerships Form ........................................................
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19:04 Aug 17, 2018
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PO 00000
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Fmt 4703
Number of
responses per
respondent
84
84
Sfmt 4703
E:\FR\FM\20AUN1.SGM
Average
burden
per response
(in hours)
2
2
20AUN1
15/60
15/60
Total burden
hours
42
42
42132
Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Number of
respondents
Type of respondent
Grant
Grant
Grant
Grant
Grant
Grant
Average
burden
per response
(in hours)
Number of
responses per
respondent
Total burden
hours
Recipient—Facilitator Training Form ...............................................
Recipient—Healthcare Linkages Form ............................................
Recipient: Participant Reach Form ..................................................
Recipient: Dosage Form ..................................................................
Recipient Fidelity Form ....................................................................
Recipient: Cost Form .......................................................................
84
84
84
84
84
84
2
2
2
2
2
1
15/60
15/60
168/60
102/60
102/60
30/60
42
42
470
286
286
42
Total ....................................................................................................
........................
........................
........................
1252
Terry Clark,
Office of the Secretary, Asst Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2018–17812 Filed 8–17–18; 8:45 am]
BILLING CODE 4168–11–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Committee on
Children and Disasters Public
Teleconference
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services is hereby giving notice that the
National Advisory Committee on
Children and Disasters (NACCD) will
hold a public teleconference on
September 11, 2018.
DATES: The NACCD Public
Teleconference is September 11, 2018,
from 2:00 p.m. to 3:00 p.m. Eastern
Daylight Time (EDT).
ADDRESSES: We encourage members of
the public to attend the public meetings.
To register, send an email to naccd@
hhs.gov with ‘‘NACCD Registration’’ in
the subject line. Submit your comments
to naccd@hhs.gov or via the NACCD
Contact Form located at https://
www.phe.gov/Preparedness/legal/
boards/naccd/Pages/contact.aspx. For
additional information, visit the NACCD
website located at https://www.phe.gov/
naccd.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
of 1972 (5 U.S.C., Appendix, as
amended), and Section 2811A of the
Public Health Service (PHS) Act (42
U.S.C. 300hh–10a), as added by Section
103 of the Pandemic and All-Hazards
Preparedness Reauthorization Act of
2013 (Pub. L. 113–5), the HHS
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:04 Aug 17, 2018
Jkt 244001
Secretary, in consultation with the
Secretary of the U.S. Department of
Homeland Security, established the
NACCD. The purpose of the NACCD is
to provide advice and consultation to
the HHS Secretary with respect to the
medical and public health needs of
children in relation to disasters.
Background: The September 11, 2018,
public teleconference of the NACCD is
dedicated to the presentation,
deliberation, and vote on the Pediatric
Disaster Training Work Group (PDTWG)
and Identifying Metrics of Baseline
Vulnerability (IMBV) reports.
Established under the NACCD in 2017,
the PDTWG met several times over the
past year to evaluate progress since the
2011 National Center for Disaster
Medicine and Public Health consensus
report and to develop recommendations
to further improve pediatric training to
ensure the safety and health of children
in disasters. Separately, in 2018, the
ASPR identified metrics of baseline
community vulnerability as a topic he
would like the NACCD to address and
provide recommendations. On June 28,
2018, the NACCD met publically and inperson to develop metrics via a
facilitated discussion. Takeaways from
this discussion served as the basis for
the IMBV report. We will post
modifications to the agenda on the
NACCD meeting website, which is
located at https://www.phe.gov/naccd.
Availability of Materials: We will post
all teleconference materials prior to the
teleconference on September 11, 2018,
at the website located at https://
www.phe.gov/naccd.
Procedures for Providing Public Input:
Members of the public may attend the
public teleconference via a toll-free callin phone number, which is available on
the NACCD website at https://
www.phe.gov/naccd.
We encourage members of the public
to provide written comments that are
relevant to the NACCD public
teleconference prior to September 11,
2018. Send written comments by email
to naccd@hhs.gov with ‘‘NACCD Public
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Comment’’ in the subject line. The
NACCD Chair will respond to comments
received by September 10, 2018, during
the public teleconference.
Dated: August 13, 2018.
Robert P. Kadlec,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2018–17901 Filed 8–17–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Committee on
Children and Disasters and National
Biodefense Science Board Public
Teleconference
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services is hereby giving notice that the
National Advisory Committee on
Children and Disasters (NACCD) and
National Biodefense Science Board
(NBSB), also known as the National
Preparedness and Response Science
Board (NPRSB), will hold a joint public
teleconference on September 12, 2018.
DATES: The NBSB and NACCD Joint
Public Teleconference is September 12,
2018, from 2:00 p.m. to 3:00 p.m.
Eastern Daylight Time (EDT).
ADDRESSES: We encourage members of
the public to attend the public meetings.
To register, send an email to naccd@
hhs.gov with ‘‘NACCD Registration’’ in
the subject line, or to nprsb@hhs.gov
with ‘‘NBSB Registration’’ in the subject
line. Submit your comments to naccd@
hhs.gov, nprsb@hhs.gov, the NBSB
Contact Form located at https://
www.phe.gov/Preparedness/legal/
boards/nprsb/Pages/RFNBSBComments.
aspx, or the NACCD Contact Form
SUMMARY:
E:\FR\FM\20AUN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42131-42132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17812]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0438]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before September 19,
2018.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Office of Adolescent Health Teen Pregnancy
Prevention, FY 2015-2020 Performance Measure Collection.
Type of Collection: Extension.
OMB No. 0990-0438.
Abstract: The Office of Adolescent Health (OAH), U.S. Department of
Health and Human Services (HHS), is requesting renewal by OMB of the
existing information collection request for performance measures
collection from the TPP grant recipients. Performance measure data
collection is a requirement of TPP grants; the extension will allow for
the completion of data collection from cohort 2. The collection will
provide OAH with performance data to inform planning decisions;
identify technical assistance needs for grantees; facilitate grantees'
continuous quality improvement in program implementation; and provide
HHS, Congress, OMB, and the general public with information about the
individuals who participate in TPP-funded activities.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Grant Recipient--Dissemination Form.......... 84 2 15/60 42
Grant Recipient--Partnerships Form........... 84 2 15/60 42
[[Page 42132]]
Grant Recipient--Facilitator Training Form... 84 2 15/60 42
Grant Recipient--Healthcare Linkages Form.... 84 2 15/60 42
Grant Recipient: Participant Reach Form...... 84 2 168/60 470
Grant Recipient: Dosage Form................. 84 2 102/60 286
Grant Recipient Fidelity Form................ 84 2 102/60 286
Grant Recipient: Cost Form................... 84 1 30/60 42
------------------------------------------------------------------
Total.................................... .............. .............. .............. 1252
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2018-17812 Filed 8-17-18; 8:45 am]
BILLING CODE 4168-11-P
