Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau Research and Training Grants, OMB No. 0906-New, 46504-46505 [2018-19903]
Download as PDF
<![CDATA[
46504
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section and activity
Total Hours (§ 1107.1(c)) ..............................................
Number of
respondents
Number of
responses per
respondent 2
Total annual
responses
Average
burden per
response
(in hours)
........................
........................
........................
........................
Total hours
732
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemptions granted by Secretary under section 905(j)(3)
Abbreviated report submitted to demonstrate tobacco
product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and
compliant, and modifications covered by exemptions
granted by Secretary under section 905(j)(3) ..................
1217
1
1217
3
3,651
Total Hours (section 905(j)(1)(A)(ii)) of the FD&C Act
........................
........................
........................
........................
3,651
Total Hours Exemptions From Substantial Equivalence Requirements ..................................................
........................
........................
........................
........................
23,871
daltland on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that we will receive
812 exemption requests under
§ 1107.1(b) for 24 hours per response
including EA for a total of 19,488 hours.
Since an EA is required for each
§ 1107.1(b) (Optional Preparation of
Tobacco Product Exemption From
Substantial Equivalence Request), the
burden per response for EAs (12 hours)
has been combined with the 12 hours
for an SE request for a total of 24 hours
per response.
FDA further estimates that we will
receive 244 submissions requiring
additional information in support of the
initial exemption request, and it is
expected that it will take an average of
3 hours to prepare the additional
information for a total of 732 hours.
FDA estimates that 1,217 respondents
will prepare 1,217 responses and each
response will take approximately 3
hours to prepare, as required by section
905(j)(1)(A)(ii) of the FD&C Act, for a
total of 3,651 hours.
This collection of information
requires a manufacturer to submit a
report at least 90 days prior to making
an introduction or delivery for
introduction into interstate commerce
for commercial distribution of a tobacco
product. Section 905(j)(1)(A)(ii) of the
FD&C Act states that if an exemption
has been requested and granted, the
manufacturer must submit to FDA a
report that demonstrates that the
tobacco product is modified within the
meaning of section 905(j)(3), the
modifications are to a product that is
commercially marketed and in
compliance with the requirements of the
FD&C Act, and all the modifications are
covered by exemptions granted by the
Secretary under section 905(j)(3). FDA
estimates the total hours for exemptions
VerDate Sep<11>2014
19:20 Sep 12, 2018
Jkt 244001
from Substantial Equivalence
Requirements will be 23,871 hours.
FDA’s estimates are based on full
analysis of economic impacts and
information gathered from other FDAregulated products. Based on a review of
the currently approved information
collection, we have made no
adjustments to our burden estimate.
Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19913 Filed 9–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Forms for Use With
Applications to the Maternal and Child
Health Bureau Research and Training
Grants, OMB No. 0906—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
public regarding the burden estimate
below or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than November 13,
2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Forms for Use with Applications to the
Maternal and Child Health Bureau
Research and Training Grants, OMB No.
0906–xxxx—New.
Abstract: HRSA currently utilizes the
National Institute of Health’s (NIH)
Biographical Sketch and Public Health
Service (PHS) Inclusion Enrollment
forms (0925–0001) for HRSA’s SF424
Research & Related application package
research grants. In order to update the
forms to meet HRSA’s needs, HRSA
plans to remove the NIH-specific
references and obtain its own OMB
control number for the collection of this
information.
Need and Proposed Use of the
Information: HRSA’s Maternal and
Child Health Bureau (MCHB) plans to
modify the Biographical Sketch and the
E:\FR\FM\13SEN1.SGM
13SEN1
46505
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
PHS Inclusion Enrollment Form in
slightly different ways in order to meet
the needs of its own research and
training grant programs. In MCHB’s
research grant programs, the modified
Biographical Sketch form will be used
by applicants to summarize the
qualifications of each key personnel on
their proposed research team, and grant
reviewers will use this information to
assess the capabilities of the research
team to carry out the research project as
planned. Monitoring inclusion
enrollment is one important component
of ensuring demographic diversity (race,
ethnicity, and gender) among research
study participants in MCHB’s research
grant portfolio. MCHB’s modified PHS
Inclusion Enrollment form will be used
by applicants to summarize their
expected population of research study
participants at the time of submission of
their proposal, and it will also be used
for Enrollment Reporting during the
annual Noncompeting Continuation
Award.
Likely Respondents: Respondents are
applicants to MCHB’s research
programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel to be able to respond to a
collection of information; to search data
sources; to complete and review the
collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
Biographical Sketch for MCHB research grant applicants ..
PHS Inclusion Enrollment form for MCHB research grant
applications .......................................................................
200
5
1,000
2.0
2,000
200
1
200
0.5
100
Total ..............................................................................
400
........................
1,200
........................
2,100
HRSA specifically requests comments
on: (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.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–19903 Filed 9–12–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses
per
respondent
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
VerDate Sep<11>2014
19:20 Sep 12, 2018
Jkt 244001
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
General Medical Sciences Special Emphasis
Panel; Review of NIGMS Support of
Competitive Research (SCORE) Award
Applications.
Date: November 14, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Nina Sidorova, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN.22, Bethesda, MD
20892–6200, 301–594–3663, sidorova@
nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
Dated: September 10, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–19915 Filed 9–12–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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: NIGMS Initial Review
Group; Training and Workforce Development
Subcommittee—C; Review of MARC/RISE
Applications.
Date: October 29–30, 2018.
Time: 8:00 a.m. to 5:00 p.m.
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46504-46505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Forms for Use With Applications to the Maternal
and Child Health Bureau Research and Training Grants, OMB No. 0906--New
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate below or any other aspect of the
ICR.
DATES: Comments on this ICR must be received no later than November 13,
2018.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Forms for Use with
Applications to the Maternal and Child Health Bureau Research and
Training Grants, OMB No. 0906-xxxx--New.
Abstract: HRSA currently utilizes the National Institute of
Health's (NIH) Biographical Sketch and Public Health Service (PHS)
Inclusion Enrollment forms (0925-0001) for HRSA's SF424 Research &
Related application package research grants. In order to update the
forms to meet HRSA's needs, HRSA plans to remove the NIH-specific
references and obtain its own OMB control number for the collection of
this information.
Need and Proposed Use of the Information: HRSA's Maternal and Child
Health Bureau (MCHB) plans to modify the Biographical Sketch and the
[[Page 46505]]
PHS Inclusion Enrollment Form in slightly different ways in order to
meet the needs of its own research and training grant programs. In
MCHB's research grant programs, the modified Biographical Sketch form
will be used by applicants to summarize the qualifications of each key
personnel on their proposed research team, and grant reviewers will use
this information to assess the capabilities of the research team to
carry out the research project as planned. Monitoring inclusion
enrollment is one important component of ensuring demographic diversity
(race, ethnicity, and gender) among research study participants in
MCHB's research grant portfolio. MCHB's modified PHS Inclusion
Enrollment form will be used by applicants to summarize their expected
population of research study participants at the time of submission of
their proposal, and it will also be used for Enrollment Reporting
during the annual Noncompeting Continuation Award.
Likely Respondents: Respondents are applicants to MCHB's research
programs.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel to be able to respond to a
collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Biographical Sketch for MCHB 200 5 1,000 2.0 2,000
research grant applicants......
PHS Inclusion Enrollment form 200 1 200 0.5 100
for MCHB research grant
applications...................
-------------------------------------------------------------------------------
Total....................... 400 .............. 1,200 .............. 2,100
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on: (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.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-19903 Filed 9-12-18; 8:45 am]
BILLING CODE 4165-15-P
