Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Maternal Health Portfolio Evaluation Design, OMB No. 0906-xxxx-NEW, 66569-66570 [2020-23114]
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Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Notices
customer who did not have a
prescription for them. A member of the
conspiracy caused the customs
declaration on the parcel to falsely
report that the parcel contained a health
product sample with no declared value.
As a result of this conviction, FDA
sent Mr. Komar, by certified mail on
June 11, 2020, a notice proposing to
debar him for a 5-year period from
importing or offering for import any
drug into the United States. The
proposal was based on a finding under
section 306(b)(3)(C) of the FD&C Act
that Mr. Komar’s felony conviction for
one felony count under Federal law for
mail fraud was for conduct relating to
the importation into the United States of
any drug or controlled substance
because he illegally caused
bicalutamide and isotretinoin to be
introduced in interstate commerce from
Mumbai, India, by selling to a consumer
who did not have a prescription through
the U.S. mail in violation of 18 U.S.C.
1341.
In proposing a debarment period,
FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C
Act that it considered applicable to Mr.
Komar’s offenses and concluded that
this felony offense warranted the
imposition of a 5-year period of
debarment. The proposal informed Mr.
Komar of the proposed debarment and
offered Mr. Komar an opportunity to
request a hearing, providing him 30
days from the date of receipt of the letter
in which to file the request, and advised
him that failure to request a hearing
constituted a waiver of the opportunity
for a hearing and of any contentions
concerning this action. Mr. Komar
received the proposal and notice of
opportunity for a hearing on June 22,
2020. Mr. Komar failed to request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
his opportunity for a hearing and
waived any contentions concerning his
debarment (21 CFR part 12).
years from importing or offering for
import any drug into the United States,
effective (see DATES). Pursuant to section
301(cc) of the FD&C Act (21 U.S.C.
331(cc)), the importing or offering for
import into the United States of any
drug or controlled substance by, with
the assistance of, or at the direction of
Mr. Komar is a prohibited act.
Any application by Mr. Komar for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2020–
N–1058 and sent to the Dockets
Management Staff (see ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Keith
Komar has been convicted of a felony
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offense should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Komar is debarred for a period of 5
SUMMARY:
VerDate Sep<11>2014
18:08 Oct 19, 2020
Jkt 253001
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23135 Filed 10–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Maternal Health
Portfolio Evaluation Design, OMB No.
0906–xxxx–NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
Comments on this ICR should be
received no later than November 19,
2020.
DATES:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
66569
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Maternal Health Portfolio Evaluation
Design, OMB No. 0906–xxxx [NEW].
Abstract: HRSA programs provide
health care to people who are
geographically isolated, economically,
or medically vulnerable. HRSA
programs help those in need of high
quality primary health care, such as
pregnant women and mothers.
Improving maternal health outcomes
and access to quality maternity care
services is a key component of the
HRSA mission. HRSA’s Maternal and
Child Health Bureau (MCHB) provides
funding to address some of the most
urgent issues influencing the high rates
of maternal mortality. Recent efforts to
address persistent disparities in
maternal, infant, and child health have
employed a ‘‘life course’’ perspective
and health equity lens focused on health
promotion and disease prevention. Life
course approach can be defined as
analyzing people’s lives within
structural, social, and cultural contexts
through a defined sequence of age
categories that people are normally
expected to pass through as they
progress from birth to death. Health
equity is defined as the attainment of
the highest level of health for all people.
Achieving health equity for pregnant
and postpartum women will require
attention to barriers in access to quality
health services and promotion of equal
opportunities to seek the highest
possible level of health and well-being.
Achieving health equity also requires a
focus on social determinants of health.
With this emphasis on improving
maternal health across the life course
and promoting optimal health for all
mothers, HRSA is employing a
multipronged strategy to address
maternal mortality and severe maternal
morbidity through the following suite of
programs:
1. The State Maternal Health
Innovation Program;
ADDRESSES:
E:\FR\FM\20OCN1.SGM
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66570
Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Notices
2. The Alliance for Innovation on
Maternal Health Program:
3. The Alliance for Innovation on
Maternal Health—Community Care
Initiative;
4. The Rural Maternity and Obstetrics
Management Strategies Program; and,
5. The Supporting Maternal Health
Innovation Program.
MCHB is conducting a portfolio-wide
evaluation of HRSA-supported Maternal
Health (MH) Programs with a primary
focus on reducing maternal mortality.
Through this evaluation, MCHB seeks to
identify individual and/or collective
strategies, interrelated activities, and
common themes within and across the
MH Programs that may be contributing
to or driving improvements in key
maternal health outcomes. MCHB seeks
to ascertain which components should
be elevated and replicated to the
national level, as well as inform future
investments to reduce rates of maternal
mortality and severe maternal
morbidity.
A 60-day notice was published in the
Federal Register on June 8, 2020, vol.
85, No. 110; pp. 34739–40. There were
no public comments.
Need and Proposed Use of the
Information: MCHB seeks to understand
the impact of HRSA’s investments in
MH programs. These five programs
represent a total of 12 state-based
programs and three programs with the
potential for national reach. In
understanding the strategies that are
most effective in reducing maternal
morbidity and mortality, program
elements could be replicated and/or
scaled up nationally.
Likely Respondents: Likely
respondents are recipients of the
cooperative agreements mentioned
above (The State Maternal Health
Innovation Program; The Alliance for
Innovation on Maternal Health Program;
The Alliance for Innovation on Maternal
Health—Community Care Initiative; The
Rural Maternity and Obstetrics
Management Strategies Program; and,
The Supporting Maternal Health
Innovation Program) which represents
11 state health agencies, two national
organizations, and two academic
organizations.
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 and 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 ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Instrument
Instrument
Instrument
Instrument
1:
2:
3:
4:
Number
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Interview guide for grantee staff ....................
Interview guide for HRSA POs ......................
Partnership Survey ........................................
Web-based data collection tool .....................
75
7
290
15
1
1
1
1
75
7
290
15
1.00
1.50
0.25
0.50
75.0
10.5
72.5
7.5
Total ..............................................................................
387
........................
387
........................
165.5
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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–23114 Filed 10–19–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Sep<11>2014
18:08 Oct 19, 2020
Jkt 253001
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: Center for Scientific
Review Special Emphasis Panel; Societal and
Ethical Issues in Research.
Date: November 12, 2020.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Benjamin Greenberg
Shapero, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Room 3182, Bethesda, MD 20892, (301) 402–
4786, shaperobg@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Stress, Sleep, Disparities, and
Aging.
Date: November 16, 2020.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Benjamin G. Shapero,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
Bethesda, MD 20892, (301) 402–4786,
shaperobg@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Cancer Immunology and Immunotherapy.
Date: November 17–18, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sarita Kandula Sastry,
Ph.D., Scientific Review Officer, Center for
E:\FR\FM\20OCN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Notices]
[Pages 66569-66570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23114]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request Title: Maternal Health Portfolio Evaluation Design, OMB No.
0906-xxxx-NEW
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the 30
day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than November
19, 2020.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to 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.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION: Information Collection Request Title:
Maternal Health Portfolio Evaluation Design, OMB No. 0906-xxxx [NEW].
Abstract: HRSA programs provide health care to people who are
geographically isolated, economically, or medically vulnerable. HRSA
programs help those in need of high quality primary health care, such
as pregnant women and mothers. Improving maternal health outcomes and
access to quality maternity care services is a key component of the
HRSA mission. HRSA's Maternal and Child Health Bureau (MCHB) provides
funding to address some of the most urgent issues influencing the high
rates of maternal mortality. Recent efforts to address persistent
disparities in maternal, infant, and child health have employed a
``life course'' perspective and health equity lens focused on health
promotion and disease prevention. Life course approach can be defined
as analyzing people's lives within structural, social, and cultural
contexts through a defined sequence of age categories that people are
normally expected to pass through as they progress from birth to death.
Health equity is defined as the attainment of the highest level of
health for all people.
Achieving health equity for pregnant and postpartum women will
require attention to barriers in access to quality health services and
promotion of equal opportunities to seek the highest possible level of
health and well-being. Achieving health equity also requires a focus on
social determinants of health.
With this emphasis on improving maternal health across the life
course and promoting optimal health for all mothers, HRSA is employing
a multipronged strategy to address maternal mortality and severe
maternal morbidity through the following suite of programs:
1. The State Maternal Health Innovation Program;
[[Page 66570]]
2. The Alliance for Innovation on Maternal Health Program:
3. The Alliance for Innovation on Maternal Health--Community Care
Initiative;
4. The Rural Maternity and Obstetrics Management Strategies
Program; and,
5. The Supporting Maternal Health Innovation Program.
MCHB is conducting a portfolio-wide evaluation of HRSA-supported
Maternal Health (MH) Programs with a primary focus on reducing maternal
mortality. Through this evaluation, MCHB seeks to identify individual
and/or collective strategies, interrelated activities, and common
themes within and across the MH Programs that may be contributing to or
driving improvements in key maternal health outcomes. MCHB seeks to
ascertain which components should be elevated and replicated to the
national level, as well as inform future investments to reduce rates of
maternal mortality and severe maternal morbidity.
A 60-day notice was published in the Federal Register on June 8,
2020, vol. 85, No. 110; pp. 34739-40. There were no public comments.
Need and Proposed Use of the Information: MCHB seeks to understand
the impact of HRSA's investments in MH programs. These five programs
represent a total of 12 state-based programs and three programs with
the potential for national reach. In understanding the strategies that
are most effective in reducing maternal morbidity and mortality,
program elements could be replicated and/or scaled up nationally.
Likely Respondents: Likely respondents are recipients of the
cooperative agreements mentioned above (The State Maternal Health
Innovation Program; The Alliance for Innovation on Maternal Health
Program; The Alliance for Innovation on Maternal Health--Community Care
Initiative; The Rural Maternity and Obstetrics Management Strategies
Program; and, The Supporting Maternal Health Innovation Program) which
represents 11 state health agencies, two national organizations, and
two academic organizations.
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 and 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 ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Instrument 1: Interview guide 75 1 75 1.00 75.0
for grantee staff..............
Instrument 2: Interview guide 7 1 7 1.50 10.5
for HRSA POs...................
Instrument 3: Partnership Survey 290 1 290 0.25 72.5
Instrument 4: Web-based data 15 1 15 0.50 7.5
collection tool................
-------------------------------------------------------------------------------
Total....................... 387 .............. 387 .............. 165.5
----------------------------------------------------------------------------------------------------------------
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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-23114 Filed 10-19-20; 8:45 am]
BILLING CODE 4165-15-P
