Agency Forms Undergoing Paperwork Reduction Act Review, 56458-56459 [2019-23018]
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56458
Federal Register / Vol. 84, No. 204 / Tuesday, October 22, 2019 / Notices
purpose of this revision is three-fold: (1)
Implement updates to the web-based
system to improve performance,
functionality, and accessibility, (2) add
new data elements to the system and
minimal revisions to the NVDRS coding
manual; and (3) modify burden hours to
account for the increase in violent
deaths that have occurred in the U.S.
since 2003.
Consequently, these revisions impact
the number of responses per
respondent, increasing it from 1,000 (as
(Puerto Rico, Guam, American Samoa,
and the Commonwealth of the Northern
Mariana Islands (Northern Marianas,
U.S. Virgin Islands). Our request is to
continue with the number of
respondents at 56, continuing to
exclude large local health departments
as an independent respondent in
NVDRS. CDC requests approval for an
estimated 37,800 burden hours,
annually. There are no costs to
respondents other than their time.
written in previous OMB requests) to
1,350, resulting in an increase in the
total burden hours for retrieval of these
records from 29,500 to 37,800. NVDRS
has always had the goal to be a
nationally representative surveillance
system, operating in all 50 states, the
District of Columbia, and U.S.
territories. In the previous OMB
package, we calculated the number of
respondents to be 56, which included
50 states, the District of Columbia, and
5 U.S. territory health departments
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Form name
Public Agencies ................................
Retrieving and refile records (Att. 6)
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–23017 Filed 10–21–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–19AWX]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled WISEWOMAN
National Program Evaluation to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on May 30, 2019 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
VerDate Sep<11>2014
17:02 Oct 21, 2019
No. of
respondents
Jkt 250001
30/60
37,800
........................
........................
........................
37,800
WISEWOMAN National Program
Evaluation—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Fmt 4703
Total burden
hours
1,350
Proposed Project
Frm 00048
Average
burden per
response
(in hours)
56
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
PO 00000
No. responses
per
respondent
Sfmt 4703
Background and Brief Description
The CDC has supported the
WISEWOMAN (Well-Integrated
Screening and Evaluation for Women
Across the Nation) program since 1995.
The WISEWOMAN program is designed
to serve low-income women ages 40–64
who have elevated risk factors for
cardiovascular disease (CVD) and have
no health insurance, or are
underinsured for medical and
preventive care services. Through the
WISEWOMAN program, women have
access to screening services for selected
CVD risk factors such as elevated blood
cholesterol, hypertension, and abnormal
blood glucose levels; referrals to heathy
behavior support programs; and
referrals to medical care. WISEWOMAN
participants must be co-enrolled in the
CDC-sponsored National Breast and
Cervical Cancer Early Detection Program
(NBCCEDP).
The WISEWOMAN program is
administered through cooperative
agreements with state, territorial, or
tribal health departments. Each
WISEWOMAN recipient submits to CDC
an annual progress report that describes
program objectives and activities, and
semi-annual data reports (known as
minimum data elements, or MDE) on
the screening, assessment, and healthy
behavior support services offered to
women who participate in the program.
Participant-level MDE are de-identified
prior to transmission to CDC.
In 2018, CDC released the fifth
funding opportunity announcement
(FOA) for the WISEWOMAN program
(DP18–1816), which resulted in fiveyear cooperative agreements with 24
state, territorial, and tribal health
E:\FR\FM\22OCN1.SGM
22OCN1
56459
Federal Register / Vol. 84, No. 204 / Tuesday, October 22, 2019 / Notices
departments, including six new and 18
continuing awardees from the previous
NOFO. Key program elements were
retained (e.g., provision of screening
services, promotion of healthy lifestyle
behaviors, and linkage to healthy
behavior support services and
community based resources), but a
number of changes were incorporated
into the program at that time. The
current FOA reflects increased emphasis
on three strategies to reduce CVD risk
and support hypertension control and
management, including: (1) Tracking
and monitoring clinical measures, (2)
implementing team-based care, and (3)
linking community resources and
clinical services to support care
coordination, self-management, and
lifestyle change.
CDC seeks to conduct a one-time,
multi-component evaluation to assess
the effectiveness of the program on
individual-, organizational-, and
community-level outcomes. The indepth assessment is designed to
complement the routine progress and
MDE information already being
collected from WISEWOMAN program
recipients. The new data collection will
focus on obtaining qualitative and
quantitative information at the
organizational and community levels
about process and procedures
implemented, and barriers, facilitators,
and other contextual factors that affect
program implementation and
participant outcomes. Data collection
activities will include a Program Survey
with all WISEWOMAN awardee
programs, administered in the second
and fourth program years, and a onetime site visit to each recipient spread
across the three-year data collection
effort. During site visits, semi-structured
interviews will be conducted with
WISEWOMAN staff members and staff
at partner organizations, such as clinical
providers and community-based
resource providers, who are positioned
to provide a variety of perspectives on
program implementation.
OMB approval is requested for three
years. Participation is voluntary and
there are no costs to respondents other
than their time. The estimated annual
burden is 84 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
WISEWOMAN Recipient Administrators ........
Program survey ..............................................
Site Visit Discussion Guide ............................
Innovation Site Visit Discussion Guide ..........
Site Visit Discussion Guide ............................
Innovation Site Visit Discussion Guide ..........
Site Visit Discussion Guide ............................
Innovation Site Visit Discussion Guide ..........
Site Visit Discussion Guide ............................
Innovation Site Visit Discussion Guide ..........
Recipient partners ...........................................
Healthy behavior support staff ........................
Clinical providers .............................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–23018 Filed 10–21–19; 8:45 am]
BILLING CODE 4163–18–P
determination allows FDA to approve
abbreviated new drug applications
(ANDAs) for midodrine hydrochloride
tablets, 2.5 mg, 5 mg, and 10 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6262,
Silver Spring, MD 20993–0002, 301–
796–3601.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4466]
Determination That PROAMATINE
(Midodrine Hydrochloride) Tablets, 2.5
Milligrams, 5 Milligrams, and 10
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that PROAMATINE
(midodrine hydrochloride) tablets, 2.5
milligrams (mg), 5 mg, and 10 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. This
SUMMARY:
VerDate Sep<11>2014
17:02 Oct 21, 2019
Jkt 250001
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
18
8
2
16
2
16
2
16
2
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
Average
burden
per response
(in hours)
1
90/60
45/60
1
45/60
1
45/60
1
45/60
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7)(A) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(7)(A)), which requires
FDA to publish a list of all approved
drugs. FDA publishes this list as part of
the ‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
PROAMATINE (midodrine
hydrochloride) tablets, 2.5 mg, 5 mg,
and 10 mg, is the subject of NDA
019815, held by Shire Development LLC
(Shire), and initially approved on
September 6, 1996, under the
accelerated approval process (see 21
E:\FR\FM\22OCN1.SGM
22OCN1
]]>Agencies
[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Notices]
[Pages 56458-56459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23018]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-20-19AWX]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled WISEWOMAN National Program Evaluation to the
Office of Management and Budget (OMB) for review and approval. CDC
previously published a ``Proposed Data Collection Submitted for Public
Comment and Recommendations'' notice on May 30, 2019 to obtain comments
from the public and affected agencies. CDC did not receive comments
related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
WISEWOMAN National Program Evaluation--New--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The CDC has supported the WISEWOMAN (Well-Integrated Screening and
Evaluation for Women Across the Nation) program since 1995. The
WISEWOMAN program is designed to serve low-income women ages 40-64 who
have elevated risk factors for cardiovascular disease (CVD) and have no
health insurance, or are underinsured for medical and preventive care
services. Through the WISEWOMAN program, women have access to screening
services for selected CVD risk factors such as elevated blood
cholesterol, hypertension, and abnormal blood glucose levels; referrals
to heathy behavior support programs; and referrals to medical care.
WISEWOMAN participants must be co-enrolled in the CDC-sponsored
National Breast and Cervical Cancer Early Detection Program (NBCCEDP).
The WISEWOMAN program is administered through cooperative
agreements with state, territorial, or tribal health departments. Each
WISEWOMAN recipient submits to CDC an annual progress report that
describes program objectives and activities, and semi-annual data
reports (known as minimum data elements, or MDE) on the screening,
assessment, and healthy behavior support services offered to women who
participate in the program. Participant-level MDE are de-identified
prior to transmission to CDC.
In 2018, CDC released the fifth funding opportunity announcement
(FOA) for the WISEWOMAN program (DP18-1816), which resulted in five-
year cooperative agreements with 24 state, territorial, and tribal
health
[[Page 56459]]
departments, including six new and 18 continuing awardees from the
previous NOFO. Key program elements were retained (e.g., provision of
screening services, promotion of healthy lifestyle behaviors, and
linkage to healthy behavior support services and community based
resources), but a number of changes were incorporated into the program
at that time. The current FOA reflects increased emphasis on three
strategies to reduce CVD risk and support hypertension control and
management, including: (1) Tracking and monitoring clinical measures,
(2) implementing team-based care, and (3) linking community resources
and clinical services to support care coordination, self-management,
and lifestyle change.
CDC seeks to conduct a one-time, multi-component evaluation to
assess the effectiveness of the program on individual-, organizational-
, and community-level outcomes. The in-depth assessment is designed to
complement the routine progress and MDE information already being
collected from WISEWOMAN program recipients. The new data collection
will focus on obtaining qualitative and quantitative information at the
organizational and community levels about process and procedures
implemented, and barriers, facilitators, and other contextual factors
that affect program implementation and participant outcomes. Data
collection activities will include a Program Survey with all WISEWOMAN
awardee programs, administered in the second and fourth program years,
and a one-time site visit to each recipient spread across the three-
year data collection effort. During site visits, semi-structured
interviews will be conducted with WISEWOMAN staff members and staff at
partner organizations, such as clinical providers and community-based
resource providers, who are positioned to provide a variety of
perspectives on program implementation.
OMB approval is requested for three years. Participation is
voluntary and there are no costs to respondents other than their time.
The estimated annual burden is 84 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
WISEWOMAN Recipient Administrators. Program survey............. 18 1 1
Site Visit Discussion Guide 8 1 90/60
Innovation Site Visit 2 1 45/60
Discussion Guide.
Recipient partners................. Site Visit Discussion Guide 16 1 1
Innovation Site Visit 2 1 45/60
Discussion Guide.
Healthy behavior support staff..... Site Visit Discussion Guide 16 1 1
Innovation Site Visit 2 1 45/60
Discussion Guide.
Clinical providers................. Site Visit Discussion Guide 16 1 1
Innovation Site Visit 2 1 45/60
Discussion Guide.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-23018 Filed 10-21-19; 8:45 am]
BILLING CODE 4163-18-P
