Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Evaluation of the Maternal and Child Health Bureau's Autism CARES Act Initiative, OMB No. 0915-0335-Revision, 35940-35941 [2020-12730]
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Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device User Fee Cover Sheet,
Form FDA 3601 and Device Facility
User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910–0511—
Revision
The Federal Food, Drug, and Cosmetic
Act, as amended by the Medical Device
User Fee and Modernization Act of 2002
(Pub. L. 107–250), and the Medical
Device User Fee Amendments of 2007
(Title II of the Food and Drug
Administration Amendments Act of
2007), authorizes FDA to collect user
fees for certain medical device
applications. Under this authority,
companies pay a fee for certain new
medical device applications or
supplements submitted to the Agency
for review. Because the submission of
user fees concurrently with applications
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet,’’
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference between the fees
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health and FDA’s Center for Biologics
Evaluation and Research to initiate the
administrative screening of new medical
device applications and supplemental
applications.
We are revising the information
collection to add Form FDA 3601a, the
‘‘Device Facility User Fee Cover Sheet.’’
Owners or operators of places of
business (also called establishments or
facilities) that are involved in the
production and distribution of medical
devices intended for use in the United
States are required to register annually
with FDA, a process known as
establishment registration (21 CFR part
807, subparts A through D). (The
information collection for medical
device establishment registration and
listing is approved under OMB control
number 0910–0625.) All establishments
required to register must pay a user fee.
Form FDA 3601a, the ‘‘Device Facility
User Fee Cover Sheet,’’ is designed to
collect payments for the annual
establishment registration fee for
medical device establishments.
The total number of annual responses
for Form FDA 3601 is based on the
average number of cover sheet
submissions received by FDA in recent
years. The number of received annual
responses includes cover sheets for
applications that were qualified for
small businesses and fee waivers or
reductions. The estimated hours per
response are based on past FDA
experience with the various cover sheet
submissions and range from 5 to 30
minutes. For this analysis, we estimate
18 minutes per coversheet.
The total number of annual responses
for Form FDA 3601a is based on the
average number of cover sheet
submissions received by FDA in recent
years. Based on past FDA experience
with various cover sheet submissions,
we estimate 10 minutes per response.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 2
Number of
respondents
FDA Form No.
Average
burden per
response
Total annual
responses
Total hours
3601 .............................................................................
3601a ...........................................................................
6,182
24,086
1
1
6,182
24,086
0.30 (18 minutes) ..
0.17 (10 minutes) ..
1,855
4,095
Total ......................................................................
........................
........................
30,268
................................
5,950
1
2
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Number of
responses per
respondent
There are no capital costs or operating and maintenance costs associated with this collection of information.
Numbers have been rounded.
Our estimated burden for the
information collection reflects an
overall increase of 4,036 hours and a
corresponding increase of 23,889
responses/records. We attribute these
increases to two factors: we have revised
the burden estimate to include Form
FDA 3601a and we have adjusted the
number of respondents for Form FDA
3601 to reflect our current data.
Dated: June 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Evaluation of
the Maternal and Child Health Bureau’s
Autism CARES Act Initiative, OMB No.
0915–0335—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
PO 00000
Frm 00045
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ACTION:
Notice.
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.
SUMMARY:
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35941
Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
Comments on this ICR must be
received no later than July 13, 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
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Evaluation of the Maternal and Child
Health Bureau’s Autism CARES Act
Initiative, OMB No. 0915–0335–
Revision.
Abstract: In response to the growing
need for research and resources devoted
to autism spectrum disorder and other
developmental disabilities, the U.S.
Congress passed the Combating Autism
Act of 2006 (Pub. L. 109–416); it was
reauthorized by the Combating Autism
Reauthorization Act of 2011 (Pub. L.
112–32), the Autism Collaboration,
DATES:
Accountability, Research, Education,
and Support (Autism CARES) Act of
2014 (Pub. L. 113–157) and the Autism
CARES Act of 2019 (Pub. L. 116–60).
Through these Autism CARES public
laws, HRSA has been tasked with
increasing awareness of autism
spectrum disorder and developmental
disabilities, reducing barriers to
screening and diagnosis, promoting
evidence-based interventions, and
training healthcare professionals in the
use of valid and reliable diagnostic
tools.
Need and Proposed Use of the
Information: The purpose of this
information collection is to design and
implement an impact evaluation to
assess the effectiveness of HRSA’s
Maternal and Child Health Bureau’s
activities in meeting the goals and
objectives of the Autism CARES Act.
This ICR is a revision to an existing
package; this study is the fourth
evaluation of HRSA’s autism activities
and employs similar data collection
methodologies as the prior studies.
Grantee interviews remain the primary
form of data collection. Minor proposed
revisions to the data collection process
include (1) modifications to the
interview questions based on the
current legislation and HRSA’s Notices
of Funding Opportunity and (2) the
creation of a new Grantee Survey to
collect common data elements across
the three program areas that focus on
training, research, and state systems.
Likely Respondents: Grantees funded
by HRSA’s Autism programs will be the
respondents for this data collection
activity. The grantees are from the
following HRSA programs: Leadership
Education in Neurodevelopmental and
Related Disabilities Training Program;
Developmental Behavioral Pediatrics
Training Program; State Innovation in
Care Integration Program; State
Innovation in Care Coordination
Program; Research Network Program;
Research Program; Interdisciplinary
Technical Assistance Center; and the
State Public Health Autism Center
Resource Center.
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
jbell on DSKJLSW7X2PROD with NOTICES
Average
number of
responses per
respondent
Number of
respondents
Grant Program/form name
Average
hours per
response
Total
responses
Total hour
burden
Grantee Survey (Training and Research Grantees) ...........
Grantee Survey (State Systems Grantees) .........................
Training Interview Guide ......................................................
State Systems Interview Guide ...........................................
Research Interview Guide ...................................................
Research Quantitative Data Collection Form ......................
Interdisciplinary Technical Assistance Center Interview
Guide ................................................................................
State Public Health Autism Center Interview Guide ............
80
5
64
5
24
6
3
3
1.5
1.5
1.5
1
240
15
96
7.5
36
6
0.5
........................
1.25
1.25
1
1
120
7.5
120
9.375
36
6
1
1
2
2
2
2
1
1
2
2
Total ..............................................................................
186
........................
404.5
........................
302.9
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
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technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
National Institutes of Health
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Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35940-35941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: Evaluation
of the Maternal and Child Health Bureau's Autism CARES Act Initiative,
OMB No. 0915-0335--Revision
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.
[[Page 35941]]
DATES: Comments on this ICR must be received no later than July 13,
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: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Evaluation of the Maternal
and Child Health Bureau's Autism CARES Act Initiative, OMB No. 0915-
0335-Revision.
Abstract: In response to the growing need for research and
resources devoted to autism spectrum disorder and other developmental
disabilities, the U.S. Congress passed the Combating Autism Act of 2006
(Pub. L. 109-416); it was reauthorized by the Combating Autism
Reauthorization Act of 2011 (Pub. L. 112-32), the Autism Collaboration,
Accountability, Research, Education, and Support (Autism CARES) Act of
2014 (Pub. L. 113-157) and the Autism CARES Act of 2019 (Pub. L. 116-
60). Through these Autism CARES public laws, HRSA has been tasked with
increasing awareness of autism spectrum disorder and developmental
disabilities, reducing barriers to screening and diagnosis, promoting
evidence-based interventions, and training healthcare professionals in
the use of valid and reliable diagnostic tools.
Need and Proposed Use of the Information: The purpose of this
information collection is to design and implement an impact evaluation
to assess the effectiveness of HRSA's Maternal and Child Health
Bureau's activities in meeting the goals and objectives of the Autism
CARES Act. This ICR is a revision to an existing package; this study is
the fourth evaluation of HRSA's autism activities and employs similar
data collection methodologies as the prior studies. Grantee interviews
remain the primary form of data collection. Minor proposed revisions to
the data collection process include (1) modifications to the interview
questions based on the current legislation and HRSA's Notices of
Funding Opportunity and (2) the creation of a new Grantee Survey to
collect common data elements across the three program areas that focus
on training, research, and state systems.
Likely Respondents: Grantees funded by HRSA's Autism programs will
be the respondents for this data collection activity. The grantees are
from the following HRSA programs: Leadership Education in
Neurodevelopmental and Related Disabilities Training Program;
Developmental Behavioral Pediatrics Training Program; State Innovation
in Care Integration Program; State Innovation in Care Coordination
Program; Research Network Program; Research Program; Interdisciplinary
Technical Assistance Center; and the State Public Health Autism Center
Resource Center.
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
----------------------------------------------------------------------------------------------------------------
Average
Number of number of Total Average hours Total hour
Grant Program/form name respondents responses per responses per response burden
respondent
----------------------------------------------------------------------------------------------------------------
Grantee Survey (Training and 80 3 240 0.5 120
Research Grantees).............
Grantee Survey (State Systems 5 3 15 .............. 7.5
Grantees)......................
Training Interview Guide........ 64 1.5 96 1.25 120
State Systems Interview Guide... 5 1.5 7.5 1.25 9.375
Research Interview Guide........ 24 1.5 36 1 36
Research Quantitative Data 6 1 6 1 6
Collection Form................
Interdisciplinary Technical 1 2 2 1 2
Assistance Center Interview
Guide..........................
State Public Health Autism 1 2 2 1 2
Center Interview Guide.........
-------------------------------------------------------------------------------
Total....................... 186 .............. 404.5 .............. 302.9
----------------------------------------------------------------------------------------------------------------
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. 2020-12730 Filed 6-11-20; 8:45 am]
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