Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Patient Survey, OMB No. 0915-0368-Reinstatement, 65988-65989 [2019-26027]
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65988
Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices
Pediatric Uses of Devices; Requirement
for Submission of Information on
Pediatric Subpopulations That Suffer
From a Disease or Condition That a
Device Is Intended To Treat, Diagnose,
or Cure Under Section 515A of the
Federal Food, Drug, and Cosmetic
Act—21 CFR 814
OMB Control Number 0910–0748—
Extension
Section 515A(a) of the Food, Drug,
and Cosmetic Act (21 U.S.C. 360e–1)
(FD&C Act) requires applicants who
submit certain medical device
applications to include readily available
information providing a description of
any pediatric subpopulations that suffer
from the disease or condition that the
device is intended to treat, diagnose, or
cure, and the number of affected
pediatric patients. The information
submitted will allow FDA to track the
number of approved devices for which
there is a pediatric subpopulation that
suffers from the disease or condition
that the device is intended to treat,
diagnose, or cure and the review time
for each such device application.
These requirements apply to
applicants who submit humanitarian
device exemption requests (HDEs),
premarket approval applications (PMAs)
or PMA amendments or supplements, or
a product development protocol (PDP).
FDA expects to receive approximately
47 original PMA/PDP/HDE applications
each year, 1 of which FDA expects to be
HDEs. This estimate is based on the
average of FDA’s receipt of new PMA
applications. The Agency estimates that
11 of the estimated 47 original PMA
submissions will fail to provide the
required pediatric use information and
their sponsors will therefore be required
to submit PMA amendments. The
Agency also expects to receive
approximately 928 supplements that
will include the pediatric use
information required by section 515A(a)
of the FD&C Act and part 814 (21 CFR
part 814).
All that is required is to gather,
organize, and submit information that is
readily available, using any approach
that meets the requirements of section
515A(a) of the FD&C Act and part 814.
We believe that because the applicant is
required to organize and submit only
readily available information, no more
than 8 hours will be required to comply.
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Pediatric information in an original PMA or PDP—
814.20(b)(13) ....................................................................
Pediatric information in a PMA amendment—814.37(b)(2)
Pediatric
information
in
a
PMA
supplement—
814.39(c)(2)(i) ...................................................................
Pediatric information in an HDE—814.104(b)(6) .................
Pediatric information for uses outside approved indication
11
5
1
1
11
5
8
8
88
40
928
1
800
1
1
1
928
1
800
2
8
.5
1,856
8
400
Total ..............................................................................
........................
........................
........................
........................
2,392
1 There
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
Furthermore, because supplements may
include readily available information on
pediatric populations by referencing a
previous submission, FDA estimates the
average time to obtain and submit the
required information is a supplement to
be 2 hours. FDA estimates that the total
estimated burden is 2,392 hours.
Additionally, the guidance document
entitled ‘‘Providing Information About
Pediatric Uses of Medical Devices—
Guidance for Industry and Food and
Drug Administration Staff’’ describes
how to compile and submit the readily
available pediatric use information
required under section 515A(a) of the
FD&C Act. Respondents are permitted to
submit information relating to uses of
the device outside the approved or
proposed indication if such uses are
described or acknowledged in
acceptable sources of readily available
information. We estimate that 20
percent of respondents submitting
information required by section 515A(a)
of the FD&C Act will choose to submit
this information and that it will take 30
minutes for them to do so.
FDA estimates the burden of this
collection of information as follows:
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden and
corresponding responses reflect the
requirements under section 515A(a) of
the FD&C Act, in addition to the
submission of data related to pediatric
uses outside an approved indication, as
described in the guidance document
entitled ‘‘Providing Information About
Pediatric Uses of Medical Devices—
Guidance for Industry and Food and
Drug Administration Staff.’’ OMB
previously approved the information
collection related to uses outside an
approved indication under OMB control
number 0910–0762. As the information
collection uses the same data and relies
upon the same legal authority as OMB
control number 0910–0748, we have
discontinued OMB control number
0910–0762 and merged the information
collection accordingly. Additionally, we
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17:10 Nov 29, 2019
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have altered the title of the collection to
reflect all collections of pediatric uses.
Our estimated burden for the
information collection reflects an
overall increase of 632 hours and a
corresponding increase of supplements
and of uses outside of approved
indications. We attribute this
adjustment to an increase in the number
of supplements we received over the
last 5 years and merging data from
discontinued OMB control number
0910–0762.
Dated: November 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25980 Filed 11–29–19; 8:45 am]
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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; Health Center Patient Survey,
OMB No. 0915–0368—Reinstatement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with 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
SUMMARY:
E:\FR\FM\02DEN1.SGM
02DEN1
65989
Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices
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 January 2, 2020.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
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.
DATES:
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Center Patient Survey OMB No.
0915–0368—Reinstatement.
Abstract: HRSA supported health
centers (those entities funded under
section 330 of the Public Health Service
(PHS) Act) deliver comprehensive,
affordable, quality primary health care
to over 28 million patients nationwide,
regardless of their ability to pay. Nearly
1,400 health centers operate
approximately 12,000 service delivery
sites in every U.S. state, the District of
Columbia, Puerto Rico, the U.S. Virgin
Islands, and the Pacific Basin. In the
past, HRSA has conducted the Health
Center Patient Survey (HCPS), which
surveys patients of HRSA-funded health
centers. The HCPS collects information
about sociodemographic characteristics,
health conditions, health behaviors,
access to and utilization of health care
services, and satisfaction with health
care received at HRSA-funded health
centers. The reinstatement of the HCPS
will utilize the same modules from the
2014 HCPS (OMB #0915–0368).
Overarching changes will streamline the
questionnaire to minimize burden,
standardize questions with other
national surveys to enable comparative
analyses with particular focus on HHS
and HRSA priority areas (e.g., mental
health and substance use). Survey
results come from in-person, one-on-one
interviews with patients who are
selected as nationally representative of
the Health Center Program patient
population.
A 60-day notice was published in the
Federal Register on July 24, 2019, vol.
84, No. 142; pp. 35683–84. There were
two public comments.
Need and Proposed Use of the
Information: The HCPS is unique
because it focuses on comprehensive,
nationally representative, individual
level data from the perspective of health
center patients. By investigating how
well HRSA-funded health centers meet
health care needs of the medically
underserved and how patients perceive
their quality of care, the HCPS serves as
an empirically based resource to inform
HRSA policy, funding, and planning
decisions.
HRSA updated this Notice to reflect
the following changes since the
publication of the 60-day Notice. The
number of estimated respondents
changed from 9,058 to 9,000. This
change came about because of the
separation of the cognitive testing
package from the national survey
package. Based on completing the
cognitive testing, the estimated overall
burden on survey respondents dropped
from 1.25 hours to 1.00 hour. HRSA
discontinued use of the term ‘‘Grantee’’
when referring to recipients of HRSA
funding; therefore, in its place in the
burden table below, the term ‘‘Grantee
Recruitment’’ has been changed to
‘‘Awardee Recruitment.’’ HRSA added a
Short Blessed Scale to account for the
patient’s time if they are screened for
impairment before or during the survey
administration. HRSA utilized The
Short Blessed Scale for 0.2 percent of
respondents in the 2014 HCPS.
Likely Respondents: Patients at
HRSA-supported health centers.
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
Number of
responses per
respondent
Total
responses
Total burden
hours
Awardee Recruitment ..........................................................
Site Recruitment and Training .............................................
Patient Screening .................................................................
Patient Screening: Short Blessed Scale ..............................
Patient Survey ......................................................................
220
700
13,120
18
9,000
1
1
1
1
1
220
700
13,120
18
9,000
2.00
3.15
0.17
0.05
1.00
440.00
2,205.00
2,230.40
0.90
9,000.00
Total National Study .....................................................
23,058
........................
23,058
........................
13,876.30
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019–26027 Filed 11–29–19; 8:45 am]
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Average
burden per
response
(in hours)
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]]>Agencies
[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Pages 65988-65989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26027]
-----------------------------------------------------------------------
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; Health Center Patient
Survey, OMB No. 0915-0368--Reinstatement
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with 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
[[Page 65989]]
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 January 2,
2020.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to 202-395-5806.
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: Health
Center Patient Survey OMB No. 0915-0368--Reinstatement.
Abstract: HRSA supported health centers (those entities funded
under section 330 of the Public Health Service (PHS) Act) deliver
comprehensive, affordable, quality primary health care to over 28
million patients nationwide, regardless of their ability to pay. Nearly
1,400 health centers operate approximately 12,000 service delivery
sites in every U.S. state, the District of Columbia, Puerto Rico, the
U.S. Virgin Islands, and the Pacific Basin. In the past, HRSA has
conducted the Health Center Patient Survey (HCPS), which surveys
patients of HRSA-funded health centers. The HCPS collects information
about sociodemographic characteristics, health conditions, health
behaviors, access to and utilization of health care services, and
satisfaction with health care received at HRSA-funded health centers.
The reinstatement of the HCPS will utilize the same modules from the
2014 HCPS (OMB #0915-0368). Overarching changes will streamline the
questionnaire to minimize burden, standardize questions with other
national surveys to enable comparative analyses with particular focus
on HHS and HRSA priority areas (e.g., mental health and substance use).
Survey results come from in-person, one-on-one interviews with patients
who are selected as nationally representative of the Health Center
Program patient population.
A 60-day notice was published in the Federal Register on July 24,
2019, vol. 84, No. 142; pp. 35683-84. There were two public comments.
Need and Proposed Use of the Information: The HCPS is unique
because it focuses on comprehensive, nationally representative,
individual level data from the perspective of health center patients.
By investigating how well HRSA-funded health centers meet health care
needs of the medically underserved and how patients perceive their
quality of care, the HCPS serves as an empirically based resource to
inform HRSA policy, funding, and planning decisions.
HRSA updated this Notice to reflect the following changes since the
publication of the 60-day Notice. The number of estimated respondents
changed from 9,058 to 9,000. This change came about because of the
separation of the cognitive testing package from the national survey
package. Based on completing the cognitive testing, the estimated
overall burden on survey respondents dropped from 1.25 hours to 1.00
hour. HRSA discontinued use of the term ``Grantee'' when referring to
recipients of HRSA funding; therefore, in its place in the burden table
below, the term ``Grantee Recruitment'' has been changed to ``Awardee
Recruitment.'' HRSA added a Short Blessed Scale to account for the
patient's time if they are screened for impairment before or during the
survey administration. HRSA utilized The Short Blessed Scale for 0.2
percent of respondents in the 2014 HCPS.
Likely Respondents: Patients at HRSA-supported health centers.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Awardee Recruitment............. 220 1 220 2.00 440.00
Site Recruitment and Training... 700 1 700 3.15 2,205.00
Patient Screening............... 13,120 1 13,120 0.17 2,230.40
Patient Screening: Short Blessed 18 1 18 0.05 0.90
Scale..........................
Patient Survey.................. 9,000 1 9,000 1.00 9,000.00
-------------------------------------------------------------------------------
Total National Study........ 23,058 .............. 23,058 .............. 13,876.30
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-26027 Filed 11-29-19; 8:45 am]
BILLING CODE 4165-15-P
