Agency Information Collection Request; 60-Day Public Comment Request, 6795-6796 [2019-03546]
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Federal Register / Vol. 84, No. 40 / Thursday, February 28, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR Part 112
Disclosure under §§ 112.2, 112.6, 112.31, 112.33, and
112.142 .............................................................................
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1 There
Number of
disclosures
per
respondent
77,165
Total
disclosures
3.459
Average
burden per
disclosure
(in hours)
266,914
Total hours
1.422
379,551
are no capital costs or operating or maintenance costs associated with annual disclosure.
Section 112.7 (21 CFR 112.7) requires
farms eligible for the qualified
exemption in accordance with § 112.5
(21 CFR 112.5) to maintain the records
necessary to demonstrate that the farm
satisfies the criteria for the qualified
exemption, including a written record
reflecting that the owner, operator, or
agent in charge of the farm has
performed an annual review and
verification of the farm’s continued
eligibility for the qualified exemption.
We estimate that 3,285 farms are eligible
for the qualified exemption and that
each farm will spend an average of 0.5
hours per year to maintain one record.
Therefore, 3,285 recordkeepers × 0.5
average hours per recordkeeping =
1,642.5 hours (rounded to 1,643) to meet
the recordkeeping requirements of
§ 112.7.
Section 112.30 (21 CFR 112.30)
requires the maintenance of records of
required training of personnel,
including the date of training, topics
covered, and persons trained. We
estimate that 24,420 farms will maintain
one record of required training and
spend an average of 7.25 hours per year
on recordkeeping. Therefore, 24,420
recordkeepers × 7.25 average hours per
recordkeeping = 177,045 hours to meet
the recordkeeping requirements of
§ 112.30.
Section 112.46 (21 CFR 112.46)
requires testing agricultural water
subject to the requirements of §§ 112.44
and 112.45 (21 CFR 112.44 and 112.45).
We estimate that 48,361 farms that will
conduct these tests. Thus, it is estimated
that about three (2.990) records for each
farm will spend an average of 0.825
hours per record on testing water.
Therefore, 48,361 farms × 2.990 records
× 0.825 average hours per recordkeeping
= 119,294.175 hours (rounded to
119,294) to meet the recordkeeping
requirements of §§ 112.44 and 112.45.
For records related to agricultural
water, FDA estimates that there are
160,605 recordkeepers each maintaining
just over 2 records (2.242), with each
recordkeeping taking just over 2 hours
(2.160). Therefore, 160,605
recordkeepers × 2.242 records × 2.160
hours = 777,765.046 hours (rounded to
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17:52 Feb 27, 2019
Jkt 247001
777,765) for the recordkeeping burden
related to agricultural water.
Sections 112.144, 112.145, and
112.147 (21 CFR 112.144, 112.145, and
112. 147) require testing for sprouts. We
estimate that 256 recordkeepers will
conduct these tests. Thus, it is estimated
that about 245 (245.660) records for
each recordkeeper will spend an average
of 0.403 hour per record on testing
sprouts. Therefore, 256 recordkeepers ×
245.660 records × 0.403 average hours
per recordkeeping = 25,344.251 hours
(rounded to 25,344) to meet the
recordkeeping requirements of
§§ 112.144, 112.145, and 112.147.
We estimate that there are 1,023
recordkeepers for other records related
to sprouts. Thus, it is estimated that
about 62 (62.061) records for each
recordkeepers will spend an average of
0.174 hour per record. Therefore, 1,023
recordkeepers × 62.061 records × 0.174
average hour per recordkeeping =
11,046.982 (rounded to 11,047) hours
for the burden to maintain records
related to sprouts.
We estimate 1,023 recordkeepers will
utilize the recommendations in the
Sprouts draft guidance, once finalized,
to maintain additional records related to
sprouts. We estimate each
recordkeeping will take about an hour
for a recordkeeping burden of 1,023
hours.
Section 112.2 relates to
documentation supporting compliance.
We estimate that there are 4,568
recordkeepers each maintaining a record
of compliance. We estimate that each
recordkeeper will spend 0.079 hour
maintaining their record. Therefore,
4,568 recordkeepers × 0.079 hour =
360.872 (rounded to 361) hours for the
burden to maintain documentation
supporting compliance.
Sections 112.2, 112.6, 112.31, 112.33,
and 112.142 (21 CFR 112.2, 112.6,
112.31, 112.33, and 112.142) require
third-party disclosures. We estimate that
77,165 respondents are making these
disclosures. Thus, it is estimated that
each respondent has around three
(3.459) disclosures and will spend an
average of 1.422 hours per disclosure.
Therefore, 77,165 respondents × 3.459
disclosures × 1.422 average hours per
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Fmt 4703
Sfmt 4703
disclosure = 379,551.331 hours
(rounded to 379,551) for the third-party
disclosure burden to meet the
requirements of §§ 112.2, 112.6, 112.31,
112.33, and 112.142.
The burden estimate reflects
adjustments resulting in an overall
decrease of 19,847 hours. We have
removed one-time burden that has been
realized since establishing the
regulations; however, we have added
burden we attribute to our estimate of
recordkeepers following the
recommendations in the Sprouts draft
guidance.
Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–03507 Filed 2–27–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0407]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before April 29, 2019.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0407–
60D, and project title for reference, to
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
SUMMARY:
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6796
Federal Register / Vol. 84, No. 40 / Thursday, February 28, 2019 / Notices
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: Think Cultural
Health (TCH) website Quality
Improvement Effort—OMB No. 0990–
0407—Revision—HHS/OS/OMH.
Abstract: The Office of Minority
Health (OMH), Office of the Secretary
(OS), Department of Health and Human
Services (HHS) is requesting approval
by OMB on a revision to a previously
approved data collection. The Think
Cultural Health (TCH) website is an
initiative of the HHS OMH’s Center for
Linguistic and Cultural Competence in
Health Care (CLCCHC), and is a
repository of the latest resources and
tools to promote cultural and linguistic
competency in health and health care.
The TCH website is unlike other
government websites in that its suite of
e-learning programs affords health and
health care professionals the ability to
earn continuing education credits
through training in cultural and
linguistic competency. The revision to
this information collection request
includes the online website registration
form, course/unit evaluations specific to
the resource or e-learning program
course/unit completed, follow up
surveys, focus groups, and key
informant interviews.
Need and Proposed Use of the
Information: The data will be used to
ensure that the offerings on the TCH
website are relevant, useful, and
appropriate to their target audiences.
The findings from the data collection
will be of interest to HHS OMH in
supporting maintenance and revisions
of the offerings on the TCH website.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number
responses per
respondent
Average
burden per
response
(hours)
Total burden
(hours)
Type of respondent
Registration Form ..........
Course/unit Evaluation
Form.
Follow-Up Survey ..........
Follow-Up Survey ..........
Focus Groups ................
Key Informant Interviews
Key Informant Interviews
Health and Health Care Professionals ................
Health and Health Care Professionals ................
9,460
9,460
1.00
1.00
3/60
5/60
473
788
Health and Health Care Professionals ................
Community Health Workers ................................
Health and Health Care Professionals ................
Health and Health Care Professionals ................
Community Health Workers ................................
4,208
6
15
13
25
1.00
2.00
1.00
1.00
1.00
10/60
10/60
120/60
60/60
60/60
701
2
29
13
25
Total ........................
..............................................................................
23,187
........................
........................
2,031
Terry Clark,
Asst Paperwork Reduction Act Reports
Clearance Officer, Office of the Secretary.
FOR FURTHER INFORMATION CONTACT:
RADM Francis Frazier, Director, Office
of Public Health Support, IHS, 5600
Fishers Lane, Mail Stop: 09E10D,
Rockville, Maryland 20857. Telephone
number: 301–443–0222 (This is not a
toll-free number), email address:
IHSStrategicPlan@ihs.gov. In addition,
progress on the IHS Strategic Plan will
be periodically updated on the IHS
website at: https://www.ihs.gov/
strategicplan/.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–03546 Filed 2–27–19; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Indian Health Service Strategic Plan
Fiscal Year 2019–2023
General Information
Indian Health Service, IHS.
ACTION: Notice.
AGENCY:
In follow-up to the Indian
Health Service (IHS) request for
comments on the Draft IHS Strategic
Plan Fiscal Year (FY) 2018–2022 issued
in the Federal Register (FR) on July 24,
2018, (see 83 FR 35012; July 24, 2018;
hereafter ‘‘July 2018 FR document’’), the
IHS is announcing the final plan
entitled: IHS Strategic Plan FY 2019–
2023. The IHS is also making available
on the IHS Strategic Plan website, a
response to comments document that
addresses comments received on the
Draft IHS Strategic Plan from the July
2018 FR document.
SUMMARY:
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Number of
respondent
Form name
VerDate Sep<11>2014
17:52 Feb 27, 2019
Jkt 247001
The IHS, an agency within the U.S.
Department of Health and Human
Services (HHS), is responsible for
providing federal health services to
American Indians and Alaska Natives.
The provision of health services to
members of federally-recognized Tribes
grew out of the special government-togovernment relationship between the
federal government and Indian Tribes.
Established in 1787, this relationship is
based on Article I, Section 8 of the U.S.
Constitution and has been given form
and substance by numerous treaties,
laws, Supreme Court decisions, and
Executive Orders. The IHS is the
principal federal health care provider
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Fmt 4703
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and health care advocate for Indian
people. The IHS provides a
comprehensive health service delivery
system for American Indians and Alaska
Natives.
The IHS Strategic Plan, covering FY
2019–2023, includes a mission
statement, a vision statement, and
details on how the IHS will achieve its
mission through three strategic goals: (1)
To ensure that comprehensive,
culturally appropriate personal and
public health services are available and
accessible to American Indian and
Alaska Native people; (2) To promote
excellence and quality through
innovation of the Indian health system
into an optimally performing
organization; and (3) To strengthen IHS
program management and operations.
These strategic goals are supported by
objectives that reflect the outcomes the
IHS is working to achieve and strategies
describe how the IHS plans to make
progress toward the objectives.
Background
The IHS Strategic Plan reflects the
feedback received from Tribes, Tribal
organizations, urban Indian
organizations, staff, and other
stakeholders. The IHS used a process
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]]>Agencies
[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Notices]
[Pages 6795-6796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03546]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0407]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before April 29,
2019.
ADDRESSES: Submit your comments to Sherrette.Funn@hhs.gov or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0407-60D, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call 202-795-7714.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any
[[Page 6796]]
other aspect of this collection of information, including any of the
following subjects: (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.
Title of the Collection: Think Cultural Health (TCH) website
Quality Improvement Effort--OMB No. 0990-0407--Revision--HHS/OS/OMH.
Abstract: The Office of Minority Health (OMH), Office of the
Secretary (OS), Department of Health and Human Services (HHS) is
requesting approval by OMB on a revision to a previously approved data
collection. The Think Cultural Health (TCH) website is an initiative of
the HHS OMH's Center for Linguistic and Cultural Competence in Health
Care (CLCCHC), and is a repository of the latest resources and tools to
promote cultural and linguistic competency in health and health care.
The TCH website is unlike other government websites in that its suite
of e-learning programs affords health and health care professionals the
ability to earn continuing education credits through training in
cultural and linguistic competency. The revision to this information
collection request includes the online website registration form,
course/unit evaluations specific to the resource or e-learning program
course/unit completed, follow up surveys, focus groups, and key
informant interviews.
Need and Proposed Use of the Information: The data will be used to
ensure that the offerings on the TCH website are relevant, useful, and
appropriate to their target audiences. The findings from the data
collection will be of interest to HHS OMH in supporting maintenance and
revisions of the offerings on the TCH website.
Total Estimated Annualized Burden--Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number Average burden
Form name Type of respondent Number of responses per per response Total burden
respondent respondent (hours) (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration Form.............................. Health and Health Care Professionals... 9,460 1.00 3/60 473
Course/unit Evaluation Form.................... Health and Health Care Professionals... 9,460 1.00 5/60 788
Follow-Up Survey............................... Health and Health Care Professionals... 4,208 1.00 10/60 701
Follow-Up Survey............................... Community Health Workers............... 6 2.00 10/60 2
Focus Groups................................... Health and Health Care Professionals... 15 1.00 120/60 29
Key Informant Interviews....................... Health and Health Care Professionals... 13 1.00 60/60 13
Key Informant Interviews....................... Community Health Workers............... 25 1.00 60/60 25
---------------------------------------------------------------
Total...................................... ....................................... 23,187 .............. .............. 2,031
--------------------------------------------------------------------------------------------------------------------------------------------------------
Terry Clark,
Asst Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2019-03546 Filed 2-27-19; 8:45 am]
BILLING CODE 4150-29-P
