Agency Information Collection Request. 30-Day Public Comment Request, 48449-48450 [2018-20815]
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daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Gretchen Opper, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on recommendations for requalification
of blood donors deferred because of
reactive test results for antibodies to
human T-lymphotropic virus types I
and II (anti-HTLV–I/II). It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
I. Background
FDA is announcing the availability of
a draft document entitled
‘‘Recommendations for Requalification
of Blood Donors Deferred Because of
Reactive Test Results for Antibodies to
Human T-Lymphotropic Virus Types I
and II (anti-HTLV–I/II); Draft Guidance
for Industry.’’ The draft guidance
provides blood establishments that
collect Whole Blood and blood
components with recommendations for
a requalification method under 21 CFR
610.41(b) for deferred donors, based on
a determination that their previous
reactive test results for anti-HTLV–I/II
were falsely positive. Blood
establishments are not required to test
Source Plasma for HLTV I/II (21 CFR
610.40 (a)(2)(ii)). Therefore, this
guidance does not apply to the
collection of Source Plasma.
Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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17:40 Sep 24, 2018
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II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 601 and Form FDA 356h
have been approved under OMB control
number 0910–0338, and the collections
of information in 21 CFR parts 610 and
606 have been approved under OMB
control number 0910–0116.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
[FR Doc. 2018–20775 Filed 9–24–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0016]
Agency Information Collection
Request. 30-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
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
48449
following summary of a proposed
collection for public comment.
Comments on the ICR must be
received on or before October 25, 2018.
DATES:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
4040–0016–30D and project title for
reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
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 Collections:
INSTRUCTIONS FOR THE SF–429 Real
Property Status Report, SF–429 Real
Property Status Report (Cover Page),
SF–429–A Real Property Status Report
ATTACHMENT A (General Reporting),
SF–429–B Real Property Status Report
ATTACHMENT B (Request to Acquire,
Improve or Furnish), and SF–429–C
Real Property Status Report
ATTACHMENT C (Disposition or
Encumbrance Request) forms.
Type of Collection: Extension.
OMB No.: 4040–0016.
Abstract: INSTRUCTIONS FOR THE
SF–429 Real Property Status Report,
SF–429 Real Property Status Report
(Cover Page), SF–429–A Real Property
Status Report ATTACHMENT A
(General Reporting), SF–429–B Real
Property Status Report ATTACHMENT
B (Request to Acquire, Improve or
Furnish), and SF–429–C Real Property
Status Report ATTACHMENT C
(Disposition or Encumbrance Request)
forms are OMB-approved collections
(4040–0016). These information
collections are used by grant awardees
to report on their grant award . The ICs
expire on January 31, 2019. We are
requesting a three-year clearance of
these collections.
SUPPLEMENTARY INFORMATION:
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48450
Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
INSTRUCTIONS FOR THE:
SF–429 Real Property Status Report .......................................................
SF–429 Real Property Status Report (Cover Page) ................................
SF–429–A Real Property Status Report—ATTACHMENT A ..................
SF–429–B Real Property Status Report—ATTACHMENT B (Request to
Acquire, Improve or Furnish) ................................................................
SF–429–C Real Property Status Report—ATTACHMENT C (Disposition or Encumbrance Request) .............................................................
Total ...................................................................................................
Terry Clark,
Asst. Paperwork Reduction Act Reports
Clearance Officer, Office of the Secretary.
[FR Doc. 2018–20815 Filed 9–24–18; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30-Day
Proposed Information Collection:
Indian Health Service Purchased/
Referred Care Proof of Residency
Indian Health Service, HHS.
Notice and request for
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) is
submitting to the Office of Management
and Budget (OMB) a request for
approval of a new collection of
information titled, ‘‘Purchased/Referred
Care Proof of Residency’’ (OMB Control
Number 0917–XXXX). This proposed
information collection project was
recently published in the Federal
Register (83 FR 13764) on March 30,
2018, and allowed 60 days for public
comment. The IHS received one
comment regarding this collection. The
question summary and response is
listed in the notice. The purpose of this
notice is to allow 30 days for public
comment to be submitted directly to
OMB.
A copy of the draft supporting
statement is available at
www.regulations.gov (see Docket ID
IHS_FRDOC_0001).
DATES: October 25, 2018. Your
comments regarding this information
collection are best assured of having full
effect if received within 30 days of the
date of this publication.
Direct Your Comments to OMB: Send
your comments and suggestions
regarding the proposed information
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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17:40 Sep 24, 2018
Jkt 244001
Number of
responses per
respondent
Number of
respondents
Forms
Frm 00042
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Sfmt 4703
Total burden
hours
100,000
100,000
100,000
1
1
1
0.5
1
1
50,000
100,000
100,000
100,000
1
1
100,000
100,000
1
1
100,000
500,000
........................
........................
450,000
collection contained in this notice,
especially regarding the estimated
public burden and associated response
time to: Office of Management and
Budget, Office of Regulatory Affairs,
New Executive Office Building, Room
10235, Washington, DC 20503,
Attention: Desk Officer for IHS.
Public Comments: The Agency
received one comment.
Comment: The commenter asked for
clarification of the Proof of Residency
form, to whom it would apply and
requested a copy of the data collection
instrument and instruction.
Response: The Proof of Residency
form, IHS–976, is a Federal form
applicable to only Federal Purchased/
Referred Care (PRC) programs. For
Tribes operating under Title I contracts
or Title V compacts in accordance with
Indian Self-Determination Education
Assistance Act (ISDEAA) the IHS–976 is
an optional use. Tribes may adopt usage
of the form but all OMB text and the
OMB Burden Statement should be
removed. The form is developed to
document residency within a PRC
delivery area. The PRC eligibility
requires residency documentation and
the form will be used during the process
of a PRC eligibility determination. The
form is included in the IHS Indian
Health Manual Part 2, Chapter 3,
Purchased/Referred Care Manual. On
May 23, IHS initiated Tribal
Consultation per the ISDEAA for the
manual.
SUPPLEMENTARY INFORMATION: The IHS
Office of Resource Access and
Partnerships/Division of Contract Care
is submitting the proposed information
collection to OMB for review, as
required by the Paperwork Reduction
Act of 1995.
This notice is soliciting comments
from members of the public and affected
agencies concerning the proposed
collection of information to: (1) Evaluate
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
PO 00000
Average
burden hours
per response
agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the agency’s
estimate of the burden of the proposed
collection of information; (3) Enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Minimize the burden of the collection of
information on those who are to
respond; including through the use of
appropriate automated collection
techniques of other forms of information
technology, e.g., permitting electronic
submission of responses.
Proposed Collection: Title: 0917–
XXXX, ‘‘Indian Health Service
Purchased/Referred Care Proof of
Residency.’’
Type of Information Collection
Request: This is a new information
request for a three year approval of this
new information collection, 0917–
XXXX.
Forms: Purchase/Referred Care Proof
of Residency Form.
OMB Control Number: To be assigned.
Need and Use of Information
Collection: The IHS PRC Program needs
this information to certify that the
health care services requested and
authorized by the IHS have been
provided to individuals who are
documented to meet the eligibility
requirements to receive medical services
from PRC provider(s); and to serve as a
legal document for health and medical
care authorized by IHS and rendered by
health care providers under contract
with the IHS.
Agency Form Number: ‘‘None’’.
Members of Affected Public: Patients.
Status of the Proposed Information
Collection: New request.
Type of Respondents: Individuals.
The table below provides: Types of
data collection instruments; estimation
to number of respondents, number of
responses per respondent, annual
number of responses, average burden
hour per response, and total annual
burden hours.
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[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48449-48450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20815]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-4040-0016]
Agency Information Collection Request. 30-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 October 25,
2018.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 4040-0016-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any 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 Collections: INSTRUCTIONS FOR THE SF-429 Real Property
Status Report, SF-429 Real Property Status Report (Cover Page), SF-429-
A Real Property Status Report ATTACHMENT A (General Reporting), SF-429-
B Real Property Status Report ATTACHMENT B (Request to Acquire, Improve
or Furnish), and SF-429-C Real Property Status Report ATTACHMENT C
(Disposition or Encumbrance Request) forms.
Type of Collection: Extension.
OMB No.: 4040-0016.
Abstract: INSTRUCTIONS FOR THE SF-429 Real Property Status Report,
SF-429 Real Property Status Report (Cover Page), SF-429-A Real Property
Status Report ATTACHMENT A (General Reporting), SF-429-B Real Property
Status Report ATTACHMENT B (Request to Acquire, Improve or Furnish),
and SF-429-C Real Property Status Report ATTACHMENT C (Disposition or
Encumbrance Request) forms are OMB-approved collections (4040-0016).
These information collections are used by grant awardees to report on
their grant award . The ICs expire on January 31, 2019. We are
requesting a three-year clearance of these collections.
[[Page 48450]]
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
INSTRUCTIONS FOR THE:
SF-429 Real Property Status Report.......... 100,000 1 0.5 50,000
SF-429 Real Property Status Report (Cover 100,000 1 1 100,000
Page)......................................
SF-429-A Real Property Status Report-- 100,000 1 1 100,000
ATTACHMENT A...............................
SF-429-B Real Property Status Report-- 100,000 1 1 100,000
ATTACHMENT B (Request to Acquire, Improve
or Furnish)................................
SF-429-C Real Property Status Report-- 100,000 1 1 100,000
ATTACHMENT C (Disposition or Encumbrance
Request)...................................
---------------------------------------------------------------
Total................................... 500,000 .............. .............. 450,000
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Asst. Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2018-20815 Filed 9-24-18; 8:45 am]
BILLING CODE 4151-AE-P
