83_FR_48635 83 FR 48449 - Agency Information Collection Request. 30-Day Public Comment Request

83 FR 48449 - Agency Information Collection Request. 30-Day Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 186 (September 25, 2018)

Page Range48449-48450
FR Document2018-20815

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.

Federal Register, Volume 83 Issue 186 (Tuesday, September 25, 2018)
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48449-48450]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20815]


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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



                                                                         Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices                                           48449

                                               FR 56469, September 18, 2015, or access                    This draft guidance is being issued                following summary of a proposed
                                               the information at: https://www.gpo.gov/                consistent with FDA’s good guidance                   collection for public comment.
                                               fdsys/pkg/FR-2015-09-18/pdf/2015-                       practices regulation (21 CFR 10.115).                 DATES: Comments on the ICR must be
                                               23389.pdf.                                              The draft guidance, when finalized, will              received on or before October 25, 2018.
                                                  Docket: For access to the docket to                  represent the current thinking of FDA
                                               read background documents or the                        on recommendations for requalification                ADDRESSES:   Submit your comments to
                                               electronic and written/paper comments                   of blood donors deferred because of                   OIRA_submission@omb.eop.gov or via
                                               received, go to https://                                reactive test results for antibodies to               facsimile to (202) 395–5806.
                                               www.regulations.gov and insert the                      human T-lymphotropic virus types I                    FOR FURTHER INFORMATION CONTACT:
                                               docket number, found in brackets in the                 and II (anti-HTLV–I/II). It does not                  Sherrette Funn, Sherrette.Funn@hhs.gov
                                               heading of this document, into the                      establish any rights for any person and               or (202) 795–7714. When submitting
                                               ‘‘Search’’ box and follow the prompts                   is not binding on FDA or the public.                  comments or requesting information,
                                               and/or go to the Dockets Management                     You can use an alternative approach if                please include the document identifier
                                               Staff, 5630 Fishers Lane, Rm. 1061,                     it satisfies the requirements of the                  4040–0016–30D and project title for
                                               Rockville, MD 20852.                                    applicable statutes and regulations. This             reference.
                                                  You may submit comments on any                       guidance is not subject to Executive
                                               guidance at any time (see 21 CFR                        Order 12866.                                          SUPPLEMENTARY INFORMATION:      Interested
                                               10.115(g)(5)).                                                                                                persons are invited to send comments
                                                  Submit written requests for single                   II. Paperwork Reduction Act of 1995                   regarding this burden estimate or any
                                               copies of the draft guidance to the Office                 This guidance refers to previously                 other aspect of this collection of
                                               of Communication, Outreach and                          approved collections of information                   information, including any of the
                                               Development, Center for Biologics                       found in FDA regulations. These                       following subjects: (1) The necessity and
                                               Evaluation and Research (CBER), Food                    collections of information are subject to             utility of the proposed information
                                               and Drug Administration, 10903 New                      review by the Office of Management and                collection for the proper performance of
                                               Hampshire Ave., Bldg. 71, Rm. 3128,                     Budget (OMB) under the Paperwork                      the agency’s functions; (2) the accuracy
                                               Silver Spring, MD 20993–0002. Send                      Reduction Act of 1995 (44 U.S.C. 3501–                of the estimated burden; (3) ways to
                                               one self-addressed adhesive label to                    3520). The collections of information in              enhance the quality, utility, and clarity
                                               assist the office in processing your                    21 CFR part 601 and Form FDA 356h                     of the information to be collected; and
                                               requests. The draft guidance may also be                have been approved under OMB control                  (4) the use of automated collection
                                               obtained by mail by calling CBER at 1–                  number 0910–0338, and the collections                 techniques or other forms of information
                                               800–835–4709 or 240–402–8010. See                       of information in 21 CFR parts 610 and                technology to minimize the information
                                               the SUPPLEMENTARY INFORMATION section                   606 have been approved under OMB                      collection burden.
                                               for electronic access to the draft                      control number 0910–0116.                               Title of the Collections:
                                               guidance document.                                                                                            INSTRUCTIONS FOR THE SF–429 Real
                                               FOR FURTHER INFORMATION CONTACT:
                                                                                                       III. Electronic Access
                                                                                                                                                             Property Status Report, SF–429 Real
                                               Gretchen Opper, Center for Biologics                       Persons with access to the internet                Property Status Report (Cover Page),
                                               Evaluation and Research, Food and                       may obtain the draft guidance at either               SF–429–A Real Property Status Report
                                               Drug Administration, 10903 New                          https://www.fda.gov/BiologicsBlood                    ATTACHMENT A (General Reporting),
                                               Hampshire Ave., Bldg. 71, Rm. 7301,                     Vaccines/GuidanceCompliance                           SF–429–B Real Property Status Report
                                               Silver Spring, MD 20993–0002, 240–                      RegulatoryInformation/Guidances/                      ATTACHMENT B (Request to Acquire,
                                               402–7911.                                               default.htm or https://                               Improve or Furnish), and SF–429–C
                                               SUPPLEMENTARY INFORMATION:                              www.regulations.gov.                                  Real Property Status Report
                                               I. Background                                             Dated: September 18, 2018.                          ATTACHMENT C (Disposition or
                                                                                                       Leslie Kux,                                           Encumbrance Request) forms.
                                                  FDA is announcing the availability of
                                                                                                       Associate Commissioner for Policy.                      Type of Collection: Extension.
                                               a draft document entitled
                                                                                                       [FR Doc. 2018–20775 Filed 9–24–18; 8:45 am]             OMB No.: 4040–0016.
                                               ‘‘Recommendations for Requalification
                                               of Blood Donors Deferred Because of                     BILLING CODE 4164–01–P                                  Abstract: INSTRUCTIONS FOR THE
                                               Reactive Test Results for Antibodies to                                                                       SF–429 Real Property Status Report,
                                               Human T-Lymphotropic Virus Types I                                                                            SF–429 Real Property Status Report
                                                                                                       DEPARTMENT OF HEALTH AND
                                               and II (anti-HTLV–I/II); Draft Guidance                                                                       (Cover Page), SF–429–A Real Property
                                                                                                       HUMAN SERVICES
                                               for Industry.’’ The draft guidance                                                                            Status Report ATTACHMENT A
                                               provides blood establishments that                      [Document Identifier: OS–4040–0016]                   (General Reporting), SF–429–B Real
                                               collect Whole Blood and blood                                                                                 Property Status Report ATTACHMENT
                                               components with recommendations for                     Agency Information Collection                         B (Request to Acquire, Improve or
                                               a requalification method under 21 CFR                   Request. 30-Day Public Comment                        Furnish), and SF–429–C Real Property
                                               610.41(b) for deferred donors, based on                 Request                                               Status Report ATTACHMENT C
                                               a determination that their previous                     AGENCY:   Office of the Secretary, HHS.               (Disposition or Encumbrance Request)
                                               reactive test results for anti-HTLV–I/II                ACTION:   Notice.                                     forms are OMB-approved collections
                                               were falsely positive. Blood                                                                                  (4040–0016). These information
                                               establishments are not required to test                 SUMMARY:   In compliance with the                     collections are used by grant awardees
                                               Source Plasma for HLTV I/II (21 CFR                     requirement of the Paperwork                          to report on their grant award . The ICs
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                                               610.40 (a)(2)(ii)). Therefore, this                     Reduction Act of 1995, the Office of the              expire on January 31, 2019. We are
                                               guidance does not apply to the                          Secretary (OS), Department of Health                  requesting a three-year clearance of
                                               collection of Source Plasma.                            and Human Services, is publishing the                 these collections.




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                                               48450                             Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices

                                                                                                                        ESTIMATED ANNUALIZED BURDEN TABLE
                                                                                                                                                                                         Number of                  Average
                                                                                                                                                                       Number of                                                            Total burden
                                                                                                  Forms                                                                                responses per              burden hours
                                                                                                                                                                      respondents                                                              hours
                                                                                                                                                                                         respondent               per response

                                               INSTRUCTIONS FOR THE:
                                                   SF–429 Real Property Status Report .......................................................                               100,000                        1                        0.5           50,000
                                                   SF–429 Real Property Status Report (Cover Page) ................................                                         100,000                        1                          1          100,000
                                                   SF–429–A Real Property Status Report—ATTACHMENT A ..................                                                     100,000                        1                          1          100,000
                                                   SF–429–B Real Property Status Report—ATTACHMENT B (Request to
                                                     Acquire, Improve or Furnish) ................................................................                          100,000                         1                          1         100,000
                                                   SF–429–C Real Property Status Report—ATTACHMENT C (Disposi-
                                                     tion or Encumbrance Request) .............................................................                             100,000                         1                         1          100,000

                                                          Total ...................................................................................................         500,000   ........................   ........................        450,000



                                               Terry Clark,                                                              collection contained in this notice,                             agency, including whether the
                                               Asst. Paperwork Reduction Act Reports                                     especially regarding the estimated                               information will have practical utility;
                                               Clearance Officer, Office of the Secretary.                               public burden and associated response                            (2) Evaluate the accuracy of the agency’s
                                               [FR Doc. 2018–20815 Filed 9–24–18; 8:45 am]                               time to: Office of Management and                                estimate of the burden of the proposed
                                               BILLING CODE 4151–AE–P                                                    Budget, Office of Regulatory Affairs,                            collection of information; (3) Enhance
                                                                                                                         New Executive Office Building, Room                              the quality, utility, and clarity of the
                                                                                                                         10235, Washington, DC 20503,                                     information to be collected; and (4)
                                               DEPARTMENT OF HEALTH AND                                                  Attention: Desk Officer for IHS.                                 Minimize the burden of the collection of
                                               HUMAN SERVICES                                                               Public Comments: The Agency                                   information on those who are to
                                                                                                                         received one comment.                                            respond; including through the use of
                                               Indian Health Service                                                        Comment: The commenter asked for                              appropriate automated collection
                                                                                                                         clarification of the Proof of Residency                          techniques of other forms of information
                                               Request for Public Comment: 30-Day                                        form, to whom it would apply and                                 technology, e.g., permitting electronic
                                               Proposed Information Collection:                                          requested a copy of the data collection                          submission of responses.
                                               Indian Health Service Purchased/                                          instrument and instruction.
                                               Referred Care Proof of Residency                                                                                                             Proposed Collection: Title: 0917–
                                                                                                                            Response: The Proof of Residency                              XXXX, ‘‘Indian Health Service
                                                     Indian Health Service, HHS.
                                               AGENCY:
                                                                                                                         form, IHS–976, is a Federal form                                 Purchased/Referred Care Proof of
                                                                                                                         applicable to only Federal Purchased/                            Residency.’’
                                                     Notice and request for
                                               ACTION:
                                                                                                                         Referred Care (PRC) programs. For
                                               comments.                                                                                                                                    Type of Information Collection
                                                                                                                         Tribes operating under Title I contracts
                                                                                                                                                                                          Request: This is a new information
                                               SUMMARY:    In compliance with the                                        or Title V compacts in accordance with
                                                                                                                                                                                          request for a three year approval of this
                                               Paperwork Reduction Act of 1995, the                                      Indian Self-Determination Education
                                                                                                                                                                                          new information collection, 0917–
                                               Indian Health Service (IHS) is                                            Assistance Act (ISDEAA) the IHS–976 is
                                                                                                                                                                                          XXXX.
                                               submitting to the Office of Management                                    an optional use. Tribes may adopt usage
                                                                                                                         of the form but all OMB text and the                               Forms: Purchase/Referred Care Proof
                                               and Budget (OMB) a request for                                                                                                             of Residency Form.
                                               approval of a new collection of                                           OMB Burden Statement should be
                                                                                                                         removed. The form is developed to                                  OMB Control Number: To be assigned.
                                               information titled, ‘‘Purchased/Referred
                                               Care Proof of Residency’’ (OMB Control                                    document residency within a PRC                                    Need and Use of Information
                                               Number 0917–XXXX). This proposed                                          delivery area. The PRC eligibility                               Collection: The IHS PRC Program needs
                                               information collection project was                                        requires residency documentation and                             this information to certify that the
                                               recently published in the Federal                                         the form will be used during the process                         health care services requested and
                                               Register (83 FR 13764) on March 30,                                       of a PRC eligibility determination. The                          authorized by the IHS have been
                                               2018, and allowed 60 days for public                                      form is included in the IHS Indian                               provided to individuals who are
                                               comment. The IHS received one                                             Health Manual Part 2, Chapter 3,                                 documented to meet the eligibility
                                               comment regarding this collection. The                                    Purchased/Referred Care Manual. On                               requirements to receive medical services
                                               question summary and response is                                          May 23, IHS initiated Tribal                                     from PRC provider(s); and to serve as a
                                               listed in the notice. The purpose of this                                 Consultation per the ISDEAA for the                              legal document for health and medical
                                               notice is to allow 30 days for public                                     manual.                                                          care authorized by IHS and rendered by
                                               comment to be submitted directly to                                                                                                        health care providers under contract
                                                                                                                         SUPPLEMENTARY INFORMATION: The IHS
                                               OMB.                                                                                                                                       with the IHS.
                                                                                                                         Office of Resource Access and
                                                  A copy of the draft supporting                                         Partnerships/Division of Contract Care                              Agency Form Number: ‘‘None’’.
                                               statement is available at                                                 is submitting the proposed information                              Members of Affected Public: Patients.
                                               www.regulations.gov (see Docket ID                                        collection to OMB for review, as                                    Status of the Proposed Information
                                               IHS_FRDOC_0001).                                                          required by the Paperwork Reduction                              Collection: New request.
                                               DATES: October 25, 2018. Your                                             Act of 1995.                                                        Type of Respondents: Individuals.
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                                               comments regarding this information                                          This notice is soliciting comments                               The table below provides: Types of
                                               collection are best assured of having full                                from members of the public and affected                          data collection instruments; estimation
                                               effect if received within 30 days of the                                  agencies concerning the proposed                                 to number of respondents, number of
                                               date of this publication.                                                 collection of information to: (1) Evaluate                       responses per respondent, annual
                                                  Direct Your Comments to OMB: Send                                      whether the proposed collection of                               number of responses, average burden
                                               your comments and suggestions                                             information is necessary for the proper                          hour per response, and total annual
                                               regarding the proposed information                                        performance of the functions of the                              burden hours.


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Document Created: 2018-09-25 00:22:37
Document Modified: 2018-09-25 00:22:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on the ICR must be received on or before October 25, 2018.
ContactSherrette 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.
FR Citation83 FR 48449 

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